国产与进口低分子肝素在血液透析中抗凝作用的比较

Comparison of anticoagulation efficacy and clinical safety between imported and domestically manufactured low-molecular-weight heparin during hemodialysis

目的比较国产与进口低分子肝素在血液透析中的抗凝效果和安全性。方法60例血液透析病人随机分为2组,透析过程中分别注射单剂量国产和进口低分子肝素。透析时取血检测部分凝血活酶时间(aPTT)、凝血酶原时间(PT)、凝血酶时间(TT)及因子Xa活性;透析结束后观察透析器及管道凝血情况、动脉穿刺点压迫止血时间。结果两组病人体外循环凝血发生率低且无显著差异,患者均无出血倾向。两组患者在动脉穿刺点压迫止血时间、血浆因子Xa水平及aPTT、TT、PT的变化等方面均无显著差异(P>0.05)。结论国产与进口低分子肝素在血液透析中的抗凝效果及安全性基本相同,国产低分子肝素可替代进口低分子肝素。

Objective To compare the anticoagulation efficacy and clinical safety of domestically manufactured and imported low-molecular-weight-heparin during hemodialysis. Methods Sixty patients on hemodialysis were randomly divided into 2 groups, who received intravascular injections of domestically manufactured or imported low-molecular-weight heparin to prevent coagulation. Active partial thromboplastin time (aPTT), prothrombin time (PT), thrombin time (TT) and factor Xa activity were determined during dialysis. Results No incidence of major bleeding was encountered in all of these patients. Similarly low incidences of clotting in extracorporeal circuit were found in either group. No significant differences in aPTT, PT, TT and plasma levels of factor Xa were observed between the two groups. Conclusion Low-molecular-weight heparin domestically manufactured is safe and efficient for anticoagulation during hemodialysis as compared with the imported heparin.