N-乙酰半胱氨酸或碳酸氢钠预防 ST 段抬高型心肌梗死患者对比剂肾病的前瞻性随机开放标签试验。
Prevention of contrast-induced nephropathy with N-acetylcysteine or sodium bicarbonate in patients with ST-segment-myocardial infarction: a prospective, randomized, open-labeled trial.
机构信息
From the Department of Cardiology, Odense University Hospital, Odense, Denmark (P.T., K.N.H., H.S.H., A.J., K.T.V., L.O.J.); Department of Cardiology, Aarhus University Hospital, Skejby, Denmark (J.F.L., E.H.C., L.T.); and Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark (S.E.J., J.R.).
出版信息
Circ Cardiovasc Interv. 2014 Apr;7(2):216-24. doi: 10.1161/CIRCINTERVENTIONS.113.000653. Epub 2014 Apr 8.
BACKGROUND
Contrast-induced nephropathy (CIN) is a serious condition in patients with ST-segment-elevation myocardial infarction treated with primary percutaneous coronary intervention. We compared the risk of acute CIN and the influence of preventive strategies in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.
METHODS AND RESULTS
A total of 720 patients were randomized in the Prevention of Contrast-induced Nephropathy in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (CINSTEMI) trial. Patients were randomly assigned in a 1:1:1:1 ratio to receive hydration with sodium chloride together with 1 of 4 prophylactic regimes (1) N-acetylcysteine (NAC), (2) sodium bicarbonate (NaHCO3) infusion, (3) NAC in combination with NaHCO3, or (4) hydration with sodium chloride infusion alone. Patients in cardiogenic shock were excluded. Acute CIN was defined as an increase in serum creatinine concentration >25% from the baseline value within a 3-day period. Overall, CIN occurred in 141 (21.9%) patients. The prevention treatment with NAC, NaHCO3, or the combined NAC and NaHCO3 did not reduce the rate of CIN significantly compared with hydration with intravenous sodium chloride infusion alone (20.1% versus 20.1% versus 20.8% versus 26.5%; P=NS). However, an increase in serum creatinine >25% from the baseline value to 30 day was significantly lower in patients treated with combined NAC and NaHCO3 (18.7% versus 19.1% versus 9.2% versus 21.3%; P=0.033).
CONCLUSIONS
Treatment with NAC or NaHCO3 did not reduce the rate of acute CIN significantly. Combined treatment with NAC and NaHCO3 may reduce the risk of renal dysfunction after 30 days.
CLINICAL TRIAL REGISTRATION URL
http://www.clinicaltrials.gov. Unique identifier: NCT01160627.
背景
对比剂诱导肾病（CIN）是接受直接经皮冠状动脉介入治疗的 ST 段抬高型心肌梗死患者的一种严重情况。我们比较了接受直接经皮冠状动脉介入治疗的 ST 段抬高型心肌梗死患者中急性 CIN 的风险和预防策略的影响。
方法和结果
共有 720 例患者参与了预防对比剂诱导的 ST 段抬高型心肌梗死患者经皮冠状动脉介入治疗后的肾病（CINSTEMI）试验。患者按照 1:1:1:1 的比例随机分配接受氯化钠水化治疗，同时接受 4 种预防方案中的 1 种：（1）N-乙酰半胱氨酸（NAC），（2）碳酸氢钠（NaHCO3）输注，（3）NAC 联合 NaHCO3，或（4）单独接受氯化钠水化治疗。心源性休克患者被排除在外。急性 CIN 的定义为在 3 天内血清肌酐浓度比基线值升高>25%。总的来说，141 例（21.9%）患者发生 CIN。与单独接受静脉注射氯化钠水化治疗相比，NAC、NaHCO3 或 NAC 联合 NaHCO3 的预防治疗并未显著降低 CIN 的发生率（20.1%比 20.1%比 20.8%比 26.5%；P=NS）。然而，与单独接受氯化钠水化治疗的患者相比，治疗后 30 天内血清肌酐比基线值升高>25%的患者比例显著降低（18.7%比 19.1%比 9.2%比 21.3%；P=0.033）。
结论
NAC 或 NaHCO3 的治疗并未显著降低急性 CIN 的发生率。NAC 和 NaHCO3 的联合治疗可能会降低 30 天后肾功能障碍的风险。
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