3种清热解毒类中药注射剂治疗小儿手足口病的Meta分析

Meta-analysis of Three Kinds of Heat-clearing and Detoxifying Traditional Chinese Medicine Injections in the Treatment of Children with Hand-foot-mouth Disease

目的:评价清热解毒类中药注射剂在手足口病治疗中的临床应用的疗效和安全性。方法:计算机检索Pub Med、Cochrane Library、CNKI,VIP和Wan Fang Data数据库,搜集清热解毒类中药注射剂治疗小儿手足口病的随机对照试验(RCTs),检索时限均为建库至2019年3月,由两名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用Rev Man 5.3软件进行Meta分析。结果:共纳入11个RCTs,共2 071例患儿。Meta分析结果显示,与西药常规疗法组比较,中药注射剂组治疗小儿手足口病可提高总有效率[OR=2.88,95%CI(1.62,5.10),P=0.000 3]、缩短退热起效时间[MD=-8.10,95%CI(-11.77,-4.42),P<0.000 1]、缩短体温恢复正常时间[MD=-16.63,95%CI(-22.68,-10.59),P<0.000 01]、缩短手足皮疹消退时间[MD=-29.57,95%CI(-47.18,-11.95),P=0.001];在不良反应发生率、重症转化率上,两组的差异无统计学意义(P>0.05)。结论:清热解毒类中药注射剂治疗小儿手足口病具有一定的优势,可在临床推广使用。但现有高质量文献不多,因此本研究最终纳入文献数量较少,未能对3种中药注射剂之间的疗效和安全性进行比较,需要更多设计严谨的高质量、多中心的随机双盲临床研究进一步验证。

Objective: To evaluate the efficacy and safety of heat-clearing and detoxifying traditional Chinese medicine injections in the treatment of hand-foot-mouth disease. Methods: Pubmed,Cochrane Library,CNKI,VIP and Wan Fang Data were electronically searched to collect randomized controlled trials( RCTs) of antipyretic and detoxifying traditional Chinese medicine injections in the treatment of children with hand-foot-mouth disease from inception to March,2019. Two researchers independently screened the literatures,extracted data and assessed the risk of bias of included studies,and then,meta-analysis was performed by Rev Man 5. 3 software. Results: A total of 11 RCTs involving a total of 2 071 children were included. Meta-analysis results showed that compared with western medicine group,traditional Chinese medicine injections group could significantly improve total effective rate of children with hand-foot-mouth disease( OR = 2. 88,95% CI-1. 62 to 5. 10,P = 0. 000 3),reduce antipyretic onset time( MD =-8. 10,95% CI-11. 77 to-4. 42,P < 0. 000 1),reduce recovery time of body temperature( MD =-16. 63,95% CI-22. 68 to-10. 59,P <0. 000 01) and skin rash of hand-foot-mouth disease( MD =-29. 57,95% CI-47. 18 to-11. 95,P = 0. 001). There were no significant differences in the incidence of adverse reactions and the rate of intensive conversion( P > 0. 05). Conclusion: Heat-clearing and detoxifying traditional Chinese medicine injections show certain advantages in treating hand-foot-mouth disease in children,it can be widely used in clinic. But there are few high-quality literatures,so the meta analysis was not included in the number of documents,failed to compare the efficacy and safety of the three traditional Chinese medicine injections,suggesting more rigorous high quality multi-center randomized double-blind clinical studies are required for verification.