Background:High-dose dual therapy (HDDT) with proton pump inhibitors (PPIs) and amoxicillin has attracted widespread attention due to its favorable efficacy in eradicating Helicobacter pylori (H. pylori). This study aimed to compare the efficacy and safety of high-dose PPI–amoxicillin dual therapy and bismuth-containing quadruple therapy for H. pylori rescue treatment.Methods:This was a prospective, randomized, multicenter, non-inferiority trial. Patients recruited from eight centers who had failed previous treatment were randomly (1:1) allocated to two eradication groups: HDDT (esomeprazole 40 mg and amoxicillin 1000 mg three times daily; the HDDT group) and bismuth-containing quadruple therapy (esomeprazole 40 mg, bismuth potassium citrate 220 mg, and furazolidone 100 mg twice daily, combined with tetracycline 500 mg three times daily; the tetracycline, furazolidone, esomeprazole, and bismuth [TFEB] group) for 14 days. The primary endpoint was the H. pylori eradication rate. The secondary endpoints were adverse effects, symptom improvement rates, and patient compliance.Results:A total of 658 patients who met the criteria were enrolled in this study. The HDDT group achieved eradication rates of 75.4% (248/329), 81.0% (248/306), and 81.3% (248/305) asdetermined by the intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analyses, respectively. The eradication rates were similar to those in the TFEB group: 78.1% (257/329), 84.2% (257/305), and 85.1% (257/302). The lower 95% confidence interval boundary (−9.19% in the ITT analysis, − 9.21% in the MITT analysis, and −9.73% in the PP analysis) was greater than the predefined non-inferiority margin of −10%, establishing a non-inferiority of the HDDT group vs. the TFEB group. The incidence of adverse events in the HDDT group was significantly lower than that in the TFEB group (11.1% vs. 26.8%, P < 0.001). Symptom improvement rates and patients’ compliance were similar between the two groups.Conclusions:Fourteen-day HDDT is non-inferior to bismuth-containing quadruple therapy, with fewer adverse effects and good treatment compliance, suggesting HDDT as an alternative for H. pylori rescue treatment in the local region.Trial registration:Clinicaltrials.gov, NCT04678492.
Background:Previous studies have reported conflicting results for the relationship between dipeptidyl peptidase-4 (DPP-4) inhibitor drugs and acute pancreatitis. The aim of this study was to investigate the association between DPP-4 inhibitors and an increased risk of acute pancreatitis using meta-analysis.Methods:We conducted a comprehensive search in PubMed, Embase, Web of Science, and Cochrane library from inception to March 4, 2017. Original articles with data on DPP-4 inhibitors and acute pancreatitis were included. We used random-effects models or fixed-effects models to combine the relative risks (RRs), odds ratio (OR), and hazard ratio (HRs) with 95% confidence intervals (CIs) in randomized controlled studies, case–control study and cohort study, respectively.Results:Five case–control studies, 5 randomized controlled studies, and 3 cohort studies were selected of the 451 retrieved abstracts. A higher risk of acute pancreatitis was observed with the following RR/OR and 95%CI: RR 1.67 (1.08–2.59) in randomized controlled studies and OR 1.45 (1.30–1.61) in case–control studies. However, the pooled HR of the 3 cohort studies failed to confirm this association.Conclusion:There is a marginally higher risk of acute pancreatitis with DPP-4 inhibitors. However, this risk was not observed in cohort studies. Thus, further clinical trials are required to confirm this finding.
Objective: Previous studies have reported an association between cyclooxygenase-2 ( COX - 2 ) polymorphism and gastric cancer (GC) susceptibility, but their results are controversial. This meta-analysis was intended to evaluate the relationship between the COX - 2 rs20417 polymorphism and GC susceptibility in different ethnic groups. Methods: We searched PubMed, EMBASE, Web of Knowledge, and the Chinese Biomedical Database (CBM) for relevant case-control studies published up to October 6, 2018, which reported an association between the COX - 2 rs20417 polymorphism and gastric cancer risk. Odds ratios (ORs) with 95% confidence intervals (CIs) were used to assess the strength of this association. Results: 15 papers detailing case-control studies were included in the analysis, which included a total of 2848 GC cases and 4962 healthy controls. The meta-analysis results indicated that the COX - 2 rs20417 polymorphism was associated with increased GC susceptibility under allele (G vs C: OR = 1.67, 95%CI = 1.19–2.35, P = .003), heterozygous (GG vs CG: OR = 1.44, 95%CI = 1.03–2.02, P = .034), dominant (GC+CC vs GG: OR = 1.66, 95%CI = 1.18–2.34, P = .004), homozygous (GG vs CC:OR = 2.20, 95%CI = 1.07–4.54, P = .033), and recessive models (CC vs GG+CG:OR = 2.05, 95%CI = 1.09–3.85, P = .025). An analysis of ethnic subgroups revealed that the COX - 2 rs20417 polymorphism was significantly associated with GC susceptibility in Asians under all 5 models (G vs C: OR = 2.22, 95%CI = 1.66–2.96, P < .001; GG vs CC: OR = 4.29, 95%CI = 1.94–9.50, P < .001; GG vs CG: OR = 1.86, 95%CI = 1.34–2.58, P < .001; CC vs GG+CG: OR = 3.73, 95%CI = 1.92–7.24, P < .001; GC+CC vs GG: OR = 2.20, 95%CI = 1.65–2.93, P < .001). Helicobacter pylori positive patients suffered a high risk of GC, compared to H pylori negative patients under the dominant model (OR = 3.09, 95%CI = 1.80–5.32, P < .001). Conclusion: This meta-analysis of 15 case-control studies provides strong evidence that the COX - 2 rs20417 polymorphism increases the risk of GC susceptibility in general populations, especially in Asians. Helicobacter pylori positive patients and those with the COX - 2 rs20417 polymorphism had...
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