Botto G L, Capucci A, Bonini W, Boriani G, Broffoni T, Barone P, Espureo M, Lombardi R, Molteni S, Ferrari G
Division of Cardiology, St Anna Hospital, Como, Italy.
Int J Cardiol. 1997 Jan 3;58(1):55-61. doi: 10.1016/s0167-5273(96)02841-0.
A population of 105 patients with recent onset (< 72 h) atrial fibrillation was randomly treated with propafenone as a single oral loading dose of 450 mg (Regimen A) or 600 mg (Regimen B) or with placebo. A 24-h Holter was performed. Criteria of efficacy were conversion to sinus rhythm at 2, 4 and 8 h compared to placebo and also significant reduction of mean ventricular rate in persistent atrial fibrillation. After 2 h, regimen B was more effective than either regimen A (43% vs. 8%; p = 0.001) or placebo (11%; p = 0.004). At 4 h, both the active treatments were more effective than placebo (17% vs. 46% regimen A and 57% vs. regimen B; p < 0.04 and p < 0.001, respectively). Sinus rhythm resumed within 24 h in 71%, 80% and 69% of the patients with regimen A, B and placebo, respectively (p = not significant). The mean ventricular rate reduction after 1 h was 8%, 11% and 4% for regimen A, B and placebo, respectively (p < 0.005 vs. regimen B), and 17%, 25% and 6% respectively (p < 0.001 placebo vs. regimen A and B, p < 0.05 regimen B vs. A) at 2 h. No major adverse effect occurred. Atrial flutter with 1:1 atrioventricular conduction only in one case who received placebo. Propafenone acute oral administration is more effective than placebo in rapidly converting recent-onset atrial fibrillation to sinus rhythm and may be the treatment of choice in this setting limiting hospitalization and contributing to improved quality of life.
105例近期发作（<72小时）房颤患者被随机分为三组，分别接受单次口服450毫克普罗帕酮（方案A）、600毫克普罗帕酮（方案B）或安慰剂治疗。进行了24小时动态心电图监测。疗效标准为与安慰剂相比，在2小时、4小时和8小时时转为窦性心律，以及持续性房颤时平均心室率显著降低。2小时后，方案B比方案A（43%对8%；p=0.001）或安慰剂（11%；p=0.004）更有效。4小时时，两种活性治疗均比安慰剂更有效（方案A为17%对46%，方案B为57%；p分别<0.04和p<0.001）。方案A、B和安慰剂组分别有71%、80%和69%的患者在24小时内恢复窦性心律（p无显著性差异）。方案A、B和安慰剂组1小时后平均心室率分别降低8%、11%和4%（与方案B相比p<0.005），2小时时分别降低17%、25%和6%（安慰剂与方案A和B相比p<0.001，方案B与A相比p<0.05）。未发生重大不良反应。仅1例接受安慰剂的患者出现1:1房室传导的心房扑动。普罗帕酮急性口服给药在将近期发作的房颤快速转为窦性心律方面比安慰剂更有效，可能是这种情况下的治疗选择，可减少住院并有助于提高生活质量。
