Shenzhen Longgang Central Hospital, Shenzhen, 518116, China.
Department of Respiratory Medicine, Traditional Chinese Medicine Innovation Research Center, Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine, Shenzhen, China.
Sci Rep. 2024 Nov 29;14(1):29739. doi: 10.1038/s41598-024-81342-w.
It's well known that sex is a risk factor for the occurrence of adverse events (AEs), most of which have found sex differences. Real-world data studies on the sex differences of fall-risk-increasing drugs (FRIDs) are few and far between, with most small-scale retrospective studies based on FRID classes. To establish a list of FRIDs and describe their sex differences, we used preferred terms from the Medical Dictionary for Regulatory Activities to search for AEs in the FDA Adverse Event Reporting System (FAERS), and then perform disproportionality analyses and female/male ratio analyses. During January 2004 to March 2023, 101,746 fall-related AEs were reported in FAERS from patients aged 50 to 100, with 68,492 (67.3%) females and 32,547 (32.0%) males. We found 261 signals for females while 284 for males. For females, the top 3 signals with the highest reporting odds ratio (ROR) were anethole trithione, clopenthixol, nikethamide (ROR: 388.88, 212.10, 113.94), while the top 3 signals with the highest lower limit of information component (IC) were nikethamide, anethole trithione, benzbromarone (IC: 3.91, 3.15, 2.49). For males, the top 3 signals with the highest ROR were fluprednidene acetate, potassium hydroxide, ketazolam (ROR: 216.86, 108.43, 108.43), while the top 3 signals with the highest IC were clomethiazole, piribedil, melperone (IC: 3.31, 3.24, 2.99). Moreover, among the 119 shared signals found between males and females, 33 were positively correlated with falls in females and 38 with falls in males. Signals showing significant sex differences were mainly concentrated on agents of the immune, nervous, musculo-skeletal, and cardiovascular systems. We offered a series of FRIDs and suggested their sex differences in falls through the FAERS. In the future, it is essential to balance the inclusion of women and men, and analyse sex-stratified for FRIDs.
众所周知，性别是发生不良事件（AEs）的一个风险因素，其中大多数都存在性别差异。关于增加跌倒风险药物（FRIDs）的性别差异的真实世界数据研究很少，而且大多数都是基于 FRID 类别的小规模回顾性研究。为了建立 FRIDs 清单并描述其性别差异，我们使用监管活动医学词典的首选术语在 FDA 不良事件报告系统（FAERS）中搜索 AE，然后进行比例失衡分析和女性/男性比例分析。在 2004 年 1 月至 2023 年 3 月期间，FAERS 报告了来自 50 至 100 岁患者的 101,746 例与跌倒相关的 AE，其中 68,492（67.3%）例为女性，32,547（32.0%）例为男性。我们发现女性有 261 个信号，男性有 284 个信号。对于女性，报告优势比（ROR）最高的前 3 个信号是茴香三硫醚、氯哌噻唑和烟酰胺（ROR：388.88、212.10、113.94），而信息成分（IC）下限最高的前 3 个信号是烟酰胺、茴香三硫醚和苯溴马隆（IC：3.91、3.15、2.49）。对于男性，报告优势比（ROR）最高的前 3 个信号是氟尼缩松醋酸酯、氢氧化钾和噻唑安定（ROR：216.86、108.43、108.43），而信息成分（IC）下限最高的前 3 个信号是氯甲噻唑、吡贝地尔和美利曲辛（IC：3.31、3.24、2.99）。此外，在男性和女性之间发现的 119 个共有信号中，有 33 个信号与女性跌倒呈正相关，有 38 个信号与男性跌倒呈正相关。显示出显著性别差异的信号主要集中在免疫系统、神经系统、肌肉骨骼系统和心血管系统的药物上。我们通过 FAERS 提供了一系列 FRIDs，并提出了它们与跌倒的性别差异。未来，必须平衡纳入女性和男性，并对 FRIDs 进行性别分层分析。
