布拉酵母菌对三联疗法治疗儿童幽门螺杆菌感染的影响

The effect of addition of Saccharomyces boulardii to the triple therapy on Helicobacter pylori infection in children

目的观察布拉酵母菌在三联疗法抗幽门螺杆菌感染治疗中预防不良反应发生,即安全性的作用,以及对幽门螺杆菌根除有效性的影响。方法幽门螺杆菌感染的82例患儿随机分为2组,观察组接受布拉酵母菌联合三联疗法抗幽门螺杆菌治疗,对照组仅使用三联疗法。在治疗及随访期间,采用改良的格拉斯哥(GDQ)问卷,记录不良反应的发生情况,针对问卷表对不良反应及耐受性进行评估;疗程结束停药后4周,复查幽门螺杆菌根除情况。结果发生腹泻的患儿观察组5例(12.2%),对照组13例(31.7%),差异有统计学意义(P<0.05)。腹上区不适及腹胀患儿在观察组中分别有6例(14.6%)、4例(9.8%),对照组中分别有16例(39.0%)、12例(29.3%),差异均有统计学意义(P<0.05)。恶心、味觉障碍、皮疹等症状在两组患儿中的发生率相近。在治疗及随访期间,GDQ计分显示,观察组患儿的不良反应程度显著轻于对照组,差异有统计学意义(P<0.05)。从意图治疗方案分析,观察组与对照组患儿的幽门螺杆菌根除率差异无统计学意义(P>0.05);而从试验方案分析,两组患儿的差异有统计学意义(χ2=4.68,P<0.05)。结论布拉酵母菌联合三联疗法抗幽门螺杆菌感染可以减少抗生素相关性腹泻的发生,减轻腹上区不适及腹胀,提高治疗的安全性。从试验方案分析来看,布拉酵母菌可以提高幽门螺杆菌的根除率,增加治疗的有效性。

Objective To observe the safety and efficacy of addition ofSaccharomyces boulardii （S. boulardii） to the triple therapy for the eradication of helicobacter pylori （H. pylori） infection. Methods Eighty-two children with H. pylori infection were randomly divided into two groups. The observation group received S. boulardii in addition of anti-H, pylori triple therapy; the control group received the triple therapy only. During the treatment and follow-up period, side effects were recorded by using modified Glasgow Dyspepsia Questionnaire （GDQ）. Adverse reaction and tolerance were evaluated by using a symptom-based questionnaire. H. pylori status was rechecked 4 weeks after completion of eradication therapy. Results Five （12.2%） children in the observation group and 13 （31.7%） children in the control group experienced diarrhea. There was statistically significant dif- ference of diarrhea rate in two groups （P〈0.05）. The rates of both epigastric discomfort and abdominal distension were higher in the control group than those in the observation group [16 （39.0%） versus 6 （14.6%）, 12 （29.3%） versus 4 （9.8%）] and the diffe- rences were significant （P〈0.05）. The rates of nausea, taste disturbance and urticaria were similar in two groups. During the treatment and follow-up period, GDQ scores for adverse reactions in the observation group were significantly lower than those in the con- trol group （P〈0.05）. hr. pylori eradication rate was not statistically different between two groups with use of an intention-to-treat analysis （P〉0.05）. In a per-protocol analysis, there was significant difference of H. pylori eradication rate between two groups （χ^2=4.68, P〈0.05）. Conclusions Addition of S. boulardii combined with anti-H, pylori triple therapy could reduce the incidence of antibiotic-associated diarrhea, relieve epigastric discomfort and abdominal distension, and further improve the safety of triple therapy. In per-protocol analysis, S. boulardii supplement could enhance the eradication rate of H. pylori and increase the efficacy of treatment