Momeni A Z, Aminjavaheri M, Omidghaemi M R
Isfahan University of Medical Sciences, PO Box 81465/1191, Isfahan, Iran.
J Dermatolog Treat. 2003 Jan;14(1):26-9. doi: 10.1080/09546630305552.
Cutaneous leishmaniasis (CL) is endemic in many countries. It has been recognized as a major public health problem in Iran. Many drugs have been suggested for the treatment of CL but most of them used intramuscularly or intravenously. Recently, a ketoconazole tablet has been used for the treatment of CL.
To compare the efficacy of ketoconazole cream with placebo in the treatment of CL.
The study was a double-blind, placebo-controlled trial. Patients with proven CL were treated with ketoconazole cream or placebo cream. The duration of treatment was 21 days and the patients were visited on days 7, 14 and 21. Follow-up was for 1 month after the end of treatment.
The study was completed in 73 patients (45 male, 28 female). The mean age of the patients was 19.9 years. A total of 38 patients received ketoconazole and 35 patients were treated with the placebo cream. At the end of treatment (day 21), complete healing had occurred in 15.7% of the ketoconazole group in comparison with 14.3% of the patients who were treated with the placebo cream (p=0.86). One month after the end of treatment the lesions in 28.9% of the ketoconazole group and 22.8% of the placebo group were healed (p=0.55).
Although the ketoconazole tablet has been reported to be effective in the treatment of some cases of CL, the low response rate in patients receiving ketoconazole cream indicates that it cannot be used as the single agent in the treatment of CL patients.
皮肤利什曼病（CL）在许多国家呈地方性流行。在伊朗，它已被公认为一个主要的公共卫生问题。许多药物被建议用于治疗CL，但大多数是通过肌肉注射或静脉注射使用。最近，酮康唑片剂已被用于治疗CL。
比较酮康唑乳膏与安慰剂治疗CL的疗效。
该研究为双盲、安慰剂对照试验。确诊为CL的患者接受酮康唑乳膏或安慰剂乳膏治疗。治疗持续21天，在第7天、14天和21天对患者进行访视。治疗结束后随访1个月。
该研究纳入73例患者（45例男性，28例女性）完成。患者的平均年龄为19.9岁。共有38例患者接受酮康唑治疗，35例患者接受安慰剂乳膏治疗。在治疗结束时（第21天），酮康唑组15.7%的患者完全愈合，而接受安慰剂乳膏治疗的患者为14.3%（p = 0.86）。治疗结束1个月后，酮康唑组28.9%的患者皮损愈合，安慰剂组为22.8%（p = 0.55）。
尽管据报道酮康唑片剂对某些CL病例有效，但接受酮康唑乳膏治疗的患者反应率较低，表明它不能作为治疗CL患者的单一药物。
