儿童心脏手术中的custodiol与血液心脏:一个随机对照试验
Ahmed F Elmahrouk1,2, Mohammad S Shihata3, Osman O Al-Radi3,4
1Cardiothoracic Surgery Department, King Faisal Specialist Hospital and Research Centre,, MBC J-16, P.O. Box: 40047, 21499, Jeddah, Saudi Arabia. A_marouky@hotmail.com.
European journal of medical research
|October 5, 2023
概括
在儿科心脏外科手术中,Custodiol心脏与基于血液的心脏在心肌保护方面同样有效. 这项随机试验在两种方法之间的关键结果中没有发现显著差异.
科学领域:
- 心血管外科心血管外科
- 儿童心脏病学 儿童心脏病学
- 心脏的解决方案 心脏的解决方案
背景情况:
- 基于血液的心脏是儿科心脏手术中心肌保护的标准.
- 卡斯托迪奥尔 (histidine-tryptophan-ketoglutarate) 是一种可以治疗心脏的替代药物.
- 需要对Custodiol与血液性心脏的比较有效性进行研究.
研究的目的:
- 为了测试Custodiol心脏是否不劣于基于血液的心脏,用于儿童心脏手术中的心肌保护.
- 评估Custodiol在接受心脏手术的儿科患者的安全性和有效性.
- 为了比较Custodiol和基于血液的心脏的临床结果.
主要方法:
- 进行了一项随机对照试验,对结果进行了盲目评估.
- 接受心脏手术的儿科患者有资格接受心肺旁路手术,但紧急情况除外.
- 主要结局是30天死亡率,长时间的ICU住院或需要干预的心律失常的组合.
主要成果:
- 在Custodiol (60.75%) 和血液心症 (59.66%) 组 (P=0.87) 之间的复合初级终点中没有发现显著差异.
- 二级终点包括住院,内性得分,热素水平和心室功能没有显著差异.
- 长期生存分析 (中位数随访32.75个月) 也显示,两组之间没有差异.
结论:
- 在儿童心脏外科手术中,Custodiol心脏显示出对基于血液的心脏进行心肌保护的非劣势.
- 这些发现支持Custodiol作为这种患者群体中血液型心脏的可行替代品.
- 进一步的研究可能会探索特定的子组或长期的功能结果.
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