Crawford F, Hart R, Bell-Syer S, Torgerson D, Young P, Russell I
Department of Health Sciences & Clinical Evaluation, The University of York, Alciun College, Heslington, York, UK, YO1 5DD.
Cochrane Database Syst Rev. 2000(2):CD001434. doi: 10.1002/14651858.CD001434.
The objective of this review is to identify and evaluate the evidence of efficacy for topical treatments for fungal infections of the skin and nails of the human foot. To establish the effectiveness of topical treatments in achieving a cured condition and in preventing recurrence
Randomised controlled trials were identified from the MEDLINE, EMBASE and CINHAL databases, from the beginning of these databases to December 1997. Also we screened the Cochrane Controlled Trials Register, the Science Citation Index BIOSIS, CAB - Health, Healthstar and Economic databases. References and unpublished studies were searched, podiatry journals handsearched and the pharmaceutical industry contacted.
Only randomised controlled trials (RCTs) using participants who have mycologically diagnosed fungal infections of the skin and nails of the human foot are included in the analysis.
Two reviewers independently summarised the included trials and appraised their quality of reporting using a structured data extraction tool which assessed 12 quality criteria.
Of 126 trials identified in 121 papers, 72 met the inclusion criteria. Placebo-controlled trials yielded the following pooled relative risks of failure to cure (RRFC) for skin infections: allylamines 0.30 (95% confidence interval 0.23 to 0.37); azoles 0.53 (0.42 to 0.68); undecenoic acid 0.28 (0.11 to 0.74); tolnaftate 0.46 (0.17 to 1.22). Though meta-analysis of 11 trials comparing allylamines and azoles showed an RRFC of 0.88 (0.78 to 0.99) in favour of allylamines, there was evidence of language bias. Seven English language reports favoured allylamines (RRFC = 0.79; 0.68 to 0.93) but four foreign language reports showed no difference between the two drugs (RRFC = 1.00; 0.90 to 1.12). The two trials of nail infections did not provide any evidence of benefit for topical treatments compared with placebo.
In placebo-controlled trials allylamines, azoles and undecenoic acid were efficacious. There are sufficient comparative trials to judge relative efficacy only between allylamines and azoles. Allylamines cure slightly more infections than azoles but are much more expensive. The most cost-effective strategy is first to treat with azoles or undecenoic acid and to use allylamines only if that fails.
本综述的目的是识别和评估用于治疗人类足部皮肤和指甲真菌感染的局部治疗方法的疗效证据，以确定局部治疗在实现治愈和预防复发方面的有效性。
从MEDLINE、EMBASE和CINHAL数据库自创建之初至1997年12月，检索随机对照试验。我们还检索了Cochrane对照试验注册库、科学引文索引BIOSIS、CAB - Health、Healthstar和经济数据库。检索参考文献和未发表的研究，手工检索足病学杂志并联系制药行业。
分析仅纳入使用经真菌学诊断患有人类足部皮肤和指甲真菌感染参与者的随机对照试验（RCT）。
两名综述员独立总结纳入的试验，并使用评估12项质量标准的结构化数据提取工具评估其报告质量。
在121篇论文中识别出的126项试验中，72项符合纳入标准。安慰剂对照试验得出皮肤感染未治愈的合并相对风险（RRFC）如下：烯丙胺类0.30（95%置信区间0.23至0.37）；唑类0.53（0.42至0.68）；十一烯酸0.28（0.11至0.74）；托萘酯0.46（0.17至1.22）。虽然对比较烯丙胺类和唑类的11项试验进行的荟萃分析显示，烯丙胺类的RRFC为0.88（0.78至0.99），有利于烯丙胺类，但存在语言偏倚的证据。七篇英文报告支持烯丙胺类（RRFC = 0.79；0.68至0.93），但四篇外语报告显示两种药物之间无差异（RRFC = 1.00；0.90至1.12）。两项指甲感染试验未提供与安慰剂相比局部治疗有任何益处的证据。
在安慰剂对照试验中，烯丙胺类、唑类和十一烯酸是有效的。只有足够的比较试验来判断烯丙胺类和唑类之间的相对疗效。烯丙胺类比唑类治愈的感染略多，但成本高得多。最具成本效益的策略是首先用唑类或十一烯酸治疗，只有在治疗失败时才使用烯丙胺类。
