基于FDA不良事件报告系统数据库的3种二氢吡啶类钙通道阻滞剂不良反应信号比值失衡分析  

Adverse reaction signal ratio imbalance analysis of three dihydropyridine calcium channel blockers based on the FDA Adverse Event Reporting System(FAERS)database

作　　者：王惠铎 郭浩 杨宏昕 WANG Huiduo;GUO Hao;YANGHongxin(the School of Pharmaceutical Sciences,Baotou Medical College,Inner Mongolia Autonomous Region Baotou 014040,China;Department of Pharmacy,Inner Mongolia Autonomous Region People's Hospital,Hohhot 010010,China)

机构地区：[1]包头医学院药学院,内蒙古自治区包头014040 [2]内蒙古自治区人民医院药学处,呼和浩特010010

出　　处：《临床药物治疗杂志》2025年第1期77-81,共5页Clinical Medication Journal

基　　金：内蒙古自治区人民医院院内基金(2020YN23)。

摘　　要：目的 基于FDA不良事件报告系统(FAERS)数据库获取氨氯地平、硝苯地平、非洛地平3种二氢吡啶类钙通道阻滞剂(DHP-CCB)上市后的药品不良反应(ADR)信号,为临床合理用药提供参考。方法 检索FAERS数据库,收集自2004年1月至2023年12月,以上述3种DHP-CCBs为首要怀疑药物的ADR报告。对ADR发生例数进行描述性统计,并采用报告比值比法(ROR)和比例报告比值法(PRR)行信号筛选。结果 检索到氨氯地平ADR报告45 206例、硝苯地平5604例、非洛地平747例。3种药物报告频次前20位的ADR中均包括低血压、外周水肿、头晕、头痛、呼吸困难、恶心等,且被说明书收录。信号强度前20位的ADR中,氨氯地平主要累及的系统器官分类(SOC)为心脏器官疾病(3个)和皮肤及皮下组织类疾病(3个),信号最强的首选术语(PT)为非心源性肺水肿;硝苯地平主要累及的SOC为妊娠期、产褥期及围产期状况(10个),信号最强的PT为胎儿心动过缓;非洛地平主要累及的SOC为胃肠系统疾病(4个)和血管与淋巴管类疾病(4个),信号最强的PT为牙龈肥大;氨氯地平、硝苯地平、非洛地平3种药品分别检出说明书未收录的阳性信号19、18、10个。结论 不同DHP-CCBs的ADR信号特征存在差异;孕产妇使用硝苯地平时应谨慎评估其风险与获益。Objective The adverse drug reaction(ADR)signals of three dihydropyridine calcium channel blockers(DHP-CCBs)were extracted from the FDA Adverse Event Reporting System(FAERS)database to provide a reference for guiding rational clinical drug use.Methods The FDA Adverse Event Reporting System database was searched,and the ADR reports for three DHP-CCBs drugs as the primary suspect drugs were collected from January 2004 to December 2023.The number of ADR cases was analyzed using descriptive statistics,and signal detection was performed using the report odds ratio(ROR)and proportional report ratio(PRR)methods.Results A total of 45,206 ADR reports were identified for amlodipine,5,604 for nifedipine,and 747 for felodipine.Among the top 20 ADRs by frequency,hypotension,peripheral edema,dizziness,headache,dyspnea,and nausea were common to all the three drugs and were consistent with their package inserts.Among the top 20 ADRs by signal strength,the primary System Organ Classes(SOCs)for amlodipine were cardiac disorders(3)and skin and subcutaneous tissue disorders(3),with the strongest signal Preferred Term(PT)being non-cardiogenic pulmonary edema.For nifedipine,the main SOCs were pregnancy,puerperium and perinatal conditions(10),with the strongest signal PT being fetal bradycardia.For felodipine,the primary SOCs were gastrointestinal disorders(4)and vascular disorders(4),with the strongest signal PT being gingival hypertrophy.Additionally,amlodipine,nifedipine and felodipine generated 19,18 and 10 positive signals,respectively,that were not included in their prescribing information.Conclusion The ADR signal characteristics of different DHP-CCBs vary.The risks and benefits of nifedipine should be carefully evaluated when used in pregnant women.

关 键 词：氨氯地平 硝苯地平 非洛地平 FDA不良事件报告系统 药物不良事件 药物不良反应 

分 类 号：R969.3[医药卫生—药理学] R972.4[医药卫生—药学]