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非洛地平与美托洛尔对老年高血压患者的控制:一项双盲、安慰剂对照临床试验。

Control of hypertension in elderly patients with felodipine and metoprolol: a double-blind, placebo-controlled clinical trial.

作者信息

Freeling P, Davis R H, Goves J R, Burton R H, Orme-Smith E A

机构信息

Department of General Practice, St George's Hospital Medical School, London.

出版信息

Br J Clin Pharmacol. 1987 Oct;24(4):459-64. doi: 10.1111/j.1365-2125.1987.tb03198.x.

Abstract
  1. Forty-nine patients aged 65-80 years, whose Phase V diastolic blood pressure (dBP) was above 95 mmHg after 4 weeks open treatment with metoprolol 50 mg twice daily were randomized to receive, double-blind, the calcium antagonist felodipine (n = 32) 2.5 mg twice daily or placebo (n = 17) in addition to metoprolol for 2 weeks. If the dBP remained greater than 95 mmHg, the dose of felodipine or placebo was doubled for a further 2 weeks; if the dBP was still greater than 95 mmHg, the dose of felodipine was doubled again to 10 mg twice daily or the corresponding placebo dose given. The duration of the double-blind period was 6 weeks, all patients receiving metoprolol 50 mg twice daily throughout. 2. At the end of the double-blind period, the seated dBP was reduced from 103 +/- 5 (mean +/- s.d.) to 88 +/- 7 mmHg (P less than 0.001) by felodipine and from 105 +/- 100 +/- 11 mmHg (NS) by placebo. The differences between these reductions (P less than 0.01) and between the final dBPs (P less than 0.001) were significant. Eighty-nine per cent of patients receiving felodipine and 33% of those receiving placebo (P less than 0.001) had controlled (dBP less than or equal to 95 mmHg) BPs. Half (14/27 completing) of the patients receiving felodipine required 2.5 mg throughout; 9/27 needed 5 mg and 4/27 10 mg twice daily. Adverse events occurred with equal frequency in the two groups, but the profile was different.(ABSTRACT TRUNCATED AT 250 WORDS)
摘要
  1. 49名年龄在65至80岁之间的患者,在接受每日两次50毫克美托洛尔开放治疗4周后,其V期舒张压(dBP)高于95毫米汞柱,被随机分为两组,进行双盲试验。一组(n = 32)除继续服用美托洛尔外,每日两次服用2.5毫克钙拮抗剂非洛地平;另一组(n = 17)除美托洛尔外,每日两次服用安慰剂,为期2周。如果舒张压仍大于95毫米汞柱,则非洛地平或安慰剂剂量在接下来的2周内加倍;如果舒张压仍大于95毫米汞柱,则非洛地平剂量再次加倍至每日两次10毫克,或给予相应的安慰剂剂量。双盲期持续6周,所有患者在此期间均每日两次服用50毫克美托洛尔。2. 在双盲期结束时,非洛地平使坐位舒张压从103±5(平均值±标准差)降至88±7毫米汞柱(P<0.001),安慰剂使其从105±10降至100±11毫米汞柱(无显著性差异)。这些降幅之间的差异(P<0.01)以及最终舒张压之间的差异(P<0.001)均具有显著性。接受非洛地平治疗的患者中有89%、接受安慰剂治疗的患者中有33%的血压得到控制(舒张压小于或等于95毫米汞柱)。接受非洛地平治疗的患者中有一半(27名完成治疗患者中的14名)全程需要2.5毫克剂量;27名患者中有9名需要5毫克剂量,4名患者需要每日两次10毫克剂量。两组不良事件发生频率相同,但情况有所不同。(摘要截选至250词)

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