Drici M D, Roux M, Ferrari E, Lapalus P, Morand P
Laboratoire de pharmacologie expérimentale et clinique, faculté de médecine, Nice.
Arch Mal Coeur Vaiss. 1990 Jul;83(8):1111-4.
The administration of placebo (pharmacologically inactive substance) is justified in clinical trials of antihypertensive drugs, in order to avoid the inclusion of placebo-responders. The evaluation of antihypertensive treatments during exercise is an interesting end point, since aerobic exercising is part of antihypertensive treatment. The aims of this study are to determine the placebo impact on blood pressure, heart rate and catecholamine secretion profiles during exercise testing.
10 untreated essential mild to moderate hypertensives participated to a single blind study comprising two successive submaximal exercise testings (85% of maximal theoretical heart rate), separated by a single oral administration of placebo. Blood pressure and heart rate were measured after 10 minutes of resting position and at the end of each effort step (2 mm, 20 Watts), both before and after placebo. Blood samples (5 ml) were collected at rest and during maximal exercise before and after placebo, in order to determine the effect of placebo on circulating catecholamines.
there was no significant variations between the "control" and exercise testings after placebo, neither on blood pressure or heart rate profiles, nor in values of circulating catecholamines [Noradrenaline at rest: 1.88 +/- 0.96, exercise: 6.43 +/- 1.93 nm/l before placebo, 1.65 +/- 0.83 nm/l and 5.71 +/- 2.12 nm/l after placebo respectively (NS)].
the placebo, which effect is generally determined on blood pressure at rest by sphygmomanometry, seems devoid of any activity on blood pressure, heart rate or catecholamine profile during exercise, in essential moderate hypertensives. Thus, antihypertensive treatments at exercise can be evaluated by comparison to baseline cardiovascular parameters without placebo groups.
在抗高血压药物的临床试验中,给予安慰剂(药理惰性物质)是合理的,以避免纳入安慰剂反应者。运动期间抗高血压治疗的评估是一个有趣的终点,因为有氧运动是抗高血压治疗的一部分。本研究的目的是确定安慰剂对运动测试期间血压、心率和儿茶酚胺分泌谱的影响。
10名未经治疗的原发性轻度至中度高血压患者参与了一项单盲研究,该研究包括两次连续的次极量运动测试(最大理论心率的85%),中间口服一次安慰剂。在休息10分钟后以及每次运动阶段(2毫米汞柱,20瓦特)结束时,在服用安慰剂前后测量血压和心率。在休息时以及安慰剂前后最大运动期间采集血样(5毫升),以确定安慰剂对循环儿茶酚胺的影响。
服用安慰剂后,“对照”和运动测试之间在血压或心率谱以及循环儿茶酚胺值方面均无显著差异[静息时去甲肾上腺素:安慰剂前为1.88±0.96,运动时为6.43±1.93纳摩尔/升,安慰剂后分别为1.65±0.83纳摩尔/升和5.71±2.12纳摩尔/升(无统计学意义)]。
安慰剂的作用通常通过血压计在静息血压上确定,在原发性中度高血压患者中,运动期间对血压、心率或儿茶酚胺谱似乎没有任何作用。因此,运动时的抗高血压治疗可以通过与无安慰剂组的基线心血管参数进行比较来评估。