在患有急性不补偿心力衰竭的患者中,尼西里蒂德对功能恶化的风险

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Jonathan D Sackner-Bernstein¹, Hal A Skopicki, Keith D Aaronson

¹Clinical Scholars Program, Division of Cardiology, North Shore University Hospital, Manhasset, NY 11030, USA. jonathansb@yahoo.com

|March 23, 2005

概括

对急性不补偿性心力衰竭 (ADHF) 的内西利治疗显著增加了恶化功能的风险. 需要进一步的试验来了解这是否是一种血液动力学效应或损伤.

科学领域:

心脏病学心脏病学
腎臟病學 (nephrology) 是一種醫學專業.
药理学药理学是指药理学的学科.

背景情况:

功能是急性不补偿性心力衰竭 (ADHF) 患者的关键预后指标.
尼西里提德是ADHF的治疗选择,但其对脏的影响需要彻底调查.

研究的目的:

为了研究尼西里提德在ADHF患者的效应.
为了比较尼西里和对照疗法之间的功能恶化的风险和需要透析的风险.

主要方法:

在ADHF患者中,随机临床试验的元分析比较尼西里提德与安慰剂或活性对照.
包括FDA文件在内的电子和手动搜索被用于识别相关研究.
恶化功能被定义为血清肌素>0.5 mg/dL的增加.

主要成果:

与对照疗法相比,在FDA批准的剂量 (<或=0.03微克 x 千克-1) x 分钟-1) 中,涅西里提德显著增加了功能恶化的风险 (RRH),1.54;95% CI,1.19至1.98;P=0.001).
即使是低剂量的内西里提德 (<或=0.015微克克公斤{-1) x分钟{-1)) 也显著增加了风险.
在涅西里提德和对照组之间没有观察到透析需要的显著差异.

结论:

在ADHF患者中,纳西里提德的使用与功能恶化的风险显著增加有关.
导致功能恶化的确切机制 (血液动力学效应与损伤) 尚不清楚.
功能变化的预后意义需要在强大的临床试验中进一步调查.

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