中国药物经济学2025，Vol.20Issue(12)：28-32,5.DOI:10.12010/j.issn.1673-5846.2025.12.006
基于中国医院药物警戒系统分析传统/新型抗凝血药物的临床安全性
Assessment of Clinical Security of Conventional/novel Anticoagulants Using China Hospital Pharmacovigilance Strategy
摘要
Abstract
Objective To evaluate the clinical safety of traditional/new anticoagulant drugs based on Chinese hospital pharmacovigilance system(CHPS).Methods Based on the active monitoring and drug evaluation functions of CHPS,the electronic medical records of adverse drug reactions(ADR)using traditional/new anticoagulant drugs in Guangxi Zhuang Autonomous Region Brain Hospital from June 2020 to December 2021 were retrospectively selected,and statistical analysis was carried out according to the types of anticoagulant drugs.We statistically analyzed the occurrence status of ADRs such as liver and kidney function damage,bleeding,and abnormal coagulation function.Results A total of 1,1960 ADR reports related to anticoagulant drugs were collected.Among them,there were more male patients than female patients(male∶female=1.37∶1),with an average age of(66.03±12.75)years.The age group of 70-79 years had the highest proportion,with 558 cases(28.47%).Among all the ADR reports,aspirin had the largest number of reports(598 cases),followed by heparin(488 cases),and dabigatran etexilate had the fewest(7 cases).Bleeding accounted for 45.75%of all ADRs,followed by other ADRs(29.37%),including allergic reactions in the skin,respiratory tract,gastrointestinal tract and cardiovascular system,as well as various neurological and endocrine system symptoms.Abnormal coagulation function accounted for 18.34%,and liver and kidney function damage caused by anticoagulant drugs was the lowest(6.54%).The main ADR manifestations of monoclonal antibodies,bispecific antibodies and trispecific antibodies are bleeding.Among them,the bleeding rate of monoclonal antibody application is lower than that of bispecific antibodies and trispecific antibodies.Conclusion The use of traditional/new anticoagulant drugs carries the risk of inducing serious ADRs such as liver and kidney function damage,bleeding,and abnormal coagulation function.In clinical medication,it is necessary to strengthen the monitoring and management of ADRs caused by anticoagulant drugs.关键词
中国医院药物警戒系统/抗凝血药物/安全性/不良反应Key words
Chinese hospital pharmacovigilance system/Anticoagulants/Safety/Adverse reactions分类
医药卫生引用本文复制引用
PAN Xiu-Ming,SHI Mei,SU Wen-Sheng,YU Hong-Shui,YAO Ming-Shi,DENG Hua,TANG Xiao-Ling,LI Shu,LI Jian-Zhong..基于中国医院药物警戒系统分析传统/新型抗凝血药物的临床安全性[J].中国药物经济学,2025,20(12):28-32,5.基金项目
广西药品监督管理局科研项目(桂药科{2020-03号}) （桂药科{2020-03号}）
