"获得正确的剂量" - - 重温这个主题,重点关注生物剂
Diane R Mould1, Richard N Upton1,2
1Projections Research Inc, Phoenixville, Pennsylvania, USA.
Clinical pharmacology and therapeutics
|April 29, 2024
概括
优化生物药物剂量,特别是单克隆抗体 (MAbs),已经得到了改进,但需要进一步关注. 诸如治疗药物监测等策略可以提高治疗的有效性和安全性.
科学领域:
- 药理学 药理学是指药理学的学科.
- 免疫学 免疫学 免疫学
- 药物开发 药物开发
背景情况:
- 在Peck和Cross之后近20年,对生物剂量建议的审查.
- 单克隆抗体 (MAbs) 在批准后显示出混合的临床成功,特别是在炎症性疾病和瘤学中.
- 与MAbs同时使用类固醇和免疫抑制剂复杂化了治疗和安全性.
研究的目的:
- 评估目前的生物剂量状态,专注于单克隆抗体.
- 确定MAb剂量策略的持续挑战和改进领域.
- 探索优化MAb治疗的潜在解决方案,包括标记和监测.
主要方法:
- 对已发表的文献和生物剂量的临床经验的审查.
- 对炎症性疾病和瘤学中单克隆抗体的剂量趋势和结果的分析.
- 评估同时服用药物和抗药抗体 (ADA) 的影响.
主要成果:
- 生物剂量建议的整体改善,证实了更少的药物戒断.
- 由于疾病负担的变化,在炎症性疾病中对MAb疗效和安全性存在持续问题.
- 瘤学中MAbs的过度治疗的可能性,导致成本增加和不良事件.
结论:
- 虽然生物剂量有所改善,但仍然存在挑战,特别是单克隆抗体.
- 产品标签应包括替代剂量策略和治疗药物监测,以实现剂量个性化.
- 需要进一步优化,以改善临床反应,减少抗药抗体发生率,并管理治疗成本.
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