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复方口服避孕药治疗痤疮。

Combined oral contraceptive pills for treatment of acne.

作者信息

Arowojolu Ayodele O, Gallo Maria F, Lopez Laureen M, Grimes David A

机构信息

Department of Obstetrics and Gynaecology, College of Medicine, University College Hospital, Ibadan,

出版信息

Cochrane Database Syst Rev. 2012 Jun 13(6):CD004425. doi: 10.1002/14651858.CD004425.pub5.

DOI:10.1002/14651858.CD004425.pub5
PMID:22696343
Abstract

BACKGROUND

Acne is a common skin disorder among women. Although no uniform approach to the management of acne exists, combination oral contraceptives (COCs), which contain an estrogen and a progestin, often are prescribed for women.

OBJECTIVES

To determine the effectiveness of combined oral contraceptives (COCs) for the treatment of facial acne compared to placebo or other active therapies.

SEARCH METHODS

In January 2012, we searched for randomized controlled trials of COCs and acne in the computerized databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, POPLINE, and LILACS. We also searched for clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform (ICTRP) (Aug 2011). For the initial review, we wrote to researchers to seek any unpublished or published trials that we might have missed.

SELECTION CRITERIA

We considered randomized controlled trials reported in any language that compared the effectiveness of a COC containing an estrogen and a progestin to placebo or another active therapy for acne in women.

DATA COLLECTION AND ANALYSIS

We extracted data on facial lesion counts, both total and specific (i.e., open or closed comedones, papules, pustules and nodules); acne severity grades; global assessments by the clinician or the participant, and discontinuation due to adverse events. Data were entered and analyzed in RevMan. For continuous data, we calculated the mean difference (MD) and 95% confidence interval (CI). For dichotomous data, we calculated the Peto odds ratio (OR) and 95% CI.

MAIN RESULTS

The review includes 31 trials with 12,579 participants. Of 24 comparisons made, 6 compared a COC to placebo, 17 different COCs, and 1 compared a COC to an antibiotic. Of nine placebo-controlled trials with data for analysis, all showed COCs reduced acne lesion counts, severity grades and self-assessed acne compared to placebo. A levonorgestrel-COC group had fewer total lesion counts (MD -9.98; 95% CI -16.51 to -3.45), inflammatory and non-inflammatory lesion counts, and were more likely to have a clinician assessment of clear or almost clear lesions and participant self-assessment of improved acne lesions. A norethindrone acetate COC had better results for clinician global assessment of no acne to mild acne (OR 1.86; 95% CI 1.32 to 2.62). In two combined trials, a norgestimate COC showed reduced total lesion counts (MD-9.32; 95% CI -14.19 to -4.45), reduced inflammatory lesion and comedones counts, and more with clinician assessment of improved acne. For two combined trials of a drospirenone COC, the investigators' assessment of clear or almost clear skin favored the drospirenone group (OR 3.02; 95% CI 1.99 to 4.59). In one trial, the drospirenone-COC group showed greater (more positive) percent changes for total lesion count (MD 29.08; 95% CI 3.13 to 55.03), inflammatory and non-inflammatory lesion counts, and papule and closed comedone counts. A dienogest-COC group had greater percentage decreases in total lesion count (MD -15.30; 95% CI -19.98 to -10.62) and inflammatory lesion count, and more women assessed with overall improvement of facial acne. A CMA-COC group had more 'responders,' those with 50% or greater decrease in facial papules and pustules (OR 2.31; 95% CI 1.50 to 3.55)Differences in the comparative effectiveness of COCs containing varying progestin types and dosages were less clear, and data were limited for any particular comparison. COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel. A COC with cyproterone acetate showed better acne outcomes than one with desogestrel, but the studies produced conflicting results. Likewise, levonorgestrel showed a slight improvement over desogestrel in acne outcomes, but results were not consistent. A drospirenone COC appeared to be more effective than norgestimate or nomegestrol acetate plus 17β-estradiol but less effective than cyproterone acetate.

AUTHORS' CONCLUSIONS: This update yielded six new trials but no change in conclusions. The six COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions. Few important and consistent differences were found between COC types in their effectiveness for treating acne. How COCs compare to alternative acne treatments is unknown since only one trial addressed this issue. The use of standardized methods for assessing acne severity would help in synthesizing results across trials as well as aid in interpretation.

摘要

背景

痤疮是女性常见的皮肤疾病。尽管目前尚无统一的痤疮治疗方法,但含有雌激素和孕激素的复方口服避孕药(COC)常用于女性痤疮患者。

目的

比较复方口服避孕药(COC)与安慰剂或其他有效治疗方法治疗面部痤疮的疗效。

检索方法

2012年1月,我们检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE、POPLINE和LILACS等计算机数据库中关于COC与痤疮的随机对照试验。我们还检索了ClinicalTrials.gov和国际临床试验注册平台(ICTRP,2011年8月)中的临床试验。在初步综述时,我们写信给研究人员,寻找可能遗漏的未发表或已发表的试验。

入选标准

我们纳入了以任何语言发表的随机对照试验,这些试验比较了含雌激素和孕激素的COC与安慰剂或其他有效治疗方法治疗女性痤疮的疗效。

数据收集与分析

我们提取了面部皮损计数数据,包括总数和特定类型(即开放性或闭合性粉刺、丘疹、脓疱和结节);痤疮严重程度分级;临床医生或患者的整体评估,以及因不良事件而停药的数据。数据录入RevMan软件进行分析。对于连续性数据,我们计算了平均差(MD)和95%置信区间(CI)。对于二分法数据,我们计算了Peto比值比(OR)和95%CI。

主要结果

本综述纳入了31项试验,共12579名参与者。在进行的24项比较中,6项是COC与安慰剂的比较,17项是不同COC之间的比较,1项是COC与抗生素的比较。在9项有分析数据的安慰剂对照试验中,所有试验均显示COC与安慰剂相比可减少痤疮皮损计数、严重程度分级及自我评估的痤疮情况。左炔诺孕酮COC组的皮损总数(MD -9.98;95%CI -16.51至-3.45)、炎性和非炎性皮损计数更少,临床医生评估为皮损清除或几乎清除以及患者自我评估痤疮皮损改善的可能性更大。醋酸炔诺酮COC在临床医生对无痤疮至轻度痤疮的整体评估方面效果更好(OR 1.86;95%CI 1.32至2.62)。在两项联合试验中,去氧孕烯COC显示皮损总数减少(MD -9.32;95%CI -14.19至-4.45),炎性皮损和粉刺计数减少,更多患者经临床医生评估痤疮有所改善。在两项屈螺酮COC的联合试验中,研究人员对皮肤清除或几乎清除的评估更倾向于屈螺酮组(OR 3.02;95%CI 1.99至4.59)。在一项试验中,屈螺酮COC组在皮损总数(MD 29.08;95%CI 3.13至55.03)、炎性和非炎性皮损计数以及丘疹和闭合性粉刺计数方面的百分比变化更大(更积极)。地诺孕素COC组的皮损总数(MD -15.30;95%CI -19.98至-10.62)和炎性皮损计数的百分比下降更大,更多女性经评估面部痤疮整体改善。醋酸氯地孕酮COC组有更多“反应者”,即面部丘疹和脓疱减少50%或更多的患者(OR 2.31;95%CI 1.50至3.55)。含不同类型和剂量孕激素的COC在比较疗效上的差异不太明显,且任何特定比较的数据都有限。含醋酸氯地孕酮或醋酸环丙孕酮的COC比左炔诺孕酮能更好地改善痤疮。含醋酸环丙孕酮的COC比含去氧孕烯的COC痤疮治疗效果更好,但研究结果相互矛盾。同样,左炔诺孕酮在痤疮治疗效果上比去氧孕烯略有改善,但结果不一致。屈螺酮COC似乎比去氧孕烯或醋酸诺美孕酮加17β-雌二醇更有效,但比醋酸环丙孕酮效果差。

作者结论

本次更新纳入了6项新试验,但结论未变。在安慰剂对照试验中评估的6种COC均可有效减少面部炎性和非炎性痤疮皮损。在治疗痤疮的疗效方面,不同类型COC之间未发现重要且一致的差异。由于仅一项试验涉及此问题,COC与其他痤疮治疗方法的比较尚不清楚。采用标准化方法评估痤疮严重程度将有助于综合各试验结果并辅助解读。

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