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局部抗真菌药治疗皮肤真菌病的疗效和安全性:系统评价。

Efficacy and safety of topical antifungals in the treatment of dermatomycosis: a systematic review.

机构信息

Federal University of Parana, Curitiba, Parana, Brazil.

出版信息

Br J Dermatol. 2012 May;166(5):927-33. doi: 10.1111/j.1365-2133.2012.10815.x.

Abstract

The analysis of comparative efficacy and safety of topical antifungals in the literature is restricted to the treatment of tinea pedis and onychomycosis. Therefore our objective was to evaluate and compare the efficacy and safety of topical antifungals used in the treatment of dermatomycosis, we performed a comprehensive search for randomized controlled trials (RCTs) in the following databases: Medline, Cochrane Central Register of Controlled Trials, EMBASE, Lilacs and International Pharmaceutical Abstracts, we identified studies that compared the use of topical antifungals with other antifungals or with placebo published up to July 2010 in English, Spanish or Portuguese. The quality of reporting was assessed according to the Jadad scale; only studies with a score of 3 or more were included. The outcomes evaluated were mycological cure at the end of treatment, sustained cure, occurrence of adverse events and tolerability, including withdrawals due to adverse events. A total of 104 RCTs satisfied the inclusion criteria, containing a total of 135 comparisons, with 55 out of 120 possible comparisons among the 16 drugs evaluated. Pooled data on efficacy showed that all the antifungals were better than placebo. There were no significant differences among antifungal classes. No differences were found in safety or tolerability in any direct comparison. Sensitivity analysis indicated the robustness of the findings. Our results indicate the clear superiority of topical antifungals over placebo but that there is no consistent difference among classes. Mixed treatment comparisons are necessary to rank antifungals, as direct comparisons among many of them are lacking.

摘要

文献中关于局部抗真菌药物的疗效和安全性分析仅限于足癣和甲真菌病的治疗。因此,我们的目的是评估和比较治疗皮肤真菌病时局部使用的抗真菌药物的疗效和安全性,我们在以下数据库中进行了全面的随机对照试验(RCT)检索:Medline、Cochrane 对照试验中心注册库、EMBASE、Lilacs 和国际药学文摘,我们确定了比较局部抗真菌药物与其他抗真菌药物或安慰剂治疗的研究,这些研究发表于 2010 年 7 月之前,语言为英语、西班牙语或葡萄牙语。根据 Jadad 量表评估报告质量;仅纳入评分达到 3 分或更高的研究。评估的结局包括治疗结束时的真菌学治愈、持续治愈、不良事件和耐受性的发生,包括因不良事件而停药。共有 104 项 RCT 符合纳入标准,共包含 135 项比较,在评估的 16 种药物中,有 55 项比较是 120 项可能比较中的。疗效的汇总数据显示,所有抗真菌药物均优于安慰剂。不同药物类别之间没有显著差异。在任何直接比较中,安全性或耐受性方面均无差异。敏感性分析表明结果具有稳健性。我们的研究结果表明,局部抗真菌药物明显优于安慰剂,但不同类别之间没有一致的差异。需要混合治疗比较来对抗真菌药物进行排序,因为许多抗真菌药物之间缺乏直接比较。

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