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【NEJM】心力衰竭患者接受除颤器治疗或胺碘酮治
Daniel B. Mark, M.D., M.P.H., Kevin J. Anstrom, Ph.D., Jie L. Sun, M.S., Nancy E. Clapp-Channing, R.N., M.P.H., Anastasios A. Tsiatis, Ph.D., Linda Davidson-Ray, M.A., Kerry L. Lee, Ph.D., Gust H. Bardy, M.D., for the Sudden Cardiac Death in Heart Failure Trial Investigators
ABSTRACT
Background Implantable cardioverter–defibrillator (ICD) therapy significantly prolongs life in patients at increased risk for sudden death from depressed left ventricular function. However, whether this increased longevity is accompanied by deterioration in the quality of life is unclear.
Methods In a randomized trial, we compared ICD therapy or amiodarone with state-of-the-art medical therapy alone in 2521 patients who had stable heart failure with depressed left ventricular function. We prospectively measured quality of life at baseline and at months 3, 12, and 30; data collection was 93 to 98% complete. The Duke Activity Status Index (which measures cardiac physical functioning) and the Medical Outcomes Study 36-Item Short-Form Mental Health Inventory 5 (which measures psychological well-being) were prespecified primary outcomes. Multiple additional quality-of-life outcomes were also examined.
Results Psychological well-being in the ICD group, as compared with medical therapy alone, was significantly improved at 3 months (P=0.01) and at 12 months (P=0.003) but not at 30 months. No clinically or statistically significant differences in physical functioning among the study groups were observed. Additional quality-of-life measures were improved in the ICD group at 3 months, 12 months, or both, but there was no significant difference at 30 months. ICD shocks in the month preceding a scheduled assessment were associated with a decreased quality of life in multiple domains. The use of amiodarone had no significant effects on the primary quality-of-life outcomes.
Conclusions In a large primary-prevention population with moderately symptomatic heart failure, single-lead ICD therapy was not associated with any detectable adverse quality-of-life effects during 30 months of follow-up.
Quality of Life with Defibrillator Therapy or Amiodarone in Heart Failure
心力衰竭患者接受除颤器治疗或胺碘酮治疗对生活质量的影响
ABSTRACT
Background Implantable cardioverter–defibrillator (ICD) therapy significantly prolongs life in patients at increased risk for sudden death from depressed left ventricular function. However, whether this increased longevity is accompanied by deterioration in the quality of life is unclear.
背景：对于因左心室功能不全而具有高猝死风险的患者，埋藏式心脏电复律除颤器（ICD）治疗能显著延长其生命。但是寿命的增加是否伴随着生命质量的恶化尚不清楚。
Methods In a randomized trial, we compared ICD therapy or amiodarone with state-of-the-art medical therapy alone in 2521 patients who had stable heart failure with depressed left ventricular function. We prospectively measured quality of life at baseline and at months 3, 12, and 30; data collection was 93 to 98% complete. The Duke Activity Status Index (which measures cardiac physical functioning) and the Medical Outcomes Study 36-Item Short-Form Mental Health Inventory 5 (which measures psychological well-being) were prespecified primary outcomes. Multiple additional quality-of-life outcomes were also examined.
方法：在随机研究中，我们纳入了2521例稳定性左心功能不全的心力衰竭患者，比较ICD治疗、胺碘酮治疗或单用优化药物治疗对生命质量的影响。我们前瞻性的测量了患者基线时、3个月、12个月、30个月的生活质量，数据完整性为93%-98%。杜克活动状态指数（评价心脏生理功能）和医学预后研究36项短期精神健康问卷5（评价心理健康）被确定为主要终点。多种其它生活质量评分也同时测量。
Results Psychological well-being in the ICD group, as compared with medical therapy alone, was significantly improved at 3 months (P=0.01) and at 12 months (P=0.003) but not at 30 months. No clinically or statistically significant differences in physical functioning among the study groups were observed. Additional quality-of-life measures were improved in the ICD group at 3 months, 12 months, or both, but there was no significant difference at 30 months. ICD shocks in the month preceding a scheduled assessment were associated with a decreased quality of life in multiple domains. The use of amiodarone had no significant effects on the primary quality-of-life outcomes.
结果：ICD组的心理健康，与单用优化药物治疗相比，在3个月（P=0.01）和12个月（P=0.003）时显著改善，但在30个月时没有改善。生理功能在不同治疗组之间没有临床的和统计学上的显著差异。ICD组其它生命质量评价在3月或12月或两个时间点有改善，但在30个月没有明显差别。当ICD电击发生在预定评价生命质量的时间前一个月时，多个生命质量评价均下降。应用胺碘酮对主要生命质量预后没有改善。
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作者:admin@医学,生命科学 2011-07-31 05:14
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