不同负荷剂量氯吡格雷在急性ST段抬高心肌梗死中应用的临床对比研究

Different clopidogrel loading dose strategies for patients with acute ST-segment elevation myocardial infarction

目的对比研究经皮冠脉介入治疗(PCI)术前应用氯吡格雷常规负荷剂量(300mg)与高负荷剂量(600mg)对急性ST段抬高心肌梗死(STEMI)患者的近期疗效和安全性。方法 2006年8月至2008年2月的131例急性STEMI患者随机分为两组,其临床基本资料中,除年龄外,性别、基本用药等均无显著差异(P>0.05)。两组术前2h分别给予600mg(A组,n=65)和300mg(B组,n=66)负荷剂量氯吡格雷预治疗,之后均予75mg/d维持量。比较两组30d主要心血管事件(死亡、再发心肌梗死、紧急靶血管血运重建、心绞痛、脑卒中、再入院)、术后2hST段回落、术后心肌肌钙蛋白I(cTnI)峰值、30d出血事件和不良反应发生情况。结果两组PCI基线特征无明显差异。A组与B组比较,30d主要心血管事件〔7.7%(5/65)vs19.7%(13/66),P<0.05〕、术后2hST段回落〔70.8%(46/65)vs45.5%(30/66),P<0.05〕、术后cTnI峰值〔(15±3)μg/Lvs(22±5)μg/L,P<0.01〕差异有统计学意义;30d出血事件〔9.2%(6/65)vs7.6%(5/66),P>0.05〕和不良反应〔12.3%(8/65)vs10.6%(7/66),P>0.05〕差异无统计学意义。结论与常规负荷剂量(300mg)相比,高负荷剂量(600mg)氯吡格雷可显著改善急性STEMI行PCI患者的近期疗效,且安全性相似。

Objective To compare the short-term efficiency and safety of high （600 mg） versus low （300 mg） loading doses of clopidogrel in patients with acute ST-segment elevation myocardial infarction （STEMI） before percu- taneous coronary intervention （PCI）. Methods From August 2006 to Feburary 2008, a total of 131 patients with acute STEMI were randomly divided into two groups. Except age, there was no significant difference in baseline data between the two groups （P〉0. 05）. Two hours before PCI, the patients respectively received 600mg （group A, n= 65） and 300mg （group B, n=66） loading dose of clopidogrel administration, followed by the maintenance dose of 75 mg/d. After 30-day follow-up, the incidence of major clinical cardiovascular events including death, recurrent myocardial infarction, urgent target vessel revascularization, angina pectoris, stroke, readmission, ST segment resolution two hours after the procedure, cardiac troponin I（cTnI） peak, hemorrhagic events, and adverse reactions were compared between the two groups. Results The baseline data before PCI were not different between the two groups. The incidence of 30-day major clinical cardiovascular events （7. 7% vs 19. 7% ,P〈0. 05）, ST segment resolution two hours after the procedure （70. 8% vs 45. 5%, P〈0. 05）, and cTnI peak after the procedure [（16 ± 3） ug/L vs （22±5） ug/L, P〈0. 011 had significant difference between the two groups. The 30-day hemorrhagic events （9.2% vs 7.6%, P〉0. 05） and adverse reactions （12.3G vs 10.6%, P〉0.05） had no significant difference between the two groups. Conclusion Compared with routine loading dose （300mg）, high loading dose （600mg） clopidogrel pretreatment can significantly improve the short term outcome of the patients with acute STEMI undergoing PCI, and the safety was identical.