[关键词]
[摘要]
目的 以《中国医疗机构药品评价与遴选快速指南(第三版)》为基准构建评估体系,对治疗ROS原癌基因1受体酪氨酸激酶基因(ROS1)阳性非小细胞肺癌(NSCLC)的5种酪氨酸激酶抑制剂(TKI,克唑替尼、恩曲替尼、瑞普替尼、安奈克替尼、他雷替尼)开展多维度综合评价,旨在为临床合理用药及医疗机构药品遴选提供循证依据。方法 全面纳入参评药品的真实世界研究、Meta分析等多源证据,结合治疗ROS1阳性NSCLC药物的临床特性,以评价指南为准则进行药学特性、有效性、安全性、经济性、其他属性5个维度的量化评估。结果 5种ROS1-TKI类药物均表现出较为优秀的性能,其中瑞普替尼在安全性和经济性方面均表现最佳,但在药学特性和有效性方面稍有欠缺;有效性表现最佳的是他雷替尼和恩曲替尼,但日均治疗费用较高。结论 在治疗ROS1阳性NSCLC的5种TKI中,瑞普替尼临床综合价值更高,可为临床治疗提供参考依据。
[Key word]
[Abstract]
Objective Based on the Rapid Guide for Drug Evaluation and Selection in Chinese Medical Institutions (third Edition), an assessment system was constructed to conduct a multi-dimensional comprehensive evaluation of five tyrosine kinase inhibitors (TKI, including crizotinib, entanercept, repotilast, anaprenyl, and ticagrelor) for the treatment of ROS1-positive non-small cell lung cancer (NSCLC), aiming to provide evidence-based support for rational clinical drug use and drug selection in medical institutions. Methods Comprehensively incorporating multi-source evidence such as real-world studies and Meta-analyses of the evaluated drugs, and combining the clinical characteristics of drugs for the treatment of ROS1-positive NSCLC, a quantitative evaluation is conducted across five dimensions: Pharmaceutical properties, efficacy, safety, cost-effectiveness, and other attributes, based on evaluation guidelines. Results All five ROS1- TKI drugs have demonstrated excellent performance. Among them, rupertinib excels in both safety and cost-effectiveness, although it has some shortcomings in pharmaceutical properties and efficacy. The drugs with the best efficacy are ticagrelor and entanercept, but their daily average treatment costs are relatively high. Conclusion Among the five tyrosine kinase inhibitors used for the treatment of ROS1-positive NSCLC, rupertinib has a higher clinical comprehensive value and can provide reference for clinical treatment.
[中图分类号]
R974
[基金项目]