基于真实世界健脾益胃方联合SOX方案治疗胃癌根治术后患者的回顾性队列研究

Retrospective cohort study of Jianpi Yiwei Formula combined with SOX regimen in the treatment of patients with gastric cancer after radical gastrectomy based on the real world

目的:基于真实世界分析健脾益胃方对胃癌根治术后化疗不良反应及生存期的影响。方法:收集胃癌根治术后行SOX方案辅助化疗的患者,按是否长期接受健脾益胃方治疗分为联合治疗组和单纯化疗组,记录患者化疗不良反应发生情况,Kaplan-Meier法绘制生存曲线,Log-rank法检验两组生存情况差异。结果:共96例患者纳入研究,联合治疗组45例,单纯化疗组51例,3~4度中性粒细胞减低、血小板减低、恶心呕吐、周围神经毒性发生率单纯化疗组显著高于联合治疗组(P=0.013,P=0.008,P=0.025,P=0.045)。联合治疗组与单纯化疗组中位无病生存期分别为33.4 vs 26.1个月,中位总生存期分别为57.7 vs 48.5个月,差异有统计学意义(P=0.011,P=0.002)。结论:健脾益胃方联合SOX方案能减轻化疗不良反应,降低复发率,延长生存期。

Objective:To analyze the effect of Jianpi Yiwei Formula on the incidence of chemotherapy adverse reaction and survival time of patients with gastric cancer after radical operation.Methods:The patients who received SOX adjuvant chemotherapy after radical gastrectomy were divided into combined treatment group and simple chemotherapy group according to whether they received Jianpi Yiwei Formula for a long time.The incidence of chemotherapy adverse reaction and survival out comes of the two groups were recorded.The survival curve was drawn by Kaplan-Meier method,and the significance was tested by Log-rank method.Results:A total of 96 patients were included in the study.There were 45 patients in the combined treatment group and 51 patients in the simple chemotherapy group.The incidence of grade 3~4 neutropenia,thrombocytopenia,nausea and vomiting,peripheral neurotoxicity in the simple chemotherapy group was higher than that in the combined treatment group(P=0.013,P=0.008,P=0.025,P=0.045).The median disease-free survival time and the median overall survival time were 33.4 vs 26.1 months and 57.7 vs 48.5 months,respectively in the combined treatment group and the chemotherapy group,and the differences were statistically significant(P=0.011,P=0.002).Conclusion:Jianpi Yiwei Formula combined with SOX regimen can reduce the adverse reactions of chemotherapy,reduce the recurrence rate and prolong the survival period.