新型国产PD-1单抗拓展性应用初步评价方案建立——以派安普利单抗为例-国际医药研究前沿-CSCIED科技核心评价数据库-手机版

新型国产PD-1单抗拓展性应用初步评价方案建立——以派安普利单抗为例

Establishment of a preliminary evaluation plan for the expanded application of a new domesticallyproduced PD-1 mAb——Taking Piamprimab as an example

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DOI	10.12208/j.imrf.20220127
刊名	国际医药研究前沿 International Medical Research Frontier
年，卷(期)	2022, 6(4)
作者	王鹏翀,朱亚宁,史先鹏,雍素云,郝瑞芳,张鹏*,
作者单位	陕西省人民医院药学部陕西西安 ;
摘要	分析派安普利单抗的拓展性应用情况，建立新型国产程序性死亡受体-1（PD-1）单抗的拓展性应用的初步评价方案，为临床应用提供依据和参考。方法收集药品信息和拓展性应用循证证据，确定拓展性应用范围；检索相关指南，对于已在国外获批适应症或已得到指南推荐的拓展性应用予以推荐；筛选已获批适应症或得到指南推荐的其他同类药品，通过可替代性评价给出拓展性应用推荐意见。结果经初步筛选，确定8种拓展性应用；通过检索指南，对派安普利单抗在肝癌、鳞状非小细胞肺癌和鼻咽癌方面的拓展性应用予以推荐，对胃癌方面的应用不予推荐；通过可替代性评价对派安普利单抗头颈鳞癌、小细胞肺癌和胆管癌方面的拓展性应用进行推荐，对非鳞非小细胞肺癌方面的应用不予推荐。结论建立了一种通过指南检索和同类竞品对比从而快速评价新型国产PD-1单抗拓展性应用的初步方案。
Abstract	Objective To analyze the expanded application of piamprilumab, establish a preliminary evalua- tion plan for the expanded application of a new domestic programmed death receptor-1 (PD-1) monoclonal anti- body, and provide basis and reference for clinical application. Methods Collect drug information and evidence- based evidence of extended application to determine the scope of extended application; search relevant guidelines, and recommend extended applications that have been approved in foreign countries or have been recommended by guidelines; screened the approved indications or obtained For other similar drugs recommended by the guideline, recommendations for extended application are given through substitutable evaluation. Results After preliminary screening, 8 expanded applications were identified; through the search guide, the expanded application of piam- prilumab in liver cancer, squamous non-small cell lung cancer and nasopharyngeal carcinoma was recommended, but not in gastric cancer. It is recommended; the expanded application of pianpilimumab in head and neck squamous cell carcinoma, small cell lung cancer, and cholangiocarcinoma is recommended through the evaluation of surrogacy, and the application in non-squamous non-small cell lung cancer is not recommended. Conclusion A preliminary scheme for rapid evaluation of the expandable application of the new domestic PD-1 mAb was established through the guideline search and comparison of similar competing products.
关键词	派安普利单抗；国产PD-1单抗；拓展性应用；可替代性；快速评价
KeyWord	Pienpilimumab; Domestic PD-1 mAb; Expanded Application; Substitutability; Rapid Evaluation
基金项目
页码	12-19

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王鹏翀,朱亚宁,史先鹏,雍素云,郝瑞芳,张鹏*. 新型国产PD-1单抗拓展性应用初步评价方案建立——以派安普利单抗为例 [J]. 国际医药研究前沿. 2022; 6; (4). 12 - 19.

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