School of Medicine, University of Queensland, Brisbane, Australia.
J Am Coll Cardiol. 2011 Apr 19;57(16):1676-86. doi: 10.1016/j.jacc.2010.10.057.
We sought to determine whether pharmacologic interventions changed exercise capacity, diastolic function, and mortality in a meta-analysis of trials in heart failure with preserved ejection fraction.
Treatment strategies for heart failure with preserved ejection fraction remain unproven despite several large-scale trials.
Trials were included in the systematic review where clear comparisons between trial drug and diuretic or placebo were available. Exercise tolerance was assessed by treadmill time, and changes in diastolic function were quantified by transmitral flow (E/A ratio). The primary outcome was all-cause mortality. Weighted mean differences (MDs) and relative risks (RRs), along with their corresponding 95% confidence intervals (CIs), were computed using random-effects models for continuous and dichotomous variables, respectively. The impact of potential covariates was assessed by meta-regression.
Data from 53,878 patients enrolled in 30 published reports were collated, including 18 randomized controlled trials (n = 11,253) and 12 observational studies (n = 42,625). In the randomized controlled trials, exercise tolerance was improved by combined therapy (n = 183; weighted MD = 51.5; 95% CI: 27.3 to 75.7; p < 0.001), whereas E/A ratio was not (n = 472; weighted MD = -0.01, 95% CI: -0.02 to 0.02; p = 0.54) even after accounting for baseline E/A (p = 0.87). Over a mean follow-up of 18.6 months, all-cause mortality was not improved by therapy in randomized controlled trials (RR: 0.99, 95% CI: 0.92 to 1.06; p = 0.70), despite accounting for baseline ejection fraction (p = 0.72). In observational reports, there was a reduction in all-cause mortality with therapy in the unadjusted analyses (RR: 0.80, 95% CI: 0.66 to 0.97; p = 0.27), but not after adjustment for clinical and demographic data (RR: 0.93, 95% CI: 0.84 to 1.02; p = 0.10).
Pharmacotherapy of heart failure with preserved ejection fraction demonstrates a quantifiable improvement in exercise tolerance but not mortality.
我们旨在通过对射血分数保留型心力衰竭的试验进行荟萃分析，确定药物干预是否能改变运动能力、舒张功能和死亡率。
尽管进行了多项大型试验，但射血分数保留型心力衰竭的治疗策略仍未得到证实。
系统评价中纳入了有明确试验药物与利尿剂或安慰剂比较的试验。通过跑步机时间评估运动耐量，通过二尖瓣血流（E/A 比值）评估舒张功能变化。主要结局为全因死亡率。使用随机效应模型分别计算连续和二分类变量的加权均数差（MD）和相对风险（RR）及其相应的 95%置信区间（CI）。通过荟萃回归评估潜在协变量的影响。
共整理了 30 篇已发表报告中 53878 名患者的数据，其中包括 18 项随机对照试验（n=11253）和 12 项观察性研究（n=42625）。在随机对照试验中，联合治疗改善了运动耐量（n=183；加权 MD=51.5；95%CI：27.3 至 75.7；p<0.001），而 E/A 比值无改善（n=472；加权 MD=-0.01，95%CI：-0.02 至 0.02；p=0.54），即使考虑到基线 E/A 也是如此（p=0.87）。在平均 18.6 个月的随访中，尽管考虑了基线射血分数（p=0.72），但随机对照试验中的治疗并未改善全因死亡率（RR：0.99，95%CI：0.92 至 1.06；p=0.70）。在观察性报告中，未经调整分析时治疗有降低全因死亡率的趋势（RR：0.80，95%CI：0.66 至 0.97；p=0.27），但在调整临床和人口统计学数据后则无此趋势（RR：0.93，95%CI：0.84 至 1.02；p=0.10）。
射血分数保留型心力衰竭的药物治疗可显著改善运动耐量，但不能改善死亡率。
