中国药房2018，Vol.29Issue(12)：1702-1706,5.DOI:10.6039/j.issn.1001-0408.2018.12.27
细菌溶解产物胶囊防治儿童反复呼吸道感染有效性和安全性的Meta分析
Efficacy and Safety of Bacterial Lysates for Recurrent Respiratory Infection of Children:A Meta-analysis
摘要
Abstract
OBJECTIVE:To evaluate the efficacy and safety of Bacterial lysates(hereinafter referred to as"Broncho-Vaxom") for recurrent respiratory tract infections (RRTIs) of children,and to provide evidence-based reference for clinic. METHODS:Retrieved from PubMed,EMBase,Cochrane Library,CBM,CNKI,Wanfang database and VIP database,domestic and foreign published randomized controlled trials (RCTs) about Broncho-Vaxom (trail group) vs. placebo (control group) for RRTIs of children were collected during database establishment to Jan. 2018. After literature scanning and data extraction,the risk of bias of included trials were evaluated by using Cochrane 5.1.0 risk bias evaluation tool. Meta-analysis was performed by using Rev Man 5.3 software. RESULTS:A total of 13 RCTs involving 1 228 children were included. The results showed that the trial group was superior to control group in frequency of respiratory infection [MD＝－1.14,95%CI(－1.29,－0.99),P＜0.001],total response rate [RR＝9.47,95%CI(2.33,38.54),P＝0.002],the time of antibiotics use [MD＝－4.36,95%CI(－6.52,－2.21),P＜0.001], infection duration [MD＝－3.89,95%CI(－4.47,－3.04),P＜0.001],febrile time [MD＝－1.81,95%CI(－3.40,－0.22),P＝0.03],serum immunoglobulin (Ig)G level [MD＝1.25,95%CI(0.13,2.37)),P＝0.03],IgA level [MD＝0.77,95%CI(0.07, 1.46),P＝0.03] and the level of T cell subgroup CD4+[MD＝1.33,95%CI(0.90,1.76),P＜0.001] and CD8+[MD＝0.64,95%CI (0.24,1.04),P＝0.002],there was statistical significance. Trail group was similar to control group in respect of cough time [MD＝－6.00,95%CI(－13.86,1.86),P＝0.13] and IgM level [MD＝－0.10,95%CI(－0.32,0.12),P＝0.39] and the incidence of ADR [RR＝0.76,95%CI(0.43,1.35),P＝0.35]. CONCLUSIONS:The current evidence shows that Broncho-Vaxom could effectively prevent the RRTIs of children with good safety.关键词
泛福舒/细菌溶解产物胶囊/儿童/反复呼吸道感染/安慰剂/有效性/安全性/Meta分析Key words
Broncho-Vaxom/Bacterial lysates/Children/Recurrent respiratory tract infection/Placebo/Efficacy/Safe-ty/Meta-analysis分类
医药卫生引用本文复制引用
戎萍,马融,张喜莲,闫海虹..细菌溶解产物胶囊防治儿童反复呼吸道感染有效性和安全性的Meta分析[J].中国药房,2018,29(12):1702-1706,5.基金项目
国家自然科学基金资助项目(No.81503612) （No.81503612）
国家中医药管理局中医药标准化项目(No.国中医药法监函〔2015〕192号) （No.国中医药法监函〔2015〕192号）
