摘要
背景:糖尿病和高血压是心血管疾病两个主要可改变的风险因素。既往临床试验证明，与标准血压降低相比，强化降压可以减少心血管疾病和全因死亡风险，特别是在没有糖尿病的患者中。然而，仍然未确定糖尿病患者血压控制的最佳水平。方法:BPROAD研究是一项在中国大陆进行的多中心随机对照试验。计划从150个研究中心招募12,702名年龄≥50岁、有心血管风险、收缩压≥130mmHg的2型糖尿病患者。参与者被随机分配到强化组(收缩压目标<120mmHg)或标准组(收缩压目标<140mmHg)。参与者在前三个月每月接受一次血压管理，之后每三个月一次。主要研究结果是一个复合主要心血管事件，包括非致命性心肌梗死、非致命性中风、治疗或住院的心力衰竭和心血管死亡。数据每三个月收集一次，最多五年，一个盲态的结果委员会对所有临床结果进行裁定。BPROAD研究旨在双侧显著性水平为0.05的情况下，具有90%的统计效力来检测主要研究结果减少20%。结论:BPROAD研究将为2型糖尿病患者提供重要证据，以确定强化血压管理是否对心血管疾病和全因死亡有额外的好处。
The BPROAD Executive Committee: Guang Ning (chair and lead investigator; Ruijin Hospital, Shanghai), Jiang He (vice chair and principal investigator; Tulane University, New Orleans), Weiqing Wang (vice chair and principal investigator; Ruijin Hospital, Shanghai), Yufang Bi (vice chair and principal investigator; Ruijin Hospital, Shanghai), Dalong Zhu (Nanjing Drum Tower Hospital, Nanjing), Jiguang Wang (Ruijin Hospital, Shanghai), Shengdi Chen (Ruijin Hospital, Shanghai), Yu Xu (Ruijin Hospital, Shanghai), BPROAD coordinating team at Ruijin Hospital.The BPROAD Data and Safety Monitoring Board: Lawrence J. Appel (Chair, Johns Hopkins University, Baltimore, USA), William C. Cushman (University of Tennessee, Memphis, USA), Vivian A. Fonseca (Tulane University, New Orleans, USA), Jeff D. Williamson (Wake Forest University, Winston‐Salem, USA), David M. Reboussin (Wake Forest University, Winston‐Salem, USA), Yaling Han (General Hospital of Northern Theater Command, Shenyang, China), Hongbing Shen (Nanjing Medical University, Nanjing, China), Minghui Zhao (Peking University First Hospital, Beijing, China), and Hui Wang (Shanghai Jiaotong University, Shanghai, China).