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).Stratified analysis of antibiotics showed there was no significant difference in the incidence of diarrhea between the two groups.Multivariate Logistic regression analysis showed that the age and duration of antibiotic treatment were risk factors,but Saccharomyces boulardii was a protective factor.No drug-related adverse events were observed in both groups.ConclusionSaccharomyces boulardii can prevent diarrhea secondary to pneumonia in children without obvious adverse reactions.
出处
《中国实用儿科杂志》
CSCD
北大核心
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)。
关键词
布拉氏酵母菌
儿童
肺炎
继发性腹泻
Saccharomyces boulardii
child
pneumonia
secondary diarrhea
