首页|3类心血管疾病治疗药物肾脏安全性药物警戒研究

3类心血管疾病治疗药物肾脏安全性药物警戒研究

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  • 国家科技期刊平台
  • NETL
  • NSTL
  • 万方数据
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 13 155 例、12 623 例、2 411 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。
Kidney Safety of Three Types of Drugs for Cardiovascular Disease:A Pharmacovigilance Study
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 angiotensin Ⅱ receptor 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 13 155,12 623 and 2 411 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.

angiotensin receptor-neprilysin inhibitorangiotensin-converting enzyme inhibitorangiotensin Ⅱ receptor blockerkidney injuryadverse drug eventFDA Adverse Event Reporting Systemmedication safetysignal mining

方振威、柏杨、王棋、李玉文

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四川大学华西医院·四川大学华西临床医学院,四川 成都 610041

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

国家重点研发计划

2020YFC2008302

2024

10.3969/j.issn.1006-4931.2024.12.011

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子：1.369
ISSN：1006-4931
年,卷(期)：2024.33(12)