Lee S H, Chen S A, Tai C T, Chiang C E, Wen Z C, Chen Y J, Yu W C, Huang J L, Fong A N, Cheng J J, Chang M S
Department of Medicine, National Yang-Ming University and Veterans General Hospital-Taipei, Taiwan.
Am J Cardiol. 1997 Apr 1;79(7):905-8. doi: 10.1016/s0002-9149(97)00025-8.
The main goal of this study is to evaluate the safety and efficacy of propafenone versus sotalol as an initial choice of treatment in patients with symptomatic paroxysmal atrial fibrillation (AF), according to a double-blind randomized system. In the oral propafenone group (n = 41), 2 patients (5%) discontinued therapy because of gastrointestinal discomfort in 1 and dizziness in the other. Thirty-one (79%) of the 39 patients who continued the treatment had effective response to oral propafenone (>75% reduction of symptomatic arrhythmic attacks) on a mean dose of 663 +/- 99 mg/day with a decrease in attack frequency from 10 +/- 3 to 2 +/- 1 times per week. In the oral sotalol group (n = 38), 4 patients (11%) discontinued treatment because of dizziness in 2 and symptomatic bradycardia in 2. Twenty-six of the 34 patients (76%) who continued the treatment had effective response to oral sotalol on a mean dose of 200 +/- 57 mg/day with a decrease in attack frequency from 11 +/- 3 to 2 +/- 1 times per week. Comparisons of the results between propafenone and sotalol groups showed a similar incidence of intolerable (2 of 41 vs 4 of 38, p = 0.42) and tolerable side effects (10 of 39 vs 8 of 34, p = 1.0). The attack frequency at baseline (11 +/- 3 vs 10 +/- 4 times per week, p = 0.23) and after treatment (3 +/- 1 vs 3 +/- 2 times per week, p = 0.85) did not differ significantly between the 2 groups. The incidence of effective response to drugs was also similar (31 of 39 vs 26 of 34, p = 0.78). Furthermore, the decrease of symptom scores (-32 +/- 8% vs -29 +/- 7%, p = 0.18) and percentage decrease of ventricular rate (-15 +/- 4% vs -18 +/- 4%, p = 0.10) during AF were also similar between the 2 groups. In conclusion, oral propafenone and sotalol are equally effective and safe in preventing attacks and alleviating symptoms of paroxysmal AF.
本研究的主要目的是根据双盲随机系统,评估普罗帕酮与索他洛尔作为有症状阵发性心房颤动(AF)患者初始治疗选择的安全性和有效性。口服普罗帕酮组(n = 41)中,2例患者(5%)因1例胃肠道不适和另1例头晕而停药。继续治疗的39例患者中,31例(79%)在平均剂量663±99 mg/天的情况下对口服普罗帕酮有有效反应(症状性心律失常发作减少>75%),发作频率从每周10±3次降至2±1次。口服索他洛尔组(n = 38)中,4例患者(11%)因2例头晕和2例症状性心动过缓而停药。继续治疗的34例患者中,26例(76%)在平均剂量200±57 mg/天的情况下对口服索他洛尔有有效反应,发作频率从每周11±3次降至2±1次。普罗帕酮组和索他洛尔组结果的比较显示,不耐受(41例中的2例 vs 38例中的4例,p = 0.42)和可耐受副作用(39例中的10例 vs 34例中的8例,p = 1.0)的发生率相似。两组在基线时(每周11±3次 vs 10±4次,p = 0.23)和治疗后(每周3±1次 vs 3±2次,p = 0.85)的发作频率无显著差异。药物有效反应的发生率也相似(39例中的31例 vs 34例中的26例,p = 0.78)。此外,两组在房颤期间症状评分的降低(-32±8% vs -29±7%,p = 0.18)和心室率降低的百分比(-15±4% vs -18±4%,p = 0.10)也相似。总之,口服普罗帕酮和索他洛尔在预防阵发性房颤发作和缓解症状方面同样有效且安全。