国产替罗非班对急性冠脉综合征的疗效分析

Primary evaluation to safety and value in high risk strati-ficated patients with ACS referred to Tirofiban therapy

目的对急性冠脉综合症患者行PCI术,在抗血小板抗凝基础上加用国产替罗非班(欣维宁),观察疗效并行安全性评价,尤其对高危患者安全性评价作初步探讨。方法选择2005年6-2006年2月入院并明确诊断为急性冠脉综合征患者(UA/NSTEMI),符合入选条件80例,按照TIMI RISK SCORE评分方法,将入院病例分为三组:低危组(14例),中危组(45例),高危组(21例),经皮血管成形术,观察临床特征,PCI术情况,使用国产替罗非班的并发症,出血倾向,渗血,血小板减少症,在住院期间及随访期间主要心血管事件(MACE)。结果三组临床基线基本相似,但住院天数高危组明显高于中危组和低危组,有统计学差异。PCI术中病变数,其中三支病变数高危组占66.6%,中危组31.1%,低危组没有;双支病变高危组38%,中危组48.9%,低危组28.6%,三组没有明显统计学差异。使用国产替罗非班观察中,高危组并发症及出血比例较高,血尿19%,黑粪症23.5%,胃溃疡大出血2例(9.5%),脑出血1例(4.8%),但与其他两组比较没有统计学差异;渗血发生率,低危组21.4%(3例),中危组15.6%(7例),高危组28.5%(6例);血小板减少症高危组9.5%(2例),中危组2.2%(1例);咯血低危组21.4%,中危组13.3%。住院期间MACE非致命心梗,高危组14.3%(3例),中危组8.9%(4例);心脏性死亡高危组4.8%(1例),中危组4.4%(2例),随访期间MACE总死亡率,高危组51.7%(12例),中危组35.6%(16例),低危组28.6%(4例),三组之间没有显著差异。结论国产替罗非班治疗对经皮血管成形术后急性冠脉综合征(UA/NSTEMI)患者是安全有效的,对高危险分层患者亦可安全使用。

Objective To investigate the values and safety of Tirofiban in high risk stratificated patients with acute coronary syndromes referred to percutaneous coronary intervention（PCI）. Methods Eighty patients suffered from acute coronary syndromes （UA/NSTEMI） between June 2005 and February 2006 were selected and divided into 3 groups according to TIMI Risk Score： low risk group（ 14 cases） ,medial risk groups（45 cases）, high risk group（21 cases）. These patients who had undergone PCI were observed on clinical characteristics, PCI outcomes, the rate of bleeding, transfusion, thrombocytopenia and the incidence of complications by Tirofiban, the major cardiovascular events （MACE） during the hospital days and the follow-up period of 4-12 months （means 10.6 monthes） were analyzed. Results The clinical characteristics were similar for 3 groups, but the duration of hospitalization was longer in high risk group than that of the others （ 16.52 ± 4.56 days in high risk group vs. 12.17 ± 7.97 days in medial group, and 11.65 ± 3.98 days in low risk group, P〈0.05）. PCI outcomes showed that three artery stenosis was 66.6% in high risk group,31.1% in medial, none found in low risk group; two coronary artery stenosis was 38% in high risk group,48.9% in medial group,25.6% in low risk group, no statistical significant difference observed. The bleeding and complications due to Tirofiban was higher in high risk group： 19%gross hematuria, 23.5% melena, 9.5% gastric ulcer bleeding,4.8% cerebrovascular diseases, but there was no statistical significance as compared with the other groups. The rate of transfusion was 21.4% in low risk group, 15.6% in medial risk group, 28.3% in high risk group. The incidence proportion of thromhocytopenia was 9.5 % in high risk group, 2.2 % in medial risk group; emptysis was 21.4% in low risk group, 13.3% in medial risk group. During hospitalization, the incidence proportion of MACE including non-fatal myocardial infarction, the high risk group was 14.3% （3 cases）, 8.9% in medial risk group （4 cases）. Cardiac death in the high risk group was 4.8 % （ 1 case）, 4.4 % in medial risk group（2 case）, the total rate of MACE in follow-up period was 51.7% in high risk group （ 12 case）, 35.6% in medial risk group（16 cases）, 28.6% in low risk group（4 cases）, there was no statistical significant difference among the three groups. Conclusion The results suggest that Tirofiban is a safe and tolerable therapy drug for ACS （UA/NSTEMI） patients referred to percutaneous coronary intervention , the same as to high risk stratificated patients.