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

缪阳; 孟中如; 祁旺; 张丹; 许康世; 王红霞

doi:10.6039/j.issn.1001-0408.2024.20.14

您当前的位置：

首页 >

文章列表页 >

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

药物与临床 | 更新时间：2024-10-25

- 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
- 中国药房 2024年35卷第20期页码：2522-2526
- 作者机构：
  
  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
- 作者简介：
  
  副主任药师，硕士。研究方向：临床药学。E-mail：352380337@qq.com
  主任药师，硕士。研究方向：医院药学。E-mail：805353057@qq.com
- 基金信息：
  
  江苏省药学会-奥赛康医院药学基金科研项目(A202149);盐城市卫生健康委科研项目(YK2023057)
- DOI：10.6039/j.issn.1001-0408.2024.20.14
  中图分类号： R973+.2
- 纸质出版日期：2024-10-30，
  
  收稿日期：2024-07-18，
  
  修回日期：2024-09-06，
- 稿件说明：
移动端阅览
缪阳,孟中如,祁旺等.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 ^Δ[J].中国药房,2024,35(20):2522-2526.

MIAO Yang,MENG Zhongru,QI Wang,et al.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[J].ZHONGGUO YAOFANG,2024,35(20):2522-2526.
缪阳,孟中如,祁旺等.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 ^Δ[J].中国药房,2024,35(20):2522-2526. DOI： 10.6039/j.issn.1001-0408.2024.20.14.

MIAO Yang,MENG Zhongru,QI Wang,et al.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[J].ZHONGGUO YAOFANG,2024,35(20):2522-2526. 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（

＞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。

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 r

outine 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 （

＞0.05）.

CONCLUSIONS

During a 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

Keywords

acute coronary syndromepercu-taneous coronary interventiongeneric drugoriginal drugcentralized procurementefficacysafety

references

BYRNE R A，ROSSELLO X，COUGHLAN J J，et al. 2023 ESC Guidelines for the management of acute coronary syndromes[J]. Eur Heart J Acute Cardiovasc Care，2024，13（1）：55-161.

中华医学会心血管病学分会，中华心血管病杂志编辑委员会. 非ST段抬高型急性冠脉综合征诊断和治疗指南：2024[J]. 中华心血管病杂志，2024，52（6）：615-646.

Chinese Society of Cardiology，Chinese Medical Association，Editorial Board of Chinese Journal of Cardiology. Guidelines for the management of non-ST elevation acute coronary syndromes：2024[J]. Chin J Cardiol，2024，52（6）：615-646.

KABIL M F，ABO DENA A S，EL-SHERBINY I M. Ticagrelor[M]//Profiles of Drug Substances，Excipients and Related Methodology. Amsterdam：Elsevier，2022：91-111.

VALGIMIGLI M，GRAGNANO F，BRANCA M，et al. Ticagrelor or clopidogrel monotherapy vs dual antiplatelet therapy after percutaneous coronary intervention：a systematic review and patient-level meta-analysis[J]. JAMA Cardiol，2024，9（5）：437-448.

姜禹存，顾琳，陆赛花，等. 公众对药品价格与国产仿制药认可度的真实世界调查[J]. 上海医药，2021，42（15）：47-49.

JIANG Y C，GU L，LU S H，et al. Real world survey of the public’s recognition on drug prices and domestic generic drugs[J]. Edible Med Mushrooms，2021，42（15）：47-49.

WESTPHAL E S，ALADEEN T，VANINI D，et al. Generic clopidogrel：has substitution for brand name plavix® been effective?[J]. J Pharm Pract，2022，35（4）：536-540.

中国医师协会急诊医师分会，国家卫健委能力建设与继续教育中心急诊学专家委员会，中国医疗保健国际交流促进会急诊急救分会. 急性冠脉综合征急诊快速诊治指南：2019[J]. 中国急救医学，2019，39（4）：301-308.

Chinese College of Emergency Physicians，Expert Committee on Emergency Medicine of National Health Commission Capacity Building and Continuing Education Center，Emergency Medicine and First Aid Branch of China International Exchange and Promotive Association for Medical and Health Care. Guidelines for emergency rapid diagnosis and treatment of acute coronary syndrome：2019[J]. Chin J Crit Care Med，2019，39（4）：301-308.

HAN J K，HWANG D，YANG S，et al. Comparison of 3- to 6-month versus 12-month dual antiplatelet therapy after coronary intervention using the contemporary drug-eluting stents with ultrathin struts：the HOST-IDEA randomized clinical trial[J]. Circulation，2023，147（18）：1358-1368.

MEHRAN R，RAO S V，BHATT D L，et al. Standardized bleeding definitions for cardiovascular clinical trials：a consensus report from the Bleeding Academic Research Consortium[J]. Circulation，2011，123（23）：2736-2747.

苏华，郭瑞臣.仿制药一致性评价的背景、实施及结局[J].中国医院药学杂志，2022，42（14）：1502-1505.

SU H，GUO R C.The background，implementation and outcome of the consistency evaluation of generic drugs[J].Chin J Hosp Pharm，2022，42（14）：1502-1505.

GLERUM P J，NEEF C，BURGER D M，et al. Pharmacokinetics and generic drug switching：a regulator’s view[J]. Clin Pharmacokinet，2020，59（9）：1065-1069.

张卓成，李芳，安娜，等. 我国化学仿制药参比制剂遴选与管理方式浅析[J]. 中国新药杂志，2023，32（5）：476-480.

ZHANG Z C，LI F，AN N，et al. Introduction to selection and management of reference listed drug for chemical generic drugs in China[J]. Chin J N Drugs，2023，32（5）：476-480.

SANDERSON N C，PARKER W A E，STOREY R F. Ticagrelor：clinical development and future potential[J]. Rev Cardiovasc Med，2021，22（2）：373-394.

袁勇程，刘尚军.氯吡格雷和替格瑞洛对老年冠心病患者PCI术后血小板功能、炎性反应及主要不良心血管事件的影响[J].中国药物应用与监测，2022，19（2）：72-75.

YUAN Y C，LIU S J. Effects of clopidogrel and ticagrelor on platelet function，inflammatory response and major adverse cardiovascular events in elderly patients with coronary heart disease after PCI[J].Chin J Drug Appl Monit，2022，19（2）：72-75.

谢秋芬，许俊羽，王洁，等. 替格瑞洛片在中国健康志愿者空腹和进食条件下的生物等效性[J]. 中国新药杂志，2019，28（24）：2974-2980.

XIE Q F，XU J Y，WANG J，et al. Bioequivalence study of ticagrelor under fasting and fed conditions in Chinese healthy volunteers[J]. Chin J N Drugs，2019，28（24）：2974-2980.

宋锐，王亮，刘毅，等. 国产替格瑞洛与进口替格瑞洛对冠心病患者血小板抑制率影响[J]. 心脏杂志，2023，35（3）：269-273.

SONG R，WANG L，LIU Y，et al. Effect of domestic and imported ticagrelor on platelet inhibition rate in patients with coronary heart disease[J]. Chin Heart J，2023，35（3）：269-273.

周洋，张泽华，彭文星，等. 原研和仿制替格瑞洛在经皮冠状动脉介入术后应用的相关对比研究[J]. 中国医药，2023，18（10）：1441-1445.

ZHOU Y，ZHANG Z H，PENG W X，et al. Comparative study on applications of original and generic ticagrelor in patients after percutaneous coronary intervention[J]. China Med，2023，18（10）：1441-1445.

GAO R L，WU Y J，LIU H L，et al. Safety and incidence of cardiovascular events in Chinese patients with acute coronary syndrome treated with ticagrelor：the 12-month，phase Ⅳ，multicenter，single-arm DAYU study[J]. Cardiovasc Drugs Ther，2018，32（1）：47-56.

LAINE M，PANAGIDES V，FRÈRE C，et al. On-ticagrelor platelet reactivity and clinical outcome in patients undergoing percutaneous coronary intervention for acute coronary syndrome[J]. Thromb Haemost，2021，121（7）：923-930.

KOCH T，LAHU S，COUGHLAN J J，et al. Association between platelet count and treatment effect of ticagrelor or prasugrel in patients with acute coronary syndromes[J]. Thromb Haemost，2023，123（4）：464-477.

孟凯. 替格瑞洛在不稳定型心绞痛经皮冠状动脉介入治疗患者中应用的临床疗效探讨[J]. 系统医学，2020，5（21）：77-79.

MENG K. The clinical effect of ticagrelor in the treatment of unstable angina pectoris by percutaneous coronary intervention[J]. Syst Med，2020，5（21）：77-79.

浏览量

下载量

CSCD

文章被引用时，请邮件提醒。

提交

工具集

关联资源

维奈克拉联合高三尖杉酯碱和阿糖胞苷治疗急性髓系白血病的临床观察

卡瑞利珠单抗联合索拉非尼治疗晚期肝癌的临床观察

ABCB1基因型对紫杉烷类药物用于乳腺癌疗效和安全性影响的Meta分析

托法替布联合羟氯喹治疗难治性类风湿关节炎的临床观察

咪达唑仑与右美托咪定/丙泊酚对机械通气危重症患者镇静治疗有效性和安全性的Meta分析