Sennesael J, Lamote J, Violet I, Tasse S, Verbeelen D
Renal Unit, Academisch Ziekenhuis, Vrije Universiteit Brussel, Belgium.
Hypertension. 1995 Sep;26(3):436-44. doi: 10.1161/01.hyp.26.3.436.
The objective of this study was to compare the antihypertensive efficacy and influence on renal function of perindopril and amlodipine in cyclosporine-treated renal allograft recipients with mild to moderate hypertension. We conducted a randomized, double-blind, double-dummy crossover trial in ambulatory patients. Four phases were conducted: 2 weeks on placebo, 8 weeks of maintenance (perindopril or amlodipine), and 2 weeks of washout between treatment periods. Ten hypertensive patients with stable renal allograft function transplanted more than 6 months previously and receiving cyclosporine as part of their immunosuppressive regimen were studied. The patients were allocated to perindopril (2 or 4 mg/d) and amlodipine (5 mg/d) in a random sequence. If office diastolic pressure was greater than or equal to 90 mm Hg after 4 weeks, the dosage was doubled and continued for another 4 weeks. The main outcome measures were office and 24-hour ambulatory blood pressure changes after 8 weeks of active treatment and treatment and time effect on glomerular filtration rate and effective renal plasma flow. Perindopril and amlodipine were equally effective in lowering office blood pressure and similarly efficacious for the 24-hour period of the day. Neither drug affected glomerular filtration rate or effective renal plasma flow. Both agents demonstrated equivalent capacity (time x treatment, P = .955) to reverse renal vascular resistance (amlodipine from 0.35 +/- 0.02 to 0.30 +/- 0.02 mm Hg/mL per minute per 1.73 m2; perindopril from 0.36 +/- 0.03 to 0.32 +/- 0.01) (time effect of all treatments together, P = .043).(ABSTRACT TRUNCATED AT 250 WORDS)
本研究的目的是比较培哚普利和氨氯地平在接受环孢素治疗的轻至中度高血压肾移植受者中的降压疗效及对肾功能的影响。我们对门诊患者进行了一项随机、双盲、双模拟交叉试验。试验分为四个阶段:安慰剂治疗2周、维持治疗8周(培哚普利或氨氯地平)以及治疗期之间的洗脱期2周。研究了10例高血压患者,他们的肾移植功能稳定,移植时间超过6个月,且作为免疫抑制方案的一部分接受环孢素治疗。患者被随机分配接受培哚普利(2或4 mg/d)和氨氯地平(5 mg/d)治疗。如果4周后诊室舒张压大于或等于90 mmHg,则剂量加倍并继续治疗4周。主要观察指标为积极治疗8周后的诊室和24小时动态血压变化,以及治疗和时间对肾小球滤过率和有效肾血浆流量的影响。培哚普利和氨氯地平在降低诊室血压方面同样有效,且在一天的24小时内疗效相似。两种药物均未影响肾小球滤过率或有效肾血浆流量。两种药物在逆转肾血管阻力方面显示出同等能力(时间×治疗,P = 0.955)(氨氯地平从0.35±0.02降至0.30±0.02 mmHg/mL每分钟每1.73 m2;培哚普利从0.36±0.03降至0.32±0.01)(所有治疗的时间效应,P = 0.043)。(摘要截短于250字)