单克隆抗体序贯治疗视神经脊髓炎谱系疾病的药物遴选综合评价

Comprehensive evaluation of drug selection for sequential treatment of neuromyelitis optica spectrum disorders with monoclonal antibodies

关键词:  单克隆抗体  药物综合评价  视神经脊髓炎谱系疾病  合理用药

Key words:  monoclonal antibody  drug comprehensive evaluation  neuromyelitis optica spectrum disorders (NMOSD)  rational drug use

摘要:

目的 对5种单克隆抗体序贯治疗视神经脊髓炎谱系疾病进行临床综合评价，为药物遴选提供参考。方法 根据《中国医疗机构药品评价与遴选快速指南（第二版）》，结合各药品说明书、临床指南、文献查询等相关信息，从药学特性、有效性、安全性、经济性及其他属性5个维度，对5种单克隆抗体（利妥昔单抗、萨特利珠单抗、伊奈丽珠单抗、依库珠单抗及托珠单抗）序贯治疗视神经脊髓炎谱系疾病进行赋分与评价。结果 对纳入评价的单克隆抗体药物综合评分：利妥昔单抗71.05分，依库珠单抗68.11分，萨特丽珠单抗67.67，伊奈利珠单抗65.28，托珠单抗58.09。依库珠单抗、萨特丽珠单抗、伊奈利珠单抗在不同属性方面各有优势，然而经济性方面劣于利妥昔单抗。结论 利妥昔单抗属于强推荐药品，推荐保留在医疗机构药品使用目录；依库珠单抗、萨特丽珠单抗、伊奈利珠单抗可根据患者人群特点及是否有可替代药品决定是否引进；托珠单抗不建议用于序贯治疗视神经脊髓炎谱系疾病。

Abstract:

OBJECTIVE The clinical evaluation of 5 monoclonal antibodies in sequential treatment of neuromyelitis optica spectrum disorders was carried out to provide reference for clinical drug decision. METHODS According to 《the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (the Second Edition)》, combined with drug instructions, clinical treatment guidelines, and relevant literature, Five monoclonal antibodies (Rituximab, Satralizumab, Inebilizumab, Eculizumab and Tocilizumab) were assigned and evaluated from five dimensions of pharmaceutical properties, efficacy, safety, economy and other attributes. RESULTS The comprehensive scores for the monoclonal antibody drugs evaluated are as follows: Rituximab received 71.05 points, Eculizumab 68.11 points, Satralizumab 67.67 points, Inebilizumab 65.28 points, and Tocilizumab 58.09 points. Eculizumab, Satralizumab, and Inebilizumab each excel in different attributes, but they lag behind Rituximab in terms of economic viability. CONCLUSION Rituximab is a highly recommended drug and is suggested to be kept in the drug usage catalog of medical institutions; Eculizumab, Satralizumab, and Inebilizumab may be introduced or not based on the characteristics of the patient population and the availability of alternative drugs; Tocilizumab is not recommended for the sequential treatment of neuromyelitis optica spectrum disorders.