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Aims: To investigate the efficacy and safety of Cerebrolysin and Cerebrolysin plus nootropics in the routine treatment of patients with acute ischemic stroke (AIS). Background: Acute ischemic stroke (AIS) is a leading cause of disability with unmet treatment needs lacking effective drug therapy. Multimodal drugs modulating stroke pathophysiology as Cerebrolysin constitute a good therapeutic option. Objective: In this study, we assessed the effects of Cerebrolysin and Cerebrolysin plus nootropics, in comparison with other nootropic drugs alone, on functional, neurological and cognitive recovery of patients with AIS in Vietnam. Methods.: This non-interventional, controlled, open-label, prospective and multicenter study included 398 AIS patients (234 males) treated with Cerebrolysin (n=190; 20 i.v. infusions of 10 ml), other nootropics (comparator group; n=86), or a combination of both (n=122). The study primary endpoint was the modified Ranking Scale (mRS) score on day 90. Secondary endpoints included study-period change in NIHSS score; percentage of well-recovered (mRS 0-2) patients, the proportion of good NIHSS response (≥6 points) cases, and MoCA scores at day 90; and safety indicators. Results: Compared with other nootropics, both Cerebrolysin and combined therapy induced significant improvements (p11) cases only. No drug-related adverse events were reported. Conclusion: Cerebrolysin alone or combined with other nootropics was effective and safe in routine AIS treatment, during both acute and recovery phases, which supports its use in daily clinical practice. Other: According to the results of this multicenter study, the importance of reducing differences in the treatment regimens of AIS in Vietnam should be further emphasized.

HIV reverse transcriptase (RT) inhibitors are the important components of highly active antiretroviral therapies (HAARTs) for anti-HIV treatment and pre-exposure prophylaxis in clinical practice. Many RT inhibitors and their combination regimens have been approved in the past ten years, but a review on their drug discovery, pharmacology, and clinical efficacy is lacking. Here, we provide a comprehensive review of RT inhibitors (tenofovir alafenamide, rilpivirine, doravirine, dapivirine, azvudine and elsulfavirine) approved in the past decade, regarding their drug discovery, pharmacology, and clinical efficacy in randomized controlled trials. Novel RT inhibitors such as islatravir, MK-8504, MK-8507, MK8583, IQP-0528, and MIV-150 will be also highlighted. Future development may focus on the new generation of novel antiretroviral inhibitors with higher bioavailability, longer elimination half-life, more favorable side-effect profiles, fewer drug-drug interactions, and higher activities against circulating drug-resistant strains. ispartof: Acta Pharm Sin B vol:12 issue:4 pages:1567-1590 ispartof: location:Netherlands status: published

Purpose: To establish recommended phase II dose (RP2D) in phase I and evaluate safety and efficacy of abivertinib in patients with EGFR Thr790Met point mutation (T790M)-positive(+) non–small cell lung cancer (NSCLC) with disease progression from prior EGFR inhibitors in phase II. Patients and Methods: This multicenter, open-label study included 367 adult Chinese patients. Abivertinib at doses of 50 mg twice a day to 350 mg twice a day was evaluated in phase I in continual 28-day cycles, and the RP2D of 300 mg twice a day was used in phase II in continual 21-day cycles. Primary endpoints include RP2D in phase I and objective response rate (ORR) at RP2D in phase II. Results: The RP2D of 300 mg twice a day for abivertinib was established based on pharmacokinetics, efficacy, and safety profiles across doses in phase I. In phase II, 227 patients received RP2D for a median treatment duration of 24.6 weeks (0.43–129). Among 209 response–evaluable patients, confirmed ORR was 52.2% [109/209; 95% confidence interval (CI): 45.2–59.1]. Disease control rate (DCR) was 88.0% (184/209; 95% CI: 82.9–92.1). The median duration of response (DoR) and progression-free survival (PFS) was 8.5 months (95% CI: 6.1–9.2) and 7.5 months (95% CI: 6.0–8.8), respectively. The median overall survival (OS) was 24.9 months [95% CI: 22.4–not reachable (NR)]. All (227/227) patients reported at least 1 adverse event (AE), with 96.9% (220/227) of treatment-related AEs. Treatment-related serious AEs were reported in 13.7% (31/227) of patients. Death was reported in 4.4% (10/227) of patients, and none was deemed as treatment-related. Conclusions: Abivertinib of 300 mg twice a day demonstrated favorable clinical efficacy with manageable side effects in patients with EGFR T790M+ NSCLC.

The objective of the study was to improve the treatment of acute obstructive bronchitis in infants by optimizing the anti-inflammatory therapy based on the evaluation of its clinical, immunological and molecular genetic efficiency. Materials and methods. We have carried out a comprehensive examination of 80 children aged 6 months to 3 years with acute obstructive bronchitis. Patients were divided into two groups: children of the first group (n = 40) received systemic glucocorticosteroids, children of the second group (n = 40) were treated with inhaled glucocorticosteroids. Before and after the treatment, in all children we have studied the content of IFN-γ, IL-4 and IL-13 in the blood serum using enzyme linked immunosorbent assay, the concentration of total IgE — by means of electrochemiluminescent immunoassay. The level of expression of the transcription factor NF-κB in peripheral blood lymphocytes was determined using flow cytometry. Results. Transcription factor NF-κB, having almost the same effect on the concentration of IFN-γ and IgE in the blood serum, determines the characteristics of inflammation, mainly local, in acute obstructive bronchitis. Glucocorticosteroid therapy leads to the disappearance of NF-κB influence on the content of proinflammatory cytokines. Inhaled glucocorticosteroids, in addition, help to reduce the concentration of IgE in the blood serum and inhibition of the activity of pro-inflammatory intracellular cascades that, at high clinical efficacy and safety profile, justifies the appropriateness of their use in the treatment of acute obstructive bronchitis in infants as pathogenetic therapy.

We used real-world and large-scale data to assess the clinical efficacy and safety of pembrolizumab in older patients with advanced urothelial carcinoma (UC).A total of 608 patients who received pembrolizumab for the treatment of chemoresistant UC were retrospectively analyzed. All patients were histologically diagnosed with pure UC. Using propensity score matching (PSM) (ECOG performance status, site of metastasis, hemoglobin level and neutrophil-to-lymphocyte ratio, 1:1 matching), the overall survival (OS) and adverse events (AEs) of patients75 and ≥75 years old were compared.The median follow-up (IQR) period was 16.1 (9.9-20.5) months. After PSM, there were 215 patients each in the aged75 years and aged ≥75-year-old groups. The median OS of all patients was estimated to be 10.4 months (95% confidence interval [CI] = 8.8-12.1). After PSM, the median OS was 7.8 months (95% CI = 5.2-10.4) in the75-year-old group and 10.4 months (95% CI = 7.3-13.5) in the ≥75-year-old group (P = 0.186). Any-grade AEs were more frequently reported in the ≥75-year-old group in comparison to the age75-year-old group (55.3% vs. 41.9%, P = 0.007), whereas there was no significant difference between the two groups in the incidence of grade ≥3 AEs (10.2% vs. 12.6%, P = 0.544). The objective response rate, defined as complete remission or a partial response, was 22.8% in the75-year-old group and 25.1% in the ≥75-year-old group (P = 0.651).The present study demonstrates that age does not affect the efficacy and safety of pembrolizumab treatment for advanced chemoresistant UC. Pembrolizumab treatment should not be avoided based on chronological age; however, close monitoring for the development of treatment-related AE should be considered for older patients.

Objective To evaluate the clinical effect of scraping therapy in the treatment of perimenopausal syndrome (PMS). Methods Thirty recruited PMS subjects were treated with scraping therapy in the Outpatient Department, Acupuncture-Moxibustion Hospital, China Academy of Chinese Medical Sciences, at the areas including Shenting (神庭GV24)—Bǎihui (百会GV20), Qihǎi (气海CV6)—Guānyuan (关元CV4), Zǐgōng (子宫EX-CA1), Zusānlǐ (足三里ST36)—Xiajuxū (下巨虚ST39), Dijī (地机SP8)—Sanyīnjiāo (三阴交SP6), Taichōng (太冲LR3)—Xingjiān (行间LR2), Gānshū (肝俞BL18)—Dǎnshū (胆俞BL19), Pishū (脾俞BL20)—Weishū (胃俞BL 21), and Sānjiāoshū (三焦俞BL 22)—Shenshū (肾俞BL 23), with an even reinforcing-reducing method. Before and after treatment, the serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) were tested. And before treatment and at the 4th week, 8th week, and 12th week of treatment, the Kupperman index (KI) and menopause-specific quality of life questionnaire (MENQOL) symptom scores were recorded for evaluating the clinical efficacy. Results Comparing with before treatment, the modified Kupperman symptom scores were all decreased after treatment, the difference was statistically significant (P 0.05); the total effective rate was 86% after the 4 weeks’ treatment, 97% after the 8 weeks’ treatment, and 96% after the 12 weeks’ treatment. Conclusion scraping therapy can relieve the PMS symptoms to some extent. It can improve the life quality of PMS subjects. Its influence on the estrogen levels of PMS subjects was not obvious.

Objective: To evaluate the clinical effects of erlotinib combined with concurrent chemoradiotherapy in the treatment of locally advanced pancreatic cancer. Methods: Eighty patients with locally advanced pancreatic cancer who attended Shijiazhuang People’s Hospital or Anhui Cancer Hospital between January 2018 and January 2020 were randomly divided into two groups, with 40 cases in each group. Patients in the control group were treated with concurrent chemoradiotherapy, while those in the experimental group were treated with erlotinib tablets based on the treatment regimen of the control group. Anti-tumor efficacy evaluation was conducted for all patients in both groups, and the adverse drug reactions, improvement of performance status after treatment were compared and analyzed between the two groups. Results: The overall response rate of the experimental group was 47.5%, which was significantly better than the 25% of the control group (p=0.03). The incidence of adverse drug reactions in the experimental group was 40%, while that in the control group was 30%. The incidence of adverse drug reactions in the experimental group was higher than that in the control group, but there was no statistical significance (p=0.34). Moreover, the improvement rate of performance status score in the experimental group was significantly higher than that in the control group (p=0.00). Conclusion: Erlotinib combined with concurrent chemoradiotherapy has been preliminarily proved to be safe and effective in the treatment of locally advanced pancreatic cancer, which can improve the physical condition of patients to a certain extent without significantly increasing adverse reactions. doi: https://doi.org/10.12669/pjms.38.1.4150 How to cite this:Liu C, Yu H, Hou Y, Gao Z, Zhang Y. Clinical efficacy evaluation of Erlotinib Combined with Concurrent Chemoradiotherapy in the treatment of locally advanced Pancreatic Cancer. Pak J Med Sci. 2022;38(1):118-122. doi: https://doi.org/10.12669/pjms.38.1.4150 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Introduction Programmed death 1 (PD‐1)/programmed death‐ligand 1 (PD‐L1) inhibitors are proved to be promising and are applied for the treatment of a variety of solid tumors. This retrospective study evaluated the efficacy of PD‐1/PD‐L1 inhibitors in patients with advanced solid tumors and explore the effect of clinical characteristics on it. Materials and Methods From October 2017 to April 2020, a total of 90 patients from Capital Medical University Affiliated Beijing Friendship Hospital were enrolled. Results At a median follow‐up of 10.55 months, objective response was observed in 23 patients and the objective response rate was 25.6%. The median progression‐free survival (PFS) was 5.5 months (95% confidence interval [CI], 3.69–7.37). The 6m‐PFS was 45.8% and 12m‐PFS was 25.1%. The median overall survival (OS) was 16.9 months (95% CI, not reached [NR]‐NR). The 12m‐OS was 58.1% and 18m‐OS was 48.1%. Conclusion The efficacy of PD‐1/PD‐L1 inhibitors in the treatment of advanced solid tumors was comparable to previous studies. ECOG performance status, smoking status, liver metastasis, neutrophil‐to‐lymphocyte ratio were independently correlated with PFS while liver metastasis and lactate dehydrogenase level were independently correlated with OS., we evaluate the efficacy of programmed death 1 (PD‐1)/programmed death‐ligand 1 (PD‐1/PD‐L1) inhibitors in patients with advanced solid tumors and explore the effect of clinical characteristics. ECOG status, smoking status, liver metastasis status, and NLR might predict the recurrence between PD‐1/PD‐L1 inhibitors treatment and liver metastasis, lactate dehydrogenase might predict the survival. This finding has great significance and value of the guidance for the application of immunotherapy.

It has taken four decades of research to see the first major breakthrough for KRAS-driven cancers. In particular, the last decade has seen a paradigm shift with the discovery of druggable pockets on KRAS and clinical efficacy with covalent KRASG12C inhibitors, culminating in the first approval of sotorasib monotherapy as second-line treatment in KRASG12C-driven non–small-cell lung cancer. Nevertheless, 85% of all KRAS-mutated cancers still lack novel agents. In this review, we will outline the structure, function, and post-translational modifications of KRAS and highlight the various approaches being adopted to drug KRAS, ranging from selective to pan concepts. The range of molecular modalities being explored, including PROTACs and glues, will also be described. Finally, an outlook toward the next wave of KRAS drugs and the challenges of resistance will be given.

Cancer is most dreadful disease affecting mankind. Many innovative healing modalities and hundreds of cancer treatments have resulted from extensive research. With chemotherapy and radiotherapy, surgical excision is the oldest and most tested method. This leads to therapy problems, poor health, and a decline in quality of life, all of which necessitate treatment discontinuation. Anorexia, diarrhoea, nausea, vomiting, and mucositis can all be caused by psychological causes. The anorexiacachexia syndrome is the most common cause of death among cancer patients. Cancer cachexia is characterised by metabolic, hormonal, and cytokine abnormalities that lead to progressive wasting. Swarna Vanga is a Kupipakwa Rasayana mentioned in Rasatarangini. Chemically it is stannous sulphide containing Shuddha Parad, Shuddha Vanga, Shuddha Gandhak, Shuddha Navasadar. Till today, no study has been carried out using Swarna Vanga for its Rasayana and Balya properties. Hence an attempt was given to study the pharmaceutical preparation, standardization and clinical efficacy of the drug in reducing adverse effects of chemotherapy with special reference to its Rasayana property through this dissertation. Thus the present study entitled “Pharmaceutical preparation and standardization of Swarna Vanga and its clinical efficacy as adjuvant to reduce adverse effects of chemotherapy with special reference to its Rasayana property” was carried out. Keywords: Swarna Vanga, adjuvant, Rasayana, cancer, chemotherapy, adverse effects, standardization.

Objective: To study the changes of several inflammatory index mechanism factors in the clinical efficacy of tablet and methotrexate in rheumatoid arthritis. Methods: 20 patients with rheumatoid arthritis were randomly divided into observation (n =10) and control (n =10), then normal people as normal (n=10), all three groups were given methotrexate and the observation group were treated with Qin interest pain tablets. Expression of inflammatory index mechanism factors in each group. Results: After treatment, inflammatory index mechanism factors were detected; a significant decrease of IFN-g, IL-1b, IL-10, IL-37, TNF-a and other factors was found before and after combination treatment (P

Purpose: To determine the curative impact of mesalazine (MSZ)-BTVCs combination on ulcerative colitis (UC), and its influence on inflammation and oxidative stress in the patients.Methods: 100 UC patients were randomely assigned to a control group given MSZ capsule treatment only, and a combination group treated with BTVCs and MSZ. Treatment effectiveness, inflammatory response, and oxidative stress in the two groups before and after treatment were compared.Results: The combination group had higher total effectiveness than the control group. The serum levels of MDA, high-sensitivity C-reactive protein (hs-CRP), TNF-α and interleukin-6 (IL-6) were lower, while serum levels of superoxide dismutase (SOD) and interleukin-10 (IL-10) were markedly increased in patients given combination treatment, when compared with controls. Pre-drug exposure UC disease activity index (UC-DAI) and clinical symptom scores were similar in both cohorts of patients, but the post-treatment scores were statistically decreased, especially in the combination group.Conclusion: The combined use of MSZ and BTVCs was more effective against UC than monotherapy, as it effectively relieved inflammation and oxidative stress in patients, resulting in better clinical efficacy.

Стаття присвячена лікуванню пацієнтів із хронічним рецидивуючим болем у нижній частині спини. Наведено дані дослідження клінічної ефективності та безпеки препарату Артрида®, застосування якого в комплексній терапії в момент загострення і наявності актуального больового синдрому дозволяло скорочувати терміни прийому і дози нестероїдних протизапальних препаратів, а також сприяло поліпшенню біомеханічних показників і функціональної здатності пацієнтів.

Background. To compare the diagnostic value of serum markers human epididymal protein 4 (HE4) and cyclooxygenase-1 (COX-1) combined with transvaginal color Doppler sonography (TVCDS) in ovarian cancer (OC) treated with Bushen Yiqi Quyu prescription. Methods. A total of 232 OC patients treated at the hospital from January 2018 to October 2020 were randomly divided into an observation group (n = 116) and control group (n = 116). The control group was treated with essential Western medication, and the observation group was treated with essential Western medication and Bushen Yiqi Quyu prescription. The clinical efficacy of the two groups was compared. The levels of HE4 and COX-1 were compared between the two groups before and after treatment. The ultrasonic features of TVCDS were compared between the two groups before and after treatment. The ROC curve was drawn to compare the sensitivity, specificity, and accuracy of single and combined detection of HE4, COX-1, and TVCDS in the observation group. Results. The total effective rate of the observation group was significantly higher than that of the control group. After treatment, HE4 and COX-1 levels in both groups were considerably lower than those before treatment, and in the observation group, they decreased significantly than in the control group. HE4 and COX-1 were positively correlated with the clinical stage of OC. The higher the clinical stage, the higher the levels of HE4 and COX-1. After treatment, there was no significant difference in tumor location and the boundary between the two groups. There were statistically significant differences in tumor echo, nature, morphology, calcification, internal blood flow, and lymph node metastasis, and the difference in the observation group was more evident than in control group. The sensitivity, specificity, accuracy, positive detection rate, and negative detection rate of combined detection were higher than those of single detection. Conclusions. Bushen Yiqi Quyu prescription has certain curative effects in the treatment of OC patients, which can significantly reduce the level of tumor markers and improve the symptoms of OC patients. The combined detection of HE4, COX-1, and TVCDS has high sensitivity, specificity, and accuracy, which can effectively detect OC and reduce missed diagnosis and misdiagnosis.

The effect of direct oral anticoagulants (DOACs) on evolution of a post-thrombotic syndrome (PTS) is unknown.This retrospective study included patients (n = 98) with a PTS occurring after a proximal deep-vein thrombosis (DVT). The PTS progression was assessed by the Villalta scale change over time from when patients were started on DOACs for the prevention of DVT recurrence according to current guidelines. The PTS evolution was compared between patients with good (n = 63) vs. poor (n = 35) DOACs adherence, defined by using a medication possession ratio cut point of 0.80. The mean follow-up was 41.7 ± 17.7 and 27.5 ± 10.5 months in patients with good or poor adherence, respectively. The primary endpoint of PTS improvement (defined when the Villalta score became5 and/or decreased by ≥30% from baseline) was higher in patients with good vs. poor adherence (66.7% vs. 20%, p 0.001). None of the patients in the good adherence group experienced at any time of follow-up the co-primary endpoint of PTS worsening (defined as the Villalta score increase ≥30%), which instead occurred in 12 (34.3%) of those with poor adherence (p 0.001). All study-defined primary endpoints occurred within 2 years. The mean values of the Villalta partial scores related to the subjective symptoms (patient-rated) and to the potentially reversible physician-rated signs were significantly improved in the good adherence group, while they were unchanged among patients with poor adherence.In this study a good vs. poor DOACs adherence was associated with a more favorable progression of PTS over a long-term follow-up. Larger studies are needed to explore the clinical efficacy of DOACs on PTS manifestations.

This meta-analysis was performed to evaluate the clinical efficacy and safety of Chinese patent medicines in the treatment of subacute thyroiditis (SAT).Chinese databases were searched using a combination of "patent Chinese medicine", "traditional Chinese medicine", "traditional Chinese and western medicine", "sub-thyroiditis", and "subacute thyroiditis". Studies that set Chinese patent medicine treatment of SAT as the experimental group were selected. Then, meta-analysis was performed by RevMan 5.3.A total of 12 studies were included, and most of them had a high risk of bias (low quality). The heterogeneity test results of clinical efficacy showed that Chi2=6.21, df=7, P=0.520.1, and I2=0%50%. Then, the fixed effects model (FEM) was used, with OR =2.80; 95% confidence interval (CI): 1.89-4.13. The heterogeneity test of recurrence rate showed that Chi2=10.69, df=9, P=0.300.1, and I2=16%50%. The heterogeneity test of erythrocyte sedimentation rate showed that I2=97%, P0.00001, MD =-10.02; 95% CI: -12.88 to -7.16, and P0.00001. The heterogeneity test of free triiodothyronine showed that Chi2=500.75, I2=99%50%, P0.00001, MD =-2.88; 95% CI: -3.85 to -1.91; Z=5.83, and P0.00001. The heterogeneity test of free thyroid hormone showed that Chi2=25.15, I2=72%50%, P=0.0007, MD =-2.48; 95% CI: -3.69 to -1.26; Z=3.99, and P0.0001. The heterogeneity test of the occurrence of adverse reactions showed that Chi2=11.28, df=11, P=0.420.1, and I2=3%50%, and the combined effect size was Z=6.49 and P0.00001, with OR =0.21; 95% CI: 0.13-0.34.The meta-analysis of this study confirms that Chinese patent medicines have considerable clinical effects in the treatment of SAT. They can reduce the recurrence rate, adjust the levels of free triiodothyronine and free thyroid hormone, and have good safety.

Objective. To unearth the clinical efficacy of tacrolimus ointment + 3 % boric acid lotion joint Chinese angelica decoction in chronic perianal eczema. Methods. Patients with chronic perianal eczema admitted to hospital from June 2018 and June 2019 were retrospectively analyzed. Patients in the control group ( n = 38 ) underwent basic therapy with tacrolimus ointment + 3 % boric acid lotion, whereas those in the observation group ( n = 38 ) were given oral Chinese angelica decoction on the basis of the above therapy. Patient’s baseline information before therapy and clinical symptoms after therapy were observed and compared, including pruritus ani score, anus drainage and damp score, skin lesion score, skin lesion area score, life quality index score, and IL-2, IL-4, and IgE levels in serum. Overall efficacy in the two groups was also evaluated. Results. No significant differences were found in the baseline information between the observation group and control group before therapy. After therapy, pruritus ani score ( P = 0.023 ), anus drainage and damp score ( P = 0.041 ), skin lesion score ( P = 0.025 ), and skin lesion area score ( P = 0.035 ) of patients in the observation group were remarkably lower than those in the control group. Significantly higher release levels of clinical symptoms of patients in the observation group were indicated. With respect to the control group, the life quality score ( P = 0.020 ) and IgE level in serum ( P = 0.003 ) of patients in the observation group were significantly lower, while IL-4 level in serum was significantly higher ( P = 0.129 ). The therapy in the observation group achieved better clinical efficacy. Overall efficacy in the observation group was markedly favorable with respect to the control group. Conclusion. With respect to tacrolimus ointment + 3 % boric acid lotion, patients with chronic perianal eczema displayed better clinical efficacy after jointly being treated by Chinese angelica decoction.

Objective: This study aims for three purposes: a) review the published MCDAs in oncology to identify the criteria considered valuable by the stakeholders, b) evaluate the adherence to best practice recommendations, and c) Propose a value tree, based on the findings of the systematic review, reflecting the most important criteria for the different stakeholders. Material and Methods: This systematic review consisted of the following phases: identification, screening, eligibility assessment, assessment of adherence to best practices, and extraction of the information. The identification was conducted in PUBMED, EMBASE, EBSCO, SCIENCE DIRECT, SCOPUS, LILACS, and Web of Science including records from January 1st, 1990, to February 28th, 2021. The adherence to best practices in MCDA were evaluated. A new value tree was made. Results: Thirteen articles were included. Colon, breast, and hematological cancer were the most frequently evaluated (n=10, 69,2%). Physicians and patients were the most representative participants. The value measurement approach was the most used (n=11, 84,6%). The overall adherence rate to the recommendations was 77,3%. One hundred ninety-five criteria were identified. The relevant criteria for all stakeholders were “Improvement clinical efficacy" (24,5%), "Severity of disease" (13,5%), and "Improvement of safety & tolerability." (10,3%). The physicians valued "Improvement clinical efficacy" (28,4%), "Severity of disease" (10,5%), and "Improvement of safety & tolerability." (8,4%) The most relevant criterion for the patients was "Severity of disease" (34,4%), "Improvement of clinical efficacy." (24,1%), and "Improvement of perceived health status" (13,8%). The significant criteria for administrative and academics were "Innovativeness of intervention" (37%) and "Improvement clinical efficacy" (14,8%). Conclusion: The number of MCDAs in oncology is scarce and with moderate adherence to best practice recommendations. A value tree based on relevant criteria was proposed.

Purpose The aim of this meta-analysis is to compare the clinical efficacy and safety of baloxavir with other anti-influenza agents or placebo in the treatment of influenza. Methods PubMed, Embase, Web of Science, Google Scholar, Scopus, CINAHL, Cochrane databases and clinical registration were searched from inception until February 15 2021 for relevant randomized controlled trials (RCTs). Only phase 3 RCTs evaluating the usefulness of baloxavir in the treatment of influenza were included. Results Three RCTs enrolling 3771 patients (baloxavir group, n = 1451; oseltamivir group, n = 1288; placebo group, n = 1032) were included. Compared with oseltamivir, baloxavir had an insignificantly shorter time to the alleviation of symptoms (mean difference [MD], −1.29 h; 95% CI, −6.80 to 4.21; I2 = 0%). In contrast, baloxavir had a significantly shorter time to the alleviation of symptoms than placebo (MD, −26.32 h; 95% CI, −33.78 to −18.86; I2 = 0%). Baloxavir was associated with a significant decline in influenza virus titers and viral RNA load compared to oseltamivir and placebo. Baloxavir was associated with a lower risk of any adverse events than oseltamivir (OR, 0.82; 95% CI, 0.69–0.98; I2 = 0%) and placebo (OR, 0.79; 95% CI, 0.66–0.96; I2 = 0%). Conclusions The findings of this meta-analysis suggested that baloxavir is superior to placebo in the treatment of influenza in both clinical outcome and virological response. Moreover, baloxavir was found to have a better virological response than oseltamivir and to be as effective as oseltamivir clinically. Compared with oseltamivir and placebo, baloxavir appears to be a relatively safe anti-influenza agent.

Introduction: [177Lu]Lu-prostate-specific membrane antigen (PSMA)-617 has emerged as a promising radiopharmaceutical for targeting PSMA in metastatic castrate-resistant prostate carcinoma (mCRPC). ...

Our previous clinical study achieved complete remission (CR) rates of >90% following chimeric antigen receptor T cells targeting CD19 (CART19) treatment of refractory/relapsed B cell acute lymphoblastic leukemia (r/r B-ALL); however, the influence of the leukemia burden in peripheral blood (PB) blasts remains unclear. Here, we retrospectively analyzed 143 patients treated with CART19 (including 36 patients with PB blasts) to evaluate the effect of peripheral leukemia burden at the time of apheresis. One hundred seventeen patients with high disease burdens achieved 91.5% CR or incomplete count recovery CR and 86.3% minimal residual disease-negative CR, and 26 patients with low disease burdens obtained 96.2% MRD− CR. Collectively, 9 of 36 (25%) patients with PB blasts and 2 of 107 (1.87%) patients without PB blasts did not respond to CART19 therapy. The leukemia burden in PB negatively influenced ex vivo cell characteristics, including the transduction efficiency of CD3+ T cells and their fold expansion, and in vivo cell dynamics, including peak CART19 proportion and absolute count, fold expansion, and persistence duration. Further studies showed that these patients had higher programmed death-1 expression in CART19 products. Our data imply that PB blasts negatively affected CART19 production and the clinical efficacy of CART19 therapy in patients with r/r B-ALL., Graphical abstract, Chunrong Tong and colleagues demonstrate for the first time the adverse effects of peripheral blood (PB) blasts in refractory/relapsed B cell acute lymphoblastic leukemia treated with chimeric antigen receptor T cells targeting CD19. Their data implied that PB blasts at the time of apheresis negatively affected ex vivo and in vivo CART19 characteristics and subsequent clinical efficacy.

To observe the clinical efficacy of ‘Tong Du Yun Pi’ (Governor Vessel-unblocking and spleen-promoting) manipulation in treating infantile diarrhea in autumn. Eighty-four kids were divided into a control group and an observation group using the random number table method, with 42 cases in each group. The control group was intervened by oral administration of montmorillonite powder, and the observation group was given additional ‘Tong Du Yun Pi’ pediatric massage (tuina) treatment. After treatment, the traditional Chinese medicine (TCM) symptoms scores, symptom improvement time, clinical efficacy and immune function indicators were compared between the two groups. After treatment, the total effective rate was 95.2% in the observation group versus 76.2% in the control group, and the between-group difference was statistically significant (P

Background: In this systematic review and meta-analysis, we aimed to assess the clinical efficacy and safety of cefoperazone–sulbactam against alternative antibiotics in the treatment of intra-abdo...

Objective: To review the pharmacology, dosing and administration, safety, clinical efficacy, and role of eptacog beta in the treatment of congenital hemophilia with inhibitors. Data Sources: A literature search of PubMed (1966 to August 2021) was conducted using the keywords eptacog beta, recombinant FVII, and hemophilia. Study Selection and Data Extraction: All relevant published articles and prescribing information on eptacog beta for the treatment of congenital hemophilia with inhibitors were reviewed. Data Synthesis: Eptacog beta is a novel recombinant activated factor VII (rVIIa) product that demonstrated efficacy in controlling bleeding and associated pain in patients with hemophilia A or B with inhibitors. Eptacog beta has limited Food and Drug Administration–approved and off-label indications compared with other bypassing agents (BPAs; activated prothrombin complex concentrates [aPCC; eptacog alfa]). Eptacog beta costs less than eptacog alfa, but still more than aPCCs. Relevance to Patient Care and Clinical Practice: This review provides insight into the role of eptacog beta for treatment of congenital hemophilia with inhibitors and reviews important health system formulary considerations for available BPAs. Conclusions: Eptacog beta is more cost-effective than eptacog alfa and, as such, may become the preferred rVIIa formulary product. However, eptacog alfa availability remains necessary for the treatment of disorders where eptacog beta has limited data. aPCC should remain the first-line BPA for the treatment of bleeding in patients with inhibitors with no contraindications to use because of its equivocal efficacy and safety and in light of the magnitude of cost savings associated with this strategy.

Objective: There are many clinical reports on traditional Chinese medicine (TCM) combined with nucleoside (acid) analogues (NAs) for the treatment of chronic hepatitis B (CHB), but its efficacy and safety are not completely clear. This meta-analysis aims to evaluate the clinical efficacy and safety thus providing evidence for clinical applications. Methods: We searched Chinese databases the China National Knowledge Infrastructure (CNKI), Wanfang Data, and China Science and Technology Journal Database (VIP), as well as English databases PubMed and Cochrane Library, from time of establishment to April 14, 2021. Literature quality was evaluated according to the bias risk assessment criteria of Cochrane Collaboration network. RevMan 5.3 and Stata 12.0 software were used to perform this research. Results: A total of 23 articles, 3 282 patients, and 25 TCM prescriptions were included in this study. NAs plus TCM remarkably improved the clinical total effective rate [Odds ratio (OR) = 3.92, P < 0.000 01], TCM syndrome score (Mean difference = − 3.73, P < 0.000 01), hepatitis B virus (HBV) DNA negative conversion rate (OR = 1.49, P = 0.000 1), hepatitis Be antigen (HBeAg) negative conversion rate (OR = 2.03, P < 0.000 01), alanine aminotransferase levels [Std mean difference (SMD) = − 0.95, P < 0.000 01], and aspartate aminotransferase levels (SMD = − 0.70, P = 0.000 4). Adverse reaction rates did not increase in the combined treatment group (OR = 0.97, P = 0.84). A comprehensive analysis of the 25 TCM prescriptions suggested that the combination of spleen-strengthening prescriptions with NAs showed better effects than other prescriptions. Conclusion: TCM in combination with NAs, demonstrated better clinical efficacy against CHB than NAs alone. In addition, the combination of spleen-strengthening prescriptions and NAs was identified as the best therapeutic strategy. However, more randomized controlled trials of high quality are needed to provide more reliable clinical basis for the application of TCM.

Objective: To analyze and evaluate the clinical efficacy of targeted navel drops in the treatment of diabetes mellitus. Methods: The time span of the study was from September 2020 to April 2021, and 288 diabetic patients were selected from our hospital. The patients were divided into research group (n = 96) group, control group 1 (n = 96) and control group 2 (n = 96) by random number table. Control group 1 was managed with diet and exercise alone, control group 2 was treated with metformin on the basis of control group 1, and based on the treatment plan of the two control groups, the research group was treated with targeted navel drops. The relevant indexes of the three groups were compared and analyzed. Results: There was no significant difference in the fasting blood glucose and 2-hour postprandial blood glucose among the three groups (p > 0.05) before the treatment. After treatment, the fasting blood glucose and 2-hour postprandial blood glucose of the research group were significantly lower than those of control group 1 and control group 2 (p < 0.05). The total effective rate of the research group was 95.8%, that of control group 1 was 85.4%, and that of control group 2 was 79.2%. The total effective rate of the research group was significantly higher than that of control group 1 and control group 2 (p < 0.05). Conclusion: There is a significant effect of targeted navel drops on diabetic patients in reducing their blood sugar levels, and its curative effect is better than using a single hypoglycemic therapy belonging to western medicine. It can be widely promoted at all levels in medical institutions.

Актуальність. Діагностика та лікування діабетичної полінейропатії мають особливе значення для хворих на цукровий діабет, оскільки вона може призводити до тяжких наслідків. Метою дослідження було підвищення ефективності лікування невропатичного болю шляхом включення препарату келтикан та поляризуючого світла в комплексну терапію діабетичної полінейропатії. Матеріали та методи. Обстежено 99 хворих на цукровий діабет 2-го типу, ускладнений діабетичною полінейропатією. Пацієнти були розподілені на 3 групи: до контрольної групи увійшли 32 пацієнти, які отримували стандартне лікування, 32 хворі 2-ї групи додатково отримували келтикан по 1 капсулі тричі на добу впродовж місяця, а 35 хворим 3-ї групи додатково було призначено 12 лікувальних процедур поляризуючим світлом. Оцінку інтенсивності невропатичного болю проводили за допомогою модифікованого опитувальника DN4. Результати. Установлено позитивний клінічний ефект лікування в усіх групах після 12-денного курсу лікування, який зберігався впродовж 3 місяців у 2-й та 3-й групах, а через 6 місяців — лише в групі з додатковим призначенням келтикану. Висновки. Використання опитувальника DN4 із модифікованою шкалою оцінки показників невропатичного болю дозволяє оптимізувати діагностику даного ускладнення у хворих на цукровий діабет. Включення препарату келтикан та поляризуючого світла в стандартну комплексну терапію діабетичної полінейропатії підвищує клінічну ефективність лікування невропатичного болю.

У статті розглядається місце пантопразолу в терапії кислотозалежних захворювань у дітей. Підкреслено, що в практичній гастроентерології окрім оригінальних інгібіторів протонної помпи (брендів) використовують також препарати-генерики, які, на відміну від оригінальних інгібіторів протонної помпи, є набагато доступнішими для більшості пацієнтів. Метою висвітленої в статті роботи було вивчення клінічної ефективності генеричного препарату пантопразолу (Золопент) при лікуванні кислотозалежних захворювань у дітей. Золопент проявив себе як високоефективний антисекреторний препарат для лікування кислотозалежних захворювань (хронічного гастродуоденіту, виразкової хвороби, гастроезофагеальної рефлюксної хвороби) у дітей, що добре переноситься дітьми й не викликає побічних реакцій.

Introduction Pelvic congestion syndrome (PCS) may be effectively managed with conservative treatment in certain patients. Treatment with venoactive drugs is common, but supportive data are limited. This study evaluated the clinical efficacy of micronized purified flavonoid fraction (MPFF) in women with PCS. Methods In a single-blind, placebo-controlled study, women with duplex ultrasound diagnosis of pelvic varicose veins (PVV) and PCS were randomized to MPFF 1000 mg once daily or placebo for 2 months. Clinical manifestations of PCS were evaluated at baseline and end of treatment (M2) using three assessment tools: disease-specific quality of life (QoL) Pelvic Varicose Vein Questionnaire (PVVQ), Pelvic Venous Clinical Severity Score (PVCSS), and the Visual Analog Scale (VAS) for the main symptoms of the disease. Results A total of 83 women were included, 42 received MPFF and 41 received placebo. In the MPFF group, the mean global PVVQ QoL index decreased significantly from 45.1 ± 14.7 at baseline to 36.6 ± 10.6 at M2 (mean change: 8.2 ± 10.4); no significant change was observed in the control group (mean change: – 0.3 ± 4.0). The between-group difference was statistically significant (P

Tabkheer-i-meda has been described as reflux of acid from stomach in the Unani classical literatures. This disease is characterized by various symptoms like indigestion, pain in abdomen, suppression of thrust, burning sensation in the epigastrium, anorexia, nausea and acid reflux etc. In modern medicine, Gastro-esophageal Reflux Disease (GERD) is defined as symptoms or mucosal damage produced by the abnormal reflux of gastric contents into the esophagus or beyond, into the oral cavity (including larynx) or lungs. The objective of the present study was to evaluate the efficacy of Safoof-i-Tabkheer on the patients suffering with associated symptoms of Tabkheer-i-Meda (Gastro-esophageal Reflux Disease). Patients were advised orally 5grams of Safoof-i-Tabkheer with water twice daily after the meal. It was observed that after the treatment, all associated symptoms of Tabkheer-i-Meda/ GRED including retrosternal burning, epigastric pain acidic brash and anorexia were significantly (p

BACKGROUND AND AIM This study aimed to determine the efficacy and safety of vedolizumab treatment with or without concomitant immunomodulator use in Japanese patients with moderate-to-severe ulcerative colitis. METHODS Among enrolled patients in a phase 3 study conducted in Japan (clinicaltrials.gov, NCT02039505), data from patients allocated to 300-mg intravenous vedolizumab for induction and maintenance phases were used for this exploratory analysis. Efficacy endpoints were clinical response, clinical remission, and mucosal healing at week 10 and clinical remission and mucosal healing at week 60, and disease worsening and treatment failure during the maintenance phase. RESULTS At week 10, the differences in clinical response, clinical remission, and mucosal healing rates between the subgroups (those with concomitant immunomodulator use minus those without) were 0.7 (95% confidence interval: -14.3, 15.7), 3.3 (95% confidence interval: -8.5, 15.2), and 1.8 (95% confidence interval: -13.0, 16.5), respectively. At week 60, the differences in clinical remission and mucosal healing between the subgroups with and without concomitant immunomodulator use were 26.1 (95% confidence interval: -3.5, 55.6) and 29.9 (95% confidence interval: 1.4, 58.4), respectively. The proportions of patients without treatment failure at day 330 of the maintenance phase were 90.7% with concomitant immunomodulator use and 73.7% without. No marked differences in incidence of infections were observed between subgroups. CONCLUSIONS This study suggested the possibility that concomitant immunomodulator use may be beneficial to maintain the clinical efficacy of vedolizumab.

The clinical efficacy of remote dielectric sensing (ReDS) monitoring is not well known. Digital databases were searched to identify relevant articles. Pooled unadjusted odds ratio (OR) for dichotomous outcomes were calculated using a random-effects model. Findings were reported as a point estimate with its 95% confidence interval (CI). A total of 985 patients across seven studies were included in the meta-analysis. Patients with heart failure monitored with ReDS had significantly lower odds of hospital readmission compared with non-ReDS patients (OR = 0.40; 95% CI 0.29–0.56; z = 5.43 p = 0.000, I2 = 0%). Subgroup analysis based on the duration of follow-up showed a lower odd of readmission within 30 days (OR = 0.36; 95% CI 0.18–0.71; z = 2.93; p = 0.003; I2 5.7%), as well as between 1 and 3 months (OR = 0.42; 95% CI 0.29–0.61; z = 4.54; p = 0.000; I2 = 0.0%). ReDS effect of lower readmissions of HF was observed irrespective of the duration of follow-up (

Background and Aim Vedolizumab is a humanized monoclonal antibody that selectively inhibits the migration of gut‐homing memory T cells into the intestinal submucosa by antagonizing the interaction of α4β7 integrin with MAdCAM‐1. Vedolizumab is employed for ulcerative colitis with moderate to severe activity; however, predictors of its clinical efficacy have not been established in real‐world clinical practice. We investigated the clinical characteristics predicting vedolizumab efficacy. Methods This was a single‐center, retrospective, observational study that enrolled patients with ulcerative colitis at Kyorin University Hospital. Fifty‐two consecutive patients who started vedolizumab induction therapy and were tracked for minimum 14 weeks between August 2018 and February 2021 were included. Clinical and endoscopic disease activities were scored at baseline and at weeks 2, 6, and 14 with the Lichtiger index and at baseline and week 24 with the Mayo endoscopic subscore, respectively. Clinical remission, clinical response, and endoscopic remission were defined as Lichtiger index of ≤3, Lichtiger index of ≤10 with a reduction of minimum 3 points from baseline, and Mayo endoscopic subscore of ≤1, respectively. Results In these cases, clinical response/remission rates at weeks 2, 6, and 14 were 26.9%/15.3%, 50.0%/46.3%, and 57.6%/50.0%, respectively. The endoscopic remission rate at week 24 was 60%. The clinical response at week 6 was significantly associated with endoscopic remission at week 24 after starting vedolizumab. Conclusions In vedolizumab treatment for ulcerative colitis, the clinical response at week 6 can be a predictor for endoscopic remission at week 24., Clinical response of vedolizumab at week 6 predicted endoscopic remission at week 24 in ulcerative colitis with moderate to severe activity.

Cervical cancer patients who develop distant metastasis are rarely curable with very limited treatment options. Chemotherapy is often administered but with limited efficacy. Immunotherapy and anti-angiogenesis therapy are recommended for selected cases of recurrent or metastatic cervical cancers. The clinical efficacy of inhibitors targeting HER2, a commonly mutated gene in cervical cancer, has not been elucidated. Herein, we report a metastatic cervical adenocarcinoma patient carrying HER2 G292R who benefited from pyrotinib after progression on radio-chemotherapy, achieving complete response (CR) with a progression-free survival of 25 months and counting. Our study sheds light on the treatment options for previously treated metastatic cervical adenocarcinoma patients harboring activating HER2 mutations.

There is no specific drug for coronavirus disease 2019 (COVID-19). We aimed to investigate the possible clinical efficacy of moderate-dose vitamin C infusion among inpatients with severe COVID-19. Data of 397 adult patients with severe COVID-19 admitted to a designated clinical center of Wuhan Union Hospital (China) between February 13 and February 29, 2020, were collected. Besides standard therapies, patients were treated with vitamin C (2–4 g/day) or not. The primary outcome was all-cause death. Secondary outcome was clinical improvement of 2 points on a 6-point ordinal scale. About 70 participants were treated with intravenous vitamin C, and 327 did not receive it. No significant association was found between vitamin C use and death on inverse probability treatment weighting (IPTW) analysis (weighted hazard ratio [HR], 2.69; 95% confidence interval [CI], 0.91–7.89). Clinical improvement occurred in 74.3% (52/70) of patients in the vitamin C group and 95.1% (311/327) in the no vitamin C group. No significant difference was observed between the two groups on IPTW analysis (weighted HR, 0.76; 95% CI, 0.55–1.07). Our findings revealed that in patients with severe COVID-19, treatment with moderate dose of intravenous vitamin C had no significant benefit on reducing the risk of death and obtaining clinical improvement.

Objective: To evaluate the clinical efficacy and safety of cefetamet pivoxil for the treatment of acute bacterial rhinosinusitis in Korean patients compared to treatment with cefdinir. Methods: A prospective, multicenter, randomized double-blind, comparative study was conducted by the Departments of Otorhinolaryngology–Head and Neck Surgery at 17 hospitals or universities in the Republic of Korea from March 2017 to April 2019. A total of 309 patients were screened and 249 patients participated in the study. Results: Treatment with cefetamet pivoxil for 2 weeks showed 82.4% clinical cure and improvement rates in patients with acute bacterial rhinosinusitis compared to 84.68% in those taking cefdinir for 2 weeks, showing that cefetamet pivoxil administered twice a day for 2 weeks was as effective as cefdinir 3 times a day for 2 weeks for the treatment of acute bacterial rhinosinusitis. The overall adverse reaction rates of both drugs were 10.56% in the cefetamet pivoxil group and 15.49% in the cefdinir group, without serious adverse events or drug reactions. Conclusions: Cefetamet pivoxil twice a day was as efficacious and safe as cefdinir 3 times a day for the treatment of acute bacterial rhinosinusitis, which suggested that cefetamet pivoxil may be a suitable alternative to cefdinir.

The main objective is to evaluate clinical efficacy and safety of using calcipotriol–betamethasone compounding agent for psoriasis treatment through a systematic review and meta-analysis. We searched MEDLINE, Embase, The Cochrane Library, China National Knowledge Infrastructure (CNKI), China Biomedical Literature Database (CBM), and WanFang Data from inception till July 31, 2020. Efficacy was evaluated based on primary outcome indicators including skin lesion improvement and overall adverse reaction rate. Secondary outcome indicators included degree of life quality improvement, clinical effectiveness rate, and specific adverse reaction rates. RevMan5.3 was used to perform the meta-analysis. 22 studies finally met our inclusion criteria for the meta-analysis. The results indicated that for short-term treatment, a sequential therapy that uses calcipotriol betamethasone compounding agent and calcipotriol improves PASI score (MD = −0.94, 95% CI − 1.38 ~ − 0.49, P

This study evaluated the clinical efficacy of leflunomide combined with low-dose prednisone (0.25 mg/kg/day) for treatment of myasthenia gravis (MG). We enrolled 32 MG patients treated with leflunomide combined with low-dose prednisone. In the control group, 14 patients were treated with low-dose prednisone. Improvement in MG composite (MGC) score of ≥ 3 points from enrollment to 12-week follow-up indicated that the treatment was effective. In the leflunomide combined low-dose prednisone group, the median of MGC score at the time of enrollment was 8.5 points. After 12 weeks, the MGC score dropped to four points. There was statistically significant difference in MGC score before and after treatment (p

Introduction.Traditional antiallergic therapy for atopic dermatitis, including allergen elimination, therapeutic cosmetic skin care, external anti-inflammatory therapy and antihistamines, does not always lead to the desired result. On this basis, the search for new methods of treatment is urgent and promisingAim.To study the clinical efficacy of a combination of Lactobacillus rhamnosus GG and prebiotics in children in the first years of life with atopic dermatitis (AD).Materials and methods. The observed children were divided into 2 parts: 30 children aged from 1 month to 3 years old, patients with AD constituted the main group, it differed in that these patients were synbiotic (combination of Lactobacillus rhamnosus GG and prebiotics) – 1 sachet per day for 14 days. This drug was prescribed as part of complex therapy. The remaining 25 children with AD made up a comparison group, which was characterized by the fact that children received only antiallergic therapy without symbiotic. Clinical methods of blood pressure examination, laboratory instrumental and specific allergological methods were carried out.Results and discussion. Against the background of the therapy in children with blood pressure in the main group, общий overall treatment effect was higher and amounted to 86.6 + 4.0%, and in the comparison group – 76.0 + 3.9%, p Conclusions.The obtained results allow us to recommend a combination of Lactobacillus rhamnosus GG and prebiotics in children in the first years of life as part of complex therapy to increase the effectiveness of treatment.

The retrospective pragmatic real-world data (RWD) study compared the healing outcomes of diabetic foot ulcers (DFUs) treated with either ovine forestomach matrix (OFM) (n = 1150) or collagen/oxidised regenerated cellulose (ORC) (n = 1072) in out-patient wound care centres. Median time to wound closure was significantly (P = .0015) faster in the OFM group (14.6 ± 0.5 weeks) relative to the collagen/ORC group (16.4 ± 0.7). A sub-group analysis was performed to understand the relative efficacy in DFUs requiring longer periods of treatment and showed that DFUs treated with OFM healed up to 5.3 weeks faster in these challenging wounds. The percentage of wounds closed at 36 weeks was significantly improved in OFM treated DFUs relative to the collagen/ORC. A Cox proportional hazards analysis showed OFM-treated wounds had a 18% greater probability of healing versus wounds managed with collagen/ORC, and the probability increased to 21% when the analysis was adjusted for multiple variables. This study represents the first large retrospective RWD analysis comparing OFM and collagen/ORC and supports the clinical efficacy of OFM in the treatment of DFUs.

Objective: To discuss the management of safe medication in the treatment of internal diseases in traditional Chinese medicine. Methods: 124 patients with medical diseases were divided into experimental group and control group by random number table method, with 62 cases in each group. The experimental group implemented safe medication management, and the control group implemented routine medication management, all of which were treated for 4 consecutive weeks. The comparison of the improvement of the quality of life, the compliance rate of safe medication and the adverse drug reactions of the two groups after clinical treatment were compared. Results: After 8 weeks of treatment, there was a significant difference in clinical efficacy between the two groups of patients. In terms of quality-of-life scores, the scores of the experimental group were better than those of the control group. The living ability, condition, physical strength and other conditions of patients were significantly different. The t-values were 15.3427, 14.0275, and 7.7113, respectively, and P

Currently chondroitin sulfate (CS) is the most studied drug from the group of «chondroprotectors». The article shows the role of CS in the treatment of osteoarthritis (OA): mechanism of action, clinical efficacy and safety in patients with OA with comorbidity. Evidence for the effectiveness and safety of the use of CS has been analyzed. The place of this drug in Russian and international clinical guidelines for the management of patients with OA is discussed.In domestic practice, the parenteral form of CS is often used in patients with OA. The parenteral form of CS for intramuscular and intra-articular administration (Chondroguard®) has a number of advantages, including the rapid onset of the effect. This enables reducing the dose in a short time or completely abandon the use of non-steroidal anti-inflammatory drugs (NSAIDs), which is extremely important for patients with OA with comorbidity. Chondroguard®can be recommended for initial use in exacerbations of chronic joint and back pain in OA, including in patients with relative and absolute contraindications for NSAID therapy.

Was ist neu? Therapie mit Givosiran Givosiran ist ein kleines synthetisches doppelsträngiges siRNA-Fragment mit 20 Basenpaaren Länge. Eine prospektive, randomisierte multizentrische Studie (Envision) zeigte erstmalig die klinische Wirksamkeit von monatlich subkutan applizierten synthetischen RNA-Molekülen („small interfering“ RNA, siRNA) zur Prävention von Attacken bei akuten hepatischen Porphyrien (AHP) 2. Die Koppelung von siRNA-Molekülen an N-Acetyl-Galaktosamin (GalNAc) und die hierdurch leberspezifische Aufnahme durch den Asialoglykoprotein-Rezeptor auf Hepatozyten sind ein Meilenstein in der Hepatologie. Dies führt zu einer hochselektiven Inhibition der Translation der bei AHP überexprimierten hepatischen Aminolävulinsäure-Synthase (ALAS1). Givosiran wurde in den USA und in Europa zur Behandlung akuter hepatischer Porphyrien zugelassen. Fazit Der Erfolg dieser innovativen Therapie eröffnet die Möglichkeit, prinzipiell jeden Prozess auf der Ebene der hepatozytären mRNA-Translation zu hemmen. Der therapeutische Effekt der stabilisierten siRNA hält über Wochen an. Die Behandlung mit Givosiran ist aktuell jedoch sehr kostenintensiv. Aufgrund von bislang unverstandenen Veränderungen der Nierenfunktion und Aminotransferasen ist im ersten halben Jahr zudem eine monatliche Überwachung nötig.

By sorting and analyzing pertinent modern studies targeting auricular point therapy treating primary insomnia (PI), to summarize the point selection rules and clinical efficacy of using auricular points alone or combining it with other therapies in treating PI. A search on China National Knowledge Infrastructure (CNKI), Wanfang Academic Journal Full-text Database (Wanfang), Chongqing VIP Database (CQVIP), PubMed, Springer and Ovid were conducted from January 1, 1998 till January 31, 2020. Point selection, diagnostic criteria and Pittsburgh sleep quality index (PSQI) in the eligible studies were analyzed and summarized. The difference in PSQI before and after using auricular point therapy alone was more significant than that of using Chinese medication alone (P

Objective: This phase 3 study aimed to test equivalence in efficacy and safety for QL1101, a bevacizumab analogue in Chinese patients with untreated locally advanced non-squamous non-small cell lung cancer (NSCLC). Methods: Eligible patients were randomly assigned 1:1 to receive carboplatin and paclitaxel in combination with either QL1101 or bevacizumab, 15 mg/kg every 3-week for 6 cycles. This was followed by maintenance treatment with single agent QL1101 every 3-week. The primary end-point was objective response rate (ORR), with secondary end-points being progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and adverse events (AEs). Results: Of 675 patients, 535 eligible patients were randomized to the QL1101 group (n = 269) and bevacizumab group (n = 266). ORRs were 52.8% and 56.8%, respectively, for the QL1101 and bevacizumab groups, with an ORR hazard ratio 0.93 (95% confidence interval: 0.8–0131.1). The PFS, OS, DCR, and AEs were comparable between the 2 groups, which remained the same after stratification according to epidermal growth factor receptor mutation or smoking history. Conclusions: QL1101 showed similar efficacy and safety profiles as compared to bevacizumab among Chinese patients with untreated locally advanced non-squamous NSCLC.

Objective: To observe the efficacy of Yin-tonifying Ophiopogonis Decoction combined with Rehabilitation New Liquid in the treatment of reflux esophagitis (RE). Methods: Seventy-four patients with RE were included in the study and they were divided into an observation group and a control group using the random number table method with 37 cases in each group. The patients in the control group were given oral Yin-tonifying Ophiopogonis Decoction whereas the patients in the observation group were additionally treated with the Rehabilitation New Liquid. The clinical efficacy, traditional Chinese medicine (TCM) symptoms, and the efficiency of gastroscopy were compared between the two groups. Results: The total effective rate of clinical symptoms, TCM symptoms, and gastroscopy results between the observation group and the control group were significantly different (P < 0.05) and were statistically significant. Conclusion: The clinical effect of Yin-tonifying Ophiopogonis Decoction combined with the Rehabilitation New Liquid in the treatment of RE is significant.

Background Osteoarthritis (OA), the most common degenerative joint disease, is associated with severe functional limitation and impairment of quality of life. Numerous reports have documented the clinical efficacy of low-dose radiotherapy (LD-RT) in the management of various inflammatory disorders, including OA. In this paper, we assessed the clinical literature involving the use of LD-RT in the treatment of OA, its dose-response features, possible underlying mechanistic features, and optimal therapeutic dose range. Methods We carried out a systematic review based on the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statements and evaluated articles meeting the inclusion criteria for this review. Results A total of 361 articles were identified from databases, such as Scopus, PubMed, Embase, and Science Direct out of which 224 articles were duplicates and were discarded. Of the remaining 137 articles, 74 articles were un-related, 27 articles were review articles, eight were conference abstracts, three were letters, two were editorials, two were notes, and one was a book chapter. Finally, 20 articles met all the inclusion criteria and were included in this systematic review. Discussion Several single-arm retrospective/prospective studies showed advantages for LD-RT in the management of OA in terms of pain relief, improvement of mobility and function, and showed minimal side effects. Mechanistic considerations involve positive subcellular effects mediated by the activation of a nuclear factor erythroid 2-related transcription factor (Nrf2) mediated antioxidant response. Further research on both the short- and long-term effects of LD-RT on OA and other inflammatory disorders is recommended.

Primary liver cancer (PLC) is one of the most common malignant tumors in China. PLC is characterized by insidious onset, rapid progress, poor quality of life, and short survival time. Notably, current treatment strategies remain unsatisfactory. Traditional Chinese medicines (TCM) have been used to treat a variety of diseases, including liver diseases, for more than 2000 years. In this study, we performed a review of the use frequency and clinical efficacy of TCM in treating PLC. Relevant literature from January 1, 2009, to January 1, 2021 was retrieved from network databases of China National Knowledge Infrastructure (CNKI), Chongqing VIP, Wanfang, PubMed, and SinoMed. The most frequently used TCM and their efficacy in PLC treatment were summarized. Based on the inclusion and exclusion criteria, 33 articles were selected. Overall, the efficacy of the combination of TCM and Western medicines in the treatment of PLC was higher than that in the control groups (i.e. treatment with Western medicines alone) (65.11% vs. 44.31%, P