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[NEJM最新论文]:碳酸氢钠与乙酰半胱氨酸无助于预防造影剂肾病
2018年03月07日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE

Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine

Steven D. Weisbord, Martin Gallagher, Hani Jneid, et al

N Engl J Med 2018; 378:603-614

DOI: 10.1056/NEJMoa1710933

Abstract

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.

静脉碳酸氢钠及口服乙酰半胱氨酸广泛用于预防血管造影后急性肾损伤及其他相关不良预后,但缺乏确切证据证实其疗效。

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名择期接受血管造影的肾脏并发症高危患者随机分为静脉输注1.26%碳酸氢钠或0.9%氯化钠溶液,以及5天口服乙酰半胱氨酸或安慰剂;其中,4993名患者纳入修订后意向治疗分析。主要预后终点为复合终点,包括90天内死亡,需要透析治疗,或血清肌酐水平较基线持续升高至少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.

在预先确定的中期分析后,赞助方终止了临床试验。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%)及氯化钠组2482名患者中116名(4.7%)发生主要预后终点事件(比数比 0.93;95%可信区间 [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%) 发生主要预后终点事件(比数比 1.02;95% CI, 0.78 to 1.33; P=0.88)。造影剂相关急性肾损伤发生率没有明显的组间差异。

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.)

在接受血管造影发生肾脏并发症的高危患者,与静脉输注氯化钠或口服安慰剂相比,静脉输注碳酸氢钠及口服乙酰半胱氨酸不能预防90天内死亡、需要血液透析治疗或肾功能持续下降,也不能预防造影剂相关急性肾损伤。

 

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