Henyan N N, White C M, Gillespie E L, Smith K, Coleman C I, Kluger J
University of Connecticut School of Pharmacy, Storrs and Farmington, CT, USA.
J Intern Med. 2006 Nov;260(5):467-73. doi: 10.1111/j.1365-2796.2006.01713.x.
Implantable cardioverter defibrillators (ICDs) are a life-saving therapy for many patients with cardiovascular disease at increased risk of fatal dysrhythmias. As men comprise the majority of the study population (67-92%) in clinical trials, the benefit to women is unknown. We performed a meta-analysis of primary prevention trials to evaluate the impact of ICDs in men and women on death from any cause.
Included trials met the following criteria: (i) randomized controlled trials versus standard of care, (ii) ICD used as primary prevention in a well-described protocol and (iii) data provided on risk of death from any cause for both male and female patients.
Five clinical trials were included in this meta-analysis. The risk of death from any cause was significantly reduced by 26% in male patients who received ICD therapy compared to control, hazard ratio (HR) 0.74 (95% CI 0.60-0.91) but not amongst female patients, HR 0.81 (95% CI 0.60-1.09). As the COMPANION trial evaluated the combination of biventricular pacemaker with ICD therapy we conducted a separate analysis without the inclusion of this study. Male patients receiving ICD therapy demonstrated a similar 24% reduction in risk of death from any cause, HR 0.76 (95% CI 0.58-0.99) whilst female patients demonstrated a reduction of only 12%, HR 0.88 (95% CI 0.63-1.22).
Unlike their male counterparts, females did not significantly benefit from ICD therapy and without concurrent biventricular pacing, appear only to achieve a nonsignificant 12% reduction in risk of death.
植入式心脏复律除颤器（ICD）是许多有致命性心律失常风险增加的心血管疾病患者的一种挽救生命的治疗方法。由于在临床试验中男性占研究人群的大多数（67%-92%），ICD对女性的益处尚不清楚。我们进行了一项一级预防试验的荟萃分析，以评估ICD对男性和女性全因死亡的影响。
纳入的试验符合以下标准：（i）与标准治疗相比的随机对照试验；（ii）在详细描述的方案中ICD用作一级预防；（iii）提供了男性和女性患者全因死亡风险的数据。
该荟萃分析纳入了五项临床试验。与对照组相比，接受ICD治疗的男性患者全因死亡风险显著降低26%，风险比（HR）为0.74（95%可信区间[CI]为0.60-0.91），但女性患者未显著降低，HR为0.81（95%CI为0.60-1.09）。由于COMPANION试验评估了双心室起搏器与ICD治疗的联合应用，我们进行了一项不纳入该研究的单独分析。接受ICD治疗的男性患者全因死亡风险同样降低了24%，HR为0.76（95%CI为0.58-0.99），而女性患者仅降低了12%，HR为0.88（95%CI为0.63-1.22）。
与男性不同，女性未从ICD治疗中显著获益，且在无同期双心室起搏的情况下，似乎仅使死亡风险非显著降低12%。
