特比萘芬片剂治疗浅部真菌病随机双盲对照多中心临床试验

A DOUBLE BLIND RANDOMIZED CONTROLLED CLINICAL TRAIL OF THE TREATMENT IN SUPERFICIAL MYCOSES WITH TERBINAFINE

特比萘芬是第一个口服丙烯胺类抗真菌药物，通过抑制真菌角鲨烯环氧化酶而干扰麦角固醇的合成，达到杀真菌作用。为了比较研究国产特比萘芬片剂与进口特比萘芬片剂对浅部真菌病的临床疗效和安全性，我们进行了随机、双盲、多中心的临床试验。两种药物的给药剂量和疗程相同，每天口服２５０ｍｇ，一次给药，体股癣连服２周，手足癣连服３周，指甲真菌病连服６周。结果表明：国产特比萘芬片剂治疗体、股癣５２例，手足癣４１例，指甲真菌病４１例。对体股癣的临床治愈率８８．５％（进口片９０．０％），有效率９６．１％（进口片９８．０％），真菌清除率９２．３％（进口片９６．０％）。对手足癣的临床治愈率６１．０％（进口片５５．０％），有效率９２．７％（进口片９２．７％），真菌清除率９２．７％（进口片９２．５％）。对指甲真菌病的临床治愈率８５．４％（进口片８５．４％），有效率９０．２％（进口片９２．７％），真菌清除率８７．８％（进口片９０．２％）。其耐受性良好，不良反应发生率５．２％（进口片３．８％）。两种药治疗浅部真菌病的临床疗效和安全性在统计学上均无显著性差异。

Terbinafine is the first orally active member of a new class of antifungal drugs, the allylamines. It inhibits ergosterol synthesis at the level of squalene epoxidase and has a fungicidal action against dermatophytes and a number of yeast and moulds. The aim of this study is to find out the efficacy and safety of terbinafine in the treatment of patients with superficial mycoses. A double blind, randomized controlled, multi-center clinical trail on oral terbinafine compared with imported terbinafine was studied. The dosage and duration of therapy of two drugs were the same. Oral terbinafine 250mg once a day, 2 weeks for tinea cruris and corporis, 3 weeks for tinea manum and pedis, 6 weeks for onychomycosis. Of 52 patients with tinea cruris and corporis, 88.5% were cured (imported terbinafine, 90.0%), 96.1% were cured and excellent (imported terbinafine, 98.0%), mycological clearance rate was 92.3%(imported terbinafine, 96.0%). Of 41 patients with tinea manum and pedis, 61.0% were cured ( imported terbinafine, 55.0%), 92.7% were cured and excellent ( imported terbinafine, 92.7%), mycological clearance rate was 92.7% (imported terbinafine, 92.5%). Of 41 patients with onychomycosis, 85.4% were cured (imported terbinafine, 85.4%), 90.2% were cured and excellent (imported terbinafine,92.7%), mycological clearance rate was 87.8% (imported terbinafine, 90.2%). Terbinafine is well tolerated. The adverse effects were 5.2%(imported terbinafine,3.8%). There were no statisitical differance of the efficacy and safety between two drugs.