TTR及FTTR评价机械瓣置换术后早期患者的抗凝治疗质量

Early evaluation of quality of anticoagulant therapy in patients with mechanical prosthetic valve replacement through TTR and FTTR

目的采用治疗范围时间(TTR)及治疗范围时间分数(FTTR)评价机械瓣膜置换术后早期患者的抗凝治疗质量,以期为进一步改善这些患者的抗凝治疗质量提供证据。方法分析2012年7月至2014年4月门诊随访时患者(术后≤6个月)的临床资料,采用目标国际标准化比值(INR)范围为1.60~2.20、可接受的INR范围为1.50~2.30及以每周为单位的华法林剂量调整方案,当INR超出可接受的INR范围时进行相应的华法林剂量调整。分析患者术后6个月内与抗凝治疗相关的血栓栓塞及出血事件,TTR和FTTR评价机械瓣置换术后早期患者抗凝治疗质量。结果共纳入机械瓣置换手术患者477例,随访总时间为78 918 d,收集患者INR检测结果共2 755份,INR检测值范围为0.92~7.72(1.83±0.64)。在目标INR范围内(1.60~2.20)患者所服用的华法林剂量为5.00~35.00(18.15±3.99)mg/周,在可接受的INR范围内(1.50~2.30)患者所服用华法林剂量为5.00~39.38(18.29±4.08)mg/周。随访期间在目标INR及可接受的INR范围内其TTR分别为36.85%(27 079.5 d/78 918.0 d),49.84%(39 331.5 d/78 918.0 d);FTTR则分别为37.31%(1 028次/2 755次),50.01%(1 378次/2 755次)。在本研究术后随访达到6个月的患者的目标INR及可接受的INR范围内的TTR分别为46.04%(3 902.5 d/8 475.5 d),59.49%(5 042.0 d/8 475.5 d);而这些患者的FTTR则分别为46.81%(206次/440次),60.45%(266次/440次)。本研究纳入的患者随访期间3例脑梗塞均发生于术后1个月内,1例术后2个月出现短暂性肢体活动障碍,1例术后6个月常规超声心动图复查发现存在左房血栓,其余患者未发现出血及死亡事件。结论本研究所采用的抗凝治疗策略对机械瓣置换术后早期患者是适当的。为进一步改善这些患者的抗凝治疗质量,术后尽早开始抗凝治疗、加强患者抗凝知识的教育及适当增加INR检测频率均是必要的。

Objective To evaluate the quality of anticoagulant therapy in patients with mechanical prosthetic valve replacement during early period through time in therapeutic range（TTR） and fraction of time in therapeutic range（FTTR）, and to provide an objective evidence for further improving quality of anticoagulant therapy. Methods All the patients were followed and registered in hospital and at outpatient clinic from July 2012 through April 2014, with a maximum of 6 months after surgery. Targeted international normalized rate （INR） was 1.60 to 2.20, acceptable INR was 1.50 to 2.30. And warfarin weekly dosage adjustment was used as the strategy of anticoagulation management. Adjusting the warfarin dosage when INR was beyond acceptable INR. Events of bleeding, thrombogenesis and thromboembolism, TTR and FTTR of these patients during the follow-up were collected to evaluate quality of anticoagulant therapy in these patients. Results A total 477 patients and 2 755 reports oflNR values were included for data analysis. The follow-up time was 78 918 days. Values of INR varied from 0.92 to 7.72（1.83±0.64）. Required weekly doses of warfarin in target INR and acceptable INR were 5.00-35.00（18.15±3.99） mg/week and 5.00-39.38（18.29±4.08） mg/week. TTR of target INR and acceptable INR was 36.85%（27 079.5 d/78 918.0 d） and 49.84% （39 331.5 d/78 918.0 d）, respectively. FTTR of target INR and acceptable INR was 37.31% （1 028 times/2 755 times）, 50.01% （1 378 times/2 755 times）, respectively. TTR of target INR and acceptable INR was 46.04%（3 902.5 d/8 475.5 d）, 59.49%（5 042 d/8 475.5 d） when the patients＇ follow-up was up to six months and FTTR of target INR and acceptable INR value of these patients was 46.81%（206 times/440 times）, 60.45%（266 times/440 times）. During the follow-up, there were 3 thromboembolism events, 1 transient physical abnormal activity, and 1 thrombogenesis in the left atrium, and there was no bleeding and death events. Conclusion The strategy of anticoagulation management used in our study is reasonable. In order to further improve the patients＇ quality of anticoagulant therapy, it is necessary to start anticoagulation after operation as soon as possible, to strengthen the education of patients with anticoagulant knowledge and to increase INR test frequency properly.