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一项针对造影剂肾病高危患者预防措施的前瞻性随机试验:P.R.I.N.C.E. 研究结果。放射性造影剂所致肾病的预防临床评估。

A prospective randomized trial of prevention measures in patients at high risk for contrast nephropathy: results of the P.R.I.N.C.E. Study. Prevention of Radiocontrast Induced Nephropathy Clinical Evaluation.

作者信息

Stevens M A, McCullough P A, Tobin K J, Speck J P, Westveer D C, Guido-Allen D A, Timmis G C, O'Neill W W

机构信息

William Beaumont Hospital, Royal Oak, Michigan, USA.

出版信息

J Am Coll Cardiol. 1999 Feb;33(2):403-11. doi: 10.1016/s0735-1097(98)00574-9.

DOI:10.1016/s0735-1097(98)00574-9
PMID:9973020
Abstract

OBJECTIVES

This study was done to test the hypothesis that a forced diuresis with maintenance of intravascular volume after contrast exposure would reduce the rate of contrast-induced renal injury.

BACKGROUND

We have previously shown a graded relationship with the degree of postprocedure renal failure and the probability of in-hospital death in patients undergoing percutaneous coronary intervention. Earlier studies of singular prevention strategies (atrial natriuretic factor, loop diuretics, dopamine, mannitol) have shown no clear benefit across a spectrum of patients at risk.

METHODS

A prospective, randomized, controlled, single-blind trial was conducted where 98 participants were randomized to forced diuresis with intravenous crystalloid, furosemide, mannitol (if pulmonary capillary wedge pressure <20 mm Hg), and low-dose dopamine (n = 43) versus intravenous crystalloid and matching placebos (n = 55).

RESULTS

The groups were similar with respect to baseline serum creatinine (2.44+/-0.80 and 2.55+/-0.91 mg/dl), age, weight, diabetic status, left ventricular function, degree of prehydration, contrast volume and ionicity, and extent of peripheral vascular disease. The forced diuresis resulted in higher urine flow rate (163.26+/-54.47 vs. 122.57+/-54.27 ml/h) over the 24 h after contrast exposure (p = 0.001). Two participants in the experimental arm versus five in the control arm required dialysis, with all seven cases having measured flow rates <145 ml/h in the 24 h after the procedure. The mean individual change in serum creatinine at 48 h, the primary end point, was 0.48+/-0.86 versus 0.51+/-0.87, in the experimental and control arms, respectively, p = 0.87. There were no differences in the rates of renal failure across six definitions of renal failure by intent-to-treat analysis. However, in all participants combined, the rise in serum creatinine was related to the degree of induced diuresis after controlling for baseline renal function, r = -0.36, p = 0.005. The rates of renal failure in those with urine flow rates greater than 150 ml/h in the postprocedure period were significantly lower, 8/37 (21.6%) versus 28/61 (45.9%), p = 0.03.

CONCLUSIONS

Forced diuresis with intravenous crystalloid, furosemide, and mannitol if hemodynamics permit, beginning at the start of angiography provides a modest benefit against contrast-induced nephropathy provided a high urine flow rate can be achieved.

摘要

目的

本研究旨在验证以下假设,即造影剂暴露后通过强制利尿并维持血管内容量可降低造影剂诱导的肾损伤发生率。

背景

我们之前已经表明,在接受经皮冠状动脉介入治疗的患者中,术后肾衰竭程度与院内死亡概率呈分级关系。早期关于单一预防策略(心房利钠因子、袢利尿剂、多巴胺、甘露醇)的研究表明,在各类有风险的患者中未显示出明确益处。

方法

进行了一项前瞻性、随机、对照、单盲试验,98名参与者被随机分为两组,一组接受静脉输注晶体液、呋塞米、甘露醇(如果肺毛细血管楔压<20 mmHg)和小剂量多巴胺进行强制利尿(n = 43),另一组接受静脉输注晶体液及匹配的安慰剂(n = 55)。

结果

两组在基线血清肌酐(2.44±0.80和2.55±0.91 mg/dl)、年龄、体重、糖尿病状态、左心室功能、预水化程度、造影剂体积和离子性以及外周血管疾病程度方面相似。造影剂暴露后24小时内,强制利尿组的尿流率更高(163.26±54.47 vs. 122.57±54.27 ml/h)(p = 0.001)。试验组有2名参与者需要透析,而对照组有5名,所有7例在术后24小时内测量的尿流率均<l45 ml/h。主要终点48小时时血清肌酐的个体平均变化,试验组为0.48±0.86,对照组为0.51±0.87,p = 0.87。意向性分析显示,在六种肾衰竭定义下,肾衰竭发生率无差异。然而,在所有参与者中,在控制基线肾功能后,血清肌酐的升高与诱导利尿程度相关,r = -0.36,p = 0.005。术后尿流率大于150 ml/h者的肾衰竭发生率显著更低,分别为8/37(21.6%)和28/61(45.9%),p = 0.03。

结论

如果血流动力学允许,在血管造影开始时即开始用静脉晶体液、呋塞米和甘露醇进行强制利尿,只要能实现高尿流率,对造影剂诱导的肾病有一定益处。

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