Jensen H, Garsdal P, Davies J
Medical Department G, Bispebjerg Hospital, Copenhagen, Denmark.
J Hum Hypertens. 1990 Oct;4(5):541-5.
The efficacy and toleration of amlodipine (10 mg once daily) was compared with placebo in a four-week double-blind parallel group two-centre study in 38 patients who were receiving enalapril. Patients were moderate to severe hypertensives whose blood pressure was not adequately controlled by enalapril (5-10 mg once daily) (diastolic blood pressure greater than 95 mmHg after four weeks). Results are expressed as the mean difference, in baseline to final changes, between the two treatment groups. At the end of the double-blind period amlodipine patients had significantly greater decreases in supine (-19.4/-10.2 mmHg, P less than 0.001/P less than 0.001) and standing (-16.2/-10.2 mmHg, P less than 0.005/P less than 0.001) blood pressures than the placebo group. There was a greater fall (P = 0.005) in standing diastolic blood pressure at the UK centre (-17.1 mmHg) than in Denmark (-11.2 mmHg). However, pooling the standing diastolic blood pressure data from the two centres gave an overall significant mean treatment difference (-10.2 +/- 2.4 mmHg/P less than 0.001). There were no clinically or statistically significant changes in mean heart rate. Nineteen out of 20 patients in the amlodipine group compared to seven out of 18 patients on placebo, were assessed as improved by the investigator. Similarly 14 out of 19 patients receiving amlodipine were classified as responding to treatment (supine diastolic blood pressure less than 90 mmHg or reduction from baseline of greater than 10 mmHg after four weeks of double-blind therapy) in contrast to four out of 17 receiving placebo.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项为期四周的双盲平行组双中心研究中,对38例正在接受依那普利治疗的患者,比较了氨氯地平(每日一次,每次10毫克)与安慰剂的疗效及耐受性。这些患者为中重度高血压患者,其血压未被依那普利(每日一次,5 - 10毫克)充分控制(四周后舒张压大于95毫米汞柱)。结果以两个治疗组基线至最终变化的平均差值表示。在双盲期结束时,氨氯地平组患者仰卧位(-19.4 / -10.2毫米汞柱,P < 0.001 / P < 0.001)和站立位(-16.2 / -10.2毫米汞柱,P < 0.005 / P < 0.001)血压的下降幅度明显大于安慰剂组。英国中心站立位舒张压的下降幅度(-17.1毫米汞柱)大于丹麦中心(-11.2毫米汞柱)(P = 0.005)。然而,将两个中心的站立位舒张压数据合并后,总体治疗差异均值具有显著意义(-10.2 ± 2.4毫米汞柱 / P < 0.001)。平均心率无临床或统计学上的显著变化。氨氯地平组20例患者中有19例被研究者评估为病情改善,而安慰剂组18例患者中有7例。同样,接受氨氯地平治疗的19例患者中有14例被分类为对治疗有反应(双盲治疗四周后仰卧位舒张压小于90毫米汞柱或较基线下降超过10毫米汞柱),相比之下,接受安慰剂治疗的17例患者中有4例。(摘要截选至250字)