Hôpital Cardiologique, Service de Cardiologie, CHRU Lille, Lille, France.
Europace. 2010 May;12(5):634-42. doi: 10.1093/europace/euq007. Epub 2010 Feb 13.
Patients with atrial fibrillation (AF) consider the related symptoms disruptive to their quality of life (QoL). This study aimed to evaluate the impact of the control of symptomatic paroxysmal AF (PAF) on QoL.
Patients with symptomatic PAF were treated for 48 weeks with open-label flecainide acetate controlled release (Flec CR). Quality of life was assessed by SF-36 and Atrial Fibrillation Severity Scale scores at baseline, Week 12 (W12), W24, and W48. Of the 229 treated patients, 217 were analysed for QoL (123 with controlled and 94 with uncontrolled symptomatic PAF at inclusion). The controlled group had a similar or better QoL (SF-36) at baseline compared with a reference population (significantly better for: physical functioning, bodily pain, and physical component). The uncontrolled group had an inferior QoL (significantly worse for: role physical, general health, vitality, role emotional, social functioning, mental health, and mental component). When treated with Flec CR, the controlled group baseline QoL scores were maintained and the uncontrolled group scores were improved to a level comparable to the controlled group scores. Safety findings reflect the known clinical safety profile of flecainide acetate.
In this study, patients with uncontrolled symptomatic PAF at baseline had an inferior QoL to those with controlled symptomatic PAF. Following treatment with controlled-release flecainide acetate, their QoL improved to a level comparable to controlled patients.
患有心房颤动(AF)的患者认为相关症状会扰乱其生活质量(QoL)。本研究旨在评估控制有症状阵发性 AF(PAF)对 QoL 的影响。
有症状 PAF 的患者接受开放标签氟卡尼酸醋酸酯控释剂(Flec CR)治疗 48 周。在基线、第 12 周(W12)、第 24 周和第 48 周使用 SF-36 和心房颤动严重程度量表评估生活质量。在 229 例接受治疗的患者中,有 217 例进行了 QoL 分析(123 例在纳入时控制了有症状 PAF,94 例未控制)。与参考人群相比,对照组在基线时具有相似或更好的 QoL(SF-36)(身体功能、身体疼痛和身体成分方面明显更好)。未控制组的 QoL 较差(身体角色、一般健康、活力、情绪角色、社会功能、心理健康和心理成分明显更差)。用 Flec CR 治疗时,对照组的基线 QoL 评分保持不变,未控制组的评分提高到与对照组评分相当的水平。安全性发现反映了氟卡尼酸醋酸酯的已知临床安全性概况。
在这项研究中,基线时有症状未控制 PAF 的患者的 QoL 低于有症状控制 PAF 的患者。用控释氟卡尼酸醋酸酯治疗后,他们的 QoL 提高到与控制患者相当的水平。