特比萘芬和伊曲康唑治疗甲真菌病疗效和安全性的Meta分析  

Meta-analysis on Efficacy and Safety of Terbinafine and Itraconazole in Treatment of Onychomycosis

作　　者：马丽萍[1] 沈司京[1] 吝战权[1] 陈灿[1] 张蕾[1] 

机构地区：[1]北京大学首钢医院药剂科,北京100144

出　　处：《中国医院用药评价与分析》2016年第2期201-205,共5页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:系统评价特比萘芬和伊曲康唑治疗甲真菌病的有效性及安全性,为甲真菌病治疗中抗菌药物的选择提供参考。方法:使用计算机检索Cochrane临床对照试验数据库、EMbase、Pub Med、中国生物医学文献数据库、万方数据库及手工检索相关文献等,检索时间段为建库至2014年11月。查找用英文或中文发表的比较特比萘芬和伊曲康唑治疗甲真菌病有效性和安全性的随机对照试验,提取数据并进行方法学质量评价后,用Rev Man 5.1软件进行Meta分析。结果:总共纳入10个随机对照试验(1 839例患者)进行Meta分析,其中对10个研究(1 839例患者)进行了有效性(真菌治愈率)的评价,特比萘芬组的真菌治愈率优于伊曲康唑组,差异具有统计学意义[RR=1.29,95%CI=(1.13,1.46),P<0.000 1];9个研究(1 711例患者)报告了不良反应的发生情况,2组不良反应发生率无统计学意义[RR=1.04,95%CI=(0.84,1.29),P=0.72];特比萘芬组的胃痛的发生率显著高于伊曲康唑组(P=0.05),而肝功异常的发生率明显低于伊曲康唑组(P≤0.05)。所有试验中均未观察到严重不良反应。结论:现有的临床研究证据显示,特比萘芬治疗甲真菌病的疗效优于伊曲康唑,且无严重不良反应。OBJECTIVE： To systematically assess the efficacy and safety of terbinafine and itraconazole in treatment of onychomycosis, and to provide reference for the selection of antibiotics in the treatment of onychomycosis.METHODS： Computers was used to retrieve the Cochrane Central Register of Controlled Trials,EMbase,Pub Med and Chinese Bio-Medicine Database and Wanfang database and some related literatures manually searched until Nov.2014.Randomized controlled trails（ RCT） with comparison of efficacy and safety of terbinafine and itraconazole in treatment of onychomycosis in English and Chinese were searched,the data were extracted and the methodological quality of the included studies were assessed.The Cochrane Collaboration＇s software Rev Man 5.1 was used for metaanalysis.RESULTS： There were 10 RCT,including 1 839 cases in meta-analysis,of which effectiveness（ fungus cure rate） of 10 trials（ 1 839 patients） were assessed; and the fungus cure rate of terbinafine group was significantly higher than that of itraconazole group,with statistically significant difference[RR = 1.29,95% CI =（1.13,1.46）,P〈0.000 1].9 trials（1 711 patients） had adverse drug reactions,there were no significant difference between two groups[RR = 1.04,95% CI =（ 0.84,1.29）,P = 0.72].The incidence of stomachache in terbinafine group was significantly higher than that in itraconazole group（P=0.05）,but the incidence of liver function abnormalities in terbinafine group was significantly lower than that in itraconazole group（ P≤0.05）.No severe adverse reactions were observed in all trials.CONCLUSIONS： Current clinical evidence shows that terbinafine and itraconazole in treatment of onychomycosis have higher fungus cure rate and safety.And terbinafine is more effective than itraconazole in treatment of onychomycosis without severe adverse reactions.

关 键 词：特比萘芬 伊曲康唑 甲真菌病 META分析 

分 类 号：R978.1[医药卫生—药品]