Channer Kevin S, Birchall Andrew, Steeds Richard P, Walters Stephen J, Yeo Wilf W, West John N, Muthusamy Rangasamy, Rhoden Walter E, Saeed Basil T, Batin Phillip, Brooksby W Paul, Wilson Ian, Grant Simon
Royal Hallamshire Hospital, Sheffield, UK.
Eur Heart J. 2004 Jan;25(2):144-50. doi: 10.1016/j.ehj.2003.10.020.
The efficacy of cardioversion (DCCV) for restoration of sinus rhythm (SR) in persistent atrial fibrillation (AF) is limited by a high relapse rate. Relapse may be reduced by amiodarone but no placebo-controlled trials of efficacy have been performed and the appropriate duration of therapy is unknown.
In this double-blind study, 161 subjects with persistent AF were randomized to one of three groups-placebo (n=38); amiodarone 400mg BD for 2 weeks prior to DCCV and 200mg daily for 8 weeks followed by placebo for 44 weeks (n=62, short-term amiodarone); amiodarone 400mg BD for 2 weeks then 200mg daily for 52 weeks (n=61, long-term amiodarone). Spontaneous reversion to SR occurred before DCCV in 21% (26/123) patients on amiodarone and none of the 38 patients on placebo (absolute difference 21%, 95% confidence interval (CI): 10 to 29%, P=0.002). At 8 weeks following DCCV, 51% (63/123) patients on amiodarone remained in SR compared to 16% (6/38) taking placebo (difference-35% 95% CI: -48 to -18%, P<0.001). At 1 year, 49% (30/61) patients on long-term amiodarone were in SR compared to 33% (21/62) taking short-term amiodarone (difference-15%, 95% CI: -31 to 2%, P=0.085). There was no difference in adverse event rate or quality of life scores between groups.
Amiodarone pre-treatment before electrical DCCV for persistent AF allows chemical conversion in one-fifth of patients without altering the efficacy of subsequent DC conversion. Amiodarone is more effective than placebo in the maintenance of SR when continued for 8 weeks following successful DCCV. More patients taking long-term amiodarone remained in SR at 52 weeks, but more had serious adverse effects requiring discontinuation of therapy. Eight weeks of adjuvant therapy with amiodarone following successful DCCV may be the preferred option.
持续性心房颤动（AF）患者中，转复心律（DCCV）恢复窦性心律（SR）的疗效受复发率高的限制。胺碘酮可能会降低复发率，但尚未进行安慰剂对照的疗效试验，且合适的治疗时长未知。
在这项双盲研究中，161例持续性AF患者被随机分为三组之一：安慰剂组（n = 38）；在DCCV前2周给予胺碘酮400mg，每日两次，共2周，之后8周给予每日20mg，随后44周给予安慰剂（n = 62，短期胺碘酮组）；胺碘酮400mg，每日两次，共2周，然后每日200mg，共52周（n = 61，长期胺碘酮组）。在DCCV前，21%（26/123）服用胺碘酮的患者自发恢复为SR，而38例服用安慰剂的患者均未恢复（绝对差异21%，95%置信区间（CI）：10%至29%，P = 0.002）。DCCV后8周，服用胺碘酮的患者中有51%（63/123）维持窦性心律，而服用安慰剂的患者中这一比例为16%（6/38）（差异-35%，95%CI：-48%至-18%，P<0.001）。1年时，长期服用胺碘酮的患者中有49%（30/61）维持窦性心律，而短期服用胺碘酮的患者中这一比例为33%（21/62）（差异-15%，95%CI：-31%至2%，P = 0.085）。各组间不良事件发生率或生活质量评分无差异。
对于持续性AF患者，在进行电DCCV前使用胺碘酮预处理可使五分之一的患者实现化学转复，且不改变后续直流电转复的疗效。成功进行DCCV后持续使用8周胺碘酮，在维持窦性心律方面比安慰剂更有效。更多长期服用胺碘酮的患者在52周时维持窦性心律，但更多患者出现严重不良反应而需要停药。成功进行DCCV后使用胺碘酮进行8周辅助治疗可能是首选方案。
