基于Meta分析的热毒宁注射液联合利巴韦林治疗小儿手足口病有效性和安全性评价被引量：15

Efficacy and Safety of Reduning Injection Combined with Ribavirin Therapy for HFMD:a Meta-analysis

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摘要目的:采用Meta分析的方法评价热毒宁注射液联合利巴韦林治疗小儿手足口病(HFMD)的有效性和安全性。方法:计算机检索the Cochrane Library、PubMed、Embase、CNKI、WanFang Data、VIP、SinoMed数据库,搜集关于热毒宁注射液联合利巴韦林治疗小儿HFMD的随机对照试验(RCT),检索时限均为建库至2019年1月,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,运用RevMan 5.3软件进行Meta分析。结果:共纳入20个RCT,共2221例患儿。Meta分析结果显示,与单用利巴韦林相比,热毒宁注射液联合利巴韦林治疗小儿HFMD可明显提高临床总有效率[RR=1.23,95%CI(1.18,1.29),P<0.001]、缩短退热时间[MD=-1.48,95%CI(-1.29,-0.77),P<0.001]、皮疹消退时间[MD=-1.82,95%CI(-2.16,-1.47),P<0.001]、口腔疱疹消退时间[MD=-1.82,95%CI(-2.20,-1.45),P<0.001]及住院时间[MD=-2.17,95%CI(-3.09,-1.25),P<0.001],可降低白细胞计数[MD=-1.32,95%CI(-1.44,-1.20),P<0.001]、超敏C反应蛋白[MD=-2.40,95%CI(-2.81,-2.00),P<0.001]、丙氨酸氨基转移酶[MD=-5.44,95%CI(-5.88,-4.99),P<0.001]、天冬氨酸氨基转移酶水平[MD=-2.87,95%CI(-5.03,-0.72),P=0.009];10项研究提及药品不良反应,3项研究未发生不良反应,其他研究未提及药品不良反应。结论:当前证据表明热毒宁注射液联合利巴韦林治疗小儿HFMD在总有效率、临床症状指标等方面优于单用利巴韦林,但其安全性需进一步探讨。 Objective:To systematically evaluate the clinical efficacy and safety of Reduning injection(RDN)combined with ribavirin(RBV)in treatment of hand-foot-and-mouth disease(HFMD).Methods:The Cochrane Library,PubMed,Embase,CNKI,WanFang Data,VIP and SinoMed were electronically searched to collect randomized controlled trials(RCT)comparing RDN plus RBV and RBV alone in treating HFMD from inception to January,2019.Two reviewers independently screened literature,extracted data and assessed risk of bias of included studies.Meta-analysis was performed using RevMan 5.3 software.Results:A total of twenty RCTs involving 2221 participants were included.The results of Meta-analysis showed that:compared with single RBV,RDN and RBV combination therapy could significantly improve total effective rate(RR=1.23,95%CI 1.18 to 1.29,P<0.001),and shorten antipyretic time(MD=-1.48,95%CI-1.29 to-0.77,P<0.001),skin rash subsiding time(MD=-1.82,95%CI-2.16 to-1.47,P<0.001),oral herpes regression time(MD=-1.82,95%CI-2.20 to-1.45,P<0.001)and hospital stays(MD=-2.17,95%CI-3.09 to-1.25,P<0.001).In addition,it could lower WBC levels(MD=-1.32,95%CI-1.44 to-1.20,P<0.001),hs-CRP levels(MD=-2.40,95%CI-2.81 to-2.00,P<0.001),AST levels(MD=-5.44,95%CI-5.88 to-4.99,P<0.001)and ALT levels(MD=-2.87,95%CI-5.03 to-0.72,P=0.009).Ten studies reported the occurrences of adverse events.Three studies reported that there was no adverse events in studies and the rest studies didn’t refer to adverse events.Conclusion:Current evidence indicates that RDN combined with RBV is superior to RBV is superior to RBV alone of HFMD about overall effectiveness,clinical symptom and so on,but its safety needs to be futher explored.

作者于梦琦张婉乔王成祥秦楠坤赖晓静杨飞李双双马群 Yu Mengqi;Zhang Wanqiao;Wang Chengxiang;Qin Nankun;Lai Xiaojing;Yang Fei;Li Shuangshuang;Ma Qun(Department of Analysis of Chinese Medicines,School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区北京中医药大学中药学院中药分析系

出处《药物流行病学杂志》 CAS 2020年第2期97-104,共8页 Chinese Journal of Pharmacoepidemiology

关键词热毒宁注射液利巴韦林手足口病 META分析随机对照试验 Reduning injection Ribavirin Hand-foot-and-mouth disease Meta-analysis Randomized controlled trial

分类号 R725.1 [医药卫生—儿科]

作者简介通讯作者:马群,Tel:13910186491,E-mail:maqun99@163.com