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研究生:何啟正
研究生(外文):Chi-Cheng Ho
論文名稱:心導管術後造影劑相關急性腎毒性之危險因子評估:案例對照研究
論文名稱(外文):Evaluation of Risk Factors for Contrast Medium-Associated Acute Nephrotoxicity after Cardiac Catheterization: A Case-Control Study
指導教授:廖朝崧陳燕惠陳燕惠引用關係
指導教授(外文):Chiau-Suong LiauYen-Huei Chen
學位類別:碩士
校院名稱:國立臺灣大學
系所名稱:臨床藥學研究所
學門:醫藥衛生學門
學類:藥學學類
論文種類:學術論文
論文出版年:2003
畢業學年度:92
語文別:中文
論文頁數:106
中文關鍵詞:心導管術造影劑相關急性腎毒性危險因子案例對照研究
外文關鍵詞:Cardiac catheterizationcontrastmedium-related acute nephrotoxicityrisk factorscase-control study
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研究背景:心導管術的併發症中,與造影劑相關的急性腎毒性是相當重要的一種,且隨著病人危險因子的增加,其發生率也顯著提高。雖然大部分病人的腎功能將會在數日內自然恢復,但在少數高危險群的病人,造影劑相關的腎毒性可能會延長病人住院時間,增加醫療花費,病患甚至可能需要接受緊急洗腎。文獻中曾提及的危險因子包括慢性腎功能不全、糖尿病、較高的造影劑量、鬱滯性心衰竭等等,但其定義及切點(cutoff point)的歧異性相當大,且對於其他可能造成腎毒性或腎衰竭的因子如各種具血管作用或腎毒性的藥品並未有詳細的評估。另外,目前台灣並沒有本土性的造影劑相關急性腎毒性的藥物流行病學資料,因此國內行心導管術之病人群在腎毒性的表現及危險因子是否有不同之處,仍然無法確知。
研究方法:以回溯性之病例對照研究法(Case-control study)篩選出民國91年6月至92年5月間於台大醫院進行心導管術且術前兩天內及術後二到五天內有監測腎功能之病患,並根據急性腎毒性之定義(定義為術後二到五天內之Scr值較術前上升超過0.5mg/dL或25%)篩選出病例組,對照組則由不符合腎毒性定義之病人中,以和病例組為一比一的方式隨機選出。排除條件包括術前已發生急性腎衰竭、長期洗腎或術前一週內進行短期洗腎之病患。評估變項包括病患之基本資料、潛在疾病、心導管術相關資料、實驗室檢驗值、生命徵象、臨床上重要事件(如休克、術後進行外科手術等)、藥品之使用及腎功能相關指標隨時間之變化,並利用邏輯斯迴歸模式之單變項及多變項分析,找出心導管術後造影劑相關急性腎毒性的危險因子。
研究結果:於研究期間內進行心導管術之病人共有2691人次,其中於術前兩天內及術後二到五天內有監測腎功能者共421人次,按照納入及排除條件,篩選出病例組及對照組各77人,共154人。病例組病人之血清肌酸酐值約在術後二到三天達到頂峰,約有25%的病人出現寡尿或無尿的情形,並有約23.4%的病人接受洗腎治療。多變項邏輯斯迴歸分析的結果顯示,女性性別、鬱滯性心衰竭、糖尿病、術後重覆接受造影劑注射、外科手術、術前至術後一天內新處方或增加劑量的利尿劑、inotropic agents及造影劑用量等八個變項為心導管術後造影劑相關腎毒性之獨立影響因子,另外有關腎功能的變項(術前血清肌酸酐及肌酸酐廓清率)在單變項分析中也都達到統計上顯著差異,顯示這些變項與造影劑相關急性腎毒性的發生有關。
結論:除了其他於文獻中已被證實的危險因子之外(慢性腎功能不全、糖尿病、造影劑用量等),本研究發現利尿劑及某些具血管作用之藥品(如Inotropic agents)也可能對造影劑相關急性腎毒性具有一定的影響,可做為醫療人員之參考,以提高心導管術之安全性。
Background: Contrast medium-associated acute nephrotoxicity (CAN) is one of the most important complications of cardiac catheterization, and the incidence of CAN rises as the number of risk factors. Although renal function of patients with CAN usually recovers in a few days, CAN may lead to prolongation of hospital stay, increased medical expenditures, or even emergent dialysis in high-risk patients. According to the literature, important risk factors for CAN are preexisting renal dysfunction, diabetic mellitus and a larger volume of contrast medium administration, congestive heart failure, etc. However, the definition and cutoff point of these risk factors vary with different studies, and the effect of other factors contributable to CAN, like vaso-acting agents or other nephrotoxic drugs, remains unknown. Besides, there is no pharmaco-epidemiological data of CAN in Taiwan Chinese population, leaving the presentation of CAN and differences in risk factors between populations undetected.
Method: A retrospective case-control study was conducted in NTUH between June 2002 and May 2003. Patients undergoing cardiac catheterization were included if they had serum creatinine monitored within 2 days pre-procedure and 2 to 5 days post-procedure. Cases were selected if the criteria of CAN (Defined as a more than 0.5mg/dL or 25% increase in serum creatinine) were met, while controls were randomly selected in a 1:1 manner with cases from those who didn’t meet the criteria of CAN. Exclusion criteria were established acute renal failure pre-procedure, regular dialysis or intermittent dialysis within 1 week pre-procedure. Demographic data, underlying disease, data of cardiac catheterization, lab tests, vital signs, important clinical events (ex: shock of any cause, any post-procedure surgery, etc.), concurrent medications and renal function-related variables were all recorded. Logistic regression was utilized to find out important risk factors and independent predictors of CAN after cardiac catheterization.
Result: There were 2691 consecutive procedures of cardiac catheterization during study period, and 154 patients were selected according to inclusion/exclusion criteria, including 77 cases and 77 controls. Peak concentration of serum creatinine was achieved 2 to 3 days after the procedure among cases. 25% of cases developed oligouria or unuria after the procedure, and 23.4% of cases received dialysis. Multivariate logistic regression showed that female gender, congestive heart failure, diabetic mellitus, repeated contrast medium injection, post-procedure surgery, new or increased dose of diuretics, new or increased dose of inotropic agents and dose of contrast medium were independent predictors of CAN. Baseline serum creatinine and creatinine clearance were also statistically significant variables in simple logistic regression analysis.
Conclusion: In addition to other proved risk factors according to literature like chronic renal insufficiency, diabetic mellitus and dose of contrast medium, we found that diuretics and some vaso-acting drugs like inotropic agents may also play a role in CAN. The results may provide clinicians more information of CAN to improve the safety of cardiac catheterization.
目錄
中文摘要……………………………………………………………Ⅰ
英文摘要……………………………………………………………Ⅲ
重要名詞中英對照…………………………………………………Ⅴ
目錄…………………………………………………………………Ⅵ
表目錄………………………………………………………………Ⅸ
圖目錄………………………………………………………………Ⅹ
第一章 前言………………………………………………………1
第二章 文獻探討…………………………………………………4
第一節 心導管術之併發症與造影劑腎毒性……………………4
一、 心導管術之併發症………………………………………4
二、 造影劑之種類及腎毒性…………………………………6
三、 造影劑腎毒性之病理生理學過程………………………7
四、 目前台大醫院心導管室使用之造影劑…………………9
第二節 心導管術後造影劑相關急性腎毒性之危險因子………11
一、 慢性腎功能不全…………………………………………11
二、 糖尿病……………………………………………………11
三、 造影劑劑量………………………………………………12
四、 鬱滯性心衰竭及體液不足………………………………13
五、 多發性骨髓瘤……………………………………………14
六、 其他文獻中提及的危險因子……………………………14
七、 其他依學理可能影響腎毒性發生之因子………………15
第三節 預防造影劑急性腎毒性之措施及研究…………………17
一、 連續性靜脈輸液…………………………………………17
二、 鈣離子阻斷劑……………………………………………19
三、 利尿劑……………………………………………………19
四、 前列腺素類藥品…………………………………………20
五、 Xanthine derivatives…………………………………20
六、 Dopamine receptor agonist…………………………21
七、 Acetylcysteine…………………………………………21
八、 腎功能之監測及其他藥品相關注意事項………………23
第四節 心導管術後造影劑相關急性腎毒性之處理方式………26
第三章 研究目的…………………………………………………27
第四章 研究方法…………………………………………………28
第一節 試驗設計與流程…………………………………………28
一、 研究對象…………………………………………………28
二、 納入條件…………………………………………………29
三、 排除條件…………………………………………………30
四、 資料來源…………………………………………………30
五、 研究進行流程……………………………………………30
第二節 臨床評估變項及定義……………………………………33
一、 Index date………………………………………………33
二、 基本資料及病人結果……………………………………33
三、 心血管疾病及其他潛在疾病……………………………35
四、 實驗室檢查及生命徵象…………………………………36
五、 不良習慣…………………………………………………36
六、 重要臨床事件……………………………………………36
七、 與心導管術相關之變項…………………………………37
八、 腎功能、尿量及體重監測………………………………37
九、 併用藥品…………………………………………………37
十、 靜脈輸液…………………………………………………39
十一、有關腎毒性及病患結果之變項……………………………39
第三節 資料處理與統計分析……………………………………40
一、 原始資料處理……………………………………………40
二、 統計分析…………………………………………………40
第五章 研究結果…………………………………………………42
第一節 心導管術病人腎功能分佈及監測型態…………………42
第二節 研究對象篩選及基本資料分析…………………………44
一、 病患之篩選………………………………………………44
二、 基本資料分析……………………………………………46
第三節 病例組病人之腎毒性分析………………………………55
一、 腎毒性的發生型態及其他造影劑相關反應……………55
二、 腎功能相關指標之變化…………………………………57
三、 腎毒性的處理及認知……………………………………60
四、 腎毒性與index date至出院前發生之重要臨床事件…60
第四節 心導管術後造影劑相關急性腎毒性之危險因子分析…62
一、 單變項分析………………………………………………62
二、 變項的選擇與多變項邏輯斯迴歸模式的建立…………68
第五節 各因子間相關性分析……………………………………73
第六章 討論………………………………………………………76
第一節 心導管術病人腎功能分佈及監測型態…………………76
第二節 研究對象篩選及基本資料分析…………………………79
第三節 病例組病人之腎毒性分析………………………………83
第四節 心導管術後造影劑相關急性腎毒性之危險因子分析…86
一、 單變項分析………………………………………………86
二、 多變項分析及邏輯斯迴歸模式的建立…………………89
第五節 研究限制…………………………………………………92
第七章 結論及建議………………………………………………93
第八章 參考文獻…………………………………………………94
附錄一 Case report form………………………………………104
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