口腔瘤学药物的风险评估和缓解策略 (REMS):增加安全性或进入障碍?
Vincent Harris1, Ming-Hei Tai2
1Department of Pharmacy, Atrium Health Levine Cancer Institute, Charlotte, NC, USA.
概括
许多口腔癌药物会伤害发育中的胎儿,需要特殊的风险评估和缓解策略 (REMS). 目前尚不清楚在REMS中仅限于某些口服瘤治疗药物是否有利于患者.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 甲状腺学 甲状腺学
背景情况:
- 口服瘤治疗药物向快速分裂的细胞,导致潜在的毒性.
- 风险评估和缓解策略 (REMS) 适用于具有已证明胚胎胎毒性的选择性口服瘤学药物.
- 对于有限的口服抗瘤药物子集,REMS的具体益处仍然不确定.
研究的目的:
- 评估风险评估和缓解策略 (REMS) 的必要性和益处,用于已知对胚胎和胎儿有毒性的口服瘤学药物.
- 澄清实施REMS程序的标准,以治疗致性口腔癌.
主要方法:
- 对口服瘤学药物及其原性作用的现有文献的综述.
- 分析目前的风险评估和缓解策略 (REMS) 计划对口服瘤学药物的任务.
- 对胚胎和胎儿毒性数据的比较评估与口服瘤杀伤剂的REMS计划纳入.
主要成果:
- 有相当数量的口服抗瘤药物具有致性潜力.
- 目前,只有很小一部分这些原剂受到REMS计划限制.
- 对于口服瘤学药物及其相关的胚胎胎毒性,包括在REMS中的标准并未得到一致的应用.
结论:
- 目前对口服瘤学药物的风险评估和缓解策略 (REMS) 的应用可能无法完全解决胚胎-胎儿毒性风险的范围.
- 需要进一步调查,以确定所有致病性口服瘤学药物的最佳风险管理策略.
- 基于可靠的胚胎胎毒性数据的REMS标准的标准化对于患者安全至关重要.
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