替格瑞洛集采中标药与原研药用于ACS患者PCI后的疗效与安全性比较  

Comparison of the efficacy and safety between the drug winning the bidding for centralized procurement and the original drug of ticagrelor in acute coronary syndrome patients after percutaneous coronary intervention

作　　者：缪阳 孟中如 祁旺 张丹 许康世 王红霞 MIAO Yang;MENG Zhongru;QI Wang;ZHANG Dan;XU Kangshi;WANG Hongxia(Dept.of Pharmacy,Yancheng First Hospital Affiliated of Nanjing University Medical School/Yancheng No.1 People’s Hospital,Jiangsu Yancheng 224000,China;Dept.of Cardiovascular Medicine,Yancheng First Hospital Affiliated of Nanjing University Medical School/Yancheng No.1 People’s Hospital,Jiangsu Yancheng 224000,China)

机构地区：[1]南京大学医学院附属盐城第一医院/盐城市第一人民医院药学部,江苏盐城224000 [2]南京大学医学院附属盐城第一医院/盐城市第一人民医院心血管内科,江苏盐城224000

出　　处：《中国药房》2024年第20期2522-2526,共5页China Pharmacy

基　　金：江苏省药学会-奥赛康医院药学基金科研项目(No.A202149);盐城市卫生健康委科研项目(No.YK2023057)。

摘　　要：目的比较替格瑞洛集采中标药与原研药用于急性冠脉综合征(ACS)患者经皮冠脉介入术(PCI)后1年的疗效与安全性。方法选择2021年7月至2023年6月我院收治的接受PCI的ACS患者420例,根据使用的替格瑞洛品种分为集采组(156例)和原研组(264例)。所有患者均规律服用阿司匹林肠溶片100 mg,每日1次;在此基础上,集采组患者给予集采中标的替格瑞洛片,原研组患者给予原研药替格瑞洛片,两组患者的用药剂量均为90 mg,每日2次,疗程均为12个月。比较两组患者治疗前及治疗1周后的血液常规指标,PCI后随访1年的净不良临床事件(NACE)、主要心脑血管不良事件(MACCE)、出血事件发生率和无MACCE及无出血事件生存率。结果两组患者治疗前及治疗1周后血液常规指标、PCI后随访1年的NACE、MACCE、出血事件发生率和无MACCE及无出血事件生存率比较,差异均无统计学意义(P>0.05)。结论PCI后随访1年,替格瑞洛集采中标药的临床疗效和安全性与其原研药相当。OBJECTIVE To compare the efficacy and safety between the drug winning the bidding for centralized procurement and the original drug of ticagrelor in acute coronary syndrome(ACS)patients one year after percutaneous coronary intervention(PCI).METHODS Overall 420 ACS patients treated with PCI in our hospital from July 2021 to June 2023 were divided into centralized procurement group(156 cases)and original drug group(264 cases)according to the different varieties of ticagrelor.All patients were given Aspirin enteric-coated tablets 100 mg regularly,once a day;on this basis,patients in the centralized procurement group were given Ticagrelor tablets winning the bidding,while patients in the original drug group were given the original drug of Ticagrelor tablets.The dosage of Ticagrelor tablets taken by both groups of patients was 90 mg,twice a day,and the course of treatment was 12 months.The blood routine indicators were compared before treatment and one week after treatment,while the incidence of net adverse clinical events(NACE),major adverse cardiovascular and cerebrovascular events(MACCE)and bleeding events,and the survival rate without MACCE and bleeding events during a one-year follow-up after PCI were also compared between two groups.RESULTS There were no statistically significant differences in blood routine indicators before treatment and one week after treatment,as well as the incidence of NACE,MACCE and bleeding events,survival rate without MACCE and bleeding events during a one-year follow-up after PCI between the two groups(P>0.05).CONCLUSIONS During a·2522·China Pharmacy 2024 Vol.35 No.20 one-year follow-up after PCI,the efficacy and safety of the drug winning the bidding for centralized procurement of ticagrelor are comparable to the original drug.

关 键 词：替格瑞洛 急性冠脉综合征 经皮冠脉介入术 仿制药 原研药 集中采购 疗效 安全性 

分 类 号：R973.2[医药卫生—药品]