Abstract：
Many compounding pharmacies use the phrase \"bioidentical hormone\" as a marketing term to imply that these preparations are natural and, thus, safer and more effective than U.S. Food and Drug Administration (FDA)-approved menopausal medications that use bioidentical or synthetic hormones or both. However, evidence to support marketing claims of safety and effectiveness is lacking. Compounded bioidentical menopausal hormone therapy should not be prescribed routinely when FDA-approved formulations exist. Clinicians should counsel patients that FDA-approved menopausal hormone therapies are recommended for the management of menopausal symptoms over compounded bioidentical menopausal hormone therapy. If a patient requests the use of compounded bioidentical menopausal hormone therapy, clinicians should educate them on the lack of FDA approval of these preparations and their potential risks and benefits, including the risks specific to compounding. To truly understand the benefits and harms of compounded bioidentical menopausal hormone therapy, high quality placebo-controlled randomized controlled trials with long-term follow-up comparing custom-compounded products with FDA-approved menopausal hormone therapy are needed.
摘要：
结论：许多复合药房使用短语“生物相同激素”作为营销术语，暗示这些制剂是天然的，并且，因此，比美国食品和药物管理局（FDA）批准的更年期药物更安全，更有效，这些药物使用生物相同或合成激素或两者。然而,缺乏支持安全性和有效性营销主张的证据。当FDA批准的制剂存在时，不应常规规定复合生物相同的绝经期激素疗法。临床医生应告知患者，建议使用FDA批准的更年期激素疗法来管理更年期症状，而不是复合生物相同的更年期激素疗法。如果患者要求使用复合生物相同的更年期激素治疗，临床医生应该教育他们缺乏FDA批准这些制剂及其潜在的风险和益处，包括复利特有的风险。为了真正了解复合生物同合更年期激素治疗的益处和危害，需要进行高质量的安慰剂对照随机对照试验,并进行长期随访,比较定制复方产品与FDA批准的更年期激素治疗.
