静脉注射N-乙酰半胱氨酸和碳酸氢钠能否预防高渗性造影剂所致急性肾损伤？一项随机对照试验。
Do intravenous N-acetylcysteine and sodium bicarbonate prevent high osmolal contrast-induced acute kidney injury? A randomized controlled trial.
作者信息
Inda-Filho Antonio Jose, Caixeta Adriano, Manggini Marcia, Schor Nestor
机构信息
Divisão de Nefrologia, Hospital Universitário de Brasília, Universidade de Brasília, Brasília, DF, Brazil.
Cardiologia, Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.
出版信息
PLoS One. 2014 Sep 25;9(9):e107602. doi: 10.1371/journal.pone.0107602. eCollection 2014.
BACKGROUND
N-acetylcysteine (NAC) or sodium bicarbonate (NaHCO3), singly or combined, inconsistently prevent patients exposed to radiographic contrast media from developing contrast-induced acute kidney injury (CI-AKI).
OBJECTIVE
We asked whether intravenous isotonic saline and either NaHCO3 in 5% dextrose or else a high dose of NAC in 5% dextrose prevent CI-AKI in outpatients exposed to high-osmolal iodinated contrast medium more than does saline alone.
METHODS
This completed prospective, parallel, superiority, open-label, controlled, computer-randomized, single-center, Brazilian trial (NCT01612013) hydrated 500 adult outpatients (214 at high risk of developing CI-AKI) exposed to ioxitalamate during elective coronary angiography and ventriculography. From 1 hour before through 6 hours after exposure, 126 patients (group 1) received a high dose of NAC and saline, 125 (group 2) received NaHCO3 and saline, 124 (group 3) received both treatments, and 125 (group 4) received only saline.
RESULTS
Groups were similar with respect to age, gender, weight, pre-existing renal dysfunction, hypertension, medication, and baseline serum creatinine and serum cystatin C, but diabetes mellitus was significantly less prevalent in group 1. CI-AKI incidence 72 hours after exposure to contrast medium was 51.4% (257/500), measured as serum creatinine > (baseline+0.3 mg/dL) and/or serum cystatin C > (1.1 · baseline), and 7.6% (38/500), measured as both serum creatinine and serum cystatin C > (baseline+0.3 mg/dL) or > (1.25 · baseline). CI-AKI incidence measured less sensitively was similar among groups. Measured more sensitively, incidence in group 1 was significantly (p<0.05) lower than in groups 2 and 3 but not group 4; adjustment for confounding by infused volume equalized incidence in groups 1 and 3.
CONCLUSION
We found no evidence that intravenous isotonic saline and either NaHCO3 or else a high dose of NAC prevent CI-AKI in outpatients exposed to high osmolal iodinated contrast medium more than does saline alone.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01612013.
背景
N-乙酰半胱氨酸（NAC）或碳酸氢钠（NaHCO₃）单独使用或联合使用时，对接受放射造影剂的患者预防造影剂诱导的急性肾损伤（CI-AKI）的效果并不一致。
目的
我们探讨静脉输注等渗盐水与5%葡萄糖中的NaHCO₃或5%葡萄糖中的高剂量NAC相比，单独使用盐水时，能否更有效地预防接受高渗碘化造影剂的门诊患者发生CI-AKI。
方法
这项已完成的前瞻性、平行、优效性、开放标签、对照、计算机随机、单中心巴西试验（NCT01612013）纳入了500名成年门诊患者（其中214名有发生CI-AKI的高风险），这些患者在择期冠状动脉造影和心室造影期间接受了碘他拉酸盐。从接触前1小时至接触后6小时，126名患者（第1组）接受高剂量NAC和盐水，125名（第2组）接受NaHCO₃和盐水，124名（第3组）接受两种治疗组合，125名（第4组）仅接受盐水。
结果
各组在年龄、性别、体重、既往肾功能不全、高血压、用药情况以及基线血清肌酐和血清胱抑素C方面相似，但第1组糖尿病的患病率显著较低。接触造影剂72小时后CI-AKI的发生率为51.4%（257/500），定义为血清肌酐>（基线+0.3mg/dL）和/或血清胱抑素C>（1.1·基线），以及7.6%（38/500），定义为血清肌酐和血清胱抑素C均>（基线+0.3mg/dL）或>（1.25·基线）。以较不敏感的标准衡量，各组间CI-AKI发生率相似。以更敏感的标准衡量，第1组的发生率显著低于第2组和第3组（p<0.05），但与第4组无差异；通过输注量对混杂因素进行调整后，第1组和第3组的发生率趋于均衡。
结论
我们没有发现证据表明静脉输注等渗盐水与NaHCO₃或高剂量NAC联合使用时比单独使用盐水能更有效地预防接受高渗碘化造影剂的门诊患者发生CI-AKI。
试验注册
ClinicalTrials.gov NCT01612013。
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