特比萘芬治疗甲真菌病的系统评价  

Effectiveness and safety of terbinafine for onychomycosis: A systematic review

作　　者：刘海波[1] 刘芳[1] 桑红[1] 

机构地区：[1]南京军区南京总医院皮肤科,南京医学博士210002

出　　处：《医学研究生学报》2014年第6期608-614,共7页Journal of Medical Postgraduates

基　　金：国家自然科学基金(81071331)

摘　　要：目的特比萘芬标准持续治疗方案是治疗甲真菌病的经典方法,但由于其多个方面的缺陷,研究者们尝试了多种其他治疗方案。文中拟对特比萘芬标准持续治疗方案对比其他方案治疗甲真菌病的有效性和安全性进行系统评价。方法计算机检索Pubmed、Cochrane图书馆、EMbase、CNKI、CBMdisc和万方数据库中关于特比萘芬治疗甲真菌病的随机对照试验(randomized controlled trial,RCT)。由2名研究者按照计划书进行选择文献、提取数据、核对,而后进行Meta分析。结果共纳入20个RCT。Meta分析结果提示,标准持续治疗方案在长期真菌学治愈要优于冲击治疗方案[P=0.01,RR=0.81(0.69,0.96)]、COMBO方案[P=0.05,RR=0.68(0.46,1.01)]和间歇给药方案[P=0.0001,RR=0.81(0.73,0.90)]。而标准持续治疗方案在长期真菌学治愈方面要亚于持续治疗联合局部治疗方案[P=0.005,RR=1.19(1.05,1.35)]和持续治疗>3月方案[P=0.02,RR=1.12(1.02,1.24)]。对中-重度甲真菌病患,持续治疗联合清创术方案与标准方案相比有潜在的优势。在安全性方面,持续联合局部治疗方案在胃肠道反应发生低于标准方案[P=0.03,RR=0.24(0.07,0.90)],间歇给药方案在所有不良事件[P=0.03,RR=0.81(0.67,0.98)]和味觉障碍[P=0.05,RR=0.44(0.19,1.00)]发生低于标准治疗方案。在评价研究质量方面,根据Cochrane图书馆推荐的"偏倚风险评估"工具评估后发现某些高度偏倚可能对结果影响较大。结论特比萘芬治疗甲真菌病的最佳治疗方案尚待更多高质量的RCT来证实。Objective The standard continuous terbinafine regimen（ SCTR） is a classical treatment for onychomycosis but has many deficiencies.Therefore,researchers have tried several other therapeutic options.This study systematically evaluated the effectiveness and safety of SCTR versus other therapeutic options in the treatment of onychomycosis.Methods We searched the PubMed,Cochrane Library,Embase,CNKI,CBMdisc and Wanfang databases for the randomized controlled trials on the treatment of onychomycosis with terbinafine.According to the study design,two authors independently selected the literature,extracted data,conducted data checking,and then performed meta-analysis.Results Totally,20 randomized controlled trials were included.The pooled analysis showed that SCTR had a higher long-term mycological cure rate than pulse therapy（ P = 0.01,RR = 0.81 [0.69,0.96]）,COMBO（ P = 0.05,RR = 0.68 [0.46,1.01]）,and intermittent strategy（ P = 0.0001,RR = 0.81 [0.73,0.90]）.However,SCTR exhibited a lower long-term mycological cure rate than continuous ＋ topical treatment（ P = 0.005,RR = 1.19[1.05,1.35]） and ＆gt;3 mo continuous therapy（ P =0.02,RR =1.12 [1.02,1.24]）.For moderate-to-severe mycological infections,SCTR ＋ aggressive debridement had potential advantages over SCTR alone.Compared with SCTR,continuous ＋ topical treatment induced fewer gastrointestinal reactions（ P = 0.03,RR = 0.24 [0.07,0.90]）,and intermittent therapy had lower incidences of adverse events（ P = 0.03,RR = 0.81 [0.67,0.98]） and taste disorders（ P = 0.05,RR = 0.44 [0.19,1.00]）.Bias risk assessment based the tool ＂ a domain-based evaluation＂ recommended by the Cochrane Library found that some high-risk biases in the included studies might impair the credibility of the results.Conclusion The best terbinafine regimen for onychomycosis remains to be further investigated with more high-quality randomized controlled trials.

关 键 词：特比萘芬 甲真菌病 系统评价 随机对照试验 

分 类 号：R978.5[医药卫生—药品]