瑞卢戈利心血管安全风险信号的挖掘与评价  

Mining and evaluation of relugolix-related cardiovascular safety signals

作　　者：林永春[1] 蒙龙[2] 郑佳峻 蒋慧明 LIN Yongchun;MENG Long;ZHENG Jiajun;JIANG Huiming(Dept.of Clinical Pharmacy,Central People’s Hospital of Zhanjiang,Guangdong Zhanjiang 524037,China;Dept.of Pharmacy,the First Affiliated Hospital of Chongqing Medical University,Chongqing 400016,China;School of Big Data&Software Engineering,Chongqing University,Chongqing 401331,China)

机构地区：[1]湛江中心人民医院临床药学科,广东湛江524037 [2]重庆医科大学附属第一医院药学部,重庆400016 [3]重庆大学大数据与软件学院,重庆401331

出　　处：《中国药房》2024年第18期2278-2282,共5页China Pharmacy

基　　金：重庆市科卫联合医学科研项目(No.2023QNXM039)。

摘　　要：目的挖掘瑞卢戈利的心血管安全风险信号,为该药在我国上市及未来的临床安全用药评估提供参考。方法收集美国FDA不良事件报告系统(FAERS)中2021年第1季度至2023年第3季度以瑞卢戈利为主要/次要怀疑药物的不良事件(AE)报告,采用报告比值比(ROR)法进行数据挖掘。利用《国际医学用语词典》(MedDRA)24.0版中的首选术语(PT)对药物AE名称进行编码;采用狭义标准MedDRA查询(SMQ)术语和高位语(HLT)术语定义和分析目标AE。分别通过以瑞卢戈利为主要/次要怀疑药物或与药物相互作用、伴随使用药物有关的AE和广义SMQ术语进行敏感性分析。结果共得到瑞卢戈利AE报告4354份。得到狭义SMQ术语9个,含异常血脂症、高血糖症/新发糖尿病2个阳性信号;得到HLT术语11个,含胆固醇各项分析、甘油三酯分析和各种高血糖状况(不另分类)3个阳性信号。敏感性分析结果显示,上述研究结果可靠。结论瑞卢戈利存在高血脂和高血糖风险信号,但未发现高血压、心脏病和脑卒中等风险信号。临床在使用瑞卢戈利时,需关注患者的高血脂、高血糖AE。OBJECTIVE To mine the cardiovascular safety signal of relugolix,and provide a reference for the listing of this drug in China and future clinical safety drug evaluation.METHODS The adverse event(AE)report data of relugolix,as the primary or secondary suspected drug,was collected from the FDA Adverse Event Reporting System(FAERS)from the first quarter of 2021 to the third quarter of 2023.The reporting odds ratio(ROR)method was used for data mining.The AEs in the FAERS database were identified and coded using preferred terms(PT)stated in version 24.0 of the Medical Dictionary for Drug Regulatory Activities(MedDRA).The AEs of the target drug were identified by the narrow standardized MedDRA query(SMQ)terms and high-level term(HLT).Sensitivity analysis was conducted using AEs suspected to be primarily or secondarily related to relugolix or related to drug interaction and concomitant drug,and broad SMQ terms.RESULTS A total of 4354 relugolix-related AE reports were extracted.In the primary analysis,nine SMQ terms were analyzed,involving 2 positive signals such as dyslipidemia and hyperglycemia/new onset diabetes mellitus.Eleven HLTs were analyzed,and three positive signals were detected for three terms including cholesterol analyses,triglyceride analyses and hyperglycemia conditions(non-alternative analysis).Sensitivity analysis results indicated the reliability of the study findings.CONCLUSIONS Relugolix may induce risk signals related to high blood lipids and high blood glucose,but no moderate risk signals such as hypertension,heart disease,and stroke are found.During relugolix treatment in clinical practice,attention must be paid to hyperlipidemia and hyperglycemia-related AE.

关 键 词：瑞卢戈利 促性腺激素释放激素拮抗剂 不良事件 心血管事件 高血脂 高血糖 

分 类 号：R969.3[医药卫生—药理学]