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创伤性脑损伤. 在孤儿病理学中重新考虑药理学临床试验

Roberto Imberti¹

¹Direzione Scientifica, Phase I Clinical Trials Unit and Experimental Therapy, Fondazione IRCCS Policlinico, San Matteo, Pavia, Italy.

Expert review of clinical pharmacology

|August 8, 2025

概括

开发用于创伤性脑损伤 (TBI) 的新药需要改变范式. 探索超越传统措施的替代临床终点可能会鼓励制药公司对TBI治疗的投资.

科学领域:

神经科学是一个神经科学.
药理学药理学是指药理学的学科.
临床试验临床试验

背景情况:

创伤性脑损伤 (TBI) 每年影响全球超过5000万人,严重病例导致高死亡率和残疾.
目前,没有经批准的药理疗法可以最终改善人类TBI患者的治疗结果,这导致制药行业对投资不情愿.

研究的目的:

审查TBI急性阶段的药理学试验.
讨论治疗效率不足的原因.
建议改变TBI药物开发的研究范式.

主要方法:

对急性TBI中药理学试验的PubMed索引研究的综述.
分析导致治疗无效的因素.
讨论其他临床终点.

主要成果:

目前对TBI的药理学试验已经显示出持续缺乏疗效.
在TBI人口的异质性和随机化挑战研究设计的局限性.
目前的临床终点太变化了,很难可靠地评估治疗效果.

结论:

持续寻找TBI药理疗法是必不可少的.
需要改变范式,接受随机化和分层化对于TBI患者同质性来说是不够的.
采用替代的,病理生理终点 (例如,ICP,生物标志物,MRI) 可能会激励对TBI的药物开发.

关键词:

创伤性脑损伤是一种创伤性脑损伤.临床试验的设计.神经保护药物神经保护药物预测模型的预测模型.随机化是一种随机化.

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