Wang Hui, Kong Qing Zhou, Li Yue Yue, Yang Xiao Yun, Zuo Xiu Li
Department of Gastroenterology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong Province, China.
Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong Province, China.
J Dig Dis. 2024 Mar;25(3):163-175. doi: 10.1111/1751-2980.13263. Epub 2024 Apr 5.
To update evidence-based data comparing the efficacy and safety of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) in eradicating Helicobacter pylori infection through meta-analysis.
Multiple databases were systematically searched for randomized controlled trials (RCTs) published up to May 18, 2023. Dichotomous data were evaluated using risk ratio (RR) and 95% confidence interval (CI). Subgroup analysis, sensitivity analysis, risk of bias assessment, and quality of evidence evaluation were performed.
Twenty RCTs containing 7891 subjects were included in the analysis. There was no statistically significant difference in H. pylori eradication rate between HDDT and BQT in the intention-to-treat (ITT) analysis (86.31% vs 84.88%; RR 1.02, 95% CI 1.00-1.04, P = 0.12). In the per-protocol (PP) analysis, the eradication rates for HDDT and BQT were 90.27% and 89.94%, respectively (RR 1.01, 95% CI 0.99-1.03, P = 0.44). Adverse events were significantly lower with HDDT than with BQT (RR 0.44, 95% CI 0.38-0.51, P < 0.00001). Patient adherence was significantly different between the two groups (RR 1.01, 95% CI 1.00-1.03, P = 0.02). Subgroup analysis based on antibiotic combinations within the BQT group showed a significantly higher eradication rate for HDDT than for BQT only when BQT used amoxicillin combined with clarithromycin (P = 0.0009).
HDDT showed comparable efficacy with BQT for H. pylori eradication, with fewer adverse effects and higher compliance. Due to regional differences, antibiotic resistance rates, and combined BQT antibiotics, more studies are needed for further validation and optimization of HDDT.
通过荟萃分析更新基于证据的数据，比较大剂量双联疗法（HDDT）和含铋四联疗法（BQT）根除幽门螺杆菌感染的疗效和安全性。
系统检索多个数据库，查找截至2023年5月18日发表的随机对照试验（RCT）。使用风险比（RR）和95%置信区间（CI）评估二分数据。进行亚组分析、敏感性分析、偏倚风险评估和证据质量评估。
分析纳入了20项包含7891名受试者的RCT。意向性分析（ITT）中，HDDT和BQT的幽门螺杆菌根除率无统计学显著差异（86.31%对84.88%；RR 1.02，95% CI 1.00 - 1.04，P = 0.12）。符合方案分析（PP）中，HDDT和BQT的根除率分别为90.27%和89.94%（RR 1.01，95% CI 0.99 - 1.03，P = 0.44）。HDDT的不良事件显著低于BQT（RR 0.44，95% CI 0.38 - 0.51，P < 0.00001）。两组患者的依从性有显著差异（RR 1.01，95% CI 1.00 - 1.03，P = 0.02）。BQT组内基于抗生素组合的亚组分析显示，仅当BQT使用阿莫西林联合克拉霉素时，HDDT的根除率显著高于BQT（P = 0.0009）。
HDDT在根除幽门螺杆菌方面显示出与BQT相当的疗效，不良事件更少，依从性更高。由于地区差异、抗生素耐药率以及BQT联合使用的抗生素不同，需要更多研究来进一步验证和优化HDDT。
