Hebert P R, Bolt R J, Borhani N O, Cook N R, Cohen J D, Cutler J A, Hollis J F, Kuller L H, Lasser N L, Oberman A
Department of Medicine, Brigham and Women's Hospital, Boston, MA 02215-1204, USA.
Ann Epidemiol. 1995 Mar;5(2):130-9. doi: 10.1016/1047-2797(94)00057-z.
Phase II of the Trials of Hypertension Prevention (TOHP) is a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute designed to test whether weight loss alone, sodium reduction alone, or the combination of weight loss and sodium reduction will decrease diastolic (DBP) and systolic blood pressure (SBP) as well as the incidence of hypertension (DBP > or = 90 mm Hg, SBP > or = 140 mm Hg, and/or use of antihypertensive medications) in subjects with high-normal DBP (83 to 89 mm Hg) and SBP less than 140 mm Hg at entry. These interventions were chosen for longer-term testing with end points including hypertension prevention as well as blood pressure (BP) change based on their demonstrated short-term efficacy in reducing BP in phase I of TOHP. The phase II study population is comprised of 2382 participants (1566 men and 816 women) who are 110 to 165% of desirable body weight, allocated at random to the four treatment arms using a 2 x 2 factorial design. The trial has 80% power to detect an overall treatment effect on DBP of 1.2 mm Hg for weight loss or sodium reduction and a difference of 1.6 mm Hg between the combined intervention and placebo groups. BP observers are blinded to participant treatment assignments. Participants will be followed for 3 to 4 years. This trial may have important public policy implications concerning the ability of life-style modifications to reduce BP and prevent the development of hypertension over the long term, thereby avoiding the need for drug therapy which while effective is costly and may have side effects.
高血压预防试验（TOHP）的第二阶段是一项多中心随机试验，由美国国立心肺血液研究所资助，旨在测试单独减重、单独减少钠摄入，或减重与减少钠摄入相结合，是否会降低舒张压（DBP）和收缩压（SBP），以及降低血压正常高值（DBP为83至89毫米汞柱）且入组时SBP低于140毫米汞柱的受试者的高血压发病率（DBP≥90毫米汞柱，SBP≥140毫米汞柱，和/或使用抗高血压药物）。选择这些干预措施进行长期测试，其终点包括高血压预防以及血压（BP）变化，这是基于它们在TOHP第一阶段降低血压的短期疗效得到证实。第二阶段研究人群包括2382名参与者（1566名男性和816名女性），他们的体重为理想体重的110%至165%，采用2×2析因设计随机分配到四个治疗组。该试验有80%的把握度检测出减重或减少钠摄入对DBP的总体治疗效果为1.2毫米汞柱，以及联合干预组与安慰剂组之间的差异为1.6毫米汞柱。血压观测者对参与者的治疗分配不知情。参与者将被随访3至4年。该试验可能对生活方式改变在长期降低血压和预防高血压发生方面的能力具有重要的公共政策意义，从而避免使用虽有效但成本高昂且可能有副作用的药物治疗。
