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: 2634316
• 负责人: GARY C. CURHAN
• 金额: $ 51.83万
• 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/2634316
• 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：止痛剂相关的肾病具有潜在的致命性 成本高昂，但完全可以预防，因为这是导致肾功能障碍的一个原因。 回顾研究报告了肾功能不全的风险增加。 与大量服用扑热息痛和 非类固醇抗炎药(NSAIDs)，但不是阿司匹林。因为这些 止痛药被广泛获得和使用，它们与肾脏的关系 功能障碍尤其重要。这项研究的主要目的是 就是前瞻性地研究长期消费与 扑热息痛、阿司匹林和非甾体抗炎药与慢性肾脏风险 功能障碍，定义为血清肌酐增加或 计算5年研究期内的内生肌酐清除量。从… 两个大型女性队列的参与者，护士健康研究I和 将确定三组妇女，每组包括 1150名参与者(每组一半)，他们报告经常使用 扑热息痛、阿司匹林或非甾体抗炎药，以及第四组1150名女性 报告说没有使用过这些止痛药。剂量和剂量的详细信息 止痛药的使用时间将通过补充获得 在01年、03年和05年邮寄的问卷，已经 被证明是可复制的。开始时将招收4600名护士， 在排除了患有常见肾脏疾病的女性和辍学的女性之后， 预计将有4000人在05年内完成这项研究。结果是： 血清肌酐的变化和计算的肌酸清除量，在 所有受试者的基线和03和05年。混合效应回归 将被用来分析非接触者肾功能的斜率 暴露组在5年的研究期间。大约2000年 在国家卫生研究院的受试者中，储存的血液将用于执行相同的操作 历时13年的分析。这项研究将提供：前瞻性数据 慢性使用止痛药对肾功能影响的研究 这些止痛药的安全累积剂量和持续时间；以及 基于人群的发病率和可归因性风险 止痛药相关的慢性肾功能障碍。