McBane Sarah E, Borgelt Laura M, Barnes Kylie N, Westberg Sarah M, Lodise Nicole M, Stassinos Martha
Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla, California.
Pharmacotherapy. 2014;34(4):410-23. doi: 10.1002/phar.1394. Epub 2014 Jan 4.
Menopausal symptoms affect a significant portion of women. Traditional treatment with manufactured hormone therapy can alleviate these symptoms, but many women and their health care providers are concerned about the risks, such as venous thromboembolism and certain types of cancer, demonstrated with manufactured hormone therapy. Compounded bioidentical hormone therapy has been proposed and is often used as a solution for these concerns. Despite this use, no data are currently available to support the claims that compounded bioidentical hormone therapy is a safer or more efficacious option compared with manufactured hormone therapy. A common misperception is that all manufactured products consist of synthetic hormones and all compounded medications consist of natural hormones; however, in fact, significant overlap exists. Several key stakeholder organizations have issued statements expressing concern about the lack of evidence regarding the efficacy and safety of compounded bioidentical hormone therapy, in addition to concerns regarding prescribing patterns. The Women's Health Practice and Research Network of the American College of Clinical Pharmacy recommends against the consistent use of compounded bioidentical hormones as a safer option compared with manufactured therapy and supports the statements of other key organizations, acknowledging the need for more robust clinical studies to evaluate the potential advantages and disadvantages of compounded bioidentical products compared with manufactured products.
更年期症状影响着很大一部分女性。传统的人工合成激素疗法可以缓解这些症状，但许多女性及其医疗保健提供者担心人工合成激素疗法存在的风险，如静脉血栓栓塞和某些类型的癌症。复方生物同源激素疗法已被提出，并经常被用作解决这些担忧的方法。尽管有这种应用，但目前尚无数据支持复方生物同源激素疗法比人工合成激素疗法更安全或更有效的说法。一种常见的误解是，所有人工合成产品都由合成激素组成，所有复方药物都由天然激素组成；然而，事实上，它们之间存在很大重叠。除了对处方模式的担忧外，几个关键的利益相关者组织已发表声明，对复方生物同源激素疗法的有效性和安全性缺乏证据表示担忧。美国临床药学院的女性健康实践与研究网络建议，不要一贯地将复方生物同源激素作为比人工合成疗法更安全的选择，并支持其他关键组织的声明，承认需要进行更有力的临床研究，以评估复方生物同源产品与人工合成产品相比的潜在优缺点。
