非那雄胺治疗男性雄激素源性秃发的随机、双盲、安慰剂对照临床研究  

A Double Blind Randomized Placebo Controlled Clinical Trial of Finasteride in the Treatment of Androgenetic Alopecia

作　　者：杨淑霞[1] 季素珍[1] 陈伟[1] 王丹[1] 汪科[1] 王卉[1] 王爱平[1] 韩钢文[1] 刘玲玲[1] 杨海珍[1] 朱学骏[1] 

机构地区：[1]北京大学第一医院皮肤性病科,北京100034

出　　处：《中国临床药理学杂志》2002年第1期3-6,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的通过双盲、随机、安慰剂对照研究，评价非那雄胺（保法止■）1ｍｇ／日治疗中国男性雄激素源性秃发的疗效和安全性。方法选择符合Ｎｏｒｗｏｏｄ／Ｈａｍｉｌｔｏｎ分级Ⅲ－Ⅳ的男性患者，随机分为非那雄胺治疗组和安慰剂对照组，分别为 １１５人和 １１３人，分别口服非那雄胺 1ｍｇ／日或安慰剂共２４周。疗效由独立的专家对治疗前后秃发区的照片比较、研究者的观察和患者的自我评价来判断。并记录临床和实验室不良事件进行安全性评价。结果根据独立的专家对治疗前后秃发区照片的判断，非那雄胺治疗组的有效率为７０．８％，而安慰剂对照组为２５．５％。两组比较有显著性差异（Ｐ＜０.００１）。研究者的观察和患者的自我评价结果与之相似，分别为治疗组 ５４．７％和 ４０％，对照组 １４．２％和 １７．６％。两组中，与治疗可能、很可能或肯定有关的不良事件发生率均很低，治疗组为０．９％，对照组为 １．８％。结论每日口服非那雄胺 ｌｍｇ治疗中国男性的雄激素源性秃发有良好的疗效和安全性。OBJECTIVE: To evaluate the efficacy and safety of 1mg/day oral finasteride (propecia■) in the treatment of androgenetic alopecia in Chinese men. METHODS: 24 weeks double blind, randomized, placebo controlled trial in 228 Chinese men (age from 18 to 41 years old) with male pattern hair loss (Stage Ⅲ to Ⅳ of Norwood/ Hamilton Classification. Efficacy was evaluated by an independent expert panel through photographic review and by patient self-assessment and investigator observation. RESULTS: According to the judgement of photographs by expert panel, the total efficacy rate in finasteride group is 70.75%. However the total efficacy rate in placebo group is 25.47%. There are statistically significant between the two groups (P<O.OOl). This result is in consistent with patients' self-assessment and investigators' observation. Adverse effects in both groups are minimal. The incidence of side effects in finasteride group is 0.87%, while in placebo group is 1. 77%. Conclusion: The treatment of androgenetic alopeica with 1mg/day oral fiansteride is effective and safe in Chinese.

关 键 词：雄激素源性秃发 非那雄胺 保法止 男性型 

分 类 号：R758.710.5[医药卫生—皮肤病学与性病学]