NEJM:碳酸氢钠和乙酰半胱氨酸对造影后AKI的预防效果如何?

2017-11-14 xing.T MedSci原创

由此可见,在进行血管造影高并发症风险的患者中,静脉注射碳酸氢钠相比于静脉注射氯化钠或口服乙酰半胱氨酸相比安慰剂对于预防死亡、需要透析或90天肾功能持续下降或用于预防造影相关的急性肾损伤方面并没有显著的益处。

静脉注射碳酸氢钠和口服乙酰半胱氨酸被广泛用于预防对比剂肾病(对比剂所致的急性肾损伤)和相关的不良后果,但无确切的证据来证明其疗效。最近,顶级医学期刊NEJM上针对这一问题发表了一篇研究文章。  


研究人员采用2×2因子设计,就接受血管造影的5177名肾脏并发症高危患者随机分配给予静脉注射碳酸氢钠或静脉滴注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,有4993名受试者被纳入改良的意向治疗分析。该研究的主要终点为死亡、需要透析或90天血清肌酐水平持续上升至少50%的复合终点。造影剂相关的急性肾损伤是次要终点。 

研究者在预先指定的中期分析后停止了试验。对于主要终点,碳酸氢钠和乙酰半胱氨酸之间没有相互作用(P=0.33)。在碳酸氢钠组的2511例受试者中有110例(4.4%)受试者发生了主要终点,氯化钠组的2482例受试者中有116例(4.7%)受试者发生了主要终点(比值比为0.93,95%可信区间[CI]为0.72-1.22; P=0.62);乙酰半胱氨酸组的2495例受试者中有114例(4.6%)受试者发生了主要终点,安慰剂组的2498例受试者中有112例(4.5%)受试者发生了主要终点(比值比为1.02,95%CI为0.78-1.33; P=0.88)。造影剂相关急性肾损伤的发生率组间没有显著差异。  

由此可见,在进行血管造影高并发症风险的患者中,静脉注射碳酸氢钠相比于静脉注射氯化钠或口服乙酰半胱氨酸相比安慰剂对于预防死亡、需要透析或90天肾功能持续下降或用于预防造影相关的急性肾损伤方面并没有显著的益处。

梅斯医学点评:

碳酸氢钠和乙酰半胱氨酸用于对比剂肾病的预防,争议已很多年。有关NAC的作用,在此前很多研究中都已证实并无实际作用。而碳酸氢钠研究相对较少,在临床上一般认为只要充分水化,就可以减少对比剂肾病的发生。
在中国韩雅玲院士发现他汀具有显著的保护对比剂肾病后(ESC 2013:韩雅玲教授发现瑞舒伐他汀可显著降低DM合并慢性肾病患者的对比剂急性肾损伤风险),他汀已广泛应用,AKI的发生已经大幅度下降,从过去报道的7%-25%,到现在5%以内。此时,如果采用他汀进行预防以后,象NAC,水化等是否还具有“保护”作用,就更为存疑了。
同时,这个研究进一步确认了碳酸氢钠和NAC也不存在协同作用。通过本研究,基本可以否认碳酸氢钠和NAC在对比剂肾病中的重要作用了。当前存在的科学问题是,还存在5%左右的对比剂肾病,如何进一步降低?是通过改变对比剂,还是加用新型的具有预防作用的药物?这是值得探索的,但是研究的难度会越来越大。
同样,这么一个老话题,为什么能发表NEJM呢,有以下几个原因:(1)析因设计,这是巧妙的,不仅回答两种方法是否有用,还可以回答二者是否存在交互作用。(2)老问题在新环境下重新审视。在今天,他汀广泛应用的前提下,过去一些“保护”方式是否仍然有效,这就是本研究的出发点。如果没有效果的话,其实可以抛弃了,是应该研究新的保护策略了,不必要过去这些旧的方法上下工夫,也节约了临床PCI的时间。

原始出处:

Steven D. Weisbord,et al. Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine.NEJM.2017. http://www.nejm.org/doi/full/10.1056/NEJMoa1710933

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    2017-11-16 智慧医人
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    2017-11-16 sodoo
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    2017-11-14 lovetcm

    梅斯医学的小编怎么这么厉害.啥都会.点评的这么精彩

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