中医药干预治疗广泛期小细胞肺癌的回顾性队列研究

Retrospective Cohort Study of Interventional Treatment of Extensive Stage Small Cell Lung Cancer with Traditional Chinese Medicine

目的 评价中医药干预治疗对广泛期小细胞肺癌(ES-SCLC)患者无进展生存期(PFS)的影响。方法 采用回顾性队列分析方法,以连续接受中医药治疗时间≥1个月作为暴露因素,分为暴露组和非暴露组,以无进展生存期作为最终结局。应用Kaplan-Meier曲线对PFS进行描述,估计中位无进展生存时间,两组之间采用Logrank检验进行比较,并建立COX回归模型分析影响ES-SCLC的预后因素。结果 共有209例ES-SCLC的患者被纳入本研究,其中暴露组97例,出现终点事件90例,非暴露组112例,出现终点事件108例。暴露组的中位无进展生存期为6.9个月(95%CI:6.662~7.138个月),非暴露组的中位无进展生存期为4.9个月(95%CI:4.534~5.266个月),通过单因素Log-rank检验结果显示,两组差异有统计学意义(P<0.05)。COX回归显示:中医药干预治疗是保护因素(HR=0.269,95%CI:0.194~0.373),脑转移、肝转移和合并放疗均对无进展生存期有影响(P<0.05),是无进展生存期的独立影响因素。未发现化疗方案、胸水、其他脏器转移及年龄、性别、吸烟史、恶性肿瘤家族史等个人因素影响ES-SCLC无进展生存期的相关证据(P>0.05)。结论 中医药对ES-SCLC患者有辅助治疗作用,有利于提高患者的无进展生存期。

Objective To evaluate the effect of traditional Chinese medicine intervention on progression-free survival(PFS)of patients with extensive stage small cell lung cancer(ES-SCLC).Methods Retrospective cohort analysis was used, and the continuous treatment time of traditional Chinese medicine≥1 month was taken as the exposure factor, which was divided into exposed group and non-exposed group, and progression-free survival was taken as the final outcome.The Kaplan-Meier curve was used to describe PFS and the median progression-free survival was estimated.LogRank test was used to compare the two groups, and Cox regression model was established to analyze the prognostic factors affecting ES-SCLC.Results A total of 209 patients with ES-SCLC were included in this study, including 97 patients in the exposure group and 90 patients with endpoint events.Among 112 cases in the non-exposed group, 108 cases had end events.Median progression-free survival(PFS)was 6.9 months(95%CI:6.662-7.138)for the exposed group and 4.9 months(95%CI:4.534-5.266)for the non-exposed group.Univariate log-rank test showed a statistically significant difference between the two groups(P<0.05).Cox regression showed that TCM intervention was a protective factor(HR=0.269,95%CI:0.194-0.373),and brain metastasis, liver metastasis and combined radiotherapy all had effects on progression-free survival(P<0.05)and was an independent factor for progression-free survival.No evidence was found that chemotherapy regimen, pleural effusion, metastasis to other organs and personal factors such as age, gender, smoking history and family history of malignant tumors affected the progression-free survival of ES-SCLC(P>0.05).Conclusion Traditional Chinese medicine has an adjuvant effect on patients with ES-SCLC,which is beneficial to improve the progression-free survival of patients.