不同剂量氯吡格雷对经皮冠状动脉介入治疗的冠状动脉左主干病变患者的疗效与安全性

目的：评价不同剂量氯吡格雷对经皮冠状动脉介入治疗(PCI)的冠状动脉左主干病变患者的近期疗效和安全性。方法：2006年1月至2010年1月因冠状动脉左主干病变(左主干狭窄＞75％)在北京安贞医院抢救中心接受PCI、年龄≤75岁的患者为研究对象，收集其临床资料进行回顾性分析。根据服用氯吡格雷剂量将患者分为75 mg剂量组(PCI治疗后第1～30天口服氯吡格雷75 mg/d)和150 rmg剂量组(PCI治疗后第1～30天口服氯吡格雷150 mg/d)。记录2组患者PCI治疗前和治疗后1、7、14、30 d 血小板最大聚集率和最大聚集时间，观察2组患者住院期间不良反应的发生情况。结果：共120例PCI治疗后住院患者纳入研究。其中，75 mg剂量组男性46例，女性18例，平均年龄(55±7)岁；150 mg剂量组男性35例，女性21例，平均年龄(50±8)岁。PCI治疗前和治疗后1、7、14、30 d血小板最大聚集率和最大聚集时间，75 mg剂量组分别为84％±18％和(240±48)s、81％±14％和(238±44)s、59％±12％和(210±42)s、48％±10％和(199±40)s、43％±10％和(184±30)s,150 mg剂量组分别为86％±16％和(244±46)s、77％±16％和(239±46)s、51％±11％和(180±41)s、40％±10％和(166±33)s、38％±9％和(159±35)s，治疗后2组患者血小板最大聚集率和最大聚集时间均呈下降趋势,但150 mg剂量组这2项指标均低于75 mg剂量组(均P＜0.01)。2组2项指标治疗后7、14、30 d分别与治疗前、治疗后1 d相比差异均有统计学意义(均P＜0.05)；2组血小板最大聚集率治疗后14、30 d与治疗后7 d相比差异有统计学意义(P＜0.05)；150 mg剂量组血小板最大聚集率治疗后1 d与治疗前相比差异有统计学意义(均P＜0.05)。2组患者均未出现严重出血、再发心肌梗死、中风等心血管事件。*轻微出血和腹痛、消化不良、便秘、皮疹、头晕、头痛等不良反应发生率(75 mg剂量组12例、18.7％，150 mg剂量组13例、23.1％)组间差异无统计学意义(x2=1.046，P=0.593)。结论：在冠状动脉左主干病变患者经皮冠状动脉介入治疗后的抗血栓治疗中，氯吡格雷150 mg/d和75 mg/d均为有效、安全的剂量，但150 mg/d较75 mg/d能更明显地降低血小板聚集且不增加出血风险，可能更有利于减少PCI治疗后血栓的发生。

Efficacy and safety of different doses of clopidogrel therapy in patients with left main coronary artery disease undergoing percutaneous coronary intervention

Objective： To evaluate the short-term efficacy and safety of different doses of elopidogrel therapy in patients with left main coronary artery disease undergoing pereutaneous coronary intervention （PCI）. Methods： The ~〈 75-year-old patients with left main coronary artery disease （a 〉75% steaosis in the left main stem） undergoing PCI were hospitalized in Emergency Department of Beijing Anzhen Hospital from January 20136 to January 2010 and served as the subjects. All clinical data from the subjects were collected and retrospective analysis was conducted. Patients were divided into the 75 mg dose group （ oral administration of 75 mg/d on days 1-30 after PCI） and the 150 mE dose group （oral administration of 150 mg/d on days 1-30 after PCI） according to the doses of elopidogrel use. Maximal platelet aggregation rate and time was measured and recorded before PCI and 1,7, 14 and 30 days after PCI, and adverse events were observed during haspitalization. Results： A total of 120 hospitalized patients undergoing PCI were enrolled in this study. Of them, 46 were male and 18 were female with mean age of （52 ± 7 ） years in the 75 mg dose group and 35 were male and 21 were female with mean age of （50 ±8） years in the 150 mg dose group. The maximal platelet aggregation rates and time before PCI and 1, 7, 14, 30 days after PCI were 84% ± 18% and （240 ± 48） s. 81% ± 14% and（238±44） s. 59% ± 12% and （210 ± 42） s.48% ± 10% and （ 199 ± 40）s, 43% ± 10% and （ 184 ± 30） s in the 75 mg dose group, and 86% ± 16% and （244 ± 46） s, 77% ± 16% and （239±46）s, 51% ±11% and （180±41）s, 40% ±10% and （166±33）s, 38% ±9% and （159±35）s in the 150 mg dose group. The results of maximal platelet aggregation rate and time showed a decreasing trend after PCI in both groups and the values of the 2 indexes in the 150 mg dose group were lower than those in the 75 mg dose group （all P 〈0.01）. In a comparison of the two platelet aggregation index values 7, 14 and 30 days after PCI with those before PCI or one day after PCI in both groups respectively, the differences were statistically significant （ all P 〈 0.05 ）. A comparison of maximal platelet aggregation rate 14 and 30 days after PCI with those 7 days after PCI in both groups showed that the differences were statistically significant （ all P 〈0.05）. In the 150 mg dose group, a comparison of maximal platelet aggregation rate one day after PCI with that before PCI revealed that the difference was statistically significant （P 〈 0.05 ）. There were no cardiovascular events such as severe bleeding, myocardial reinfarction and stroke in patients in both groups. No statistically significant between-group difference was found in the incidence [ 12 cases （ 18.7% ） in the 75 mg dose group, 13 cases （23. 1% ） in the 150 mg dose group] of adverse reactions, including mild bleeding, abdominal pain, dyspepsia, constipation, rash , dizziness, and headache （ χ2 = 1. 046,P = 0.593 ）. Conclusion： The dose of elopidogrel 75 mg/d or 150 mg/d is effective and safe in the treatment of patients with left main coronary artery disease undergoing PCI. However, compared with the dose of 75 mg/d, clopidogrel 150 mg/d could significantly inhibit the platelet aggregation and not increase the risk of bleeding, so it might be more beneficial to reduction of the ocurrenee of thrombosis after PCI.