Effectiveness of spironolactone for women with acne vulgaris (SAFA) trial: a critically appraised topic.
Effectiveness of spironolactone for women with acne vulgaris (SAFA) trial: a critically appraised topic.
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螺内酯对女性寻常痤疮 (SAFA) 试验的有效性：一个受到严格评价的话题。
DOI：
10.1093/bjd/ljad270
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发表时间：
2023
期刊：
影响因子：
--
通讯作者：
Barbieri,JohnS
中科院分区：
文献类型：
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作者：
Shields,Ali;Barbieri,JohnS
螺内酯治疗成年女性痤疮(SAFA)试验是一项多中心、双盲、随机对照试验，评估螺内酯与安慰剂治疗女性面部痤疮的疗效。1名患有面部痤疮至少6个月的18岁女性≥被分配接受螺内酯或安慰剂治疗。随机接受螺内酯治疗的参与者开始每天服用50毫克，持续6周，如果治疗被发现是可耐受的，则增加到100毫克。参与者被允许在24周的研究期间继续进行局部治疗。有410名妇女被随机分配到安体舒通组或对照组，342名妇女被纳入初步分析。主要结果是在12周和24周时评估AcneQOL(痤疮特异性生活质量衡量标准)。次要结果是参与者自我评估的改善情况、研究人员对治疗成功和不良反应的全球评估(IGA)。研究发现，与安慰剂相比，螺内酯改善了初次和继发性的结果，24周的差异比12周的差异更大。调整后的AcneQOL症状子量表评分组之间的平均差异显示，螺内酯组的改善在统计学上显著更大(12周和24周分别为1.27和3.45)。服用50毫克和100毫克的螺内酯耐受性很好，除了头痛(20%比12%)和头晕(19%比12%)外，副作用与安慰剂的差异很小。52周的随访数据发现，螺内酯组口服抗生素的使用率较低(5.8%比13.5%)。SAFA试验是迄今为止评估螺内酯治疗痤疮有效性的最大规模的随机试验。这项研究设计严谨，各方都有适当的盲目。此外，这项研究采取了一种务实的方法，允许参与者继续使用他们的局部治疗，这提高了对当前标准做法的概括性。预先指定的亚组分析显示，无论基线痤疮严重程度(IGA)、体重指数、多囊卵巢综合征状态、种族、局部治疗使用还是激素治疗使用，服用螺内酯的参与者在痤疮结果中都显示出类似的益处。这项试验也有一些局限性。选择在前6周每天服用50毫克可能限制了在12周和24周发现治疗差异的能力，因为患者本来应该每天服用100毫克的
The Spironolactone for Adult Female Acne (SAFA) trial was a multicentre, double-blind, randomized controlled trial evaluating spironolactone vs. placebo in the treatment of facial acne in women. 1 Females≥ 18 years with facial acne for at least 6 months were assigned to receive either spironolactone or placebo. Participants randomized to treatment with spironolactone were started on a daily dose of 50 mg for 6 weeks, which was increased to 100 mg if the treatment was found to be tolerable. Participants were allowed to continue their topical treatments during the 24-week study period. There were 410 women randomly assigned to the spironolactone arm or the control arm, and 342 were included in the primary analysis. The primary outcome was the AcneQoL (acne-specific quality of life measure) that was assessed at 12 and 24 weeks. The secondary outcomes were participant self-assessed improvement, Investigator Global Assessment (IGA) for treatment success and adverse reactions. The study found spironolactone improved outcomes, both primary and secondary, compared with placebo, with greater differences at week 24 than week 12. The adjusted mean difference between groups in the AcneQoL symptom subscale score showed a statistically significant greater improvement in the spironolactone group (1.27 and 3.45 at 12 and 24 weeks, respectively). Spironolactone at doses of 50 mg and 100 mg was well tolerated with minimal sideeffect differences vs. placebo besides headache (20% vs. 12%) and lightheadedness (19% vs. 12%). Follow-up data at 52 weeks found lower use of oral antibiotics in the spironolactone arm (5.8% vs. 13.5%). The SAFA trial is the largest randomized trial to date evaluating the effectiveness of spironolactone in the treatment of acne. The study was rigorously designed with appropriate blinding of all parties. In addition, the study had a pragmatic approach in allowing participants to continue use of their topical treatments, which improves generalizability to current standard practices. Prespecified subgroup analyses showed that participants given spironolactone showed similar benefit in acne outcomes, regardless of baseline acne severity (IGA), body mass index, polycystic ovary syndrome status, ethnic group, topical treatment use or hormonal treatment use.This trial also has some limitations. The choice to start at 50 mg daily for the first 6 weeks may have limited the ability to detect treatment differences at 12 and 24 weeks as patients would have been on the 100 mg daily dose for