Gass Margery L S, Stuenkel Cynthia A, Utian Wulf H, LaCroix Andrea, Liu James H, Shifren Jan L
1North American Menopause Society, Mayfield Heights, OH 2Endocrinology and Metabolism Service, University of California, San Diego, School of Medicine 3Division of Epidemiology, University of California, San Diego, School of Medicine 4Department of Obstetrics and Gynecology, University Hospitals Case Medical Center, Cleveland, OH 5Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, MA.
Menopause. 2015 Dec;22(12):1276-84. doi: 10.1097/GME.0000000000000553.
A national survey was conducted to determine the extent of use of compounded hormone therapy (C-HT) and to characterize the differences between C-HT users and users of hormone therapy approved by the US Food and Drug Administration (FDA-HT users).
This Internet survey enrolled 3,725 women aged 40 to 84 years who were postmenopausal or experiencing the menopause transition. The sample was weighted slightly by age, region, education, and race to reflect population attributes based on US Census data.
Overall, 9% of women were current users of HT, and 28% of all respondents were ever-users of HT. C-HT users represented 31% of ever-users of HT, 35% of current users of HT, and 41% of ever-users aged 40 to 49 years. Approximately 13% of ever-users indicated current or past use of testosterone. The most cited reason for using HT was vasomotor symptoms (∼70%). Nonapproved indications for using HT were selected more often by C-HT users. There were four reports of endometrial cancer among the 326 C-HT users compared with none reported among the 738 FDA-HT users. Significance was not determined because of small numbers.
This survey indicates substantial use of C-HT across the country and the possibility of higher rates of endometrial side effects with such products. There is a need for standardized data collection on the extent of use of compounded hormones and their potential risks.
开展一项全国性调查,以确定复方激素疗法(C-HT)的使用程度,并描述C-HT使用者与美国食品药品监督管理局批准的激素疗法使用者(FDA-HT使用者)之间的差异。
这项网络调查纳入了3725名年龄在40至84岁之间的绝经后或处于绝经过渡阶段的女性。根据美国人口普查数据,样本在年龄、地区、教育程度和种族方面进行了轻微加权,以反映总体特征。
总体而言,9%的女性为当前激素疗法使用者,28%的受访者曾使用过激素疗法。C-HT使用者占激素疗法曾使用者的31%、当前使用者的35%以及40至49岁曾使用者的41%。约13%的曾使用者表示当前或过去使用过睾酮。使用激素疗法最常提及的原因是血管舒缩症状(约70%)。C-HT使用者更常选择激素疗法的非批准适应症。在326名C-HT使用者中有4例子宫内膜癌报告,而738名FDA-HT使用者中无报告。由于数量较少,未确定显著性。
这项调查表明全国范围内C-HT的使用广泛,且此类产品导致子宫内膜副作用的发生率可能更高。需要对复方激素的使用程度及其潜在风险进行标准化数据收集。