Page 82 - 《中国药房》2025年12期

·药物与临床·

基于真实世界数据的安罗替尼三线治疗晚期非小细胞肺癌的临
床评价
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吴 健 ，李培培 ，祝永福 ，张东伟 ，汪永忠 ，陈 浩 （1. 安徽中医药大学第一附属医院药学部，合肥
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230031；2.安徽中医药大学第一附属医院肿瘤科，合肥 230031）
中图分类号 R734.2；R979.1 文献标志码 A 文章编号 1001-0408（2025）12-1488-07
DOI 10.6039/j.issn.1001-0408.2025.12.12
摘 要 目的 基于真实世界数据评估安罗替尼用于晚期非小细胞肺癌（NSCLC）患者三线治疗的临床价值。方法 回顾性收集
2021年2月－2024年12月在安徽中医药大学第一附属医院接受治疗的晚期NSCLC患者的临床资料。根据治疗方案的不同分为
安罗替尼组（27例，接受安罗替尼治疗）和免疫治疗组（22例，接受免疫制剂单用或联合化疗药物治疗），比较两组患者的无进展生
存期（PFS）、总生存期（OS），并记录其治疗期间不良反应发生情况；采用分区生存模型，从医疗卫生体系视角出发，采用成本-效用
分析法对两种方案进行经济学评价。结果 安罗替尼组患者的中位PFS为5.93个月，中位OS为11.27个月；免疫治疗组患者的中
位PFS为5.33个月，中位OS为9.77个月；组间比较差异均无统计学意义（P＞0.05）。两组患者的总不良反应发生率和3～4级严
重不良反应发生率比较，差异均无统计学意义（P＞0.05）。与免疫治疗组相比，安罗替尼组的增量成本-效果比为 1 806 724.60
元/质量调整生命年（QALY），高于3倍2024年我国人均国内生产总值（287 247元/QALY）。结论 对于晚期NSCLC患者的三线治
疗，安罗替尼的疗效不劣于免疫制剂单用或联合化疗药物，安全性亦与之相当，但不具有经济性。
关键词 安罗替尼；晚期非小细胞肺癌；三线治疗；免疫治疗；真实世界数据；有效性；安全性；经济性

Clinical evaluation of anlotinib in third-line treatment for advanced non-small cell lung cancer based on
real-world data
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WU Jian ，LI Peipei ，ZHU Yongfu ，ZHANG Dongwei ，WANG Yongzhong ，CHEN Hao（1. Dept. of Pharmacy，
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the First Affiliated Hospital of Anhui University of Chinese Medicine， Hefei 230031， China；2. Dept. of Medical
Oncology， the First Affiliated Hospital of Anhui University of Chinese Medicine， Hefei 230031， China）
ABSTRACT OBJECTIVE To evaluate the clinical value of anlotinib in third-line treatment for patients with advanced non-small
cell lung cancer （NSCLC） through real-world data. METHODS Clinical data of patients with advanced NSCLC who received
treatment at the First Affiliated Hospital of Anhui University of Chinese Medicine from February 2021 to December 2024 were
retrospectively collected. They were divided into anlotinib group （27 cases， receiving anlotinib therapy） and immunotherapy group
（22 cases， receiving immunotherapy agents alone or in combination with chemotherapy drugs） according to treatment regimens.
The progression-free survival （PFS） and overall survival （OS） of patients were compared between the two groups， and the
occurrence of adverse drug reactions during the treatment period was recorded. Using a partitioned survival model， an economic
evaluation of the two treatment regimens was conducted with a cost-utility analysis approach from the perspective of the healthcare
system. RESULTS The median PFS and OS of patients in the anlotinib group were 5.93 months and 11.27 months， respectively；
the median PFS and OS of patients in the immunotherapy group were 5.33 months and 9.77 months， respectively； the difference
was not statistically significant （P＞0.05）. There was no statistical difference in the total incidence of adverse drug reactions and
grade 3-4 serious adverse drug reactions between the two groups （P＞0.05）. Compared with the immunotherapy group， the
incremental cost-effectiveness ratio of the anlotinib group was 1 806 724.60 yuan/quality-adjusted life year （QALY）， which was
significantly higher than three times China’s per capita gross domestic product in 2024 （287 247 yuan/QALY）. CONCLUSIONS
For third-line treatment of advanced NSCLC patients， the
efficacy of anlotinib is no worse than that of immunotherapy
Δ 基金项目 国家中医优势专科（临床药学）建设单位项目（No.国
alone or in combination with chemotherapy drugs， and the
中医药医政函〔2024〕90号）；安徽省卫生健康委员会盐酸安罗替尼胶
safety of the two groups is comparable. However， anlotinib is
囊临床综合评价工作项目（No.K2023047）
＊第一作者 副主任药师，硕士。研究方向：临床药学、药事管理。 not cost-effective.
电话：0551-62838557。E-mail：wujian7997@163.com KEYWORDS anlotinib； advanced non-small cell lung
# 通信作者 主任药师，硕士生导师。研究方向：医院药学、药事管 cancer； third-line treatment； immunotherapy； real-world data；
理。电话：0551-62838556。E-mail：chenhao071522@163.com efficacy； safety； economics

· 1488 · China Pharmacy 2025 Vol. 36 No. 12 中国药房 2025年第36卷第12期