新型口服抗凝剂用于非瓣膜性心房颤动患者经导管射频消融术后抗凝治疗的观察

发布时间：2018-06-28 21:25

本文选题：非瓣膜性心房颤动 + 导管射频消融术　；参考：《浙江大学》2017年硕士论文

【摘要】：目的:评价新型口服抗凝剂(利伐沙班和达比加群酯)与华法林用于非瓣膜性心房颤动患者导管射频消融术后抗凝治疗的效果。方法:本研究为回顾性观察研究。选择研究对象为2014年6月至2015年5月在本中心非瓣膜性持续性或者阵发性心房颤动患者246例,观察导管射频消融术后抗凝治疗,其中利伐沙班组和华法林组两两配对各62例,术后利伐沙班组每天给予15mg,qd,po。华法林组每天给予3-5mg,根据国际标准化比值(international normalized ratio,INR)控制INR在2.0-3.0之间。同期达比加群酯和华法林配对各61例,达比加群组每天给予110mg,bid,po。华法林组同上。所有患者术后3个月抗凝期均选用同一种药物。统计手术后3个月,抗凝疗效终点是脑卒中或全身栓塞事件;安全终点是重大出血,房颤复发率、并发症等不良事件发生情况。结果:1.基线水平的比较:利伐沙班与华法林组患者的基线特征和达比加群酯与华法林组患者的基线特征:包括年龄、BMI、房颤类型(阵发性和持续性)、CHA2DS2-VASc评分、HAS-BLED评分、术前化验指标(HB、ALT、CCR、PT、APTT、TT),既往合并症(充血性心力衰竭、高血压、糖尿病、甲状腺功能异常、COPD、脑卒中/全身性栓塞/TIA)、术前LAD、EF%术前用药(可达龙、阿司匹林、华法林、ACEI、β-受体阻滞剂)术前使用华法林患者两组比较有显著性差异,其他比较差异无统计学意义(P0.05)。2.抗凝疗效和安全终点比较:均为消融术后3个月随访。(1)利伐沙班和华法林组均无死亡病例,利伐沙班组无栓塞事件(脑卒中/TIA/全身性栓塞),对照华法林组TIA1例,无脑卒中,全身栓塞事件。两组在卒中风险比较上差别均无统计学意义(P0.05)。两组患者均未出现严重出血事件,利伐沙班组牙龈出血3例,无痰中带血,血尿6例,皮下出血2例,腹股沟血肿3例。对照华法林组牙龈出血1例,痰中带血3例,血尿6例,腹股沟血肿3例,患者停药后出血症状消失。两组不明显出血事件比较差别均无统计学意义(P0.05)。(2)达比加群酯组和华法林组均无死亡病例,达比加群酯组TIA2例,无脑卒中和全身栓塞事件,对照华法林组无栓塞事件(TIA/脑卒中/全身性栓塞).两组在卒中风险比较上差别均无统计学意义(P0.05)。两组患者均未出现严重出血事件,达比加群酯组牙龈出血1例,无痰中带血,血尿8例,皮下出血3例,腹股沟血肿4例。对照华法林组牙龈出血4例,痰中带血3例,血尿4例,腹股沟血肿2例,患者停药后出血症状消失。两组不明显出血事件比较差别均无统计学意义(P0.05)。3.房颤复发,并发症比较(1)利伐沙班和华法林组利伐沙班组检查房颤复发10例,电复律5例,发热10例。华法林组房颤复发13例,电复律5例,发热4例。其并发症经对症治疗均在出院时痊愈。两组复发和并发症比较差别均无统计学意义(P0.05)。两组依从性比较差别均无统计学意义(P0.05)。(2)达比加群酯和华法林组达比加群酯组和华法林组电复律各6例。达比加群酯房颤复发20例,发热9例。华法林组房颤复发16例,发热4例。其并发症经对症治疗均在出院时痊愈。两组复发和并发症比较差别均无统计学意义(P0.05)。两组依从性比较差别均无统计学意义(P0.05)。结论:口服利伐沙班和达比加群酯用于非瓣膜性房颤经导管射频消融术抗凝治疗,在卒中和出血风险上均安全有效,不劣于华法林且无需检测凝血指标。
[Abstract]:Objective: To evaluate the effect of new oral anticoagulants (Lev Shaaban and dabatagate) and Hua Falin for anticoagulant therapy after catheter radiofrequency ablation for non valvular atrial fibrillation. Methods: This study was a retrospective study. The selected subjects were the non valvular or paroxysmal heart in this center from June 2014 to May 2015. 246 patients with atrial fibrillation were treated with anticoagulant therapy after radiofrequency catheter ablation. Among them, 62 cases were matched in the rivara group and the warfarin group in 22. 15mg, QD, po. warfarin group were given 3-5mg every day after the operation, and INR was controlled by the international standardized ratio (international normalized ratio, INR) between 2.0-3.0. 61 cases were added with group of ester and Hua Falin. Dabiga group was given 110mg, bid, and po. Hua Falin. All patients selected the same drug at 3 months after operation. 3 months after operation, the end point of anticoagulant effect was stroke or systemic embolism; the end of safety was major bleeding, recurrence rate of atrial fibrillation, complications and other adverse events. Results: 1. baseline levels: baseline characteristics of patients with LEV Shaaban and warfarin group and baseline characteristics of dabiga group and warfarin group: age, BMI, atrial fibrillation type (paroxysmal and persistent), CHA2DS2-VASc score, HAS-BLED score, preoperative test indicators (HB, ALT, CCR, PT, APTT, TT), previous complication (hyperemia) Heart failure, hypertension, diabetes, thyroid dysfunction, COPD, cerebral apoplexy / systemic embolism /TIA), pre operation LAD, EF% before operation (Aron, aspirin, Hua Falin, ACEI, beta blocker) before the operation of the two groups of Hua Falin patients were significantly different, the other comparison was not statistically significant (P0.05).2. anticoagulant efficacy and safety All end point comparison: 3 months after ablation. (1) there was no death case in rivah Shaaban and Hua Falin group. There was no embolism event in rivah group (/TIA/ systemic embolism of stroke), compared with group TIA1 in Hua Falin group, no stroke and whole body embolism. There was no statistical difference between the two groups in stroke risk comparison (P0.05). Two groups were all patients. There were no serious bleeding events, 3 cases of gingival bleeding in the rivana group, 6 cases of bleeding in the sputum, 6 cases of hematuria, 2 cases of subcutaneous hemorrhage, 3 cases of inguinal hematoma, 1 cases of gingival bleeding in the control warfarin group, 3 cases of blood in the phlegm, 6 cases of hematuria, 3 cases of inguinal hematoma, and the loss of bleeding symptoms after stopping the drug. The difference of no significant bleeding events in the two groups was not statistically significant. (P0.05). (2) there were no deaths in the dabiga group and the Hua Falin group, and the dabiga group was TIA2, without stroke and systemic embolism, compared with the Hua Falin group without embolization (TIA/ stroke / systemic embolism). The difference between the two groups was not significant (P0.05) in the stroke risk comparison (P0.05). There was no serious bleeding event in the two groups. There were 1 cases of gingival bleeding in dababatm group, 8 cases in no sputum with blood, hematuria, 3 cases of subcutaneous hemorrhage, 4 cases of inguinal hematoma, 4 cases of gingival bleeding in the control warfarin group, 3 cases of blood in the phlegm, 4 cases of hematuria, 2 cases of inguinal hematoma, and the bleeding symptoms disappeared in the patients after stopping medicine. There was no statistically significant difference between the two groups (P0.05) the recurrence of.3. atrial fibrillation in the two groups. Complications were compared (1) there were 10 cases of recurrence of atrial fibrillation in Rivelling Shaaban and warfarin group, 5 cases of electric cardioversion, 10 cases of fever, 13 cases of atrial fibrillation in warfarin group, 5 cases of electric cardioversion, 4 cases of fever. The complications were all healed at discharge. The recurrence and complications of the two groups were not statistically significant (P0.05). The compliance ratio of the two groups was not significant. The difference was not statistically significant (P0.05). (2) dabiga group ester and Hua Falin group Dabi group ester group and Hua Falin group electric cardioversion each 6 cases. Dabiga group ester atrial fibrillation recurrence 20 cases, fever 9 cases. Hua Falin group atrial fibrillation recurrence 16 cases, 4 cases of fever. The complications are all cured at the time of hospital treatment. The two groups of recurrence and complications are all the difference is no Statistical significance (P0.05). There was no significant difference in the compliance of the two groups (P0.05). Conclusion: oral Lev Shaaban and dabiaga were used for anticoagulant therapy of non valvular atrial fibrillation via catheter radiofrequency ablation, which were safe and effective in the risk of stroke and bleeding, not inferior to warfarin and no need to detect coagulation indexes.
【学位授予单位】：浙江大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R541.75

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