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强化降压与标准降压比较试验的最终报告
Final Report of a Trial of Intensive versus Standard Blood-Pressure Control


The SPRINT Research Group* 心脑血管疾病 • 2021.05.20
相关阅读
• 关于降压目标的SPRINT研究:最终报告 • 超声肾交感神经消融术对顽固性高血压发挥一定疗效 • 心脏不良事件高危患者是否都应降低血压 • 强化降压与标准降压比较的随机试验 • 强化与标准血压控制的成本效益比较 • 强化降压治疗对患者报告结局的影响

摘要


背景

在之前发表的收缩压标准降压和强化降压的随机试验中,一些结局事件数据尚有待裁定,试验后随访数据也尚未收集。


方法

我们将9,361例心血管疾病风险增加,但未患糖尿病,也无卒中病史的参与者随机分组,两组分别遵循强化治疗目标(收缩压,<120 mmHg)和标准治疗目标(收缩压,<140 mmHg)。主要结局是由心肌梗死、其他急性冠脉综合征、卒中、急性失代偿性心力衰竭或心血管原因死亡构成的复合结局。截至干预期结束时(2015年8月20日)发生的其他主要结局事件在主要分析的数据锁定后进行了裁定。我们还分析了截至2016年7月29日的试验后观察随访数据。


结果

中位3.33年随访时,强化治疗组在试验期间的主要结局发生率和全因死亡率显著低于标准治疗组(主要结局发生率,每年1.77% vs. 每年2.40%;风险比,0.73;95% CI,0.63~0.86;全因死亡率,每年1.06% vs. 每年1.41%;风险比,0.75;95% CI,0.61~0.92)。低血压、电解质异常、急性肾损伤或肾衰竭、晕厥等严重不良事件的发生率在强化治疗组中显著较高。将试验数据和试验后随访数据合并后(共计3.88年),我们在治疗益处和不良事件方面观察到类似模式,但心力衰竭的发生率不再有组间差异。


结论

在心血管风险增加的患者中,与低于140 mmHg的收缩压目标相比,低于120 mmHg的收缩压目标在患者接受随机分配的治疗期间和试验之后均降低了主要心血管不良事件的发生率和全因死亡率。强化治疗组的某些不良事件发生率较高(由美国国立卫生研究院资助,SPRINT在ClinicalTrials.gov注册号为NCT01206062)。





作者信息

The SPRINT Research Group*
The affiliations of the members of the writing committee are as follows: the Department of Epidemiology, School of Public Health (C.E.L.), and the Divisions of Preventive Medicine (C.E.L.) and Cardiovascular Disease (S.O.), Department of Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham; the Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (L.J.F., J.A.C., J.K.S.); the Division of Nephrology and Hypertension, University of Utah, and Medical Service, Veterans Affairs Salt Lake City Health Care System, Salt Lake City (S.B., A.K.C.); the Department of Preventive Medicine, University of Tennessee Health Science Center (W.C.C., K.C.J.), and Medical Service, Veterans Affairs Medical Center (W.C.C.), Memphis; the Department of Biostatistics and Data Science (G.W.E., D.M.R., W.T.A.), the Division of Cardiovascular Medicine (D.W.K.) and Section of Nephrology (M.V.R.), Department of Internal Medicine, and the Sticht Center for Healthy Aging and Alzheimer’s Prevention and Division of Geriatric Medicine (K.M.S., J.D.W.), Wake Forest School of Medicine, Winston Salem, NC; the Division of Nephrology and Hypertension, Louis Stokes Cleveland Veterans Affairs Medical Center (M.R.), and the Division of Nephrology and Hypertension, University Hospitals Cleveland Medical Center, Case Western Reserve University (M.R., J.T.W.), Cleveland; and the Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans (P.K.W.). Address reprint requests to Dr. Lewis at the Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, RPHB 210C, 1720 2nd Ave. S., Birmingham, AL 35294-0022, or at celewis@ubmc.edu. *A complete list of the members of the SPRINT Research Group is provided in the Supplementary Appendix, available at NEJM.org.

 

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