Floyd R, Hodgson C
Clin Ther. 1986;8(2):181-6.
In a randomized, double-blind trial, the efficacy and safety of a new single-dose clotrimazole vaginal tablet were compared with that of three-day clotrimazole therapy. Forty-two patients with clinically and mycologically confirmed vulvo-vaginal candidiasis received either one 500-mg clotrimazole tablet for one day or two 100-mg tablets daily for three days. Follow-up visits were performed approximately one week and one month after treatment. Thirty-six patients were evaluated for drug efficacy. There was no significant difference in clinical and mycological responses to the two regimens (P = 1.00, Fisher's exact test). At the final visit, 16 (89%) of the 18 patients receiving one-day treatment showed mycological and clinical clearance of infection, as compared to 15 (83%) of the 18 patients receiving three-day therapy. One patient in the three-day treatment group presented moderate edema of the vulva which was judged to be remotely related to treatment. The findings indicate that a single 500-mg tablet of clotrimazole is as effective and safe in the treatment of vulvovaginal candidiasis as a three-day course of 200 mg/day.
在一项随机双盲试验中,将新型单剂量克霉唑阴道片的疗效和安全性与为期三天的克霉唑疗法进行了比较。42例临床和真菌学确诊的外阴阴道念珠菌病患者,分别接受一日一次500毫克克霉唑片治疗或每日两次100毫克克霉唑片,连服三天。在治疗后约一周和一个月进行随访。对36例患者进行了药物疗效评估。两种治疗方案的临床和真菌学反应无显著差异(P = 1.00,Fisher精确检验)。在最后一次随访时,接受一日治疗的18例患者中有16例(89%)感染的真菌学和临床症状均已消除,而接受三日治疗的18例患者中有15例(8-%)。三日治疗组中有1例患者出现中度外阴水肿,判定与治疗有间接关系。研究结果表明,单剂量500毫克克霉唑片在治疗外阴阴道念珠菌病方面与每日200毫克、连服三天的疗程同样有效且安全。