米诺地尔凝胶治疗斑秃的多中心随机双盲安慰剂对照临床试验

Multicenter double blind randomized placebo controlled clinical trial of minoxidil gel in the treatment of alopecia areata

目的评价2.2%米诺地尔凝胶(抗斑秃药)治疗斑秃的疗效和安全性。方法用随机双盲安慰剂对照多中心研究,选择脱发<40%头皮面积、病程在1年以内的患者,随机进入米诺地尔凝胶试验组(66例)或凝胶基质对照组(62例),分别给予米诺地尔凝胶或基质,每日2次,外用,共3个月。结果在毛发开始生长时间、生长长度、脱发面积减少和综合评价,试验组均优于对照组;2组药物不良反应发生率分别为7.58%,6.45%(P>0.05)。结论米诺地尔凝胶治疗斑秃安全、有效。

Objective To compare the efficacy and safety of 2.2% minoxidil gel and placebo in the treatment of alopecia areata. Methods A double - bind, randomized, placebo - controlled, muhicenter trial was conducted. The patients with alopecia areata applied 2.2% minoxidil gel or placebo twice daily for 3 months. Results One hundred and twenty eight cases were taken into the analysis of efficacy and safety including 66 cases for 2.2% minoxidil gel and 62 cases for placebo. The time hair began to regrow, the length of hair growth, the decrease of bald area and the overall evaluation in minoxidil group were all significantly better than those in placebo group. Adverse reaction were observed in 7. 58%, 6, 45% of patients in the two groups, and there was not significant difference between two groups. Conclusion 2.2% minoxidil gel was effective and safe in the treatment of alopecia areata.