择期PCI术前应用那屈肝素和达肝素钠安全性有效性的对比研究

The comparative research in safety and efficacy between nadroparin and dalteparin before elective percutaneous coronary intervention

目的:评价经皮冠状动脉介入(PCI)术前皮下注射那屈肝素和达肝素钠抗凝的安全性和有效时间。探讨2种药物抗Ⅹa因子活性与活化部分凝血活酶时间(APTT)及活化凝血时间(ACT)的关系。方法:选择行PCI术的患者101例,随机分为那屈肝素组(50例,0.01mL/kg)和达肝素钠组(51例,120IU/kg)均皮下注射,2次/d,应用至少48h后行PCI。测定血浆抗Ⅹa因子活性、ACT及APTT。观察术后1个月内出血并发症、死亡、急性心肌梗死情况。结果:1.4h后2组抗Ⅹa因子活性>0.5IU/mL均为92.0%以上;8h、12h后,那屈肝素组比例为74.0%、36.0%;达肝素钠组比例为54.9%、23.5%,2者间差异无统计学意义;24h、48h后,2组均为96.0%以上。2.2组抗Ⅹa因子活性与APTT在给药后4h、24h和48h呈正相关(P<0.05);与ACT差异无统计学意义。3.2组30d内均未发生不良临床事件,出血事件发生率相同。结论:择期PCI术前应用那屈肝素和达肝素钠抗凝安全、有效,强度至少可以维持8h。APTT能反应2种药物的有效抗凝强度,ACT则不能。

Objective： To compare the safety and efficacy between nadroparin and dalteparin before elective percutaneous coronary intervention （PCI）. Investigate the relationship among anti-Xa activities APTT and ACT, between nadropariu and dalteparin. Method： A total of 101 consecutive patients undergoing elective PCI were randomized to either nadroparin （50 cases） or dalteparin （51 cases） group for procedural antieoagulation. According to protocol, the patients in nadroparin or dalteparin group were given nadroparin （0.01 mL/kg） or daheparin （120 IU/kg） subcutaneously more than 48 hours twice per day before PCI. All patients were monitored for anticoagulation before and after PCI and adverse events （i.e. death, myocardial infarction） 30 days after PCI. Result： 101 patients were completed. 1. The proportion, plasma anti-Xa activities of patients in nadroparin or dalteparin group above 0.5 IU/mL, exceeded 92% after 4 hours subcutaneous injection. The proportion descended to 74% and 36% in nadroparin group after 8 hours and 12 hours, 54.9% and 23.5% in dalteparin group, but had no significantly difference compared with nadroparin group. After 24 hours and 48 hours, the proportion of plasma anti-Xa activities of patients in both groups were above 0.5 IU/mL, achieved steady state and exceeded 96.0% . 2. The plasma anti-Xa activities correlated with APTT significantly in both groups after 4 hours 24 hours and 48 hours （ P 〈 0.05 ） o The plasma anti-Xa activities were hardly correlated with ACT, and had no difference in Statistics. 3. There were no adverse events in 30 days, and no significantly difference about bleeding events between the two groups. Conclusion： The subcutaneous injection of nadroparin or dalteparin for anticoagulatlon in patients before elective PCI is safe and effective. Anticoagulation effects can be maintained for at least 8 hours. APTT can response to the anticoagulation effects of nadroparin or dalteparin by subcutaneous injection. ACT can not response to the effects.