Bulpitt C J, Connor M, Schulte M, Fletcher A E
Section of Care of the Elderly, Imperial College School of Medicine, Hammersmith Hospital, London, UK. The European Bisoprolol Trial Inestigators.
J Hum Hypertens. 2000 Mar;14(3):205-12. doi: 10.1038/sj.jhh.1000972.
Subjects over the age 60 with sustained sitting diastolic pressures of 95-115 mm Hg were randomised to a regime based on bisoprolol (n = 368) or nifedipine retard (n = 379) for 24 weeks. The goal diastolic pressure was < or =90 mm Hg and to achieve this, double-blind medication could be doubled (5/10 mg bisoprolol, 40/80 mg nifedipine retard) or hydrochlorothiazide 25 mg (unblinded) could be added to the higher dose. In an intention-to-treat analysis, 309 subjects in both the bisoprolol and nifedipine retard treated group provided at least a baseline and a second quality of life assessment (82%). An excess of symptoms was observed in the nifedipine group for oedema of the legs, nocturia, constipation, racing heart and heart thumping. Fewer patients reported wheeze in the nifedipine group. For quality of life, there were no statistically significant differences between the two groups after 8 weeks. However, when analysing the results of the last available assessment (usually at 24 weeks) there were significant (P < 0.05) improvements in tension/anxiety, anger/ hostility, vigour/activity, and confusion/bewilderment, assessed by the Profile of Mood States (POMS) in patients receiving bisoprolol in comparison to those receiving nifedipine retard. The Sickness Impact Profile and objective tests of cognitive function did not differ statistically between the two groups. Quality of life was maintained at a good level on both treatments with advantages for bisoprolol in certain areas. Journal of Human Hypertension (2000) 14, 205-212.
60岁以上、静息舒张压为95 - 115 mmHg的受试者被随机分为两组,一组接受比索洛尔治疗(n = 368),另一组接受缓释硝苯地平治疗(n = 379),疗程为24周。目标舒张压为≤90 mmHg,为达到此目标,双盲药物剂量可加倍(5/10 mg比索洛尔,40/80 mg缓释硝苯地平),或可将25 mg氢氯噻嗪(非盲法)加至较高剂量。在意向性分析中,比索洛尔治疗组和缓释硝苯地平治疗组的309名受试者至少提供了一次基线和第二次生活质量评估(82%)。硝苯地平组出现腿部水肿、夜尿、便秘、心跳过速和心悸等症状的情况更多。硝苯地平组报告喘息的患者较少。在生活质量方面,8周后两组之间无统计学显著差异。然而,在分析最后一次可用评估(通常在24周时)的结果时,与接受缓释硝苯地平治疗的患者相比,接受比索洛尔治疗的患者在通过情绪状态量表(POMS)评估的紧张/焦虑、愤怒/敌意、活力/活动和困惑/迷茫方面有显著(P < 0.05)改善。两组在疾病影响量表和认知功能客观测试方面无统计学差异。两种治疗方法均能将生活质量维持在良好水平,比索洛尔在某些方面具有优势。《人类高血压杂志》(2000年)14卷,205 - 212页 。