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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。
Objective: To investigate the efficacy and safety of early use of clopidogrel 75 mg / d and clopidogrel 75 mg / d plus aspirin 100 mg / d in patients with acute coronary syndrome (ACS). Methods: 202 patients with ACS were randomly divided into three groups. A group (aspirin group) 67 cases, the first dose of 150mg / d, then 100mg / d; B group (clopidogrel group) 68 cases, the first dose of 300mg / d, then 75gm / d; C group (clopidogrel plus aspirin Group), aspirin 100 mg / d and clopidogrel 75 mg / d for 2 years. The occurrence of cardiovascular and cerebrovascular events during hospitalization and follow-up, anti-inflammatory factors, improvement of cardiac function and reduction of carotid intima- Thickness (IMT) effect, adverse drug reactions. Results: Cardiovascular and cerebrovascular events were reduced during hospitalization and follow-up of 2 years. However, the incidence of recurrent angina pectoris (AP), arrhythmia and heart failure (HF) in hospitalized group C was better than that in group B (P> 0.05) ) Was superior to group A (P <0.05), while group B was better than group A (p> 0.05); Follow-up 2 years, relapse AP, non-fatal MI, arrhythmia, (PCI / CABG) undergoing percutaneous transluminal coronary angioplasty and coronary artery bypass grafting (PCI / CABG), hospitalization due to ischemic attack, and C group were significantly less than those of A group (P <0.05). At the same time, P-selectin, PAI-1, D-dimer, fibrinogen (FG), high sensitivity C-reactive protein (hs-CRP) were significantly lower than before treatment (P <0.01). The effect of group C on reducing the above five inflammatory substances was better than that of group B (P <0.05), which was better than group A (p <0.05); Group B was better than group A, but P> 0.05.3 (P <0.05), and significantly improved the left ventricular ejection fraction (LNEF), left ventricular fractional shortening (FS), mitral valve filling velocity and atrial systolic velocity ratio (E / A) <0.01). The improvement of the above three indexes was better in group C than in group A (P <0.05) and group B (P> 0.05), in group B was superior to group A (P> 0.05) (P <0.05-0.01), which were significantly lower than those of group A (P <0.05) and group B (P <0.05), while group B was better than group A (P> 0.05). 3 adverse reactions were mild. CONCLUSIONS: Early application of clopidogrel 75 mg / d or clopidogrel 75 mg / d plus aspirin 100 mg / d for 2 years has significantly reduced cardiovascular events during hospitalization and follow-up, markedly suppressed inflammatory cytokines, and improved systolic / diastolic Function, reduce ICA / CCA IMT, and good safety tolerance, it is worth clinical application.