[关键词]
[摘要]
目的 对5种布鲁顿酪氨酸激酶抑制剂(BTKis)进行量化评估,为医疗机构遴选B细胞淋巴瘤治疗药物提供依据。方法 基于《中国医疗机构药品评价与遴选快速指南(第三版)》,按各药物在国内获批的不同适应证,包括套细胞淋巴瘤(MCL)、慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(SLL/CLL)及华氏巨球蛋白血症(WM),对5种药进行量化评分。结果 泽布替尼在MCL、CLL/SLL和WM适应证的评分分别为81、80和81;阿可替尼与奥布替尼在MCL适应证和CLL/SLL适应证得分接近,均优于伊布替尼。在WM适应证,伊布替尼得74.22分。结论 泽布替尼在3大适应证的评分最高,可作为医疗机构用药目录“强推荐”引进或保留品种,伊布替尼虽可“保留”,但面临更优替代品的挑战。在MCL和CLL/SLL适应证,阿可替尼与奥布替尼为“强推荐”引进目录的适宜选择。匹妥布替尼在MCL中为“弱推荐”,引进需审慎评估其临床不可替代性。
[Key word]
[Abstract]
Objectives A quantitative assessment of five Bruton’s tyrosine kinase inhibitors (BTKis) was conducted to provide evidence for healthcare institutions in selecting drugs for the treatment of B-cell lymphoma. Methods Based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (the Third Edition), five drugs were quantitatively scored according to their different approved indications in China, including mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (SLL/CLL), and Waldenström’s macroglobulinemia (WM). Results The scores for zanubrutinib in MCL, CLL/SLL, and WM were 81, 80, and 81, respectively. Acalabrutinib and orelabrutinib scored similarly for MCL and CLL/SLL indications, both outperforming ibrutinib. For WM indication, ibrutinib scored 74.22. Conclusion Zanubrutinib achieved the highest scores across all three indications and is recommended as a ‘strong recommendation’ for inclusion or retention in institutional drug directories, while ibrutinib may be ‘retained’, it faces challenges from superior alternatives. For MCL and CLL/SLL, acalabrutinib and orelabrutinib are ‘strongly recommended’ as suitable options for inclusion in hospital drug formularies. Pituobtinib is ‘weakly recommended’ for MCL, requiring careful evaluation of its clinical value.
[中图分类号]
R979.1
[基金项目]
国家自然科学基金资助项目(82174065);云南省科技厅社会发展专项-重点研发计划项目(202303AC100025)