高剂量双重疗法铋剂四联疗法根除幽门螺杆菌：一项采用试验序贯分析的系统评价和Meta分析
High-dose dual therapy bismuth-containing quadruple therapy for eradication: a systematic review and meta-analysis with trial sequential analysis.
作者信息
Zhou Ben-Gang, Mei Yu-Zhou, Zhang Min, Jiang Xin, Li Yao-Yao, Ding Yan-Bing
机构信息
Dalian Medical University, Dalian, Liaoning Province, China.
Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou, Jiangsu Province, China.
出版信息
Therap Adv Gastroenterol. 2023 Jan 10;16:17562848221147756. doi: 10.1177/17562848221147756. eCollection 2023.
BACKGROUND AND OBJECTIVE
Recently, a large number of trials on proton pump inhibitor-amoxicillin-containing high-dose dual therapy (HDDT) bismuth-containing quadruple therapy (BQT) for () eradication have been published with controversial and inconsistent conclusions. The aim of this meta-analysis was to determine the effects of HDDT for eradication compared to BQT.
DESIGN
A systematic review and meta-analysis was conducted.
METHODS
PubMed, Embase, and the Cochrane library database were searched to collect all randomized controlled trials (RCTs) assessing the effects of HDDT BQT to eradication from inception to September 2022. Meta-analysis was conducted to estimate the pooled relative risk (RR) with 95% confidence intervals (CIs) using a random-effects model. Quality of evidence was appraised using Grading of Recommendations, Assessment, Development and Evaluation system. Trial sequential analysis (TSA) was performed to determine the reliability and conclusiveness.
RESULTS
A total of 14 RCTs with 5121 patients were included. The results of meta-analysis showed that there was no statistical significance in the eradication rate between HDDT and BQT (intention-to-treat analysis: 86.7% 85.1%, RR = 1.01, 95% CI: 0.98-1.04; per-protocol analysis: 89.9% 89.4%, RR = 1.01, 95% CI: 0.98-1.03; moderate-quality evidence). The incidence of total adverse effects in HDDT group was significantly lower than in BQT group (5.9% 34.1%, RR = 0.42, 95% CI: 0.34-0.50; low-quality evidence). No statistical significance was observed in compliance between HDDT and BQT (RR = 1.01, 95% CI, 1.00-1.03, = 0.07; low-quality evidence). The TSA result for eradication rate indicated that the effect was conclusive.
CONCLUSIONS
Evidence from our updated meta-analysis suggests that HDDT is as effective as BQT in eradicating , with fewer adverse effects and similar compliance.
REGISTRATION
Open Science Framework registries (No: osf.io/th4vd).
背景与目的
最近，大量关于含质子泵抑制剂 - 阿莫西林的高剂量双联疗法（HDDT）与含铋四联疗法（BQT）根除（某种病菌，原文括号处缺失具体病菌名称）的试验已发表，但结论存在争议且不一致。本荟萃分析的目的是确定与BQT相比，HDDT根除（该病菌）的效果。
设计
进行了一项系统评价和荟萃分析。
方法
检索了PubMed、Embase和Cochrane图书馆数据库，以收集从起始至2022年9月评估HDDT与BQT根除（该病菌）效果的所有随机对照试验（RCT）。采用随机效应模型进行荟萃分析，以估计合并相对风险（RR）及95%置信区间（CI）。使用推荐分级、评估、制定与评价系统对证据质量进行评估。进行试验序贯分析（TSA）以确定可靠性和结论性。
结果
共纳入14项RCT，涉及5121例患者。荟萃分析结果显示，HDDT与BQT之间的根除率无统计学意义（意向性分析：86.7%对85.1%，RR = 1.01，95%CI：0.98 - 1.04；符合方案分析：89.9%对89.4%，RR = 1.01，95%CI：0.98 - 1.03；中等质量证据）。HDDT组的总不良反应发生率显著低于BQT组（5.9%对34.1%，RR = 0.42，95%CI：0.34 - 0.50；低质量证据）。HDDT与BQT之间的依从性未观察到统计学意义（RR = 1.01，95%CI，1.00 - 1.03，P = 0.07；低质量证据）。TSA结果显示根除率的效果具有结论性。
结论
我们更新的荟萃分析证据表明，HDDT在根除（该病菌）方面与BQT一样有效，不良反应更少且依从性相似。
注册
开放科学框架注册库（编号：osf.io/th4vd）
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