经皮冠状动脉介入术中选择不同剂量达肝素抗凝的安全性和有效性研究

Research of safety and effectiveness by different doses of dalteparin for anticoagulation in percutaneous coronary intervention

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 safety and effectiveness by daheparin for anticoagulation in percutaneous coronary intervention （PCI）. Methods A total of 300 patients receiving stent implantation after coronary angiogram operation were randomly divided into UFH group（unfractionated heparin by 100 U/kg）. 60 IU group （daheparin by 60 IU/kg） and 80 IU group （daheparin by 80 IU/kg）, with 100 cases in each group. Records were made on anti-Xa factor activity and their standard reaching rate in 60 IU group and 80 IU group at different time points. Occurrence of adverse cardiac events and bleeding events were observed in the three groups. Results There was no statistically significant difference of incidence of adverse cardiac events in the three groups （P〉0.05）. Incidence of bleeding events in 60 IU group and 80 IU group were obviously lower than that in UFH group, and their difference had statistical significance （P〈0.05）, while the difference of incidence of bleeding events had no statistical significance between 60 IU group and 80 IU group （P〉0.05）. At each time points after dalteparin injection, there was no statistically significant difference of anti- Xa factor activity between 60 IU group and 80 IU group （P〉0.05）. Standard reaching rate of anti- Xa factor activity in 80 IU group after 1, 2 h of daheparin injection was respectively 100% and 93%, which were obviously higher than 93% and 80% in 60 IU group, and their difference had statistical significance （P〈O.05）. The difference of standard reaching rate of anti-Xa factor activity at the other time points had no statistical significance between the two groups （P〉0.05）, Conclusion Dalteparin shows similar safety and effectiveness as unfractionated heparin for anticoagulation effect in PCI, along with much fewer bleeding events. Comparing with dose by 60 IU/kg, implement of dose by 80 IU/kg shows higher standard reaching rate of anti- X a factor activity within 2 h after administration, without increased incidence of bleeding events. This method is worth further clinical research.