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
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篇名: 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
TITLE:
摘要: 目的:系统评价细菌溶解产物胶囊(以下统称为“泛福舒”)防治儿童反复呼吸道感染(RRTIs)的有效性和安全性,为临床提供循证参考。方法:计算机检索PubMed、EMBase、Cochrane图书馆、中国生物医学文献数据库、中国知网、万方数据库和维普数据库等,收集泛福舒(试验组)对比安慰剂(对照组)防治儿童RRTIs的随机对照试验(RCT),检索时限均为建库起至2018年1月。筛选文献并资料提取后,采用Cochrane 5.1.0偏倚风险评估工具进行偏倚风险评价,采用Rev Man 5.3软件进行Meta分析。结果:共纳入13项RCT,共计1 228例患儿。Meta分析结果显示,试验组在呼吸道感染次数[MD=-1.14,95%CI(-1.29,-0.99),P<0.001]、总有效率[RR=9.47,95%CI(2.33,38.54),P=0.002]、抗菌药物使用时间[MD=-4.36,95%CI(-6.52,-2.21),P<0.001]、感染持续时间[MD=-3.89,95%CI(-4.47,-3.04),P<0.001]、发热时间[MD=-1.81,95%CI(-3.40,-0.22),P=0.03]、血清免疫球蛋白(Ig)G水平[MD=1.25,95%CI(0.13,2.37),P=0.03]、IgA水平[MD=0.77,95%CI(0.07,1.46),P=0.03]及T细胞亚群水平CD4+[MD=1.33,95%CI(0.90,1.76),P<0.001]、 CD8+[MD=0.64,95%CI(0.24,1.04),P=0.002]方面均显著优于对照组,差异均有统计学意义;在咳嗽时间[MD=-6.00,95%CI(-13.86,1.86),P=0.13]、IgM水平[MD=-0.10,95%CI(-0.32,0.12),P=0.39] 及不良反应发生率[RR=0.76,95%CI(0.43,1.35),P=0.35]方面均与对照组相当。结论:当前证据表明,泛福舒可有效防治儿童RRTIs,安全性较高。
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.
期刊: 2018年第29卷第12期
作者: 戎萍,马融,张喜莲,闫海虹
AUTHORS: RONG Ping,MA Rong,ZHANG Xilian,YAN Haihong
关键字: 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
KEYWORDS: Broncho-Vaxom;Bacterial lysates;Children;Recurrent respiratory tract infection; Placebo;Efficacy; Safety; Meta-analysis
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