等剂量国产与进口氯吡格雷对不稳定型心绞痛患者血小板聚集率及凝血系统影响的等效性研究  

Isoeffects of isodose domestic and imported clopidogrel on platelet function and blood clot system in patients with unstable angina

作　　者：杨玉恒[1] 孙中华[1] 熊国均[1] 罗欢[1] 陈涛[1] 米杰[1] 齐向前[1] 

机构地区：[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300457

出　　处：《临床荟萃》2011年第9期748-751,共4页Clinical Focus

摘　　要：目的探讨等剂量国产和进口氯吡格雷对血小板聚集率以及凝血系统、血细胞计数代表的血液系统的影响效果是否相同。方法连续入选199例不稳定型心绞痛患者,随机分为国产氯吡格雷(泰嘉组,89例)和进口氯吡格雷(波立维组,110例),按照相同的应用剂量及应用方法,并应用电阻法在用药前、用药后8～12小时、24～36小时、48～60小时测定二磷酸腺苷(ADP)诱导的血小板聚集率,在用药前和用药后48～60小时测定白细胞计数、红细胞计数、血小板计数、D-二聚体(D-dimer)、凝血系统[包括凝血酶原时间(PT)、凝血酶原时间国际标准化比值(INR)、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(FIB)]等指标,并进行统计学分析比较。结果泰嘉组及波立维组血小板聚集率均随用药时间延长而降低,在负荷量后降低最明显,泰嘉组与波立维组用药前、用药后8～12小时、24～36小时、48～60小时的血小板聚集率电阻值分别为(7.67±3.48)欧姆(ohm),(4.67±3.84)ohm,(3.46±3.93)ohm,(3.36±3.86)ohm和(6.84±3.25)ohm,(4.25±3.94)ohm,(2.63±3.27)ohm,(2.59±3.50)ohm,经单个重复测量因素的方差分析,两组间差异无统计学意义(F=3.092,P>0.05),血小板聚集率之间差异具有统计学意义(F=117.101,P<0.01);而凝血系统各指标和血常规的各项血细胞计数在用药前后两组均无明显改变。结论等剂量国产与进口氯吡格雷对ADP诱导的血小板聚集率具有相同的影响效果,而且二者对于凝血系统及血液系统均无明显影响。Objective To explore whether the effects of isodose domestic clopidogrel(Talcom) and imported clopidogrel(Plavix) are the same on platelet function and blood clot system in patients with unstable angina(UAP),and to compare the efficacy and safety of Talcom and Plavix.Methods 199 patients with UAP were randomized to two groups,including Talcom group(89 patients),Plavix group(110 patients).Venous blood samples were obtained before taking orally clopidogrel,8-12 hours after taking clopidogrel 300 mg,and after 75 mg/d for 24 hours,48 hours in two clopidogrel groups,platelet aggregation rate induced by adenosine diphosphate(ADP) was detected by electric resistance method.Before taking orally clopidogrel and after 75 mg/d for 48 hours in two clopidogrel groups,lencocyte count,red blood cell count,blood platelets count,D-dimer,prothrombin time(PT),international normalized ratio of prothrombin time(INR),activated partial thromboplastin time(APTT),thrombin time(TT),fibrinogen were tested.Results Before treatment there were no significant differences in the platelet aggregation rate and blood cell count and the item of blood clot system between Talcom group and Plavix group.After treatment there were no significant differences in the aforementioned markers between Talcom group and Plavix group.With the time,platelet aggregation rate of Talcom group and Plavix group was degrading,and the phenomenon was most obvious after orally loading dose,and resistance value of Talcom group and Plavix group before taking drugs orally,after orally 8-12 hours,24-36 hours,48-60 hours was(7.67±3.48) ohm,(4.67±3.84) ohm,(3.46±3.93) ohm,(3.36±3.86) ohm and(6.84±3.25) ohm,(4.25±3.94) ohm,(2.63±3.27) ohm,(2.59±3.50) ohm,respectively.There were significant differences in platelet aggretion rate by one way repeated measure factor ANOVA(F=117.101,P<0.01).Conclusion The anti-platelet aggregation and antiplatelet activation effects of isodose Talcom are similar to those of Plavix.The two drugs have similar good anti-platelet effects.Furthermo

关 键 词：心绞痛 不稳定型 血小板聚集抑制剂 血小板活化 随机对照试验 

分 类 号：R543.31[医药卫生—心血管疾病]