基于FAERS数据库的替格瑞洛相关不良事件信号检测与分析

Detection and Analysis of Ticagrelor-Related Adverse Event Signals Based on the FAERS Database

目的:挖掘与分析替格瑞洛上市后的药品不良事件信号,为临床安全使用该药提供参考。方法:从美国FDA不良事件报告系统(FAERS)数据库中提取2011年第1季度至2021年第2季度共42个季度的替格瑞洛所致不良事件报告,采用报告比值比法(ROR)和比例报告比值法(PRR)对上述不良事件报告进行数据挖掘与分析。结果:提取到以替格瑞洛为首要怀疑药物的不良事件记录共34 611条,检测到不良事件信号共317个,涉及13 930例次不良事件报告,涉及20个系统和器官分类,其中主要为心脏疾病(3 269例,占23.47%),呼吸系统、胸及纵隔疾病(3 014例,占21.64%)和全身性疾病及给药部位各种反应(1 407例,占10.10%)。发生频次较高的不良事件信号与药品说明书总体一致;未在药品说明书中提及的、临床需关注的信号主要有血压升高、记忆受损、感受异常、听力减退和室性心律等。结论:使用替格瑞洛时,除了常见的呼吸系统、出血等不良反应外,其他少见的严重不良反应如颅内出血、心动过缓和潮式呼吸也应得到临床重视。

OBJECTIVE: To explore and analyze the adverse event signals of ticagrelor after the listing, and provide reference for the safe clinical use of the drug. METHODS: From the US Food and Drug Administration Adverse Event Reporting System(FAERS) database, 42 quarters of adverse event reports due to ticagrelor were extracted from the first quarter of 2011 to the second quarter of 2021. The data mining and signal detection were performed by reporting odds ratio(ROR) and proportional reporting ratio(PRR). RESULTS: A total of 34 611 adverse event records with ticagrelor as the primary suspected drugs were extracted, and a total of 317 adverse event signals were detected, including 13 930 adverse event reports in 20 system and organ classifications, among which cardiac diseases(3 269 cases, 23.47%), respiratory system, thoracic and mediastinal diseases(3 014 cases, 21.64%) and systemic diseases and various reactions at the administration site(1 407 cases, 10.10%) took the lead. The frequency of adverse event signals was generally consistent with the drug instructions. Signals that were not mentioned in the drug instructions and required clinical concern included: increased blood pressure, memory impairment, abnormal sensation, hearing loss and ventricular rhythm. CONCLUSIONS: When using ticagrelor, in addition to the common respiratory and bleeding adverse drug reactions, other rare severe adverse drug reactions such as intracranial hemorrhage, bradycardia and tidal breathing should also receive clinical attention.