摘要
目的为临床合理、安全使用降压药物提供参考。方法利用OpenVigil 2.1平台提取美国食品和药物管理局不良事件报告系统(FAERS)2016年1月至2023年12月降压药物肾脏相关不良事件(ADE)报告。采用监管活动医学词典(MedDRA 27.0)的首选语描述ADE,采用报告比值比法和比例报告比值比法挖掘相关信号。结果共纳入10494例报告。其中,低钾血症、肾功能异常、痛风性关节炎、痛风性结晶沉积和尿酸性肾损害分别有8159,1727,446,109,53例,阳性信号数量分别有66,43,27,8,6个;男性患者在除尿酸性肾脏损害外的ADE类别中均多于女性;主要年龄以≥41岁居多;美国是报告各类ADE最多的国家。共42种降压药物显示出肾功能异常阳性信号,涉及利尿剂、α受体拮抗剂、β受体拮抗剂、钙通道阻滞剂、血管紧张素转化酶抑制剂、血管紧张素Ⅱ受体拮抗剂、肾素抑制剂和复方制剂。共8种降压药物显示出痛风性关节炎、痛风性结晶沉积阳性信号,涉及利尿剂、α受体拮抗剂、β受体拮抗剂、血管紧张素转换酶抑制剂、血管扩张剂。共18种药物具有≥3个ADR信号,其不良转归结局基本相似。结论多种降压药物均可导致肾脏相关ADE;降压治疗过程中,需严密监测肾功能异常、低钾血症、痛风性关节炎、痛风性结晶沉积和尿酸性肾损害发生风险,尤其关注产生多种ADE的降压药物。
Objective To provide a reference for the rational and safe use of antihypertensive drugs in clinical practice.Methods The renal-related adverse drug events(ADEs)reports induced by antihypertensive drugs in the FDA Adverse Event Reporting System(FAERS)from January 2016 to December 2023 were extracted by the OpenVigil 2.1 platform.The ADEs were described by the preferred term in the Medical Dictionary for Regulatory Activities(MedDRA 27.0).The relevant signals were mined by the reporting odds ratio and proportional reporting ratio methods.Results A total of 10494 cases of reports were included,among which there were 8159,1727,466,109,53 cases of hypokalemia,renal dysfunction,gouty arthritis,gouty crystal deposition,uric acid-induced kidney damage respectively,with 66,43,27,eight,six positive signals detected respectively;the cases of ADEs in males was more than those in females,except for uric acid-induced kidney damage,the patients aged≥41 years was the most,and the United States was the country that reported the most ADEs.A total of 42 antihypertensive drugs showed positive signals of renal dysfunction,involving diuretics,α-receptor antagonists,β-receptor antagonists,calcium channel blockers,angiotensin-converting enzyme inhibitors,angiotensinⅡreceptor blockers,renin inhibitors and compound preparations.Eight antihypertensive drugs showed positive signals of gouty arthritis and gouty crystal deposition,involving diuretics,α-receptor antagonists,β-receptor antagonists,angiotensin-converting enzyme inhibitors and vasodilators.There were 18 drugs with≥three ADR signals,and the adverse outcomes induced by the drugs were basically similar.Conclusion Multiple antihypertensive drugs can induce the renal-related ADEs.During the antihypertensive therapy,it is necessary to closely monitor the risks of renal dysfunction,hypokalemia,gouty arthritis,gouty crystal deposition and uric acid-induced kidney damage,especially paying attention to the antihypertensive drugs inducing multiple ADEs.
作者
曾丽梅
彭梅
王邓超
ZENG Limei;PENG Mei;WANG Dengchao(The Fourth People's Hospital of Zigong,Zigong,Sichuan,China 643000;Chongqing Red Cross Hospital·Jiangbei District People's Hospital,Chongqing,China 400020)
出处
《中国药业》
CAS
2024年第20期122-125,共4页
China Pharmaceuticals
基金
四川省医学(青年创新)科研课题[Q22071]。
