达比加群酯应用于不同肌酐清除率高龄非瓣膜性心房纤颤患者疗效观察

摘要

Objective To observe the curative effect and safety of dabigatran in elderly patients with non-valvular atrial fibrillation (NVAF) and different creatinine clearance rate (CCr). Methods The patients (n=36) were, according to kidney function, divided into compensated group (CCr from 51 mL/min to 70 mL/min, n=19) and decompensated group (CCr from 31 mL/min to 50 mL/min, n=17), and 2 groups were given dabigatran in different doses respectively (110 mg bid and 110 mg qd). The changes of coagulation indexes, liver function and kidney function were detected at different time points (before and 1 m, 3 m and 6 m after treatment). The incidence of major adverse cardiovascular events (MACE) and drug adverse reactions were observed after treatment for 6 m. Results After treatment for 1 m, 3 m and 6 m, prothrombin time (PT), activated partial thromboplastin time (APTT) and thrombin time (TT) were prolonged gradually than before (P<0.05) in 2 groups. PT, APTT and TT had statistical difference after treatment for 3 m and 6 m compared with those after treatment for 1 m (P<0.05) in 2 groups. The difference in CCr, international normalized ratio (INR) and D-dimer had no statistical significance before and after treatment (P>0.05), and indexes of liver function and kidney function had no significant changes in 2 groups. There were no MACE and bleeding events observed in 2 groups after treatment for 6 m. Conclusion Dabigatran is administrated in different doses according to kidney function will reduce the risk of embolism and bleeding in elderly patients.%目的：观察不同剂量达比加群酯应用于不同肌酐清除率高龄老年非瓣膜性心房纤颤（NVAF）患者中的疗效与安全性。方法纳入36例高龄非瓣膜性房颤患者，根据肾功能分为2组，肾功能不全代偿期组[肌酐清除率（CCr）（51~70）ml/min组，n=19]及肾功能不全失代偿期[肌酐清除率（31~50）ml/min组，n=17]，分别给予达比加群酯110 mg 2/日及110 mg 1/日口服，检测达比加群酯抗凝治疗前、及治疗后1个月、3个月、6个月时凝血指标及肝肾功能等变化，同时观察患者治疗6个月时心脑血管事件及药物不良副作用发生情况。结果两组患者达比加群酯治疗后1个月、3个月、6个月时，凝血酶原时间（PT）、活化的部分凝血酶时间（APTT）、凝血酶时间（TT）均逐渐延长，与治疗前相比差异均具有统计学意义（P＜0.05）；抗凝治疗3个月及6个月时 PT、APTT、TT时间与治疗1个月时亦有统计学差异（P＜0.05）。CCr、国际标准化比值（INR）和D-二聚体水平在治疗前、后差异均无统计学意义（P＞0.05）。肝肾功能指标治疗前后无显著变化。两组患者观察6个月时均未出现心脑血管事件及出血事件。结论高龄患者根据肾功能情况给予不同剂量的达比加群酯抗凝治疗可能会更好的平衡栓塞与出血风险。