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外用特比萘芬治疗皮肤利什曼病:三盲随机临床试验

Topical terbinafine in the treatment of cutaneous leishmaniasis: triple blind randomized clinical trial.

作者信息

Farajzadeh Saeedeh, Heshmatkhah Amireh, Vares Behrooz, Mohebbi Elham, Mohebbi Azadeh, Aflatoonian Mahin, Eybpoosh Sana, Sharifi Iraj, Aflatoonian Mohammad Reza, Shamsi Meymandi Simin, Fekri Ali Reza, Mostafavi Mahshid

机构信息

Leishmaniasis Research Center, Kerman University of Medical Sciences, Kerman, Iran.

Department of Dermatology, Kerman University of Medical Sciences, Kerman, Iran.

出版信息

J Parasit Dis. 2016 Dec;40(4):1159-1164. doi: 10.1007/s12639-014-0641-1. Epub 2015 Jan 22.

DOI:10.1007/s12639-014-0641-1
PMID:27876906
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5118267/
Abstract

Leishmaniasis is a spectrum of disease condition with considerable health impacts, caused by different species of . This disease is currently endemic in 98 countries and territories in the world. There are many treatment modalities for cutaneous leishmaniasis. The use of topical terbinafine in the treatment of cutaneous leishmaniasis has recently been considered. Eighty-eight participants more than two years old with proven acute CL by a positive direct smear were randomly allocated to one of the two study arms: first group received meglumine antimoniate (Glucantime) 20 mg/kg/day intramuscular injection (IM) plus a placebo ointment (Mahan Vaseline) for 20 days. The second group received meglumine antimoniate (Glucantime) 20 mg/kg/day IM plus topical terbinafine, for 20 days and were monitored closely by dermatologist during the course of the study. Crude regression analysis showed that there was no significant difference between placebo and intervention group regarding partial or complete treatment (partial treatment: HR = 1.1, CI 95 % = 0.7-1.7; complete treatment: HR = 1.1, CI 95 % = 0.8-1.7). Although, there was no statistically significant different between the two treatment groups, but clinically it seems that the treatment rate in those who receive glucantime plus terbinafine was more effective than the other group. However this rate depended on the type of lesions. As data indicated ulcerated nodules, papules and plaque in experimental group have been completely improved two times faster than placebo group. Ulcerated nodules, nodules and plaque were partially improved faster in those used tebinafine than placebo ointment.

摘要

利什曼病是由不同种类的利什曼原虫引起的一系列对健康有重大影响的疾病。这种疾病目前在世界上98个国家和地区流行。皮肤利什曼病有多种治疗方式。最近有人考虑使用外用特比萘芬治疗皮肤利什曼病。88名两岁以上经直接涂片阳性确诊为急性皮肤利什曼病的参与者被随机分配到两个研究组之一:第一组接受葡甲胺锑酸盐(葡糖胺锑)20mg/kg/天肌肉注射(IM)加安慰剂软膏(马汉凡士林),共20天。第二组接受葡甲胺锑酸盐(葡糖胺锑)20mg/kg/天肌肉注射加外用特比萘芬,共20天,在研究过程中由皮肤科医生密切监测。粗回归分析显示,在部分或完全治疗方面,安慰剂组和干预组之间没有显著差异(部分治疗:风险比=1.1,95%置信区间=0.7-1.7;完全治疗:风险比=1.1,95%置信区间=0.8-1.7)。虽然两个治疗组之间没有统计学上的显著差异,但临床上接受葡糖胺锑加特比萘芬治疗的患者的治愈率似乎比另一组更高。然而,这个治愈率取决于病变类型。数据表明,实验组的溃疡结节、丘疹和斑块完全改善的速度比安慰剂组快两倍。使用特比萘芬的患者的溃疡结节、结节和斑块部分改善的速度比安慰剂软膏组快。

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