| Background:Over the past two centuries, the Industrial and Technological Revolutions and their associated economic and social transformations have resulted in dramatic shifts in the diseases responsible for illness and death. Cardiovascular disease (CVD) has emerged as the dominant chronic disease in many parts of the world, and early in the 21st century it is predicted to become the main cause of disability and death worldwide. CVD is a major disease threaten human health, especially coronary atherosclerotic heart disease (CAD). Morbidity and mortality of CAD rises year by year and the burden of CAD is more and more accelerating in China. Percutaneous coronary interventions has been the major and effect therapy and there were more and more CAD patients to underwent CAG and PCI, however, there were more and more stent thrombus complication correlation PCI. Dual antiplatelet therapy (aspirin and clopidogrel) has been the standard proposal after PCI, however, the cost of imported clopidogrel (PlavixTM) is expensive and the domestic generic clopidogrel (TalcomTM) is cheap relative PlavixTM. There are not large sample data to confirm the effect to inhibit platelet aggregation and the effect and safety after PCI of TalcomTM.Objective:1.To explore whether the effects of isodose domestic clopidogrel (TalcomTM) and imported clopidogrel (PlavixTM) on platelet function in patients with unstable angina (UAP).2. To explore whether the effects of isodose TalcomTM and PlavixTM on parameters of blood clot system in patients with unstable angina (UAP). 3. To explore whether the safety of isodose TalcomTM and PlavixTM on parameters of blood routin test in patients with unstable angina (UAP).4. To compare the efficacy and safety of TalcomTM and PlavixTM on PCI.5. To compare the efficacy and safety of TalcomTM and PlavixTM on directed PCI in AMI patients.Methods:1.199 patients with UAP were randomized to two groups, including TalcomTM group (n=89), PlavixTM group (n=110). Venous blood samples were obtained before taking orally clopidogrel,8-12 hours after taking loading dose clopidogrel 300 mg, and after 75 mg/day for 24 hours,48 hours in two clopidogrel groups in order to test platelet aggregation rate induced by adenosine diphosphate (ADP) detected by electric resistance method and before taking orally clopidogrel and after 75 mg/day for 48 hours in two clopidogrel groups in order to test 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.2.1798 patients with CAD to undergo CAG+PCI were randomized to two groups, including TalcomTM group (n=1104), PlavixTM group (n=694).300mg loading dose clopidogrel was oral before PCI and 75mg/d foreword one year. There were follow-up 3-28 month to survey the incidence rate of MACE of combination end point of acute, subacute, late stage, very late stage stent thrombus and AMI, cardiac death, stroke and correlated adverse reaction of bleed, major bleed, gastrointestinal complaint, and etc. 3.204 patients with AMI to undergo directed CAG+PCI were randomized to two groups, including TalcomTM group (n=123), PlavixTM group (n=81).300mg loading dose clopidogrel was oral before PCI in emergency room and 75mg/d foreword one year. There were follow-up 3-28 month to survey the incidence rate of MACE of combination end point of acute, subacute, late stage, very late stage stent thrombus and AMI, cardiac death, stroke and correlated adverse reaction of bleed, major bleed, gastrointestinal complaint, and etc.Results: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 before treatment. There were no significant differences in the aforementioned markers between TalcomTM group and PlavixTM group after treatment. With the time, platelet aggregation rate of TalcomTM group and PlavixTM group was degrading, and there was the most obviously after orally loading dose, and resistance value of TalcomTM group and PlavixTM group in before taking orally, after orally 8?12 hour, 24?36 hour,48?60 hour was 7.67±3.48ohm,4.67±3.84 ohm,3.46±3.93 ohm, 3.36±3.86 ohm and 6.84±3.25ohm,4.25±3.94ohm,2.63±3.27ohm,2.59±3.50ohm, respectively. There were significant differences in 4 repeated detected platelet aggretion rate by one way repeated measure factor ANOVA, (F=117.101, P=0.000). There were no significant differences in the parameters (PT, INR, APTT, TT, FIB, D-dimer) of blood clot system between TalcomTM group and PlavixTM group before treatment (t value 0.825,1.260,1.448,0.299,1.112,0.388, P value 0.411, 0.209,0.149,0.765,0.267,0.699, respectively); There were no significant differences in the parameters (PT, INR, APTT, TT, FIB, D-dimer) of blood clot system between TalcomTM group and PlavixTM group after treatment (t value 1.350?1.159?1.406?0.915?1.810?0.372, P value 0.179?0.248?0.161?0.361?0.072? 0.710, respectively); There were no significant differences in the parameters (WBC, RBC, HGB, PLT) of blood routin test between TalcomTM group and PlavixTM group before treatment (t value 1.840,0.101,0.664,2.027, P value 0.067,0.920,0.507, 0.054, respectively); There were no significant differences in the parameters (WBC, RBC, HGB, PLT) of blood routin test between TalcomTM group and PlavixTM group after treatment (t value 1.404,0.083,0.565,1.581, P value 0.162,0.934,0.574,0.116, respectively). There were no significant differences in the parameters (PT, INR, APTT, TT, FIB, D-dimer) of blood clot system between before and after treatment both TalcomTM group and PlavixTM group by paired sample t test (t value 1.198 and 1.016,0.989 and 0.697,0.872 and 0.981,0.368 and 1.225,0.051 and 0.032, P value 0.234 and 0.311,0.325 and 0.487,0.385 and 0.328,0.714 and 0.223,0.959 and 0.975, respectively); but the level of FIB of after treatment is increase to compare to before treatment both TalcomTM group and PlavixTM group by paired sample t test (t value 3.389 and 2.074, P value 0.001 and 0.040, respectively); There were no significant differences in the parameters (WBC and PLT) of blood routin test to compare to before treatment both TalcomTM group and PlavixTM group by paired sample t test (t value 0.248 and 0.808,1.654 and 1.618, P value 0.804 and 0.421,0.102 and 0.109, respectively); but the level of the count of RBC and the quantitation of HGB of after treatment is decrease to compare to before treatment both TalcomTM group and PlavixTM group by paired sample t test (t value 7.539 and 9.562,9.224 and 10.856, P value 0.000 and 0.000,0.000 and 0.000, respectively).2. There were no significant differences in the incidence of target vessel revascularization and combination end point between TalcomTM group and PlavixTM group (X2 value 2.176,3.287, P value 0.140,0.070). There were no significant differences in the incidence of stent thrombus and cardiac death between TalcomTM group and PlavixTM group by Fisher's exact probability (P value 0.440,0.149). There were no significant differences in the incidence of bleed and major bleed between TalcomTM group and PlavixTM group (P value 0.072 and 0.380). There were no significant differences in survival without event and accumulation MACE hazard analysised by Kaplan-Meier survival analysis (X2 3.438 and 1.076, P=0.064 and 0.300).3. There were not stent thrombus and bleed event both TalcomTM group and PlavixTM group. There are two patients death of cardiac shock and heart rupture in PlavixTM group. There were no significant differences in the incidence of target vessel revascularization and combination end point between TalcomTM group and PlavixTM group (X2 value 0.000 and 0.921, P value 0.989 and 0.337). There were no significant differences in accumulation MACE hazard analysised by Kaplan-Meier survival analysis(X20.679, P=0.410).Conclusions:1.The anti-platelet aggregation and antiplatelet activation effects of isodose TalcomTM are similar to those of PlavixTM. The two drugs have good anti-platelet effects. Furthermore, the two drugs have no significant adverse drug reaction.2. Effects and safety of isodose TalcomTM used in underwent PCI patients are similar to those of PlavixTM.3. Effects and safety of isodose TalcomTM used in AMI patients that underwent directed PCI are similar to those of PlavixTM. |
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