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氟他胺对比醋酸环丙孕酮-炔雌醇联合治疗中度痤疮:一项初步随机临床试验。

Flutamide versus a cyproterone acetate-ethinyl estradiol combination in moderate acne: a pilot randomized clinical trial.

机构信息

Department of Dermatology, Faculty of Medicine, Ardabil University of Medical Sciences, Ardabil.

出版信息

Clin Cosmet Investig Dermatol. 2011;4:117-21. doi: 10.2147/CCID.S20543. Epub 2011 Jul 26.

DOI:10.2147/CCID.S20543
PMID:21833162
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3149479/
Abstract

BACKGROUND

The use of oral flutamide is rarely investigated in acne therapy. The aim of this study was to compare the efficacy of oral flutamide with that of a cyproterone-estradiol combination in treating acne lesions.

METHODS

A randomized clinical trial enrolled patients with moderate acne into two equal groups to receive either oral flutamide or the cyproterone-estradiol combination for 6 months. Lesion count, Acne Severity Index, and Global Acne Grading system (GAGS) scores were used to assess improvement in acne lesions. The dichotomous measurement scale for primary endpoint assessment was defined as improvement from moderate to mild acne based on GAGS score. Patient satisfaction and dermal fat were also assessed. Intention to treat and per protocol analyses were done, reporting related effect sizes.

RESULTS

Both treatments resulted in substantial improvement in acne lesions. Although flutamide seemed to have higher efficacy, an intention to treat analysis did not find the two treatment protocols to be different. The relative risk in intention to treat analysis was 1.8 (95% confidence interval [CI] 0.89-1.6), and was 1.33 (95% CI 1.03-1.72) for the per protocol analysis. The number needed to treat for flutamide compared with the cyproterone-estradiol combination was 7.7 and 4.2 in the intention to treat and per protocol analyses, respectively.

CONCLUSION

Flutamide appears to be more effective than a cyproterone-estradiol combination in some aspects of acne treatment, but this requires confirmation in a larger trial.

摘要

背景

口服氟他胺在痤疮治疗中的应用很少被研究。本研究旨在比较口服氟他胺与环丙孕酮-雌二醇联合治疗痤疮皮损的疗效。

方法

一项随机临床试验将中度痤疮患者分为两组,分别接受口服氟他胺或环丙孕酮-雌二醇联合治疗 6 个月。采用皮损计数、痤疮严重程度指数和全球痤疮分级系统(GAGS)评分评估痤疮皮损改善情况。主要终点评估的二分类测量量表定义为 GAGS 评分从中度改善为轻度痤疮。还评估了患者满意度和真皮脂肪。进行了意向治疗和方案分析,并报告了相关的效应量。

结果

两种治疗方法均使痤疮皮损得到显著改善。虽然氟他胺似乎疗效更高,但意向治疗分析并未发现两种治疗方案存在差异。意向治疗分析的相对风险为 1.8(95%置信区间[CI]0.89-1.6),方案分析的相对风险为 1.33(95%CI1.03-1.72)。氟他胺与环丙孕酮-雌二醇联合治疗的治疗需要数分别为 7.7 和 4.2。

结论

氟他胺在痤疮治疗的某些方面似乎比环丙孕酮-雌二醇联合治疗更有效,但这需要更大规模的试验来证实。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/41f7/3149479/220b742268dd/ccid-4-117f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/41f7/3149479/1657571570ac/ccid-4-117f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/41f7/3149479/220b742268dd/ccid-4-117f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/41f7/3149479/1657571570ac/ccid-4-117f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/41f7/3149479/220b742268dd/ccid-4-117f2.jpg

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