黄芪桂枝五物汤治疗非小细胞肺癌软脑膜转移患者培美曲塞鞘内化疗神经毒性的随机对照研究
Huangqi Guizhi Wuwu Decoction in the Treatment of Pemetrexed Intrathecal Chemotherapy-induced Neurotoxicity in NSCLC Patients with Leptomeningeal Metastases:A Randomized Controlled Trial
摘要
Abstract
Background and objective Leptomeningeal metastasis(LM)is a severe complication of non-small cell lung cancer(NSCLC).Although intrathecal Pemetrexed chemotherapy can effectively prolong patient survival,a high inci-dence of neurotoxicity has emerged as a critical factor limiting its clinical application.This study aims to investigate the efficacy and safety of Huangqi Guizhi Wuwu decoction(HGWD)in mitigating neurotoxicity induced by intrathecal Pemetrexed che-motherapy in NSCLC patients with LM.Methods In a prospective,randomized,double-blind,controlled trial,220 NSCLC patients with LM were enrolled and randomly assigned to either the treatment group(HGWD+intrathecal chemotherapy)or the control group(placebo+intrathecal chemotherapy),with 110 patients in each group.The incidence and grade of neurotox-icity,disease control rate(DCR),progression-free survival(PFS),overall survival(OS),quality of life,and adverse reactions were observed and compared between the two groups.Results The incidence of neurotoxicity in the treatment group was 29.1％,significantly lower than that in the control group(51.8％)(P<0.001).The incidences of both grade 1-2 and grade 3-4 neurotoxicity were lower in the treatment group than in the control group(P<0.010).Nerve conduction studies showed that the sensory nerve action potential amplitude of the sural nerve was significantly higher in the treatment group than in the con-trol group(P=0.012),and the conduction velocities of the median and ulnar nerves showed a trend toward improvement.The DCR was 76.4％in the treatment group,higher than 69.1％in the control group(P=0.045).Both median PFS(7.8 vs 6.1 mon,P<0.001)and median OS(10.5 vs 8.9 mon,P=0.007)were significantly prolonged in the treatment group.Improvements in quality of life and traditional Chinese medicine syndrome scores were superior in the treatment group(P<0.05).No significant difference in adverse reactions were observed.Conclusion HGWD can significantly reduce the incidence of neurotoxicity induced by Pemetrexed intrathecal chemotherapy,improve chemotherapy tolerance and survival benefits,with a good safety profile in NSCLC patients with LM.关键词
肺肿瘤/软脑膜转移/培美曲塞/神经毒性/黄芪桂枝五物汤Key words
Lung neoplasms/Leptomeningeal metastases/Pemetrexed/Neurotoxicity/Huangqi Guizhi Wuwu decoction引用本文复制引用
李会颖,陈鑫,谢宇,蒋澄,林永娟,俞婷婷,尹震宇..黄芪桂枝五物汤治疗非小细胞肺癌软脑膜转移患者培美曲塞鞘内化疗神经毒性的随机对照研究[J].中国肺癌杂志,2026,29(2):124-130,7.基金项目
本研究受国家自然科学基金项目(No.82304567)、2025年南京市临床基础研究项目(No.202511073)、江苏省干部保健科研课题(No.BJ2408)、江苏省老龄健康科研课题(No.LKZ2023013)及南京鼓楼医院临床研究专项资金项目(No.2023-LCYJ-MS-14,No.2024-LCYJ-MS-07,No.2025-LCYJ-PY-03)资助 This study was supported by the grants from National Natural Science Foundation of China Young Scientists Fund(No.82304567,to Huiying LI),the 2025 Nanjing Municipal Clinical and Basic Research Project(No.202511073,to Zhenyu YIN),the Jiangsu Provincial Cadre Health Research Project(No.BJ2408,to Zhenyu YIN),the Jiangsu Provincial Aging and Health Research Project(No.LKZ2023013,to Zhenyu YIN),and the General Project of the Clinical Research Special Fund of Nanjing Drum Tower Hospital(No.2023-LCYJ-MS-14,to Zhenyu YIN （No.82304567）
No.2024-LCYJ-MS-07,to Yu XIE （）
No.2025-LCYJ-PY-03,to Huiying LI). （）
