Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Department of Emergency Medicine, Mayo Clinic Arizona, Phoenix, AZ; Mayo Clinic College of Medicine, Rochester, MN; Department of Emergency Medicine, Mayo Clinic Arizona, Phoenix, AZ.
Indiana University School of Medicine, Indianapolis, IN.
Ann Emerg Med. 2013 Nov;62(5):511-520.e25. doi: 10.1016/j.annemergmed.2013.04.012. Epub 2013 Jun 14.
We test the hypothesis that N-acetylcysteine plus normal saline solution is more effective than normal saline solution alone in the prevention of contrast-induced nephropathy.
The design was a randomized, double blind, 2-center, placebo-controlled interventional trial. Inclusion criteria were patients undergoing chest, abdominal, or pelvic computed tomography (CT) scan with intravenous contrast, older than 18 years, and at least one contrast-induced nephropathy risk factor. Exclusion criteria were end-stage renal disease, pregnancy, N-acetylcysteine allergy, or clinical instability. Intervention for the treatment group was N-acetylcysteine 3 g in 500 mL normal saline solution as an intravenous bolus and then 200 mg/hour (67 mL/hour) for up to 24 hours; and for the placebo group was 500 mL normal saline solution and then 67 mL/hour for up to 24 hours. The primary outcome was contrast-induced nephropathy, defined as an increase in creatinine level of 25% or 0.5 mg/dL, measured 48 to 72 hours after CT.
The data safety and monitoring board terminated the study early for futility. Of 399 patients enrolled, 357 (89%) completed follow-up and were included. The N-acetylcysteine plus saline solution group contrast-induced nephropathy rate was 14 of 185 (7.6%) versus 12 of 172 (7.0%) in the normal saline solution only group (absolute risk difference 0.6%; 95% confidence interval -4.8% to 6.0%). The contrast-induced nephropathy rate in patients receiving less than 1 L intravenous fluids in the emergency department (ED) was 19 of 147 (12.9%) versus 7 of 210 (3.3%) for greater than 1 L intravenous fluids (difference 9.6%; 95% confidence interval 3.7% to 15.5%), a 69% risk reduction (odds ratio 0.41; 95% confidence interval 0.21 to 0.80) per liter of intravenous fluids.
We did not find evidence of a benefit for N-acetylcysteine administration to our ED patients undergoing contrast-enhanced CT. However, we did find a significant association between volume of intravenous fluids administered and reduction in contrast-induced nephropathy.
我们检验了以下假说，即在预防对比剂肾病方面，N-乙酰半胱氨酸联合生理盐水溶液比单独使用生理盐水溶液更有效。
本研究设计为一项随机、双盲、两中心、安慰剂对照的干预性试验。纳入标准为：接受胸部、腹部或盆腔 CT 扫描且静脉注射造影剂的患者，年龄大于 18 岁，且至少存在一个对比剂肾病风险因素。排除标准为：终末期肾病、妊娠、N-乙酰半胱氨酸过敏或临床不稳定。治疗组的干预措施为 N-乙酰半胱氨酸 3 g 溶于 500 mL 生理盐水溶液中静脉推注，然后以 200 mg/小时（67 mL/小时）的速度持续 24 小时；安慰剂组则给予 500 mL 生理盐水溶液，然后以 67 mL/小时的速度持续 24 小时。主要结局为对比剂肾病，定义为 CT 后 48 至 72 小时肌酐水平升高 25%或 0.5 mg/dL。
数据安全和监测委员会因无效性提前终止了该研究。399 名入组患者中，357 名（89%）完成了随访并纳入分析。N-乙酰半胱氨酸联合生理盐水溶液组对比剂肾病发生率为 185 例中的 14 例（7.6%），生理盐水溶液组为 172 例中的 12 例（7.0%）（绝对风险差异 0.6%；95%置信区间-4.8%至 6.0%）。在急诊科（ED）接受少于 1 L 静脉补液的患者中，对比剂肾病发生率为 147 例中的 19 例（12.9%），而接受大于 1 L 静脉补液的患者中为 210 例中的 7 例（3.3%）（差异 9.6%；95%置信区间 3.7%至 15.5%），每增加 1 L 静脉补液可降低 69%的风险（比值比 0.41；95%置信区间 0.21 至 0.80）。
我们未发现 ED 患者接受 CT 增强造影时使用 N-乙酰半胱氨酸有益的证据。然而，我们确实发现静脉补液量与对比剂肾病发生率降低之间存在显著关联。
