Dahlöf B, Jönsson L, Borgholst O, Ekblad G, Engstrand C, Grundestam I, Lindh A
Department of Medicine, Ostra Hospital, Göteborg, Sweden.
Blood Press Suppl. 1993;1:37-45.
In this double-blind, randomised, three-way crossover (latin square design), multicentre study, the aim was to compare the efficacy and tolerability of the fixed combination of felodipine and metoprolol with the individual components as monotherapy. A total of 58 patients with supine diastolic blood pressure of 100-115 mmHg were treated with (1) a fixed combination of felodipine plus metoprolol 5/50-10/100 mg (FM), (2) felodipine 5-10 mg (F) or (3) metoprolol 50-100 mg (M), for 12 weeks each. All treatments were extended-release formulations administered once daily and blood pressure was measured 24 h after dosing. Dose titration was performed after 6 weeks if diastolic blood pressure was > 90 mmHg. After 12 weeks of active treatment, the mean supine blood pressures were 153/89, 159/93 and 163/94 mmHg with FM, F and M, respectively. The mean differences in systolic/diastolic blood pressure were -5.6/-3.1 mmHg (p = 0.007/p = 0.002), -10.2/-4.4 mmHg (p < 0.0001/p < 0.0001) and -4.6/-1.4 mmHg (p = 0.03/p = 0.15) for FM vs F, FM vs M, and F vs M, respectively. Blood pressure control (supine diastolic blood pressure < or = 90 mmHg) after 12 weeks was achieved in a significantly greater proportion of patients during treatment with FM than with F or M; 71%, 45% and 40% were controlled with the respective treatments. With FM, 45% of the patients were taking the higher dose after 12 weeks of treatment. The corresponding figures for F and M were 60% and 67%, respectively. Thirteen of the 58 patients (22%) were controlled only with FM.(ABSTRACT TRUNCATED AT 250 WORDS)
在这项双盲、随机、三向交叉（拉丁方设计）的多中心研究中，目的是比较非洛地平与美托洛尔固定复方制剂和单一成分单药治疗的疗效及耐受性。共有58例仰卧位舒张压为100 - 115 mmHg的患者接受如下治疗：（1）非洛地平加美托洛尔5/50 - 10/100 mg的固定复方制剂（FM），（2）非洛地平5 - 10 mg（F）或（3）美托洛尔50 - 100 mg（M），每种治疗为期12周。所有治疗均为每日一次给药的缓释制剂，给药24小时后测量血压。如果舒张压>90 mmHg，则在6周后进行剂量滴定。积极治疗12周后，FM、F和M组的仰卧位平均血压分别为153/89、159/93和163/94 mmHg。FM与F、FM与M、F与M相比，收缩压/舒张压的平均差值分别为-5.6/-3.1 mmHg（p = 0.007/p = 0.002）、-10.2/-4.4 mmHg（p < 0.0001/p < 0.0001）和-4.6/-1.4 mmHg（p = 0.03/p = 0.15）。治疗12周后，接受FM治疗的患者中血压得到控制（仰卧位舒张压≤90 mmHg）的比例显著高于接受F或M治疗的患者；分别有71%、45%和40%的患者通过相应治疗实现血压控制。接受FM治疗的患者中，45%在治疗12周后服用较高剂量。F和M的相应数字分别为60%和67%。58例患者中有13例（22%）仅通过FM治疗实现血压控制。（摘要截短至250字）
