Arora Rohit R, Venkatesh Prasanna Kumar, Molnar Janos
The Department of Medicine, The Chicago Medical School, Chicago, IL 60064, USA.
Am Heart J. 2006 Dec;152(6):1084-90. doi: 10.1016/j.ahj.2006.07.002.
Nesiritide (recombinant human B-type natriuretic peptide) has been shown to provide symptomatic and hemodynamic improvement in acute decompensated heart failure. A previous meta-analysis of 3 randomized controlled trials has suggested an increased short-term risk of death with nesiritide use. We performed a meta-analysis of 7 available randomized controlled trials to evaluate the short- and long-term risk of death with nesiritide use for acute decompensated heart failure.
Seven large randomized controlled nonmortality trials on nesiritide with available data on 30-day mortality were included. Data on 180-day mortality were available only in 4 trials. Mortality data in nesiritide and control arms were extracted from the selected trials and the nesiritide database (Scios Inc, Fremont, CA).
The pooled estimate of the relative risks (RRs) for unadjusted 30- and 180-day mortality revealed no significant differences between the nesiritide arm (RR 1.243, 95% CI 0.798-1.935) and control arm (RR, 0.002, 95% CI 0.798-1.259), respectively).
Unlike a previous analysis, our meta-analysis indicates that nesiritide is not associated with a higher 30- or 180-day mortality. Further analysis of mortality adjusted for confounding variables such as nesiritide dose, duration of infusion, concurrent use of inotropes, heart failure stage, and arrhythmias may reveal subgroups in jeopardy. Large-scale randomized controlled trials powered to evaluate mortality are required to conclusively address these findings.
奈西立肽(重组人B型利钠肽)已被证明可改善急性失代偿性心力衰竭的症状和血流动力学。之前对3项随机对照试验的荟萃分析表明,使用奈西立肽会增加短期死亡风险。我们对7项可用的随机对照试验进行了荟萃分析,以评估使用奈西立肽治疗急性失代偿性心力衰竭的短期和长期死亡风险。
纳入7项关于奈西立肽的大型随机对照非死亡率试验,这些试验提供了30天死亡率的数据。只有4项试验有180天死亡率的数据。从选定的试验和奈西立肽数据库(Scios公司,加利福尼亚州弗里蒙特)中提取奈西立肽组和对照组的死亡率数据。
未调整的30天和180天死亡率的相对风险(RR)合并估计显示,奈西立肽组(RR 1.243,95% CI 0.798 - 1.935)和对照组(RR 0.002,95% CI 0.798 - 1.259)之间分别无显著差异。
与之前的分析不同,我们的荟萃分析表明,奈西立肽与30天或180天死亡率升高无关。对诸如奈西立肽剂量、输注持续时间、同时使用正性肌力药物、心力衰竭分期和心律失常等混杂变量进行调整后的死亡率进一步分析,可能会揭示处于危险中的亚组。需要进行大规模的随机对照试验来评估死亡率,以最终证实这些发现。