Millikan L E
Department of Dermatology, Tulane University School of Medicine, New Orleans, LA 70112.
J Am Acad Dermatol. 1990 Oct;23(4 Pt 2):795-9. doi: 10.1016/0190-9622(90)70291-o.
Thirty men with clinical and mycologic evidence of tinea cruris were enrolled in a controlled, randomized, double-blind trial comparing terbinafine 1% cream and its cream vehicle as placebo. Patients applied the test medications to the affected area twice daily for 2 weeks. Therapeutic response was evaluable in 18 patients after each week of treatment and at a follow-up visit 2 weeks after therapy ended. At each visit, terbinafine was found to be more effective than the cream vehicle in the reduction of the signs and symptoms of infection and in the conversion of culture and microscopy findings to negative or normal. At the end of treatment, therapy was effective in 67% of the nine terbinafine-treated patients compared with only 11% of the nine placebo-treated patients. At the follow-up examination, efficacy rates were 78% in the terbinafine treatment group and 33% in the placebo group--a difference of borderline statistical significance (p = 0.077). Possible reasons for this result may include the higher incidence of chronic disease in the terbinafine group and the large number of patients who were classified as delayed exclusions because of negative initial culture for dermatophytes. No side effects or significant alterations in laboratory or hematologic tests were observed in either treatment group.
30名有股癣临床和真菌学证据的男性参与了一项对照、随机、双盲试验，比较1%特比萘芬乳膏及其乳膏基质作为安慰剂的效果。患者每天两次将受试药物涂抹于患处，持续2周。治疗1周后及治疗结束后2周的随访时，对18名患者的治疗反应进行评估。每次访视时，发现特比萘芬在减轻感染体征和症状以及使培养和显微镜检查结果转为阴性或正常方面比乳膏基质更有效。治疗结束时，9名接受特比萘芬治疗的患者中有67%治疗有效，而9名接受安慰剂治疗的患者中只有11%有效。在随访检查时，特比萘芬治疗组的有效率为78%，安慰剂组为33%——差异具有临界统计学意义（p = 0.077）。这一结果的可能原因包括特比萘芬组慢性病发病率较高，以及大量因皮肤癣菌初始培养阴性而被归类为延迟排除的患者。两个治疗组均未观察到副作用或实验室及血液学检查的显著改变。
