晚期肝癌一线系统治疗药品的临床综合评价

Clinical application evaluation of the first-line system therapy drugs for treatment of advanced liver cancer

目的通过药品临床综合评价的方法,比较晚期肝癌一线系统治疗药品(索拉非尼、仑伐替尼和FOLFOX4方案)的临床综合价值,以期为医院临床合理用药和目录准入决策提供参考。方法首先,根据《药品临床综合评价管理指南(2021年版试行)》,通过文献复习、专家调研和专家论证会构建晚期肝癌一线系统治疗药品临床综合评价指标体系。其次,采用系统文献综述、Meta分析及其他相关数据资料分析的方法,根据指标体系对索拉非尼、仑伐替尼和FOLFOX4方案各维度、各指标进行定性、定量整合分析。结果各维度综合评价结果显示,在安全性、有效性和创新性方面,索拉非尼治疗晚期肝癌患者的3级及以上不良反应发生率低于仑伐替尼及FOLFOX4方案;索拉非尼与仑伐替尼临床疗效明确,获多篇临床指南推荐,显著优于FOLFOX4方案;索拉非尼与仑伐替尼为多靶点靶向治疗药物,其创新价值显著优于FOLFOX4方案。在经济性、适宜性和可及性方面,仑伐替尼由于上市时间短且价格较高,索拉非尼的成本-效果优于仑伐替尼;索拉非尼和FOLFOX4方案的药品配备率较高,可及性可满足患者需求,显著优于仑伐替尼。结论相比于仑伐替尼和FOLFOX4方案,索拉非尼在6个维度均具有较好的表现,其临床综合价值高于仑伐替尼、FOLFOX4方案。

Objective To compare the clinical application evaluation of the first-line system therapy drugs for advanced liver cancer(Sorafenib,Lenvatinib and FOLFOX4),in order to provide reference for the hospital's clinical rational use and catalogue access decision-making.Methods Firstly,a clinical application evaluation index system for the first-line system therapy drugs of advanced liver cancer was constructed through literature review,expert surveys and expert demonstrations,and the analytic hierarchy process was used to determine the weight of each index.Secondly,using systematic literature review,Meta analysis and other related data analysis methods,Sorafenib,Lenvatinib and FOLFOX4 were analyzed according to the indicator system.Results The incidence of grade 3 side effects of Sorafenib in patients with advanced liver cancer is lower than that of Lenvatinib and FOLFOX4.Sorafenib and Lenvatinib have clear clinical effects and have been recommended by many clinical guidelines,which are significantly better than the FOLFOX4.Due to the short time to market and higher price of Lenvatinib,the cost-effectiveness of Sorafenib is better than that of Lenvatinib.Sorafenib and FOLFOX4 have a higher drug provision rate which can meet the needs of patients,which is significantly better than Lenvatinib.Conclusion The comprehensive clinical value of Sorafenib is higher than that of Lenvatinib and FOLFOX4.