索他洛尔治疗阵发性心房颤动的前瞻性多中心临床研究

A prospective multicenter clinical study on the optimal dasage,effectiveness,and safety of sotalol in patients with paroxysmal atrial fibrillation

目的 研究索他洛尔对控制国人阵发性心房颤动的疗效、合适剂量和安全性。方法 2 0个医疗中心入选 2 40例阵发性心房颤动患者用索他洛尔治疗 ,剂量从 80 m g/ d开始 ,根据具体情况 ,适量渐增 ,最大剂量不超过 2 40 mg/ d。观察临床疗效及心电图、动态心电图指标。结果 完成疗程观察者共 2 1 2例 ,男性 1 2 6例 ,女性 86例 ,平均年龄 (5 6 .2± 9.6 )岁。服药时间平均 (1 0 .5 9± 4.6 3)周。治疗后 3周的有效率 :80 m g/ d者 (2 1 2例 )为 5 7% ;1 6 0 m g/ d者 (91例 )为 81 .3% ;2 40 m g/ d者 (2 4例 )为 87.5 %。发生副作用者共 9例 (4.4% ) ,包括心动过缓 5例 ,头晕 1例 ,左束支阻滞 1例 ,乏力 2例。服药后 6周 ,心率平均下降 1 4 % ,有 6例因心率 <6 0次 / min而停药。对血压影响较小 ,但有 2例因收缩压降至 90mm Hg (1 m m Hg=0 .1 33k Pa)而停药。服药后校正 QT间期从 (0 .389± 0 .0 2 0 ) s增加至 (0 .42 1±0 .0 30 ) s(P<0 .0 5 ) ,但 QT间期离散度从 (73.5 3± 4.0 0 ) s降至 (5 3.90± 37.5 0 ) s(P<0 .0 1 )。结论 本研究结果显示索他洛尔是一种控制阵发性心房颤动的有效药物 ,副作用小 ,安全性较好 ,剂量推荐为 80～1 6 0 m g/ d,亦可用至 2 40 mg/ d,疗效发生于 1～ 3周内 。

Objective To assess the clinical therapeutic effect of sotalol on atrial paroxysmal fibrillation. Methods Two hundred and forty patients with paroxysmal atrial fibrillation were enrolled in a cooperation working group including 20 medical centers,and 212 patients [126 males,86 females,average age (56 2±9 6)]completed a three month therapeutic regimen.Sotalol was taken orally starting from 40 mg bid,and increased appropriately according to the patient's tolerance (maximum dosage 120 mg bid). Results The effective rates at the end of 3 weeks after different sotalol dosages were 57% for 40 mg bid (in 212 patients),81 3% for 80 mg bid (in 91 patients) and 87 5% for 120 mg bid(in 24 patients).Side effects were observed in 9 patients(4 4%),including sinus bradycardia in 5,dizzyness in 1,left bandle branch block in 1 and fatigue in 2 patients.There was an increase of QTc from(0 389±0 020)s to (0 421±0 030)s( P <0 05),but the QTcd decreased from (72 6±32 1)s to (51 7±12 6)s after sotalol treatment. Conclusion Sotalol can effectively control paroxysmal atrial fibrillation with minor side effects.The recommended dose was 80～160 mg/d and may be increased to 240 mg if tolerable.Therapeutic effects usually occurred whithin 1 3 weeks,and may be further increased on maintanence.