Watts R W, Dufek A, Wing L M
Investigator Clinic, Port Lincoln, Australia.
Blood Press. 1993 Mar;2(1):53-8. doi: 10.3109/08037059309077527.
This study compared the efficacy and tolerability of monotherapy with felodipine and enalapril in patients with essential hypertension using a double-blind randomised crossover design. Thirty-five subjects (22 male, 13 female--ages: median 48 years, range 31-69 years) entered the randomised phases of the study and 32 subjects completed the study. Following a 4-week run-in placebo phase, the treatments were felodipine ("Plendil ER") 5-20 mg and enalapril 5-20 mg orally once daily for 8 weeks, each with matching placebos. Dose titration was at 2 and/or 4 weeks in each phase. Number of subjects with each different end-of-phase dose were for felodipine: 5 mg--8, 10 mg--11, 20 mg--13 and enalapril: 5 mg--6, 10 mg--9, 20 mg--17. Predose supine blood pressure (mean +/- SEM) was reduced in both active treatment phases compared with the run-in phase (159 + 2/101 +/- 1), but there was no significant difference in blood pressure between the active phases: felodipine 143 +/- 2/90 +/- 1 and enalapril 146 +/- 2/92 +/- 1. The most common adverse effects were for felodipine: headache, flushing, ankle swelling; and for enalapril: cough. Felodipine and enalapril as once daily monotherapy are thus of similar antihypertensive efficacy but with predictably different adverse effect profiles.
本研究采用双盲随机交叉设计，比较了非洛地平和依那普利单药治疗原发性高血压患者的疗效和耐受性。35名受试者（22名男性，13名女性，年龄中位数48岁，范围31 - 69岁）进入研究的随机阶段，32名受试者完成了研究。在为期4周的导入期安慰剂阶段后，治疗药物为非洛地平（“波依定缓释片”）5 - 20mg和依那普利5 - 20mg，均每日口服1次，持续8周，各伴有匹配的安慰剂。每个阶段在第2周和/或第4周进行剂量滴定。每个不同阶段末剂量的受试者数量，非洛地平组为：5mg - 8例，10mg - 11例，20mg - 13例；依那普利组为：5mg - 6例，10mg - 9例，20mg - 17例。与导入期相比，两个活性治疗阶段的给药前仰卧血压（均值±标准误）均有所降低（159 + 2/101 ± 1），但活性治疗阶段之间的血压无显著差异：非洛地平组为143 ± 2/90 ± 1，依那普利组为146 ± 2/92 ± 1。最常见的不良反应，非洛地平组为：头痛、面部潮红、脚踝肿胀；依那普利组为：咳嗽。因此，非洛地平和依那普利作为每日一次的单药治疗，具有相似的降压疗效，但不良反应谱可预测地有所不同。
