Obstet Gynecol. 2023 Nov 1;142(5):1266-1273. doi: 10.1097/AOG.0000000000005395.
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.
许多复方药剂师使用“生物等同激素”这一术语作为营销术语，暗示这些制剂是天然的，因此比美国食品和药物管理局 (FDA) 批准的使用生物等同或合成激素或两者兼用的更年期药物更安全、更有效。然而，缺乏支持安全性和有效性营销声明的证据。当存在 FDA 批准的制剂时，不应常规开处复方生物等同更年期激素治疗。临床医生应告知患者，对于更年期症状的管理，推荐使用 FDA 批准的更年期激素治疗，而不是复方生物等同更年期激素治疗。如果患者要求使用复方生物等同更年期激素治疗，临床医生应告知他们这些制剂缺乏 FDA 批准及其潜在风险和益处，包括与制剂特定相关的风险。为了真正了解复方生物等同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，对定制的产品与 FDA 批准的更年期激素治疗进行长期随访比较。
