3类心血管疾病治疗药物肾脏安全性药物警戒研究  

Kidney Safety of Three Types of Drugs for Cardiovascular Disease:A Pharmacovigilance Study

作　　者：方振威 柏杨 王棋 李玉文 FANG Zhenwei;BAI Yang;WANG Qi;LI Yuwen(West China Hospital,Sichuan University·West China Clinical Medical College,Sichuan University,Chengdu,Sichuan,China 610041)

机构地区：[1]四川大学华西医院·四川大学华西临床医学院,四川成都610041

出　　处：《中国药业》2024年第12期45-49,共5页China Pharmaceuticals

基　　金：国家重点研发计划课题[2020YFC2008302]。

摘　　要：目的为临床心血管疾病(CVD)治疗药物的选择提供参考。方法检索美国食品和药物管理局不良事件报告系统(FAERS)2004年至2021年收到的血管紧张素受体脑啡肽酶抑制剂(ARNI)、血管紧张素转化酶抑制剂(ACEI)和血管紧张素Ⅱ受体拮抗剂(ARB)相关肾损伤药品不良事件(ADE)报告,采用报告比值比(ROR)法和信息成分(IC)法挖掘并分析ADE信号。结果ACEI,ARB,ARNI的相关肾损伤病例分别有13155例、12623例、2411例,3类药物均挖掘出了急性肾损伤(AKI)、慢性肾脏病(CKD)阳性信号。与ACEI及ARB相比,ARNI相关AKI和CKD的阳性信号更强,且ARNI相关AKI病例的死亡构成比(18.31%比13.05%,P<0.05;18.31%比10.53%,P<0.05)和CKD病例的死亡构成比(23.50%比19.78%,P<0.05;23.50%比11.41%,P<0.05)均显著更高。结论与ACEI和ARB相比,ARNI相关AKI和CKD的发生风险可能更高。Objective To provide a reference for the selection of drugs for cardiovascular disease(CVD)in clinical practice.Methods The kidney injury-related adverse drug events(ADEs)induced by angiotensin receptor-neprilysin inhibitors(ARNIs),angiotensin-converting enzyme inhibitors(ACEIs)and angiotensinⅡreceptor blockers(ARBs)in the FDA Adverse Event Reporting System(FAERS)from 2004 to 2021 were searched,the reporting odds ratio(ROR)and information component(IC)methods were used to mine and analyze ADE signals.Results There were 13155,12623 and 2411 cases of kidney injury induced by ACEIs,ARBs and ARNIs respectively.Positive signals for acute kidney injury(AKI)and chronic kidney disease(CKD)were detected in all the three drugs.Compared with those induced by ACEIs and ARBs,the positive signals of AKI and CKD induced by ARNIs were stronger,the mortality composition ratios of patients with AKI(18.31%vs.13.05%,P<0.05;18.31%vs.10.53%,P<0.05)and CKD(23.50%vs.19.78%,P<0.05;23.50%vs.11.41%,P<0.05)induced by ARNIs were significantly higher.Conclusion Compared with ACEIs and ARBs,ARNIs may have a higher risk of AKI and CKD.

关 键 词：血管紧张素受体脑啡肽酶抑制剂 血管紧张素转化酶抑制剂 血管紧张素Ⅱ受体拮抗剂 肾损伤 药品不良事件 美国食品和药物管理局不良反应事件报告系统 用药安全 信号挖掘 

分 类 号：R969.4[医药卫生—药理学] R972[医药卫生—药学]