N-乙酰半胱氨酸与抗坏血酸预防肾功能不全患者冠状动脉造影时对比剂肾病的疗效比较：NASPI研究——一项前瞻性随机对照试验

N-acetylcysteine versus AScorbic acid for preventing contrast-Induced nephropathy in patients with renal insufficiency undergoing coronary angiography NASPI study-a prospective randomized controlled trial.

作者信息

Jo Sang-Ho, Koo Bon-Kwon, Park Jin-Shik, Kang Hyun-Jae, Kim Yong-Jin, Kim Hack-Lyoung, Chae In-Ho, Choi Dong-Ju, Sohn Dae-Won, Oh Byung-Hee, Park Young-Bae, Choi Yun-Shik, Kim Hyo-Soo

机构信息

Department of Internal Medicine, Seoul National University College of Medicine/Cardiovascular Center, Seoul National University Hospital, Korea.

出版信息

Am Heart J. 2009 Mar;157(3):576-83. doi: 10.1016/j.ahj.2008.11.010. Epub 2009 Feb 6.

DOI:10.1016/j.ahj.2008.11.010

PMID:19249432

Abstract

BACKGROUND

Contrast-induced nephropathy (CIN) is a leading cause of hospital-acquired renal failure and affects mortality and morbidity. There has been no study comparing the efficacy of N-acetylcysteine (NAC) and ascorbic acid that have potential for CIN prevention in patients with renal insufficiency.

METHODS

We conducted a prospective randomized controlled trial. A total of 212 patients who had pre-existing renal impairment with basal creatinine clearance < or =60 mL/min and/or serum creatinine (SCr) level of > or =1.1 mg/dL, were randomized to have either high-dose NAC (1,200 mg orally twice a day before and on the day of coronary catheterization, n = 106) or ascorbic acid (3 g and 2 g orally before, and 2 g twice after coronary catheterization with a 12-hour interval, n = 106). The primary end point was the maximum increase of SCr level, and the secondary end point was the incidence of CIN.

RESULTS

The maximum increase of SCr level was significantly lower in NAC group than in ascorbic acid group as follows: -0.03 +/- 0.18 mg/dL versus 0.04 +/- 0.20 mg/mL, respectively (P = .026). Patients with diabetes or who had received a high dose of contrast media experienced significantly less rise of SCr level with NAC than ascorbic acid; in diabetic subgroup, -0.05 +/- 0.22 mg/dL versus 0.09 +/- 0.29 mg/mL, respectively (P = .020); in patients with high dose of dye, -0.03 +/- 0.17 mg/dL versus 0.04 +/- 0.21 mg/mL, respectively (P = .032). The incidence of CIN, the secondary end point, tended to be in favor of NAC rather than ascorbic acid, 1.2% versus 4.4%, respectively (P = .370). Notably, among the diabetes patients, the NAC significantly lowered CIN rate than ascorbic acid, 0% (0/38) versus 12.5% (4/32), respectively (P = .039).

CONCLUSION

High-dose NAC seems more beneficial than ascorbic acid in preventing contrast-induced renal function deterioration in patients, especially diabetic patients, with renal insufficiency undergoing coronary angiography.

摘要

背景

对比剂肾病（CIN）是医院获得性肾衰竭的主要原因，影响死亡率和发病率。尚无研究比较N-乙酰半胱氨酸（NAC）和维生素C在预防肾功能不全患者CIN方面的疗效。

方法

我们进行了一项前瞻性随机对照试验。共有212例已有肾功能损害（基础肌酐清除率≤60 mL/分钟和/或血清肌酐（SCr）水平≥1.1 mg/dL）的患者，被随机分为接受高剂量NAC组（冠状动脉造影术前及当天每天口服两次1200 mg，n = 106）或维生素C组（冠状动脉造影术前口服3 g和2 g，术后间隔12小时两次口服2 g，n = 106）。主要终点是SCr水平的最大升高值，次要终点是CIN的发生率。

结果

NAC组SCr水平的最大升高值显著低于维生素C组，分别为-0.03±0.18 mg/dL和0.04±0.20 mg/mL（P = 0.026）。糖尿病患者或接受高剂量造影剂的患者，NAC组的SCr水平升高明显低于维生素C组；在糖尿病亚组中，分别为-0.05±0.22 mg/dL和0.09±0.29 mg/mL（P = 0.020）；在高剂量造影剂患者中，分别为-0.03±0.17 mg/dL和0.04±0.21 mg/mL（P = 0.032）。次要终点CIN的发生率倾向于NAC组而非维生素C组，分别为1.2%和4.4%（P = 0.370）。值得注意的是，在糖尿病患者中，NAC组的CIN发生率显著低于维生素C组，分别为0%（0/38）和12.5%（4/32）（P = 0.039）。