基于FAERS的α1受体拮抗剂相关性功能障碍不良事件数据挖掘研究

目的：基于美国FDA不良事件报告系统（FAERS）大数据，对肾上腺素能α₁受体拮抗剂（α₁RA）相关性功能障碍不良事件进行数据挖掘，为临床安全使用α₁RA提供参考。方法：下载2004Q1至2018Q4共60个季度的FAERS数据，经过MedEx药品名称标准化、MedDRA不良事件系统分类等数据清洗后，提取α₁RA相关性功能障碍不良事件，采用比例报告比值法（PRR）和报告比值比法（ROR）进行信号检测。结果：共提取到α₁RA相关性功能障碍不良事件报告记录1651条，其中坦索罗辛1075条（1.76%）、特拉唑嗪164条（1.47%）、赛洛多辛158条（5.16%）、阿呋唑嗪134条（1.57%）和多沙唑嗪120条（0.72%）。6个HLTs检索到ADEs报告，5种α₁RAs在"勃起和射精状态和障碍"均提示信号，坦索罗辛和赛洛多辛在"性欲障碍类"提示信号，特拉唑嗪在"性功能障碍"提示信号，坦索罗辛、赛洛多辛和阿呋唑嗪在"性高潮障碍和失调"提示信号，坦索罗辛和赛洛多辛在"精子发生和精液疾病"提示信号。报告超过100例的不良事件有："勃起功能障碍" 722例（0.72%）、"射精障碍"596例（0.59%）、"性欲障碍"295例（0.29%）、"勃起增强"211例（0.21%）、"性功能障碍"200例（0.20%），均以坦索罗辛报告数最多。结论：应警惕α₁RA相关性功能障碍不良事件风险。

Datamining and analysis of alpha-1 receptor antagonists related adverse events of sexual dysfunctions based on FAERS

OBJECTIVE To detect and analyze signals of adrenergic alpha-1 receptor antagonists (α₁RA) related adverse events of sexual dysfunctions through data mining methods based on FAERS big data.METHODS FAERS data of 60 quarters from 2004Q1 to 2018Q4 were downloaded.After data cleaning such as MedEx drug name standardization and MedDRA adverse event system classification,α₁RA-related dysfunction adverse events were extracted and signal detection was performed using proportional reporting ratio (PRR) and reporting ratio ratio (ROR).RESULTS A total of 1651 sexual dysfunction events of the five α₁RAs were gathered,including 1075 (1.76%) reports for tamsulosin,164 (1.47%) reports for terazosin,158 (5.16%) reports for silodosin,134 (1.57%) reports for alfuzosin and 120 (0.72%) reports for doxazosin.Adverse events reports were detected in 6 HLTs domains.All the five α₁RAs had signal detected in "erection and ejaculation conditions and disorders",other drugs and signals detected were:tamsulosin,silodosin and "sexual desire disorders";terazosin and "sexual dysfunction NEC";tamsulosin,silodosin,alfuzosin and "orgasmic disorders and disturbances";tamsulosin,silodosin and "spermatogenesis and semen disorders".The following PT had more than 100 reports:"erectile dysfunction" 722 reports (0.72%)、"ejaculation disorder" 596 reports (0.59%)、"libido disorder" 295 reports (0.29%)、"erection increased" 211 reports (0.21%)、"sexual dysfunction" 200 reports (0.20%),tamsulosin had the most reports in each PT.CONCLUSION It is suggested that sexual dysfunctions attributed to α₁RAs should be paid more attention.