Singh Bramah N, Singh Steven N, Reda Domenic J, Tang X Charlene, Lopez Becky, Harris Crystal L, Fletcher Ross D, Sharma Satish C, Atwood J Edwin, Jacobson Alan K, Lewis H Daniel, Raisch Dennis W, Ezekowitz Michael D
Department of Veterans Affairs Medical Center, West Los Angeles, Calif 90073, USA.
N Engl J Med. 2005 May 5;352(18):1861-72. doi: 10.1056/NEJMoa041705.
The optimal pharmacologic means to restore and maintain sinus rhythm in patients with atrial fibrillation remains controversial.
In this double-blind, placebo-controlled trial, we randomly assigned 665 patients who were receiving anticoagulants and had persistent atrial fibrillation to receive amiodarone (267 patients), sotalol (261 patients), or placebo (137 patients) and monitored them for 1 to 4.5 years. The primary end point was the time to recurrence of atrial fibrillation beginning on day 28, determined by means of weekly transtelephonic monitoring.
Spontaneous conversion occurred in 27.1 percent of the amiodarone group, 24.2 percent of the sotalol group, and 0.8 percent of the placebo group, and direct-current cardioversion failed in 27.7 percent, 26.5 percent, and 32.1 percent, respectively. The median times to a recurrence of atrial fibrillation were 487 days in the amiodarone group, 74 days in the sotalol group, and 6 days in the placebo group according to intention to treat and 809, 209, and 13 days, respectively, according to treatment received. Amiodarone was superior to sotalol (P<0.001) and to placebo (P<0.001), and sotalol was superior to placebo (P<0.001). In patients with ischemic heart disease, the median time to a recurrence of atrial fibrillation was 569 days with amiodarone therapy and 428 days with sotalol therapy (P=0.53). Restoration and maintenance of sinus rhythm significantly improved the quality of life and exercise capacity. There were no significant differences in major adverse events among the three groups.
Amiodarone and sotalol are equally efficacious in converting atrial fibrillation to sinus rhythm. Amiodarone is superior for maintaining sinus rhythm, but both drugs have similar efficacy in patients with ischemic heart disease. Sustained sinus rhythm is associated with an improved quality of life and improved exercise performance.
恢复并维持心房颤动患者的窦性心律的最佳药物治疗方法仍存在争议。
在这项双盲、安慰剂对照试验中，我们将665名正在接受抗凝治疗且患有持续性心房颤动的患者随机分配，分别给予胺碘酮（267例患者）、索他洛尔（261例患者）或安慰剂（137例患者），并对他们进行1至4.5年的监测。主要终点是自第28天起心房颤动复发的时间，通过每周的电话监测来确定。
胺碘酮组27.1%、索他洛尔组24.2%、安慰剂组0.8%的患者发生了自发心律转复，直流电复律失败率分别为27.7%、26.5%和32.1%。按照意向性分析，胺碘酮组、索他洛尔组和安慰剂组心房颤动复发的中位时间分别为487天、74天和6天；按照实际接受的治疗分析，分别为809天、209天和13天。胺碘酮优于索他洛尔（P<0.001）和安慰剂（P<0.001），索他洛尔优于安慰剂（P<0.001）。在患有缺血性心脏病的患者中，胺碘酮治疗时心房颤动复发的中位时间为569天，索他洛尔治疗时为428天（P=0.53）。恢复并维持窦性心律显著改善了生活质量和运动能力。三组之间的主要不良事件无显著差异。
胺碘酮和索他洛尔在将心房颤动转复为窦性心律方面疗效相当。胺碘酮在维持窦性心律方面更具优势，但两种药物在患有缺血性心脏病的患者中疗效相似。持续的窦性心律与生活质量的改善和运动表现的提高相关。
