摘要
氟康唑是三唑类新型抗真菌药，它能特异地与真菌细胞色素Ｐ４５０结合，影响真菌麦角甾醇的合成，从而达到抑制真菌的效果。它不仅抗菌谱广，而且有分子量小，易溶于水，口服吸收好，组织分布广等特点。临床上用于浅部及深部真菌感染均有较好的疗效，无明显不良反应。本研究为多中心随机双盲，用上海三维制药公司生产的氟康唑１５０ｍｇ／ｗｋ口服１次，治疗浅部真菌病及念珠菌外阴阴道炎。体股癣服３ｗｋ，手足癣服４ｗｋ，念珠菌外阴阴道炎为单剂量口服１次，取得了满意的临床疗效与真菌清除结果。其中治疗浅部真菌病８６例，临床痊愈率为７０．９％（６１／８６），有效率９０．７％（７８／８６），真菌清除率为９２．０％（６９／７５）。治疗念珠菌外阴阴道炎３０例，临床痊愈率为７０．０％（２１／３０），有效率８６．７％（２６／３０），真菌清除率为８５．２％（２３／２７）。不良反应发生率为２．６％（３／１１６）。国产氟康唑与进口氟康唑随机对照治疗浅部真菌病和念珠菌外阴阴道炎的临床痊愈显效率，真菌清除率及不良反应发生率比较均无显著性差异。
The aim of this study is to find out the efficacy and safety of fluconazole (offered by San Wei Pharmaceutical Ltd.)in the treatment of patients with dermatophytosis and vulvovaginal candidiasis. A double blind, randomized controlled, multi-center clinical trial on oral fluconazole compared with difluca was studied. The dosage and duration of therapy of two drugs were the same. Oral fluconazole 150 mg once a week, 3 weeks for tinea cruris and corporis,4 weeks for tinea manuum and pedis,and 1week for vulvovaginal candidiasis. Of 86 patients with dermatophytosis, 90.7% were cured and excellent (78/86). Culture clearance rate was 92% (69/75).Of 30 patients with vulvovaginal candidiasis, 86.7% were cured and excellent(26/30).Culture clearance rate was 85.2% (23/27). Fluconazole is well tolerated.The adverse effects were 2.6%(3/ll6). There were no statistical differamce of the efficacy and safety between two drugs.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
1995年第1期1-6,共6页
The Chinese Journal of Clinical Pharmacology
关键词
氟康唑
真菌病
含珠菌
阴道炎
随机双盲对照
fluconazole
double blind
randomized controlled
multi-center clinical trial
superficial mycosis
