Search

Purpose: To assess the effectiveness and safety of topical vancomycin powder (VP) in preventing surgical site infections (SSIs) in spinal deformity surgeries. Methods: A literature search was conducted on Web of Science, PubMed, and Cochrane Library databases for comparative studies of VP in spinal deformity surgeries published before February 2024. Two reviewers independently screened eligible articles based on the inclusion and exclusion criteria, assessed study quality, and extracted data. Data analysis was performed using Review Manager 5.4 software. Results: Of all 143 papers screened, a meta-analysis was conducted on 10 articles, which included a total of 8,166 surgeries. The results of the meta-analysis indicated that the incidence of deep SSI in VP group was 0.28 times that in non-VP group (p < 0.001). In the subgroup analysis, VP treatment significantly reduced the risk of deep SSI in both adult spinal deformity (ASD) (RR 0.40, 95% CI 0.21–0.77, p = 0.006) and pediatric scoliosis (PS) (RR 0.25, 95% CI 0.16–0.38, p < 0.001) surgeries. However, this effect was not observed in neuromuscular scoliosis (NMS) patients (RR 0.66, 95% CI 0.26–1.66, p = 0.38). Bacterial culture results indicated that VP treatment significantly reduced polymicrobial infections (p = 0.007) and gram-positive infections (p = 0.001). Conclusion: From the literature available at present, VP was associated with reduced deep SSIs rates in spinal deformity patients. However, particular attention should be paid to the lack of the effectiveness of VP in NMS patients. The current literature did not report local cytotoxicity or renal toxicity related to VP in spinal deformity patients. [ABSTRACT FROM AUTHOR]

Background: The expanding roles and popularity of glucagon-like peptide-1 (GLP-1) and GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists has created access barriers to medication use. We sought to describe an adverse drug event which occurred after reinitiation of a GLP-1 receptor agonist following a prolonged lapse in therapy due to poor medication access. Case Summary : Once-weekly injectable semaglutide was prescribed to an outpatient 33-year-old male for chronic weight management. After a delayed initiation due to global shortage, semaglutide was initiated and titrated over five months before a seven week lapse in therapy due to prior authorization interruption. Despite the extended treatment gap, the patient was directed to reinitiate semaglutide at the target dose rather than starting dose, which was followed by recurrent, symptomatic nausea and vomiting requiring medical intervention. Practice Implications: A prolonged lapse in GLP-1 receptor agonist therapy, typically defined as missing three or more doses of a once-weekly injectable, warrants consideration of reinitiation at a reduced dose, personalized to the patient's prior gastrointestinal tolerability, efficacy goals, and therapy lapse duration. Therapy lapses with GLP-1 receptor agonists may be prevented by utilizing a multi-modal approach including extended dosing intervals, intermediate doses, agent interchange, efficient prior authorization communication, and cautious initiation of GLP-1 recent agonists while supply cannot meet demand. [ABSTRACT FROM AUTHOR]

Context: Traditional Chinese medicines (TCMs) have emerged as potential adjuvant therapies to treat non-small cell lung cancer. More direct comparative studies must be conducted among various oral TCMs. Objective: This network meta-analysis evaluates the efficacy and safety of seven oral tcMs combined with chemotherapy in treating NSCLC. Methods: The analysis included Zilongjin, Banmao, hongdoushan, huachansu, Kanglaite, Xihuang, and Pingxiao TCMs. Randomized-controlled trials (RCTs) were identified from the following databases: china National infrastructure, Wanfang, PubMed, embase, and the cochrane library up to april 2023. Two researchers independently extracted data. Results: Sixty-eight RCTs (5,099 patients) were included. Compared to chemotherapy, Banmao capsules [odds ratio (OR) = 2.69, 95% confidence interval (CI) 1.96-3.69)] and huachansu tablets [OR = 2.35, 95%CI (1.81, 3.05)] ranked in the top two in terms of increasing disease control rate. The two main TCMs to improve the objective response rate were Banmao capsules [OR = 3.49, 95%CI (2.17, 5.60)] and Zilongjin tablets [OR = 2.62, 95%CI (1.92, 3.57)]. Zilongjin tablets [OR = 3.47, 95%ci (2.14, 5.63)] and huachansu tablets [OR = 3.30, 95%ci (1.65, 6.60)] were ranked as the top two in improving Karnofsky performance status. Hongdoushan capsules (SUCRA = 18.8%) and Banmao capsules (SUCRA = 19.8%) were the top two in reducing gastrointestinal toxicity. Zilongjin tablets (SUCRA = 18.9%) and Banmao capsules (SUCRA = 26.6%) were the top two to reduce liver and kidney toxicity. Hongdoushan capsules (SUCRA = 15.7%) and huachansu tablets (SUCRA = 16.8%) ranked the top two in reducing thrombocytopenia. Banmao capsules (SUCRA = 14.3%) and Zilongjin tablets (SUCRA = 26.3%) were the top two decreasing leukopenia. Conclusions: combining oral TCMs with platinum-based chemotherapy has shown superior efficacy compared to platinum-based chemotherapy alone in treating NSCLC. [ABSTRACT FROM AUTHOR]

Background: To compare the effectiveness, cost, and safety of four regimens recommended by the World Health Organization (WHO) for rifampicin resistance/multidrug-resistance tuberculosis (RR/MDR-TB) Treatment in Eastern China. Methods: We performed a cohort study among patients with RR/MDR between 2020 and 2022 in Jiangsu Province. The treatment success rate, cost, and drug adverse reaction rate were compared. Results: Between 2020 and 2022, 253 RR/MDR-TB patients were enrolled in the study. 37 (14.62%), 76 (30.04%), 74 (29.25%), and 66 (26.09%) patients had the short-term regimens, the new long-term oral regimens, the new long-term injectable regimens, and the traditional long-term regimens, respectively. The treatment success rate was the highest among patients treated with the short-term regimen (75.68%) and was the lowest among patients treated with the traditional long-term regimens (60.61%). The estimated mean cost per favorable outcome was 142.61 thousand Chinese Yuan (CNY), and the short-term regimens showed the lowest cost in the four regimes (88.51 thousand CNY vs. 174.24 thousand CNY, 144.00 thousand CNY, and 134.98 thousand CNY). Incremental cost-effectiveness ratios of the short-term regimens, the new long-term oral regimen, and the new long-term injectable regimens were -3083.04, 6040.09, and 819.68 CNY compared to the traditional long-term regimens. Conclusions: For RR/MDR-TB patients in China who meet the criteria for short-term regimens, the short-term regimens were proven to be the most cost-effective of the four regimens recommended by WHO. For RR/MDR-TB patients in China who don't meet the criteria for short-term regimens, the new long-term injectable regimens are more cost-effective than the remaining two regimens. [ABSTRACT FROM AUTHOR]

AbstractDrug-induced photosensitivity is a potential adverse event of many drugs and chemicals used across a wide range of specialties in clinical medicine. In the present study, we investigated the feasibility of predicting the photosensitising effects of drugs and chemical compounds via state-of-the-art artificial intelligence-based workflows. A dataset of 2200 drugs was used to train three distinct models (logistic regression, XGBoost and a deep learning model (Chemprop)) to predict photosensitising attributes. Labels were obtained from a list of previously published photosensitisers by string matching and manual validation. External evaluation of the different models was performed using the tox21 dataset. ROC-AUC ranged between 0.8939 (Chemprop) and 0.9525 (XGBoost) during training, while in the test partition it ranged between 0.7785 (Chemprop) and 0.7927 (XGBoost). Analysis of the top 200 compounds of each model resulted in 55 overlapping molecules in the external validation set. Prediction scores in fluoroquinolones within this subset corresponded well with culprit substructures such as fluorinated aryl halides suspected of mediating photosensitising effects. All three models appeared capable of predicting photosensitising effects of chemical compounds. However, compared to the simpler model, the complex models appeared to be more confident in their predictions as exhibited by their distribution of prediction scores. [ABSTRACT FROM AUTHOR]

Introduction: DNA methylation inhibitors (azacitidine, decitabine) have revolutionized the treatment dilemma of myelodysplastic syndromes (MDS), a group of malignant hematopoietic disorders. This study evaluates the adverse drug reactions (ADRs) following the use of DNA methylation inhibitors in the World Health Organization (WHO) VigiAccess database and compares the characteristics of ADRs between the two drugs to select the drug with the minimum individualized risk for patients. Methods: This study employed a retrospective descriptive analysis method. We compiled ADR reports for two marketed DNA methylation inhibitors for the treatment of MDS from WHO-VigiAccess. Data collected included demographic data such as age groups, gender, and regions of global patients covered by ADR reports, as well as data on the disease systems and symptoms caused by ADRs recorded in the annual reports and reports received by WHO. By calculating the proportion of ADRs reported for each drug, we compared the similarities and differences in ADRs between the two drugs. Results: Overall, 23,763 adverse events (AEs) related to the two DNA methylation inhibitors were reported in VigiAccess. The results showed that the top 10 most common AEs were febrile neutropenia, bone marrow suppression, neutropenia, anemia, pancytopenia, leukopenia, thrombocytopenia, bone marrow failure, agranulocytosis, and hematotoxicity. The top five common types of DNA methylation inhibitor AEs were blood and lymphatic system disorders (11,178 cases, 47.0%), cardiac organ diseases (1,488 cases, 6.3%), various congenital familial genetic diseases (49 cases, 0.2%), ear and labyrinth diseases (100, 4.2%), and endocrine system diseases (57, 2.4%). Conclusion: There is no Strong correlation between DNA methylation inhibitors and ADRs. Current comparative observational studies of these inhibitors show that there are common and specific adverse reactions in the ADR reports received by WHO for these drugs. Clinicians should improve the rational use of these drugs based on the characteristics of ADRs. [ABSTRACT FROM AUTHOR]

Intravenous zoledronic acid is an established and generally well tolerated form of antiresorptive therapy for osteoporosis. Although mild arthralgias are a well-documented manifestation of the acute phase response to intravenous bisphosphonates, more severe musculoskeletal reactions manifesting as debilitating pain and joint effusions have been rarely documented in the current literature. In this case report, we discuss the case of a 55-year-old woman who developed severe painful bilateral knee effusions within 1 week of her first zoledronic acid infusion for osteoporosis. Prescribing physicians and patients should be made aware of this uncommon but important adverse effect to zoledronic acid. [ABSTRACT FROM AUTHOR]

Background: A new intervention called high-intensity focused ultrasound (HIFU) targets fibroids with high-intensity ultrasound pulses using ultrasound probes. This noninvasive method, which can be carried out with either magnetic resonance imaging or ultrasound guidance, results in immediate coagulated necrosis within a clearly defined area a few millimeters in diameter. Methods: This systematic review evaluated the safety of HIFU in the treatment of uterine fibroids regardless of site or size. We specifically aimed to determine the incidence of side effects that can occur during and after HIFU. We searched the PubMed, Scopus, ScienceDirect, and Mendeley archive using only the terms HIFU and fibroid. After identifying 1077 studies of different types from 2014 to March 2024, 300 studies were screened and 60 included. Results: According to Society of Interventional Radiology guidelines, class A adverse events (AEs) showed no significant results, and individuals with these AEs required no treatment and had no long-term consequences. Similarly, there were no class B significant results. However, 3943 of 10,204 patients (38%) complained of lower abdominal pain after the procedure, a class B AE, which resolved by analgesics. Further, 153 of 24,700 patients (0.6%) had skin burns, blisters, or nodules, and these issues resolved with conservative treatment. Additionally, 74 of 23,741 patients (0.3%) had hematuria; 882 of 5970 patients (14.7%) had abnormal vaginal discharge; 414 of 23,449 (1.7%) had vaginal bleeding; and 267 of 7598 (3.5%) had leg paresthesia. Major AEs (class C and D) were almost nonexistent, and the incidence of death in our study was zero. Conclusion: HIFU ablation of uterine fibroids is generally safe, causing mostly mild side effects and very few severe complications. The relative safety of HIFU compared to other minimally invasive techniques, such as uterine artery embolization, still needs further evaluation. [ABSTRACT FROM AUTHOR]

Introduction: DNA methylation inhibitors (azacitidine, decitabine) have revolutionized the treatment dilemma of myelodysplastic syndromes (MDS), a group of malignant hematopoietic disorders. This study evaluates the adverse drug reactions (ADRs) following the use of DNA methylation inhibitors in the World Health Organization (WHO) VigiAccess database and compares the characteristics of ADRs between the two drugs to select the drug with the minimum individualized risk for patients. Methods: This study employed a retrospective descriptive analysis method. We compiled ADR reports for two marketed DNA methylation inhibitors for the treatment of MDS from WHO-VigiAccess. Data collected included demographic data such as age groups, gender, and regions of global patients covered by ADR reports, as well as data on the disease systems and symptoms caused by ADRs recorded in the annual reports and reports received by WHO. By calculating the proportion of ADRs reported for each drug, we compared the similarities and differences in ADRs between the two drugs. Results: Overall, 23,763 adverse events (AEs) related to the two DNA methylation inhibitors were reported in VigiAccess. The results showed that the top 10 most common AEs were febrile neutropenia, bone marrow suppression, neutropenia, anemia, pancytopenia, leukopenia, thrombocytopenia, bone marrow failure, agranulocytosis, and hematotoxicity. The top five common types of DNA methylation inhibitor AEs were blood and lymphatic system disorders (11,178 cases, 47.0%), cardiac organ diseases (1,488 cases, 6.3%), various congenital familial genetic diseases (49 cases, 0.2%), ear and labyrinth diseases (100, 4.2%), and endocrine system diseases (57, 2.4%). Conclusion: There is no Strong correlation between DNA methylation inhibitors and ADRs. Current comparative observational studies of these inhibitors show that there are common and specific adverse reactions in the ADR reports received by WHO for these drugs. Clinicians should improve the rational use of these drugs based on the characteristics of ADRs. [ABSTRACT FROM AUTHOR]

Objective To analyze the efficacy of metoprolol combined with amiodarone in the treatment of coronary heart disease (CHD) complicating premature ventricular contraction (PVC). Methods A total of 198 patients with CHD complicating PVC were divided into control and observation groups in the random number table method, with 99 cases in each group. The control group was treated with amiodarone while the observation group was treated with amiodarone combined with metoprolol following oral administration. The course of medication was both one month in the two groups. The clinical efficacy, ambulatory electrocardiography (AECG) indexes, heart rate variability (HRV) indexes, cardiac function indicators, and the occurrence of adverse reactions were compared between the two groups. Results The total effective rate of the observation group was significantly higher than that of the control group; QT interval dispersion and corrected QT interval dispersion after treatment were both lower than those in the control group while each HRV index and cardiac function indicator were all better than those in the control group (all P<0. 05) . There was no adverse reaction during treatment in both groups. Conclusion Metoprolol plus amiodarone could further improve HRV indexes and cardiac function in CHD patients complicated by PVC, and significantly promote the efficacy. It is worthy of clinical promotion and application. [ABSTRACT FROM AUTHOR]

The global aging population is leading to an increasing incidence of cancer, exacerbating the global burden of cancer. By 2040, the total number of cancer patients worldwide is projected to reach 28 million. With advancements in tumor molecular biology research and the widespread application of next-generation sequencing technology, precision treatment for cancer has made significant progress in clinical settings. Selective targeting of the Braf gene has emerged as one of the early successful cases of precision medicine for tumors. Braf gene mutations can result in unrestricted activation of downstream kinases in the mitogen-activated protein kinase (MAPK) cell signaling pathway, promoting rapid proliferation of tumor cells. BRAF inhibitors, either as monotherapy or in combination with MEK inhibitor, have been approved for various cancers, including melanoma, non-small cell lung cancer, thyroid cancer, colorectal cancer and glioma, among others. Clinical studies related to BRAF inhibitors are continuously exploring new applications. However, there is currently no consensus on the use of BRAF inhibitors in the diagnosis and treatment of multiple solid cancers in China. This article integrates clinical evidence of Braf mutations in multiple solid cancers to establish an expert consensus on the diagnosis and treatment of malignant solid cancers with Braf gene mutations. The goal is to promote and guide the standardized application of BRAF inhibitors. [ABSTRACT FROM AUTHOR]

Background: This meta-analysis aimed to evaluate the effectiveness and adverse effects of specific immunotherapy (SIT) in the management of respiratory allergens, including allergic asthma, rhinitis, and related disorders, based on a review of current literature up to November 8, 2022. Methods: We conducted a search of databases, including PubMed, Embase, Cochrane, and Web of Science, to identify relevant randomized controlled trials (RCTs) assessing respiratory allergy-specific immunotherapy. We employed the Consolidated Standards of Reporting Trials (CONSORT) Statement to select RCTs that adhered to rigorous reporting standards. Specifically, we focused on double-blind placebo-controlled (DBPC) trials and open studies involving both adults and children, considering factors such as dosage, inclusion criteria, allergens, and primary outcome measurements. Results: A total of 25 meta-analyses were included in this study. Among them, 14 evaluated sublingual-specific allergen immunotherapy (SLIT), 4 assessed subcutaneous allergen immunotherapy (SCIT), 4 explored both sublingual and subcutaneous immunotherapy, and 3 investigated intralymphatic immunotherapy. The outcomes of these meta-analyses indicated a reduction in medication scores in 20 cases and a decrease in symptom scores in 23 cases. Additionally, six studies reported on changes in IgE levels, seven studies focused on IgG4, four studies examined FEV1 (forced expiratory volume in 1 s), and eight studies reported on symptom and medication scores. Furthermore, 11 studies reported on differences in adverse reactions. Conclusion: The results of our meta-analysis suggest that specific immunotherapy, while associated with some adverse effects, effectively reduces the symptoms of asthma and rhinitis. Therefore, we recommend its use in the treatment of respiratory allergies. [ABSTRACT FROM AUTHOR]

Copyright of Journal of New Remedies & Clinic / Shin'Yaku to Rinsho is the property of Iyaku-Joho-Kenkyujo, Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Sepsis is marked by a dysregulated immune response to infection. Calcineurin inhibitors (CNIs), commonly used as immunosuppressants, have unique properties that may help mitigate the overactive immune response in sepsis, potentially leading to better patient outcomes. This study aims to assess whether CNIs improve prognosis in septic patients and to evaluate any associated adverse reactions. Methods: We utilized the Medical Information Mart for Intensive Care IV 2.2 (MIMIC-IV 2.2) database to identify septic patients who were treated with CNIs and those who were not. Propensity score matching (PSM) was employed to balance baseline characteristics between the CNI user group and the non-user group. The primary outcome was 28-day mortality, analyzed using the Kaplan-Meier method and Cox proportional hazard regression models to examine the relationship between CNI use and patient survival. Results: From the MIMIC-IV database, 22,517 septic patients were identified. After propensity score matching, a sample of 874 patients was analyzed. The CNI group exhibited a significantly lower 28-day mortality risk compared to the non-user group (HR: 0.26; 95% CI: 0.17, 0.41) in the univariate Cox hazard analysis. Kaplan-Meier survival curves also demonstrated a significantly higher 28- and 365-day survival rate for CNI users compared to non-users (log-rank test p-value = 0.001). No significant association was found between CNI use and an increased risk of new-onset infection (p = 0.144), but an association with mild hypertension (P < 0.001) and liver injury (P < 0.001) was observed. Conclusion: The use of calcineurin inhibitors was associated with reduced shortand long-term mortality in septic patients without an increased incidence of new-onset infections, hyperkalemia, severe hypertension, or acute kidney injury (AKI). However, CNI use may lead to adverse effects, such as liver injury and mild hypertension. [ABSTRACT FROM AUTHOR]

Purpose of Review: Cephalosporins are one of the most prescribed antibiotics worldwide and are implicated in a wide range of hypersensitivity reactions (HSR). This review summarizes recent updates in cephalosporin hypersensitivity with a focus on diagnostic testing. Recent Findings: Reported testing strategies to evaluate different immediate and delayed cephalosporin HSR have included skin testing, in vitro testing, and diagnostic drug challenges. However, the diagnostic performance of in vivo and in vitro tests remains unclear across different hypersensitivity endotypes; adequately powered studies investigating the true positive and negative predictive value of these diagnostic modalities are needed using the reference standard of drug challenges to define cephalosporin hypersensitivity. Summary: Refinement of diagnostic testing should be guided by growth in our understanding of cephalosporin antigenic determinants. This growth will be crucial in driving further clarification of cross-reactivity between cephalosporins, and potentially delineating streamlined evaluation processes resulting in reduced unnecessary antibiotic avoidance. [ABSTRACT FROM AUTHOR]

Acute adverse reactions to COVID-19 mRNA vaccines are a major concern, as autopsy reports indicate that deaths most commonly occur on the same day of or one day following vaccination. These acute reactions may be due to cytokine storms triggered by lipid nanoparticles (LNPs) and anaphylaxis induced by polyethene glycol (PEG), both of which are vital constituents of the mRNA-LNP vaccines. Kounis syndrome, in which anaphylaxis triggers acute coronary syndrome (ACS), may also be responsible for these cardiovascular events. Furthermore, COVID-19 mRNA-LNP vaccines encompass adjuvants, such as LNPs, which trigger inflammatory cytokines, including interleukin (IL)-1β and IL-6. These vaccines also produce spike proteins which facilitate the release of inflammatory cytokines. Apart from this, histamine released from mast cells during allergic reactions plays a critical role in IL-6 secretion, which intensifies inflammatory responses. In light of these events, early reduction of IL-1β and IL-6 is imperative for managing post-vaccine cytokine storms, ACS, and myocarditis. Corticosteroids can restrict inflammatory cytokines and mitigate allergic responses, while colchicine, known for its IL-1β-reducing capabilities, could also prove effective. The anti-IL-6 antibody tocilizumab also displays promising treatment of cytokine release syndrome. Aside from its significance for treating anaphylaxis, epinephrine can induce coronary artery spasms and myocardial ischemia in Kounis syndrome, making accurate diagnosis essential. The upcoming self-amplifying COVID-19 mRNA-LNP vaccines also contain LNPs. Given that these vaccines can cause a cytokine storm and allergic reactions post vaccination, it is crucial to consider corticosteroids and measure IL-6 levels for effective management. [ABSTRACT FROM AUTHOR]

Abstract Cystic fibrosis (CF) is a rare autosomal recessive genetic disorder that is now commonly treated with cystic fibrosis transmembrane conductance regulator (CFTR) modulators. Typical adverse events comprise new onset (drug‐induced) acneiform eruption as well as worsening of pre‐existing acne vulgaris. We present a case report of a young adult with rapid CFTR‐modulator‐induced worsening of pre‐existing acne vulgaris refractory to minocycline treatment, which resolved within 8 months of low dose isotretinoin therapy. Monthly laboratory monitoring of liver function, lipid levels and blood count were unremarkable in this case. The optimal treatment of acne vulgaris in CF‐patients and the management of drug‐induced acne remain a challenge. The latter may jeopardize drug adherence. CFTR‐modulators might be capable to induce acneiform skin lesions by altering electrolyte concentrations and sweat production with subsequential changes of the microbiome and follicular inflammatory response. The exact mechanism remains elusive at this point and warrants further investigation.

Background: Patient-reported outcomes (PROs) are reports provided by patients themselves detailing their medical health state or behavior related to an illness or medication use, without any interpretation by healthcare professionals. PROs are used to evaluate health status that cannot be quantified through tangible measures, for primary outcomes such as pain severity, and secondary outcomes such as quality of life. Patient-reported outcome measures (PROMs) are instruments or methods developed by professionals to assess data on PROs directly provided by patients during reporting procedures. In the oncology field, they are important to determine the impact of cancer and chemotherapy on patient's physical symptoms, mental well-being, and social functioning. The health system turned towards using PROMs as tools for remote monitoring, conducting visits when needed, and alerting stakeholders at the right time. Aim: To describe the uses and types of PROMs in use in clinical practice and the simplified PROMs that have been developed in oncology. Conclusion: PROMs are widely used in oncology for data collection. It became necessary to simplify measures by using patients' language, downsizing content, and promoting electronic PROMs through technological programs.

Abstract Background Neuroleptic malignant syndrome (NMS) is a rare and potentially life‐threatening condition that may arise at any point during treatment and is often associated with adverse reactions to dopamine‐blocking agents. This syndrome is normally characterized by features such as muscle rigidity, alteration in consciousness, autonomic instability, and leukocytosis. Aim The aim of this study is to investigate a borderline intellectual functioning (BIF) case in which NMS with insidious disease progression and long prodromal symptoms was developed. Case Presentation The investigated patient was a 38‐year‐old female diagnosed with bipolar disorder and a variety of corresponding disorders. The patient exhibited gastrointestinal symptoms and restlessness in the weeks leading up to the study, subsequent to the administration of elevated doses of haloperidol, risperidone, and lithium. In addition, she was hospitalized for restlessness and aggressiveness in the summer of 2023. Furthermore, due to her chief complaint, she received parenteral haloperidol twice in the emergency room, subsequently experiencing fever, altered consciousness, generalized rigidity, and dysphagia. Moreover, the patient's initial creatine phosphokinase (CPK) level was 2550 IU/L, and she was hospitalized in an intensive care unit with the diagnosis of NMS for 8 days. Conclusions This case study highlights the necessity of being attentive about prodromal symptoms of NMS and emergent interventions.

Abstract Objective To assess the immunization efficacy and incidence of adverse reactions after hepatitis B vaccination in children with thalassemia based on data from real-world studies. Methods A total of 625 children were recruited into this cross-sectional study. Subgroup analyses of different thalassemia types were performed using binary logistic regression, the factors affecting HBsAb levels were identified using multiple linear regression, and the dose-response relationship between the duration of immunization and seroconversion was explored using the restricted cubic spline (RCS) model to further assess the protective duration of the hepatitis B vaccine. Results HBsAb positivity in enrolled children was 87.3% in the thalassemia group and 81.4% in the control group. Multifactorial analysis revealed that the duration of immunization, age at completion of vaccination, and whether the first dose was delayed were significant factors influencing HBsAb levels in children (P

Background: Despite widespread consensus on the need to reduce benzodiazepine (BZD) use in older adults, prescription rates in the U.S. have paradoxically increased over the past few decades. Objective: We examined (1) the characteristics of the BZD adverse reaction cases in patients aged 50 and older that were admitted to a healthcare facility (HCF) and experienced major effects/death, and (2) the associations between the concomitant use of opioids and/or antidepressants and HCF admission and major effects/death among BZD cases. Methods: We used the 2015–2022 National Poison Data System (NPDS), which contained data from 55 America’s Poison Centers. We fitted two multivariable logistic regression models to examine the associations between the co-use of opioids and/or antidepressants and HCF admission and major effects/death. Results: Of the BZD cases that were examined (N = 1979), 14.9% or 295 cases were admitted to healthcare facilities, and 8.5% of those who were followed up (77 out of 893 cases) experienced major effects or death. The number of co-used substances, co-use of opioids and antidepressants, atypical antipsychotics, anticonvulsants, muscle relaxants, and Gabapentin were associated with greater odds of healthcare admission. Co-use of opioids and healthcare admission were associated with greater odds of major effects/death. Conclusions: Adverse reactions and healthcare admissions are likely to be prevented when healthcare providers limit and carefully monitor BZD prescribing, especially for those who are on other medications, including prescription opioids and antidepressants.

Abstract Background Enterococcus gallinarum (EG) is typically found in the gastrointestinal tracts of birds and mammals. Although its strains are rarely isolated from clinical specimens, EG can lead to septicemia in immunocompromised individuals. EG infections are uncommon in household settings, but their incidence has been rising due to increased antibiotic usage and invasive treatments, particularly in Neonatal Intensive Care Units (NICUs). EG inherently exhibits resistance to vancomycin but is highly sensitive to linezolid. Despite showing in vitro resistance, vancomycin has shown clinical efficacy in treating EG meningitis. Case presentation A neonate born at 30 + 2 weeks gestation was admitted to the Neonatal Intensive Care Unit (NICU) after EG was detected in blood and cerebrospinal fluid cultures. Susceptibility testing indicated that the bacterial strain was resistant to vancomycin and sensitive to linezolid. Initially, vancomycin was selected for treatment. However, due to persistent EG cultures in the blood and cerebrospinal fluid, the treatment was adjusted to linezolid. This led to a rapid decrease in platelet (PLT) count, suspected to be an adverse reaction. Concurrently, the patient experienced recurrent fever and elevated inflammatory marker levels, prompting the discontinuation of linezolid and a return to vancomycin. Subsequent administration of vancomycin stabilized the patient’s condition, as evidenced by improved C-reactive protein (CRP), procalcitonin (PCT), and cerebrospinal fluid parameters, ultimately leading to discharge after an eight-week treatment period. Conclusion This retrospective analysis highlights the efficacy of vancomycin in treating EG infections, suggesting that specific genetic phenotypes may influence treatment sensitivity. Monitoring vancomycin blood levels is crucial for determining treatment effectiveness.

Objective To investigate the adverse reactions, short-term and long-term effects of DP(docetaxel+cisplatin) regimen and PF(cisplatin+5-fluorouracil) regimen combined with intensity modulated radiation therapy(IMRT)in patients with distant metastatic esophageal squamous carcinoma. Methods From January 2021 to June 2022, 96 patients with non-metastatic esophageal squamous carcinoma were randomly divided into 48 cases in Taihe County People′s Hospital of Fuyang City, Anhui province and 48 cases in control group. Which was treated with DP plus IMRT. The observation group was treated with PF plus IMRT. The occurrence of adverse reactions and the effect of both groups were compared. Results Compared with control group, the difference in the incidence of adverse reaction was not significant. The total effective rate was higher in the observation group than in that in control group (83.3% vs 62.5%, P＜0.05). Overall survival, 1-year survival, 3-year survival in observation and in control group were 70.83% vs 50.00%, 79.36% vs 60.23% and 65.10% vs 35.52%. Long-term outcomes were observed and compared. The median survival time was 34.40 months in the observation group and 18.3 months in control group (P＜0.05). Conclusions DP regimen combined with IMRT is more effective than PF regimen combined with IMRT in the treatment of patients with distant metastatic esophageal squamous carcinoma.

Objective: To assess the immunization efficacy and incidence of adverse reactions after hepatitis B vaccination in children with thalassemia based on data from real-world studies. Methods: A total of 625 children were recruited into this cross-sectional study. Subgroup analyses of different thalassemia types were performed using binary logistic regression, the factors affecting HBsAb levels were identified using multiple linear regression, and the dose-response relationship between the duration of immunization and seroconversion was explored using the restricted cubic spline (RCS) model to further assess the protective duration of the hepatitis B vaccine. Results: HBsAb positivity in enrolled children was 87.3% in the thalassemia group and 81.4% in the control group. Multifactorial analysis revealed that the duration of immunization, age at completion of vaccination, and whether the first dose was delayed were significant factors influencing HBsAb levels in children (P < 0.05). The threshold for HBsAb positivity may be reached when the immunization duration reaches approximately 30 months. A subgroup analysis revealed that the HBsAb positivity rate was lower in children with β-thalassemia minor compared to those with α-thalassemia minor (P = 0.001, 95% CI: 0.097 ∼ 0.536). Adverse reactions after hepatitis B vaccination were dominated by general reactions, with a statistically significant difference in injection-site redness and swelling between the thalassemia and control groups (P < 0.05). Conclusions: The immunization response to the hepatitis B vaccine in children with thalassemia minor was comparable to healthy children, with no abnormal adverse effects seen. [ABSTRACT FROM AUTHOR]

Background: Neuroleptic malignant syndrome (NMS) is a rare and potentially life‐threatening condition that may arise at any point during treatment and is often associated with adverse reactions to dopamine‐blocking agents. This syndrome is normally characterized by features such as muscle rigidity, alteration in consciousness, autonomic instability, and leukocytosis. Aim: The aim of this study is to investigate a borderline intellectual functioning (BIF) case in which NMS with insidious disease progression and long prodromal symptoms was developed. Case Presentation: The investigated patient was a 38‐year‐old female diagnosed with bipolar disorder and a variety of corresponding disorders. The patient exhibited gastrointestinal symptoms and restlessness in the weeks leading up to the study, subsequent to the administration of elevated doses of haloperidol, risperidone, and lithium. In addition, she was hospitalized for restlessness and aggressiveness in the summer of 2023. Furthermore, due to her chief complaint, she received parenteral haloperidol twice in the emergency room, subsequently experiencing fever, altered consciousness, generalized rigidity, and dysphagia. Moreover, the patient's initial creatine phosphokinase (CPK) level was 2550 IU/L, and she was hospitalized in an intensive care unit with the diagnosis of NMS for 8 days. Conclusions: This case study highlights the necessity of being attentive about prodromal symptoms of NMS and emergent interventions. [ABSTRACT FROM AUTHOR]

Background: Despite widespread consensus on the need to reduce benzodiazepine (BZD) use in older adults, prescription rates in the U.S. have paradoxically increased over the past few decades. Objective: We examined (1) the characteristics of the BZD adverse reaction cases in patients aged 50 and older that were admitted to a healthcare facility (HCF) and experienced major effects/death, and (2) the associations between the concomitant use of opioids and/or antidepressants and HCF admission and major effects/death among BZD cases. Methods: We used the 2015–2022 National Poison Data System (NPDS), which contained data from 55 America's Poison Centers. We fitted two multivariable logistic regression models to examine the associations between the co-use of opioids and/or antidepressants and HCF admission and major effects/death. Results: Of the BZD cases that were examined (N = 1979), 14.9% or 295 cases were admitted to healthcare facilities, and 8.5% of those who were followed up (77 out of 893 cases) experienced major effects or death. The number of co-used substances, co-use of opioids and antidepressants, atypical antipsychotics, anticonvulsants, muscle relaxants, and Gabapentin were associated with greater odds of healthcare admission. Co-use of opioids and healthcare admission were associated with greater odds of major effects/death. Conclusions: Adverse reactions and healthcare admissions are likely to be prevented when healthcare providers limit and carefully monitor BZD prescribing, especially for those who are on other medications, including prescription opioids and antidepressants. [ABSTRACT FROM AUTHOR]

Copyright of Detergent & Cosmetics is the property of Detergent & Cosmetics Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Clinical Nursing in Practice is the property of Journal of Clinical Nursing in Practice (Editorial Board, Shanghai Jiao Tong University Press) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Acupuncture is widely accepted as a therapeutic treatment by patients and healthcare providers globally. The safety record has been well established in acupuncture practice although some rare adverse events (AEs) were reported in the literature. While acupuncture-related AEs are generally defined as any undesirable event that occurs in patients during acupuncture treatment that may or may not be associated with the treatment, acupuncture-related adverse reactions (ARs) are defined as any undesirable or harmful reaction induced by trained practitioners practicing acupuncture treatment with standard doses. In this review, we clarify the relationship between AEs and ARs. Furthermore, we compile a list of acupuncture-related AEs reported in systematic reviews and meta-analysis articles. We find that serious acupuncture-related AEs are rare, with serious AEs occurring at a rate of approximately 0.04–0.08 per 10,000 treatments. The most likely serious AEs are pneumothorax, central and peripheral nerve injuries, heart injuries, abdominal organ injuries, infections, and needle breakage. Commonly reported minor AEs include bruising, hematoma, or bleeding at the needling site, as well as vasovagal reactions such as tiredness, dizziness, fainting, or residual pain at insertion points. The analysis identifies contributing factors for serious AEs being deep needle penetration, incorrect acupoint selection, and improper needle manipulation. It also addresses infections caused by contaminated needles, environmental factors, and inadequate skin disinfection. Moreover, other serious AEs, like needle breakage, are mostly due to aggressive manipulation and repeated reheating. Importantly, most acupuncture-related AEs are preventable. To avoid such AEs, acupuncturists in clinical practice should carefully select needling areas, be aware of cautions and contraindications of acupuncture, maintain safe acupuncture depth and hygiene, and strictly adhere to standard operating procedures. [ABSTRACT FROM AUTHOR]

Background: Enterococcus gallinarum (EG) is typically found in the gastrointestinal tracts of birds and mammals. Although its strains are rarely isolated from clinical specimens, EG can lead to septicemia in immunocompromised individuals. EG infections are uncommon in household settings, but their incidence has been rising due to increased antibiotic usage and invasive treatments, particularly in Neonatal Intensive Care Units (NICUs). EG inherently exhibits resistance to vancomycin but is highly sensitive to linezolid. Despite showing in vitro resistance, vancomycin has shown clinical efficacy in treating EG meningitis. Case presentation: A neonate born at 30 + 2 weeks gestation was admitted to the Neonatal Intensive Care Unit (NICU) after EG was detected in blood and cerebrospinal fluid cultures. Susceptibility testing indicated that the bacterial strain was resistant to vancomycin and sensitive to linezolid. Initially, vancomycin was selected for treatment. However, due to persistent EG cultures in the blood and cerebrospinal fluid, the treatment was adjusted to linezolid. This led to a rapid decrease in platelet (PLT) count, suspected to be an adverse reaction. Concurrently, the patient experienced recurrent fever and elevated inflammatory marker levels, prompting the discontinuation of linezolid and a return to vancomycin. Subsequent administration of vancomycin stabilized the patient's condition, as evidenced by improved C-reactive protein (CRP), procalcitonin (PCT), and cerebrospinal fluid parameters, ultimately leading to discharge after an eight-week treatment period. Conclusion: This retrospective analysis highlights the efficacy of vancomycin in treating EG infections, suggesting that specific genetic phenotypes may influence treatment sensitivity. Monitoring vancomycin blood levels is crucial for determining treatment effectiveness. [ABSTRACT FROM AUTHOR]

Drug-induced liver injury (DILI) is one of the most frequently adverse reactions in clinical drug use, usually caused by drugs or herbal compounds. Compared with other populations, cancer patients are more prone to abnormal liver function due to primary or secondary liver malignant tumor, radiation-induced liver injury and other reasons, making potential adverse reactions from liver damage caused by anticancer drugs of particular concernduring clinical treatment process. In recent years, the application of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) has changed the treatment status of a series of solid malignant tumors. Unfortunately, the increasing incidence of hepatotoxicitylimits the clinical application of EGFR-TKIs. The mechanisms of liver injury caused by EGFR-TKIs were complex. Despite more than a decade of research, other than direct damage to hepatocytes caused by inhibition of cellular DNA synthesis and resulting in hepatocyte necrosis, the rest of the specific mechanisms remain unclear, and few effective solutions are available. This review focuses on the clinical feature, incidence rates and the recent advances on the discovery of mechanism of hepatotoxicity in EGFR-TKIs, as well as rechallenge and therapeutic strategies underlying hepatotoxicity of EGFR-TKIs. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study is to explore and analyze the FDA Adverse Event Reporting System (FAERS) database to identify drug adverse reaction signals associated with angioedema. The findings aim to provide valuable insights for clinical drug safety considerations. Methods: The Open Vigil 2.1 data platform was utilized to collect adverse event reports related to angioedema from the first quarter of 2004 to the fourth quarter of 2023. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) were employed as disproportionality measures to detect adverse reaction signals Sof drugs associated with angioedema. Results: A total of 38,921 reports were retrieved, with the majority being reported by healthcare professionals. The analysis included predominantly adult patients (=18 years of age), with slightly higher representation of females compared tomales. Among the top 30 drugs associated with the occurrence of angioedema, 24 drugs showed positive signals in the risk analysis. Based on the individual drug reporting odds ratio (95% confidence interval) as ameasure of risk signal strength, the top five drugs are as follows: lisinopril [ROR (95% CI): 46.43 (42.59-50.62)], enalapril [ROR (95% CI): 43.51 (39.88-47.46)], perindopril [ROR (95% CI): 31.17 (27.5-35.32)], alteplase [ROR (95% CI): 29.3 (26.95-31.85)], ramipril [ROR (95% CI): 20.93 (19.66-22.28)]. After categorizing the drugs, the strongest positive signal was observed in the antithrombotic agents [ROR (95% CI): 22.53 (21.16-23.99)], following that, cardiovascular drugs [ROR (95% CI): 9.17 (8.87-9.48)], antibiotics [ROR (95% CI): 6.42 (5.91-6.96)], immunosuppressors [ROR (95% CI): 5.95 (5.55-6.39)], anti-inflammatory analgesics [ROR (95% CI): 4.65 (4.45-4.86)], antiallergic drugs [ROR (95% CI): 4.47 (3.99-5)], antiasthmatics [ROR (95% CI): 2.49 (2.14-2.89)], blood sugar control drugs [ROR (95% CI): 1.65 (1.38-1.97)], and digestive system drugs [ROR (95% CI): 1.59 (1.45-1.74)] exhibited progressively decreasing ROR values. Conclusion: Many medications are associated with a high risk of angioedema. These medications play a crucial and potentially preventable role in controlling the occurrence of angioedema. It is essential to consider the risk level of druginduced angioedema in clinical practice to optimize medication therapy. [ABSTRACT FROM AUTHOR]

Introduction: Concomitant use of drugs in the same or different indications can sometimes lead to undesirable interactions. The prevalence of drug interactions is high in cancer patients. In this study, we aimed to determine the frequency and clinical severity of drug interactions in outpatient lung cancer patients. Methods: The drugs used, kidney and liver blood analysis results of 160 outpatient lung cancer patients over the age of 18 years who received chemotherapy between October 2020 and July 2021 were evaluated. The Lexi-Interact online database was used to identify the types of clinically significant drug interactions, frequently interacting drugs, and clinical outcomes predicted by the databases. Results: The average number of drugs per patient was 4.2 ± 2.3. It was determined that there was a relationship between multidrug use and comorbidity, and the number of drugs used increased as the number of diagnoses increased. A relationship was also found between potential drug-drug interactions (pDDIs), which we observed in 52.5% of the patients, and the number of drugs used and age. The most common clinically significant C- (36.9%), D- (16.9%), and X- (10.6%) type pDDIs were detected between conventional paclitaxel-hydrochlorothiazide, conventional paclitaxel-carboplatin, and ipratropium-tiotropium, respectively. Conclusions: The use of frequently interacting drugs in outpatient lung cancer patients can lead to pDDIs. In these patients, the application of therapy by observing the drug-drug interaction may improve the quality of life. [ABSTRACT FROM AUTHOR]

Objective To investigate the adverse reactions, short-term and long-term effects of DP (docetaxel+cisplatin) regimen and PF (cisplatin+5-fluorouracil) regimen combined with intensity modulated radiation therapy (IMRT) in patients with distant metastatic esophageal squamous carcinoma. Methods From January 2021 to June 2022, 96 patients with non-metastatic esophageal squamous carcinoma were randomly divided into 48 cases in Taihe County People's Hospital of Fuyang City, Anhui province and 48 cases in control group. Which was treated with DP plus IMRT. The observation group was treated with PF plus IMRT. The occurrence of adverse reactions and the effect of both groups were compared. Results Compared with control group, the difference in the incidence of adverse reaction was not significant. The total effective rate was higher in the observation group than in that in control group (83.3% $ 62.5%, P<0.05). Overall survival, 1-year survival, 3-year survival in observation and in control group were 70. 83% vs 50.00%, 79.36% vs 60. 23% and 65. 10% us 35.52%. Long-term outcomes were observed and compared. The median survival time was 34. 40 months in the observation group and 18.3 months in control group (P<0.05). Conclusions DP regimen combined with IMRT is more effective than PF regimen combined with IMRT in the treatment of patients with distant metastatic esophageal squamous carcinoma. [ABSTRACT FROM AUTHOR]

Objective To explore the efficacy and safety of thalidomide, arsenic trioxide, dexamethasone and ascorbic acid(TADA)regimen in the treatment of early relapsed multiple myeloma(MM)patients(tumor progression within 12 months after initial treatment). Methods This study retrospectively analyzed 62 patients on TADA chemotherapy regimen and 57 patients on bortezomib, lenalidomide, dexamethasone(velcade, revlimid, dexamethasone, VRD)chemotherapy regimen for multiple myeloma(MM)in early stage relapse, who visited the Department of Hematology of Yanbian University Hospital between 2008 and 2020. We collected the general data profile, follow-up data during 3 courses of treatment, and laboratory data of all patients before and after chemotherapy. The efficacy of the patients was assessed by overall response rate(ORR)and complete response rate(CRR), and the occurrence of adverse reactions was collected for statistical analysis. Kaplan-Meier curves were plotted for the TADA and VRD groups under different renal function conditions, cytogenetically different risk stratification, and different ISS scenarios; the prognosis of patients on the TADA chemotherapy regimen was analyzed. Results There were no statistical differences in age, gender, immunochemical subtypes, ISS staging and high-risk FISH indicators between the two groups(P>0.05). After chemotherapy, the haemoglobin and serum albumin of patients in the TADA group were significantly lower than those in the VRD group, whereas the percentage of blood calcium, blood β2 microglobulin, creatinine and bone marrow plasma cells were significantly higher than those in the VRD group(P<0.05). In addition, the incidence of peripheral neuropathy was significantly lower than that in the VRD group(P<0.05), and there was no statistically significant difference in other adverse reactions(P>0.05).Compared with those in the VRD group, the overall survival(OS)(χ²=8.201, P=0.004)and progression free survival(PFS)(χ²=7.568, P=0.006)survival curves were statistically significant in the TADA group. In the TADA group OS(χ2=3.924, P=0.048)in patients with normal and impaired renal function at the time of enrolment and PFS(χ²=9.008, P=0.003), OS(χ²=9.330, P=0.002)and PFS(χ²=16.090, P<0.001)in ISS stage Ⅰ/Ⅱ and ISS stage Ⅲ at enrolment, OS(χ²=10.149,P<0.001)in high-risk FISH and non-high-risk patients at enrolment and PFS(χ²=11.286, P<0.001)survival curve results showed statistically significant differences. Conclusion The TADA regimen has better efficacy and safety in patients with early recurrence of MM. Renal function, ISS staging and FISH stratification are important factors affecting patients' prognosis. [ABSTRACT FROM AUTHOR]

The COVID-19 outbreak has been declared the sixth Public Health Emergency of International Concern certified by the World Health Organization. With the extensive application of COVID-19 vaccines, rare but serious adverse reactions have gradually emerged, among which systemic capillary leak syndrome (SCLS) deserves our attention. SCLS is difficult to diagnose. Not only can it exacerbate various diseases, but also can lead to pulmonary edema, kidney failure, and even death. We summarized and discussed case reports of SCLS induced by COVID-19 vaccines to raise awareness of COVID-19 vaccine-associated rare diseases. We conducted a comprehensive search in Web of Science, PubMed and Embase and collected case reports of SCLS induced by COVID-19 vaccine before February 19, 2024. We identified and analyzed 12 articles, encompassing 15 cases. We synthesized the data to summerize possible mechanisms of SCLS, clinical manifestations, differential diagnoses, and therapeutic approaches. Most SCLS occurred after vaccination with the Pfe-Biontech mRNA vaccine (9/15) and following the second vaccination (10/15). Almost all patients experienced hypotension (13/15) and tachycardia (11/15). Most patients received intravenous fluids (9/15) and corticosteroids (9/15). 11 patients were recovered and were discharged, while 4 patients died. Inflammation and endothelial cell damage may be linked to SCLS and COVID-19 vaccines. These findings highlight the necessity of focusing on serious adverse reactions of COVID-19 vaccines and the urgency to reconsider the safety of COVID-19 vaccines.

ABSTRACTConsidering the widespread use of COVID-19 vaccines as a preventive measure against the spread of the virus, it’s necessary to direct attention to the adverse effects associated with vaccines in a limited group of populations. Multiple evanescent white dot syndrome (MEWDS) following COVID-19 vaccination is a rare adverse reaction associated with COVID-19 vaccines. In this systematic review, we collected 19 articles with 27 patients up to November 1, 2023, summarizing the basic information, clinical manifestations, examinations, treatments, and recoveries of the 27 patients. The 27 enrolled patients (6 males, 21 females) had a median age of 34.1 years (15–71 years old) and were mainly from 5 regions: Asia (8), the Mediterranean region (8), North America (7), Oceania (3) and Brazil (1). Symptoms occurred post-first dose in 9 patients, post-second dose in 14 (1 with symptoms after both), post-third dose in 1, and both post-second and booster doses in 1, while details on 2 cases were not disclosed. Treatments included tapered oral steroids (6), topical steroids (3), tapered prednisone with antiviral drugs and vitamins (1), and valacyclovir and acetazolamide (1), while 16 received no treatment. All patients experienced symptom improvement, and nearly all patients ultimately recovered. Moreover, we summarized possible hypotheses concerning the mechanism of COVID-19 vaccine-associated MEWDS. The findings provide insights into the clinical aspects of COVID-19 vaccine-associated MEWDS. More attention should be given to patients with vaccine-associated MEWDS, and necessary treatment should be provided to patients experiencing a substantial decline in visual acuity to improve their quality of life.

ABSTRACTWith the widespread vaccination of COVID-19 vaccine, a few cases have been reported that COVID-19 vaccine may cause endocrine disorders. A 59-y-old man presented with a loss of appetite after the first COVID-19 vaccination, which resolved spontaneously after 3 d. After the second COVID-19 vaccination, the symptoms including the loss of appetite, nausea, and vomiting reappeared and worsened along with loss of vision. He was found to have severe hyponatremia, and further investigations revealed secondary adrenal insufficiency, secondary hypothyroidism and Rathke’s cleft cyst. The patient responded well to glucocorticoid and levothyroxine supplementation, and at 1-y follow-up the patient developed hypogonadism. We hypothesize that hypophysitis is probably induced by COVID-19 vaccine and report the rare but serious adverse reactions for early recognition and intervention.

IntroductionThe system of Risk Management Plan in Japan (J-RMP) is a relatively new system, implemented in 2013; thus, its effect on safety measures is still unclear. One of the purposes of J-RMP is to enhance the postmarketing safety measures to be ensured by publishing J-RMP and sharing information on risk management among healthcare professionals. We hypothesized that this might enable information about postmarketing adverse events to be accumulated rapidly, potentially accelerating the identification of adverse reactions (ARs). Herein, we focused on the speed of adding clinically significant ARs (CSARs) to package inserts (PIs) as an indicator of the rapidity of AR identification, investigated the impact of the J-RMP system on PI revisions.MethodsWe investigated the “Notice of Revision of Precautions” on the website of Pharmaceuticals and Medical Devices Agency (PMDA), targeting PI revisions with the addition of CSARs from April 2003 to March 2023, which corresponds to 10 years before and after J-RMP implementation in April 2013. We created an original database from public information of PMDA and investigated the speed of adding CSARs to PIs.ResultsComparing the time lapse from drug approvals to PI revisions after J-RMP implementation (149 cases) to that before implementation (318 cases), the median value was 32 months for both. Regarding the time lapse when the additional CSARs were listed and unlisted as safety concerns at the time of approvals, it was 35 months vs. 32 months (14 cases vs. 126 cases, p = 0.7820), with no statistically significant difference. Conversely, there were significant differences within each AR and each drug therapeutic category.Discussion and conclusionsThis study revealed that the rapidity of risk identification as ARs was not affected by J-RMP, and it may be affected by the characteristics of each AR and each drug therapeutic category. It is expected that other J-RMP benefits, such as risk prevention before the occurrence, will be utilized to further develop strategies for the effective utilization of the J-RMP for safety measures in Japan.

ObjectiveTo investigate the effects of probiotics combined with bismuth quadruple therapy （BQT） on clinical efficacy、gastrointestinal adverse reactions and intestinal flora in Helicobacter pylori （HP） positive patients.MethodsThe patients who were positive for HP from May 2023 to July 2023 in the department of gastroenterology of Shanghai first people's hospital were randomly divided into 2 groups with 40 people in each group. The probiotic group was given 2 weeks of quadruple therapy with probiotics and standard BQT， followed by 4 weeks of oral probiotics after quadruple discontinuation. The placebo group was given 2 weeks of probiotic placebo and standard BQT， followed by 4 weeks of oral probiotic placebo. 13C urea breath test was used to evaluate the clinical efficacy， gastrointestinal symptoms rating Scale was used to evaluate the gastrointestinal adverse reactions of patients before and after the intervention， and microbial diversity 16S rDNA sequencing technology was used to detect the level of intestinal flora of patients before and after the intervention.ResultsThere was no significant difference in the eradication rate between the two groups （P>0.05）. Before the intervention， there was no significant difference in the scores of the gastrointestinal symptom rating scale between the probiotic group and the placebo group. After the intervention， patients in the probiotic group had significantly lower pain scores on acid reflux （1.10±0.30 vs 1.35±0.53， P

Abstract Background In Nigeria, seasonal malaria chemoprevention (SMC) is typically administered door-to-door to children under five by community medicine distributors during high transmission seasons. While door-to-door distribution (DDD) is exclusively employed in Nigeria as part of standard operating procedures of SMC programmes, some households access SMC through non-DDD channels, such as fixed-point distributions, health facilities, and private purchase. However, analysis of access to SMC medicines through non-DDD has been limited, with little evidence of its outcomes on adherence to the three-day complete course of SMC medicines and caregiver actions in the event of adverse reactions to SMC medicines. Methods Data were obtained from SMC end-of-round coverage surveys conducted in Nigeria in 2021 and 2022, including 25,278 households for the analysis. The proportion of households accessing SMC medicine through non-DDD and the distribution of various non-DDD sources of SMC medicines were described. Multivariate random-effects logistic regression models were performed to identify predictors of accessing SMC medicines through non-DDD. The associations between non-DDD, and caregiver-reporting of adherence to complete administration of SMC medicines and caregiver actions in the event of adverse reactions to SMC medicines were also assessed. Results Less than 2% (314/24003) of households accessed SMC medicines through non-DDD in the states surveyed. Over 60% of non-DDD access was via health facility personnel and community medicine distributors from different locations. Variables associated with non-DDD access included heads of household being born in the local state (OR = 0.68, 95% CI 0.47 to 0.90), households residing in the study state since the first cycle of the SMC round (OR = 0.39, 95% CI 0.17 to 0.88), households with high wealth index (OR = 1.36, 95% CI 1.01 to 1.82), and caregivers hearing about date of SMC delivery in the previous cycle (OR = 0.18, 95%CI 0.14 to 0.24). Furthermore, non-DDD was associated with reduced SMC adherence and higher caregiver non-reporting of adverse reactions to SMC medicines in children compared with DDD. Conclusion This study provides evidence on the characteristics of households accessing SMC medicines through non-DDD and its potential negative outcomes on adherence to SMC medicine and adverse reaction reporting, underscoring potential implementation issues that may arise if non-DDD delivery models are adopted in SMC, particularly in places where DDD had been firstly used.

Background: Polyoxyethylene hydrogenated castor oil (HCO ethoxylates) is a nonionic surfactant used as an excipient for ointments and injections in human and veterinary drugs. Several polyethylene glycol (PEG) derivatives can be obtained depending on the number of moles of ethylene oxide (EO). HCO ethoxylates have the potential to cause anaphylactoid reactions. There is little published information about these types of reactions in dogs. Objective: To determine the potential for HCO‐ethoxylate‐containing drugs to cause anaphylactoid reactions in dogs, employing intradermal testing (IDT) with various concentrations of HCO ethoxylates (HCO‐25, ‐40, ‐60 and ‐80). Animals: Four healthy male laboratory dogs. Materials and Methods: We performed IDT with drugs containing HCO ethoxylates and HCO ethoxylates alone to determine threshold concentrations. The IDT scores and threshold concentrations were compared. Analysis of skin biopsies from IDT sites was used to measure the percentage of degranulated mast cells. The effect of histamine at IDT sites was investigated by pre‐treatment with an antihistamine. Results: All HCO‐ethoxylate‐containing drugs caused a wheal‐and‐flare reaction. The threshold concentrations (0.001% and 0.00001%) of each HCO‐ethoxylate depended on the number of moles of EO (p < 0.05). Mast cell degranulation was enhanced by all HCO ethoxylates. The HCO‐60‐induced reaction was suppressed by an oral antihistamine. Conclusions and Clinical Relevance: The threshold concentration can serve as a consideration for developing safe new drug formulations and for clinical decision‐making around using drugs containing PEG derivatives. IDT is useful to predict the risk of adverse effects. Antihistamines could demonstrate a prophylactic effect. [ABSTRACT FROM AUTHOR]

Background: In Nigeria, seasonal malaria chemoprevention (SMC) is typically administered door-to-door to children under five by community medicine distributors during high transmission seasons. While door-to-door distribution (DDD) is exclusively employed in Nigeria as part of standard operating procedures of SMC programmes, some households access SMC through non-DDD channels, such as fixed-point distributions, health facilities, and private purchase. However, analysis of access to SMC medicines through non-DDD has been limited, with little evidence of its outcomes on adherence to the three-day complete course of SMC medicines and caregiver actions in the event of adverse reactions to SMC medicines. Methods: Data were obtained from SMC end-of-round coverage surveys conducted in Nigeria in 2021 and 2022, including 25,278 households for the analysis. The proportion of households accessing SMC medicine through non-DDD and the distribution of various non-DDD sources of SMC medicines were described. Multivariate random-effects logistic regression models were performed to identify predictors of accessing SMC medicines through non-DDD. The associations between non-DDD, and caregiver-reporting of adherence to complete administration of SMC medicines and caregiver actions in the event of adverse reactions to SMC medicines were also assessed. Results: Less than 2% (314/24003) of households accessed SMC medicines through non-DDD in the states surveyed. Over 60% of non-DDD access was via health facility personnel and community medicine distributors from different locations. Variables associated with non-DDD access included heads of household being born in the local state (OR = 0.68, 95% CI 0.47 to 0.90), households residing in the study state since the first cycle of the SMC round (OR = 0.39, 95% CI 0.17 to 0.88), households with high wealth index (OR = 1.36, 95% CI 1.01 to 1.82), and caregivers hearing about date of SMC delivery in the previous cycle (OR = 0.18, 95%CI 0.14 to 0.24). Furthermore, non-DDD was associated with reduced SMC adherence and higher caregiver non-reporting of adverse reactions to SMC medicines in children compared with DDD. Conclusion: This study provides evidence on the characteristics of households accessing SMC medicines through non-DDD and its potential negative outcomes on adherence to SMC medicine and adverse reaction reporting, underscoring potential implementation issues that may arise if non-DDD delivery models are adopted in SMC, particularly in places where DDD had been firstly used. [ABSTRACT FROM AUTHOR]

Purpose: To assess the failure modes and effects of clinical application of breviscapine-based traditional Chinese medicine injection (TCMI). Methods: 229 reports on clinical application errors, medication errors or management measures relating to breviscapine injection were collected by searching various databases. A clinical application and safety evaluation questionnaire was formulated for use in the failure mode and effects analysis (FMEA) of breviscapine injection. The questionnaire survey was then distributed to 100 doctoral, nursing and pharmaceutical personnel in Xinxiang Central Hospital who were randomly chosen to participate. Results: A total of 81 (83.5 %) valid questionnaires were retrieved. A total of 29 potential failure types, failure causes and failure effects were identified. Mean values of all risk priority numbers (RPN) of the 29 failure modes were ranked comprehensively. The failure modes identified as top 10 risk factors include; detailed information regarding the patient's medical, allergy and family disease history not being provided to physicians (75.22); incorrect choice of drug manufacturer and lot number (74.95), drugs not being dispensed on the spot (72.16); inappropriate choice of solvent (71.31); drugs not suitable for combination therapy (70.81); inappropriate choice of solvent dosage (69.14); individual patient differences not taken into consideration (67.07); infusion rate too fast (67.00); off-label drug use (65.32); and age of the patient not taken into consideration (64.96). Conclusion: As a risk management tool, the FMEA conducted in this study reduces potentially dangerous clinical application of high-risk TCMI, standardizes the medication process and significantly reduces occurrence of adverse reactions to TCMI. Future studies are required to validate these claims. [ABSTRACT FROM AUTHOR]

Objective: To analyze the application effect of narrow elastic disposable tourniquet in liposuction reduction surgery for the lower extremity lymphedema, and to provide the basis for its clinical application. Methods: The retrospective analysis was conducted on the clinical data of 309 patients who underwent liposuction reduction surgery for the lower extremity lymphedema. The patients were divided into non-narrow elastic disposable tourniquet group (n=163) and narrow elastic disposable tourniquet group (n=146). The intraoperative blood loss, rates of allogenic blood transfusion, incidence of adverse reactions related to dilation fluid into blood, incidence of blood pressure fluctuations, and preoperative and postoperative 24 h levels of hemoglobin (Hb) and albumin (Alb) of the patients in two groups were compared. Results: Compared with non-narrow elastic disposable tourniquet group, the intraoperative blood loss, allogenic blood transfusion rate, and incidence of adverse reactions related to dilation fluid into blood of the patients in narrow elastic disposable tourniquet group were decreased (P<0. 05), while the incidence of intraoperative blood pressure fluctuations was increased (P<0. 05). Compared with non-narrow elastic disposable tourniquet group, the ΔHb level (preoperative Hb levelpostoperative 24 h Hb level) and ΔAlb level (preoperative Alb level-postoperative 24 h Alb level) of the patients in narrow elastic disposable tourniquet group were decreased (P<0. 05 or P<0. 01). Conclusion: The application of narrow elastic disposable tourniquet in liposuction reduction surgery for the lower extremity lymphedema can effectively reduce the intraoperative bleeding and the need for allogenic transfusions, decrease the level of ΔAlb, and prevent the occurrence of adverse reactions related to dilation fluid into blood. However, attention should be given to the potential adverse reactions related to intraoperative circulatory fluctuations. [ABSTRACT FROM AUTHOR]

Simple Summary: Gut microbiota (GM) are closely related to hepatocellular carcinoma (HCC) occurrence and development. Furthermore, patients with HCC who have received transcatheter arterial chemoembolization (TACE) treatment often experience adverse gastrointestinal reactions, which may be related to changes in the GM caused by the chemotherapeutic drugs used in TACE. We analyzed changes in the GM of New Zealand white rabbits treated with hepatic arterial chemotherapy by measuring the levels of serological and colonic tissue markers. Simultaneously, we evaluated the correlation between the GM and these markers to explore the mechanism by which chemotherapy affects the GM. Following transarterial chemotherapy with epirubicin, the Firmicutes abundance decreased, whereas that of Proteobacteria increased, and beneficial bacteria decreased, while harmful bacteria increased. Following chemotherapy, the GM of rabbits showed a dynamic change over time, first aggravating and then subsiding. The changes were most notable on the fourth day after surgery and recovered slightly on the seventh day. The gut microbiota (GM) are closely related to hepatocellular carcinoma (HCC) occurrence and development. Furthermore, patients with HCC who have received transcatheter arterial chemoembolization (TACE) treatment often experience adverse gastrointestinal reactions, which may be related to changes in the GM caused by the chemotherapeutic drugs used in TACE. Therefore, we conducted animal experiments to investigate these changes. We analyzed changes in the GM of New Zealand white rabbits treated with hepatic arterial chemotherapy by measuring the levels of serological and colonic tissue markers. Simultaneously, we evaluated the correlation between the GM and these markers to explore the mechanism by which chemotherapy affects the GM. Following transarterial chemotherapy with epirubicin, the Firmicutes abundance decreased, whereas that of Proteobacteria increased. The relative abundance of beneficial bacteria, such as Muribaculaceae, Enterococcus, Ruminococcus, and Clostridia, decreased in the experimental group compared with those in the control group. However, the relative abundance of harmful bacteria, such as Bacteroides and Escherichia (Shigella), was higher in the experimental group than in the control group. Following chemotherapy, the GM of rabbits showed a dynamic change over time, first aggravating and then subsiding. The changes were most notable on the fourth day after surgery and recovered slightly on the seventh day. The changes in the host's GM before and after arterial chemotherapy are evident. Hepatic arterial chemotherapy induces dysbiosis of the intestinal microbiota, disrupts intestinal barrier function, damages the integrity of the intestinal mucosa, increases intestinal permeability, facilitates excessive passage of harmful substances through the gut–liver axis communication between the liver and intestine, and triggers activation of inflammatory pathways such as LPS-TLR-4-pSTAT3, ultimately leading to an inflammatory response. This study provides a theoretical basis for combining TACE with targeted GM intervention to treat HCC and reduce adverse gastrointestinal reactions. [ABSTRACT FROM AUTHOR]