不同时期小剂量国产替罗非班在急性冠状动脉综合征介入治疗中的初步应用的疗效及安全性

目的 观察小剂量国产替罗非班在急性冠状动脉综合征(ACS)介入治疗中应用的疗效及安全性.方法 共入选162 例ACS 患者,其中男90 例,女72 例,均符合冠状动脉介入治疗适应证并成功进行了冠状动脉血运重建.将入选患者随机分为两组,A 组80 例,术前30 min 或术中立即按说明书提供的剂量减半(0.2 μg· kg-1 · min-1 )静脉滴注应用国产盐酸替罗非班,30 min 后改为0.05 μg· kg-1 · min-1,连续静脉滴注24 ～48 h;B 组82 例,术后回到病房即刻应用盐酸替罗非班,剂量及方法同A 组.两组术后肝素或低分子肝素减为半量,阿司匹林及氯吡格雷按ACS 的常规剂量使用.观察用药后30 d 内任何原因的死亡、新的心肌梗死及顽固性心绞痛的发生情况.结果 A 组30 d 内因急性泵功能衰竭死亡1 例(1.25%),无新的心肌梗死及顽固性心绞痛发生;B 组30 d 内出现顽固性心绞痛1 例(1.22%),无死亡及新发心肌梗死;A、B 两组间无统计学差异(χ2 ＝0.19,P >0.05).A 组发生轻中度出血4 例(5.00%),无严重出血发生;B 组发生轻中度出血3 例(3.66%),无严重出血发生;A、B 两组间无统计学差异(χ2 ＝0.0001,P >0.05).A 组血小板聚集率从(63.5 ±17.4)%降为用药后的(31.7 ±13.5)%,差异有统计学意义(t ＝6.28,P <0.05);B 组血小板聚集率从(64.1 ±18.2)%降为用药后的(32.4 ±13.3)%,差异有统计学意义(t ＝6.28,P <0.05);A、B两组间无统计学差异(t ＝1.62,P >0.05).结论 术前30 min、术中或术后应用小剂量替罗非班均有良好的抗血小板作用,无严重出血并发症,安全性良好.

Clinical efficacy and safety of low-dose of tirofiban in percutaneous coronary intervention in patients with acute coronary syndrome

Objective To access clinical efficacy and safety of low-dose of tirofiban in percutaneous coronary intervention（PCI）in patients with acute coronary syndrome（ACS）.Methods 162 patients with ACS（90 males,72 females）,who were in line with PCI indications and received coronary revascularization successfully,were enrolled and divided into two groups.80 patients in Group A were given intravenous drip of tirofiban in a dose of 0.2 μg·kg-1·min-1 for 30 min（half dose of that provided in the instructions）,then given continuous intravenous drip in a dose of 0.05 μg·kg-1·min-1 for 24-48 h.The difference in Goup B was that 82 patients were given tirofiban after PCI.Heparin or low-molecular-weight heparin was reduced by half,and aspirin and clopidogrel were given by conventional-dose.Death for any reason,new myocardial infarction and refractory angina pectoris were observed within 30 days after use of tirofiban.Results Among 30 days of medication in Group A,one died of acute heart failure（1.25%）,no more myocardial infarction and refractory angina pectoris occurred.In Group B,one presented with refractory angina pectoris（1.22%）,no more death and myocardial infarction occurred.There was no significant difference between the two groups（χ2=0.19,P〈0.05）.In Group A,four cases presented with mild-moderate bleeding（5.00%）.Three cases presented with mild-moderate bleeding（3.66%）in Group B.None severe bleeding occurred in two groups.Platelet aggregation rates were down from（63.5±17.4）% to（31.7±13.5）% in Group A.The difference had statistical significance（t=6.28,P〈0.05）,and platelet aggregation rates were down from（64.1±18.2）% to（32.4±13.3）% in Group B,the difference also had statistical significance（t=6.28,P〈0.05）,but there was no significant difference between the two groups.Conclusions Low-dose of tirofiban is a safe drug with a good anti-platelet effect,whose using time is flexible with no serious bleeding complications.