布拉氏酵母菌辅助幽门螺杆菌补救治疗的疗效与安全性系统评价

Efficacy and safety of Saccharomyces boulardii as adjunctive therapy in rescue treatment for Helicobacter pylori infection: a systematic review

摘要

目的 系统评价布拉氏酵母菌 (S. boulardii) 联合补救性根除方案治疗幽门螺杆菌 (Hp) 感染的疗效及安全性, 为临床复治策略提供循证依据。 方法 检索中国知网、 维普、 万方、PubMed、Embase、Cochrane Library 等数据库纳入自建库至 2025 年 11 月 10 日检索出的随机对照试验 (RCT), 按预设纳入和排除标准筛选文献, 提取资料并进行质量评价, 采用 RevMan 5.4 软件进行统计分析。 结果 共纳入 7 篇 RCT, 合计 982 例至少经历 1 次根除失败的成人 Hp 感染患者。 遵循研究方案分析显示, S. boulardii 联合组 Hp 根除率为 88.1% (386/438), 对照组为 78.4% (331/422), 组间异质性较低 (I² = 25%), 随机效应模型分析显示, 联合 S. boulardii 可显著提高根除率 [RR= 1.11, 95% CI (1.03, 1.19), P= 0.004]; 在含铋四联和 PPI 三联等不同补救方案亚组中, 均呈一致获益趋势。 安全性方面, 联合组总体不良事件发生率为8.9% (34/384), 低于对照组的19.0% (72/378), 合并分析结果提示不良事件风险显著下降 [RR = 0.49, 95% CI (0.33, 0.71), P = 0.000 2]; 腹泻结局中, 联合 S. boulardii 同样显著降低腹泻发生率 [1.9% vs 7.6%, RR= 0.26, 95% CI (0.11, 0.63), P= 0.003]。 敏感性分析结果提示主要结论稳健; 漏斗图整体对称, 未观察到明显发表偏倚迹象。 结论 在 Hp 补救治疗人群中, 在标准补救方案基础上联合 S. boulardii 可进一步提高根除率, 减少总体不良事件和抗生素相关腹泻的发生, 值得临床推广应用。

Abstract

Objective To systematically evaluate the efficacy and safety of Saccharomyces boulardii (S. boulardii) as an adjuvant to rescue regimens for Helicobacter pylori (Hp) infection after initial eradication failure, and to provide evidence for clinical decision-making in retreatment. Methods We searched CNKI, VIP, Wanfang, PubMed, Embase, and Cochrane Library from their inception to November 10, 2025 for randomized controlled trials (RCT). Literature was screened according to the preset inclusion and exclusion criteria, data were extracted and quality was evaluated. Statistical analysis was conducted using RevMan 5.4 software. Results Seven RCTs were included, involving 982 adult patients with Hp infection who had experienced at least one eradication failure. Per-protocol analysis showed that the Hp eradication rate was 88.1% (386/438) in the experimental group and 78.4% (331/422) in the control group, with low heterogeneity between the two groups (I ² = 25%). Under a random-effects model, the addition of S. boulardii significantly increased the Hp eradication rate [RR = 1.11, 95% CI (1.03,1.19), P = 0.004]. In subgroup analyses of both bismuth-containing quadruple therapy and PPI-based triple regimens, the addition of S. boulardii consistently improved eradication rates. In terms of safety, the overall incidence of adverse events was 8.9% (34/384) in the experimental group, lower than 19.0% (72/378) in the control group, and the pooled results indicated a significantly reduced risk of adverse events [RR= 0.49, 95% CI (0.33,0.71), P = 0.000 2]. For the outcome of diarrhea, combination therapy with S. boulardii likewise significantly reduced its incidence [1.9% vs 7.6%, RR= 0.26, 95% CI (0.11, 0.63), P= 0.003]. Sensitivity analyses demonstrated that the main findings were robust, and funnel plots were generally symmetrical, not observing obvious publication bias. Conclusion In patients receiving rescue therapy for Hp infection, adding S. boulardii to guideline-recommended eradication regimens can further improve eradication rates and significantly reduce overall adverse events and antibiotic-associated diarrhea, which is worthy of being popularized.

关键词

幽门螺杆菌 / 布拉氏酵母菌 / 益生菌 / 治疗失败 / 补救治疗 / 铋剂四联疗法 / 系统评价 / 随机对照试验

Key words

Helicobacter pylori / Saccharomyces boulardii / probiotics / treatment failure / rescue therapy / bismuth-containing quadruple therapy / system evaluation / randomized controlled trials

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基金资助

国家科技重大专项(2025ZD0545301)