目的 探讨紫龙金片药物暴露与肺癌患者生存期之间的相关性，为紫龙金片的临床应用提供真实世界证据。方法 以课题组30家参研单位常规收集的医疗健康数据和基于研究目的主动收集的数据构成研究数据库，以是否服用紫龙金片作为暴露划分因素，提取患者人口学、肺癌诊断、治疗、中医辨证、症状、合并治疗等信息，采用Kaplan-Meier法进行单因素分析，采用回归模型控制混杂因素，Cox模型法进行多因素生存分析。结果 研究纳入2553例患者资料，暴露队列各访视点总生存率均高于非暴露队列；Kaplan-Meier生存分析显示，暴露队列估计平均生存时间高于非暴露队列（35.9个月vs 25.0个月，P＜0.001）。Cox生存分析显示，性别、年龄、临床分期、神疲乏力评分、肺气虚证、原发病灶瘤径是死亡终点事件的独立危险因素（P＜0.001），手术治疗和紫龙金暴露为独立保护因素（P＜0.001）。结论 基于当前数据及研究方法，紫龙金片暴露对于肺癌患者的生存期表现出较为明显的保护作用。

Objective To explore the correlation between the drug exposure of Zilongjin Tablets (紫龙金片) and the survival time of lung cancer patients, and to provide real world evidence for the clinical application of Zilongjin Tablets. Methods The research database was composed of routinely collected medical and health data from 30 participating research units in the research group and data proactively collected for the purpose of this study. The information of patients’ demography, lung cancer diagnosis, treatment, TCM syndrome differentiation, symptoms and combined treatment was extracted by taking Zilongjin Tablets or not as a factor of exposure classification. Kaplan-Meier method was used for univariate analysis, regression model was used to control confounding factors, Cox model was used for multivariate survival analysis. Results A total of 2553 cases were included in this study. The overall survival rates at each visit in exposed cohort was higher than that in non-exposed cohort. Kaplan-Meier survival analysis showed that the estimated mean survival time of exposed cohort was higher than that of non-exposed cohort (35.9 months vs 25.0 months, P < 0.001). Cox model survival analysis revealed that gender, age, clinical stage, fatigue score, lung qi deficiency syndrome and primary tumor size were independent risk factors for death endpoint events (P < 0.001), while surgical treatment and exposure to Zilongjin Tablets were independent protective factors (P < 0.001). Conclusion Based on the current data and research methods, Zilongjin Tablets has an obvious protective effect on the survival of lung cancer patients.

R285.41

国家“十三五”重大新药创制专项课题“创新药物全过程临床评价示范性技术平台建设”（2019ZX09734001）；2019年北京市落实中央引导地方科技发展专项（Z191100008319006）；国家自然科学基金项目（81774039）