Concerns About Compounded Bioidentical Menopausal Hormone Therapy

J. Pinkerton
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Abstract

Abstract 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.
对复合生物同质绝经期激素治疗的关注
随着妇女健康倡议数据的发布,女性开始使用复合生物同质激素治疗(cBHT),她们错误地认为比传统激素治疗更安全、更有效。新指南推荐政府批准的激素治疗,用于年龄小于60岁或绝经前10年内有症状的健康绝经妇女。对于需要生物同质激素的妇女,那些与绝经前的激素相似的激素,有许多政府批准的激素疗法,具有广泛的药代动力学,安全性和有效性数据,并提供包装说明书,描述疗效,安全性和潜在风险。对于要求非食品和药物管理局批准(cBHT)的妇女,这些cBHT缺乏药代动力学、安全性和有效性的数据,并且没有提供详细风险的标签。它们的使用应仅限于有过敏症状的女性,或者政府批准的治疗方法中没有提供的剂量或配方。为女性提供超生理激素剂量的颗粒疗法引起了更多的安全问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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