Search

BackgroundHelicobacter pylori eradication is a key goal in treating peptic ulcers with H. pylori infection, a disease highly prevalent in Asia. We present a pooled analysis of two randomized, double-blind, double-dummy, phase 3 studies to evaluate the efficacy and safety of vonoprazan-based bismuth-containing quadruple therapy in H. pylori eradication. MethodsPatients aged ≥18 years with endoscopically confirmed duodenal or gastric ulcers were randomized 1:1 to receive vonoprazan 20 mg or lansoprazole 30 mg once daily for up to 6 or 8 weeks, whereby H. pylori-positive patients received vonoprazan- or lansoprazole-based bismuth-containing quadruple therapy for the first 2 weeks. H. pylori eradication was determined by a carbon-13 urea breath test at a follow-up visit 4 weeks post-treatment. ResultsThe H. pylori eradication rate was 90.6% with vonoprazan vs 85.2% with lansoprazole (difference: 5.4%; 95% confidence interval [CI]: −0.1, 10.8). H. pylori eradication was 7.1% (95% CI: 1.4, 12.8) and 12.6% (95% CI: 3.9, 22.0) higher in patients aged H. pylori eradication rate was 92.0% with vonoprazan vs 86.0% with lansoprazole (difference: 6.1%; 95% CI: 0.5, 11.7). Treatment‑emergent adverse events occurred in 72.7% vs 62.6% of patients who were H. pylori positive at baseline in the vonoprazan vs lansoprazole arm.ConclusionsH. pylori eradication with vonoprazan-based quadruple therapy was indicated to be non-inferior to lansoprazole-based quadruple therapy and exceeded 90%, a clinically relevant threshold for determining the efficacy of H. pylori eradication regimens. (ClinicalTrials.gov identifier: NCT03050359; NCT03050307).

BACKGROUND Adult-onset Still's disease (AOSD) typically presents with a high spiking fever, polyarthritis, transient maculopapular rash, neutrophilic leukocytosis, and hepatosplenomegaly. It has a wide spectrum of clinical symptoms ranging from mild to severe, with extensive involvement of almost every organ. Although liver involvement in the form of increased hepatic enzymes and bilirubin is common, no AOSD case with liver involvement as the initial manifestation of AOSD has been reported. CASE SUMMARY A 35-year-old woman presented to the hepatology department with progressively worsening jaundice for one week. Liver chemistry tests revealed a significantly increased liver enzymes and bilirubin level. Given that the clinical examination was unremarkable, liver biopsy was considered because the patient had a history of AOSD 6 years ago. Liver histopathology revealed that most hepatic lobules were still recognizable. Fusional necrosis was observed around most central veins. A few bridging necrotic zones were also found. Infiltration of multiple plasma cells were observed in the necrotic zone, and the reticular scaffold was still expanded. Additionally, no obvious fibrosis was observed in the portal area. Mild mixed inflammatory cell infiltration was noted in the interstitium of the portal area. Further examination was unremarkable except for a remarkably high level of ferritin. Collectively, a presumptive diagnosis of liver injury secondary to AOSD was made. The hepatic involvement responded well to glucocorticoid treatment. CONCLUSION This case highlights that hepatic involvement as an initial and sole manifestation could be a pattern of relapsed AOSD. The diagnosis of AOSD should be considered in the case of nonresolving liver injury after the exclusion of common etiologies for liver diseases. A liver biopsy can be useful for the differential diagnosis of liver injury associated with AOSD.

Analysis of the value of long-term antiviral therapy using sequential Peg-IFN therapy and nucleos(t)ide analogues (NAs) improves the prognosis of HBV-related HCC. HBV-related HCC patients were classified into sequential therapy with Peg-IFNα-2a and NAs, and NAs therapy alone. All patients were followed up for 5 years. The survival rate, HCC recurrence rate, Child-Pugh score, and side effects of drugs were evaluated. Firstly, the early and late cumulative survival rate was higher in patients receiving antiviral therapy compared with the control patients (p0.05). Patients receiving sequential therapy with Peg-IFNα-2a and NAs showed a higher late cumulative survival rate and significantly reduced early and late recurrence rate, compared to those in the NA-alone group (p0.05). Single NAs therapy only reduced the late recurrence rate in HCC-patients. Secondly, NAs therapy significantly increased the Child-Pugh score after five years of therapy (five-year therapy 7.03±1.50 vs. initial score 6.63±0.85; p0.05), whereas the sequential therapy with Peg-IFNα-2a and NAs did not greatly alter the Child-Pugh score (6.88±1.26; p0.05). Compared to the control patients, patients receiving antiviral therapy (NAs alone or sequential therapy with Peg-IFNα-2a and NAs) exhibited a significantly decreased Child-Pugh score (p0.05). Compared to NAs alone, sequential therapy with Peg-IFNα-2a and NAs provided a more efficient strategy for improving both the five-year survival rate and the two-year or five-year recurrence rate in patients.

To investigate the current state of knowledge and practice of Helicobacter pylori (H. pylori) infection management in China.This nationwide, multicenter, cross-sectional questionnaire survey was conducted between March and April 2021 with respect to the diagnosis and treatment of H. pylori infection in 31 provinces, encompassing over 1000 hospitals in mainland China. General physician information, diagnostic and detection status, eradication treatment, reexamination and follow-up after treatment, and basic knowledge of physicians were collected and compared with the Fifth Chinese National Consensus Report on Management of H. pylori infection and the 2016 Maastricht V/Florence guidelines. The subgroup analysis was also performed.Of the 6873 questionnaire respondents, 48.8% were males, and 51.2% were females. Approximately, 26.5% of respondents indicated that their hospitals had dedicated clinics for managing H. pylori infection. Moreover, 88.0% of respondents prescribed a bismuth-containing quadruple regimen as the initial eradication treatment, and 92.7% deemed the gastric acid suppression critical. Furthermore, 91.0% of respondents routinely recommended a reexamination 1-2 months after eradication therapy, and 95.1% advised patients to stop PPI treatment at least 2 weeks before reexamination. The detail of following (the choice of target population/methods; the choice/availability of drugs/regimens, indications for eradication, factors influencing eradication efficacy/improvement methods and factors influencing adherence, management options/factors influencing relapse; the timing and methods, awareness of reinfection rates/prevention measures, and the approach to continuing education, awareness of guidelines, and acceptance of current core concepts of management) was also described. Subgroup analysis further revealed that significant differences were existed in being gastroenterologist or not, different education level, professional title, years of working, and provincial administrative regions.Chinese physicians' skills and knowledge about the diagnosis and treatment of H. pylori infection could be improved. More works on education are needed in future.

Duodenal ulcers, especially caused by increasingly drug-resistant Helicobacter pylori, are a concern in Asia. We compared oral vonoprazan versus lansoprazole for efficacy (healing duodenal ulcers) and safety in non-Japanese Asian patients.In this phase 3, randomized (1:1), double-blind, double-dummy, parallel-group, non-inferiority study (April 5, 2017, to July 19, 2019), patients with ≥ 1 endoscopically confirmed duodenal ulcer, at 52 hospitals (China, South Korea, and Taiwan), received vonoprazan 20 mg once daily (QD) or lansoprazole 30 mg QD for 6 weeks maximum. Patients with H. pylori received bismuth-containing quadruple therapy including vonoprazan 20 mg twice daily (BID) or lansoprazole 30 mg BID, for 2 weeks, followed by vonoprazan or lansoprazole monotherapy QD (4 weeks maximum). Endpoints were endoscopically confirmed duodenal ulcer healing (Week 4/6; primary) and H. pylori eradication (4 weeks post-treatment; secondary); non-inferiority margins were -6% and -10%, using a two-sided 95% confidence interval (CI).Of 533 enrolled patients, one was lost to follow-up and one withdrew (full analysis set: 531 patients [vonoprazan, n = 263; lansoprazole, n = 268]; 85.4% = H. pylori positive). Vonoprazan was non-inferior to lansoprazole for duodenal ulcer healing (96.9% vs 96.5%; difference 0.4% [95% CI -3.00, 3.79]). H. pylori eradication rates were 91.5% (vonoprazan) and 86.8% (lansoprazole; difference 4.7% [95% CI -1.28, 10.69]). Vonoprazan and lansoprazole were well tolerated, with similar safety profiles, no new safety signals; no deaths occurred.Vonoprazan was well tolerated and non-inferior to lansoprazole for duodenal ulcer healing and achieved H. pylori eradication above the clinically meaningful threshold (90%), in non-Japanese Asian patients.

Background: To find potential biomarkers for predicting disease progression in gastric cancer (GC). Methods: An extensive bioinformatics study of the Cancer Genome Atlas (TCGA) and Oncomine datasets was conducted to define potential mRNA biomarkers for GC. The mRNA expression profiles of 375 GC and 32 neighboring noncancerous adrenal tissues were analyzed. The Oncomine database was used to validate the hub genes. The correlation between candidate hub gene expression and survival of GC patients was analyzed using the Kaplan-Meier method. Results: Ten differentially expressed genes were identified as hub genes, and CXCL8 was the only gene validated as being up-regulated in GC tissues compared to control tissues using both the TCGA and Oncomine databases. Immunofluorescence staining showed that CXCL8 was expressed in GC tissues, and its higher expression predicted worse relapse-free survival in GC patients. Conclusions: CXCL8 is a potential biomarker for predicting disease progression in GC.

In view that researchers only control some low-dimensional chaotic power system models, this paper aims at controlling chaos in a complex six-dimensional power system model. By introducing the dynamic model of an energy storage device and static synchronous compensator, an adaptive synergetic control scheme is proposed for the model to suppress its chaotic oscillation. Since the designed controller will inevitably contain complex derivative terms of a controlled power system according to the conventional controller design process, a novel adaptive synergetic control scheme is proposed. The presented adaptive controller for the chaotic power system can completely suppress its chaotic oscillation. The prominent advantages of the proposed control scheme are that it can avoid complex derivative terms of the controlled system and can avoid chattering as in the sliding mode control method. Simulations validate the effectiveness and robustness of the proposed scheme.

Helicobacter pylori (H. pylori) recurrence remains a significant public health concern. The study aimed to assess H. pylori reinfection rate and identify its risk factors in China. This prospective open cohort, observational study was performed at 18 hospitals across 15 provinces in China. Consecutive patients who received the successful initial eradication during 1 January 2012 and 31 December 2018 were eligible for enrolment. H. pylori recurrence was defined as reinfection that occurred at more than the 12-month interval after successful initial eradication. Surveyed risk factors that might be associated with reinfection were preliminarily estimated by log-rank test and further determined by Cox regression model to calculate the hazard ratio (HR) and 95% confidence interval (CI). A total of 5193 subjects enrolled in the study. The follow-up intervals varied from 6 to 84 months with a general follow-up rate of 67.9%. Annual reinfection rate was 1.5% (95% CI: 1.2–1.8) per person-year. H. pylori reinfection was independently associated with the following five risk factors: minority groups (HR = 4.7, 95% CI: 1.6–13.9), the education at lower levels (HR = 1.7, 95% CI: 1.1–2.6), a family history of gastric cancer (HR = 9.9, 95% CI: 6.6–14.7), and the residence located in Western China (HR = 5.5, 95% CI: 2.6–11.5) following by in Central China (HR = 4.9, 95% CI: 3–8.1) (all P

The study aimed to investigate the role of androgen receptor (AR)/cell cycle-related kinase (CCRK) signalling pathway in chronic hepatitis B virus (HBV) infection and gender differences, and the contribution of AR regulatory factor signal transducer and activator of transcription 3 (STAT3) in it. AR, CCRK, and phosphorylated STAT3 expressions in liver tissues of chronic HBV-infected patients and non-HBV controls were determined by western blot and compared between genders. The relationships of expression levels with serum HBV DNA levels, liver inflammation activity, and fibrosis score were analysed in chronic HBV-infected patients. The relationships between expression levels of three proteins were also analysed. HBV-infected patients had significantly higher expression levels of AR, CCRK, and p-STAT3

This brief proposes a synergetic excitation control strategy for a seven dimensional chaotic power system. Firstly, chaotic phenomenon in the complex power system is analyzed. Then, a new macro variable expression is constructed for the power system and the excitation controller design process is carried out. In order to compare the proposed excitation control with traditional control method, the excitation controller is also designed under the traditional macro variable definition. Finally, simulation results show that the proposed excitation control method can not only effectively suppress chaotic oscillation in the power system, but also can improve bad transient phenomenon and overcome the difficulty of parameter selection in the traditional method, so that it has advantages in control performance and reducing difficulty for project implementation.

Background: Helicobacter pylori (H. pylori) is the most common cause of gastric cancer. Growing evidence suggests that the regular arrangement of collecting venules (RAC) can be used as an endoscopic marker to diagnose H. pylori infection. However, data on the diagnostic accuracy of RAC for H. pylori infection are conflicting. We performed a systematic review and meta-analysis of relevant studies to determine the diagnostic accuracy and clinical utility of RAC for the diagnosis of H. pylori infection. Methods: We systematically searched PubMed, Embase, Web of Science, and the Cochrane Library between inception and Oct 29, 2020, for studies that assessed the diagnostic accuracy of RAC for H. pylori infection. Results: The literature search yielded 2921 nonduplicated screened titles, of which 58 underwent full-text review. Fifteen studies, representing a total of 6621 patients, met the inclusion criteria. The area under the summary receiver operating characteristic curve was 0.98 (95% CI 0.96 to 0.99). The pooled estimates for RAC were 0.98 (95% CI 0.95 to 0.99) for sensitivity and 0.75 (95% CI 0.54 to 0.88) for specificity. The pooled positive likelihood ratio (PLR) and negative likelihood ratio (NLR) were 3.8 (95% CI 1.9 to 7.7) and 0.03 (95% CI 0.02 to 0.07), respectively. Conclusions: RAC can be used as an endoscopic marker for exclusion of H. pylori infection. However, it cannot be recommended as a single indicator for the confirmation of H. pylori infection. The conclusion of this study should be treated with caution because significant heterogeneity exists between the evaluated studies.

Background: Proton pump inhibitors (PPIs) are validated gastric acid suppressors and have been widely used to treat patients with active duodenal ulcers. Although existing PPIs have shown great efficacy, many scientists are still devoted to developing more effective PPIs with better safety profile. Herein, we aimed to compare the safety and efficacy of anaprazole in duodenal mucosal healing, a novel PPI, to that of rabeprazole.Methods: In this multicenter, randomized, positive-controlled, double-blinded, parallel-group phase II clinical trial, a total of 150 qualified patients with endoscopically confirmed active duodenal ulcers were randomized (1:1:1) to receive rabeprazole 10 mg, anaprazole 20 mg or anaprazole 40 mg for 4 weeks. The ulcer healing rates after 4 weeks of treatment were compared between groups by independent central review and investigator review. In addition, symptoms and safety were evaluated.Results: Based on the independent central review, the ulcer healing rates of the 10 mg rabeprazole, 20 mg anaprazole and 40 mg anaprazole groups were 88.0, 85.1, and 87.5%, respectively, in the FAS population and 88.9, 86.0, and 90.9%, respectively, in the PPS population. The ulcer healing rate difference between anaprazole 20 mg and Rabeprazole 10 mg is −2.9% (95% CI, −16.5–10.7%), and −0.5% (95% CI, −13.5–12.5%) between anaprazole 40 mg and Rabeprazole 10 mg, in the FAS population. Based on the investigator review, the ulcer healing rates of the 10 mg rabeprazole, 20 mg anaprazole, and 40 mg anaprazole groups were 72.0, 70.2, and 77.1%, respectively, in the FAS population and 75.6, 72.1, and 79.5%, respectively, in the PPS population. The ulcer healing rate difference between anaprazole 20 mg and Rabeprazole 10 mg is −1.8% (95% CI, −19.8–16.3%), and 5.1% (95% CI, −12.2–22.3%) between anaprazole 40 mg and Rabeprazole 10 mg, in the FAS population. Most patients (>90%) eventually achieved complete symptom relief. The incidence rates of adverse events were of no significant differences among the treatment groups. Potential possible better liver tolerance was observed in two anaprazole dose groups than rabeprazole 10 mg group.Conclusion: Both at a dosage of 20 and 40 mg daily, anaprazole, is effective with good safety profile in the treatment of active duodenal ulcers in this Phase 2 study, which allows anaprazole to be advanced to a phase III clinical trial.Clinical Trial Registration:https://www.clinicaltrials.gov/ct2/results?cond=&term=NCT04503629&cntry=&state=&city=&dist=, Identifier: CTR20181464, NCT04503629.

Background and aims Population-based studies suggest a strong association between the presence of nonalcoholic fatty liver disease (NAFLD) and an increased risk of urolithiasis. However, the available information on the association of the severity of NAFLD with urolithiasis is limited. We hypothesised a link between the severity of NAFLD and the risk of urolithiasis. Methods We recruited 1527 adult patients with NAFLD who completed a comprehensive health checkup. The severity of NAFLD was measured with AST to platelet ratio (APRI score). Logistic regression analysis was used to detect the association of APRI score with the risk of urolithiasis among NAFLD patients. ROC analysis was used to assess the diagnostic value of APRI score for identifying urolithiasis among NAFLD patients. Results Multivariate analysis showed three independent risk factors for urolithiasis: obesity (OR 2.06 95%CI 1.35-3.13), APRI score (OR 1.29 95%CI 1.05-1.59), and serum uric acid (OR 1.07 95%CI 1.05-1.09), suggesting an independent association between the noninvasive staging of liver fibrosis and the risk of urolithiasis in NAFLD patients. A three-variable model (obesity, APRI score, and serum uric acid) with an AUROC of 0.73 (95% CI 0.70-0.75) was significant in identifying urolithiasis. Conclusions The severity of NAFLD is associated with the risk of urolithiasis among NAFLD patients. Moreover, a three-variable model (obesity, APRI score, serum uric acid) could serve as a useful tool for identifying individuals at high risk for urolithiasis in these patients.

This paper presents a fast synergetic control scheme for chaotic oscillation in a three-bus power system model. First, the coupling dynamic model of a controlled power system with the current source converter-based STATCOM device and energy storage device is established. Then, the input-output linearization process for the controlled power system is derived step by step, the control problem for the complex nonlinear power system model is completely transformed into the control of linear systems, and a fast synergetic control scheme is proposed for these linear systems. Since the designed control inputs contain complex system functions which are very difficult to obtain and reduce the engineering practicability of the designed controllers, the assumption that system functions are bounded is introduced into the controller design process, and the controllers are redesigned. The remarkable advantages of the proposed control method are that it improves the rapidity of traditional synergetic control and avoids complex system functions in control inputs. Finally, the effectiveness and the superiority of the control scheme are verified by simulation results.

The main purpose of the paper is to control chaotic oscillation in a complex seven-dimensional power system model. Firstly, in view that there are many assumptions in the design process of existing adaptive controllers, an adaptive sliding mode control scheme is proposed for the controlled system based on equivalence principle by combining fixed-time control and adaptive control with sliding mode control. The prominent advantage of the proposed adaptive sliding mode control scheme lies in that its design process breaks through many existing assumption conditions. Then, chaotic oscillation behavior of a seven-dimensional power system is analyzed by using bifurcation and phase diagrams, and the proposed strategy is adopted to control chaotic oscillation in the power system. Finally, the effectiveness and robustness of the designed adaptive sliding mode chaos controllers are verified by simulation.

Background and aim The treatment of patients with functional dyspepsia (FD) remains unsatisfactory. We assessed the efficacy of Zhizhu Kuanzhong (ZZKZ) capsule, a traditional Chinese medicine formula, in patients with postprandial distress syndrome (PDS) of FD. Methods The study was designed as a multicenter, randomized, double-blinded, controlled clinical trial. Three-hundred ninety-two patients with PDS defined by Rome III criteria from 16 centers in China were randomly assigned to receive either ZZKZ or placebo. The proportion of the responders at 4 weeks after randomization was considered primary endpoint. Secondary endpoint was the symptom score reduction of each dyspeptic symptom relative to the baseline at 4 weeks after randomization in all subjects. Results In terms of the primary endpoint, the proportion of the responders concerning the composite PDS symptom score was 38.8% and 54.7% in placebo group and ZZKZ group, respectively (P = 0.003), in per protocol analysis at 4 weeks after randomization. Concerning the individual evaluated upper gastrointestinal symptoms, only postprandial fullness and early satiety showed significant difference in symptom score reduction at 4 weeks after randomization between placebo and ZZKZ groups. Conclusions Zhizhu Kuanzhong is superior to placebo in the treatment of PDS with FD. The exact mechanisms by which ZZKZ improves symptoms remain to be established (http://www.chictr.org.cn/ChinCTR-TRC-14004714).

This paper presents a simple fixed-time control scheme to stabilize a six dimensional chaotic power system. Based on fixed time stability theory, another fixed time stable system is proposed, and a fixed time sliding mode controller for stabilization of a second order system is designed. Based on the important idea that chaos in power system is caused by its excess energy, chaos control problem in the six dimensional power system is transformed into the stabilization of a second-order system. The control scheme not only overcomes singularity in a simple way, but also achieves fixed time convergence of controlled state variables. Compared with other chaos controllers in power systems, only one controller is needed to restore the six dimensional chaotic power system from chaotic state to equilibrium state. Simulation shows its effectiveness and robustness.

AIM To examine the relationship between the single nucleotide polymorphism CXCL10 rs1439490 and seronegative occult hepatitis C virus (HCV) infection (OCI). METHODS One hundred and three cases of seronegative OCI and 155 cases of seropositive chronic HCV infection (CHC) were diagnosed at five Liver Centers in Northeastern China, from 2012 to 2016. CXCL10 rs1439490, rs1440802, and IL-28B rs12979860 were analyzed by sequencing. Serum CXCL10 was measured by ELISA. Intrahepatic CXCL10 was determined by quantitative PCR and immunohistochemical semi-quantitative scoring. Liver necroinflammation and fibrosis were scored according to the METAVIR system. RESULTS CXCL10 rs1439490 G/G was more prevalent in OCI patients (n = 93/103; 90.3%) than in CHC patients (n = 116/155; 74.8%; P = 0.008). OCI patients had lower serum CXCL10 levels than CHC patients (192.91 ± 46.50 pg/mL vs 354.78 ± 102.91 pg/mL, P < 0.0001). Of IL-28B rs12979860 C/C patients, OCI patients with rs1439490 G/G had lower serum and liver levels of CXCL10 and lower levels of liver necroinflammation and fibrosis than non-G/G patients. OCI patients had higher alanine aminotransferase normalization rates after Peg-interferon treatment than CHC patients (P < 0.05) and serum CXCL10 decreased significantly (P < 0.0001). Liver necroinflammation and fibrosis were alleviated in 8 OCI patients after treatment. Multivariate analysis indicated that rs1439490 G/G significantly influenced the occurrence of OCI in HCV infection (OR = 0.31, 95%CI: 0.15-0.66, P = 0.002). CONCLUSION CXCL10 rs1439490 G/G is positively associated with OCI in HCV infection and antiviral outcome.

Background and aim Empirical proton pump inhibitor (PPI) treatment is recommended as a diagnostic indicator for gastroesophageal reflux disease (GERD) and as a therapy for symptomatic control, with responses generally seen within 4 weeks. However, there are no real-world data assessing the effectiveness of short-term empirical treatment with PPIs in patients with GERD in China. Methods The ENLIGHT study was a multicenter, prospective, observational study conducted in China. The primary outcome was the overall response rate after 4 weeks' empirical treatment with PPIs. Adult patients aged between 18 and 65 years of age, with a gastroesophageal reflux disease questionnaire score of ≥ 8, prescribed empirical PPI treatment by their physicians and with no planned endoscopy were eligible to participate. Statistical analyses were primarily descriptive. Results Overall, 987 patients were eligible to participate and were included in the full analysis set (FAS); 707 patients were included in the per protocol set. In the FAS, esomeprazole was received by 57.1% of patients and was the most commonly used PPI. After 4-week treatment, 71.1% (95% confidence interval [CI], 67.9% to 74.2%) of patients were considered responders to PPI. The response rate at the end of 2-week PPI treatment reached 57.0% (95% CI, 52.5% to 61.7%). The median time to response was 13 days (95% CI, 12 to 15). Response rates at 2 and 4 weeks of the per protocol set were similar to those of the FAS. Conclusions Short-term empirical PPI treatment can provide an effective relief of GERD symptoms in most Chinese patients in real-world practice.

Objectives To assess the efficacy and safety of omeprazole given with the new single capsule of bismuth, metronidazole and tetracycline (OBMT) compared with quadruple treatment consisting of omeprazole, bismuth, amoxicillin and clarithromycin (OBAC) for Helicobacter pylori eradication in duodenal ulcer patients. Methods This single-blind, randomized multicentre trial was conducted in 10 tertiary hospitals in China between January 2013 and April 2014. Patients were randomized to receive 10 days of OBMT therapy or 10 days of OBAC therapy. Our primary outcome was the H. pylori eradication rate, confirmed by negative [13C]urea breath tests 20-25 days after the end of omeprazole maintenance. Antibiotic resistance was determined by Etest. This study is registered with ClinicalTrials.gov, number ChiCTR-TRC-13003143. Results One hundred and ninety-two patients received OBMT therapy and 192 received OBAC therapy. There was no significant difference between the eradication rates achieved by OBMT and OBAC in either the ITT analysis (86.46% versus 87.50%, P = 0.762) or the PP analysis (94.58% versus 93.06%, P = 0.563). The efficacies of OBMT and OBAC were not affected by metronidazole or clarithromycin resistance. Treatment-emergent adverse events (TEAEs) for both treatments were similar; gastrointestinal and CNS symptoms were the most commonly reported. Conclusions The new single-capsule OBMT quadruple therapy is as effective and well tolerated as the widely used OBAC therapy for treatment of H. pylori in clinical practice in China. In addition, this OBMT therapy largely overcomes H. pylori metronidazole and clarithromycin resistance.

ObjectiveMounting data now support a strong link between the presence of non-alcoholic fatty liver disease (NAFLD) and an increased risk of urolithiasis. However, little is known on the association between hepatic fibrosis and the risk of urolithiasis among NAFLD patients. Therefore, this study aimed to investigate the prevalence of urolithiasis among NAFLD patients and determine whether the Fibrosis-4 (FIB-4) score, a surrogate marker of hepatic fibrosis, is associated with urolithiasis among NAFLD patients.DesignCross-sectional studies.SettingChina.MethodsA total of 2058 adult patients with NAFLD were included in this study. Logistic regression analysis was used to detect the association between FIB-4 score and urolithiasis. Receiver operating characteristic (ROC) curve analysis was used to assess the diagnostic value of FIB-4 score for the detection of urolithiasis among NAFLD patients.Results200 (9.7%) individuals had ultrasonography-diagnosed urolithiasis among 2058 NAFLD patients. FIB-4 score (OR=1.58; 95% CI 1.06 to 2.31), age (OR=1.11; 95% CI 1.08 to 1.13), obesity (OR=3.16; 95% CI 2.29 to 4.39) and hyperuricemia (OR=3.79; 95% CI 2.67 to 5.36) were independent factors associated with urolithiasis among NAFLD patients. Moreover, a novel algorithm including multiple variables (FIB-4 score, age, obesity and hyperuricemia) showed an area under a ROC curve of 0.813 (95% CI 0.795 to 0.829) for identifying urolithiasis among NAFLD patients. The optimal cut-off value of > −2.23 for the multivariate model provides a sensitivity of 76% and a specificity of 74% for predicting urolithiasis among NAFLD patients.ConclusionUrolithiasis among NAFLD patients is associated with FIB-4 score. Further, a novel algorithm based on FIB-4 score could serve as a useful tool for identifying individuals with a higher risk of urolithiasis among NAFLD patients, although prospective cohort studies are still needed in the future.

Antiviral therapy has been shown to improve the prognosis of hepatitis B virus (HBV) DNA-positive hepatocellular carcinoma (HCC) after radical treatment, but antiviral treatments require further optimization. This study aimed to evaluate the efficacies of different antiviral strategies with HCC patients after hepatectomy/ablation. This prospective, randomized, controlled and multi-centre trial enrolled HBV DNA-positive primary HCC patients after hepatectomy/ablation between January 2007 and January 2009. Patients were divided into four groups: early combination (entecavir plus Peg-interferon [IFN]α-2a co-administration during year 1); late combination (addition of Peg-IFNα-2a for 48 weeks after 1 year of entecavir); nucleos(t)ide analogue[NA] monotherapy; and non-antiviral treatment. Primary endpoints included recurrence-free survival and overall survival. A total of 447 patients were enrolled. The 2-year and 8-year recurrence-free survival and 8-year overall survival rates were significantly higher in the early combination group than in the other two antiviral groups (P .05). After 48-week treatment, more patients achieved an HBsAg reduction1500 IU/mL and the mean HBsAg level was significantly lower in the early combination group compared with the late combination and NA monotherapy groups (P .05). Multivariate analysis showed that early combination therapy and a reduction in HBsAg by1500 IU/mL after 48 weeks of therapy correlated with reduced mortality and disease recurrence. Early introduction of combination antiviral treatment may represent a more effective therapeutic strategy for patients with HBV DNA-positive HCC after hepatectomy/ablation. A reduction in HBsAg by1500 IU/mL after 48-week treatment is associated with reduced mortality and disease recurrence of HBV DNA-positive HCC patients after hepatectomy/ablation.

The objective of this study was to investigate the efficacy and safety of 10-day bismuth quadruple therapy with amoxicillin, tetracycline, or clarithromycin and different doses of rabeprazole for first-line treatment of Helicobacter pylori infection. This multicenter, randomized, parallel-controlled clinical trial was conducted between March 2013 and August 2014. A total of 431 H. pylori-infected patients with duodenal ulcers were enrolled and randomized into four treatment groups (1:1:1:1) for 10 days, as follows: (i) a group receiving a low dose of rabeprazole of 10 mg twice a day (b.i.d.) (LR dose) plus bismuth, amoxicillin, and clarithromycin (LR-BAC); (ii) a group receiving LR plus bismuth, amoxicillin, and tetracycline (LR-BAT); (iii) a group receiving a high dose of rabeprazole of 20 mg b.i.d. (HR dose) plus bismuth, amoxicillin, and clarithromycin (HR-BAC); and (iv) a group receiving HR-BAT. Antimicrobial susceptibility was assessed by the Etest method. The primary outcome was H. pylori eradication at 4 weeks after the treatment. The per-protocol (PP) eradication rates in the LR-BAC, LR-BAT, HR-BAC, and HR-BAT groups were 94.1%, 91.9%, 94.8%, and 91.9%, respectively, while the intention-to-treat (ITT) eradication rates in those groups were 87.2%, 87.2%, 87.7%, and 86%, respectively. There was no significant difference between the four groups in PP analysis (P = 0.799) and ITT analysis (P = 0.985). The efficacies of four-treatment therapy were not affected by antibiotic resistance. The adverse events in the four treatment groups were similar; central nervous system (CNS) and gastrointestinal symptoms were the most common reported. Bismuth-containing quadruple therapy with low-dose rabeprazole, amoxicillin, and tetracycline is a good option for first-line treatment of H. pylori infection in a population with high antibiotic resistance. (This study is registered at Chinese Clinical Trials Registry [www.chictr.org.cn] under number ChiCTR1800014832.).

Background The efficacy of Helicobacter pylori (H. pylori) eradication has steadily declined, primarily because of antibiotic resistance. This study aimed to evaluate the efficacy and safety of furazolidone eradication therapies as initial treatments for H. pylori infection. Methods A national, multicenter, open-label, randomized controlled trial was performed at 16 sites across 13 provinces in China to evaluate the efficacy and safety of furazolidone-containing therapies for H. pylori infection. Treatment naive patients were randomly assigned to: esomeprazole 20 mg, bismuth 220 mg, amoxicillin 1000 mg, and furazolidone 100 mg twice daily for 10 and 7 days (FAB 10 and FAB 7; the same therapy without bismuth (FA 10 and FA 7). The primary and secondary outcomes were the eradication rate and regimen safety, respectively. Treatment success was assessed by the 13 C urea breath test at least 4 weeks after treatment completion. Results Overall, according to intention-to-treat (ITT) analysis, the eradication rates for FAB 10 and FAB 7 were 86.6% (95% confidence interval [CI], 79.9%-93.2%) and 83.6% (95% CI, 76.3%-90.9%) and for FA 10 and FA 7 were 82.4% (95% CI, 74.9%-89.8%) and 77.6% (95% CI, 69.4%-85.8%), respectively. According to per-protocol analysis, the overall eradication rates for FAB 10 and FAB 7 were 94.7% (95% CI, 90.3%-99.1%) and 90.8% (95% CI, 85.1%-96.5%) and for FA 10 and FA 7 were 90.6% (95% CI, 84.9%-96.3%) and 85.1% (95% CI, 78.2%-92.1%), respectively. The overall prevalence of side effects was 8.1%. Conclusions Furazolidone-containing therapies, particularly the tested 10-day quadruple therapy, exhibited satisfactory efficacy and safety. This 10-day quadruple therapy represents a promising initial treatment strategy for Chinese patients.

The treatment of patients with functional dyspepsia (FD) remains unsatisfactory. We assessed the efficacy of Zhizhu Kuanzhong (ZZKZ) capsule, a traditional Chinese medicine formula, in patients with postprandial distress syndrome (PDS) of FD.The study was designed as a multicenter, randomized, double-blinded, controlled clinical trial. Three-hundred ninety-two patients with PDS defined by Rome III criteria from 16 centers in China were randomly assigned to receive either ZZKZ or placebo. The proportion of the responders at 4 weeks after randomization was considered primary endpoint. Secondary endpoint was the symptom score reduction of each dyspeptic symptom relative to the baseline at 4 weeks after randomization in all subjects.In terms of the primary endpoint, the proportion of the responders concerning the composite PDS symptom score was 38.8% and 54.7% in placebo group and ZZKZ group, respectively (P = 0.003), in per protocol analysis at 4 weeks after randomization. Concerning the individual evaluated upper gastrointestinal symptoms, only postprandial fullness and early satiety showed significant difference in symptom score reduction at 4 weeks after randomization between placebo and ZZKZ groups.Zhizhu Kuanzhong is superior to placebo in the treatment of PDS with FD. The exact mechanisms by which ZZKZ improves symptoms remain to be established (http://www.chictr.org.cn/ChinCTR-TRC-14004714).

Background To investigate the epidemiology of hepatitis B and C infections and the benefits of programs aimed at hepatitis prevention and control in Northeastern China. Methods Individuals receiving health examinations were recruited to complete a questionnaire and undergo laboratory tests for hepatitis infection. Data on demographic characteristics, results of hepatitis B virus (HBV) and hepatitis C virus (HCV) serological tests, for HBV and HCV infection were analyzed. Results Among 227 808 study participants, the hepatitis B surface antigen (HBsAg) and anti-HCV-positive rates were 6.1% and 3.0%, respectively. Among HBsAg-positive participants, 63.8% tested positive for HBV DNA, 20.2% had an abnormal alanine aminotransferase (ALT) level, and 10.7% had cirrhosis. Among anti-HCV-positive participants, 57.2% tested positive for HCV RNA, 29.6% had an abnormal ALT level, and 8.4% had cirrhosis. Among HBsAg- or anti-HCV-positive participants, 47.1% and 32.0%, respectively, were aware of their infection. Among participants infected with HBV or HCV and suitable for antivirus treatment, 23.5% and 16.1%, respectively, had received antivirus treatment. The HBV plus HCV coinfection rate was 0.08%. Conclusions The HBsAg-positive rate decreased significantly after implementation of recently introduced HBV control programs in China. However, the anti-HCV-positive rate showed only a slight decrease, indicating that programs for the prevention and control of hepatitis viruses require continued strengthening. Chinese clinical trials registration ChiCTR-ECS-13004009.

This study investigates the utility of Hydrogen 1 (1H) magnetic resonance spectroscopy as a noninvasive test for steatosis of response to interferon and ribavirin treatment in patients developing different severity of hepatitis C virus (HCV). Ninety chronic hepatitis C patients undergoing antiviral therapy with interferon and ribavirin underwent 1H MR spectroscopy at 3.0T before treatment, 6 month after the start of treatment and one year after the start of treatment. Peak value of lipid, area under the peak of lipid, peak ratio of lipid, water and area ratio under the peak of lipid, water statistical difference between baseline of control group and antiviral group, and also between baseline and after the start of therapy 6 month of antiviral therapy group. 1H MRS is a noninvasive technique that can be used to provide liver steatosis information on hepatic metabolic processes. This study indicates that the 1H MRS can be used as an indicator of steatosis response to antiviral treatment in chronic hepatitis C patients.Keywords: Hydrogen 1 (1H), magnetic resonance spectroscopy (MRS), hepatitis C, antiviral therapy.African Journal of Biotechnology, Vol 13(53) 4753-4760

Background Current treatments for chronic hepatitis B (CHB) include pegylated interferon alpha (PEG-IFN-α) which is an immune modulator, and nucleos(t)ide analogs (NAs) which directly inhibit HBV DNA polymerase. With the limited efficacy of PEG-IFN-α and prolonged treatment periods associated with NAs, there is an urgent need for novel therapeutic strategies, especially for patients with a poor early response to anti-viral therapy. Methods In this study, 178 patients with chronic hepatitis B (n = 131) and compensated (n = 47) HBV-induced cirrhosis were enrolled, 120 patients with HBeAg (+). All the patients were treated for 12 weeks with PEG-IFN-α. Among them, a total of 138 patients with a poor virological response after 12 weeks were treated for an additional 48 weeks with Peg-IFNα-2a (control) (n = 43), with Peg-IFNα-2a + entecavir (ETV) (n = 49), or Peg-IFNα-2a + adefovir dipivoxil (ADV) (n = 46), and were followed for 48 weeks after therapy. Early virological response was defined as undetectable HBV DNA after anti-viral therapy for 12 weeks. Sustained virological response (SVR) was defined as no change in therapeutic effectiveness after 6 months follow-up, and no recurrence.Therapeutic efficacy was determined by evaluating HBV DNA levels, serum and liver HBsAg levels, liver function tests and liver histology. Results Patients in the Peg-IFNα-2a + ETV and Peg-IFNα-2a + ADV groups showed a significantly greater decrease in HBV DNA levels over time, and a significantly higher SVR compared to patients receiving Peg-INFα-2a monotherapy (both P values

Empirical proton pump inhibitor (PPI) treatment is recommended as a diagnostic indicator for gastroesophageal reflux disease (GERD) and as a therapy for symptomatic control, with responses generally seen within 4 weeks. However, there are no real-world data assessing the effectiveness of short-term empirical treatment with PPIs in patients with GERD in China.The ENLIGHT study was a multicenter, prospective, observational study conducted in China. The primary outcome was the overall response rate after 4 weeks' empirical treatment with PPIs. Adult patients aged between 18 and 65 years of age, with a gastroesophageal reflux disease questionnaire score of ≥ 8, prescribed empirical PPI treatment by their physicians and with no planned endoscopy were eligible to participate. Statistical analyses were primarily descriptive.Overall, 987 patients were eligible to participate and were included in the full analysis set (FAS); 707 patients were included in the per protocol set. In the FAS, esomeprazole was received by 57.1% of patients and was the most commonly used PPI. After 4-week treatment, 71.1% (95% confidence interval [CI], 67.9% to 74.2%) of patients were considered responders to PPI. The response rate at the end of 2-week PPI treatment reached 57.0% (95% CI, 52.5% to 61.7%). The median time to response was 13 days (95% CI, 12 to 15). Response rates at 2 and 4 weeks of the per protocol set were similar to those of the FAS.Short-term empirical PPI treatment can provide an effective relief of GERD symptoms in most Chinese patients in real-world practice.

Single nucleotide polymorphisms (SNPs) of the interleukin 28B (IL28B) gene has proven to be associated with the clinical outcome of patients with chronic hepatitis virus B or C (HBV or HCV) infections. However, whether IL28B SNPs have an influence on the risk of hepatocellular carcinoma (HCC) among patients with HBV or HCV infection remains controversial. Therefore, this study aims to determine the association between IL28B polymorphisms and the risk of HCC in individuals with HBV or HCV infection. PubMed, EMBASE, and Chinese National Knowledge Infrastructure (CNKI) databases were used to identify studies meeting the selection requirements using the terms “interleukin 28B”, “IFN-lambda-3”, “IFNL3”, “single nucleotide polymorphisms”, “SNPs”, “hepatocellular carcinoma”, “HCC”, “liver cancer”. A total of 24 eligible original studies (1 cohort study and 23 case-control studies) involved 20238 individuals (HCC group = 8725 vs control group = 11,513) were included. Both IL28B rs12979860 CC and rs8099917 TT genotypes were significantly associated with a decreased risk of HCC among patients with HBV or HCV infection (OR = 0.71, 95% CI = 0.57–0.88; OR = 0.82, 95% CI = 0.72–0.94, respectively). Egger test and Begg test revealed no‘ publication bias (P > .05). Sensitivity analyses suggested the robustness of the results in this meta-analysis. Both IL28B rs12979860 CC and rs8099917 TT genotypes are protective factors for the development of HCC among patients with HBV or HCV infection. Future prospective studies examining the impact of IL28B polymorphisms on the risk of HCC and investigating the underlying mechanism for the protective role of IL28B polymorphisms in HCC development are warranted.