中标对比原研氯吡格雷用于急性冠脉综合征患者经皮冠状动脉介入术后治疗的临床有效性及安全性研究  

A comparative study on clinical efficacy and safety of generic versus originalclopidogrel in the treatment of acute coronary syndrome patients after percutaneous coronary intervention

作　　者：韩嘉伦 张翼 林佰弟 石秀锦[1] 赵强[1] 王依繁 闫佳琳 林阳[1] HAN Jia-lun;ZHANG Yi;LIN Bai-di;SHI Xiu-jin;ZHAO Qiang;WANG Yi-fan;YAN Jia-lin;LIN Yang(Department of Pharmacy,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China)

机构地区：[1]首都医科大学附属北京安贞医院药事部,北京100029

出　　处：《中国医院药学杂志》2021年第6期601-605,共5页Chinese Journal of Hospital Pharmacy

基　　金：北京市医院管理局临床医学发展专项“扬帆”计划(编号:ZYLX201805)。

摘　　要：目的:评估国产与进口氯吡格雷口服常释剂型的有效性和安全性及药物经济学差异,为"4+7"带量采购政策执行对患者治疗模式和医疗费用支出的影响提供数据支持。方法:提取首都医科大学附属北京安贞医院急性冠脉综合征患者药物治疗相关因素与临床结局的病例,研究患者登记数据库中使用氯吡格雷患者的基线及随访信息及医院药品费用数据,根据所用药物品种分为中标药组及原研药组进行统计分析。结果:原研药组MACCE的发生率与中标药组(4.91%vs.5.07%,P=0.83)无显著性差异,全因死亡、心血管相关死亡、心肌梗死、卒中、血运重建及支架内血栓等各单独终点事件及主要出血事件发生率与中标药组无显著性差异(log-rank P=0.60)。2019年4-9月氯吡格雷用量较政策实施前2018年同期使用金额下降874.4万元。结论:中标品种氯吡格雷与进口同类药物相比,在急性冠脉综合征患者经皮冠状动脉介入治疗后的疗效可靠,安全性好,具有较大价格优势。OBJECTIVE To evaluate the efficacy, safety and pharmacoeconomic differences between common oral release formulations of generic versus original clopidogrel to provide data support for the impact of implementing "4+7" procurement policy on patient treatment modes and medical expenses.METHODS The baseline and follow-up data of clopidogrel-dosing patients were extracted from the registration database of PHARM-ACS and expense data from Hospital Information System(HIS).Depending upon drug varieties, the relevant data were divided into generic and original drug groups and analyzed by STATA and Excel.RESULTS The incidence of MACCE event was equivalent between two groups(4.91% vs.5.07%,P=0.83).No significant difference existed in the incidence of all-cause death, cardiovascular death, myocardial infarction, stroke, blood supply reconstruction, stent thrombosis or major bleeding event(log-rank P=0.60).From April to September 2019,the using amount of clopidogrel decreased by 8.744 million yuan as compared with the same period in 2018 prior to policy implementation.CONCLUSION As compared with similar imported drugs, clopidogrel of bid-winning variety has reliable efficacy, good safety and a large price advantage after percutaneous coronary intervention in patients with acute coronary syndrome.

关 键 词：急性冠脉综合征 氯吡格雷 仿制药 带量采购 

分 类 号：R969.4[医药卫生—药理学]