ANALGESIC USE AND THE RISK OF CHRONIC RENAL FAILURE
ANALGESIC USE AND THE RISK OF CHRONIC RENAL FAILURE
批准号:
2634316
负责人:
GARY C. CURHAN
金额:
$51.83万
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-08-15 至 2003-07-31
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
中文摘要
描述:镇痛剂相关性肾病具有潜在的致死性,
作为肾功能障碍的原因,这是一种昂贵但完全可以预防的疾病。
回顾性研究报告了肾功能不全的风险增加
与摄入大量对乙酰氨基酚有关,
非甾体抗炎药(NSAID),但不是阿司匹林。 由于这些
镇痛药是广泛可用和使用的,它们与肾功能的关系
功能障碍尤其重要。 本研究的主要目的
是前瞻性地研究长期食用
对乙酰氨基酚、阿司匹林和NSAID与慢性肾功能衰竭的风险
功能障碍,定义为血清肌酐升高或
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组妇女,每组包括:
1150名参与者(每个队列各占一半),报告频繁使用
对乙酰氨基酚、阿司匹林或非甾体抗炎药,第四组1150名妇女,
报告没有使用这些止痛药。 关于剂量的详细信息和
镇痛剂使用的持续时间将通过补充
调查问卷,将在01年,03年和05年邮寄,其中已
显示出可再现性。 最初将招收4600名护士,
在排除患有普遍肾病的妇女和辍学妇女后,
预计2005年将有4000人完成这项研究。 这些成果是:
血清肌酐和计算的肌酸清除率的变化,测量时间为
所有受试者的基线以及第3年和第5年。 混合效应回归
将用于分析未暴露者的肾功能斜率,
在5年的研究期间,暴露组。 大约2000年
对于NHSI中的受试者,将使用1989年储存的血液进行相同的操作
13年来的分析。 本研究将提供:前瞻性数据
与慢性镇痛药使用相关的肾功能变化;阈值
这些镇痛剂的安全累积剂量和持续时间;以及
基于人群的发病率和归因风险
镇痛药相关的慢性肾功能不全。
英文摘要
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.
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