【摘要】 目的:探讨急性冠状动脉综合征(ACS)早期应用氯吡格雷75mg/d及氯吡格雷75mg/d加阿司匹林100mg/d的有效性及安全性。方法:将202例ACS患者随机单盲分为3组。A组(阿司匹林组)67例,首剂150mg/d,而后100mg/d;B组(氯吡格雷组)68例,首剂300mg/d,而后75gm/d;C组(氯吡格雷加阿司匹林组)67例,阿司匹林100mg/d,加氯吡格雷75mg/d,随访2年,观察住院期间及随访期间心脑血管事件发生情况,抗炎症因子,改善心功能及减少颈动脉内膜-中层厚度(IMT)作用、药物不良反应。结果:3组住院期间及随访2年中均能降低心脑事件发生,但住院期间反复发作心绞痛(AP),心律失常,心力衰竭(HF)发生危险C组优于B组(但P>0.05),优于A组(P<0.05),而B组优于A组(但p> 0.05);随访2年中,复发性AP,再发生非致死性心肌梗死(MI),心律失常、HF、需做经皮腔内冠状动脉介入术/冠脉旁路移植术(PCI/CABG)、因缺血发作需再住院等,C组明显比A组减少(P<0.05)。同时,3组治疗6周后,P-选择素、血纤溶酶原激活物抑制剂-1(PAI-1)、D-二聚体、纤维蛋白原(FG)、超敏C-反应蛋白(hs-CRP)、均较治疗前明显降低(P <0.01)。而C组在降低上述5项炎症物作用优于B组(P<0.05),优于A组(p<0.05);B组作用优于A组,但P> 0.05。3组治疗6周后,均较治疗前明显改善左室射血分数(LNEF)、左室短轴缩短率(FS),二尖瓣快速充盈期和心房收缩期血流速度比(E/A)(3组P均<0.01),上述3项指标改善C组优于A组(P<0.05)和B组(P>0.05),B组优于A组(但P>0.05);同时3组治疗1年和2年,均较治疗前明显减少颈内动脉(ICA)的IMT和颈总动脉(CCA)的IMT(P均<0.05-0.01),上述作用C组优于A组(P<0.05)和B组(P<0.05),而B组优于A组(但P>0.05)。3组不良反应均轻微。结论:ACS早期应用氯吡格雷75mg/d或氯吡格雷75mg/d加阿司匹林100mg/d且一直用2年,能明显减少住院和随访期心脑事件发生,明显抑制炎症因子,改善收缩/舒张功能,减少ICA/CCA IMT,且安全耐受性好,值得临床推广应用。更多还原

【Abstract】 Objective: To explore the safety and efficacy in the early use by 75mg/d clopidogrel or by 75mg/d clopidogrel plus 100mg/d aspirin in patients after acute coronary syndrome(ACS) ,in early stage. Methods: 202 consacutive patients with ACS were divided into 3 groups randomly. Group A(n = 67)was given 100mg/d aspirin,first doses 150mg. Group B(n = 68)was given 75mg/d clopidogrel,first doses 300mg. Group C(n = 67)was given 75mg/d clopidogrel plus 100mg/d aspirin. The cardiovascular events or incidence of stroke, the inflammatory markers, the intima - media thickness, IMT, of common carotid artery and heart function and drug adverse reaction were observing during hospitalization as well as following up for 2 years. Results: There were significantly lower cardiovascular events or incidence of stroke in groups A, B, C comparing to the control group (P < 0.05), for 2 years following up. The recurrent angina pectoris arrhythmia, congestive heart failure, non - fatal myocardial infarction, Group C was better than group B(P < 0.05), and Group B was better than group A (P < 0.05) during hospitalization. There were significantly lower on recurrent angina pectoris arrhythmia, congestive heart failure, non - fatal myocardial infarction, recanalization therapy with percutaneous coronary intervention, PCI,or with coronary artery bypass surgery,CABG,and re - hospitalization in group C comparing with group A after 2 years following up( P < 0.05) . There were significant lower in p - selection, plasmnogen activator inhibiter - 1, PAI1, plasma D - dimer, serum-plasmnogen,supersensitive C - creatin protein in the groups after 6 weeks therapy, it appears that group C was better than group B(P < 0.05), and group B was better than group A (P < 0.05) . There were improved in left ventricular ejection fraction, LVEF, shortening fraction, FS, and E/A ratio after 6 weeks treatment in the groups (respectively P < 0.01). There were significantly minimized in IMT of internal carotid artery and IMT of common carotid after 1 to 2 years following up in the groups(respectively P < 0.05 - 0.01) . The drug adverse reaction was mild and similar in the groups. Conclusion: The use of 75mg/ d clopidogrel or 75mg/ d clopidogrel plus 100mg/d aspirin for 2 years seems safety and efficacy in diminishing cardiovascular events or incidence of stroke, inhibiting inflammation markers, improving systolic and diastolic of heart function, limiting the development of IMT of internal carotid artery and common carotid artery in patients with ACS in early stage. The early use of combination of clopidogrel with aspirin in patients with ACS will be good in safety, efficacy and tolerance.更多还原