Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, CA.
Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA.
Menopause. 2019 Sep;26(9):966-971. doi: 10.1097/GME.0000000000001356.
To analytically characterize the doses of estradiol and progesterone found in compounded combined forms of oral capsule and transdermal cream formulations, and determine the consistency of the hormone formulations within a batch.
Prescriptions for combined estradiol/progesterone capsules (0.5 and 100 mg, respectively) and creams (0.5 and 100 mg/g, respectively) were sent to 15 custom-compounding pharmacies. Estradiol and progesterone levels were measured by radioimmunoassays. Hormone levels were measured in 2 capsules and 2 creams from each pharmacy; 10 capsules from 3 pharmacies; and top/middle/bottom layer of cream containers to assess consistency. The magnitude and sources of variation for the measurements were examined by analysis of variance models.
Thirteen pharmacies filled the prescriptions. Measured estradiol levels were 0.365 to 0.551 mg for capsules and 0.433 to 0.55 mg/g for creams, and progesterone levels were 90.8 to 135 mg for capsules and 93 to 118 mg/g for creams. Greater variations in estradiol levels were observed between pharmacies for estradiol in capsules than in creams; however, measured estradiol levels within pharmacies were more consistent in the capsules than the creams. Similar results were obtained for progesterone levels.
The variations in estradiol and progesterone levels observed in compounded hormone therapy formulations justify concerns regarding risks as a result of variability, which have been outlined by The North American Menopause Society, the American College of Obstetricians and Gynecologists, and the US Food and Drug Administration (FDA) in their statements regarding compounded hormone use. These data support the need for an US FDA-approved bioidentical hormone therapy. : Video Summary: Supplemental Digital Content 1, http://links.lww.com/MENO/A425.
分析口服胶囊和透皮乳膏复方制剂中雌二醇和孕酮的剂量，并确定一批激素制剂的激素含量是否一致。
将雌二醇/孕酮胶囊（分别为 0.5 和 100mg）和乳膏（分别为 0.5 和 100mg/g）的处方寄给 15 家定制配药药房。采用放射免疫分析法测量雌二醇和孕酮水平。从每个药房的 2 个胶囊和 2 个乳膏、3 个药房的 10 个胶囊以及乳膏容器的顶层/中层/底层测量激素水平，以评估一致性。通过方差分析模型检查测量值的大小和变异源。
13 家药房满足了处方要求。胶囊中雌二醇的测量值为 0.365 至 0.551mg，乳膏中为 0.433 至 0.55mg/g；胶囊中孕酮的测量值为 90.8 至 135mg，乳膏中为 93 至 118mg/g。胶囊中雌二醇的药房间差异大于乳膏；然而，胶囊中同一药房内的雌二醇测量值比乳膏更一致。孕酮水平也得到了类似的结果。
复方激素治疗制剂中雌二醇和孕酮水平的变化证明了因变异性而产生风险的担忧是合理的，北美绝经协会、美国妇产科医师学会和美国食品和药物管理局（FDA）在他们关于复方激素使用的声明中已经概述了这些风险。这些数据支持美国 FDA 批准的生物等效激素治疗的必要性。
