Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, MD 21205-2223, USA.
N Engl J Med. 2010 Sep 2;363(10):918-29. doi: 10.1056/NEJMoa0910975.
In observational studies, the relationship between blood pressure and end-stage renal disease (ESRD) is direct and progressive. The burden of hypertension-related chronic kidney disease and ESRD is especially high among black patients. Yet few trials have tested whether intensive blood-pressure control retards the progression of chronic kidney disease among black patients.
We randomly assigned 1094 black patients with hypertensive chronic kidney disease to receive either intensive or standard blood-pressure control. After completing the trial phase, patients were invited to enroll in a cohort phase in which the blood-pressure target was less than 130/80 mm Hg. The primary clinical outcome in the cohort phase was the progression of chronic kidney disease, which was defined as a doubling of the serum creatinine level, a diagnosis of ESRD, or death. Follow-up ranged from 8.8 to 12.2 years.
During the trial phase, the mean blood pressure was 130/78 mm Hg in the intensive-control group and 141/86 mm Hg in the standard-control group. During the cohort phase, corresponding mean blood pressures were 131/78 mm Hg and 134/78 mm Hg. In both phases, there was no significant between-group difference in the risk of the primary outcome (hazard ratio in the intensive-control group, 0.91; P=0.27). However, the effects differed according to the baseline level of proteinuria (P=0.02 for interaction), with a potential benefit in patients with a protein-to-creatinine ratio of more than 0.22 (hazard ratio, 0.73; P=0.01).
In overall analyses, intensive blood-pressure control had no effect on kidney disease progression. However, there may be differential effects of intensive blood-pressure control in patients with and those without baseline proteinuria. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Center on Minority Health and Health Disparities, and others.)
在观察性研究中,血压与终末期肾病(ESRD)之间的关系是直接且渐进的。高血压相关的慢性肾脏病和 ESRD 的负担在黑人群体中尤其高。然而,很少有试验测试强化血压控制是否能延缓黑人群体的慢性肾脏病进展。
我们将 1094 名患有高血压性慢性肾脏病的黑人患者随机分配到强化或标准血压控制组。在完成试验阶段后,患者被邀请参加队列阶段,在该阶段,血压目标值低于 130/80mmHg。队列阶段的主要临床结局是慢性肾脏病的进展,定义为血清肌酐水平翻倍、ESRD 诊断或死亡。随访时间为 8.8 至 12.2 年。
在试验阶段,强化控制组的平均血压为 130/78mmHg,标准控制组为 141/86mmHg。在队列阶段,相应的平均血压分别为 131/78mmHg 和 134/78mmHg。在两个阶段,主要结局的风险均无显著的组间差异(强化控制组的风险比为 0.91;P=0.27)。然而,根据蛋白尿基线水平,效果存在差异(交互作用 P=0.02),蛋白尿比值大于 0.22 的患者可能有获益(风险比为 0.73;P=0.01)。
总体分析显示,强化血压控制对肾脏疾病进展没有影响。然而,在基线蛋白尿患者和无蛋白尿患者中,强化血压控制的效果可能存在差异。(由美国国立糖尿病、消化和肾脏病研究所、国家少数民族健康和健康差异中心等资助)。