中国药物警戒 ›› 2025, Vol. 22 ›› Issue (3): 286-291.
DOI: 10.19803/j.1672-8629.20240675

• 安全与合理用药 • 上一篇    下一篇

基于自发呈报系统的降压药和降糖药不良反应分析

廖梦凡1,4, 钟利玲1, 许燕2, 刘颖2, 张业象2, 陈青松1,3,4#, 刘旭东1,4,*   

  1. 1广东药科大学公共卫生学院,广东 广州 510310;
    2广东省药品不良反应监测中心,广东 广州 510080;
    3广东省公共卫生检测与评价工程技术研究中心,广东 广州 510310;
    4国家药监局药物警戒技术与评价重点实验室,广东 广州 510310
  • 收稿日期:2024-08-30 出版日期:2025-03-15 发布日期:2025-03-17
  • 通讯作者: *刘旭东,男,博士,副教授,慢性病流行病学与分子流行病学。E-mail: xdliu.cn@hotmail.com;#为共同通信作者。
  • 作者简介:廖梦凡,女,在读硕士,疾病预防与控制。
  • 基金资助:
    广东省药品监督管理局2024科技创新项目（2024ZDZ10）;广东省药品监督管理局2022科技创新项目（2022ZDZ06）

Adverse Reactions to Antihypertensive and Hypoglycaemic Drugs Based on Spontaneous Presentation Systems

LIAO Mengfan1,4, ZHONG Liling1, XU Yan2, LIU Ying2, ZHANG Yexiang2, CHEN Qingsong1,3,4#, LIU Xudong1,4,*   

  1. 1School of Public Health, Guangdong Pharmaceutical University, Guangzhou Guangdong 510310, China;
    2Guangdong ADR Monitoring Center, Guangzhou Guangdong 510080, China;
    3Guangdong Provincial Engineering Technology Research Center for Public Health Detection and Evaluation, Guangzhou Guangdong 510310, China;
    4National Medical Products Administration Key Laboratory of Pharmacovigilance Technology and Evaluation, Guangzhou Guangdong 510310, China
  • Received:2024-08-30 Online:2025-03-15 Published:2025-03-17

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摘要： 目的 分析降压药和降糖药引起的药品不良反应（Adverse Drug Reaction, ADR）,为临床合理用药提供参考。方法 对2020年9月1日至2022年8月31日广东省ADR自发呈报系统中广东省常用降压药和降糖药所致的ADR报告进行分析并评估严重ADR发生的影响因素。结果 共纳入6 113例ADR报告,涉及9 207例次。女性和中老年患者占比较大。一般和严重ADR分别占90.22%和9.78%。新的ADR 844例（13.81%）。ADR主要涉及胃肠系统、全身性和皮肤及其附件,钙通道阻滞剂类药物和双胍类药物的发生频次较高。不同类别药物所致ADR各具特点,其中血管紧张素转换酶抑制药以呼吸系统损害为主,双胍类药物以胃肠系统损害为主。ADR主要发生在患者用药后2~7 d（29.45%）及30 d后（40.95%）,绝大多数患者均能得到好转（58.23%）和痊愈（35.25%）。原患疾病数量≥2种、有吸烟史、ADR诱导时间>7 d的患者发生严重ADR的风险更高。结论 降压药和降糖药导致的ADR在年龄、性别、累及系统-器官和药物种类等方面存在差异;严重ADR的发生与其性别、原患疾病、吸烟史和ADR诱导时间以及是否为新的ADR有关。建议医护人员在实践中针对不同药物所致ADR特点采取针对性预防措施,在用药后的关键时间点加强对患者的监测和评估,及时发现并处理潜在的ADR,保障患者用药安全。

关键词: 高血压, 糖尿病, 降压药, 降糖药, 药品不良反应, 胃肠系统

Abstract: Objective To analyze the reports of adverse drug reactions(ADR) caused by antihypertensive and hypoglycemic drugs so as to provide a reference for rational clinical use of drugs. Methods The ADR reports related to commonly-used antihypertensive and hypoglycemic drugs collected by the Guangdong ADR self-reporting system between September 1, 2020 and August 31, 2022 were analyzed, and the influential factors for the occurrence of severe ADR were identified. Results A total of 6 113 ADR reports involving 9 207 clinical cases were included. Females and middle-aged and elderly patients accounted for a large proportion. Mild ADR and severe ones accounted for 90.22% and 9.78% respectively. In addition, there were 844 new ADR (13.81%). ADR mostly involved the gastrointestinal system and the skin and its accessories or were systemic, with calcium channel blocker drugs and biguanides as the leading cause. ADR caused by different drugs varied. Most of these ADR occurred 2 to 7 days (29.45%) and 30 days (40.95%) after medication, and the majority of the patients improved (58.23%) or recovered (35.25%). Patients with two or more types of primary diseases, smoking history, and ADR induction time of over 7 days were at higher risk of severe ADR. Conclusion The ADR caused by commonly-used drugs for diabetes and hypertension vary, depending on age, gender, organs involved and types of drugs. It is recommended that clinicians take precautions, monitor and assess patients at critical time points after medication in order to detect potential ADR quickly to keep patients safe.

Key words: Hypertension, Diabetes, Anti-Hypertensive Drugs, Hypoglycemic Drugs, Adverse Drug Reaction, Gastrointestinal System

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