国产替罗非班治疗急性冠脉综合征行PCI术患者的临床效果

Clinical efficacy of China-made Tirofiban in patients with acute coronary syndrome undergoing PCI

目的评价国产血小板膜糖蛋白(GP)IIb/IIIa受体拮抗剂替罗非班(tirofiban)治疗急性冠状动脉综合征(ACS)患者在接受肝素(包括低分子肝素)、盐酸氯吡格雷、阿司匹林基础上实施经皮冠状动脉介入治疗术的有效性和安全性评价。方法将32例ACS患者按就诊顺序随机双盲分为受试组(加用替罗非班)和对照组(加用安慰剂),所有患者均正规使用肝素(包括低分子肝素)、盐酸氯吡格雷、阿司匹林。疗程48 h,观察指标为心电图改变、出血并发症、血小板聚集率,终点事件是5 d内的复合缺血事件。结果受试组心电图ST段改善情况好于对照组[(0.50±0.08)mVvs(0.42±0.07)mV,P<0.01];出血并发症比对照组有增多趋势,但无统计学差异(14%vs9%);血小板聚集率受试组明显下降(38%±8%vs44%±8%,P<0.05),受试组用药前后比较(45%±7%vs38%±8%,P<0.01),对照组用药前后比较(45%±8%vs44%±8%);5 d复合终点事件发生率受试组低于对照组(0%vs18%,但差异无显著意义)。结论替罗非班在ACS常规治疗基础上可以进一步改善心电图缺血性改变,并能进一步加强抗血小板作用,且安全性良好。

AIM To evaluate the efficacy and safety of China-made Tirofiban （Tirofiban Hydrochloride and Sodium Chloride Injection） in patients with acute coronary syndrome （ACS） undergoing PCI and treated with heparins （including low molecular weight heparins ）, clopidogrel sulfate and aspirin. METHODS Thirty-two patients, who were treated with heparins（including low molecular weight heparins） , clopidogrel sulfate and aspirin, were randomly assigned in a double-blind manner to take Tirofiban or placebo for 48 hours. The changes of ECG, bleeding and platelet aggregation rate were evaluated. The composite end point events consisted of death, myocardial infarction or refractory ischemia within 5 days. RESULTS Compared with control group, the patients of Tirofiban group had a significant improvement of ECG [ （0.50 ± 0.08） mV vs （0.42 ± 0.07） mV, P 〈 0.01 ] and bleeding occurred in 14% of the patients taking Tirofiban and in 9% of control group. A significant decrease of platelet aggregation rate was observed in the patients of Tirofiban group （38% ± 8% vs 44% ±8%, P 〈 0.05 ; before and after Tirofiban： 45% ±7% vs 38% ±8%, P〈0.01; before and after placebo： 45% ±8% vs 44% ±8%）. The frequency of the composite primary end point events within 5 days was lower in the patients taking Tirofiban than those taking placebo （0% vs 18% ）. CONCLUSION Tirofiban, as a new antiplatelet drug, may further improve electrocardiograph and safely enhance antiplatelet effect in patients with ACS on the basis of standard treatments.