论文部分内容阅读
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 oral allylamine antifungal agent to interfere with the synthesis of ergosterol by inhibiting the fungal squalene cyclo-oxygenase to achieve a fungicidal effect. To compare the clinical efficacy and safety of topical terbinafine tablets with terbinafine tablets for superficial mycosis, we conducted randomized, double-blind, multicenter clinical trials. The two drugs administered the same dose and course of treatment, oral administration of 250mg, once a day, body tinea with even 2 weeks, hand, foot and ringworm with clothes for 3 weeks, nail fungal disease even with 6 weeks. The results showed that 52 cases of domestic terbinafine tablets, jock itch, 41 cases of hand, foot and ringworm, 41 cases of nail mycosis were found. The clinical cure rate of body ringworm was 88.5% (imported piece 90.0%), the effective rate was 96.1% (imported piece 98.0%), fungal clearance rate 92.3% (imported piece 96.0% ). The clinical cure rate of rival tinea pedis was 61.0% (imported piece 55.0%), the effective rate was 92.7% (imported piece 92.7%), fungal clearance rate 92.7% (imported piece 92.5%), . The clinical cure rate of nail mycosis was 85.4% (imported piece 85.4%), the effective rate was 90.2% (imported piece 92.7%), fungal clearance rate 87.8% (imported piece 90.2% ). Its tolerability was good with a 5.2% incidence of adverse reactions (3.8% for imported tablets). The two drugs in the treatment of superficial mycosis clinical efficacy and safety were not statistically significant differences.