Anastasiou-Nana M I, Anderson J L, Askins J C, Gilbert E M, Nanas J N, Menlove R L
Am Heart J. 1987 Aug;114(2):288-96. doi: 10.1016/0002-8703(87)90493-5.
Sotalol was given for extended therapy to 22 of 29 patients with frequent (greater than or equal to 30/hour) complex premature ventricular complexes (PVCs) who had participated in a short-term study of sotalol vs placebo. Open-label sotalol was given in individually titrated divided doses of 160 to 800 mg/day (median 323, mean 386 mg/day). Response was assessed at approximately 1, 6, and 12 months or until patient discontinuation. The period of sotalol therapy averaged 9 months (range, 0.2 to 22.7). At about 1 month, 13 (59%) of 22 patients showed effective control of arrhythmia. The median percentage change in total PVCs for individual patients at 1 month was -70% and for repetitive PVCs it was -95%. At about 6 months, 10 (45%) of the 22 patients continued to be successfully treated; at about 12 months, seven patients continued on sotalol, six (27%) successfully treated according to Holter criteria. Reasons for discontinuation included lack of efficacy in nine, adverse effects in four (fatigue in three, bradycardia with sinus pauses in one), and miscellaneous reasons in two. ECG PR and especially QTc intervals increased significantly during therapy (p less than 0.02, p less than 0.01, respectively). In summary, sotalol is a moderately effective antiarrhythmic agent in patients with complex PVCs, but during long-term therapy a rather high dropout rate was observed because of arrhythmia recurrence or adverse effects.
在参与索他洛尔与安慰剂短期研究的29例频发(≥30次/小时)复杂性室性早搏(PVC)患者中,22例接受了索他洛尔的延长治疗。采用开放标签给药,索他洛尔的剂量为160至800mg/天,分剂量个体化滴定(中位数323mg/天,平均386mg/天)。在大约1、6和12个月时或直至患者停药时评估疗效。索他洛尔治疗期平均为9个月(范围0.2至22.7个月)。在大约1个月时,22例患者中有13例(59%)心律失常得到有效控制。单个患者1个月时总PVC的中位数变化百分比为-70%,重复性PVC为-95%。在大约6个月时,22例患者中有10例(45%)继续成功接受治疗;在大约12个月时,7例患者继续服用索他洛尔,根据动态心电图标准,6例(27%)成功接受治疗。停药原因包括9例无效、4例出现不良反应(3例疲劳,1例伴有窦性停搏的心动过缓)和2例其他原因。治疗期间心电图PR间期,尤其是QTc间期显著延长(分别为p<0.02,p<0.01)。总之,索他洛尔对复杂性PVC患者是一种中等有效的抗心律失常药物,但在长期治疗中,由于心律失常复发或不良反应,观察到相当高的停药率。