强化与标准血压控制对可能发生的痴呆的影响：一项随机临床试验。
Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia: A Randomized Clinical Trial.
机构信息
Section of Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.
出版信息
JAMA. 2019 Feb 12;321(6):553-561. doi: 10.1001/jama.2018.21442.
IMPORTANCE
There are currently no proven treatments to reduce the risk of mild cognitive impairment and dementia.
OBJECTIVE
To evaluate the effect of intensive blood pressure control on risk of dementia.
DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted at 102 sites in the United States and Puerto Rico among adults aged 50 years or older with hypertension but without diabetes or history of stroke. Randomization began on November 8, 2010. The trial was stopped early for benefit on its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. The final date for follow-up of cognitive outcomes was July 22, 2018.
INTERVENTIONS
Participants were randomized to a systolic blood pressure goal of either less than 120 mm Hg (intensive treatment group; n = 4678) or less than 140 mm Hg (standard treatment group; n = 4683).
MAIN OUTCOMES AND MEASURES
The primary cognitive outcome was occurrence of adjudicated probable dementia. Secondary cognitive outcomes included adjudicated mild cognitive impairment and a composite outcome of mild cognitive impairment or probable dementia.
RESULTS
Among 9361 randomized participants (mean age, 67.9 years; 3332 women [35.6%]), 8563 (91.5%) completed at least 1 follow-up cognitive assessment. The median intervention period was 3.34 years. During a total median follow-up of 5.11 years, adjudicated probable dementia occurred in 149 participants in the intensive treatment group vs 176 in the standard treatment group (7.2 vs 8.6 cases per 1000 person-years; hazard ratio [HR], 0.83; 95% CI, 0.67-1.04). Intensive BP control significantly reduced the risk of mild cognitive impairment (14.6 vs 18.3 cases per 1000 person-years; HR, 0.81; 95% CI, 0.69-0.95) and the combined rate of mild cognitive impairment or probable dementia (20.2 vs 24.1 cases per 1000 person-years; HR, 0.85; 95% CI, 0.74-0.97).
CONCLUSIONS AND RELEVANCE
Among ambulatory adults with hypertension, treating to a systolic blood pressure goal of less than 120 mm Hg compared with a goal of less than 140 mm Hg did not result in a significant reduction in the risk of probable dementia. Because of early study termination and fewer than expected cases of dementia, the study may have been underpowered for this end point.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01206062.
重要性
目前尚无经证实的治疗方法可降低轻度认知障碍和痴呆的风险。
目的
评估强化血压控制对痴呆风险的影响。
设计、地点和参与者：这是在美国和波多黎各的 102 个地点进行的一项随机临床试验，纳入了年龄在 50 岁及以上、患有高血压但无糖尿病或中风病史的成年人。随机化于 2010 年 11 月 8 日开始。由于其主要结局（心血管事件的综合指标）和全因死亡率的获益，该试验于 2015 年 8 月 20 日提前停止。认知结局的最终随访日期为 2018 年 7 月 22 日。
干预
参与者被随机分配至收缩压目标值<120mmHg（强化治疗组；n=4678）或<140mmHg（标准治疗组；n=4683）。
主要结局和测量指标
主要认知结局是经裁决的可能痴呆的发生。次要认知结局包括经裁决的轻度认知障碍和轻度认知障碍或可能痴呆的综合结局。
结果
在 9361 名随机参与者中（平均年龄 67.9 岁；3332 名女性[35.6%]），8563 名（91.5%）至少完成了 1 次随访认知评估。中位干预期为 3.34 年。在总计 5.11 年的中位随访期间，强化治疗组有 149 名参与者发生经裁决的可能痴呆，而标准治疗组有 176 名（每 1000 人年 7.2 例 vs 8.6 例；风险比[HR]，0.83；95%CI，0.67-1.04）。强化血压控制显著降低了轻度认知障碍的风险（每 1000 人年 14.6 例 vs 18.3 例；HR，0.81；95%CI，0.69-0.95）和轻度认知障碍或可能痴呆的综合发生率（每 1000 人年 20.2 例 vs 24.1 例；HR，0.85；95%CI，0.74-0.97）。
结论和相关性
在患有高血压的门诊成年人中，与将收缩压目标值控制在<140mmHg 相比，将收缩压目标值控制在<120mmHg 并不能显著降低可能痴呆的风险。由于研究提前结束且痴呆病例数低于预期，因此该研究在这一终点可能没有足够的效力。
试验注册
ClinicalTrials.gov 标识符：NCT01206062。
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