改良双联疗法作为幽门螺杆菌感染一线治疗方案的疗效和安全性：一项随机对照试验的荟萃分析。

Efficacy and Safety of Modified Dual Therapy as the First-line Regimen for the Treatment of Helicobacter pylori Infection: A Meta-Analysis of Randomized Controlled Trials.

机构信息

Department of Integrated Traditional Chinese and Western Medicine, Peking University First Hospital.

Institute of Integrated Traditional Chinese and Western Medicine, Peking University.

出版信息

J Clin Gastroenterol. 2021;55(10):856-864. doi: 10.1097/MCG.0000000000001448.

DOI:10.1097/MCG.0000000000001448

PMID:33074949

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8513521/

Abstract

BACKGROUND

In an era of antibiotic resistance, modified dual therapy has been paid much attention because of simple drug composition and low resistance of amoxicillin. However, its eradication rate as a first-line regimen remains controversial. This study is to evaluate the efficacy and safety of modified dual therapy for the initial treatment of Helicobacter pylori (H. pylori) infection compared with mainstream first-line therapies.

METHODS

PubMed, the Cochrane Library, and Embase were searched for randomized clinical trials evaluating the efficacy and safety of modified dual therapy as the initial treatment for H. pylori eradication compared with guideline-recommended first-line therapies. A meta-analysis was conducted using Review Manager 5.3 and dichotomous data were estimated by the risk ratio (RR) with the 95% confidence interval (CI). We also performed subgroup analysis according to control groups and studies with antibiotic susceptibility tests.

RESULTS

Eight studies including 1672 patients with H. pylori infection met the selection criteria and were assessed. The meta-analysis demonstrated that modified dual therapy achieved similar efficacy [85.83% vs. 86.77%, RR 0.99 (95% CI, 0.95-1.03), intention-to-treat analysis; 89.53% vs. 90.45%, RR 0.99 (95% CI, 0.96-1.02), per-protocol analysis] and compliance [95.77% vs. 95.56%, RR 1.00 (95% CI, 0.98-1.02)] compared with recommended first-line regimens. In addition, there were no significant differences in comparing the eradication rate of modified dual therapy with clarithromycin triple therapy, bismuth quadruple therapy, and concomitant therapy, respectively. Subgroup analysis based on the studies with antibiotic susceptibility tests also confirmed a similar efficacy. However, modified dual therapy showed fewer adverse effects [8.70% vs. 22.38%, RR 0.39 (95% CI, 0.28-0.54)], with a significant difference (P<0.00001).

CONCLUSION

Modified dual therapy achieved equal efficacy and compliance compared with recommended first-line regimens for H. pylori infection, and generally modified dual therapy showed fewer side effects.

摘要

背景

在抗生素耐药的时代，由于阿莫西林的药物组成简单且耐药性低，改良双联疗法受到了广泛关注。然而，作为一线方案，其根除率仍存在争议。本研究旨在评估改良双联疗法作为初始治疗幽门螺杆菌（H. pylori）感染的疗效和安全性，与主流一线治疗方案相比。

方法

检索 PubMed、Cochrane 图书馆和 Embase，评估改良双联疗法作为初始治疗 H. pylori 根除与指南推荐的一线治疗相比的疗效和安全性的随机临床试验。使用 Review Manager 5.3 进行荟萃分析，二分类数据采用风险比（RR）和 95%置信区间（CI）进行估计。我们还根据对照组和进行抗生素药敏试验的研究进行了亚组分析。

结果

符合选择标准并进行评估的包括 8 项研究，共 1672 例 H. pylori 感染患者。荟萃分析显示，改良双联疗法在疗效[85.83%比 86.77%，RR 0.99（95%CI，0.95-1.03），意向治疗分析；89.53%比 90.45%，RR 0.99（95%CI，0.96-1.02），方案治疗分析]和依从性[95.77%比 95.56%，RR 1.00（95%CI，0.98-1.02）]方面与推荐的一线方案相似。此外，改良双联疗法与克拉霉素三联疗法、铋四联疗法和联合疗法的根除率相比，差异均无统计学意义。基于抗生素药敏试验的研究进行的亚组分析也证实了相似的疗效。然而，改良双联疗法的不良反应较少[8.70%比 22.38%，RR 0.39（95%CI，0.28-0.54）]，差异有统计学意义（P<0.00001）。