Bellet M, Pagny J Y, Chatellier G, Corvol P, Ménard J
Service d'Hypertension Artérielle-Hôpital Broussais, Paris, France.
J Hypertens. 1987 Oct;5(5):599-604. doi: 10.1097/00004872-198710000-00015.
We conducted a randomized placebo-controlled double-blind study in 40 hypertensive subjects to assess the antihypertensive effect of a new galenic form of nicardipine administered at a dosage of 50 mg twice daily for 3 weeks. Regardless of whether blood pressure was measured by standard mercury sphygmomanometer, non-ambulatory automatic oscillometry or a Remler ambulatory blood pressure recorder, it dropped by a significantly larger amount in the nicardipine group than in the placebo group. In the control group, a placebo effect was observed with the ambulatory diastolic blood pressure recording, whereas it was not observed with hospital blood pressure measurements, especially when using the serial measurements performed for 30 min by an automatic recorder. The fall in blood pressure measured with the Remler recorder was correlated with the fall measured 10-20 min during one acute intravenous nicardipine perfusion before the trial, although the correlation coefficients do not suggest clinically relevant predictability of nicardipine efficacy at the individual level. The present findings support the need for controlled double-blind trials with careful office blood pressure measurements.
我们对40名高血压患者进行了一项随机、安慰剂对照双盲研究,以评估一种新的尼卡地平药剂型的降压效果,该药剂型每日两次、每次50毫克,服用3周。无论血压是通过标准汞柱式血压计、非动态自动示波法还是雷姆勒动态血压记录仪测量,尼卡地平组的血压下降幅度都显著大于安慰剂组。在对照组中,动态舒张压记录观察到了安慰剂效应,而医院血压测量中未观察到,尤其是使用自动记录仪连续测量30分钟时。尽管相关系数并未表明尼卡地平疗效在个体水平上具有临床相关的可预测性,但雷姆勒记录仪测量的血压下降与试验前一次急性静脉注射尼卡地平灌注期间10 - 20分钟测量的血压下降相关。目前的研究结果支持需要进行对照双盲试验,并仔细测量诊室血压。