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基线严重程度而非性别调节早期心力衰竭中定量山楂提取物的作用-临床试验的汇总分析。

Baseline severity but not gender modulates quantified Crataegus extract effects in early heart failure--a pooled analysis of clinical trials.

机构信息

Kardiologie Köln, Gemeinschaftspraxis Kardiologie, Köln, Germany.

出版信息

Phytomedicine. 2011 Nov 15;18(14):1214-9. doi: 10.1016/j.phymed.2011.06.022. Epub 2011 Jul 23.

DOI:10.1016/j.phymed.2011.06.022
PMID:21784624
Abstract

OBJECTIVE

The efficacy of quantified Crataegus extract in chronic heart failure (CHF) has been assessed in numerous clinical studies. The present pooled analysis evaluates the impact of baseline severity and gender on objective and patient-reported endpoints and associations between both types of outcomes in patients with early CHF.

METHODS

Available data from 687 individual patients treated with quantified Crataegus extract or placebo in ten studies were pooled. Treatment effects on physiologic outcome parameters and on symptoms were analysed for their association with baseline severity and gender. Changes in symptom scores were investigated with respect to their relation to physiologic outcome parameters. Results were compared with observations in a 3-year cohort study.

RESULTS

Physiologic outcome parameters maximal workload (MWL), left ventricular ejection fraction (LVEF) and pressure-heart rate product increase (PHRPI) at 50 W ergometric exercise improved more in active treatment than in placebo patients. Magnitude of improvement was independent from baseline for LVEF but increased for MWL and PHRPI with baseline severity. Improvement of typical symptoms like reduced exercise tolerance, exertional dyspnea, weakness, fatigue, and palpitations improved more with active treatment and in patients with more severe symptoms. A weak association between improvements in MWL, PRHP, and symptoms could be demonstrated. Gender differences in treatment effects could be explained by baseline differences. Results of the pooled analysis are in agreement with observations in the cohort study.

CONCLUSIONS

Crataegus extract treatment effects on physiologic outcomes and typical symptoms were modulated by baseline severity. Taking baseline differences into account, benefits were comparable in male and female patients with impaired exercise-tolerance in early chronic heart-failure.

摘要

目的

已有大量临床研究评估了定量山楂提取物治疗慢性心力衰竭(CHF)的疗效。本荟萃分析评估了基线严重程度和性别对客观和患者报告终点的影响,以及早期 CHF 患者两种类型结局之间的相关性。

方法

对 10 项研究中 687 名接受定量山楂提取物或安慰剂治疗的个体患者的可用数据进行了汇总。分析了治疗对生理结局参数和症状的影响,以评估其与基线严重程度和性别之间的关系。还研究了症状评分的变化与生理结局参数之间的关系。结果与一项为期 3 年的队列研究中的观察结果进行了比较。

结果

生理结局参数最大工作量(MWL)、左心室射血分数(LVEF)和压力心率乘积增加(PHRPI)在 50 W 运动试验中,活性治疗组比安慰剂组改善更明显。LVEF 的改善与基线无关,但 MWL 和 PHRPI 的改善与基线严重程度成正比。典型症状(如运动耐量降低、运动性呼吸困难、乏力、疲劳和心悸)的改善在活性治疗组和症状更严重的患者中更为明显。MWL、PRHP 和症状改善之间存在微弱的相关性。治疗效果的性别差异可以用基线差异来解释。汇总分析的结果与队列研究的观察结果一致。

结论

山楂提取物对生理结局和典型症状的治疗效果受基线严重程度的调节。考虑到基线差异,在早期慢性心力衰竭运动耐量受损的男性和女性患者中,获益相当。

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