胺碘酮和索他洛尔治疗心房颤动的随机对比研究

Effects of amiodarone versus sotalol in trea tment of atrial fibrillation: a random controlled clinical study

目的 比较胺碘酮和索他洛尔对心房颤动（房颤）的疗效及其不良反应。方法102例房颤患者随机分为胺碘酮组（51例）和索他洛尔组（51例）。胺碘酮组服胺碘酮600mg／d，7d，400mg／d再服用7d，再减为200mg／d，转为窦律后200mg／d维持。索他洛尔组服索他洛尔40～80mg／a，7d，第2周增至160mg／a，转为窦律后40～80mg／a维持。两组患者服用3周转窦律均停用药物。随访12～24个月，分别测定治疗前后超声心动图、心电图和24h动态心电图判断疗效。结果（1）胺碘酮组房颤复律成功40例，有效率78．4％；索他洛尔组房颤复律成功36例，有效率70．6％。（2）胺碘酮组在1周内转复窦律34例，索他洛尔组1周内转复窦律10例。（3）随访12个月，胺碘酮组27例（67．5％）仍维持窦律、索他洛尔组15例（41．7％）；24个月，胺碘酮组12例（44．4％）维持窦律，索他洛尔组为4例（26．7％）。（4）随访6～12个月，索他洛尔组（80mg／d）10例患者因发生房室传导阻滞、严重心动过缓停药，而胺碘酮组未出现严重的心律失常。（5）房颤持续时间〉12个月是窦律不易维持的预测因素。结论胺碘酮转复房颤有效率和索他洛尔相当，但维持窦律疗效优于索他洛尔．对心脏毒副作用小于索他洛尔。

Objective To evaluate the effects and adverse reactions of amiodarone and sotalol in treatment of atrial fibrillation. Methods One hundred and two patients with atrial fibrillation, 56 males and 46 females, aged 56±11, were randomized into 2 equal groups ： amiodarone group, taking amiodarone 600 mg/d for 7 days, 400 mg/d for 7 days, 200 mg/d for 7 days, and then 200 mg/d as maintenance dosage if conversion to sinus rhythm occurred; and sotalol group, taking sotalol 40-80 mg/d for one week, 160 mg/d for 2 weeks and then 40-80 mg/d as maintenance dosage if conversion to sinus rhythm occurred. If the cardiac rhythm failed to be converted to sinus rhythm after three week the medication was stopped. All the patients were followed up for 12-24 months and therapeutic effects were evaluated by echocardiography, electrocardiogram and Holter monitor. Results （ 1 ） Conversion to sinus rhythm occurred in 40 patients in the amiodarone group with an effective rate of 78.4% , and in 36 patients in the sotalol group with an effective rate of 70.6%. （2） Conversion to sinus rhythm occurred in the first week in 34 patients of the amiodarone group and in l0 patients of the sotalol group. （ 3 ） 67.5% of the patients with conversion to sinus rhythm in the amiodarone group and 41.7% of the patients with conversion to sinus rhythm in the sotalol group maintained sinus rhythm in the following 12 months; and 44.4% patients with conversion to sinus rhythm in the amiodarone group and 26.7% of the patients with conversion to sinus rhythm in the following 24 months. （4） 10 patients in the sotalol group taking a maintenance dosage of 80 mg/d showed atrial ventricular block and severe bradycardia during the follow-up of 6-2 months, then the medication was stopped, but there was no severe arrhythmia in amiodarone group. （5） It was difficult to maintain sinus rhythm when atrial fibrillation lasting longer than 12 months was a predictive factor of failure to maintain sinus rhythm. Conclusion There is no significant difference between amiodarone and sotalol in converting atrial fibrillation to sinus rhythm. However, amiodarone is more effective in maintenance of sinus rhythm than sotalol. The adverse reaction of amiodarone on heart is less severe than that of sotalol.