CAJ | 학술논문

目的探讨中高危非ST段抬高型急性冠状动脉综合征(NSTE-ACS)患者成功经皮冠状动脉介入治疗(PCI)后即刻应用替罗非班的疗效和安全性.方法 246例成功行PCI的中高危NSTE-ACS患者按照信封法随机分为替罗非班组(PCI后即刻静脉应用替罗非班,共122例)和对照组(PCI后即刻静脉应用生理盐水,共124例).主要有效性终点为术后30 d复合终点(死亡、心肌梗死、靶血管血运重建及缺血性卒中)的发生率；次要有效性终点为术后7d和6个月复合终点的发生率.安全性终点为术后3d出血和血小板减少症的发生率.结果两组患者的基线特征差异无统计学意义(P＞0.05).替罗非班组术后30 d主要有效性终点的发生率为0.9％ (1/117),对照组为3.3％ (4/123),差异无统计学意义(P=0.40).术后7d两组之间复合终点的发生率差异无统计学意义[0.8％ (1/122)比3.2％ (4/124),P=0.38].术后6个月,替罗非班组的复合终点发生率低于对照组,但差异无统计学意义[0.9％ (1/117)比5.9％ (7/118),P=0.07].替罗非班组术后6个月无复合终点发生的生存率显著高于对照组(99.2％比94.2％,log-rank检验P=0.03).术后3d,未发生GUSTO中重度出血和重度血小板减少.替罗非班组和对照组轻微出血[13.1％ (16/122)比7.3％ (9/124),P=0.13]和轻度血小板减少[0.8％ (1/122)比0.8％ (1/124),P=1.00]的发生率差异无统计学意义.结论对于中高危NSTE-ACS患者,成功PCI后应用替罗非班可以改善术后6个月的无事件生存率,且不增加出血.
목적 탐토중고위비ST단태고형급성관상동맥종합정(NSTE-ACS)환자성공경피관상동맥개입치료(PCI)후즉각응용체라비반적료효화안전성.방법 246례성공행PCI적중고위NSTE-ACS환자안조신봉법수궤분위체라비반조(PCI후즉각정맥응용체라비반,공122례)화대조조(PCI후즉각정맥응용생리염수,공124례).주요유효성종점위술후30 d복합종점(사망、심기경사、파혈관혈운중건급결혈성졸중)적발생솔；차요유효성종점위술후7d화6개월복합종점적발생솔.안전성종점위술후3d출혈화혈소판감소증적발생솔.결과 량조환자적기선특정차이무통계학의의(P＞0.05).체라비반조술후30 d주요유효성종점적발생솔위0.9％ (1/117),대조조위3.3％ (4/123),차이무통계학의의(P=0.40).술후7d량조지간복합종점적발생솔차이무통계학의의[0.8％ (1/122)비3.2％ (4/124),P=0.38].술후6개월,체라비반조적복합종점발생솔저우대조조,단차이무통계학의의[0.9％ (1/117)비5.9％ (7/118),P=0.07].체라비반조술후6개월무복합종점발생적생존솔현저고우대조조(99.2％비94.2％,log-rank검험P=0.03).술후3d,미발생GUSTO중중도출혈화중도혈소판감소.체라비반조화대조조경미출혈[13.1％ (16/122)비7.3％ (9/124),P=0.13]화경도혈소판감소[0.8％ (1/122)비0.8％ (1/124),P=1.00]적발생솔차이무통계학의의.결론 대우중고위NSTE-ACS환자,성공PCI후응용체라비반가이개선술후6개월적무사건생존솔,차불증가출혈.
Objective To evaluate the efficacy and safety of tirofiban use immediately after successful percutaneous coronary intervention (PCI) in patients with moderate to high risk non-ST segment elevation acute coronary syndromes (NSTE-ACS).Methods NSTE-ACS patients undergoing successful PCI (n =246) were randomized by the envelope method to tirofiban group (n =122,10 μg/kg bolus within 3 min followed by 0.10-0.15 μg · kg-1 · min-1 for 36 h i.v.) or control group (n =124,saline i.v.for 36 h).The primary efficacy composite end point was death,myocardial infarction,target vascular revascularization or ischemic stroke at 30 days.The second end point was the occurrence of composite end point at 7 days or 6 months.Key safety end points were bleeding and thrombocytopenia 3 days after PCI.Results Baseline characteristics were well-balanced between the two groups (P ＞ 0.05).The primary end point occurred in 0.9％ (1/117) patients in the tirofiban group and 3.3％ (4/123) patients of those in the control group (P =0.40).There was no significant difference in the composite end point at 7 days [0.8％ (1/122) vs.3.2％ (4/124),P=0.38] between the groups,however,there was a trend towards lower composite efficacy end points at 6 months in tirofiban group compared to control group [0.9％(1/117) vs.5.9％ (7/118),P =0.07].The probability of survival free of composite end point was significantly higher in the tirofiban group than that in the control group (99.2％ vs.94.2％,log-rank test,P =0.03).There was no GUSTO severe or moderate bleeding or severe thrombocytopenia within 3 days postPCI.There was no significant difference in mild bleeding [13.1％ (16/122) vs.7.3％ (9/124),P =0.13] or mild thrombocytopenia [0.8％(1/122) vs.0.8％(1/124),P =1.00] between the groups.Conclusion Tirofiban use after successful PCI can improve 6-month event-free survival without increasing the risk of bleeding for patients with moderate to high risk NSTE-ACS.