摘要
目的 比较4种细胞周期蛋白依赖性激酶4/6(CDK4/6)抑制剂哌柏西利、瑞波西利、阿贝西利和达尔西利联合氟维斯群治疗晚期HR阳性/HER2阴性乳腺癌患者的临床综合价值,为临床用药实践与准入决策提供参考.方法 根据《抗肿瘤药品临床综合评价技术指南》等,从有效性、安全性、经济性、适宜性、可及性、创新性6个维度构建临床综合评价指标体系,汇总相关RCT研究与药物经济性研究,通过网状meta分析比较4种CDK4/6抑制剂联合氟维斯群治疗晚期HR阳性/HER2阴性乳腺癌的安全性与有效性,通过查询各数据库信息综合评价其经济性、适宜性、可及性、创新性.结果 安全性方面,阿贝西利安全性较高;有效性方面,达尔西利较好;经济性方面,阿贝西利更具有优势;适宜性方面,阿贝西利适应证更多、适宜性较高;可及性方面,阿贝西利可获得性与可负担性较好;创新性方面,哌柏西利与达尔西利专利价值更高,阿贝西利作用靶点较广.结论 阿贝西利临床综合价值最高,具有良好的有效性、安全性、经济性、适宜性、可及性、创新性,优于哌柏西利、瑞波西利与达尔西利.
Abstract
Objective To compare the clinical comprehensive value of four CDK4/6 inhibitors,palbociclib,ribociclib,abemaciclib and dalpiciclib,combined with fulvestrant in the treatment of HR+/HER2-advanced breast cancer,and to provide a reference for the clinical practice and access decision-making.Methods According to the Technical Guidelines for Clinical Comprehensive Evaluation of Antineoplastic Drugs,a clinical comprehensive evaluation index system was constructed from six dimensions:efficacy,safety,cost-effectiveness,suitability,accessibility,and innovativeness.Relevant RCT studies and pharmacoeconomic studies were summarized,and a network meta-analysis was performed to assess the safety and effectiveness of the four CDK4/6 inhibitors combined with fluorouracil.Databases were further searched for additional information to assess each drug's cost-effectiveness,suitability,innovativeness and accessibility.Results In terms of safety,abemaciclib was safer.Dalpiciclib had the best effectiveness profile.Abemaciclib showed advantages in cost-effectiveness and had broader indications and higher suitability.Abemaciclib was also superior in accessibility,with better affordability and availability.In terms of innovativeness,the patent value of palbociclib and dalpiciclib were higher,and abemaciclib had a wider range of target.Conclusion Abemaciclib had the highest overall clinical value,with good effectiveness,safety,cost-effectiveness,suitability,accessibility,and innovativeness compared to palbociclib,ribociclib,and dalpiciclib.
NETL
NSTL
万方数据