Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine

BACKGROUND 背景

Intravenous sodium bicarbonate and oral acetylcysteine are widely used to prevent acute kidney injury and associated adverse outcomes after angiography without definitive evidence of their efficacy.

静脉碳酸氢钠和口服乙酰半胱氨酸广泛用于预防血管造影后的急性肾损伤及其相关不良预后，但并无确切证据支持其疗效。

METHODS 方法

Using a 2-by-2 factorial design, we randomly assigned 5177 patients at high risk for renal complications who were scheduled for angiography to receive intravenous 1.26% sodium bicarbonate or intravenous 0.9% sodium chloride and 5 days of oral acetylcysteine or oral placebo; of these patients, 4993 were included in the modified intention-to-treat analysis. The primary end point was a composite of death, the need for dialysis, or a persistent increase of at least 50% from baseline in the serum creatinine level at 90 days. Contrast-associated acute kidney injury was a secondary end point.

我们采用2x2析因设计，将5177名择期进行血管造影且发生肾脏并发症的高危患者随机分为静脉1.26%碳酸氢钠或静脉0.9%氯化钠，以及口服乙酰半胱氨酸或安慰剂5天；在这些患者中，4993名纳入修订后意向治疗分析。主要预后终点为复合终点，包括死亡，需要透析或90天时血清肌酐水平较基础值持续升高至少50%。造影剂相关急性肾损伤为次要终点。

RESULTS 结果

The sponsor stopped the trial after a prespecified interim analysis. There was no interaction between sodium bicarbonate and acetylcysteine with respect to the primary end point (P=0.33). The primary end point occurred in 110 of 2511 patients (4.4%) in the sodium bicarbonate group as compared with 116 of 2482 (4.7%) in the sodium chloride group (odds ratio, 0.93; 95% confidence interval [CI], 0.72 to 1.22; P=0.62) and in 114 of 2495 patients (4.6%) in the acetylcysteine group as compared with 112 of 2498 (4.5%) in the placebo group (odds ratio, 1.02; 95% CI, 0.78 to 1.33; P=0.88). There were no significant between-group differences in the rates of contrast-associated acute kidney injury.

在预先计划的中期分析后，赞助方终止了试验。碳酸氢钠和乙酰半胱氨酸对主要预后终点没有交互作用(P=0.33)。碳酸氢钠组2511名患者中110名 (4.4%) 满足主要终点，氯化钠组2482名患者中116名 (4.7%) 满足主要预后终点（比数比0.93; 95% 可信区间l [CI], 0.72 to 1.22; P=0.62），乙酰半胱氨酸组2495名患者中114名 (4.6%) 及安慰剂组2498名患者中112名 (4.5%) 满足主要终点（比数比1.02; 95% CI, 0.78 to 1.33; P=0.88）。两组患者造影剂相关急性肾损伤发生率没有显著差异。

CONCLUSIONS 结论

Among patients at high risk for renal complications who were undergoing angiography, there was no benefit of intravenous sodium bicarbonate over intravenous sodium chloride or of oral acetylcysteine over placebo for the prevention of death, need for dialysis, or persistent decline in kidney function at 90 days or for the prevention of contrast-associated acute kidney injury. (Funded by the U.S. Department of Veterans Affairs Office of Research and Development and the National Health and Medical Research Council of Australia; PRESERVE ClinicalTrials.gov number, NCT01467466.)

在接受血管造影且肾脏并发症的高危患者，在预防死亡、透析需求或90天时肾功能持续降低，或预防造影剂相关急性肾损伤方面，静脉碳酸氢钠与静脉氯化钠相比并无优势，口服乙酰半胱氨酸与安慰剂相比亦无优势。