探索性别确认荷尔蒙疗法的安全性:利用食品和药物管理局不良事件报告系统数据库开展的药物不良事件观察研究。

IF 2.3 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Annals of Pharmacotherapy Pub Date : 2024-11-01 Epub Date: 2024-02-12 DOI:10.1177/10600280241231612
Ainhoa Gomez-Lumbreras, Lorenzo Villa-Zapata
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引用次数: 0

摘要

背景:性别焦虑症患者接受激素疗法进行变性。这种疗法的适应症最初是针对异性的,因此缺乏有关潜在药物不良反应(ADR)的信息:目的:描述向美国食品和药物管理局不良事件报告系统(FAERS)数据库报告的变性人与变性药物相关的药物不良反应:方法:研究了 FAERS 数据库中截至 2023 年 6 月的数据,重点关注性别转换药物在性别障碍情况下的使用报告。ADRs 在首选术语和系统器官类别 (SOC) 层面上使用监管活动医学字典进行分类。描述性统计汇总了报告数量、药物类型、适应症和 ADR 严重程度:结果:分析了 82 份报告(230 例 ADR)中出生时被指派为女性、但性别转变为男性的患者(变性男性),他们的平均年龄为 29.5 岁。72%的报告提到了变性荷尔蒙疗法,主要来自美国(67.1%)。其中88%被归类为严重不良反应,主要是SOC损伤、中毒和手术并发症(26.5%),其次是精神障碍(14.8%)和神经系统疾病(12.2%)。在出生时被分配性别为男性、后转为女性的患者(变性女性)(81 份报告,237 例 ADR)中,平均年龄为 33.3 岁,58% 的患者表示使用药物是为了治疗性别障碍。相当大的比例(53.6%)为严重 ADR,主要是 SOC:损伤、中毒和手术并发症(26.6%):FAERS数据显示,使用激素治疗的变性人出现了严重的不良反应,有时这些不良反应并非受试者的性别所致。人群层面的研究对于加强变性人的医疗保健至关重要。像 FAERS 这样的自发监测数据库揭示了标示外 ADR,敦促医疗服务提供者在知情的情况下谨慎对待激素疗法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Exploring Safety in Gender-Affirming Hormonal Treatments: An Observational Study on Adverse Drug Events Using the Food and Drug Administration Adverse Event Reporting System Database.

Background: People with gender dysphoria are treated with hormone therapy for gender reassignment. The indication of this therapy was initially for the opposite sex, and information on potential adverse drug reaction (ADR) is lacking.

Objective: To describe ADR associated with gender transition medication in transgender individuals reported to the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: Data from the FAERS database up to June 2023 were examined, focusing on reports of gender transition medication use in the context of gender dysphoria. The ADRs were categorized using the Medical Dictionary for Regulatory Activities at both Preferred Term and System Organ Class (SOC) levels. Descriptive statistics summarized report counts, medication types, indications, and ADR severity.

Results: For individuals assigned female at birth undergoing gender transition to male (transgender men), 82 reports (230 ADRs) were analyzed, with an average age of 29.5 years. Transgender hormonal therapy was cited in 72% of reports, predominantly from the United States (67.1%). A striking 88% were categorized as serious ADRs, primarily SOC injury, poisoning, and procedural complications (26.5%), followed by psychiatric disorders (14.8%) and nervous system disorders (12.2%). Among those assigned sex male at birth transitioning to female (transgender women) (81 reports, 237 ADRs), mean age was 33.3 years, with 58% indicating use for gender dysphoria. A significant proportion (53.6%) were serious ADRs, primarily SOC: injury, poisoning, and procedural complications (26.6%).

Conclusions and relevance: The FAERS data reveal significant ADRs in transgender individuals using hormone therapy, sometimes unintended for their recipient gender. Population-level studies are crucial to enhance transgender health care. Spontaneous surveillance databases like FAERS illuminate off-label ADRs, urging health care providers to approach hormone therapies with informed caution.

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来源期刊
CiteScore
5.70
自引率
0.00%
发文量
166
审稿时长
3-8 weeks
期刊介绍: Annals of Pharmacotherapy (AOP) is a peer-reviewed journal that advances pharmacotherapy throughout the world by publishing high-quality research and review articles to achieve the most desired health outcomes.The articles provide cutting-edge information about the most efficient, safe and cost-effective pharmacotherapy for the treatment and prevention of various illnesses. This journal is a member of the Committee on Publication Ethics (COPE). Average time from submission to first decision: 14 days
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