TRIAL OF ANTIHYPERTENSIVE INTERVENTIONS AND MANAGEMENT

这项研究的目的是解决长期未解决的问题- 持续治疗对轻度高血压的长期治疗作用 以及对登记参加试验的参与者的后续行动 抗高血压干预和管理(TAIM)。塔伊姆是 一项多中心、随机、安慰剂对照试验 评估不同药物组合的有效性 和饮食干预在治疗轻度高血压中的作用 (90-100毫米汞柱)。主要终点是血压 基准线和六个月之间的变化。这项研究包括一个 3×3析因设计，参与者被随机分配 至9个药物饮食治疗组。药物包括安慰剂、利尿剂 和β-受体阻滞剂。饮食是正常的，减肥和低 钠/高钾(Na/K)。基本战略是解决 比较患者平均舒张压变化引起的临床问题 精选的饮食-药物组合。次要目标是 评估每种选择的组合：1)血清和 尿液化学；2)生活质量测量和健康状况的变化 存在(包括副作用评估)，以及3)变化 心血管风险评分。 在初步的TAIM分析中，体重减轻似乎实质上 与正常饮食或钠钾饮食相比，6个月时的舒张压较低。 两者之间的血压似乎没有差异。 Na/K组和普通饮食组。在TAIM的延续中 (COTAIM)，减肥组和随机选择的一半 通常的饮食组将在没有变化的情况下接受评估 减肥在控制轻度糖尿病中的远期疗效 高血压。减肥方案将被添加到 NA/K组和另一组随机选择一半的正常 节食组在六个月的注册期内进行评估 体重减轻和钠限制可能的相加效应 与单纯的减肥相比。COTAIM建议评估 通过比较这些不同治疗方法的有效性 首发药物血压控制比例成功 心理治疗。此外，心血管风险评分的变化和 部分抗高血压干预措施的生活质量指数 将会被分析。随访期平均为5个月。 减重的年份-通常的饮食比较，包括 泰姆随访，减重2年 失水/限钠比较。

The aim of this study is to address unresolved issues in the long- term therapy of mild hypertension of 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 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.