Prevention of Radiocontrast-induced Nephropathy with N-acetylcysteine after Cardiac Angiography in Diabetic Patients with Renal Dysfunction

目的　針對均質的高危險病患群，我們設計了一項實驗來確定N-乙醯半胱胺酸對於預防顯影劑造成之腎病變到底有沒有影響。方法　這是一個隨機、單盲、安慰劑控制的前瞻性臨床研究。包含適合之糖尿病合併慢性腎功能不全的患者（肌酐酸濃度大於1.6mg/dL或肌酐酸廓清率小於40mL/min），他們都是接受冠狀動脈攝影或介入性治療的患者，同時使用了大量之低分子量，非離子性顯影濟（iohexol，劑量大於每公斤體重1.5mL）。所有的病患在術前均接受0.45%生理食鹽水靜脈注射（每公斤體重每小時1mL，由術前12小時起，至術後12小時止）。A組的病患使用N-乙醯半胱胺酸（一日兩次，每次600mg，共4次，由術前一天開始）。B組的病患則給予安慰劑（一日兩次，共4次，由術前一天開始）。在開始接受心導管術前，心導管術後第2天，以及術後第5天各測一次肌酐酸的濃度。顯影劑造成之腎病變是定義爲術後之肌酐酸濃度上升25%，或是絕對值上升0.5mg/dL。主要的研究結果是顯影劑造成之腎病變的危險性，並採用足夠解釋小樣本差異之非母數統計分析結果。結果　有20位病患完成本試驗。在N-乙醯半胱胺酸組與控制組中，兩組在年齡、性別、體重、而壓、進行心臟血管攝影術之時間、使用的顯影劑量方面均無顯著差異。在心臟血管攝影術兩天後，肌酐酸廓清率在兩組無明顯變化（N-乙醯半胱胺酸組24.5±10.3 vs 29.6±10.6mL/min，N=11，p=0.34：控制組27.4±10.3 vs 29.6±10.6mL/min，N=9，p=0.57）：而在五天後與術前比較，肌酐酸廓清率在兩組皆無顯著差異（N-乙醯半胱胺酸組24.5±10.3 vs 27.4±11.8mL/min，N=11，p=0.40：控制組27.4±10.3 vs 24.2±8.8mL/min，N=9，p=0.43）。在N-乙醯半胱胺酸組中沒有人發生顯影劑造成之腎病變：而在控制組中有五人發生顯影劑造成之腎病變。N-乙醯半胱胺酸組在顯影劑造成腎病變發生率上較低(0% vs 56%，p=0.006，N=20)，且平均住院日較短（5.2 vs 8.1天，p=0.04，N=20）。在本試驗中，並沒有病患因發生顯影劑造成之腎病變而須接受透析治療。結論　在糖尿病患者合併慢性腎功能不全之病患進行心臟血管攝影術前給予N-乙醯半胱胺酸來預防顯影劑iohexol所造成的腎病變是有效的。

關鍵字

心臟血管攝影術；乙醯半胱胺酸；顯影劑造成之腎病變

並列摘要

Purpose. To examine the effects of N-acetylcysteine (NAC) in a homogeneous high-risk population. Methods. This is a prospective randomized single-blinded placebo-controlled clinical study. Diabetic patients with pre-existing renal insufficiency (serum creatinine concentration (SCC) above 1.6mg/dL, or estimated creatinine clearance (CCR) less than 40mL/min) who had received moderate to large amounts of non-ionic low osmolar contrast medium, Omnipaque (iohexol), during a diagnostic or interventional procedure were eligible to participate. All patients were adequately hydrated with half-saline (1mL/(kg•h) from 12 hours before to 12 hours after the procedure). They were randomized into one of two groups. Patients in the NAC group were given NAC 600mg orally twice a day, 4 doses in total; the first dose was given one day before the procedure. Patients in the control group were given placebo orally twice a day, 4 doses in total; the first dose was given one day before the procedure. SCC was assessed before hydration, 2 days after the procedure, and 5 days after the procedure. Radiocontrast-induced nephropathy (RCIN) was defined as a 25% rise from baseline or an absolute increase of 0.5mg/dL in SCC after the procedure. The primary end-point was risk of developing RCIN. Results. Twenty patients completed the study. There were no significant differences in age, sex, body mass index, blood pressure, duration of angiography, or mean volume of dye infused between the two groups. CCR did not change significantly in either group 2 days after angiography (NAC group 24.5±10.3 vs 29.6±10.6mL/min, N=11, p=0.34; control group 27.4±10.3 vs 29.6±10.6mL/min, N=9, p=0.57), or 5 days after angiography (NAC group 24.5±10.3 vs 27.4±11.8mL/min, N=11, p=0.40; control group 27.4±10.3 vs 24.2±8.8mL/min, N=9, p=0.43). None of the patients in the NAC group and five patients in the control group developed RCIN. The incidence of RCIN was lower in the NAC group (0% vs 56%, p=0.006, N=20). The average length of hospitalization was shorter in the NAC group (5.2 vs 8.1 days, p=0.04, N=20). None of the patients who developed RCIN required dialysis. Conclusion. NAC protects diabetic patients with renal dysfunction from iohexol-related RCIN after cardiac angiographic procedures.

並列關鍵字

cardiac angiography ； N-acetylcysteine ； radiocontrast-induced nephropathy

國際替代計量

Prevention of Radiocontrast-induced Nephropathy with N-acetylcysteine after Cardiac Angiography in Diabetic Patients with Renal Dysfunction

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