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.

项目摘要/摘要 痤疮是全球最常见的疾病之一，影响了85％的青少年，并且经常持续存在 成年。痤疮比牛皮癣，蜂窝炎和 黑色素瘤。虽然轻度痤疮通常可以用局部药物来治疗，但经常中度至重度痤疮 需要使用诸如口服抗生素，荷尔蒙疗法和异维诺因等全身性剂进行治疗。 值得注意的是，尽管这些药物是护理的标准部分，但很少有随机临床试验 显示功效，没有任何表现出这些常用药物之间比较有效性的；这 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。 我们小组的先前工作表明口服抗生素是使用 痤疮和患者的治疗经常使用超过一年。实际上，皮肤科医生开了 人均抗生素比任何其他专业都要多。但是，长时间的抗生素使用可能与 多种不良结果，包括细菌抗生素耐药性，咽炎，胶原蛋白血管疾病， 炎症性肠病以及乳腺癌和结肠癌。结果，国际兴趣越来越大 以及特别来自疾病控制中心，以改善抗生素管理 痤疮的门诊环境和多个临床指南建议减少使用 抗生素通过使用非抗菌疗法并限制治疗持续时间。 对于中度至重度痤疮的女性，螺内酯可能代表有效，耐受性良好的女性 替代口服抗生素。多年来一直使用为钾的利尿剂。 由于痤疮对这种疾病的荷尔蒙发病机理的影响，因此其标签外。但是，尽管有专家意见 支持螺内酯在痤疮治疗中的使用，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的，通常是回顾性的研究。 缺乏将螺内酯与其他药物（例如口服抗生素）的有效性进行比较的试验。 我们的最终目标是完成必要的计划和准备，以进行小说，潜在的， 随机临床试验评估螺内酯和口服四环素级的比较有效性 成年女性痤疮治疗的抗生素。以前没有进行过这样的研究。结果 这项研究将对痤疮和抗生素管理的治疗产生重大影响。在 此外，这项研究可能使我们能够监视A中抗生素耐药性发展的时机 健康的患者人群接受了扩展抗生素治疗的患者，并评估 在微生物组上长时间接触口服抗生素。我们提出的研究可能会极大地影响 医疗保健实践在妇女中治疗中度至重度痤疮并为政策提供信息 关于在整个医学中更适当使用抗生素。