基于OpenFDA数据库的沙库巴曲缬沙坦不良事件报告信号挖掘与分析

Signal Mining and Analysis of Adverse Event Reports of Sacubitril Valsartan Based on OpenFDA Database

目的促进临床安全使用沙库巴曲缬沙坦。方法检索美国食品和药物管理局公共数据开放项目(OpenFDA)2015年7月7日至2023年8月2日沙库巴曲缬沙坦药品不良事件(ADE)报告,采用报告比值比(ROR)法进行风险信号挖掘,并以监管活动医学词典的系统器官分类(SOC)法进行统计与分析。结果共检索到相关ADE报告97574例,发生群体男性较多;老年患者发生比例较高;上报国家以美国最多;一般和严重ADE分别占51.55%和48.45%;明确记录转归情况的报告中,25.68%的患者出现死亡,23.11%的患者未恢复。共挖掘出70个阳性信号,涉及15个SOC,全身性疾病及给药部位各种反应的信号数量最多(16个),精神疾病、耳及迷路疾病2个SOC及31个风险信号未被药品说明书收录。结论沙库巴曲缬沙坦常见ADE信号与药品说明书基本一致,但还应关注药品说明书中未收录的风险,如肺水肿、胸痛、胸部不适,射血分数下降等,以进一步保证患者的用药安全。

Objective To promote the safe use of sacubitril valsartan in clinical practice.Methods The adverse drug event(ADE)reports of sacubitril valsartan in the US Food and Drug Administration Public Data Open Project(OpenFDA)from July 7,2015 to August 2,2023 were extracted.The risk signals were mined by the reporting odds ratio(ROR)method,and the mined signals were analyzed by the system organ classification(SOC)of the Medical Dictionary for Regulatory Activities(MedDRA).Results A total of 97574 cases of ADE reports were searched,and the population was mainly male,with a higher proportion of elderly patients;the majority of reporters came from the United States;the general and severe ADEs accounted for 51.55%and 48.45%,respectively;in the reports that the outcome was clearly recorded,25.68%of patients died,and 23.11%did not recover.A total of 70 positive signals were mined,involving 15 SOCs,with the highest number of signals(16 signals)for general disorders and various reactions at the site of administration;two SOCs(psychiatric disorders,ear and labyrinth disorders)and 31 risk signals were not recorded in the drug instruction.Conclusion The common ADE signals of sacubitril valsartan are basically consistent with those in the drug instruction,but we should pay attention to the risks not recorded in the drug instruction(such as pulmonary edema,chest pain,chest discomfort,decreased ejection fraction and so on)to further ensure the patients′medication safety.