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前列腺素输注治疗严重心力衰竭的益处:重复给药的初步临床经验。

Benefit of prostaglandin infusion in severe heart failure: preliminary clinical experience of repetitive administration.

出版信息

Int J Cardiol. 2011 Jan 7;146(1):e10-5. doi: 10.1016/j.ijcard.2008.12.173. Epub 2009 Jan 28.

Abstract

BACKGROUND

Prostaglandin E1 (PGE1) is a potent vasodilating drug, which has been used in treatment of primary pulmonary hypertension. However intravenous PGE1 infusion may be of benefit and also has been proposed as a therapeutic tool in patients with end-stage heart failure. The aim of this prospective not randomized study was to assess the clinical and instrumental effects of this agent in patients with severe heart failure and pulmonary hypertension.

METHODS

To investigate the effects of PGE1 in congestive heart failure we selected 22 consecutive patients (16 males, 6 females, mean age 63±2 years) in the mean NYHA class III, because they had pulmonary hypertension (PAPs>3 m/s and left ventricular ejection fraction (LVEF) ≤35% by echocardiography. A control group of 23 patients (19M, 4F mean age 62±5 years; 9 patients were in the NYHA class IV and 14 in the NYHA class III), with the same instrumental and clinical data, received an optimized oral treatment with beta-blockers, ACE-inhibitors, furosemide and digitalis. Right heart catheterization was performed to confirm and determine the type of pulmonary hypertension, before starting the PGE1 infusion. Clinical and echocardiography evaluation was performed during follow-up. PGE1 was infused at a mean dose of 10 ng/kg/min for a total of 24 h over three consecutive days every three months.

RESULTS

Right heart catheterization confirmed a high systolic pulmonary pressure in all patients; pre-capillary pulmonary hypertension (mean PAP>25 mm/Hg) was 25%. During a mean follow-up of 36±6 months, 16 patients died (10 in the control group and 6 in the PGE1 group). The Kaplan-Meier 3-years survival analysis was not statistically significant (Log-rank test), but at 2 months survival rates began to diverge; 36 months survival: 72.7% in the PGE1 group and 56% in the control group. The mean LVEF increased from 25.78% to 32.1% in the PGE1 group and from 23.38% to 26.15 in the control group (p<0.001); the NYHA mean class improved from 3.18 to 2.24 in the PGE1 group and from 3.46 to 3.38 in the control group (p<0.05). The PAP decreased from 57.65 to 40.82 mm/Hg (p<0.001). An AICD was implanted in 3 patients in the first group and in 5 patients in the control group. Two patients were added to the heart transplantation list.

CONCLUSION

These preliminary data suggest that intermittent PGE1 infusion in patients with advanced congestive heart failure and high pulmonary pressure is able to improve NYHA mean class (p<0.05), ventricular contractility (LVEF p<0.001), pulmonary pressure and clinical data. It hasn't been associated to morbid events or increased risk of death.

摘要

背景

前列腺素 E1(PGE1)是一种有效的血管扩张药物,已用于治疗原发性肺动脉高压。然而,静脉内 PGE1 输注可能有益,也被提议作为终末期心力衰竭患者的治疗工具。本前瞻性非随机研究的目的是评估该药物在严重心力衰竭和肺动脉高压患者中的临床和仪器效应。

方法

为了研究 PGE1 在充血性心力衰竭中的作用,我们选择了 22 例连续患者(16 名男性,6 名女性,平均年龄 63±2 岁),平均 NYHA Ⅲ级,因为他们患有肺动脉高压(PAPs>3 m/s 和左心室射血分数(LVEF)<35%,通过超声心动图检查。23 例患者(19 名男性,4 名女性,平均年龄 62±5 岁;9 名患者为 NYHA Ⅳ级,14 名患者为 NYHA Ⅲ级)作为对照组,具有相同的仪器和临床数据,接受了优化的口服β受体阻滞剂、ACE 抑制剂、呋塞米和地高辛治疗。在开始 PGE1 输注之前,进行右心导管检查以确认和确定肺动脉高压的类型。在随访期间进行临床和超声心动图评估。PGE1 以 10 ng/kg/min 的平均剂量输注,连续 3 天,每天 24 小时,每 3 个月一次。

结果

右心导管检查证实所有患者的收缩压肺动脉压均升高;前毛细血管性肺动脉高压(平均 PAP>25mmHg)为 25%。在平均 36±6 个月的随访期间,16 名患者死亡(对照组 10 名,PGE1 组 6 名)。Kaplan-Meier 3 年生存率分析无统计学意义(对数秩检验),但 2 个月时生存率开始出现差异;36 个月生存率:PGE1 组 72.7%,对照组 56%。PGE1 组的平均 LVEF 从 25.78%增加到 32.1%,对照组从 23.38%增加到 26.15%(p<0.001);NYHA 平均等级从 3.18 提高到 2.24,PGE1 组从 3.46 提高到 3.38(p<0.05)。PAP 从 57.65 降至 40.82mmHg(p<0.001)。在第一组中,3 名患者植入了 AICD,对照组中 5 名患者植入了 AICD。有 2 名患者被列入心脏移植名单。

结论

这些初步数据表明,在晚期充血性心力衰竭和高肺动脉压患者中间歇性 PGE1 输注能够改善 NYHA 平均等级(p<0.05)、心室收缩力(LVEF p<0.001)、肺动脉压和临床数据。它与不良事件或死亡风险增加无关。

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