三联疗法联合布拉氏酵母菌治疗儿童幽门螺杆菌感染的临床研究

Clinical effect of triple therapy combined with Saccharomyces boulardii in the treatment of Helicobacter pylori infection in children

摘要:

目的 探讨以质子泵抑制剂（PPI）为基础的三联疗法联合布拉氏酵母菌对幽门螺杆菌（Hp）根除率和副作用的影响，以寻求更有效且副作用小的Hp 根除方案。方法 采用前瞻性随机对照研究，选取确诊为Hp 感染的患儿240 例，随机分为三联疗法组和益生菌组，每组120 例。三联疗法组给予阿莫西林[40 mg/（kg·d），Tid]、克拉霉素[15 mg/（kg·d），Bid]和奥美拉唑[0.7~0.8 mg/（kg·d），Qd]进行治疗，益生菌组在三联疗法的基础上增加布拉氏酵母菌（250 mg，Bid），疗程均为14 d。治疗过程中由患儿家长记录不良反应。停药4 周后复查¹³C 呼气试验评估Hp 根除情况，比较两组根除率及副作用的发生率。结果 治疗后三联疗法组Hp 根除率为75.8%（91/120），益生菌组为85.0%（102/120），差异无统计学意义（P>0.05）。治疗过程中副反应发生率比较：恶心、呕吐、腹痛在益生菌组稍低于三联疗法组，但差异无统计学意义（均P>0.05）；口腔炎、便秘、腹泻在益生菌组的发生率明显低于三联疗法组（均P<0.05）。结论 三联疗法联合布拉氏酵母菌并不能显著提高Hp 的根除率，但能明显降低治疗过程中口腔炎、便秘及腹泻的发生率。

Abstract:

Objective To evaluate the clinical effect of proton pump inhibitor-based triple therapy combined with Saccharomyces boulardii in the treatment of Helicobacter pylori (Hp) infection among children in terms of Hp eradication rate and incidence of adverse events. Methods A prospective randomised controlled study was conducted on 240 children with a confirmed diagnosis of Hp infection. These patients were randomized into triple therapy (n=120) and probiotics groups (n=120). The triple therapy group received amoxicillin [40 mg/(kg·d), Tid], clarithromycin [15 mg/(kg·d), Bid] and omeprazole [0.7-0.8 mg/(kg·d), Qd], while the probiotics group received Saccharomyces boulardii (250 mg, Bid) in addition to triple therapy. The course of treatment was 14 days in both groups. The adverse events in subjects were recorded by their parents during treatment. Hp eradiation was evaluated by ¹³C breath test at 4 weeks after treatment, and the eradication rate and incidence of adverse events were compared between the two groups. Results The Hp eradication rates were 75.8% (91/120) in the triple therapy group and 85% (102/120) in the probiotics group (P>0.05). Compared with the triple therapy group, the probiotics group had nonsignificantly lower incidence of nausea, vomiting, and abdominal pain (P>0.05) and significantly lower incidence of stomatitis, constipation and diarrhea (P<0.05). Conclusions Triple therapy combined with Saccharomyces boulardii cannot significantly increase Hp eradication rate, but can significantly reduce the incidence of stomatitis, constipation, and diarrhea during treatment.