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柠檬酸钾溶液预防慢性肾脏病患者择期冠状动脉成形术或血管造影术所致造影剂肾病的双盲随机临床试验

Prevention of Contrast-induced Nephropathy in Patients with Chronic Kidney Disease Undergoing Elective Coronary Angioplasty or Angiography with Sodium Potassium Citrate Solution, a Double Blind Randomized Clinical Trial.

作者信息

Ghorbani Ali, Yazdankhah Saeed, Adel Mohamad Hasan, Tabesh Hamed, Sattari Ali Reza, Sattari Shahab Aldin, Heybar Habib, Madjidi Shahla

机构信息

1Chronic Renal Failure Research Center, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

出版信息

Iran J Kidney Dis. 2019 May;13(3):182-190.

Abstract

INTRODUCTION

Contrast-induced nephropathy (CIN) is a frequent complication of contrast exposure. A recent study suggested that Na/K citrate might have a preventive role. We investigated the efficacy of Na/K citrate to prevent CIN in patients with renal dysfunction undergoing coronary intervention.

METHODS

The randomized, double-blind, placebo-controlled trial included 201 patients with estimated creatinine clearance < 90 mL/ min, randomized to receive oral Na/K citrate plus saline infusion (treatment group, 104 patients) or oral water plus saline infusion (placebo group, 97 patients). CIN was defined as an absolute increase of serum creatinine ≥ 0.5 mg/dL or a relative increase ≥ 25% or a relative decrease of estimated GFR ≥ 25% within 5 days.

RESULTS

CIN occurred in 22 patients (12.29%); 10 (11%) in treatment group and 12 (13.6%) in placebo group (P > .05). Post-exposure Cr values were not significantly different between the two groups (1.18 ± 0.28 mg/dL in the placebo vs. 1.15 ± 0.29 mg/dL in the treatment group, P > .05). CIN-negative patients in the treatment group showed a significantly higher increase in urine pH than that of CIN-positive patients (1.642 ± 0.577 vs. 1.20 ± 0.422, P < .05).

CONCLUSION

Na/K citrate solution is not effective for prophylaxis of CIN in patients with renal dysfunction. However, a probable preventive effect might exist in a subgroup of patients with at least 1.6 units increase in urine pH values following Na/K citrate administration.

摘要

引言

造影剂肾病(CIN)是造影剂暴露常见的并发症。最近一项研究表明,枸橼酸钾钠可能具有预防作用。我们研究了枸橼酸钾钠对接受冠状动脉介入治疗的肾功能不全患者预防CIN的疗效。

方法

这项随机、双盲、安慰剂对照试验纳入了201例估算肌酐清除率<90 mL/min的患者,随机分为口服枸橼酸钾钠加生理盐水输注组(治疗组,104例患者)或口服水加生理盐水输注组(安慰剂组,97例患者)。CIN定义为血清肌酐绝对值增加≥0.5 mg/dL或相对增加≥25%,或估算肾小球滤过率(GFR)在5天内相对降低≥25%。

结果

22例患者(12.29%)发生CIN;治疗组10例(11%),安慰剂组12例(13.6%)(P>.05)。两组造影剂暴露后的肌酐值无显著差异(安慰剂组为1.18±0.28 mg/dL,治疗组为1.15±0.29 mg/dL,P>.05)。治疗组中未发生CIN的患者尿pH值升高显著高于发生CIN的患者(1.642±0.577 vs. 1.20±0.422,P<.05)。

结论

枸橼酸钾钠溶液对肾功能不全患者预防CIN无效。然而,在服用枸橼酸钾钠后尿pH值至少升高1.6个单位的亚组患者中可能存在预防作用。

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