在临床药理学试验条件下,研究了进食和长时间仰卧位对健康受试者血液动力学的影响。

W Sziegoleit, C Lautenschläger, C Walther, P Presek
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引用次数: 1

摘要

在临床药理学试验条件下,研究了长时间仰卧位和食物摄入对心血管变量的影响。在一项不使用药物或安慰剂的随机交叉设计研究中,6名健康男性志愿者在试验a之前和期间吃了一顿清淡的标准餐,在试验b中禁食。在两项试验中,当他们连续仰卧超过8小时时,在开始仰卧位后24、26和28分钟(首次记录)和25次(首次记录后2至480分钟)同步记录心血管变量。采用多因素统计分析,对进食和仰卧记录时间等因素进行评价。进食导致舒张压、平均血压、PQ时间、QS₂时间显著降低,全身血管阻力呈下降趋势,收缩压、心输出量呈上升趋势。当受试者长时间保持仰卧位时,收缩压、舒张压、平均血压和全身血管阻力显著升高,心输出量和QS₂时间显著降低。因此,在心血管药物效应和伴随安慰剂对照的临床药理学研究中,进食和长时间保持仰卧位应被视为偏倚的来源。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Hemodynamic effects of eating and prolonged supine position in healthy subjects studied under clinical-pharmacological test conditions.

The influences of both being in a supine position for a prolonged period and food intake on cardiovascular variables were studied under clinical-pharmacological test conditions. In a randomized crossover design study without drug or placebo administration, 6 healthy male volunteers received a light standard meal before and during test A and fasted in test B. In both tests, while they were continuously supine for more than 8 h, a synchronous recording of cardiovascular variables was done at 24, 26 and 28 min after starting the supine position (first recordings) and 25 times from 2 to 480 min after the first recordings. Using a multifactorial statistical analysis, each parameter was evaluated regarding the factors eating and time of supine recording. Eating led to a significant decrease in diastolic and mean blood pressure, PQ time and QS₂ time, a downward trend in systemic vascular resistance and an upward trend in systolic blood pressure and cardiac output. When the subjects remained in a supine position for prolonged periods, significant increases in systolic, diastolic, mean blood pressure and systemic vascular resistance were noted as well as significant decreases in cardiac output and QS₂ time. Thus, eating and remaining in a supine position for prolonged periods should be considered as sources of bias in clinical-pharmacological studies on cardiovascular drug effects and accompanying placebo controls.

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