摘要
目的 基于回顾性队列研究评价中医药治疗不同暴露程度对Ⅳ期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者的生存期影响,并构建预测模型.方法 收集上海中医药大学附属龙华医院肿瘤三科接受中医药治疗的700例Ⅳ期非小细胞肺癌患者的临床资料,根据平均每年接受中医药治疗时间进行分组,评估比较三组队列基线分布的均衡性及中位生存期(median survival time,MST)情况,采用Kaplan-Meier法和Cox回归模型对700例晚期NSCLC患者生存期的影响因素进行单因素分析和多因素分析,建立Cox比例风险模型及列线图预测模型.结果 ①队列分析显示,中医药治疗可改善Ⅳ期NSCLC患者的生存期,高暴露组MST为37.0个月,中暴露组MST为25.0个月,低暴露组MST为18.4个月.②单因素分析结果显示,患者的性别、确诊时的体力状态(performance status,PS)评分、年龄、病理类型及临床分期、吸烟史、既往手术史、靶向治疗、口服中成药、中药静脉制剂疗程是Ⅳ期NSCLC患者的预后影响因素(P<0.05).③Cox多因素分析结果显示:性别、PS评分、临床分期、病理类型是Ⅳ期NSCLC患者预后的独立危险因素,既往手术史、靶向治疗、中药静脉制剂是Ⅳ期NSCLC患者预后的独立保护因素.④基于多因素分析结果建立的列线图模型预测Ⅳ期NSCLC患者一年、三年、五年生存概率的ROC曲线AUC值为0.796、0.762、0.765,ROC曲线及校准曲线均表明预后模型与实际观测结果拟合性较好.结论 中医药治疗时间平均每年大于6个月可延长Ⅳ期NSCLC患者的生存期.基于性别、年龄、PS评分、临床分期、病理类型、既往手术史、靶向治疗和以中医药治疗为暴露因素的队列分组而构建的Ⅳ期NSCLC患者的列线图模型具有良好的预测能力及精准度.
Abstract
Objective A retrospective cohort study was conducted to evaluate the effect of different exposure levels of traditional Chinese medicine(TCM) on the survival of patients with stage Ⅳ non-small cell lung cancer (NSCLC) and to establish a predictive model.Methods The clinical data of 700 patients with stage Ⅳ NSCLC who received TCM treatment in the Third Department of Oncology,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine was collected.The patients were divided into three groups according to the average annual time of TCM treatment.The balance of baseline distribution and median survival time(MST) among the three groups were evaluated and compared.Kaplan-Meier method and Cox regression model were used to conduct univariate and multivariate analysis on the influencing factors of survival of 700 patients with advanced NSCLC.Cox proportional hazard model and nomogram prediction model were established.Results ①Cohort analysis showed that the survival time of stage Ⅳ NSCLC patients was significantly improved by TCM treatment.The MST of high exposure group was 37.0 months,the middle exposure group was 25.0 months,and the low exposure group was 18.4 months.②The results of univariate analysis showed that gender,performance status(PS) score at the time of diagnosis,age,pathological type,clinical stage,smoking history,previous surgical history,targeted therapy,oral Chinese patent medicine,and Chinese medicine intravenous preparation treatment were prognostic factors for stage Ⅳ NSCLC patients(P<0.05).③The Cox multivariate results showed that gender,PS score,clinical stage,and pathological type were independent risk factors for the prognosis of stage Ⅳ NSCLC patients.Previous surgical history,targeted therapy,and intravenous preparation of TCM were independent protective factors for prognosis of stage Ⅳ NSCLC patients.④The AUC values of ROC curves for predicting the 1-year,3-year,and 5-year survival probability of stage Ⅳ NSCLC patients using the nomogram model based on the results of multivariate analysis were 0.796,0.762,and 0.765,respectively.Both the ROC curve and the calibration curve showed that the prognostic model had a good fit with the actual observation results.Conclusion TCM treatment for an average of more than 6 months per year can prolong the survival time of patients with stage Ⅳ NSCLC.The nomogram model of stage Ⅳ NSCLC patients constructed based on gender,age,PS score,clinical stage,pathological type,history of previous surgery,targeted therapy,and cohort with TCM treatment as exposure factor has good predictive ability and accuracy.
维普
万方数据