国产相对低分子质量肝素钠在常规血透中的应用

Efficacy and safety of domestic low molecular weight heparin in haemodialysis patients: a randomized, controlled clinical trial

目的:比较国产与进口相对低分子质量肝素钠(LMWH)注射液在常规血透患者中应用的有效性和安全性。方法:90例维持性血透患者随机分为2组,分别接受国产或进口LMWH治疗,观察透析器和透析管路的凝血情况、内瘘穿刺点压迫时间、血Xa因子活性和活化的部分凝血酶时间(APTT)变化以及药物不良反应。结果:2组患者均能顺利完成4-5.5 h的血透治疗,仅少数患者发生轻微透析器和管路凝血,2组患者在内瘘穿刺点压迫时间、血浆抗Xa因子和APTT的变化方面均相似;2组药物不良反应如肝功能损害、出血性并发症、血小板减少、过敏反应等发生率均较低;以上指标2组间比较P均>0.05。结论:国产与进口IMWH的有效性和安全性相似。

AIM:To evaluate the efficacy and safety of domestically manufactured low molecular weight heparin (LMWH) sodium in haemodialysis patients and compare with imported LMWH. METHODS: Ninety patients of maintaining haemodialysis were randomly divided into 2 groups, who received the domestically manufactured LMWH or imported LMWH to prevent coagulation respectively. Blood clotting in dialyzer and extracorporeal circuit pipes, the change of anti-Xa activity and activated partial thromboplastin time (APTT) , the time of A-V fistula compressing after dialysis were determined. RESULTS: All the patients could finish the dialysis treatment successfully. The time of A-V fistula compressing, the change of anti-Xa activity and APTT in domestically manufactured LMWH group were comparative to the imported LMWH group. No accident of bleeding was observed in the 2 groups. The incidence of clotting in extracorporeal circuit was also similar in the 2 groups. CONCLUSION: Domestically manufactured LMWH is efficient and safe for an ticoagulation in haemodialysis patients which are comparative to the imported LMWH.