From the Department of Obstetrics and Gynecology, Midlife, Health University of Virginia Health System, Charlottesville, VA.
Cancer J. 2022;28(3):241-245. doi: 10.1097/PPO.0000000000000597.
Following the release of the Women's Health Initiative data, women began to use compounded bioidentical hormone therapy (cBHT) in the misguided belief of greater safety and efficacy than traditional hormone therapy. New guidelines recommend government-approved hormone therapy for symptomatic healthy menopausal women younger than 60 years or within 10 years of menopause at the time of initiation. For women requesting bioidentical hormones, those similar to the hormones present before menopause, there are many government-approved hormone therapies with extensive pharmacokinetic, safety, and efficacy data provided with package inserts delineating efficacy, safety, and potential risks. For women requesting non-Food and Drug Administration-approved (cBHT), these cBHTs lack data on pharmacokinetics, safety, and efficacy and are not provided a label detailing risk. Their use should be restricted to women with allergies or dosing or formulations not available in government-approved therapies. Pellet therapy providing women with supraphysiologic hormone dosing raises even more safety concerns.
随着妇女健康倡议数据的发布，女性开始使用复方生物等同激素治疗（cBHT），错误地认为其比传统激素治疗更安全、更有效。新指南建议为有症状的绝经后健康女性提供政府批准的激素治疗，年龄小于 60 岁或绝经后 10 年内开始治疗。对于要求使用生物等同激素的女性，这些激素与绝经前的激素相似，有许多政府批准的激素治疗方案，具有广泛的药代动力学、安全性和疗效数据，并附有包装说明书，详细说明疗效、安全性和潜在风险。对于要求使用未经食品和药物管理局批准的（cBHT）的女性，这些 cBHT 在药代动力学、安全性和疗效方面缺乏数据，也没有详细说明风险的标签。这些药物应仅限于对政府批准的治疗方案有过敏、剂量或配方不适的女性使用。提供超生理剂量激素的丸剂治疗方法引起了更多的安全问题。
