布拉氏酵母菌散联合三联疗法对幽门螺杆菌感染根除效果的多中心随机对照研究  

A multi-center,randomized controlled study on the effect of Saccharomyces boulardii combined with triple therapy for the initial eradication of Helicobacter pylori infection

作　　者：杨桂彬[1] 胡伏莲[2] 成虹[2] 高文[2] 盛剑秋 张振玉[4] 杜奕奇 左秀丽[6] 李岩[7] 陈烨[8] 王邦茂[9] 赵子涵 Yang Guibin;Hu Fulian;Cheng Hong;Gao Wen;Sheng Jianqiu;Zhang Zhenyu;Du Yiqi;Zuo Xiuli;Li Yan;Chen Ye;Wang Bangmao;Zhao Zihan(Department of Gastroenterology,Aerospace Center Hospital,Beijing 100049,China;Department of Gastroenterology,First Hospital of Beijing University,Beijing 100034,China;Department of Gastroenterology,the Seventh Medical Center of PLA General Hospital,Beijing 100700,China;Department of Gastroenterology,Nanjing First Hospital,Nanjing 210006,China;Department of Gastroenterology,Changhai Hospital Affiliated to Naval Medical University,Shanghai 200433,China;Department of Gastroenterology,Qilu Hospital of Shandong University,Jinan 250012,China;Department of Gastroenterology,Shengjing Hospital Affiliated to China Medical University,Shenyang 110801,China;Department of Gastroenterology,Southern Hospital Affiliated to Southern Medical University,Guangzhou 510515,China;Department of Gastroenterology,General Hospital of Tianjin Medical University,Tianjin 300052,China)

机构地区：[1]航天中心医院消化科,北京100049 [2]北京大学第一医院消化科,北京100034 [3]解放军总医院第七医学中心消化内科,北京100700 [4]南京市第一医院消化科,南京210006 [5]海军军医大学附属长海医院消化科,上海200433 [6]山东大学齐鲁医院消化科,济南250012 [7]中国医科大学附属盛京医院消化科,沈阳110801 [8]南方医科大学附属南方医院消化科,广州510515 [9]天津医科大学总医院消化科,天津300052

出　　处：《中华医学杂志》2022年第18期1383-1388,共6页National Medical Journal of China

基　　金：中国健康促进基金会幽门螺杆菌防治基金(CHPF-2014-HP-001)。

摘　　要：目的观察布拉氏酵母菌散联合三联疗法作为一线方案对幽门螺杆菌(H. pylori)感染的根除治疗效果及安全性。方法纳入2018年6月至2020年1月全国9个中心接受胃镜检查并诊断非溃疡性消化不良(NUD)的H. pylori阳性患者共497例, 采用分段随机法分为3组, 进行H. pylori初次根除治疗。A组采用布拉氏酵母菌散+三联疗法(10 d后继续仅予布拉氏酵母菌至14 d);B组采用铋剂四联疗法(10 d);C组采用三联疗法(10 d)。患者均在第44天行13C-尿素呼气试验。分别观察H. pylori根除率、第14及44天症状改善情况和不良反应。结果纳入的497例患者中, 男229例, 女268例, 年龄18~69(46.1±11.8)岁, 共472例(A组158例、B组159例、C组155例)完成试验。意向性(ITT)分析:A组H. pylori根除率为77.8%(126/162), B组为80.1%(137/171), C组为65.2%(107/164)。符合方案集(PP)分析:A组根除率为79.7%(126/158), B组为86.2%(137/159), C组为69.0%(107/155)。三组间ITT及PP分析差异均有统计学意义(ITT:χ^(2)=11.14, P<0.01;PP:χ^(2)=13.86, P<0.01)。各组两两比较, ITT及PP分析A、B组之间差异均无统计学意义(均P>0.05), A组和B组与C组比较差异均有统计学意义(均P<0.05)。在第14天时, A、B组嗳气症状评分缓解程度与C组差异均有统计学意义(均P<0.05)。第44天时, A组腹胀、嗳气症状评分缓解程度与C组差异均有统计学意义(均P<0.05)。所有纳入本研究患者均无严重不良反应事件发生。A组腹泻发生率低于另外两组(均P<0.05)。结论布拉氏酵母菌散联合三联疗法作为一线方案对NUD患者初次H. pylori治疗具有较好的根除效果, 并在症状缓解上有优势, 具有较好的耐受性和临床安全性。Objective To assess the efficacy and safety of Saccharomyces boulardii(S.boulardii)in combination with triple therapy as a first-line regimen for the eradication of Helicobacter pylori(H.pylori)in non-ulcer dyspepsia(NUD)patients.Methods A total of 497 Helicobacter pylori-positive patients who underwent gastroscopy and diagnosed with NUD were enrolled from June 2018 to January 2020 in 9 medical centers across China.Participants were segmentedly randomly divided into 3 groups.Patients in group A received S.boulardii for 14 days and triple therapy for 10 days,while patients in group B received bismuth quadruple group for 10 days,and patients in group C received triple therapy for 10 days.The H.pylori status was determined by the 13C-urea breath test on the 44th day of the treatment.Symptom improvement and adverse reactions were assessed on the 14th and 44th day.Results There were 229 males and 268 females in all 497 patients enrolled.They were aged 18-69(46.1±11.8)years and 472 of them(158 cases in group A,159 cases in group B,and 155 cases in group C)completed the trial.The intention-to-treat(ITT)eradication rates in patients in patients A,B and C were 77.8%(126/162),80.1%(137/171)and 65.2%(107/164)respectively,and per protocol-based(PP)eradication rates were 79.7%(126/158),86.2%(137/159)and 69.0%(107/155)respectively.The differences were statistically significant in ITT and PP analysis among 3 groups(ITT:χ^(2)=11.14,P<0.01;PP:χ^(2)=13.86,P<0.01).There was no significant difference between eradication rates of two quadruple therapys(all P>0.05),but both of them were significantly higher than that of standard triple therapy(both P<0.05).Statistics revealed that both quadruple therapys led to significantly higher symptom improvement of belching compared with that of standard triple therapy in day 14(P<0.05).The relief of abdominal distension and belching symptom scores of group A were significantly higher than those of group C in day 44(all P<0.05).There was no serious adverse event reported.The incidence of diar

关 键 词：螺杆菌 幽门 布拉氏酵母菌 非溃疡性消化不良 随机对照试验 

分 类 号：R573[医药卫生—消化系统]