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目的评价达肝素在经皮冠状动脉介入术(PCI)中抗凝的安全性和有效性。方法 300例择期行冠状动脉造影手术后行支架置入术患者,随机分UFH组(给予普通肝素100 U/kg)、60 IU组(给予达肝素60 IU/kg)和80 IU组(给予80 IU/kg),各100例。记录60 IU组与80 IU组在不同时间的抗Ⅹa因子活性及其达标率,同时观察三组治疗期间心脏不良事件发生情况、出血事件发生情况。结果三组心脏不良事件发生率两两比较,差异无统计学意义(P>0.05);60 IU组及80 IU组出血事件发生率均明显低于UFH组,差异具有统计学意义(P<0.05);60 IU组与80 IU组出血事件发生率比较,差异无统计学意义(P>0.05);60 IU组及80 IU组注入达肝素后各时间抗Ⅹa因子活性比较差异无统计学意义(P>0.05)。80 IU组注入达肝素后1、2 h抗Ⅹa因子活性达标率分别为100%、93%,明显高于60 IU组的93%、80%,差异具有统计学意义(P<0.05);其他时间抗Ⅹa因子活性达标率比较差异无统计学意义(P>0.05)。结论达肝素与普通肝素在PCI术中的抗凝效果同样安全有效,同时出血事件更少,而在给药2 h内80 IU/kg的剂量较60 IU/kg可以使抗Ⅹa因子活性达标率更高,且不提高出血事件发生率,临床可进一步研究。
Objective To evaluate the safety and efficacy of dalteparin in anticoagulation during percutaneous coronary intervention (PCI). Methods Three hundred patients undergoing coronary angiography underwent stent placement were randomly divided into UFH group (given UFH 100 U / kg), 60 IU group (given dalteparin 60 IU / kg) and 80 IU group IU / kg), each 100 cases. The anti-factor Xa activity and compliance rate of 60 IU group and 80 IU group at different time were recorded. The occurrence of cardiac adverse events and bleeding events during the three groups were also observed. Results There was no significant difference in the incidence of cardiac adverse events among the three groups (P> 0.05). The incidence of bleeding in 60 IU group and 80 IU group was significantly lower than that in UFH group (P <0.05) ). There was no significant difference in the incidence of hemorrhage between the 60 IU group and the 80 IU group (P> 0.05). There was no significant difference in the anti-Ⅹa activity between the 60 IU group and the 80 IU group after dalteparin injection P> 0.05). The compliance rates of anti-factor Xa activity in 100 IU group at 1 and 2 h were 100% and 93%, respectively, which were significantly higher than those in 60 IU group (93% and 80%, P <0.05) Time anti-Ⅹ a factor activity compliance rate was no significant difference (P> 0.05). Conclusion The anticoagulant effect of dalteparin and unfractionated heparin in PCI is also safe and effective with fewer bleeding events. However, the dose of 80 IU / kg within 2 h after dosing is 60 IU / kg, which can make the anti-Xa activity rate Higher, and does not increase the incidence of bleeding events, clinically for further study.