急性冠状动脉综合征介入治疗中应用那屈肝素的临床研究

目的 研究急性冠状动脉综合征患者在经皮冠状动脉介入治疗前应用那屈肝素的合适剂量并评估其安全性.方法 236例急性冠状动脉综合征高危患者随机分为Ⅰ组(那屈肝素0.075ml/10 kg,120例)和Ⅱ组(那屈肝素0.1 ml/10 kg,116例).两组给予相应剂量那屈肝素,每12 h皮下注射1次,至少48 h,最后一次注射1 h后行经皮冠状动脉介入治疗,术中不再追加那屈肝素.分别在末次注射前、注射后1 h、2 h、4 h、6 h、8 h测定血浆抗Xa因子活性.观察记录患者30 d内的主要心脏不良事件(死亡、再梗死、血运重建)及出血事件.结果 两组的一般临床资料、30 d内随访主要心脏事件及出血发生率差异均无统计学意义(P>0.05).各时间点血浆抗Xa因子活性Ⅱ组高于Ⅰ组,差异有统计学意义(P<0.01).结论 在急性冠状动脉综合征介入治疗前应用两种剂量那屈肝素均能达到有效的抗凝效果.

Efficacy comparison with low and high dose natroparin for patients with acute coronary syndrome underwent percutaneous coronary intervention

Objective To evaluate the safety and optimal piror pereutaneous coronary intervention (PCI) natroparin dose in patients with acute coronary syndrome (ACS).Methods A total of 236 ACS patients were randomly treated with subcutaneously natroparin 0.075 ml/10 kg(group I,n=120) and 0.1 ml/10 kg(group Ⅱ,n=116) respectively (bid for 48 hours).PCI was the performed 1 h after final natroparin injection.No additional natroparin wag applied during PCI.Plasmic anti-Xa level was assayed before and at 1,2,4 and 8 hours after final natroparin administration.Adverse clinical events (death,myocardial infarction,need for revasculafization) and bleeding events were recorded up to 30 days post PCI.Results Baseline clinical characteristics as well as the MACE and severe bleeding events between the two groups were similar(all P>0.05).Plasmic anti-Xa level of group Ⅱ was significantly higher than that of group I post natroparin application (P<0.01).Conclusion Anticogulation effects and MACE as well fits severe bleeding events up to 30 chys post PCI were similar with either 0.075 ml/lO kg or 0.1 ml/10 kg natroparin dose in ACS patients.