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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
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缪 阳 ，孟中如 ，祁 旺 ，张 丹 ，许康世 ，王红霞 （1.南京大学医学院附属盐城第一医院/盐城市第一人
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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）
中图分类号 R973+.2 文献标志码 A 文章编号 1001-0408（2024）20-2522-05
DOI 10.6039/j.issn.1001-0408.2024.20.14
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。
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
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
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MIAO Yang ，MENG Zhongru ，QI Wang ，ZHANG Dan ，XU Kangshi ，WANG Hongxia（1. Dept. of Pharmacy，
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Yancheng First Hospital Affiliated of Nanjing University Medical School/Yancheng No. 1 People’s Hospital，
Jiangsu Yancheng 224000， China；2. Dept. of Cardiovascular Medicine， Yancheng First Hospital Affiliated of
Nanjing University Medical School/Yancheng No. 1 People’s Hospital， Jiangsu Yancheng 224000， China）
ABSTRACT 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
one-year follow-up after PCI， the efficacy and safety of the
Δ 基金项目 江苏省药学会-奥赛康医院药学基金科研项目（No.
drug winning the bidding for centralized procurement of
A202149）；盐城市卫生健康委科研项目（No.YK2023057）
＊第一作者 副主任药师，硕士。研究方向：临床药学。E-mail： ticagrelor are comparable to the original drug.
352380337@qq.com KEYWORDS ticagrelor； acute coronary syndrome； percu-
# 通信作者 主任药师，硕士。研究方向：医院药学。E-mail： taneous coronary intervention； generic drug； original drug；
805353057@qq.com centralized procurement； efficacy； safety
· 2522 · China Pharmacy 2024 Vol. 35 No. 20 中国药房 2024年第35卷第20期
