醋酸环丙孕酮治疗重度多毛症：一项双盲剂量范围研究的结果

Cyproterone acetate for severe hirsutism: results of a double-blind dose-ranging study.

作者信息

Barth J H, Cherry C A, Wojnarowska F, Dawber R P

机构信息

Department of Dermatology, Slade Hospital, Oxford, UK.

出版信息

Clin Endocrinol (Oxf). 1991 Jul;35(1):5-10. doi: 10.1111/j.1365-2265.1991.tb03489.x.

DOI:10.1111/j.1365-2265.1991.tb03489.x

PMID:1832346

Abstract

OBJECTIVE

The objective was to determine if cyproterone acetate (CPA) therapy for hirsute women demonstrated a dose response.

DESIGN

A double-blind dose-ranging study of the effect of 3 doses of cyproterone acetate for a period of 12 months.

PATIENTS

Twenty-one hirsute women received the Dianette contraceptive pill (35 micrograms ethinyl oestradiol + 2 mg CPA, Schering Healthcare, UK), 20 received Dianette plus 20 mg CPA and 19 received Dianette plus 100 mg CPA: supplementary CPA was administered on days 1-10 of the birth control pill cycle as described by Hammerstein.

MEASUREMENTS

Hair growth was measured using the clinical scale of Ferriman and Gallwey and by direct measurement of hair shaft diameter and linear growth of hair on the face, forearm, abdomen and thigh.

RESULTS

Thirty-eight women completed 12 months therapy, eight withdrew due to side-effects and 14 were lost to follow-up. All three dose schedules produced significant reductions in clinical hair growth scores. This reduction was seen after 6 months with Dianette alone (P less than 0.005) and after 3 months with both the higher doses (P less than 0.01). There were no significant differences between the effect of different doses at any of the three-monthly time points. Hair diameter measurements were reduced by all doses after 12 months: face by 27*, 37, 37%, forearm 5, 10, 8%, abdomen 22*, 39*, 33%, thigh 12, 24, 30%* (median reductions (*P less than 0.01) for Dianette, D + 20 mg CPA and D + 100 mg CPA respectively). There were no significant reductions in daily linear growth rates. A comparison of the percentage reduction in hair shaft diameter at each site demonstrated no significant difference between doses, although the reductions by the three doses on the forearm, abdomen and thigh suggested a trend towards a dose response.

CONCLUSIONS

We conclude that cyproterone acetate 2 mg daily appears to be as effective as higher doses in the therapy of hirsute women.

摘要

目的

确定醋酸环丙孕酮（CPA）治疗多毛症女性是否存在剂量反应。

设计

一项为期12个月的关于3种剂量醋酸环丙孕酮效果的双盲剂量范围研究。

患者

21名多毛症女性服用达英-35避孕药（35微克炔雌醇 + 2毫克CPA，英国先灵葆雅公司），20名服用达英-35加20毫克CPA，19名服用达英-35加100毫克CPA：补充的CPA按照哈默斯坦所述在避孕药周期的第1 - 10天给药。

测量

使用费里曼和盖尔韦临床量表以及直接测量面部、前臂、腹部和大腿毛发的毛干直径和线性生长来测量毛发生长情况。

结果

38名女性完成了12个月的治疗，8名因副作用退出，14名失访。所有三种剂量方案均使临床毛发生长评分显著降低。单独使用达英-35 6个月后出现这种降低（P < 0.005），两种高剂量在3个月后出现降低（P < 0.01）。在任何三个月的时间点，不同剂量的效果之间均无显著差异。12个月后所有剂量均使毛发直径减小：面部分别减小27%、37%、37%，前臂分别减小5%、10%、8%，腹部分别减小22%、39%、33%，大腿分别减小12%、24%、30%（达英-35、达英-35 + 20毫克CPA和达英-35 + 100毫克CPA的中位数减小幅度（*P < 0.01））。每日线性生长速率无显著降低。每个部位毛干直径减小百分比的比较显示各剂量之间无显著差异，尽管三种剂量在前臂、腹部和大腿的减小幅度显示出剂量反应趋势。