喜炎平注射液治疗手足口病的系统评价

Systematic review of Xiyanping injection for hand foot mouth disease

评价喜炎平注射液配合西药常规治疗手足口病的有效性和安全性。计算机检索Cochrane图书馆,Medline,EMbase,CBMDisc,CNKI,VIP和万方数据库,由2位研究者独立筛选和提取资料,根据Cochrane Reviewer's Handbook 5.0评价标准和工具评价纳入文献质量,采用RevMan 5.1软件进行资料分析。共24篇随机对照试验满足纳入标准,共治疗2 974名患者。仅有1篇试验采用恰当的随机分配方法,2篇试验采用不恰当的随机分配方法,其余试验均未提及随机方法、分配隐藏、盲法及失访情况。Meta分析结果显示喜炎平注射液加用常规治疗组治疗手足口病总有效率(OR=4.26,95%Cl[3.19,5.69])优于单用常规治疗组。退热时间(WMD=-1.48,95%Cl[-1.85,-1.11])和皮疹消退时间(WMD=-1.78,95%Cl[-2.84,-0.72])均短于常规治疗组。纳入的24篇研究报道的不良反应表现轻微,使用安全。喜炎平联合西药常规治疗可以提高手足口病的疗效,但由于该系统评价纳入研究均为中文文献且质量较差,上述结论尚需更多高质量的临床试验加以证实。

To assess the efficacy and safety of Xiyanping injection for hand foot mouth disease. All Clinical studies of Xiyan- ping injection for hand foot mouth disease were searched from Cochrane library, Medline, EMbase, CBM, CNKI, Wanfang and ~IP. Selection of trials for inclusion, data extraction, assessment of methodological quality were completed by two independent screening. The quality of the included documents was evaluated by the Cochrane collaboration＇s tool for assessing risk of bias and allocation con- cealment. Revman 5. 1 software was used for data analysis. Twenty-four randomized controlled trials were included （involving 2 974 patients）, in which, only one study was true RCT and two studies used incorrect methodology. The remaining studies did not provide allocation concealment, blind or loss-up information. The results of Meta-analysis were presented below. Compared with conventional treatment measures, the efficiency of Xinyanping injection group was better （OR = 4. 26, 95 % C1 [ 3. 19,5.69 ] ）. Both fever clearance time（ WMD = - 1.48,95% CI[ - 1.85, - 1.11 ] ） and skin eruption eliminating time （ WMD = - 1.78,95% C1 [ - 2. 84, - 0.72 ] ） of Xinyanping injection group were shorter than the control group. Researches with ADR/AE information of Xinyanping injection showed that the symptoms of ADR/AE were slight. The systematic review suggests that Xiyanping injection in the combination with con- ventional treatment may improve the efficacy of the treatment of hand foot mouth disease. However, as all of the included trials were published in Chinese and of poor quality, we cannot draw a sure conclusion. More rigorous trials with high quality are required.