Zannad F, Vaur L, Dutrey-Dupagne C, Genes N, Clerson P
Cardiologie C, Hôpital Central, Nancy, France.
J Hum Hypertens. 1996 Jan;10(1):51-5.
The aim of this double-blind randomized study was to compare the antihypertensive effects of trandolapril and nitrendipine in the elderly. After a 2-week placebo period, patients received either trandolapril 0.5 mg or nitrendipine 10 mg, once daily for 15 days. At the end of this period, according to a forced titration, the dose was increased to 2 mg of trandolapril or 20 mg of nitrendipine once daily for 2 months. Seventy-three hypertensive patients, aged 65 and over, entered the study. Demographic data and initial blood pressure (BP) level were comparable in the two groups. The antihypertensive effect, measured with a mercury sphygmomanometer, was assessed in 64 patients: SBP decreased by 18.6 +/- 12.1 mm Hg in the trandolapril (P < 0.001) and by 21.0 +/- 13.7 mm Hg in the nitrendipine group (P < 0.001); DBP decreased by 13.4 +/- 8.5 mm Hg in the trandolapril group (P < 0.001) and by 15.4 +/-8.2 mm Hg in the nitrendipine group (P < 0.001). No statistically significant difference was seen between the two treatment groups. A sub-group of 42 patients were evaluated by 24 h ambulatory BP monitoring. Mean 24 h ambulatory SBP/DBP decreases were 6.6 +/- 18.0/8.4 +/- 8.5 mm Hg in the trandolapril group (P < 0.001) and 5.7 +/- 11.1/7.2 +/-9.6 mm Hg in the nitrendipine group (P < 0.001). The differences between the two treatment groups were not statistically significant. The antihypertensive action of trandolapril was sustained throughout the 24 h period with a trough-to-peak ratio of 70.2% for SBP and 70.9% for DBP. Nitrendipine exerted its action mainly during the day, with a very modest antihypertensive effect during the night and early morning; its trough/peak ratio was 25.9% for SBP and 28% for DBP. The tolerance of both treatments were good; seven patients were withdrawn from the trial for adverse events (four in the nitrendipine group, three in the trandolapril group).
这项双盲随机研究的目的是比较群多普利和尼群地平在老年患者中的降压效果。经过2周的安慰剂期后，患者每日服用一次0.5毫克群多普利或10毫克尼群地平，持续15天。在此阶段结束时，根据强制滴定法，剂量增加至每日2毫克群多普利或20毫克尼群地平，持续2个月。73名65岁及以上的高血压患者进入该研究。两组的人口统计学数据和初始血压水平具有可比性。使用汞柱式血压计测量降压效果，对64名患者进行了评估：群多普利组收缩压下降了18.6±12.1毫米汞柱（P<0.001），尼群地平组下降了21.0±13.7毫米汞柱（P<0.001）；群多普利组舒张压下降了13.4±8.5毫米汞柱（P<0.001），尼群地平组下降了15.4±8.2毫米汞柱（P<0.001）。两个治疗组之间未观察到统计学上的显著差异。通过24小时动态血压监测对42名患者的亚组进行了评估。群多普利组24小时动态收缩压/舒张压平均下降幅度为6.6±18.0/8.4±8.5毫米汞柱（P<0.001），尼群地平组为5.7±11.1/7.2±9.6毫米汞柱（P<0.001）。两个治疗组之间的差异无统计学意义。群多普利的降压作用在24小时内持续存在，收缩压的谷峰比为70.2%，舒张压为70.9%。尼群地平主要在白天发挥作用，夜间和清晨的降压作用非常微弱；其收缩压的谷/峰比为25.9%，舒张压为28%。两种治疗的耐受性都很好；7名患者因不良事件退出试验（尼群地平组4名，群多普利组3名）。
