基于 vonoprazan 的三联疗法与铋四联疗法根除幽门螺杆菌的疗效的荟萃分析。

Meta-analysis of Helicobacter pylori eradication therapy using vonoprazan as an acid suppressor compared with bismuth quadruple therapy.

机构信息

State Key Laboratory of Cancer Biology, Xijing Hospital of Digestive Diseases, The Fourth Military Medical University, Xi'an, China.

Yan'an University School of Medicine, Yan'an, Shaanxi, China.

出版信息

Helicobacter. 2024 Mar-Apr;29(2):e13059. doi: 10.1111/hel.13059.

DOI:10.1111/hel.13059

PMID:38443329

Abstract

BACKGROUND

Vonoprazan, a novel acid suppressant, has recently emerged as a regimen for eradicating Helicobacter pylori. However, uncertainties exist about the effectiveness and safety of VPZ-based regimens compared with those of bismuth-based quadruple therapy in eradicating H. pylori. The present meta-analysis was performed to compare the effectiveness and safety of vonoprazan-based regimens with those of bismuth quadruple therapy in eradicating H. pylori.

MATERIALS AND METHODS

All randomized controlled trials and non-randomized controlled trials comparing the vonoprazan-based therapy with the bismuth quadruple therapy were included in this meta-analysis. Information was also extracted by two evaluators, and if heterogeneity existed, a random-effects model was used to calculate the combined relative ratio and 95% confidence interval; otherwise, a fixed-effects model was used. And subgroup analyses were performed to explore the sources of heterogeneity.

RESULTS

A total of 10 studies, comprising 2587 patients were included in the meta-analysis. The results showed that the combined eradication rate of patients treated with the vonoprazan-based regimen was significantly higher than that of patients treated with bismuth quadruple therapy, in both intention-to-treat and per-protocol analyses, and the differences were statistically significant. Among the intention-to-treat analyses results: (90.28% vs. 83.64% [odds ratio (OR) = 1.85, 95% confidence interval (CI) (1.27, 2.70), p = 0.001]); in the per-protocol analyses: (94.80% vs. 89.88%, [OR = 2.25, 95% CI (1.37, 3.69), p = 0.001]). The occurrence of adverse events was significantly lower in patients treated with vonoprazan-based regimens than in those treated with bismuth quadruple therapy, (14.50% vs. 25.89%, [OR = 0.49, 95% CI (0.32, 0.75), p = 0.001]).

CONCLUSIONS

For eradicating H. pylori, vonoprazan-based regimens are remarkably advantageous over bismuth quadruple therapy. Furthermore, vonoprazan-based regimens exhibit a lower rate of adverse events than bismuth quadruple therapy.

摘要

背景

新型抑酸剂沃诺拉赞已被应用于根除幽门螺杆菌的治疗方案中。然而，与铋剂四联疗法相比，沃诺拉赞方案在根除幽门螺杆菌方面的有效性和安全性尚存在不确定性。本荟萃分析旨在比较沃诺拉赞方案与铋剂四联疗法在根除幽门螺杆菌方面的有效性和安全性。

材料和方法

所有比较沃诺拉赞方案与铋剂四联疗法的随机对照试验和非随机对照试验均纳入本荟萃分析。由两名评估者提取信息，如果存在异质性，则采用随机效应模型计算合并相对比值及其 95%置信区间；否则采用固定效应模型。并进行亚组分析以探讨异质性来源。

结果

共纳入 10 项研究，共计 2587 例患者。结果显示，意向治疗和符合方案分析中，沃诺拉赞方案组患者的根除率均显著高于铋剂四联疗法组，差异具有统计学意义。意向治疗分析结果：（90.28%比 83.64%[比值比（OR）=1.85，95%置信区间（CI）（1.27，2.70）]，p=0.001）；符合方案分析：（94.80%比 89.88%[OR=2.25，95%CI（1.37，3.69）]，p=0.001）。沃诺拉赞方案组患者不良反应的发生率显著低于铋剂四联疗法组，（14.50%比 25.89%[OR=0.49，95%CI（0.32，0.75）]，p=0.001）。