碳酸氢钠加等渗盐水与盐水用于预防接受冠状动脉造影患者的对比剂肾病：一项随机对照试验

Sodium bicarbonate plus isotonic saline versus saline for prevention of contrast-induced nephropathy in patients undergoing coronary angiography: a randomized controlled trial.

作者信息

Vasheghani-Farahani Ali, Sadigh Gelareh, Kassaian Seyed Ebrahim, Khatami Seyed Mohammad Reza, Fotouhi Akbar, Razavi Seyed Amir Hossein, Mansournia Mohammad Ali, Yamini-Sharif Ahmad, Amirzadegan Alireza, Salarifar Mojtaba, Sadeghian Saeed, Davoodi Gholamreza, Borumand Mohammad Ali, Esfehani Farah Aiatollahzade, Darabian Sirous

机构信息

Department of Cardiology, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Am J Kidney Dis. 2009 Oct;54(4):610-8. doi: 10.1053/j.ajkd.2009.05.016. Epub 2009 Jul 19.

DOI:10.1053/j.ajkd.2009.05.016

PMID:19619921

Abstract

BACKGROUND

There is controversy about the prophylactic measures proposed for the prevention of contrast-induced nephropathy (CIN). We aim to compare the efficacy of the combination of sodium bicarbonate and isotonic saline and that of isotonic saline alone in preventing CIN.

STUDY DESIGN

Randomized double-blind controlled trial.

SETTING & PARTICIPANTS: 265 consecutive patients 18 years or older with a serum creatinine level of 1.5 mg/dL or greater undergoing elective coronary angiography from August 2007 to June 2008 in Tehran Heart Center, Tehran, Iran.

INTERVENTION

Study participants were randomly assigned to receive either 75 mL of 8.4% sodium bicarbonate added to 1 L of isotonic saline (n = 135) or isotonic saline alone (n = 130) as a bolus of 3 mL/kg for 1 hour before contrast injection, followed by an infusion of 1 mL/kg/h for 6 hours after the procedure.

OUTCOMES & MEASUREMENTS: The primary end point was an absolute (>or=0.5 mg/dL) or relative (>or=25%) increase in serum creatinine level 48 hours after the procedure (CIN).

RESULTS

There were no significant differences between the bicarbonate and saline groups regarding baseline demographic and biochemical characteristics, including baseline serum creatinine level (1.63 +/- 0.32 [SD] versus 1.66 +/- 0.50 mg/dL), baseline glomerular filtration rate (46.4 +/- 12 versus 45.4 +/- 12 mL/min/1.73 m(2)), and baseline urine pH (5.42 +/- 0.6 versus 5.46 +/- 0.8). Nine patients (7.4%) receiving sodium bicarbonate developed CIN as opposed to 7 patients (5.9%) in the saline group, which was not statistically different (odds ratio, 1.26; 95% confidence interval, 0.45 to 3.50; P = 0.6).

LIMITATIONS

The trial did not follow up participants to assess need for dialysis and mortality rate.

CONCLUSION

The combination therapy of sodium bicarbonate plus saline does not offer additional benefits over hydration with saline alone in the prevention of CIN.

摘要

背景

对于预防造影剂肾病（CIN）所提出的预防措施存在争议。我们旨在比较碳酸氢钠与等渗盐水联合使用和单独使用等渗盐水预防CIN的疗效。

研究设计

随机双盲对照试验。

设置与参与者

2007年8月至2008年6月在伊朗德黑兰心脏中心，对265例年龄18岁及以上、血清肌酐水平为1.5mg/dL或更高且接受择期冠状动脉造影的连续患者进行研究。

干预措施

研究参与者被随机分配接受在1L等渗盐水中加入75mL 8.4%碳酸氢钠（n = 135）或仅接受等渗盐水（n = 130），在注射造影剂前作为3mL/kg的推注持续1小时，然后在术后以1mL/kg/h的速度输注6小时。

结果与测量

主要终点是术后48小时血清肌酐水平绝对升高（≥0.5mg/dL）或相对升高（≥25%）（即CIN）。

结果

碳酸氢钠组和盐水组在基线人口统计学和生化特征方面无显著差异，包括基线血清肌酐水平（1.63±0.32[标准差]对1.66±0.50mg/dL）、基线肾小球滤过率（46.4±12对45.4±12mL/min/1.73m²）和基线尿液pH值（5.42±0.6对5.46±0.8）。接受碳酸氢钠治疗的9例患者（7.4%）发生了CIN，而盐水组为7例患者（5.9%），差异无统计学意义（比值比，1.26；95%置信区间，0.45至3.50；P = 0.6）。