基于报告比值比法对十一酸睾酮不良反应事件警戒信号的挖掘与评价

Vigilance signals of adverse reaction events on testosterone undecanoate:a study of mining and evaluation based on reporting odds ratio method

目的基于报告比值比法对十一酸睾酮不良反应事件进行警戒信号挖掘与评价。方法通过美国食品药品监督管理局公共数据公开项目的药品不良反应数据库,检索2004年1月至2021年7月十一酸睾酮不良反应事件报告情况,采用报告比值比法进行警戒信号挖掘。结果共检索到十一酸睾酮不良反应事件报告19466例,以男性、成年人(18~64岁)、口服给药为主;有32.23%的患者用药适应证不明确,在用药适应证前10位中,有6种用药适应证不属于说明书推荐范畴。共挖掘到十一酸睾酮不良反应事件警戒信号51个,涉及11个系统器官分类,主要系统器官分类为生殖系统疾病、心血管疾病、精神疾病及呼吸道、胸、纵隔疾病等,主要表现为梗死、深静脉血栓形成、睡眠呼吸暂停综合征、急性心肌梗死、肺栓塞。结论通过美国食品药品监督管理局公共数据公开项目的药品不良反应数据库对十一酸睾酮不良反应事件的警戒信号进行全面分析与挖掘,有助于提高医务人员对十一酸睾酮不良反应的认识。建议在临床上使用十一酸睾酮时,尤其是在合并心血管基础疾病的人群中使用该药时,应警惕心血管不良反应事件的发生。

Objective To perform the vigilance signals mining and evaluation of adverse reaction events on testosterone undecanoate based on reporting odds ratio method.Methods The reported states of adverse reaction events of testosterone undecanoate from January 2004 to July 2021 were retrieved from the drug adverse reactions database of the US Food and Drug Administration Public Data Open Project,and the vigilance signals mining was performed by using reporting odds ratio method.Results A total of 19466 reports of adverse reaction events related to testosterone undecanoate were retrieved,and most of them were males,adults(age from 18 to 64 years old),and oral administration.There were 32.23%of patients with unclear indications for medication,and 6 of the top 10 indications for medication did not fall within the recommended category of instructions.A total of 51 vigilance signals of testosterone undecanoate adverse reaction events were found,involving 11 system organ classifications,and the main system organ classifications were reproductive system diseases,cardiovascular diseases,mental diseases,and respiratory,thoracic and mediastinal disorders,etc.,manifesting as infarction,deep vein thrombosis,sleep apnoea syndrome,acute myocardial infarction,and pulmonary embolism.Conclusion Performing comprehensive analysis and mining on vigilance signals of adverse reaction events on testosterone undecanoate by the drug adverse reactions database of the US Food and Drug Administration Public Data Open Project can facilitate the awareness on adverse reactions of testosterone undecanoate for medical staff.It is suggested that precaution should be paid to the occurrence of cardiovascular adverse reaction events when using testosterone undecanoate in clinics,especially in population with concomitant basic cardiovascular diseases.