Portaluppi F, Strozzi C, degli Uberti E, Rambaldi R, Trasforini G, Margutti A, Montanari L, Fersini C, Pansini R
Institute of Clinica Medica, University of Ferrara, Italy.
Jpn Heart J. 1988 Mar;29(2):189-97. doi: 10.1536/ihj.29.189.
Placebo controlled trials have generally been used in order to evaluate the antihypertensive efficacy of drugs. There is some evidence, though, that blood pressure might not be influenced by placebo. Non-invasive devices for automatic blood pressure monitoring are likely to provide a better assessment of blood pressure response to drugs, as well as to different physiologic and pathologic conditions, than the traditional sphygmomanometric devices. The aim of this study was to investigate the effect of placebo on blood pressure recorded automatically and non-invasively. For this purpose, a chronobiologic approach to the collection, evaluation and interpretation of data seemed most appropriate. A group of 12 patients with a clinical diagnosis of essential hypertension underwent automatic blood pressure monitoring in hospital for 4 days. Measurements were taken every 15 min by an oscillometric instrument with an automatically inflated cuff. After a washout period during which the patients received no treatment, pressure recording was undertaken under basal conditions for 2 days. On the third and fourth days of study, the patients received 2 tablets of placebo, one at 10 a.m. and one at 10 p.m. In each patient a highly significant circadian rhythm was documented for systolic and diastolic pressure, both under basal conditions and during placebo administration. Blood pressure mesors were higher than reference standards and were not significantly affected by placebo. The circadian amplitudes and acrophases did not differ significantly before and during placebo. Our data indicate that automatically recorded blood pressure is not influenced by placebo.
为了评估药物的降压效果，通常会采用安慰剂对照试验。然而，有一些证据表明，安慰剂可能不会影响血压。与传统的血压计设备相比，用于自动血压监测的非侵入性设备可能会更好地评估血压对药物以及不同生理和病理状况的反应。本研究的目的是调查安慰剂对自动无创记录的血压的影响。为此，采用时间生物学方法收集、评估和解释数据似乎最为合适。一组12名临床诊断为原发性高血压的患者在医院接受了4天的自动血压监测。使用带有自动充气袖带的示波仪每15分钟进行一次测量。在患者未接受治疗的洗脱期后，在基础条件下进行2天的血压记录。在研究的第三天和第四天，患者服用2片安慰剂，一片在上午10点服用，一片在晚上10点服用。在每个患者中，无论是在基础条件下还是在服用安慰剂期间，收缩压和舒张压都记录到了高度显著的昼夜节律。血压均值高于参考标准，且未受到安慰剂的显著影响。安慰剂服用前和服用期间的昼夜振幅和峰值相位没有显著差异。我们的数据表明，自动记录的血压不受安慰剂影响。
