人工机械心脏瓣膜置换术后抗凝治疗强度与并发症发生率的关系

目的:探讨我国人工机械心脏瓣膜置换术后华法林抗凝治疗的国际标准化比值（INR）范围以及抗凝治疗INR值与不良事件的关系。方法: 对我院2007年12月~2011年9月1 684例人工机械心脏瓣膜置换术后应用华法林抗凝治疗且远期随访依从性较好的患者按照瓣膜置换位置不同分为主动脉瓣置换（AVR）组、二尖瓣置换（MVR）组、双瓣置换（DVR）组，各组再按照INR=1.4~1.7、INR=1.7~2.0、INR=2.0~2.3、INR=2.3~2.6分为四个范围进行追踪随访，对比研究出血和血栓栓塞的发生情况。其中男性 793例，女性891例，年龄18~69（44.5±18.2）岁，随访时间6个月~48个月，平均随访（2.6±1.4）年。AVR 462例，MVR 684例，DVR 538 例。结果: AVR组INR=1.4~1.7和INR=1.7~2.0出血发生率比INR=2.0~2.3和INR=2.3~2.6明显降低且差异有统计学意义。MVR组与DVR组在INR=1.4~1.7、INR=1.7~2.0、INR=2.0~2.3三个范围出血发生率都比INR=2.3~2.6明显降低且差异有统计学意义。在AVR组、MVR组、DVR组内INR=1.4~1.7、INR=1.7~2.0，INR=2.0~2.3, INR=2.3~2.6四个范围的血栓栓塞发生率均没有出现明显差异，无统计学意义。结论: 瓣膜置换术后抗凝治疗强度与并发症的发生率有关，AVR术后抗凝治疗范围控制在INR=1.4~2.0较为合适。MVR、DVR术后抗凝治疗范围控制在INR=1.4~2.3较为合适。

Clinical study of warfarin anticoagulant therapy in Chinese patients after mechanical heart valve replacement

AIM:To study the optimal international normalized ratio (INR) of warfarin anticoagulant therapy after mechanical heart valve replacement and to explore its relationship with the adverse events in China. METHODS: A long-term (6-48 months) follow-up of compliance was conducted in 1 684 patients (793 males and 891 females) who received warfarin anticoagulant therapy after mechanical heart valve prostheses from December 2007 to September 2011. The patients ［aged 18-69 years, average age (44.5±18.2) years］ were divided into three groups (AVR/462, MVR/684 or DVR/538) according to different valve prostheses. Each group was divided into four subgroups according to their INR levels (1.4-1.7, 1.7-2.0, 2.0-2.3 and 2.3-2.6). Patients with atrial fibrillation or thrombosis comprised respectively, 302 Cases and 73 cases before surgery. The occurrences of bleeding and thrombosis in these subgroups were compared. RESULTS: In AVR group, bleeding incidences in the subgroups with the INR levels at 1.4-1.7 and 1.7-2.0 decreased significantly compared with those in the subgroups with INR levels at 2.0-2.3 and 2.3-2.6. In the MVR and DVR groups, bleeding incidences in the subgroups with the INR levels at 1.4-1.7, 1.7-2.0 and 2.0-2.3 were lower than those in the 2.3-2.6 subgroup. However, no significant difference was observed in the incidence of thrombosis in all subgroups with different INR levels. CONCLUSION: The results of this study suggest that, in AVR patients, the incidence of bleeding and thrombosis was significantly lower in patients with the INR level at 1.4-2.0 than in patients with INR levels at 2.0-2.6. In MVR and DVR patients, the incidence of bleeding and thrombosis was lower in patients with INR levels at 1.4-1.7, 1.7-2.0 and 2.0-2.3 than in patients with INR levels at 2.3-2.6. Hence, after MVR and DVR, the appropriate level of INR of anticoagulation therapy should remain at 1.4-2.3.