摘要
目的 探讨紫龙金片对Ⅲ~Ⅳ期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者生存期影响及其特点。方法 利用前瞻性、观察性真实世界队列研究方法,以治疗中是否应用紫龙金片将患者分为暴露队列和非暴露队列,收集患者基本信息、人口学资料、肿瘤疾病学资料、肿瘤治疗资料、生活质量等,根据紫龙金片暴露与否、紫龙金片暴露强度及亚组分析等方面,对纳入患者进行生存分析。结果 最终纳入393例患者,其中暴露队列259例,非暴露队列134例。生存分析显示,暴露队列预估平均生存期为41.72个月,非暴露队列为33.42个月,两组差异具有统计学意义(P<0.05)。Cox回归分析显示,紫龙金片暴露是患者生存的独立保护因素。根据患者用药时间长短分为低暴露队列(用药时长≤4个月)和高暴露队列(用药时长>4个月),其中低暴露队列197例,高暴露队列62例,高暴露队列预估平均生存期高于低暴露队列约8.8个月(P<0.05)。亚组分析显示,年龄>65岁、男性、既往有吸烟史、无过敏史、无家族史、肺鳞癌、Ⅲ期、接受西医系统治疗、无中草药治疗的患者中,紫龙金片暴露队列较非暴露队列生存期存在统计学差异(P<0.05)。结论 紫龙金片暴露能够延长Ⅲ~Ⅳ期NSCLC患者生存期,且服用时间大于4个月,患者生存更易获益;年龄>65岁、男性、既往有吸烟史、无过敏史及家族史、肺鳞癌、Ⅲ期、经西医系统治疗但无中草药治疗的患者生存较易从紫龙金片暴露中获益。
Objective To investigate the efficacy of Zilongjin Tablets(紫龙金片)on the survival of non-small cell lung cancer(NSCLC)patients with stageⅢ—Ⅳand its characteristics.Methods A prospective,observational real-world cohort study was used to divide patients into exposed cohort and non-exposed cohort according to using Zilongjin Tablets or not during treatment.The information included basic information,demographic data,tumor disease data,tumor treatment data,and quality of life of patients were collected.According to exposed to Zilongjin Tablets or not,exposure intensity and other subgroup factors,survival analyses were performed for the included patients.Results The final statistical analysis included 393 patients,including 259 cases in the exposed cohort and 134 cases in the non-exposed cohort.Survival analysis showed that the estimated mean survival was 41.72 months in the exposed cohort and 33.42 months in the non-exposed cohort,with a statistically significant difference between the two cohorts(P<0.05).Cox regression analysis showed that Zilongjin Tablets exposure was an independent protective factor for patient survival.Patients were divided into low-exposure cohort(duration≤4 months)and high-exposure cohort(duration>4 months)according to the duration of medication.There were 197 patients in the low-exposure cohort and 62 patients in the high-exposure cohort.The estimated mean survival in the high-exposure cohort was 8.8 months higher than that in the low-exposure cohort(P<0.05).Subgroup analysis showed that older male(age>65 years)who ever smoked with no history of allergy and family,lung squamous cell carcinoma,stage III,received systematic medicine treatment,without traditional Chinese medicine,there were significant differences in overall survival(OS)in the exposed group compared with the non-exposed group(P<0.05).Conclusion Zilongjin Tablets exposure can prolong the survival of NSCLC patients with stageⅢ—Ⅳ.And patients who take Zilongjin Tablets for more than four months were more likely t
作者
游佳凤
于明薇
吴桐桐
李姝蒙
张兴涵
张怀锐
刘强
郭秋香
王笑民
杨国旺
YOU Jiafeng;YU Mingwei;WU Tongtong;LI Shumeng;ZHANG Xinghan;ZHANG Huairuil;LIU Qiang;GUO Qiuxiang;WANG Xiaomin;YANG Guowang(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Evaluation Centre,World Federation of Chinese Medicine Societies,Beijing 100101,China;Beijing Tianzhili Pharmaceutical Technology Co.,Ltd.,Beijing 100028,China)
出处
《中草药》
CAS
CSCD
北大核心
2024年第18期6276-6282,共7页
Chinese Traditional and Herbal Drugs
基金
2023年度北京市中医药科技发展资金项目重点项目(BJZYZD-2023-10)。
关键词
非小细胞肺癌
真实世界研究
紫龙金片
生存分析
暴露强度
non-small cell lung cancer
real word study
Zilongjin Tablets
survival analysis
exposure intensity
