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降压药物相关勃起功能障碍风险信号挖掘
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| 篇名： | 降压药物相关勃起功能障碍风险信号挖掘 |
| TITLE： | Mining of risk signals for antihypertensive drug-related erectile dysfunction |
| 摘要： | 目的 基于真实世界数据挖掘降压药物相关勃起功能障碍（ED）的风险信号，为该类药物临床安全应用与风险监测提供参考。方法提取美国FDA不良事件报告系统（FAERS）数据库中15种目标降压药物相关ED报告，检索时段为2004年第一季度至2026年第一季度。采用报告比值比、比例报告比和经验贝叶斯几何均值3种比例失衡测量方法对各类降压药物相关ED的风险信号进行挖掘，并就患者年龄、体重进行分层分析。结果共纳入15种降压药物相关ED报告997份；其中，男性患者居多（931份），年龄集中在18～＜65岁（511份），体重集中在50～＜100kg（366份），报告人以消费者/患者为主（497份）；报告数排前3位的药物依次是氨氯地平（413份）、美托洛尔（133份）、缬沙坦（82份），各药物相关报告的整体人口学分布特征相似；检出阳性信号的药物包括氨氯地平、美托洛尔等8种；阿替洛尔、坎地沙坦、美托洛尔、氢氯噻嗪、氯沙坦等药物相关ED多发生在用药后的30d内，缬沙坦、培哚普利相关ED大多发生在用药360d之后，氨氯地平相关ED的诱发时间则在各时间段均匀分布；严重报告共835份，其中钙通道阻滞剂（CCB）报告最多（占44.0%），血管紧张素转换酶抑制剂最少（占3.7%）；氨氯地平相关ED风险信号强度随年龄增长、体重增加呈递增趋势，美托洛尔信号在45～＜60岁及≥100kg人群中最为突出，缬沙坦阳性信号则仅见于≥60岁及50～＜75kg、≥100kg人群。结论降压药物相关ED报告存在明显的品种异质性和诱发时间分布差异；CCB类药物的严重报告占比最高；氨氯地平、美托洛尔、缬沙坦相关ED风险信号与年龄、体重的关系亦呈明显异质性。 |
| ABSTRACT： | OBJECTIVE To mine the risk signals associated with erectile dysfunction （ED） related to antihypertensive drugs based on real-world data， and to provide a reference for the safe clinical use and risk monitoring of these drugs.METHODS Reports of ED associated with 15 target antihypertensive drugs were extracted from the US FDA Adverse Event Reporting System （FAERS） database， covering the period from the first quarter of 2004 to the first quarter of 2026. Three proportional disproportionality measures （reporting odds ratio， proportional reporting ratio， and empirical Bayesian geometric mean） were used to mine the risk signals for ED associated with various antihypertensive drugs， and stratified analyses were performed based on patient age and body weight.RESULTS A total of 997 ED reports associated with 15 antihypertensive drugs were included. The majority were male patients （931 reports）， with age concentrated in the 18 to ＜65 years group （511 reports）， body weight in the 50 to ＜100 kg group （366 reports）， and reporters predominantly consumers/patients （497 reports）. The top three drugs by number of reports were amlodipine （413 reports）， metoprolol （133 reports）， and valsartan （82 reports）； the overall demographic distribution characteristics of reports associated with each drug were similar. Positive signals were detected for 8 drugs， including amlodipine and metoprolol. ED associated with atenolol， candesartan， metoprolol， hydrochlorothiazide， and losartan mostly occurred within 30 days after medication； ED associated with valsartan and perindopril mostly occurred over 360 days after medication； and the onset time of amlodipine-associated ED was evenly distributed across all time periods. There were a total of 835 serious reports， with calcium channel blockers （CCBs） accounting for the highest proportion （44.0%） and angiotensin-converting enzyme inhibitors for the lowest （3.7%）. The intensity of risk signals for amlodipine-associated ED increased with advancing age and higher body weight， while the signals for metoprolol were most pronounced in individuals aged 45 to ＜60 years and weighing≥100 kg； positive signals for valsartan were observed only in individuals aged≥60 years and those weighing 50 to ＜75 kg or ≥100 kg.CONCLUSIONS Reports of ED associated with antihypertensive drugs exhibit significant heterogeneity across drug types and differences in the distribution of onset times； CCBs have the highest proportion of serious reports； and the relationship between ED risk signals associated with amlodipine， metoprolol， and valsartan and age and body weight also shows marked heterogeneity. |
| 期刊： | 2026年第37卷第18期 |
| 作者： | 刘施；杨鹏；高越；王玉；高申蓉；严劲松 |
| AUTHORS： | LIU Shi，YANG Peng，GAO Yue，WANG Yu，GAO Shenrong，YAN Jinsong |
| 关键字： | 降压药物;勃起功能障碍;高血压;FAERS数据库 |
| KEYWORDS： | antihypertensive drugs;Erectile dysfunction;Hypertension;FAERS database |
| 阅读数： | 1 次 |
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