Greer D L, Jolly H W
School of Medicine, Department of Dermatology, Louisiana State University Medical Center, New Orleans 70112.
J Am Acad Dermatol. 1990 Oct;23(4 Pt 2):800-4. doi: 10.1016/0190-9622(90)70292-p.
Twenty-three patients were enrolled in a randomized, double-blind trial of terbinafine 1% cream versus its vehicle (placebo) in the treatment of tinea cruris. One patient had a negative initial culture and was excluded, and two patients were dropouts, one because of poor study compliance (terbinafine) and one because of an adverse event (placebo). Twenty patients were examined for efficacy of treatment (9 terbinafine-treated, 11 placebo-treated). Both groups were similar in age, sex, duration of disease, prior therapy, size and location of lesion, infecting organism, and predisposing factors. Terbinafine 1% cream was more effective than vehicle cream in the reduction of the signs and symptoms of tinea cruris. In addition, there was a higher conversion rate to negative culture and normal microscopy findings in the terbinafine-treated group. Clinical results combined with evaluation of mycologic tests at end of therapy showed terbinafine to be a rapid and significantly more effective treatment for tinea cruris than placebo (78% vs 18% cure rate, respectively). Follow-up cure rates confirmed these findings (89% and 18%, respectively). No significant adverse events occurred during terbinafine treatment.
23名患者参与了一项关于1%特比萘芬乳膏与其赋形剂(安慰剂)治疗股癣的随机双盲试验。1名患者初始培养结果为阴性,被排除在外,2名患者退出研究,1名是因为对研究的依从性差(使用特比萘芬组),另1名是因为出现不良事件(使用安慰剂组)。对20名患者进行了治疗效果检查(9名接受特比萘芬治疗,11名接受安慰剂治疗)。两组在年龄、性别、病程、既往治疗情况、皮损大小和部位、感染病原体以及易感因素方面相似。1%特比萘芬乳膏在减轻股癣的体征和症状方面比赋形剂乳膏更有效。此外,特比萘芬治疗组培养结果转为阴性以及显微镜检查结果正常的转化率更高。治疗结束时的临床结果与真菌学检查评估相结合表明,特比萘芬治疗股癣比安慰剂起效更快且疗效显著更佳(治愈率分别为78%和18%)。随访治愈率证实了这些结果(分别为89%和18%)。在特比萘芬治疗期间未发生显著不良事件。