中国组织工程研究Issue(47)：8175-8181,7.DOI:10.3969/j.issn.2095-4344.2013.47.006
国产与进口氯吡格雷对冠状动脉支架置入后影响的等效性比较：1798例总结
Equivalence comparison between domestic and imported clopidogrel for percutaneous coronary interventions in 1 798 cases
杨玉恒 1熊国均 2罗欢 1齐向前 1孙中华 1米杰 1钟明惠 1张健 1王勇德 1陈涛 1田刚 1臧希文1
作者信息
- 1. 天津医科大学心血管病临床学院，泰达国际心血管病医院心内科，天津市 300457
- 2. 迁安市人民医院心内3科，河北省迁安市 064400
- 折叠
摘要
Abstract
BACKGROUND:A few of studies have showed similar efficacy and safety between domestic clopidogrel (Talcom™) and imported clopidogrel (Plavix™) in patients after percutaneous coronary intervention, but there is lack of large-scale, large sample, and prospective clinical comparative study in China. <br> OBJECTIVE:To compare the efficacy and safety of Talcom™and Plavix™on percutaneous coronary intervention. <br> METHODS:Total y 1 798 patients with Coronary atherosclerotic heart disease who received percutaneous coronary interventions were divided to two groups:Talcom™group (n=1 104) and Plavix™group (n=694). 300 mg clopidogrel was administrated oral y before percutaneous coronary intervention fol owed by 75 mg/d clopidogrel sequential y for 1 year. Al the patients were fol owed for 3-28 months to observe the incidence rate of stent thrombosis at acute, subacute, late, and very late stage, major adverse cardiac events of combination end point (including myocardial infarction, cardiac death, and stroke), and correlated adverse reactions, such as bleeding. <br> RESULTS AND CONCLUSION:There were no significant differences in the incidence of stent thrombosis, target vessel revascularization, cardiac death, bleeding, major bleeding and major adverse cardiac events of combination end point between Talcom™group and Plavix™group. In addition, event-free survival also showed no difference between the two groups. After treatment, white blood cellcount, erythrocyte count, hemoglobin, hematocrit, platelet count were significantly decreased in both the two groups (P<0.05). Hemoglobin level in the Talcom™group was fewer than that in the Plavix™group (P<0.05). The results suggest that effects and safety of Talcom™are similar to those of Plavix™for percutaneous coronary interventions.关键词
生物材料/生物材料临床实践/氯吡格雷/经皮冠状动脉内介入治疗/临床对照试验/疗效/安全性/靶血管重建分类
医药卫生引用本文复制引用
杨玉恒,熊国均,罗欢,齐向前,孙中华,米杰,钟明惠,张健,王勇德,陈涛,田刚,臧希文..国产与进口氯吡格雷对冠状动脉支架置入后影响的等效性比较：1798例总结[J].中国组织工程研究,2013,(47):8175-8181,7.
