| OBJECTIVE: In this prospective, randomized study, the efficacy and safety of sotalol(SOT) and propafenone(PRO) were compared in patients with arrhythmias.METHODS: In this study there were 127 patients including 62 patients with premature ventricular contracts, 29 patients with premature atrial contracts and 36 patients with atrial fibrillation. All patients were divided into two groups.(1) In sotalol groupiits initial dose was 160mg/day, the dose may increase to 240mg/day if ineffective and the dose may decrease if adverse effects occured. (2)In propafenone group: its initial dose was 450mg/day (The 450mg/day was divided in three doses in the premature contracts group. As to atrial fibrillation group, 450mg was received in one doses the first day and in three doses later. The doses may increase to 600mg/day if ineffective and may decrease if adverse effects occurred.The patients with premature contracts were treated 2-4 weeks. And the patients with atrial fibrillation were treated 6 months. The efficacy and adverse effects were estimated by means of clincal manifestation and 24-hour hotter monitoring.RESULTS (l)As to ventricular premature contracts group, the individual efficacy criterion ($=50% VPC reduction)was achieved in 70.9% patients after oral sotalol 160mg/day two weeks, and it was achieved in 61.3% patients after oral propafenone 450mg/day two weeks.(p>0.05, sotalol vs propafenone)(2) As to atrial premature contracts group, total effective rate was achieved 78.6% after oral sotalol 160mg/day two weeks, and it was achieved 66.7% in propafenone group. (p>0.05, sotalol vs propafenone)(3) As to persistent atrial fibrillation group, the conversion of AF to sinus rhythm occurred in 10 of 18 patients (55.5%) taking sotalol, and in 3 of 18(16.7%) taking propafenone (p<0.05). The relapse-free survival rate at 3 months for the sotalol group and the propafenone group were 70% and 33.3%(p>0.05). The relapse- free survival rate at 6 months for the sotalol and the propafenone group were 50% and 33.3% (p>0.05)(4) In SOT group the QT interval increased from 384.2 + 27.50 ms to 435 ?6.23 ms (p<0.00 l);QTc interval increased from 430.43 ?27.60 to 448.27?3.03 ms (P<0.001); QTd decreased from 29.0?6.07 ms to 20.33+7.18 ms (p<0.001); QTcd decreased from 32.30 ?.47 ms to 21.40?.20 ms (p<0.00 l);mean HR decreased from 77 ?.0 beats/min to 63.4?.1 beats/min (p<0.001); systolic BP decreased from 126.2+17.6 mmHg (lmmHg=0.133Kpa) to 116.5 + 14.6mmHg (P<0.001); Diastolic BP decreased from 75.2+13.1 mmHg to 69.8?.5 mmHg (p<0.01); EF in UCG and PR interval in ECG had no significant difference.In PRO group: QTd increased from 21.38?.43 ms to 25.52?.86 ms (p<0.01);QTcd increased from 23.83 + 8.59 ms to 27.86?.17ms (p<0.05); P-R interval increased from 0.159?.018s to 0.171 + 0.023s (p<0.001); EF decreased from 64.87 + 7.45% to 61 + 7.06% (p<0.001); BP, mean HR, QT and QTc had no significant difference. (5) Adverse effects were found in 7 of the 63 sotalol treated patients (11%), and included mainly sinus brady-cardia, Adverse effects were found in 8 of the 64 propafenone-treated patients (12.5%), and included mainly atrioventricular block and heart failure. CONCLUSIONS There had no significant difference between SOT and PRO in the effect of premature contracts. But sotalol is more effective than propafenone in converting the atrial fibrillation to sinus rhythm. The main adverse effects of sotalol were sinus bradycardia. While the main adverse effects of propafenone were the inhibition of the function of heart and atrio-ventricular node. Thus in Chinese patients with arrhythmias, sotalol was relatively effective and safe, but HR and QT should be monitored.
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