乙酰半胱氨酸预防冠状动脉造影术后对比剂肾病

Acetylcysteine in the prevention of contrast-induced nephropathy after coronary angiography.

作者信息

Oldemeyer J Bradley, Biddle W Paul, Wurdeman Richard L, Mooss Aryan N, Cichowski Erica, Hilleman Daniel E

机构信息

Creighton University Cardiac Center, Omaha, Neb 68131, USA.

出版信息

Am Heart J. 2003 Dec;146(6):E23. doi: 10.1016/S0002-8703(03)00511-8.

DOI:10.1016/S0002-8703(03)00511-8

PMID:14661012

Abstract

BACKGROUND

Contrast-induced nephropathy (CIN) after coronary angiography is associated with increased morbidity and mortality rates. Preliminary studies with N-acetylcysteine (NAC) have found conflicting results in the prevention of CIN in patients undergoing coronary angiography. This study was designed to evaluate the efficacy and safety of NAC in the prevention of CIN in patients undergoing coronary angiography.

METHODS

This study was prospective, randomized, double-blind, and placebo-controlled. Patients referred for elective coronary angiography with a baseline creatinine clearance level <50 mL/min and serum creatinine >1.2 mg/dL were randomly assigned to 1500 mg NAC or placebo, starting the evening before angiography and given every 12 hours for 4 doses. The primary study end point was the development of CIN, which was defined as an increase of >0.5 mg/dL or an increase of > or =25% in serum creatinine over baseline within 48 hours of angiography. Secondary end points included changes in serum creatinine and blood urea nitrogen, requirement of dialysis, side effects of study medication, hospital length of stay, and hospital charges.

RESULTS

CIN occurred in 8.2% (4/49) of patients taking NAC and 6.4% (3/47) of patients taking placebo. Changes in BUN and serum creatinine from baseline were not significantly different in the two treatment groups. Baseline BUN and volume of contrast were the only independent predictors of CIN. More patients with diabetes had development of CIN (5/43; 12%) compared with nondiabetic patients (2/52; 4%), but the difference was not significant (P =.15). The incidence of CIN in diabetic patients was not different in the two treatment groups. No patient with development of CIN required dialysis. Side effects (mostly gastrointestinal) occurred in 16% of patients taking NAC and in none of the patients taking placebo. Length of stay and hospital charges were not different between the treatment groups.

CONCLUSIONS

In patients with reduced renal function undergoing elective coronary angiography, NAC does not reduce the risk of CIN.

摘要

背景

冠状动脉造影术后对比剂肾病（CIN）与发病率和死亡率增加相关。对N - 乙酰半胱氨酸（NAC）的初步研究在接受冠状动脉造影的患者预防CIN方面发现了相互矛盾的结果。本研究旨在评估NAC在接受冠状动脉造影的患者中预防CIN的疗效和安全性。

方法

本研究为前瞻性、随机、双盲、安慰剂对照研究。基线肌酐清除率<50 mL/min且血清肌酐>１.２mg/dL的择期冠状动脉造影患者被随机分配至1500mg NAC组或安慰剂组，在造影前一晚开始给药，每12小时给药一次，共4剂。主要研究终点为CIN的发生，定义为造影后48小时内血清肌酐较基线水平升高>0.5mg/dL或升高>或=25%。次要终点包括血清肌酐和血尿素氮的变化、透析需求、研究药物的副作用、住院时间和住院费用。

结果

服用NAC的患者中8.2%（4/49）发生CIN，服用安慰剂的患者中6.4%（3/47）发生CIN。两个治疗组中BUN和血清肌酐较基线的变化无显著差异。基线BUN和对比剂用量是CIN的唯一独立预测因素。糖尿病患者发生CIN的比例（5/43；12%）高于非糖尿病患者（2/52；4%），但差异无统计学意义（P = 0.15）。糖尿病患者中CIN的发生率在两个治疗组中无差异。发生CIN的患者均无需透析。服用NAC的患者中16%出现副作用（主要为胃肠道副作用），服用安慰剂的患者均未出现副作用。治疗组之间住院时间和住院费用无差异。