中国药物警戒 ›› 2020, Vol. 17 ›› Issue (8): 502-507.
DOI: 10.19803/j.1672-8629.2020.08.11

• 安全与合理用药 • 上一篇    下一篇

血管紧张素转化酶抑制剂/血管紧张素受体拮抗剂类药品不良反应/事件报告分析

何桂林1, 左丽2, 陈佳音1, 周学琴1, 王茜2,*   

  1. 1北京大学深圳医院药学部,广东 深圳 518036;
    2深圳市药物警戒和风险管理研究院,广东 深圳 518036
  • 收稿日期:2020-07-31 修回日期:2020-07-31 出版日期:2020-08-15 发布日期:2020-07-31
  • 通讯作者: *王茜,女,本科,主管药师,药品不良反应监测与药物警戒。E-mail：26747816@qq.com
  • 作者简介:何桂林,女,博士,主管药师,临床药学与药品不良反应。

Adverse Drug Reactions/Events Induced by ACEI/ARB

HE Guilin1, ZUO Li2, CHEN Jiayin1, ZHOU Xueqin1, Wang Qian2,*   

  1. 1Department of Pharmacy, Peking University Shenzhen Hospital, Shenzhen Guangdong 518036, China;
    2Department of Drug Monitoring, Shenzhen Institute of Pharmacovigilance and Risk Management, Shenzhen Guangdong 518036, China
  • Received:2020-07-31 Revised:2020-07-31 Online:2020-08-15 Published:2020-07-31
  • Supported by:
    深圳市卫生计生系统科研项目资助（SZFZ2017050）

PDF (PC)

151

摘要： 目的 分析血管紧张素转换酶抑制剂（ACEI）/血管紧张素受体拮抗剂（ARB）类药品不良反应/事件的发生特点及规律,为临床安全、合理用药提供参考。方法 对深圳市2014年1月1日至2017年12月31日间上报的32 068份药品不良反应/事件（ADR/AE）报告筛选出怀疑ACEI/ARB类药物的病例报告进行统计分析,共筛选出83例怀疑ACEI类药物、68例怀疑ARB类药物所致的ADR/AE报告。结果 两类药物所致ADR/AE男女比例无明显差异,年龄大者更易发生ADR/AE（ACEI≥40岁占89.16%,ARB≥40岁占89.71%）;两类药物所致ADR/AE均多发生在1~7 d内（ACEI、ARB分别为72.29%、85.29%）;ACEI类ADR/AE以呼吸系统多见（60.19%）,ARB类ADR/AE涉及系统-器官及不良反应表现多样化,以神经系统多见（30.48%）,且新的（ARB 15.88%,ACEI 7.77%）及严重的（ARB 6.54%,ACEI 2.91%）不良反应所占比例更高;ACEI类药物ADR/AE中,培哚普利（36.89%）、贝那普利（21.36%）、依那普利（21.36%）报告较多,ARB报告多为缬沙坦（42.06%）、厄贝沙坦（28.04%）及氯沙坦（17.76%）;ACEI和ARB导致的ADR/AE均较轻微,易于好转和治愈。结论 临床医师和药师在患者开始使用ACE I/ARB类药物一周内,应加强关注其不良反应,密切监测呼吸系统及神经系统等不良反应,及时鉴别、干预两类药物所致的不良反应,避免严重ADR/AE的发生。

关键词: 血管紧张素转换酶抑制剂, 血管紧张素受体拮抗剂, 药品不良反应/事件

Abstract: Objective To analyze the regularities and characteristics of adverse drug reactions/events(ADR/AE) caused by angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers(ARBs) in order to provide reference for rational drug use in the clinic. Methods Cases of ADR/AE caused by ACEI and ARB were screened and analyzed statistically from a total of 32 068 cases of ADR/AE reported in Shenzhen between 2014.1.1 and 2017.12.31. Eighty-three cases of ADR/AE caused by ACEI and 63 caused by ARB were screened out. Results There was no significant difference between males and females in the incidence of ADRs/ADEs caused by the two types of drugs, but the elders were more vulnerable to ADR/AE (for ACEI, those≥40 years old accounted for 89.16% of the cases, compared with 89.71% for ARB). The onset time of most ADR/AE associated with ACEI(72.29%) and ARB(85.29%) was within 1 to 7 days after oral medicine. The main manifestations of adverse effects by ACEI involved the respiratory system(60.19%). The involved organs/systems and manifestations by ARB outnumbered those of ACEI, and adverse drug reactions associated with the nervous system(30.48%) were common. New (ARB 15.88% vs ACEI 7.77%) and serious (ARB 6.54% vs ACEI 2.91%) ADRs/ADEs caused by ARB accounted for a high proportion. The ADRs/ADEs were related to six drug categories, respectively. The top three drug categories of ACEI were perindopril (36.89%), benapril (21.36%), and enapril (21.36%), compared with valsartan (42.06%), irbesartan (28.04%) and losartan (17.76%) for ARB. Most of the manifestations of adverse effects by ACEI and ARB were mild and had good prognosis. Conclusion Clinicians and clinical pharmacists should be alert to ADR/ADE induced by ACEI and ARB within a week of administration. ADR/AE caused by the two kinds of drugs should be distinguished and intervened in as early as possible in order to prevent serious ADR/AE

Key words: angiotensin converting dnzyme inhibitors(ACEI), Angiotensin Receptor Blockers(ARB), adverse drug reaction/adverse event(ADR/AE)

中图分类号: