TREATMENT OF MILD HYPERTENSION--SIDE EFFECTS AND EFFICAC

轻度高血压的治疗--副作用和疗效

• 批准号: 3346297
• 负责人: Thomas J. Coates
• 金额: $ 37.51万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-09-01 至 1988-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3346297
• 关键词: anxiety; behavioral medicine; beta antiadrenergic agent; blood chemistry; blood glucose; body weight; cardiovascular disorder prevention; cholesterol; drug adverse effect; ethnic group; human middle age (35-64); human subject; human therapy evaluation; hypertension; memory; perception; placebos; psychomotor reaction time; triglycerides; type A /type B personality; urinalysis; young adult human (21-34)

This is a study of behavioral factors in medical outpatients with mild hypertension. The investigators will examine: (1) the behavioral side effects (memory deficits and depressive symptoms); and (2) the efficacy in diastolic blood pressure (DBP) control of drug and nondrug strategies in the treatment of mild hypertension. The target population will be persons with mild hypertension (DBP - 90-104 mm Hg) between 18 and 59 years old working or living in San Francisco. A total of 500 participants will be recruited over an 18 month accrual period from collaborating health facilities at the UCSF Medical Center and from referrals made by the Bank of America and the Bay Area Hypertension Council screening program. Potential participants will be evaluated for eligibility and exclusion criteria during two clinic visits and baseline psychological measures will be obtained at a third clinic visit. Participants will be randomized using a stratified blocked design to one of four treatment assignments: metoprolol, placebo, nonpharmacologial plus placebo, and nonpharmacological plus metropolol. The nonpharmacological treatment is a behavioral intervention to change dietary habits and other lifestyle factors which contribute to the presence of elevated blood pressure. The pharmacological treatment with a beta adrenergic blocking drug is a standard approach to treating mild hypertension. At least 15 visits will be scheduled over the one year follow-up period and nurse practitioners will be the health care providers. The factorial design will permit the effects of these two interventions to be assessed separately and in combination. The primary outcome measurement will be memory deficits, depressive symptoms and DBP. The psychological variables will be asssessed at 3 and 12 months and DBP will be obtained at each visit. This study will have a power of at least .80 to detect a significant difference (Alpha = 0.05) in memory deficits, depressive symptoms and/or DBP control between the treatment groups. The study will also examine, though with less power, the efficacy of the interventions in specified subgroups of persons with mild hypertension. If the nonpharmacologic intervention is effective in lowering blood pressure with less biobehavioral sequelae, it will be applicable to persons with mild hypertension in other ambulatory care settings of the country. This study will also serve as a model for further investigation of nonbiobehavioral sequelae of other antihypertensive regimes.

这是一项关于轻度精神分裂症内科门诊患者行为因素的研究 高血压。调查人员将检查：(1)行为方面 影响(记忆缺陷和抑郁症状)；以及(2)对 药物与非药物策略对舒张压控制的影响 轻度高血压的治疗。 目标人群为轻度高血压患者(DBP-90-104 18至59岁，在旧金山工作或生活。一个 将在18个月的累计期内招募500名参与者 来自加州大学旧金山分校医疗中心的协作医疗设施和来自 美国银行和旧金山湾区高血压委员会的转介 筛查计划。将对潜在参与者进行评估 两次门诊期间的资格和排除标准和基线 心理测量将在第三次诊所就诊时获得。 参与者将使用分层区组设计随机分配到以下一组 四种治疗方案：美托洛尔、安慰剂、非药物加用 安慰剂，和非药物加大都会。非药理学的 治疗是一种行为干预，旨在改变饮食习惯和其他 导致血液升高的生活方式因素 压力。β肾上腺素能受体阻滞剂的药物治疗 药物是治疗轻度高血压的标准方法。至少15 探视将安排在一年的随访期内，并安排护士 从业者将是医疗保健的提供者。析因设计将 允许分别评估这两种干预措施的效果，并 结合在一起。 主要的结果测量将是记忆缺陷，抑郁 症状和舒张压。心理变量将被评估为3和 12个月和DBP将在每次访问时获得。 这项研究将具有至少0.80的威力来检测显著的 记忆缺陷、抑郁症状和/或差异(α=0.05) 治疗组间比较舒张压控制。这项研究还将检查， 虽然权力较小，但干预的效果在特定情况下 轻度高血压患者的亚组。 非药物干预在降血方面是否有效 压力与生物行为后遗症较少，它将适用于人 在该国其他门诊护理环境中患有轻度高血压。 这项研究也将作为进一步研究的模式。 其他抗高血压药物的非生物行为后遗症。