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％vs 64.86％)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.
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
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 post-centralized 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 volume-based procurement.
万方数据
维普
