Beltman F W, Heesen W F, Smit A J, May J F, de Graeff P A, Havinga T K, Schuurman F H, van der Veur E, Lie K I, Meyboom-de Jong B
Department of General Practice, University of Groningen, The Netherlands.
Blood Press. 1998 May;7(2):109-17.
The aim of the study was to compare the effects of two long-acting antihypertensive agents, the calcium-antagonist amlodipine and the ACE inhibitor lisinopril, on left ventricular mass and diastolic filling in patients with mild to moderate diastolic hypertension from primary care centres. It is a 1-year prospective, double-blind, randomized, parallel group, comparative study. Patients between 25 and 75 years of age with untreated hypertension with elevated diastolic blood pressure (> or = 95 mmHg) on three occasions (twice on the first visit and once only on the second and third visits) were recruited from a population survey. After 4 weeks placebo run-in 71 patients were randomized to dosages of amlodipine 5-10 mg or lisinopril 10-20 mg, which were titrated on the basis of the effects on blood pressure. Fifty-nine patients completed the study period. Primary endpoints were left ventricular mass index and early to atrial peak filling velocity. Office and ambulatory blood pressure and other echocardiographic measurements were considered secondary. Decrease in blood pressure was equal for both treatment regimens. A statistically significant decrease in left ventricular mass index in both treatment groups was observed: -11.0 g/m2 (95% CI: -6.0, -16.1) in the amlodipine group and -12.6 g/m2 (95% CI: -8.2, -17.0) in the lisinopril group. The higher the baseline value of left ventricular mass before treatment, the more the decrease after treatment. Early to atrial peak filling velocity did not change significantly within the treatment groups: +0.07 (95% CI: -0.01, +0.15) in the amlodipine group and +0.01 (95% CI: -0.06, +0.08) in the lisinopril group. However, analysis of time measurements of the early peak showed significant changes for both treatment groups. No significant differences in primary and secondary endpoints between treatment groups were found. Twelve patients did not complete the study, seven in amlodipine and five in lisinopril, basically due to adverse events. The effects of amlodipine and lisinopril on left ventricular mass and early to atrial filling peak velocity after 1 year of treatment in patients with previously untreated mild to moderate hypertension are similar. Further studies are recommended, particularly with a larger sample size and a follow-up of longer duration.
本研究的目的是比较两种长效抗高血压药物,即钙拮抗剂氨氯地平和血管紧张素转换酶抑制剂赖诺普利,对来自基层医疗中心的轻至中度舒张期高血压患者左心室质量和舒张期充盈的影响。这是一项为期1年的前瞻性、双盲、随机、平行组比较研究。从一项人群调查中招募年龄在25至75岁之间、未经治疗的高血压患者,其舒张压升高(≥95 mmHg),共测量三次(首次就诊时测量两次,第二次和第三次就诊时各测量一次)。经过4周的安慰剂导入期后,71例患者被随机分为氨氯地平5 - 10 mg或赖诺普利10 - 20 mg剂量组,并根据血压效果进行滴定。59例患者完成了研究期。主要终点是左心室质量指数和早期至心房峰值充盈速度。诊室血压和动态血压以及其他超声心动图测量结果被视为次要指标。两种治疗方案的血压下降幅度相同。两个治疗组的左心室质量指数均有统计学意义的下降:氨氯地平组为-11.0 g/m²(95%可信区间:-6.0,-16.1),赖诺普利组为-12.6 g/m²(95%可信区间:-8.2,-17.0)。治疗前左心室质量的基线值越高,治疗后的下降幅度越大。治疗组内早期至心房峰值充盈速度无显著变化:氨氯地平组为+0.07(95%可信区间:-0.01,+0.15),赖诺普利组为+0.01(95%可信区间:-0.06,+