中药复方治疗儿童流行性感冒疗效与安全性的Meta分析及试验序贯分析

Efficacy and safety of traditional Chinese herbal compound in the treatment of children with influenza:a meta-analysis and trial sequential analysis

目的 系统评价中药复方治疗儿童流行性感冒(简称流感)的疗效与安全性。方法 计算机检索中国知网、万方数据库、维普中文科技期刊数据库、PubMed、Embase和Cochrane library数据库中有关中药复方治疗儿童流感的所有随机对照试验,检索时间为2012年1月至2022年6月。由2名研究者独立地进行文献筛选与资料提取,对纳入研究进行质量评价,采用RevMan 5.3软件进行Meta分析,采用TSA 0.9.5.10软件进行试验序贯分析。结果 共纳入随机对照试验研究11项,共涉及3 232例患者。Meta分析结果显示,中药复方治疗儿童流感的总有效率[RR=1.25,95%CI(1.22,1.30),Z=13.83,P<0.000 01]优于对照组,主要症状缓解时间较对照组明显减少[MD=-2.62,95%CI(-3.88,-1.36),Z=4.08,P<0.000 1],且不良反应发生率低于对照组[RR=0.66,95%CI(0.47,0.94),Z=2.29,P=0.02],差异均有统计学意义。试验序贯分析结果显示中药复方治疗儿童流感确有疗效,证据可靠,且已达到期望信息值。结论 中药复方治疗儿童流感疗效确切且安全性较高,但尚需高质量的研究进一步验证。

Objective To systematically evaluate the efficacy and safety of traditional Chinese herbal compound in the treatment of children with influenza.Methods All randomized controlled trials on TCM compound in the treatment of pediatric influenza were searched for in CNKI,Wanfang database,VIP,PubMed,Embase and Cochrane Library databases,the retrieval time being from January 2012 to June 2022.Literature screening and data extraction were carried out by two researchers independently,and the quality of the included studies was evaluated.Meta-analysis was conducted by RevMan 5.3 software,and trial sequential analysis was conducted by TSA 0.9.5.10 software.Results A total of 11 RCTS were included,involving a total of 3 232 patients.Meta-analysis showed that the total effective rate [RR=1.25,95%CI(1.22,1.30),Z=13.83,P<0.000 01] was better than the control group,the main symptom relief time was significantly reduced [MD=-2.62,95%CI(-3.88,-1.36),Z=4.08,P<0.000 1],and the incidence of adverse reactions was lower than that of control group [RR=0.66,95%CI(0.47,0.94),Z=2.29,P=0.02],the differences being statistically significant.TSA results showed that Chinese herbal compound was effective in the treatment of children with influenza,and has reached the expected information value.Conclusion Traditional Chinese medicine compound is effective and safe in the treatment of children influenza,but it needs to be further verified by high-quality studies.