Comparative effectiveness of spironolactone versus oral tetracycline-class antibiotics for the treatment of moderate to severe acne in women

项目摘要/摘要 痤疮是世界范围内最常见的疾病之一，85%的青少年患有痤疮，而且经常持续存在 进入成年期。痤疮比牛皮癣、蜂窝织炎和 黑色素瘤。虽然轻度痤疮通常可以通过局部药物治疗，但中度到重度痤疮通常 需要全身性药物治疗，如口服抗生素、激素治疗和异维甲酸。 值得注意的是，虽然这些药物是护理的标准组成部分，但很少有随机临床试验 显示出有效性，而没有显示出这些常用药物之间的比较有效性； 医学研究所已将这一领域确定为比较有效性研究的最优先事项之一。 我们小组以前的工作表明，口服抗生素是最常见的全身用药 治疗痤疮的患者经常使用它们一年以上。事实上，皮肤科医生开出的处方 人均抗生素比其他任何专业都多。然而，长时间使用抗生素可能与 各种不良后果，包括细菌耐药性，咽炎，胶原蛋白血管疾病， 炎症性肠病，乳腺癌和结肠癌。因此，国际社会的兴趣与日俱增。 并特别受到疾病控制中心关于改善抗生素管理的关注 门诊设置和多个治疗痤疮的临床指南建议减少使用 通过使用非抗菌疗法和限制治疗时间来使用抗生素。 对于患有中度到严重痤疮的女性，螺内酯可能代表着一种有效的、耐受性良好的 口服抗生素的替代品。作为一种省钾利尿剂，多年来它也一直被使用 痤疮的标签外，因为它的影响，激素发病机制的这种疾病。然而，尽管专家认为 支持使用螺内酯治疗痤疮，它的使用仍然相对罕见和临床 证明螺内酯有效性的证据仅限于小型的，通常是回溯性研究。 将螺内酯与口服抗生素等其他药物的有效性进行比较的试验还很少。 我们的最终目标是完成必要的规划和准备，以进行一种新颖的、预期的、 评价螺内酯与口服四环素类药物疗效比较的随机临床试验 抗生素在治疗成年女性痤疮中的作用。此前还没有进行过这样的研究。结果是 这项研究的结果将对痤疮的治疗和抗生素的管理产生重大影响。在……里面 此外，这项研究可能使我们能够监测抗生素耐药性发展的时间 健康人群使用延长疗程抗生素治疗的效果及评价 长期接触口服抗生素对微生物群的影响。我们提议的研究可能会对 与治疗妇女中重度痤疮有关的保健实践和政策 关于在整个医学中更适当地使用抗生素的问题。

Project Summary/Abstract Acne is one of the most common diseases worldwide, affecting 85% of adolescents and often persisting into adulthood. Acne is responsible for a greater global burden of disease than psoriasis, cellulitis, and melanoma. While mild acne can usually be managed with topical medications, moderate to severe acne often requires treatment with systemic agents such as oral antibiotics, hormonal therapies, and isotretinoin. Remarkably, while these agents are a standard part of care, there are very few randomized clinical trials showing efficacy and none that show comparative effectiveness between these commonly used agents; the Institute of Medicine has identified this area as one of the top priorities for comparative effectiveness research. Previous work by our group has shown oral antibiotics are the most common systemic agent used in the treatment of acne and patients frequently use them for more than one year. In fact, dermatologists prescribe more antibiotics per capita than any other specialty. However, prolonged antibiotic use may be associated with a variety of adverse outcomes including bacterial antibiotic resistance, pharyngitis, collagen vascular illnesses, inflammatory bowel disease, and breast and colon cancer. As a result, there is growing international interest and attention specifically from the Centers for Disease Control regarding improving antibiotic stewardship in the outpatient setting and multiple clinical guidelines for acne have recommended reducing the use of antibiotics through the use of non-antimicrobial therapies and by limiting the duration of therapy. For women with moderate to severe acne, spironolactone may represent an effective, well-tolerated alternative to oral antibiotics. Developed as a potassium-sparing diuretic, for many years it has also been used off-label for acne due to its impact on hormonal pathogenesis of this disease. However, despite expert opinion supporting the use of spironolactone in the treatment of acne, its use remains relatively uncommon and clinical evidence demonstrating the effectiveness of spironolactone is limited to small, often retrospective studies. Trials comparing the effectiveness of spironolactone to that of other agents such as oral antibiotics are lacking. Our ultimate goal is to complete the necessary planning and preparation to conduct a novel, prospective, randomized clinical trial evaluating the comparative effectiveness of spironolactone and oral tetracycline-class antibiotics in the treatment of acne in adult women. No such study has previously been conducted. The results of this study would have substantial implications for the treatment of acne and antibiotic stewardship. In addition, this study may allow us to monitor for the timing of the development of antibiotic resistance in a healthy population of patients treated with extended courses of antibiotics and to evaluate the impact of prolonged exposure to oral antibiotics on the microbiome. Our proposed study could significantly influence healthcare practice with respect to the treatment of moderate to severe acne in women and inform policy regarding more appropriate use of antibiotics throughout medicine.