EFFECT OF DIETARY MODIFICATION ON BLOOD PRESSURE CONTROL

这项研究的目的是解决长期悬而未决的问题- 轻度高血压的长期治疗， 对参加抗高血压试验的受试者进行随访 干预和管理（TAIM）。 TAIM是一种多中心， 随机、安慰剂对照试验，旨在评估 药物和饮食的各种组合的有效性 轻度高血压（DBP 90-100）的治疗干预 mmHg）。 主要终点是血压变化， 基线和六个月。 该研究包括一个3 × 3的阶乘 设计，其中参与者被随机分配到9种药物饮食 治疗组。 药物包括安慰剂、利尿剂和1 β- 修颜乳液 饮食是正常的，减肥和低钠/高 钾（Na+/K+）。 基本策略是解决临床 通过比较所选患者的平均DBP变化， 饮食和药物的组合 次要目的是评估 每种选定的组合：1）血清和尿液的变化 化学; 2）生活质量指标和福祉的变化 （包括副作用的评估），以及3） 心血管风险评分。 在初步的TAIM分析中，体重减轻似乎实质上 与常规或Na+/K+饮食相比，6个月时DBP较低。 Na+/K+之间似乎没有血压差异， 和常规饮食组。 在TAIM（COTAIM）的延续中， 减肥组和随机选择的一半的日常饮食 组进行随访，以评估长期 减肥对控制轻度高血压的疗效。 的 Na+/K+组增加体重减轻方案， 另一组随机选择一半的平时饮食组， 一个月的入组期，以评价 体重减轻和钠限制与体重减轻相比 一个人 COTAIM建议评估这些措施的有效性， 通过比较血液中成功的比例， 控制初始药物治疗的压力。 此外， 心血管风险评分和生活质量指数， 将分析抗高血压干预。 的周期 随访将平均约5年的减肥-通常的饮食 比较，包括TAIM随访， 体重减轻-体重减轻/限钠比较。

The aim of this study is to address unresolved issues in the long- term therapy of mild hypertension by continuing the treatment and follow-up of participants enrolled in the Trial of Antihypertensive Interventions and Management (TAIM). TAIM is a multicenter, randomized, placebo-controlled trial designed to assess the effectiveness of various combinations of pharmacologic and dietary interventions in the treatment of mild hypertension (DBP 90-100 mmHg). The primary endpoint is blood pressure change between baseline and six months. The study consists of a 3 X 3 factorial design wherein participants are randomly allocated to 9 drug-diet treatment groups. Drugs include placebo, diuretic and 1 beta- blocker. Diets are usual, weight loss and low sodium/high potassium (Na+/K+). The basic strategy is to address clinical questions of interest by comparing mean DBP changes of selected diet-drug combinations. Secondary objectives are to assess for each selected combination: 1) changes in serum and urine chemistries; 2) change in quality of life measures and well-being (including assessment of side effects), and 3) change in cardiovascular risk score. In preliminary TAIM analyses, weight loss appears to substantially lower DBP at 6 months when compared to a usual or Na+/K+ diet. There appear to be no blood pressure differences between the Na+/K+ and usual diet groups. In the continuation of TAIM (COTAIM), the weight loss group and a randomly selected half of the usual diet group are to be followed without change to evaluate the long-term efficacy of weight loss in the control of mild hypertension. The weight loss regimen is to be added to the Na+/K+ group and the other randomly selected half of the usual diet group during a six month enrollment period to evaluate possible additive effects of weight loss and sodium restriction in comparison to weight loss alone. COTAIM proposes to assess the effectiveness of these various treatments by comparing the proportion successful in blood pressure control on initial drug therapy. In addition, changes in cardiovascular risk scores and quality of life indices for selected antihypertensive interventions will be analyzed. The periods of follow-up will average about 5 years for the weight loss-usual diet comparison, including the TAIM follow-up, and 2 years for the weight loss-weight loss/sodium restriction comparison.