小儿牛黄清心散治疗儿童上呼吸道感染有效性和安全性系统评价

Systematic Review of the Efficacy and Safety of Xiaoer Niuhuang Qingxin Powder in the Treatment of Upper Respiratory Tract Infection in Pediatric patients

目的:系统评价小儿牛黄清心散治疗儿童上呼吸道感染的有效性和安全性。方法:计算机检索PubMed数据库、Science Direct数据库、The Cochrane Library、Embase数据库、中国期刊全文数据库、万方数据库等,收集小儿牛黄清心散治疗儿童上呼吸道感染的随机对照试验(RCT),时限均为从建库起至2020年3月。筛选文献、提取资料后采用Cochrane协作网的"偏倚风险评估工具"评价文献质量,采用Rev Man 5.3软件进行Meta分析。结果:本研究共纳入20篇文献,样本总量2298例,试验组1159例,对照组1139例;Meta分析结果表明,小儿牛黄清心散治疗儿童上呼吸道感染总有效率显著优于对照组(RR=1.14,95%CI[1.11,1.17],P<0.00001),与上呼吸道感染部位无显著相关性(P=0.61);小儿牛黄清心散正常剂量组(RR=1.19,95%CI[1.10,1.29],P<0.001)和低剂量组(RR=1.12,95%CI[1.08,1.16],P<0.001)有效率均显著高于对照组,且亚组间无显著性差异(P=0.18);小儿牛黄清心散治疗1至3岁(RR=1.23,95%CI[1.08,1.39],P=0.002)和3至6岁(RR=1.12,95%CI[1.09,1.16],P<0.00001)患儿有效率均显著优于对照组,且亚组间有效率无显著性差异(P=0.18);小儿牛黄清心散治疗小儿上呼吸道感染可显著缩短退热时间(MD=-1.22,95%CI[-1.35,-1.10],P<0.00001),降低高热惊厥再发生次数(RR=0.15,95%CI[0.05,0.51],P=0.002);不良反应方面试验组与对照组无统计学差异(RR=0.82,95%CI[0.51,1.31],P=0.40),且无严重的不良反应发生。结论:小儿牛黄清心散可显著提高1至6岁儿童上呼吸道感染的治疗总有效率,改善临床症状,且安全有效。

Objective:To evaluate the efficacy and safety of xiaoer Niuhuang qingxin powder in treating upper respiratory tract infection of children.Method:Computer retrieval PubMed,Science Direct,The Cochrane Library,Embase,CNKI,Wanfang database.A randomized controlled trial(RCT)of xiaoer niuhuang qingxin Powder for the treatment of upper respiratory tract infection in children was collected.The time frames are from the time of construction to March 2020.After selecting the literature and extracting the data,the"bias risk assessment tool"Cochrane the collaborative network was used to evaluate the quality of the literature.Using Rev Man 5.3 software for Meta analysis.Results:A total of 2298 randomized controlled trials were included in this study.Results of Meta-analysis showed that the overall effective rate of xiaoer niuhuang qingxin Powder in the treatment of upper respiratory tract infection in children is better than that of the control group(RR=1.14,95%CI[1.11,1.17],P<0.00001),which was no significant correlation with upper respiratory tract infection site(P=0.61).The effective rates of Xiaoer Niuhuang Qingxin powder in normal dose group(RR=1.19,95%CI[1.10,1.29],P<0.001)and in low dose group(RR=1.12,95%CI[1.08,1.16],P<0.001)were significantly higher than the control group,and there was no significant difference between subgroups(P=0.18).It was significantly better than the control group,which compared with between the children aged from 1 to 3(RR=1.23,95%CI[1.08,1.39],P=0.002)and 3 to 6(RR=1.12,95%CI[1.09,1.16],P<0.00001)who was treated by Xiaoer Niuhuang Qingxin powder.It was no significant difference in the efficiency among the subgroups of different age(P=0.18).Xiaoer Niuhuang Qingxin powder could significantly shorten the time of antipyretic(MD=-1.22,95%CI[-1.35,-1.10],P<0.00001)and reduce the recurrence rate of febrile convulsion(RR=0.15,95%CI[0.05,0.51],P=0.002).There was no significant difference between the adverse reactions and the control group(RR=0.82,95%CI[0.51,1.31],P=0.40),and no serious adverse reactions occurred.Conclusion:Xiaoer Niuhuang qingxin powder can improve significantly the total effective rate of treatment of upper respiratory tract infection in children aged 1 to 6,improving clinical symptoms,and be safe and effective.