药物诱导的肝损伤的新生物标志物
Christopher Humphries1,2, James W Dear1,2
1Pharmacology, Toxicology and Therapeutics, Centre for Cardiovascular Sciences, University of Edinburgh, The Queens Medical Research Institute, Edinburgh, UK.
Clinical toxicology (Philadelphia, Pa.)
|September 28, 2023
概括
新的生物标志物有望比目前的方法更早,更准确地检测药物诱导性肝损伤 (DILI). 这些新型生物标志物可以通过提供更好的诊断和预后信息来改善患者的治疗结果,并简化药物开发.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 毒理学 毒理学 毒理学
- 生物标志物发现发现
背景情况:
- 药物诱导性肝损伤 (DILI) 在临床实践和药物开发中构成了重大挑战.
- 目前用于DILI的生物标志物,如氨酸转移酶和胆红素,在特异性和预后能力方面存在局限性.
- 全球正在努力识别和验证新的生物标志物,得到生物标志物资格认证的既定监管途径的支持.
研究的目的:
- 提供对DILI机制的全面概述.
- 讨论DILI新兴的新生物标志物.
- 突出最近在药物开发和临床实践中识别,验证和应用这些生物标志物的进展.
主要方法:
- 审查关于DILI机制和生物标志物的现有文献.
- 讨论主要的候选新生物标记物,包括细胞克拉丁-18,谷氨酸脱酶和microRNA-122.
- 对将新生物标志物转化为常规临床使用的潜在应用和挑战的分析.
主要成果:
- 已经确立的生物标志物,如氨酸转移酶缺乏DILI的特异性和预后价值.
- 一些新的生物标志物,包括细胞克拉丁-18,谷氨酸脱酶和microRNA-122,正在成为有前途的候选者.
- 新的生物标志物可能有助于早期DILI检测,氨酸转移酶水平的解释,以及临床试验剂量升级决策.
结论:
- 新型生物标志物为早期和更准确的DILI检测和风险分层提供了潜力.
- 通过强大的试验进行临床验证对于广泛采用新生物标志物至关重要.
- 在成本,发病率或死亡率方面展示明确的好处对于新型DILI生物标志物的常规使用至关重要.
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