基于openFDA数据对阿贝西利不良事件的信号检测与分析

Signal detection and analysis of the adverse events induced by abemaciclib based on openFDA

目的:基于openFDA数据分析阿贝西利的不良事件报告,为临床安全用药提供参考。方法:通过访问openFDA药物不良事件端点,检索2018年2月26日至2021年9月15日期间阿贝西利的不良事件报告并进行描述性统计分析,采用报告比值比(reporting odds ratio,ROR)法和比例报告比值法(proportional reporting ratio,PRR)2种方法,按药物不良反应术语集的首选系统器官分类(system organ classification,SOC)和首选术语(preferred term,PT)对阿贝西利的不良事件(adverse events,AE)进行分类并挖掘可疑风险信号。结果:检索时段中阿贝西利的不良事件报告共4734份,患者首发AE年龄平均为63.55岁,集中在50~74岁;女性患者占绝大部分;主要上报国家是美国;消费者或非健康专业人员为主要上报人;适应证多为乳腺癌;严重不良事件占44.70%。根据阳性标准共筛选出45个不良反应风险信号,涉及11个SOC分类。腹泻、肺炎、间质性肺病、血肌酐增加、肝功能异常和白细胞减少症等25个信号较强,另外说明书未提及的治疗改变、乳腺癌转移、疾病进展、脱水和肝病等20个可疑信号需给予关注。结论:对阿贝西利真实世界的不良事件数据进行挖掘,有助于发现潜在不良反应风险信号,提示临床除关注说明书提及的不良反应外,对说明书未提及的信号应引起重视,并采取干预措施,保障患者用药安全。

OBJECTIVE To research and analyze the adverse event reports of abemaciclib based on openFDA, so as to provide reference for rational drug use in clinic.METHODS The adverse events of abemaciclib were collected from February 26, 2018 to September 15, 2021 through visiting the API sample panel of the openFDA. The data of abemaciclib were analyzed by descriptive statistics, and the risk signals were mined by the method of reporting odds ratio(ROR) and proportional reporting ratio(PRR). Adverse events of abemaciclib were classified according to the preferred system organ classification and preferred term, and suspected risk signals were mined. RESULTS A total of 4 734 reports of adverse events related to abemaciclib were retrieved. The average age of patients in first-episode AE was 63.55 years old, and the age was mostly from 50 to 74 years;the main drug use population was female;the main reporting country was the United States;consumers or non-health professionals were the main informants;breast cancer was the main indication and the serious adverse events accounted for 44.70 %. Totally 45 suspicious risk signals of adverse drug reactions were detected, which involved 11 kinds of SOC according to the screening conditions. A total of 25 adverse drug reactions listed in package insert were with enhanced signals, including diarrhea, pneumonia, interstitial lung disease, serum creatinine rise, abnormal hepatic function and leukopenia, etc. In addition, a total of 20 suspicious signals were not mentioned in the existing instructions, such as therapy change, malignant tumor development, dehydration, hypokalemia and liver disorder.CONCLUSION Using real-word data for assessing the potential adverse drug reactions of abemacilib may help to monitor specific adverse events. Not only the ADRs mentioned in drug instructions, but also the ADRs not listed in drug instructions should be paid attention to ensure the safety and effectiveness of drug in clinic.