论文部分内容阅读
背景尽管效应和频发的负性事件自相矛盾,抗心律失常药常用于预防房颤。有建议,导管消融可作为阵发性房颤的替代疗法。目的治疗症状性阵发性房颤,与抗心律失常药对照,确定导管消融的效果。设计、机构和受试者从19家医院抽取至少对1种抗心律失常药物无反应,且抽样前6个月,至少有3次阵发性房颤发作的167例患者进行前瞻、多中心、随机(2:1)、非盲、Bayesian研究。2004年10月25日至2007年10月11日作为参试者纳入期,2009年1月19日作为最后随访日。干预导管消融(n=106)或抗心律失常药物疗法(n=61),经9个月跟踪期做效果评估。主要结果测量按定义记录治疗失败时间。也需报告采取导管消融或抗心律失常药物治疗,30 d内发生与治疗相关的严重负性事件的患者比例。结果 9个月有效性评估期末,导管消融组未出现所定义的治疗失败占66%,而抗心律失常药物组仅占16%。导管消融与抗心律失常药物危害比为0.30[95%CI(0.19,0.47),P<0.001]。30 d内,抗心律失常药物组57例患者中有5例(8.8%),而导管消融组103例患者有5例(4.9%)发生与治疗相关严重负性事件。第3个月,与抗心律失常药物组比,导管消融组患者生活质量平均分数改善要显著,在研究期间依然保持改善趋势。结论至少对1种抗心律失常药不反应的阵发性房颤患者,经9个月跟踪,与抗心律失常药物相比,导管消融疗法出现治疗失败的时间要久。
Background Although anti-arrhythmic drugs are often contradictory to the effects and frequent negative events, they are often used to prevent atrial fibrillation. It is suggested that catheter ablation can be used as an alternative therapy to paroxysmal atrial fibrillation. Objective To treat symptomatic paroxysmal atrial fibrillation and antiarrhythmic drug control, to determine the effect of catheter ablation. DESIGN, INSTITUTIONS, AND SUBJECTS 167 prospective, multicentre, and multicenter trials of patients with at least one episode of arrhythmic drug taken from 19 hospitals and at least 3 episodes of paroxysmal atrial fibrillation 6 months prior to sampling, Randomized (2: 1), non-blind, Bayesian studies. October 25, 2004 to October 11, 2007 as the participants into the period, January 19, 2009 as the last follow-up date. Interventions for catheter ablation (n = 106) or antiarrhythmic drug therapy (n = 61) were evaluated for effectiveness over a 9-month follow-up period. The primary outcome measure records the treatment failure time as defined. Also report the percentage of patients who have undergone catheter ablation or antiarrhythmic drug therapy within 30 days of a serious negative event related to treatment. Results At the end of the 9-month validity evaluation, the defined absence of treatment failure in the catheter ablation group did not account for 66%, whereas the antiarrhythmic drug group accounted for only 16%. The hazard ratio of catheter ablation to antiarrhythmic drug was 0.30 [95% CI (0.19, 0.47), P <0.001]. Within 30 days, 5 of 57 (8.8%) patients in the anti-arrhythmic drug group experienced treatment-related serious adverse events in 5 of 103 (4.9%) patients in the catheter ablation group. At Month 3, the mean quality of life improvement was significantly greater in the catheter ablation group compared with the antiarrhythmic drug group and remained improving during the study period. CONCLUSIONS: At least 9 months after randomization to at least one antiarrhythmic drug-refractory paroxysmal atrial fibrillation, catheter ablation therapy has been unsuccessful for longer than any antiarrhythmic drug treatment.