ANALGESIC USE AND THE RISK OF CHRONIC RENAL FAILURE

镇痛药的使用和慢性肾功能衰竭的风险

• 批准号: 6215864
• 负责人: GARY C. CURHAN
• 金额: $ 18.25万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-08-15 至 2003-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6215864
• 关键词: acetaminophen; analgesics; aspirin; blood chemistry; chronic renal failure; clearance rate; clinical research; creatinine; cryopreservation; disease /disorder proneness /risk; dosage; drug administration rate /duration; drug adverse effect; female; health surveys; human data; human subject; human tissue; iatrogenic disease; longitudinal human study; nonsteroidal antiinflammatory agent; nurses; outcomes research; questionnaires; statistics /biometry; urinalysis

DESCRIPTION: Analgesic-associated nephropathy is potentially fatal and costly yet completely preventable as a cause of renal dysfunction. Retrospective studies have reported an increased risk of renal dysfunction associated with consumption of large amounts of acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) but not aspirin. Since these analgesics are widely available and used, their association with renal dysfunction is particularly important. The primary objective of this study is to examine, prospectively, the association between chronic consumption of acetaminophen, aspirin and NSAIDs, and the risk of chronic renal dysfunction, defined as an increase in serum creatinine or a decrease in calculated creatinine clearance during the 5-year study period. From participants in two large female cohorts, the Nurses' Health Studies I and II (NHSI, NHSII), 3 groups of women will be identified, each comprised of 1150 participants (half from each cohort), who reported frequent use of acetaminophen, aspirin, or NSAIDs, and a fourth group of 1150 women who reported no use of these analgesics. Detailed information on dosage and duration of analgesic use will be obtained through supplementary questionnaires, to be mailed in the 01, 03, and 05 years, which have been shown to be reproducible. 4600 nurses will be enrolled at the outset and, after excluding women with prevalent renal disease and those who drop out, an expected 4000 will complete the study in the 05 year. The outcomes are: change in serum creatinine and calculated creatine clearance, measured at baseline and years 03 and 05 from all subjects. Mixed effects regression will be used to analyze the slope of renal function in the unexposed and exposed groups during the 5 year study period. For approximately 2000 subjects in NHSI, stored blood from 1989 will be used to perform the same analyses over a 13 year period. This study will provide: prospective data on change in renal function associated with chronic analgesic use; threshold levels of safe cumulative dose and duration of these analgesics; and population-based incidence rates and attributable risks of analgesic-associated chronic renal dysfunction.

描述：镇痛相关肾病可能致命， 作为肾功能障碍的原因，费用昂贵但完全可以预防。 回顾性研究报告肾功能障碍的风险增加 与大量服用对乙酰氨基酚和 非甾体抗炎药 (NSAID)，但不是阿司匹林。 由于这些 镇痛药被广泛使用和使用，但它们与肾病有关 功能障碍尤为重要。 本研究的主要目的 是前瞻性地检查长期消费之间的关联 对乙酰氨基酚、阿司匹林和非甾体抗炎药，以及慢性肾病的风险 功能障碍，定义为血清肌酐升高或肌酐降低 计算5年研究期间的肌酐清除率。 从 两个大型女性队列的参与者：护士健康研究 I 和 II（NHSI、NHSII），将确定 3 组女性，每组包括 1150 名参与者（每个队列各占一半），他们报告经常使用 对乙酰氨基酚、阿司匹林或非甾体抗炎药，以及第四组 1150 名女性 报告没有使用这些镇痛药。 有关剂量和剂量的详细信息 镇痛使用的持续时间将通过补充获得 调查问卷分别于01年、03年、05年邮寄，已 表明是可重现的。 一开始将招募 4600 名护士， 在排除患有流行性肾病的女性和辍学的女性后， 预计 4000 人将在 05 年完成这项研究。 结果是： 血清肌酐的变化和计算的肌酸清除率，测量于 所有受试者的基线以及 03 和 05 年。 混合效应回归 将用于分析未暴露和暴露的肾功能的斜率 5年研究期间暴露的群体。 大约2000 NHSI 的受试者，1989 年储存的血液将用于执行相同的操作 13 年期间的分析。 本研究将提供： 前瞻性数据 与长期使用镇痛药相关的肾功能变化；临界点 这些镇痛药的安全累积剂量和持续时间的水平；和 基于人群的发病率和归因风险 镇痛相关的慢性肾功能不全。