复杂冠状动脉病变择期介入治疗中使用替罗非班的临床研究

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目的观察在复杂冠状动脉病变患者择期介入治疗中使用替罗非班对患者术后心脏标记物、血小板聚集率和不良心脏事件的影响,探讨其安全性和有效性。方法选择2006年8月至2007年12月首都医科大学附属北京安贞医院收治的676例复杂冠状动脉病变患者分入常规治疗组和替罗非班组。两组患者术前均常规使用阿司匹林和氯吡格雷治疗,替罗非班组患者于术中给予替罗非班并持续至少24h。观察院内实验室检查结果和术后6个月主要不良心脏事件(再发心绞痛、再次血管重建、非致死性心肌梗死、心源性死亡)的发生。结果两组间基线危险无明显差别。术后24h替罗非班组血小板聚集率(12%对41%,P=0.015)、肌钙蛋白I(21%对68%,P=0.033)和CK-MB(14%对52%,P=0.016)均明显低于常规治疗组。随访6个月时,替罗非班组再发性心绞痛(9.3%对14.3%,P=0.046)和不良心脏事件(17.3%对23.6%,P=0.043)的发生低于常规治疗组,再次血管重建、非致死性心肌梗死和心源性死亡的发生无明显差别。替罗非班组血小板数量无明显降低[(238±57)×109/L对(224±46)×109/L,P=0.328]。替罗非班组小出血事件增多(8.2%对3.7%,P=0.024),1例患者出现胃肠道出血事件,无颅内出血事件。结论使用替罗非班可以明显降低血小板聚集率,减少冠状动脉复杂病变介入治疗术后心肌标记物(TnI、CK-MB)的升高,减少患者术后6个月不良心脏事件的发生,且安全性良好。 Objective To observe the effect of tirofiban on postoperative cardiac markers, platelet aggregation rate and adverse cardiac events in patients with complicated coronary artery disease undergoing elective interventional therapy, and to investigate its safety and efficacy. Methods A total of 676 patients with complicated coronary artery disease admitted from Beijing Anzhen Hospital Affiliated to Capital Medical University from August 2006 to December 2007 were divided into two groups: conventional treatment group and tirofiban group. Both groups were routinely treated with aspirin and clopidogrel preoperatively and tirofiban was given intraoperatively in tirofiban group for at least 24 h. Intra-hospital laboratory tests and major adverse cardiac events (recurrence of angina, revascularization, non-fatal myocardial infarction, cardiac death) at 6 months were observed. Results There was no significant difference in baseline risk between the two groups. The levels of platelet aggregation (12% vs 41%, P = 0.015), troponin I (21% vs 68%, P = 0.033) and CK-MB (14% vs 52%, P = 0.016) were significantly lower than the conventional treatment group. At 6 months of follow-up, the incidence of recurrent angina (9.3% versus 14.3%, P = 0.046) and adverse cardiac events (17.3% vs. 23.6%, P = 0.043) was lower in the tirofiban group than in the conventional treatment group, Reconstruction, non-fatal myocardial infarction and cardiac death occurred no significant difference. There was no significant reduction in the number of platelets in the tirofiban group [(238 ± 57) × 109 / L versus (224 ± 46) × 109 / L, P = 0.328]. There was an increase in small bleeding in the tirofiban group (8.2% vs 3.7%, P = 0.024), 1 case of gastrointestinal bleeding, and no intracranial hemorrhage. Conclusion The use of tirofiban can significantly reduce the platelet aggregation rate and decrease the increase of myocardial markers (TnI and CK-MB) after interventional treatment of complex coronary lesions, and reduce the occurrence of adverse cardiac events 6 months after operation Good safety.
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