低毒性缺血性脑病变后的早期和延长性红素单疗法:一个多中心双盲试验随机对照试验
Reema Garegrat1, Atul Londhe2, Swati Manerkar3
1Centre for Perinatal Neuroscience, Department of Brain Sciences, Imperial College London, London, UK r.garegrat@imperial.ac.uk.
概括
早期的红色素单疗是可行的治疗低毒性缺血性脑病变 (HIE) 在南亚新生儿. 这项试点研究显示了降低死亡率和脑损伤的潜力,支持进一步研究HIE治疗.
科学领域:
- 新生儿神经学 新生儿神经学
- 儿科重症监护中心儿童重症监护中心
- 药理学 药理学是指药理学的学科.
背景情况:
- 低毒性缺血性脑病变 (HIE) 对新生儿构成重大威胁,特别是在南亚.
- 早期干预策略对于改善HIE结果至关重要.
- 素正在研究其神经保护性质.
研究的目的:
- 评估早期和延长期对HIE新生儿进行红素单一治疗的可行性.
- 评估这种治疗方法在南亚环境中的安全性和有效性.
- 确定减少脑损伤和死亡率的潜力.
主要方法:
- 在南亚的八个新生儿病房中进行了一项双盲试点随机对照试验.
- 符合条件的新生儿 (怀孕36周以上) 患有中度至重度的HIE,在出生后6小时内接受红素 (每天500个单位/公斤) 或安慰剂,持续9天.
- 脑损伤在2周大时使用MRI进行评估.
主要成果:
- 招募和药物管理是可行的,注册了50名新生儿.
- 与安慰剂相比,红素组 (19%) 的出院死亡率较低 (46%),特别是中度HIE (13%vs40.9%).
- 虽然一些受伤模式显示出有利于红色素的趋势,但红色素组中的两名新生儿患有鼻静脉血栓症.
结论:
- 早期和延长的红素单疗似乎是南亚HIE管理的可行方案.
- 观察到的降低死亡率的趋势需要进一步调查红色素的疗效.
- 仔细监测潜在的不良事件,如鼻静脉血栓形成是必不可少的.
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