集中带量采购替格瑞洛仿制药与原研药用于行支架辅助弹簧圈栓塞术颅内动脉瘤患者的有效性及安全性比较  

Comparison of efficacy and safety of generic and branded ticagrelor in patients with intracranial stent placement before and after the implementation of the centralized volume-based procurement policy

作　　者：李一辰[1,3,4,5] 伊曼曼 邵腾飞 庄宗[5] 那世杰 李俐 葛卫红[1,4] LI Yichen;YI Manman;SHAO Tengfei;ZHUANG Zong;NA Shijie;LI Li;GE Weihong(Department of Pharmacy,the Drum Tower Hospital Affiliated to Medical School of Nanjing University,Nanjing 210008,China;Department of Pharmacy,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China;School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing 211198,China;Nanjing Clinical Pharmacy Center,Nanjing 210008,China;Department of Neurosurgery,the Drum Tower Hospital Affiliated to Medical School of Nanjing University,Nanjing 210008,China)

机构地区：[1]南京大学医学院附属鼓楼医院药学部,南京210008 [2]首都医科大学附属北京安贞医院药事部,北京100029 [3]中国药科大学基础医学与临床药学学院,南京211198 [4]南京临床药学中心,南京210008 [5]南京大学医学院附属鼓楼医院神经外科,南京210008

出　　处：《中国临床药学杂志》2024年第9期661-666,共6页Chinese Journal of Clinical Pharmacy

基　　金：江苏省药学会-天晴医院药学基金科研项目(编号Q202005);南京大学医院管理研究所管理项目课题(编号NDYG2020032);江苏省药学会-奥赛康医院药学科研项目(编号A202308)。

摘　　要：目的 比较集中带量采购(简称“集采”)替格瑞洛仿制药和原研药用于行支架辅助弹簧圈栓塞术颅内动脉瘤患者的有效性和安全性。方法 纳入2020年1月至2021年11月行支架辅助弹簧圈栓塞术的颅内动脉瘤病例181例,根据使用替格瑞洛品种的不同分为集采前组(n=93)和集采后组(n=88)。比较2组在住院期间的二磷酸腺苷(ADP)抑制率和ADP抑制率的达标率,随访并比较2组术后出院6个月的改良Rankin量表(mRS)评分、格拉斯哥预后量表(GOS)评分、缺血事件和出血事件发生率。结果集采后组和集采前组住院期间的ADP抑制率[(59.01±29.05)%vs(62.35±27.62)%]和ADP抑制率的达标率(60.00%vs64.86%)比较,差异均无统计学意义(P>0.05)。集采后组和集采前组术后6个月的缺血事件发生率(5.88%vs 4.71%)、出血事件发生率(18.82%vs 15.29%)、GOS评分(4.89±7.05 vs 4.85±7.12)和mRS评分(0.50±0.21 vs 0.62±0.24)比较,差异均无统计学意义(P>0.05)。结论 对于行支架辅助弹簧圈栓塞术的颅内动脉瘤患者,集采替格瑞洛仿制药和原研药的有效性和安全性相当。AIM To explore the efficacy and safety of generic branded ticagrelor after centralized volume-based procurement in patients with intracranial aneurysm undergoing stent-assisted coil embolization.METHODS Patients with intracranial aneurysms who underwent stent-assisted coil embolization from January 2020 to November 2021 were included and divided into 2 groups according to the use of ticagrelor varieties before centralized volume-based procurement(January to November 2020)and after procurement(December 2020 to November 2021).The inhibition rate of platelet aggregation function after medication in the hospital was recorded in 2 groups.The modified Rankin scale(mRS),Glasgow outcome scale(GOS)and incidence of ischemic and bleeding events were followed up 6 months after discharge,and the above indexes were compared between the 2 groups.RESULTS The ADP inhibition rates during hospitalization for the postcentralized procurement group and the pre-centralized procurement group were(59.01±29.05%vs 62.35±27.62%),and the achievement rates for the ADP inhibition rates were(60.00%vs 64.86%),respectively,with no statistical difference(P>0.05).At 6 months post-discharge,the incidence rates of ischemic events(5.88%vs 4.71%),bleeding events(18.82%vs 15.29%),and the scores for the GOS(4.89±7.05 vs 4.85±7.12)and the mRS(0.50±0.21 vs 0.62±0.24)were also compared between the post-centralized procurement group and the pre-centralized procurement group,with no statistical difference(P>0.05).CONCLUSION For patients with intracranial aneurysmal who undergo stent-assisted coil embolization,there is no significant difference in the efficacy and safety of generic and branded ticagrelor before and after centralized volumebased procurement.

关 键 词：集中带量采购 替格瑞洛 颅内动脉瘤 支架辅助弹簧圈栓塞术 

分 类 号：R743[医药卫生—神经病学与精神病学]