鱼油对植入埋藏式心脏复律除颤器患者室性快速性心律失常及死亡的影响:ω-3脂肪酸与室性心律失常(SOFA)随机化研究

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Context: Very-long-chain n-3 polyunsaturated fatty acids(omega-3 PUFAs) from fish are thought to reduce risk of sudden death, possibly by reducing susceptibility to cardiac arrhythmia. Objective: To study the effect of supplemental fish oil vs placebo on ventricular tachyarrhythmia or death. Design, Setting, and Patients: The Study on Omega-3 Fatty acids and ventricular Arrhythmia(SOFA) was a randomized, parallel, placebo-controlled, double-blind trial conducted at 26 cardiology clinics across Europe. A total of 546 patients with implantable cardioverter-defibrillators(ICDs) and prior documented malignant ventricular tachycardia(VT) or ventricular fibrillation(VF) were enrolled between October 2001 and August 2004. Patients were randomly assigned to receive 2 g/d of fish oil(n=273) or placebo(n=273) for a median period of 356 days(range, 14-379 days). Main Outcome Measure: Appropriate ICD intervention for VT or VF, or all-cause death. Results: The primary end point occurred in 81(30%) patients taking fish oil vs 90(33%) patients taking placebo(hazard ratio[HR], 0.86; 95%confidence interval[CI], 0.64-1.16; P=.33). In prespecified subgroup analyses, the HR was 0.91(95%CI, 0.66-1.26) for fish oil vs placebo in the 411 patients who had experienced VT in the year before the study, and 0.76(95%CI, 0.52-1.11) for 332 patients with prior myocardial infarctions. Conclusion: Our findings do not indicate evidence of a strong protective effect of intake of omega-3 PUFAs from fish oil against ventricular arrhythmia in patients with ICDs. Context: Very-long-chain n-3 polyunsaturated fatty acids (omega-3 PUFAs) from fish are thought to reduce risk of sudden death, possibly by reducing susceptibility to cardiac arrhythmia. Objective: To study the effect of supplemental fish oil vs placebo on ventricular tachyarrhythmia or death. Design, Setting, and Patients: The Study on Omega-3 Fatty acids and ventricular Arrhythmia (SOFA) was a randomized, parallel, placebo-controlled, double- blind trial conducted at 26 cardiology clinics across Europe. A total of 546 patients with implantable cardioverter-defibrillators (ICDs) and prior documented malignant ventricular tachycardia (VT) or ventricular fibrillation (VF) were enrolled between October 2001 and August 2004. Patients were randomly assigned to receive 2 g / d of fish oil ( Results: The primary end (range, 14-379 days). Main Outcome Measure: Appropriate ICD intervention for VT or VF, or all-cause death. point occurred in 81 (30%) Patients taking fish oil vs 90 (33%) patients taking placebo (hazard ratio [HR], 0.86; 95% confidence interval CI], 0.64-1.16; P = .33). In prespecified subgroup analyzes, HR was 0.91 95% CI, 0.66-1.26) for fish oil vs placebo in the 411 patients who had experienced VT in the year before the study, and 0.76 (95% CI, 0.52-1.11) for 332 patients with prior myocardial infarctions. Conclusion: Our findings do not indicate evidence of a strong protective effect of intake of omega-3 PUFAs from fish oil against ventricular arrhythmia in patients with ICDs.
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