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慢性主动脉瓣关闭不全的长期血管扩张剂治疗。一项随机双盲、安慰剂对照临床试验。

Long-term vasodilator therapy of chronic aortic insufficiency. A randomized double-blinded, placebo-controlled clinical trial.

作者信息

Greenberg B, Massie B, Bristow J D, Cheitlin M, Siemienczuk D, Topic N, Wilson R A, Szlachcic J, Thomas D

机构信息

Department of Medicine, Oregon Health Sciences University, Portland 97201.

出版信息

Circulation. 1988 Jul;78(1):92-103. doi: 10.1161/01.cir.78.1.92.

DOI:10.1161/01.cir.78.1.92
PMID:3289791
Abstract

Although vasodilator drugs acutely reduce regurgitation and improve cardiac performance in aortic insufficiency, their long-term effects on left ventricular size and function are uncertain. Consequently, we performed a double-blinded, placebo-controlled trial using hydralazine in 80 minimally symptomatic patients who had clinically stable, moderate-to-severe aortic insufficiency. Patients randomized to hydralazine displayed a progressive reduction in left ventricular end-diastolic volume index (LVEDVI) measured by radionuclide angiography, the predetermined end point of the study. At 24 months, mean LVEDVI had been reduced by 30 +/- 38 ml/m2, an 18% reduction from baseline. In contrast, LVEDVI changed minimally in patients randomized to placebo, and the intergroup differences over time were statistically significant (p less than 0.03). The hydralazine group also experienced reductions in left ventricular end-systolic volume index and increases in ejection fraction that were significantly different (both p less than 0.01) from changes in placebo-treated patients. These findings show that long-term treatment with hydralazine reduces the volume overload in aortic insufficiency and suggest that such therapy may have a beneficial effect on the natural history of the disease.

摘要

尽管血管扩张剂能在急性情况下减少主动脉瓣关闭不全时的反流并改善心脏功能,但其对左心室大小和功能的长期影响尚不确定。因此,我们对80例有轻度症状、临床病情稳定的中重度主动脉瓣关闭不全患者进行了一项使用肼屈嗪的双盲、安慰剂对照试验。随机分配到肼屈嗪组的患者,通过放射性核素血管造影测量的左心室舒张末期容积指数(LVEDVI)呈现进行性下降,这是该研究的预定终点。在24个月时,平均LVEDVI降低了30±38 ml/m²,较基线降低了18%。相比之下,随机分配到安慰剂组的患者LVEDVI变化极小,且两组随时间的差异具有统计学意义(p<0.03)。肼屈嗪组的左心室收缩末期容积指数也有所降低,射血分数增加,与安慰剂治疗患者的变化相比有显著差异(p均<0.01)。这些发现表明,长期使用肼屈嗪治疗可减轻主动脉瓣关闭不全时的容量负荷过重,并提示这种治疗可能对该疾病的自然病程产生有益影响。

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