2023 年第 10 期 第 18 卷

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

Comparative study on applications of original and generic ticagrelor in patients after percutaneous coronary intervention

作者：周洋1张泽华1,2彭文星1张芸楠1,2韩嘉伦1,2石秀锦1林阳1

英文作者：Zhou Yang1 Zhang Zehua12 Peng Wenxing1 Zhang Yunnan12 Han Jialun12 Shi Xiujin1 Lin Yang1

单位：1首都医科大学附属北京安贞医院药事部，北京100029；2首都医科大学药学院临床药学系，北京100069

英文单位：1Department of Pharmacy Beijing Anzhen Hospital Capital Medical University Beijing 100029 China; 2Department of Clinical Pharmacy School of Pharmaceutical Sciences Capital Medical University Beijing 100069 China

关键词：急性冠状动脉综合征；替格瑞洛；仿制药；血小板最大聚集率

英文关键词：Acutecoronarysyndromes;Ticagrelor;Genericdrug;Maximumplateletaggregationrate

• 摘要：

• 目的  通过对比原研与仿制替格瑞洛在经皮冠状动脉介入（PCI）术后应用的有效性、安全性与经济性，为临床决策与政策实施提供参考。方法  回顾性收集首都医科大学附属北京安贞医院2019年1月至2021年12月诊断为急性冠状动脉综合征（ACS）并接受了PCI手术治疗的患者的相关就诊与随访数据，根据患者使用的替格瑞洛品种分为原研药组与仿制药组。比较2组有效性（血小板最大聚集率及其达标率）、安全性(出血事件)和经济性（用药频度、日均费用）相关指标。结果  共纳入2 685例患者，原研药组1 838例，仿制药组847例。倾向性评分匹配后2组各841例。2组血小板最大聚集率、血小板最大聚集率达标率比较差异均无统计学意义（均P＞0.05）。原研药组共9例患者出现便潜血事件，发生率为1.1%（9/841），仿制药组共10例患者出现便潜血事件，发生率为1.2%（10/841）。带量采购政策实施后替格瑞洛仿制药用药频度明显高于原研药且日均费用有较大下降。结论  仿制替格瑞洛与原研替格瑞洛的有效性与安全性无显著差异，但具有更好的经济性。

• Objective  To compare the efficacy, safety and economics between original and generic ticagrelor after percutaneous coronary intervention (PCI), and to provide reference for clinical decision-making and policy implementation. Methods  Data were collected from patients diagnosed with acute coronary syndrome and treated with PCI in Beijing Anzhen Hospital, Capital Medical University retrospectively from January 2019 to December 2021. According to types of ticagrelor use, patients were divided into original group and generic group. The efficacy (maximum platelet aggregation rate and its compliance rate), safety (bleeding events), and economic (frequency of medication, daily average cost) related indicators were compared between the two groups. Results  A total of 2 685 patients were included, 1 838 in the original group and 847 in the generic group. Finally, 841 patients enrolled in each of the two groups after propensity score matching. There were no significant differences in the maximum platelet aggregation rate and on target rate of maximum platelet aggregation rate between the two groups (both P＞0.05). A total of 9 patients in the original group experienced a fecal occult bleeding event, which occurred in 1.1%(9/841), and 10 patients in the generic group experienced a fecal occult bleeding event, which occurred in 1.2%(10/841). After the policy was implemented, the defined daily dose system of generic drug were significantly higher than the original drug, and defined daily dose cost decreased significantly. Conclusion  There are no statistically significant differences in efficacy and safety between original and generic ticagrelor, but generic ticagrelor has a large price advantage.