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Title: | 使用非類固醇抗發炎藥產生急性腎損傷之風險評估:病例交叉研究 Risk of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Induced Acute Kidney Injury: A Case-Crossover Study |
Authors: | Shao-En Weng 翁紹恩 |
Advisor: | 李啟明(Chi-Ming Lee) |
Co-Advisor: | 蕭斐元(Fei-Yuan Hsiao) |
Keyword: | 急性腎損傷,非類固醇消炎止痛藥(NSAIDs),腎素-血管張力素抑制劑(RAS blockade),利尿劑,藥物交互作用,病例交叉研究,全民健保資料庫, acute kidney injury,nonsteroidal anti-inflammatory drugs (NSAIDs),renin-angiotensin system blockade (RAS blockade),diuretics,drug-drug interactions,case-crossover study,National Health Insurance Research Database (NHIRD), |
Publication Year : | 2019 |
Degree: | 碩士 |
Abstract: | 研究背景 非類固醇消炎止痛藥物 (Non-steroidal anti-inflammatory drugs, NSAIDs)主要作用為抑制環氧合酶 (cyclooxygenase, COX)以降低前列腺素 (prostaglandins) 的產生,達到抑制發炎反應的效果。此類藥物廣泛使用於治療關節炎或骨關節炎所引起的症狀的,然而近期研究顯示不論單一使用或合併其他藥物,NSAIDs都有可能增加急性腎衰竭的風險。
研究目的 本研究希望藉由全民健康保險資料庫,探討使用NSAIDs與急性腎損傷之相關性,並深入了解是否隨著NSAIDs的投藥途徑、同時使用多種NSAIDs、類別 (COX-2專一性或非專一性)、累積劑量而有不同的風險;更進一步探討NSAIDs與利尿劑或腎素-血管張力素系統抑制劑(renin-angiotensin system blockade, RAS blockade)併用情況下對於急性腎損傷之影響。 研究材料與方法 本研究為一病例交叉研究,以全民健康保險研究資料庫中2005及2010年二個承保抽樣歸人檔(涵蓋人口約200萬人)為資料來源,篩選自2003年至2013年期間,第一次因主要診斷為急性腎衰竭而住院的病人。定義病人因急性腎衰竭住院當天為急性腎衰竭發生日(index date),index date前1-7天為病例期 (case period),index date前181-187天為對照期 (control date)。評估病例期與對照期二期,使用NSAIDs (包含使用途徑、數量、藥物類別或累積劑量)、NSAID併用利尿劑或RAS blockade、NSAID和利尿劑以及RAS blckade三者同時使用是否有差異。資料分析採用mutivariable conditional logistic regression並校正病例期與對照期不一致的共病與藥品,估算勝算比(odds ratio,ORs) 與95%信賴區間,並且以不同的時間區間執行敏感性分析,讓結果更加穩健。 研究結果 本研究共收納1,284位因急性腎損傷而住院之病人。在校正不一致疾病與藥物後,發現使用NSAIDs病人發生AKI之風險增加為3.55倍 (95%CI: 2.70-4.65),不論使用專一或非專一性的NSAIDs,都有可能增加風險,其中diclofenac為最常處方之NSAIDs。併用多種NSAIDs、針劑、以及高累積劑量,其產生急性腎損傷的風險也較高。併用藥物方面,NSAID合併腎素-血管張力素抑制劑或利尿劑風險分別增加為6.95倍 (95%CI 4.04-11.93)與15.84倍 (95%CI 8.98-27.96),三個同時併用則風險高達29.22倍 (95%CI 12.82-66.64)。 結論 本研究發現,使用NSAIDs確實會增加急性腎損傷發生的風險,其中以同時使用數量越多、針劑與高累積劑量之風險較高,使用傳統非選擇性NSAIDs與COX 2抑制劑皆會增加風險。於併用藥物方面,併用腎素-血管張力素抑制劑或利尿劑或三者同時併用,都會增加病人急性腎損傷之風險,其中更以三者同時併用風險最高。 Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for the symptom relief of arthritis and osteoarthritis. The pharmaceutical actions involve the inhibition of both cyclooxygenase (COX) resulting in the reduction of prostaglandins (PGs), a known mediator involved in the inflammatory response. However, previous studies has shown that NSAIDs are associated with an increased risk of acute kidney injury (AKI), and the concomitant use of renin-angiotensin system blockade or diuretics may further potentiate the risk. Objective: This study aimed to investigate the risk of AKI associated with NSAIDs (including routes, concomitant use of different NSAIDs, categories (traditional NSAIDs or COX-2 inhibitors), and cumulative doses of NSAIDs) and to evaluate the risk of AKI associated with dual or triple combination of NSAIDs with renin-angiotensin system blockade (RAS blockade) and/or diuretics. Materials and Methods: A case-crossover study was conducted using two sets of longitudinal data from the Taiwan’s National Health Insurance Research Database (NHIRD). Patients who were newly admitted with a primary diagnosis of AKI were included as study subjects, and the date of first admission was defined as the index date. The 1-7 days and 181-187 days prior to the index date were defined as the case period and the control period for each patient. Exposure to NSAIDs and co-exposures of RAS blockade and/or diuretics within the case period and the control period were evaluated. Multivariable conditional logistic regression models adjusted for potential confounders were used to estimate the adjusted odds ratios (aORs) and 95% confidence intervals (CIs) of AKI associated with NSAIDs, dual combination, or triple combination. Sensitivity analyses were conducted to examine the robustness of the results by varying the length of case period and control period. Results: A total of 1,284 newly diagnosed AKI patients were included in the study. Overall, NSAIDs was associated with a 3.55-fold increased risk of AKI (aOR: 3.55; 95% CI 2.70-4.65), and the risk was similar between traditional NSAIDs and COX-2 inhibitors. Using more kinds of NSAIDs , using parenteral dosage form of NSAIDs, and higher cumulative doses of NSAIDs were associated with higher risk of AKI. Dual combination with either RAS blockade or diuretics was associated with a 6.95-fold increase risk (aOR: 6.95; 95%CI 4.04-11.93), and a 15.84-fold increase risk (aOR: 15.84; 95%CI 8.98-27.96) of AKI, respectively. A triple combination was associated with the highest increased risk of AKI (aOR: 29.22; 95%CI 12.82-66.64). Conclusions: The current study confirmed that NSAIDs can indeed increase the risk of AKI, and both non-selective NSAIDs and COX2 inhibitors were found to increase the risk. Using more kinds of NSAIDs, using parenteral dosage form of NSAIDs, and higher cumulative doses of NSAIDs were associated with higher risk of AKI. Dual combination of RAS blockade with NSAIDs or diuretics with NSAIDs and triple combination with NSAIDs, RAS blockade and diuretics further potentiate the risk of AKI, while triple therapy was associated with the highest risk. |
URI: | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/78582 |
DOI: | 10.6342/NTU201903360 |
Fulltext Rights: | 有償授權 |
metadata.dc.date.embargo-lift: | 2024-06-30 |
Appears in Collections: | 臨床藥學研究所 |
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ntu-108-R05451005-1.pdf Restricted Access | 1.85 MB | Adobe PDF |
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