外用2%及5%米诺地尔溶液治疗女性型脱发的随机对照临床研究  

A randomized controlled clinical study on 2% and 5% topical minoxidil solution in the treatment of female pattern hair loss

作　　者：盛友渔[1] 芮文龙 徐峰[1] 齐思思[1] 胡瑞铭[1] 缪盈[1] 韩毓梅[1] 杨勤萍[1] 

机构地区：[1]复旦大学附属华山医院皮肤科,上海200040

出　　处：《临床皮肤科杂志》2014年第10期583-585,共3页Journal of Clinical Dermatology

摘　　要：目的：评估并比较外用2％及5％米诺地尔溶液治疗女性型脱发（FPHL）的有效性与安全性。方法：将264例LudwigⅡ～Ⅲ级的FPHL患者随机分为两组，每组132例，分别予2％及5％米诺地尔溶液外用，每日2次，每次1mL，连续治疗6个月。在基线、治疗3个月及6个月时进行全局照相评估，根据患者治疗前后脱发面积和程度的变化判断疗效。研究期间记录不良事件，统计两组不良事件发生率。结果：治疗3个月后，2％和5％米诺地尔溶液组有效率分别为20．61％和38．02％，两组间差异有统计学意义（P=0．002），治疗6个月后，2％和5％米诺地尔溶液组有效率分别为53．44％和64．46％．两组间差异无统计学意义（P=0．076）。LudwigⅡ级患者治疗3个月时，2％和5％米诺地尔溶液组有效率分别为21．36％和32．94％，两组间差异无统计学意义（P=0．074）；治疗6个月2％和5％米诺地尔溶液组有效率分别为52．43％和57．65％，两组间差异无统计学意义（P=0．474）。LudwigⅢ级患者治疗3个月时，2％和5％米诺地尔溶液组有效率分别为17．86％和50．00％，两组间差异有统计学意义（P=0．008）；治疗6个月时，2％和5％米诺地尔溶液组有效率分别为57．14％和80．56％，两组间有效率差异有统计学意义（P=0．042）。2％及5％米诺地尔溶液组不良事件发生率分别为2．27％和6．82％。结论：外用2％及5％米诺地尔溶液治疗FPHL均安全有效。与2％米诺地尔溶液相比，5％米诺地尔溶液对重度（LudwigⅢ级）FPHL患者疗效更好。但不良事件发生率更高。Objective： To evaluate and compare the efficacy and safety of 2% and 5% topical minoxidil solution for the treatment of female pattern hair loss （FPHL）. Methods： Two hundred and sixty-four Ludwig＇s type Ⅱ-Ⅲ FPHL patients were randomly divided into 2 groups, each was 132 cases. All patitents of the 2 groups were given 1 mL 2% or 5% topical minoxidil solution respectively, twice a day for 6 months. Global photography was performed at baseline, 3 months and 6 months in order to evaluate the drug efficacy, according to the changes of areas and degrees of hair loss before and after treatment. Adverse events were recorded during the whole study. Results： After treatment for 3 months, 20.61% patients improved in 2% minoxidil group, while 38.02% improved in 5% minoxidil group with statistical difference（P=0.002）. After treatment for 6 months, the effective rates of 2 groups were 53.44% （2% minoxidil group） and 64.46% （5% minoxidil group） with no statistical difference（P=0.076）. For Ludwig＇s type Ⅱ FPHL patients, the effective rates of 2 groups were 21.36.% （2% minoxidil group） and 32.94% （5% minoxidil group） after 3 months treatment, while after 6 months treatment, they were 52.43% （2% minoxidil group） and 57.65% （5% minoxidil group）, the difference between 2 groups both had no statistical significance （P1=0.074, P2=0.474）. For Ludwig＇s type Ⅲ FPHL patients, the effective rates of 2 groups were 17.86.% （2% minoxidil group） and 50.00% （5% minoxidil group） after 3 months treatment, while after 6 months treatment, they were 57.14% （2% minoxidil group） and 80.56% （5% minoxidil group）, the difference between 2 groups both had statistical significance （P1=0.008, P2=0.042）. The incidence of adverse events of 2% minoxidil group was 2.27%, and 6.82% in 5% minoxidil group. Conclusion： Both 2% and 5% topical minoxidil solution are effective and safe for the treatment of FPHL 5% topical minoxidil is superior to 2% topical minoxidil in the therapeutic e

关 键 词：脱发 女性型 米诺地尔 

分 类 号：R758.71[医药卫生—皮肤病学与性病学]