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N-乙酰半胱氨酸预防慢性肾功能不全患者心脏手术中急性肾衰竭的前瞻性随机临床试验

N-acetylcysteine for prevention of acute renal failure in patients with chronic renal insufficiency undergoing cardiac surgery: a prospective, randomized, clinical trial.

作者信息

Sisillo Erminio, Ceriani Roberto, Bortone Franco, Juliano Glauco, Salvi Luca, Veglia Fabrizio, Fiorentini Cesare, Marenzi Giancarlo

机构信息

Anesthesia and Critical Care Unit, Centro Cardiologico Monzino, I.R.C.C.S, Institute of Cardiology, University of Milan, Milan, Italy.

出版信息

Crit Care Med. 2008 Jan;36(1):81-6. doi: 10.1097/01.CCM.0000295305.22281.1D.

DOI:10.1097/01.CCM.0000295305.22281.1D
PMID:18090169
Abstract

OBJECTIVE

To assess the preventive effect of the antioxidant N-acetylcysteine on postoperative acute renal failure in patients with renal insufficiency undergoing cardiac surgery.

DESIGN

Randomized, placebo-controlled, prospective study.

SETTING

University cardiology center.

PATIENTS

Two hundred fifty-four consecutive patients with chronic renal insufficiency (estimated creatinine clearance < or = 60 mL/min) undergoing elective cardiac surgery.

INTERVENTIONS

Patients were randomized to receive N-acetylcysteine (n = 129) or placebo (n = 125). Patients of the N-acetylcysteine group received four boluses of intravenous N-acetylcysteine (1200 mg every 12 hrs, starting immediately before cardiac surgery).

MEASUREMENTS AND MAIN RESULTS

The incidence of postoperative acute renal failure (> 25% increase in serum creatinine from baseline) and the in-hospital clinical course were evaluated. Acute renal failure occurred in 46% of patients and was associated with increased in-hospital mortality (7% vs. 0.7%; p = .024). It occurred in 52% of control patients and 40% of N-acetylcysteine-treated patients (p = .06). In-hospital mortality and need for renal replacement therapy were not affected by N-acetylcysteine, but a lower percentage of N-acetylcysteine-treated patients required mechanical ventilation prolonged for > 48 hrs (3% vs. 18%; p < .001) and had an intensive care unit stay > 4 days (13% vs. 33%; p < .001).

CONCLUSIONS

Intravenous administration of N-acetylcysteine does not clearly prevent postoperative acute renal failure in patients with renal insufficiency undergoing cardiac surgery.

摘要

目的

评估抗氧化剂N - 乙酰半胱氨酸对行心脏手术的肾功能不全患者术后急性肾衰竭的预防作用。

设计

随机、安慰剂对照、前瞻性研究。

地点

大学心脏病中心。

患者

254例连续接受择期心脏手术的慢性肾功能不全患者(估计肌酐清除率≤60 mL/分钟)。

干预措施

患者被随机分为接受N - 乙酰半胱氨酸组(n = 129)或安慰剂组(n = 125)。N - 乙酰半胱氨酸组患者静脉注射4次N - 乙酰半胱氨酸(每12小时1200 mg,在心脏手术即将开始前即刻开始)。

测量指标及主要结果

评估术后急性肾衰竭(血清肌酐较基线水平升高>25%)的发生率及住院期间的临床病程。46%的患者发生急性肾衰竭,且与住院死亡率增加相关(7%对0.7%;p = 0.024)。对照组患者中52%发生急性肾衰竭,N - 乙酰半胱氨酸治疗组患者中40%发生急性肾衰竭(p = 0.06)。N - 乙酰半胱氨酸对住院死亡率及肾脏替代治疗需求无影响,但接受N - 乙酰半胱氨酸治疗的患者中,需要机械通气超过48小时的比例较低(3%对18%;p < 0.001),且入住重症监护病房超过4天的比例较低(13%对33%;p < 0.001)。

结论

静脉给予N - 乙酰半胱氨酸并不能明确预防行心脏手术的肾功能不全患者术后急性肾衰竭。

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