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沙特阿拉伯东部省份局部用克霉唑与咪康唑治疗皮肤利什曼病的随机双盲临床试验

A randomized, double-blind, clinical trial of topical clotrimazole versus miconazole for treatment of cutaneous leishmaniasis in the eastern province of Saudi Arabia.

作者信息

Larbi E B, al-Khawajah A, al-Gindan Y, Jain S, Abahusain A, al-Zayer A

机构信息

Department of Pharmacology, College of Medicine, King Faisal University, Dammam, Saudi Arabia.

出版信息

Am J Trop Med Hyg. 1995 Feb;52(2):166-8. doi: 10.4269/ajtmh.1995.52.166.

DOI:10.4269/ajtmh.1995.52.166
PMID:7872446
Abstract

The parenteral treatment currently available for cutaneous leishmaniasis (CL) is painful and potentially exposes patients to serious side effects. Thus, effective, topical therapy would be valuable. We assessed the efficacy of topical 1% clotrimazole and 2% miconazole creams in relation to early healing of lesions in CL in a randomized, double-blind clinical trial in 54 patients with 151 lesions treated for 30 consecutive days. Response to treatment was assessed at two weeks and 30 days and classified as fully healed, size reduced, no change, and size increased or worse. Of 89 lesions treated with clotrimazole, 14 (15.7%) healed fully, 42 (47.2%) were reduced in size, 20 (22.5%) showed no change, and 13 (14.6%) got worse. Correspondingly, in the 62 lesions treated with miconazole, none healed fully, 22 (35.5%) were reduced in size, 16 (25.8%) showed no change, and 24 (38.7%) got worse. The differences were statistically significant (P < 0.001). No side effects were observed. It is concluded that clotrimazole was the more effective of the two imidazoline compounds and is recommended as initial treatment for simple lesions.

摘要

目前用于治疗皮肤利什曼病(CL)的肠胃外治疗方法很痛苦,且可能会让患者面临严重的副作用。因此,有效的局部治疗将很有价值。在一项随机双盲临床试验中,我们评估了局部使用1%克霉唑乳膏和2%咪康唑乳膏对54例患者151处皮损的早期愈合情况,连续治疗30天。在两周和30天时评估治疗反应,并分类为完全愈合、尺寸缩小、无变化、尺寸增大或恶化。在接受克霉唑治疗的89处皮损中,14处(15.7%)完全愈合,42处(47.2%)尺寸缩小,20处(22.5%)无变化,13处(14.6%)恶化。相应地,在接受咪康唑治疗的62处皮损中,无一处完全愈合,22处(35.5%)尺寸缩小,16处(25.8%)无变化,24处(38.7%)恶化。差异具有统计学意义(P<0.001)。未观察到副作用。结论是,克霉唑是两种咪唑啉化合物中更有效的一种,推荐作为简单皮损的初始治疗药物。

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