Kurnik B R, Allgren R L, Genter F C, Solomon R J, Bates E R, Weisberg L S
Department of Medicine, UMDNJ/Robert Wood Johnson Medical School, Camden, NJ 08103, USA.
Am J Kidney Dis. 1998 Apr;31(4):674-80. doi: 10.1053/ajkd.1998.v31.pm9531185.
Radiocontrast-induced nephropathy (RCIN) is a common cause of hospital-acquired acute renal failure and is associated with a high mortality rate. RCIN is potentially preventable, because administration of the radiocontrast agent is predictable, and a high-risk population has been identified. This multicenter, prospective, randomized, double-blind, placebo-controlled trial was performed to evaluate the efficacy of intravenous atrial natriuretic peptide (anaritide, ANP 4-28) to prevent RCIN. Patients with stable chronic renal failure (serum creatinine greater than 1.8 mg/dL or serum creatinine between 1.5 and 1.8 mg/dL with estimated creatinine clearance of < or = 65 mL/min) were assigned to receive either placebo or one of three doses of anaritide (0.01 microg/kg/min, 0.05 microg/kg/min, or 0.1 microg/kg/min) for 30 minutes before and continuing for 30 minutes after radiocontrast administration. All patients were given intravenous 0.45% saline for 12 hours before the radiocontrast procedure and continuing for 12 hours after the last dose of radiocontrast. Both ionic and nonionic radiocontrast agents were administered. RCIN was defined as either an absolute increase of serum creatinine of > or = 0.5 mg/dL or a percent increase of > or = 25% over baseline. Of the 247 patients who completed the study, 50% had diabetes mellitus. There were no statistical differences in baseline serum creatinine, change in serum creatinine, or the incidence of RCIN. The incidence of RCIN was placebo, 19%; anaritide (0.01), 23%; anaritide (0.05), 23%; anaritide (0.1), 25%. Patients with diabetes mellitus had a significantly greater incidence of RCIN: placebo, 26% versus 9%; anaritide (0.01), 33% versus 13%; anaritide (0.05), 26% versus 21%; anaritide (0.1), 39% versus 8% (diabetic v nondiabetic, P < 0.002). There was no effect in the diabetic or nondiabetic groups by anaritide on the incidence of RCIN. Comparison of the highest-risk group of patients, defined as patients with diabetes mellitus and a baseline serum creatinine > or = 1.8 mg/dL, with the lowest-risk group, defined as patients without diabetes mellitus and a baseline serum creatinine of 1.8 mg/dL or less, did not show a beneficial effect of anaritide administration. In conclusion, administration of intravenous anaritide before and during a radiocontrast study did not reduce the incidence of RCIN in patients with preexisting chronic renal failure, with or without diabetes mellitus.
放射性造影剂所致肾病（RCIN）是医院获得性急性肾衰竭的常见病因，且与高死亡率相关。RCIN具有潜在可预防性，因为放射性造影剂的使用是可预测的，并且已识别出高危人群。开展这项多中心、前瞻性、随机、双盲、安慰剂对照试验以评估静脉注射心钠素（阿那立肽，ANP 4-28）预防RCIN的疗效。将稳定的慢性肾衰竭患者（血清肌酐大于1.8 mg/dL或血清肌酐在1.5至1.8 mg/dL之间且估计肌酐清除率≤65 mL/min）分配为接受安慰剂或三种剂量阿那立肽（0.01μg/kg/min、0.05μg/kg/min或0.1μg/kg/min）之一，在注射放射性造影剂前30分钟给药并持续至注射后30分钟。所有患者在放射性造影检查前静脉输注0.45%盐水12小时，并在最后一剂放射性造影剂后持续12小时。离子型和非离子型放射性造影剂均有使用。RCIN定义为血清肌酐绝对升高≥0.5 mg/dL或较基线升高≥25%。在完成研究的247例患者中，50%患有糖尿病。基线血清肌酐、血清肌酐变化或RCIN发生率无统计学差异。RCIN发生率为：安慰剂组19%；阿那立肽（0.01）组23%；阿那立肽（0.05）组23%；阿那立肽（0.1）组25%。糖尿病患者的RCIN发生率显著更高：安慰剂组为26%对9%；阿那立肽（0.01）组为33%对13%；阿那立肽（0.05）组为26%对21%；阿那立肽（0.1）组为39%对8%（糖尿病患者与非糖尿病患者，P<0.002）。阿那立肽对糖尿病组或非糖尿病组的RCIN发生率均无影响。将最高危患者组（定义为患有糖尿病且基线血清肌酐≥1.8 mg/dL的患者）与最低危患者组（定义为无糖尿病且基线血清肌酐≤1.8 mg/dL的患者）进行比较，未显示阿那立肽给药有有益作用。总之，在放射性造影检查前及检查期间静脉注射阿那立肽并不能降低已存在慢性肾衰竭患者（无论有无糖尿病）的RCIN发生率。
