王　婷，熊　芬，涂　星，唐洪梅*

1.广州中医药大学(广东 广州 510405)2.广州中医药大学第一附属医院(广东 广州 510405)3.湖北民族学院(湖北 恩施 445000)



·论著·

热毒宁治疗儿童手足口病疗效和安全性的Meta分析

王婷1，熊芬2，涂星3，唐洪梅2*

1.广州中医药大学(广东 广州 510405)2.广州中医药大学第一附属医院(广东 广州 510405)3.湖北民族学院(湖北 恩施 445000)

目的探讨热毒宁注射液治疗儿童手足口病的临床疗效和安全性。方法通过计算机检索CNKI、维普、万方、Pubmed、Cochrane library自建库到2015年8月国内外公开发表的关于热毒宁注射液治疗儿童手足口病普通病例的研究；两位研究人员独立对符合纳入标准的文献进行筛选和资料提取；对纳入文献进行文献质量评价；应用Review Manager 5.3进行数据分析，采用优势比OR或均数差WMD作为合并统计量，并用95%CI表示；统计学异质性检验采用Q统计量的I2检验分析。结果共检索到符合纳入标准的文献10篇(n=1 316)，所纳入的文献偏倚风险较小。Meta分析结果显示：①热毒宁治疗儿童手足口病的退热时间(WMD=-0.96，95%CI为-1.09～-0.82)、退疹时间(WMD=-1.57，95%CI为-1.73～-1.42)、口腔溃疡/疱疹消退时间(WMD=-1.75，95%CI为-2.12～-1.38)、总病程(WMD=-2.22，95%CI为-3.40～-1.05)显著短于利巴韦林(P<0.01)；②热毒宁治疗儿童手足口病的总有效率(OR=5.62，95%CI为3.74～8.46)显著高于利巴韦林(P<0.01)；③热毒宁治疗儿童手足口病的不良反应发生率(OR=0.45，95%CI为0.21～0.97)显著低于利巴韦林。结论热毒宁治疗儿童手足口病普通病例比利巴韦林有更好的疗效和安全性。

手足口病；热毒宁；疗效；安全性；系统评价

【Abstract】Objective To assess the efficacy and safety of Reduninginjection in treatment of hand-foot-mouth disease.Methods We collected both domestic and overseas published documents about Reduning Injection in treatment of HFMD through CNKI,VIP,WAN FANG Data,Pubmed and Cochrane library up to the time of August 2015.The selection and data collection were conducted independently by 2 investigators,and the included studies were assessed.All the meta-analyses were performed by Review Manager 5.3.The weighted mean difference (WMD) and odds ratio (OR) were used to compare continuous and dichotomous variables,respectively.All results were reported with 95% confidence intervals (Cls),and heterogeneity was quantified by theI2statistic.Results Ten articles that included a total of 1 316 patients were analyzed in the meta-analysis and the articles showed lower bias risk.①Time for fever recovery (WMD=-0.96，95%CI: -1.09 to -0.82),time for rash disappearance (WMD=-1.57，95%CI:-1.73 to -1.42), time for mouth ulcer disappearance (WMD=-1.75，95%CI:-2.12 to -1.38) and the total course(WMD=-2.22，95%CI:-3.40 to -1.05) in treatment of HFMD by ReduningInjection showed shorter than Ribavirin (P<0.01).②The total effective rate in treatment of HFMD by Reduning Injection(OR=5.62，95%CI:3.74 to 8.46) showed increased comparing to Ribavirin (P<0.01).③The incidence of adverse effect in treatment of HFMD by Reduning Injection showed lower than Ribavirin (P<0.05).Conclusion Reduning Injection has better clinical efficacy and safety than Ribavirin in treatment of HFMD.

【Key words】HFMD;Reduning Injection;efficacy;safety;systematic review

手足口病(hand-food-mouth disease,HFMD)是由肠道病毒引起的急性传染病，近年来在国内的发病率显著升高，并呈现季节性流行和全年散发趋势[1]。目前治疗HFMD并没有特效药，西医治疗常用抗病毒药物如利巴韦林、阿昔洛韦等，易导致白细胞下降、皮疹、腹泻等不良反应。中医治疗HFMD辨证施治、内外兼顾，有减轻病情和缩短病程等优势。根据我国卫生部办公厅发布的《手足口病诊疗指南(2010年版)》,治疗HFMD普通病例(湿热郁蒸证)和重型病例(毒热动风证)，中成药可选用热毒宁注射液。……