Mann S, O'Brien K P
Wellington Hospital, Auckland.
N Z Med J. 1994 Oct 12;107(987):391-4.
To validate and compare the 24-hour antihypertensive efficacy of the angiotensin-converting-enzyme inhibitors, captopril and lisinopril.
A randomised, doubleblind, doubledummy crossover study was performed with single-blind placebo run-in and washout periods and titration opportunities during therapeutic phases (captopril 25mg, 50mg and 100mg daily, lisinopril 10mg, 20mg and 40mg daily). The study was monitored using standard office blood pressure measurements, clinical and laboratory assessment. 24 patients of either sex and between 18 and 70 years with essential hypertension were enrolled, 20 met randomisation criteria (of sitting diastolic pressure 95-115mmHg), 3 withdrew from the study during its active phase and one was excluded from analysis having been found retrospectively to have not met randomisation criteria at the appropriate visit. Predetermined endpoints were blood pressure levels during different time periods of ambulatory monitoring performed at the end of each placebo or treatment phase.
In the 17 patients who completed the protocol, lisinopril produced a greater reduction of blood pressure at all time periods although the differences were not all statistically significant. The differences were most marked 19-24 hours post dosage time when pressures (systolic/diastolic) during lisinopril therapy were lower than during captopril by 18.0/14.5 mmHg (p < 0.001 for both). As measured by clinic pressures, lisinopril also achieved a considerably higher degree of blood pressure control with less dose titration.
In this study, lisinopril proved a more effective once daily antihypertensive agent than captopril, especially in the last 6 hours of the 24-hour dosage interval.
验证并比较血管紧张素转换酶抑制剂卡托普利和赖诺普利的24小时降压疗效。
进行了一项随机、双盲、双模拟交叉研究,包括单盲安慰剂导入期和洗脱期,以及治疗阶段的滴定机会(卡托普利每日25毫克、50毫克和100毫克,赖诺普利每日10毫克、20毫克和40毫克)。该研究通过标准诊室血压测量、临床和实验室评估进行监测。纳入了24名年龄在18至70岁之间的原发性高血压患者,其中20名符合随机化标准(坐位舒张压95 - 115毫米汞柱),3名在研究活跃期退出,1名在回顾性分析中发现未在适当访视时符合随机化标准而被排除在分析之外。预定终点是在每个安慰剂或治疗阶段结束时进行的动态监测不同时间段的血压水平。
在完成方案的17名患者中,赖诺普利在所有时间段都使血压有更大幅度的降低,尽管差异并非都具有统计学意义。差异在给药后19 - 24小时最为明显,此时赖诺普利治疗期间的血压(收缩压/舒张压)比卡托普利治疗时低18.0/14.5毫米汞柱(两者p均<0.001)。通过诊室血压测量,赖诺普利在较少剂量滴定的情况下也实现了相当高程度的血压控制。
在本研究中,赖诺普利被证明是一种比卡托普利更有效的每日一次降压药物,尤其是在24小时给药间隔的最后6小时。