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

螺内酯与口服四环素类抗生素治疗女性中度至重度痤疮的疗效比较

• 批准号: 9815052
• 负责人: David Margolis
• 金额: $ 24.95万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9815052
• 关键词: Acne; Adolescent; Adult; Affect; Antibiotic Resistance; Antibiotic Therapy; Antibiotics; Area; Attention; Bacterial Antibiotic Resistance; Blood Vessels; Budgets; Caring; Cellulitis; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical trial protocol document; Collagen; Colon Carcinoma; Data; Data Coordinating Center; Dermatologist; Development; Disease; Diuretics; Effectiveness; Enrollment; Expert Opinion; Exposure to; Feeling; Goals; Guidelines; Healthcare; Hormonal; Inflammatory Bowel Diseases; Infrastructure; Institute of Medicine (U.S.); Institutional Review Boards; International; Investigational Drugs; Isotretinoin; Manuals; Medicine; Minority; Monitor; Oral; Outpatients; Pathogenesis; Patients; Pharmaceutical Preparations; Pharyngitis; Policies; Potassium; Preparation; Procedures; Process; Protocols documentation; Provider; Psoriasis; Randomized Clinical Trials; Research Design; Research Personnel; Retrospective Studies; Sample Size; Site; Spironolactone; Statistical Data Interpretation; Tetracyclines; TimeLine; United States National Institutes of Health; Woman; Work; adverse outcome; bacterial resistance; burden of illness; clinical research site; comparative effectiveness; compare effectiveness; design; effectiveness research; hormone therapy; improved; informatics infrastructure; interest; malignant breast neoplasm; medical specialties; meetings; melanoma; microbiome; novel; off-label use; patient population; prospective; recruit; success; therapy duration; trial comparing

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.

项目总结/摘要 痤疮是世界范围内最常见的疾病之一，影响85%的青少年，并且经常持续存在 长大成人痤疮是负责一个更大的全球疾病负担比牛皮癣，蜂窝织炎， 黑素瘤虽然轻度痤疮通常可以用局部药物治疗，但中度至重度痤疮通常 需要用全身性药物如口服抗生素、激素疗法和异维甲酸治疗。 值得注意的是，虽然这些药物是护理的标准部分，但很少有随机临床试验 这些常用药物之间显示出有效性，而没有显示出比较有效性; 医学研究所已将这一领域确定为比较有效性研究的首要任务之一。 我们小组以前的工作表明，口服抗生素是最常见的全身性药物， 治疗痤疮和患者经常使用它们超过一年。事实上，皮肤科医生会开 人均抗生素比其他任何专科都多。然而，长期使用抗生素可能与 各种不良后果，包括细菌抗生素耐药性，咽炎，胶原血管疾病， 炎症性肠病以及乳腺癌和结肠癌。因此，国际社会对 疾病控制中心特别关注改善抗生素管理， 门诊设置和痤疮的多个临床指南建议减少使用 通过使用非抗菌治疗和限制治疗持续时间来减少抗生素。 对于中度至重度痤疮的女性，螺内酯可能是一种有效的，耐受性良好的药物， 替代口服抗生素。作为一种保钾利尿剂开发，多年来它也被用于 由于其对这种疾病的激素发病机制的影响，尽管专家认为 支持使用螺内酯治疗痤疮，其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、通常是回顾性的研究。 缺乏将螺内酯与其他药物（如口服抗生素）的有效性进行比较的试验。 我们的最终目标是完成必要的规划和准备，进行一个新颖的，前瞻性的， 评价螺内酯和口服四环素类药物疗效的随机临床试验 痤疮的治疗方法有哪些？以前没有进行过这样的研究。结果 这项研究的结果将对痤疮的治疗和抗生素管理产生重大影响。在 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， 接受延长抗生素疗程治疗的健康患者人群，并评估 长期暴露于口服抗生素对微生物组的影响。我们提出的研究可能会显著影响 关于治疗女性中度至重度痤疮的医疗实践和知情政策 关于在整个医疗过程中更恰当地使用抗生素的建议。