Momeni A Z, Jalayer T, Emamjomeh M, Bashardost N, Ghassemi R L, Meghdadi M, Javadi A, Aminjavaheri M
Isfahan University of the Medical Sciences, Iran.
Arch Dermatol. 1996 Jul;132(7):784-6.
To compare the efficacy of itraconazole with placebo in the treatment of cutaneous leishmaniasis caused by Leishmania major.
Double-blind placebo-controlled study.
Patients were selected from volunteers wit cutaneous leishmaniasis who lived in a hyperendemic area.
One hundred forty patients were randomly selected for this double-blind study. Exclusion criteria were pregnancy, gestation, age younger than 12 years, and duration of disease of more than 4 months.
Each patient received itraconazole (7 mg/kg per day) or placebo for a 3-week period. The patients were kept under observation for an additional 30-day period. OUTCOME. The study was completed as planned in 131 patients.
Complete healing occurred in 59% of the itraconazole group in comparison with 44.3% of the patients who were treated with placebo capsules. No difference was found between the 2 groups with respect to adverse effects.
Although itraconazole has the advantage of being an oral agent that is used in the treatment of cutaneous leishmaniasis, the low response rate in patients receiving itraconazole indicates that itraconazole cannot be used as the single agent in the treatment of patients with cutaneous leishmaniasis caused by L. major.
比较伊曲康唑与安慰剂治疗由硕大利什曼原虫引起的皮肤利什曼病的疗效。
双盲安慰剂对照研究。
从生活在高度流行区的皮肤利什曼病志愿者中选取患者。
140名患者被随机选入该双盲研究。排除标准为妊娠、孕期、年龄小于12岁以及病程超过4个月。
每位患者接受伊曲康唑（每日7mg/kg）或安慰剂治疗3周。患者再接受30天的观察。结果。131名患者按计划完成研究。
伊曲康唑组59%的患者完全治愈，而接受安慰剂胶囊治疗的患者为44.3%。两组在不良反应方面未发现差异。
尽管伊曲康唑作为用于治疗皮肤利什曼病的口服药物有其优势，但接受伊曲康唑治疗的患者中低反应率表明，伊曲康唑不能作为治疗由硕大利什曼原虫引起的皮肤利什曼病患者的单一药物。
