Luczak D, Dabrowski R, Szwed H, Gasior Z, Stanke A, Jasek S, Skrabucha B, Matar A, Kowalik I
Kliniki Choroby Wieńcowej Instytutu Kardiologii w Warszawie.
Pol Merkur Lekarski. 1997 Feb;2(8):122-5.
Antiarrhythmic efficacy of sotalol--noncardioselective beta-adrenergic blocking agent with class III antiarrhythmic action was evaluated in 34 patients [pts] (mean age 55 +/- 11) with chronic ventricular arrhythmias and coronary artery disease, 38% with previous myocardial infarction. Two schedules of dosing were tested: 3 x 80 mg and 2 x 160 mg during 28 days of therapy. Pts with Lown class II and IV arrhythmia derived from 24-hours Holter recording were assigned. Ventricular premature complexes [VPCs] and couplets reduction by 80% and total elimination of runs defined antiarrhythmic efficacy. Proarrhythmia was defined by four times increase in VPCs, ten times increase in couplets and runs or sustained VT episodes.
Antiarrhythmic efficacy of two doses of sotalol according to study criterion was: 31% for lower dose (3 x 80 mg) and 24% for higher dose (2 x 160 mg). Overall efficacy for both doses was 55%. According to Morganroth criterion, lower dose was effective in 29% pts and both doses, lower and higher, in 41% pts. According to other commonly used criterion: 70% VPCs reduction, 90% couplets reduction and total elimination of runs, lower dose of sotalol was effective in 32% pts and both doses in 47% pts. Significant reduction of heart rate and prolongation of QT and QTc were observed. In 3 pts QT was prolonged over 500 ms. Proarrhythmia according to Velebit criterion was suspected in one patient after one week of 3 x 80 mg teratment which caused premature cessation of therapy. No significant abnormalities in laboratory values were observed.
Antiarrhythmic efficacy of sotalol was comparable to other studies. Its value in pts with malignant ventricular tachyarrhythmias: sustained ventricular tachycardia and ventricular fibrillation requires further studies with higher number of patients.
索他洛尔是一种具有Ⅲ类抗心律失常作用的非选择性β肾上腺素能阻滞剂，对34例（平均年龄55±11岁）患有慢性室性心律失常和冠状动脉疾病的患者进行了评估，其中38%有既往心肌梗死病史。测试了两种给药方案：治疗28天期间每日3次，每次80mg和每日2次，每次160mg。根据24小时动态心电图记录，纳入LownⅡ级和Ⅳ级心律失常患者。室性早搏（VPCs）和成对早搏减少80%以及连续室性心动过速完全消除定义为抗心律失常疗效。致心律失常作用定义为VPCs增加4倍、成对早搏和连续室性心动过速增加10倍或持续性室性心动过速发作。
根据研究标准，两种剂量索他洛尔的抗心律失常疗效分别为：低剂量（每日3次，每次80mg）为31%，高剂量（每日2次，每次160mg）为24%。两种剂量的总体疗效为55%。根据Morganroth标准，低剂量对29%的患者有效，低剂量和高剂量联合对41%的患者有效。根据其他常用标准：VPCs减少70%、成对早搏减少90%以及连续室性心动过速完全消除，低剂量索他洛尔对32%的患者有效，两种剂量联合对47%的患者有效。观察到心率显著降低以及QT和QTc延长。3例患者QT延长超过500ms。在接受每日3次，每次80mg治疗1周后，1例患者疑似出现符合Velebit标准的致心律失常作用，导致治疗提前终止。未观察到实验室值有明显异常。
索他洛尔的抗心律失常疗效与其他研究相当。其在恶性室性快速心律失常（持续性室性心动过速和心室颤动）患者中的价值需要在更多患者中进行进一步研究。
