Spiekermann P H, Young M D
Arch Dermatol. 1976 Mar;112(3):350-2.
The efficacy and safety of the broad-spectrum, topically applied antifungal agent clotrimazole were evaluated in two double-blind, multicentric trials. Ten investigators reported on a total of 1,361 cases in which a 1% solution or a 1% cream formulation was compared with its respective vehicle. Clotrimazole was therapeutically effective, as confirmed by mycological cure (negative microscopy and culture) and clinical improvement, in tinea pedis, tinea cruris, tinea corporis, pityriasis versicolor, and cutaneous candidasis. Furthermore, species identification established the efficacy of clotrimazole against Trichophyton rubrum, T mentagrophytes, Epidermophyton floccosum, Microsporum canis, Malassezia furfur (Pityrosporum orbiculare), and Candida albicans. Safety was demonstrated by the low incidence of possibly drug-related adverse experiences, namely, 19 (2.7%) of 699 patients who were treated with clotrimazole, of whom four (0.6%) discontinued treatment.
在两项双盲、多中心试验中评估了外用广谱抗真菌药克霉唑的疗效和安全性。10名研究者报告了总共1361例病例,其中将1%溶液或1%乳膏制剂与其各自的赋形剂进行了比较。在足癣、股癣、体癣、花斑糠疹和皮肤念珠菌病中,克霉唑经真菌学治愈(显微镜检查和培养阴性)及临床改善证实具有治疗效果。此外,菌种鉴定确定了克霉唑对红色毛癣菌、须癣毛癣菌、絮状表皮癣菌、犬小孢子菌、糠秕马拉色菌(圆形糠秕孢子菌)和白色念珠菌的疗效。安全性体现在可能与药物相关的不良事件发生率较低,即699例接受克霉唑治疗的患者中有19例(2.7%)出现不良事件,其中4例(0.6%)停止治疗。