肿瘤药学2025，Vol.15Issue(2)：237-244,8.DOI:10.3969/j.issn.2095-1264.2025.02.12
以奥妥珠单抗为基础的联合方案治疗B细胞非霍奇金淋巴瘤的临床综合评价
Comprehensive clinical evaluation of obinutuzumab-based regimen in treatment of B-cell non-Hodgkin lymphoma
摘要
Abstract
Objective To evaluate the clinical value of obinutuzumab-based combination regimens in treating B-cell non-Hodgkin lymphoma(B-NHL),and to provide evidence for rational clinical drug use.Methods Following the Guide-lines for Comprehensive Clinical Evaluation of Drugs(Trial Version 2021),a rapid health technology assessment was con-ducted.Data from drug instructions,the National Medical Products Administration,and other professional platforms were systematically integrated,as well as relevant literature and economic evaluation evidence of obinutuzumab-based combina-tion regimens in the treatment of B-NHL.The comprehensive evaluation was conducted from six dimensions of safety,effec-tiveness,economy,innovation,suitability and accessibility.Results In terms of effectiveness,compared with rituximab-based regimen,obinutuzumab-based regimen significantly prolonged the progression-free survival(PFS)in newly diag-nosed or relapsed/refractory B-NHL patients,though no significant difference in overall survival(OS)was observed.In terms of safety,the obinutuzumab-based regimen exhibited higher incidences of overall adverse events(AEs),grade≥3 AEs,infusion-related reactions,neutropenia and thrombocytopenia than the rituximab-based regimen.Pharmaco-economically,obinutuzumab-based regimens showed economic advantages across countries despite variations in willing-ness-to-pay thresholds.In terms of innovation,obinutuzumab is the first Fc-glycosylation modified humanized type Ⅱanti-CD20 monoclonal antibody globally approved.Its suitability was enhanced by fixed-dose administration without body surface area(BSA)-adjusted dosing.In accessibility,obinutuzumab has been included in China's National Medical Insur-ance Negotiated Drug List,demonstrating high regional and market coverage with improved affordability and availability.Conclusion Obinutuzumab-based regimen outperform rituximab-based regimen in efficacy and cost-effectiveness in the treatment of newly diagnosed or relapsed/refractory B-NHL,albeit with higher AE rates.As the first-in-class humanized type Ⅱ anti-CD20 monoclonal antibody,obinutuzumab exhibits superior innovation,suitability,and accessibility.关键词
奥妥珠单抗/非霍奇金淋巴瘤/临床综合评价/卫生技术评估Key words
Obinutuzumab/B-cell non-Hodgkin lymphoma/Comprehensive clinical evaluation/Health technology assessment分类
药学引用本文复制引用
赵新才,宋陆茜,陈娟,徐嵘,郭澄,张剑萍..以奥妥珠单抗为基础的联合方案治疗B细胞非霍奇金淋巴瘤的临床综合评价[J].肿瘤药学,2025,15(2):237-244,8.基金项目
上海市医院协会临床药事管理专业委员会抗肿瘤药物临床应用管理项目(No.YS2021001). （No.YS2021001）
