摘要
目的评价氯吡格雷600mg负荷量后予150mg维持量治疗对植入药物洗脱支架(drug eluting stents,DES)的急性冠脉综合征(acute coronary syndromes,ACS)患者的长期疗效及安全性。方法2004年12月到2005年12月前瞻性入选608名成功行DES植入术的ACS患者。所有患者于术前顿服600mg负荷量氯吡格雷,术后在服用阿司匹林基础上随机接受每日75mg(n=307)或150mg(n=301)维持量的氯吡格雷治疗30d,30d后所有患者接受每日75mg的氯吡格雷治疗直至术后1年。主要终点包括全因死亡、致死或非致死性心肌梗死(myocardial infarction,MI)以及靶血管血运重建(target vessel revascularization,TVR)。次级终点包括严重及轻微出血事件。结果平均随访时间为18个月。150mg组MI及再次血运重建发生率均显著低于75mg组(P<0.05)。包括死亡、MI及TVR的主要终点发生率三联组亦显著低于两联组(13%比20.2%,绝对风险降低7.2%,P=0.017)。两组全因病死率无明显差异(2.7%比4.2%,P=0.375)。两组间严重出血(2.3%比1.6%,P=0.574)、轻微出血(9.0%比6.8%,P=0.368)和输血(2.0%比1.3%,P=0.542)的风险无差异。结论在600mg负荷量治疗后再给予150mg高维持量氯吡格雷可降低ACS行DES植入术的患者术后长期发生不良事件的风险,并且不增加出血事件的发生。
Objective by 150 mg as maintenance To evaluate the efficacy and safety dose in patients with acute coronary （DES） implantation. Methods Totally 608 consecutive ACS of a 600 mg loading dose of clopidogrel followed syndrome （ACS） undergoing drug-eluting stent patients undergoing DES implantation were enrolled in our hospital from December 2004 to December 2005. A 600 mg loading dose was administered before percutaneous coronary intervention （ PCI）, and then the patients were randomized to receive clopidogrel 75 mg （n =307）or 150 mg （n =301 ）per day for30 d in addition to 300 mg aspirin daily. From 30 d to 12 months after the operation, all patients received 75 mg/d clopidogrel and were followed up for a mean period of 18 months. Results The ratios of fatal or non-fatal myocardial infarction （MI） and target vessel revascularization （TVR） were significantly lower in the 150 mg group than in the 75 mg group （3.7% vs 8.1%, P = 0. 025; 9% vs 14.7%, P =0.033）. So the overall incidence of primary end point including death, MI and TVR was obviously lower in the 150 mg group than in the 75 mg group （ 13% vs 20.2% absolute risk reduction 7.2%, P =0.017）. There was no significant difference in the incidence of all-cause death between 2 groups （2.7% vs 4.2%, P =0. 375）. While for secondary end points such as major and minor bleeding difference was seen between 2 groups （2.3% vs 1.6% , P =0.574 ; 9.0% vs 6.8% , P events, no significant =0. 368）. So was the need for blood transfusions （2.0% vs 1. 3 %, P = 0.542）. Conclusion A high clopidogrel maintenance dose of 150 mg daily for the first month after PCI procedure following a 600 mg loading dose reduces the risk of adverse events in patients with ACS undergoing DES implantation and appears to be safe.
出处
《第三军医大学学报》
CAS
CSCD
北大核心
2008年第5期435-438,共4页
Journal of Third Military Medical University
关键词
血管成形术
经皮
经腔
氯吡格雷
维持量
percutaneous transluminal coronary angioplasty
clopidogrel
maintenance dose
