药物诱导的肝损伤与新兴的癌症疗法有关
Piotr Chodup1, Sophia L Samodelov1, Michele Visentin1
1Department of Clinical Pharmacology and Toxicology, University Hospital Zürich, University of Zürich, Zürich, Switzerland.
概括
针对性疗法和免疫疗法等新型癌症疗法显示出希望,但了解它们罕见的严重肝损伤 (肝毒性) 风险对于药物开发至关重要. 这些救命治疗需要量身定制的安全评估.
科学领域:
- 肝病学和瘤学 药物开发 药物开发
背景情况:
- 向疗法和免疫疗法为癌症治疗提供了更好的疗效和安全性.
- 虽然肝检测异常在酶抑制剂和免疫治疗中很常见,但与化疗相比,严重的肝毒性很少见.
- 由于新型瘤疗法导致严重肝毒性的机制和危险因素尚不清楚,复杂化了药物诱导性肝损伤 (DILI) 风险评估.
研究的目的:
- 描述有关新型瘤疗法的肝毒性流行病学和临床特征的当前知识.
- 总结在药物开发过程中评估DILI风险的工具,突出新癌症治疗的局限性.
- 引入新兴工具,以优化安全评估,并获得对DILI的机制性见解.
主要方法:
- 针对性治疗和免疫疗法相关的肝毒性现有文献的综述.
- 在临床前和临床药物开发中对DILI风险评估现有工具和新兴方法的分析.
- 讨论瘤学安全性评估的独特考虑,因为它可能有救命的益处.
主要成果:
- 新型瘤学药物的严重肝毒性比化疗更少,但需要仔细监测.
- 当前的DILI评估工具在应用于新型癌症疗法时存在局限性.
- 新兴工具为更好地理解和预测瘤药物开发中的DILI提供了希望.
结论:
- 针对性安全评估对于新瘤疗法至关重要,考虑到癌症患者的益处风险平衡.
- 需要对DILI机制,频率,严重程度和预后有更深入的了解.
- 通过改进DILI评估来简化药物开发和监管过程对于患者安全至关重要.
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