Hall W D, Kusek J W, Kirk K A, Appel L J, Schulman G, Agodoa L Y, Glassock R, Grim C, Randall O S, Massry S G
National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.
Am J Kidney Dis. 1997 May;29(5):720-8. doi: 10.1016/s0272-6386(97)90125-6.
The African-American Study of Kidney Disease and Hypertension pilot study randomized 94 nondiabetic black men and women (mean age, 53 years; 75% male) with presumed hypertensive nephrosclerosis and a baseline glomerular filtration rate (GFR) of 25 to 70 mL/min/1.73 m2 (mean, 52.3 mL/min/1.73 m2) to blood pressure control at either a low mean arterial pressure (MAP) goal of < or = 92 mm Hg or a usual MAP goal of 102 to 107 mm Hg and an antihypertensive drug regimen that included either a calcium antagonist (amlodipine), a beta-blocker (atenolol), or an angiotensin-converting enzyme (ACE) inhibitor (enalapril). After 3 months of follow-up (n = 90), the mean GFR was similar (53.0 mL/min/1.73 m2 v 53.7 mL/min/1.73 m2) to the baseline levels in participants randomized to the low MAP group (n = 44), whereas the mean GFR increased by 3.9 mL/min/1.73 m2 (P = 0.02) in participants randomized to the usual MAP group (n = 46). During the same period of time, the mean GFR increased significantly in participants randomized to the calcium channel blocker regimen (n = 28) (5.7 mL/min/ 1.73 m2; P = 0.01) but not in participants randomized to the beta-blocker regimen (n = 31) (1.7 mL/min/1.73 m2; P = 0.10) or the ACE inhibitor regimen (n = 31) (1.1 mL/min/1.73 m2; P = 0.52). Changes in GFR at 3 months were significantly different among the three treatment groups (P = 0.04). We conclude that the magnitude of short-term effects of blood pressure control and antihypertensive drug regimens on GFR should be considered when estimating sample size for clinical trials designed to evaluate the effects of these interventions on long-term changes in GFR slope.
非裔美国人肾脏疾病与高血压试验性研究将94名非糖尿病黑人男性和女性(平均年龄53岁;75%为男性)随机分组,这些人被诊断患有疑似高血压性肾硬化,基线肾小球滤过率(GFR)为25至70毫升/分钟/1.73平方米(平均52.3毫升/分钟/1.73平方米),分别接受平均动脉压(MAP)目标为≤92毫米汞柱的低目标血压控制,或102至107毫米汞柱的常规MAP目标血压控制,并采用包括钙拮抗剂(氨氯地平)、β受体阻滞剂(阿替洛尔)或血管紧张素转换酶(ACE)抑制剂(依那普利)的降压药物治疗方案。经过3个月的随访(n = 90),随机分配至低MAP组(n = 44)的参与者的平均GFR与基线水平相似(53.0毫升/分钟/1.73平方米对53.7毫升/分钟/1.73平方米),而随机分配至常规MAP组(n = 46)的参与者的平均GFR增加了3.9毫升/分钟/1.73平方米(P = 0.02)。在同一时间段内,随机分配至钙通道阻滞剂治疗方案组(n = 28)的参与者的平均GFR显著增加(5.7毫升/分钟/1.73平方米;P = 0.01),但随机分配至β受体阻滞剂治疗方案组(n = 31)的参与者(1.7毫升/分钟/1.73平方米;P = 0.10)或ACE抑制剂治疗方案组(n = 31)的参与者(1.1毫升/分钟/1.73平方米;P = 0.52)则没有显著增加。3个月时GFR的变化在三个治疗组之间存在显著差异(P = 0.04)。我们得出结论,在为评估这些干预措施对GFR斜率长期变化的影响而设计的临床试验中,估计样本量时应考虑血压控制和降压药物治疗方案对GFR的短期影响程度。