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仿制和原研氯吡格雷在冠状动脉介入术后有效性、安全性和经济性的对比研究 被引量:6

A comparative study of efficacy,safety and economy between generic and original clopidogrel in patients undergoing percutaneous coronary intervention
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摘要 目的:评价在“4+7”药品带量采购背景下,仿制氯吡格雷和原研氯吡格雷在急性冠脉综合征(ACS)患者接受冠状动脉介入术(PCI)后抗血小板治疗中的有效性、安全性和经济性。方法:回顾性收集2018年10月-2019年9月在我院门诊就诊的接受过PCI治疗的ACS患者数据,共计1294例患者,分为原研药组(n=618)和仿制药组(n=676),两组均联合使用阿司匹林。主要终点为二磷酸腺苷(ADP)诱导的血小板最大聚集率,并观察出血事件的发生。经济性评价统计“4+7”政策实施前后的用药频度(DDDs)和日均费用(DDC)。结果:两组患者在血小板最大聚集率方面差异无统计学意义(P=0.484)。两组患者在总出血事件方面差异无统计学意义(P=0.315)。仿制氯吡格雷的日均费用低于原研氯吡格雷。结论:与原研氯吡格雷相比,仿制氯吡格雷在有效性和安全性上无明显差别,但在经济性上有显著优势。 Objective:To evaluate the efficacy,safety and economy of the generic and the original clopidogrel in patients with acute coronary syndrome(ACS)undergoing percutaneous coronary intervention(PCI)under the background of"4+7"drug procurement.Methods:The data of ACS patients who received PCI treatment in our hospital from October 2018 to September 2019 were collected retrospectively.A total of 1294 patients were divided into the original drug group(n=618)and the generic drug group(n=676).Both groups were treated with aspirin.The primary end point was the maximum platelet aggregation rate induced by adenosine diphosphate(ADP),and the occurrence of bleeding events was observed.The defined daily doses(DDDs)and defined daily cost(DDC)before and after the implementation of"4+7"policy were statistically analyzed.Results:No significant difference was observed in maximum platelet aggregation rate(P=0.484)and total bleeding events(P=0.315)between the two groups.The DDC of generic drug group was lower than that of original drug group.Conclusion:There was no significant difference in efficacy and safety between generic and original clopidogrel,but generic clopidogrel might has more economic advantages than original clopidogrel.
作者 赵强 石秀锦 张翼 林阳 ZHAO Qiang;SHI Xiu-jin;ZHANG Yi;LIN Yang(School of Pharmaceutical Sciences,Capital Medical University,Beijing 100069,China;Department of Pharmacy,Anzhen Hospital of Capital Medical University,Beijing 100029,China)
出处 《中国药物应用与监测》 CAS 2021年第2期74-78,共5页 Chinese Journal of Drug Application and Monitoring
基金 北京市医院管理局临床药学专项“扬帆”计划(ZYLX201805)。
关键词 氯吡格雷 经皮冠状动脉介入治疗 血小板最大聚集率 出血 经济性 Clopidogrel Percutaneous coronary intervention Maximum platelet aggregation rate Bleeding Economy
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