Macedo Etienne, Abdulkader Regina, Castro Isac, Sobrinho Augusto C C, Yu Lius, Vieira Jose M
Renal Division, Hospital das Clínícas, University of São Paulo, São Paulo, Brazil.
Nephrol Dial Transplant. 2006 Jul;21(7):1863-9. doi: 10.1093/ndt/gfl079. Epub 2006 Mar 7.
N-acetylcysteine (NAC) is an antioxidant drug largely tested in different clinical situations. Recently, NAC has been employed with variable success in the prevention of radiocontrast nephropathy. Since aortic aneurysm surgical repair is a condition that is frequently accompanied by acute renal failure (ARF), we sought to investigate whether NAC has any role in preventing ARF in this scenario.
A randomized, placebo-controlled, double-blind trial with the following inclusion criteria: elective aortic aneurysm repair in patients with stable renal function. The groups were randomly matched for age, gender, presence of diabetes and pre-existent renal failure. NAC or placebo (control) was administered p.o. for 24 h before operation and maintained i.v. for 48 h after operation. The dose of NAC was 1200 mg b.i.d. the day before surgery and 600 mg b.i.d. after. The primary endpoint was the development of ARF up to the third post-operative day, defined as an increase in SCr > or = 25% from baseline. Secondary endpoints were: ICU mortality and ICU length of stay.
Forty-two patients (n = 18 for NAC group and n = 24 for control) were studied. The baseline SCr and calculated GFR did not differ between the groups (1.19 +/- 0.33 vs 1.37 +/- 0.49 mg/dl; and 64.6 +/- 26.22 vs 65.7 +/- 28.32 ml/min, NAC vs control, respectively, P = 0.17 and P = 0.90). Need for suprarenal aortic cross-clamping and its duration, occurrence of major bleeding, intra-operative hypotension and the post-operative peak of CPK did not differ between NAC and control groups. The overall incidence of ARF in the study was 36% (13/36), but it was not significantly different between groups (7/14, 50% in NAC vs 6/22, 27.3% in control, P = 0.16). The overall mortality was 23% (10/42) and was not different (P = 0.209) in NAC group (33.3%) when compared with control (16.7%), the same occurring with the length of ICU stay (2.93 +/- 1.53 vs 2.52 +/- 1.36 days, P = 0.40).
This study suggests that the putative beneficial effects of NAC on radiocontrast nephropathy might not be applicable to other situations, such as ARF associated with elective aortic aneurysm repair.
N-乙酰半胱氨酸(NAC)是一种抗氧化药物,已在不同临床情况下进行了大量试验。最近,NAC在预防放射性造影剂肾病方面取得了不同程度的成功。由于主动脉瘤手术修复常伴有急性肾衰竭(ARF),我们试图研究NAC在这种情况下对预防ARF是否有作用。
一项随机、安慰剂对照、双盲试验,纳入标准如下:肾功能稳定的择期主动脉瘤修复患者。根据年龄、性别、糖尿病的存在情况和既往肾衰竭情况将各组随机匹配。术前口服NAC或安慰剂(对照)24小时,术后静脉维持48小时。NAC的剂量为术前一天每日两次1200毫克,术后每日两次600毫克。主要终点是术后第三天内ARF的发生,定义为血清肌酐(SCr)较基线水平升高≥25%。次要终点包括:重症监护病房(ICU)死亡率和ICU住院时间。
共研究了42例患者(NAC组18例,对照组24例)。两组间基线SCr和计算的肾小球滤过率(GFR)无差异(分别为1.19±0.33 vs 1.37±0.49毫克/分升;64.6±26.22 vs 65.7±28.32毫升/分钟,NAC组vs对照组,P = 0.17和P = 0.90)。NAC组和对照组在肾上主动脉交叉阻断的必要性及其持续时间、大出血的发生、术中低血压以及术后肌酸磷酸激酶(CPK)峰值方面无差异。研究中ARF的总体发生率为36%(13/36),但两组间无显著差异(NAC组7/14,50%;对照组6/22,27.3%,P = 0.16)。总体死亡率为23%(10/42),NAC组(33.3%)与对照组(16.7%)相比无差异(P = 0.209),ICU住院时间也是如此(2.93±1.53 vs 2.52±1.36天,P = 0.40)。
本研究表明,NAC对放射性造影剂肾病的假定有益作用可能不适用于其他情况,如与择期主动脉瘤修复相关的ARF。