外用醋酸环丙孕酮酒精洗剂与安慰剂治疗轻至中度寻常痤疮的疗效：一项双盲研究。

The efficacy of topical cyproterone acetate alcohol lotion versus placebo in the treatment of the mild to moderate acne vulgaris: a double blind study.

作者信息

Iraji Fariba, Momeni Ali, Naji Seyed Morteza, Siadat Amir Hossein

出版信息

Dermatol Online J. 2006 Mar 30;12(3):26.

Abstract

Acne is an inflammatory condition of the pilosebaceous unit. One of the essential factors for development of acne lesions is increased sebum excretion that is promoted by androgen. It is shown that oral cyproterone acetate significantly reduces the sebum excretion. In this study we evaluated the efficacy of cyproterone acetate alcohol lotion (CAAL) in the treatment of the mild to moderate acne vulgaris. This was a randomized double-blind clinical trial performed on 86 female patients with mild to moderate acne. They were randomly divided into 3 groups and were treated with 0.5 percent CAAL (n = 30), 1 percent CAAL (n = 13) and placebo (n = 43). They were followed every 15 days for a period of 45 days. Response to treatment was evaluated by the total acne lesions counting (TLC) and acne severity index (ASI) and was analyzed statistically by SPSS program. The efficacy of treatment on TLC was maximum for 1 percent CAAL (90 % reduction in TLC)(P value = 0.000). CAAL at 0.5 percent was able to reduce TLC as high as 80.8 percent during 6 weeks followup. The efficacy of placebo was determined to be 38.5 percent. Regarding TLC, 1 percent CAAL was 2.33 times more effective than placebo. CAAL at 0.5 percent was 2.09 times more effective than placebo in this respect. The efficacy of treatment on ASI was maximum for 1 percent CAAL (88 % reduction in ASI)(P value = 0.000). CAAL at 0.5 percent reduced ASI as much as 79.5 percent during 6 weeks of followup. The efficacy of placebo was calculated to be 9.8 percent in reduction of ASI . Regarding ASI, 1 percent CAAL was 8.97 times more effective than placebo. CAAL at 0.5 percent was 8.06 times more effective than placebo. Regarding the results of this study, we suggest the use of cyproterone acetate alcohol lotion as one of the main treatments for mild-moderate acne in female patients and as an adjuvant treatment for moderate to severe acne vulgaris.

摘要

痤疮是一种毛囊皮脂腺的炎症性疾病。痤疮皮损形成的一个关键因素是雄激素促使皮脂分泌增加。研究表明，口服醋酸环丙孕酮可显著减少皮脂分泌。在本研究中，我们评估了醋酸环丙孕酮酒精洗剂（CAAL）治疗轻至中度寻常痤疮的疗效。这是一项对86例轻至中度痤疮女性患者进行的随机双盲临床试验。她们被随机分为3组，分别接受0.5% CAAL治疗（n = 30）、1% CAAL治疗（n = 13）和安慰剂治疗（n = 43）。在45天的时间里，每15天对她们进行一次随访。通过痤疮皮损总数计数（TLC）和痤疮严重程度指数（ASI）评估治疗反应，并使用SPSS软件进行统计学分析。1% CAAL对TLC的治疗效果最佳（TLC减少了90%）（P值 = 0.000）。在6周的随访期间，0.5%的CAAL能够使TLC减少高达80.8%。安慰剂的疗效为38.5%。就TLC而言，1% CAAL的疗效是安慰剂的2.33倍。在这方面，0.5%的CAAL疗效是安慰剂的2.09倍。1% CAAL对ASI的治疗效果最佳（ASI减少了88%）（P值 = 0.000）。在6周的随访期间，0.5%的CAAL使ASI减少了79.5%。安慰剂减少ASI的疗效经计算为9.8%。就ASI而言，1% CAAL的疗效是安慰剂的8.97倍。0.5%的CAAL疗效是安慰剂的8.06倍。基于本研究结果，我们建议将醋酸环丙孕酮酒精洗剂作为女性轻至中度痤疮的主要治疗方法之一，以及中重度寻常痤疮的辅助治疗方法。