摘要
目的 探讨紫龙金片参与治疗对中晚期非小细胞肺癌患者生存时间的影响.方法 采用前瞻性、观察性真实世界队列研究方法,收集首都医科大学附属北京中医医院肿瘤科中晚期肺癌的医疗健康数据及基于研究目的采集的数据构成数据库,从中调取临床分期为ⅢB～Ⅳ期患者相关资料.以是否服用紫龙金片为暴露因素,提取患者人口学、肺癌诊断、治疗、紫龙金片服用等相关信息,采用Kaplan-Meier法进行单因素分析,COX模型法进行多因素生存分析.结果 最终301例患者纳入研究,其中暴露队列99例、非暴露队列202例.暴露队列经手术治疗比例高于非暴露队列(P<0.05).暴露队列预估平均生存时间为1085.990 d[95％CI(964.694,1207.286)],高于非暴露队列的840.074 d[95％CI(748.942,931.207)],差异有统计学意义(P=0.002).单因素分析结果显示,患者性别、年龄、病理类型、TNM临床分期、手术治疗、紫龙金片暴露与生存时间相关(P≤0.1).COX回归模型多因素分析结果显示,老年、肺鳞状细胞癌、较晚临床分期是死亡终点时间的独立危险因素,而女性、接受手术治疗、化学药物治疗、靶向治疗、紫龙金片治疗为独立保护因素,其中临床分期、手术治疗、紫龙金片暴露差异有统计学意义(P<0.05).结论 基于当前数据及分析方法,紫龙金片参与治疗对于中晚期非小细胞肺癌患者的生存时间表现出较为明显的保护作用.
Abstract
Objetive To investigate the effect of Zilongjin Tablets on the survival time of patients with advanced non-small cell lung cancer. Methods A prospective,observational real-world study was used. The research database was composed of data proactively collected for the purpose of this study,medical and health data from Beijing Hospital of Traditional Chinese Medicine. The data of patients in the Phase ⅢB～Ⅳ clinical stage were extracted. Whether or not Taking Zilongjin tablets was considered as an exposure factor. The information including patients' demography, lung cancer diagnosis, treatment, and administration of ZilongjinTtablets were extracted and Kaplan-Meier method was used for univariate analysis,and COX model method was used for multivariate survival analysis. Results A total of 301 cases were included, including 99 exposed queues and 202 unexposed queues. The proportion of surgical treatment in exposed group was higher than that in non-exposed group (P<0.05). The estimated mean survival time in the exposed cohort was 1085.990 d [95％ CI (964.694,1207.286)], higher than that in the non-exposed cohort 840.074 d[95％ CI(748.942,931.207)], the difference was statistically significant (P=0.002). Univariate analysis showed that sex, age, pathological type, TNM clinical stage, surgical treatment and exposure to Zi Long gold tablets were related to survival time (P≤0.1). COX survival analysis showed that older age, squamous cell carcinoma and late clinical stage were independent risk factors for terminal events, while female, surgery, chemotherapy, targeted therapy and exposure to Zilongjin Tablets were independent protective factors, among which there were statistically significant differences between clinical stage, surgery and exposure to Zilongjin Tablets (P<0.05). Conclusion Based on the current data and analysis methods,the treatment with Zilongjin Tablets has a relatively clear protective effect on the survival in patients with advanced non-small cell lung cancer.
基金项目
北京市中医药科技发展资金重点项目(BJZYZD-2023-10)
国家自然科学基金面上项目(81774039)
中华中医药学会青年求实项目(2021-QNQS-07)
"重大新药创制"科技重大专项(2019ZX09734-001)
维普
万方数据