Rietschel R L, Duncan S H
J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):677-85. doi: 10.1016/s0190-9622(87)70087-5.
Of 149 subjects with androgenetic alopecia, 102 completed 1 year of a double-blind, randomized study comparing 2% minoxidil and 3% minoxidil solutions for safety and efficacy. One third of the subjects used a vehicle placebo for the first 4 months and then switched to 3% minoxidil. At 12 months the 2% minoxidil group switched to a 3% solution. During months 5 to 12 a steady increase in terminal hair counts occurred to an equal degree within the 2% and 3% minoxidil groups and the 3% treatment group switched from placebo. Total hair counts at 12 months increased from a baseline mean of 63.5 to 180.6 in the 2% treatment group, from 61.0 to 179.9 in the 3% group, and from 65.0 to 191.1 in the placebo to 3% crossover group. Although all 102 subjects completing 12 months of the study thought that visible hair growth had resulted, 89 were considered by the investigators to have visible growth. Dense hair growth, defined as hair long enough to cut or comb, was present in 48 subjects by their own evaluation and in 33 subjects by investigator evaluation. There were no serious side effects. Two instances of allergic contact dermatitis and four of pruritus were attributed to use of the drug. Two individuals complained of impotence, which disappeared within a few days of discontinuation of topical minoxidil. This effect has not been reported during the use of minoxidil in its oral form (Loniten) for the treatment of hypertension.(ABSTRACT TRUNCATED AT 250 WORDS)
在149名雄激素性脱发患者中,102名完成了一项为期1年的双盲随机研究,该研究比较了2%米诺地尔溶液和3%米诺地尔溶液的安全性和有效性。三分之一的受试者在前4个月使用赋形剂安慰剂,然后改用3%米诺地尔。在12个月时,2%米诺地尔组改用3%溶液。在第5至12个月期间,2%米诺地尔组、3%米诺地尔组以及从安慰剂改用3%米诺地尔的治疗组中,终毛数量均稳步增加,且增加程度相同。2%治疗组12个月时的总毛发数量从基线平均值63.5增加到180.6,3%治疗组从61.0增加到179.9,安慰剂改用3%米诺地尔的交叉组从65.0增加到191.1。尽管所有完成12个月研究的102名受试者都认为有明显的头发生长,但研究人员认为其中89名有明显生长。根据受试者自身评估,48名受试者有浓密头发生长(定义为头发长到足以修剪或梳理),根据研究人员评估则为33名。没有严重的副作用。有两例过敏性接触性皮炎和四例瘙痒归因于药物使用。两名患者抱怨阳痿,在停用外用米诺地尔后几天内消失。在使用米诺地尔口服制剂(Loniten)治疗高血压期间尚未报道过这种效应。(摘要截选至250词)