布拉氏酵母菌预防儿童肺炎继发性腹泻的多中心随机对照研究  

Efficacy of Saccharomyces boulardii in the prevention of diarrhea secondary to pneumonia in children:A randomized controlled multicenter clinical study

作　　者：无 韩艳 楼金玕[20] 楼绮茵 金莉[4] 汤卫红 虞燕萍[6] 袁新华 熊斌[8] 吴鸣 王有成[10] 王凯旋[11] 潜丽俊[12] 陈官进 郦凡[14] 蒋叶均[15] 方玉红 魏洪平[17] 王其莉[18] 徐嘉望 无;LOU Jin-gan(Clinical Research Collaboration Group on the Prevention of Diarrhea Secondary to Pneumonia in Children by Saccharomyces boulardii;不详)

机构地区：[1]布拉氏酵母菌预防儿童肺炎继发腹泻临床协作组 [2]浙江大学医学院附属儿童医院 [3]东阳市人民医院巍山分院 [4]海宁市人民医院 [5]杭州市儿童医院 [6]杭州市第一人民医院 [7]湖州市妇幼保健院 [8]湖州市中心医院 [9]嘉兴市第二医院 [10]金华市人民医院 [11]金华市中心医院 [12]丽水市中心医院 [13]青田县人民医院 [14]绍兴第二医院 [15]绍兴市妇幼保健院 [16]桐庐县人民医院 [17]义乌市中心医院 [18]浙江省中医院 [19]浙江萧山医院 [20]浙江大学医学院附属儿童医院消化内科,国家儿童健康与疾病临床医学研究中心,浙江杭州310052

出　　处：《中国实用儿科杂志》2020年第11期866-871,共6页Chinese Journal of Practical Pediatrics

基　　金：浙江省卫生厅研究项目(2014KYB146);浙江省教育厅研究项目(Y201738367)。

摘　　要：目的评价布拉氏酵母菌在预防儿童肺炎继发性腹泻的临床疗效。方法采用多中心、随机、开放、空白对照的研究方法,纳入499例1月龄~6周岁因肺炎于2014年8月至2017年12月间在浙江省18家医院住院治疗的患儿。采用随机数字表将患儿随机分成对照组与研究组。对照组接受常规抗生素+对症治疗,研究组在常规抗生素+对症治疗基础上,加用布拉氏酵母菌口服(1月龄~3周岁:1包/次,1次/d;>3~6周岁,1包/次,2次/d),并随访至停用抗生素后14 d。观察并记录患儿每日排便次数、大便性状,统计腹泻发生率、住院时间、住院费用、抗生素使用时间及药物相关不良反应等指标。结果符合纳入标准的肺炎患儿499例,回收病例报告表434例,纳入疗效分析的患儿370例,其中研究组192例,对照组178例,两组患儿一般资料差异无统计学意义;研究组的继发性腹泻发生率低于对照组(P=0.017<0.05),两组患儿在抗生素使用时间、住院时间、住院费用上差异无统计学意义;年龄分层分析发现患儿年龄≤1岁时两组腹泻发生率差异无统计学意义,年龄>1岁时研究组患儿腹泻发生率明显低于对照组(P=0.006<0.05);抗生素分层分析发现两组患儿腹泻发生率差异无统计学意义;多因素Logistic回归分析结果显示,患儿日龄、抗生素使用时间是危险因素,布拉氏酵母菌的应用为保护因素;两组患儿均未观察到药物相关不良事件。结论布拉氏酵母菌可以预防儿童肺炎继发性腹泻,且安全性好。ObjectiveTo evaluate the clinical efficacy of Saccharomyces boulardii in preventing diarrhea secondary to pneumonia in children.MethodsA multi-center,randomized,open and blank control study was conducted,and 499 children aged 1 month to 6 years old with pneumonia were enrolled,who were treated in 18 hospitals in Zhejiang province from August 2014 to December 2017.The children were randomly divided into control group and study group by random number table.The study group was treated with antibiotics plus symptomatic treatment plus Saccharomyces boulardii orally,while the control group was treated with antibiotics plus symptomatic treatment.The usage of Saccharomyces boulardii was 1 pack/time,1 time/day for children aged from 1 month to 3 years old and 1 pack/time,2 times/day for children aged from 3 to 6 years old.The children were followed up until 14 d after withdrawal of antibiotics.Observe and record the times of bowel movement and stool property.The results,such as the incidence of diarrhea,the antibiotic use time,the hospitalization time,the hospital costs and adverse drug reactions,were observed and recorded.ResultsTotally 499 cases were randomly divided into two groups,among which report of 434 cases were received,and 370 cases were included for effect analysis(192 cases in the study group,178 cases in the control group).There was no significant difference in general information between the two groups.The overall incidence of secondary diarrhea in the study group was lower than that in the control group(P=0.017<0.05).There was no significant difference between the two groups in terms of the antibiotic use time,hospitalization time or hospital costs.Stratified analysis of age found that when the age of children was less than or equal to 1 year old,there was no significant difference in the incidence of diarrhea between the two groups,but when the age of children was more than 1 year old,the incidence of diarrhea in the study group was significantly lower than that in the control group(P=0.006<0.05).Stratifi

关 键 词：布拉氏酵母菌 儿童 肺炎 继发性腹泻 

分 类 号：R72[医药卫生—儿科]