Boriani G, Biffi M, Capucci A, Botto G L, Broffoni T, Rubino I, Della Casa S, Sanguinetti M, Magnani B
Università degli Studi di Bologna, Italy.
Ann Intern Med. 1997 Apr 15;126(8):621-5. doi: 10.7326/0003-4819-126-8-199704150-00006.
The effectiveness of oral propafenone in converting recent-onset atrial fibrillation to sinus rhythm has been established by controlled trials. However, it is not clear whether the effectiveness of propafenone is affected by the presence or absence of underlying heart disease.
To investigate the safety and effectiveness of oral propafenone and the role of underlying heart disease.
Randomized, single-blind, controlled study.
3 teaching hospitals.
240 hospitalized patients with recent-onset atrial fibrillation.
Propafenone (one 500-mg oral dose) or placebo.
Conversion rates at 3 and 8 hours.
Propafenone was more effective than placebo for converting atrial fibrillation to sinus rhythm at 3 hours: Fifty-four of 119 patients (45%) receiving propafenone and 22 of 121 patients (18%) receiving placebo had conversion (P < 0.001). It was also more effective at 8 hours: Ninety-one of 119 patients (76%) receiving propafenone and 45 of 121 patients (37%) receiving placebo had conversion (P < 0.001). Subgroup analysis showed that among patients without heart disease, 78% of those receiving propafenone and 56% of those receiving placebo converted to sinus rhythm within 8 hours (P = 0.02). In those with hypertension, the rate was 70% for those receiving propafenone and 27% for those receiving placebo (P < 0.001); in patients with structural heart disease, the rate was 81% for those receiving propafenone and 17% for those receiving placebo (P < 0.001).
Oral loading of propafenone was more effective than placebo for conversion to sinus rhythm within 8 hours and had a favorable safety profile. The rate of spontaneous conversion to sinus rhythm was higher in patients without structural heart disease; this finding has important implications for the assessment of drug effectiveness in recent-onset atrial fibrillation.
对照试验已证实口服普罗帕酮将近期发作的房颤转复为窦性心律的有效性。然而，普罗帕酮的有效性是否受潜在心脏病存在与否的影响尚不清楚。
研究口服普罗帕酮的安全性和有效性以及潜在心脏病的作用。
随机、单盲、对照研究。
3家教学医院。
240例近期发作房颤的住院患者。
普罗帕酮（口服500毫克单剂量）或安慰剂。
3小时和8小时时的转复率。
在3小时时，普罗帕酮在将房颤转复为窦性心律方面比安慰剂更有效：接受普罗帕酮的119例患者中有54例（45%）转复，接受安慰剂的121例患者中有22例（18%）转复（P<0.001）。在8小时时也更有效：接受普罗帕酮的119例患者中有91例（76%）转复，接受安慰剂的121例患者中有45例（37%）转复（P<0.001）。亚组分析显示，在无心脏病的患者中，接受普罗帕酮的患者8小时内78%转复为窦性心律，接受安慰剂的患者为56%（P=0.02）。在高血压患者中，接受普罗帕酮的患者转复率为70%，接受安慰剂的患者为27%（P<0.001）；在有结构性心脏病的患者中，接受普罗帕酮的患者转复率为81%，接受安慰剂的患者为17%（P<0.001）。
口服负荷量普罗帕酮在8小时内转复为窦性心律比安慰剂更有效，且安全性良好。无结构性心脏病患者自发转复为窦性心律的比例更高；这一发现对评估近期发作房颤的药物有效性具有重要意义。
