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两种不同硝酸甘油制剂对肺动脉压和手指脉搏曲线影响的比较。

Comparison of the effects of two different galenical preparations of glyceryl trinitrate on pulmonary artery pressure and on the finger pulse curve.

作者信息

Buschmann M, Wiegand A, Schnellbacher K, Bonn R, Rehe A, Trenk D, Jähnchen E, Roskamm H

机构信息

Benedikt Kreutz Rehabilitationszentrum, Bad Krozingen, Germany.

出版信息

Eur J Clin Pharmacol. 1993;44(5):451-6. doi: 10.1007/BF00315542.

Abstract

The time course and the magnitude of the effect of glyceryl trinitrate (GTN) on central venous (pulmonary artery diastolic pressure-PAPd) and peripheral arterial (a/b-ratio of the finger pulse wave) haemodynamics were compared in a randomized double-blind cross-over study in 12 patients suffering from congestive heart failure (NYHA II-III) with elevated PAPd at rest (> or = 15 mmHg). The data were obtained in a bioavailability study of two sprays of glyceryl trinitrate, which differed in their galenical characteristics and in the dose of GTN (0.4 mg vs. 0.8 mg). Following sublingual administration of each spray, PAPd, a/b-ratio and the plasma concentrations of GTN and its metabolites were measured up to 30 min. The relative bioavailability of GTN of the test preparation was estimated to be 157%, 161% and 147%, when calculated from the plasma concentration-time data or the integrated effect of GTN on a/b-ratio or PAPd, respectively. The mean time courses of the decrease in PAPd and the increase in the a/b-ratio of the finger pulse curve were mirror images. Thus, there was a strong correlation between the mean values of PAPd and a/b-ratio following the administration of glyceryl trinitrate. Since the slope of the relationship differed considerably between the patients, the magnitude of effect of GTN on PAPd in the individual patient could not be predicted from the changes in a/b-ratio.

摘要

在一项随机双盲交叉研究中,对12例静息时肺动脉舒张压(PAPd)升高(≥15 mmHg)的充血性心力衰竭(纽约心脏协会II - III级)患者,比较了硝酸甘油(GTN)对中心静脉(肺动脉舒张压 - PAPd)和外周动脉(手指脉搏波的a/b比值)血流动力学影响的时间过程和程度。数据来自两种硝酸甘油喷雾剂的生物利用度研究,这两种喷雾剂的药剂学特性和GTN剂量(0.4 mg对0.8 mg)不同。每次舌下给药后,在30分钟内测量PAPd、a/b比值以及GTN及其代谢产物的血浆浓度。当分别根据血浆浓度 - 时间数据或GTN对a/b比值或PAPd的综合效应计算时,测试制剂中GTN的相对生物利用度估计分别为157%、161%和147%。PAPd降低和手指脉搏曲线a/b比值增加的平均时间过程呈镜像关系。因此,硝酸甘油给药后PAPd和a/b比值的平均值之间存在很强的相关性。由于患者之间这种关系的斜率差异很大,无法根据a/b比值的变化预测GTN对个体患者PAPd的影响程度。

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