伊曲康唑不同治疗方案对比特比萘芬治疗甲真菌病疗效和安全性的Meta分析

Therapeutic Efficacy and Safety of Different Therapy Schemes of Itraconazole versus Terbinafine in the Treatment of Onychomycosis:A Meta-analysis

目的:系统评价伊曲康唑不同治疗方案对比特比萘芬治疗甲真菌病的临床疗效与安全性,以为临床治疗提供循证参考。方法:计算机检索Pub Med、EMBase、Medline、The Cochrane Library、中国期刊全文数据库、维普中文科技期刊全文数据库、万方数字化期刊全文库,收集伊曲康唑对比特比萘芬治疗甲真菌病的随机对照试验(RCT),提取资料并评价质量后,采用Rev Man 5.2统计软件进行Meta分析。结果:共纳入11项RCT,合计1 886例患者。Meta分析结果显示,伊曲康唑连续治疗的临床治愈率[RR=0.94,95%CI(0.76,1.18),P=0.61]与特比萘芬比较差异无统计学意义,而真菌学治愈率[RR=0.80,95%CI(0.68,0.95),P=0.01]和总治愈率低于特比萘芬,两组比较差异有统计学意义;伊曲康唑冲击治疗的临床治愈率[RR=0.75,95%CI(0.65,0.87),P<0.000]和总治愈率[OR=0.39,95%CI(0.27,0.55),P<0.000]低于特比萘芬,而真菌学治愈率与特比萘芬比较差异无统计学意义[RR=0.82,95%CI(0.63,1.07),P=0.14];两组患者消化系统不良反应发生率比较,差异无统计学意义[OR=1.02,95%CI(0.83,1.25),P=0.86]。结论:伊曲康唑不同治疗方案治疗甲真菌病的疗效均低于特比萘芬,安全性相似。由于纳入研究数量较少、质量一般,该结论尚有待大样本、高质量的RCT进一步验证。

OBJECTIVE：To evaluate the therapeutic efficacy and safety of different therapy schemes of itraconazole versus terbinafine in the treatment of onychomycosis,and to provide evidence-based reference for clinical treatment. METHODS：Retrieved from Pub Med, EMBase, Medline,The Cochrane Library, CNKI,VIP and Wanfang database, randomized controlled trials（RCTs）about itraconazole vs. terbinafine in the treatment of onychomycosis were collected. Meta-analysis was performed by using Rev Man 5.2 statistical software after evaluating the quality of included studies and extracting data. RESULTS：11 RCTs were included,involving 1 886 patients. Meta-analysis showed that：there was no statistical significance in cure rate between itraconazole consecutive treatment [RR=0.94,95% CI（0.76,1.18）,P=0.61] and terbinafine;the mycological cure rate [RR=0.80,95% CI（0.68,0.95）,P=0.01] and total cure rate of itraconazole consecutive treatment were lower than those of terbinafine;there was statistical significance. The clinical cure rate [RR=0.75,95%CI（0.65,0.87）,P〈0.000] and total cure rate [OR=0.39,95%CI（0.27,0.55）,P〈0.000] of itraconazole pulse therapy were lower than those of terbinafine;there was no significant difference in mycological cure rate between 2 groups [RR=0.82,95%CI（0.63,1.07）,P=0.14]. There was no significant difference of the incidence of digestive system adverse reactions between 2 groups[OR=1.02,95%CI（0.83,1.25）,P=0.86].CONCLUSIONS：Therapeutic efficacy of different schemes of itraconazole is lower than terbinafine in the treatment of onychomycosis. More large-scale and high quality RCTs are required for further validation due to small scale and ordinary quality of include studies.