目的 评价中医药干预联合奥铂及氟尿嘧啶类药物的化疗方案对晚期胃癌的临床疗效。方法 初治晚期胃癌患者一线治疗采用奥铂及氟尿嘧啶类药物的化疗方案，并根据是否接受健脾中药治疗分为中药组和同期非中药组，在基线均衡的条件下比较患者的生存期及1、2、3、5年生存率。Cox多因素回归模型分析影响晚期胃癌预后的独立性因素，Kaplan-Meier法估算中位生存时间（OS）。结果 共有205例晚期胃癌病例纳入研究，包括87例中药组和118例非中药组。Cox多因素分析显示，性别（P = 0.002），化疗周期（P = 0.000），靶向治疗（P = 0.043），健脾中药（P = 0.003）是影响晚期胃癌病例生存期的独立因素。在非靶向治疗的亚组中，中药组的中位生存期为21.271个月较非中药组的10.849个月显著延长（P = 0.001，Log-rank检验），服用中药的相对危险度是0.549（95%CI：0.384-0.782）。中药组的1、2、3、5年生存率分别为76%、40%、27%、22%，非中药组的1、2、3、5年生存率分别为46%、22%、13%、7%。结论 健脾中药是影响晚期胃癌患者预后的独立保护性因素，及早健脾中药干预并联合奥铂及氟尿嘧啶类药物的化疗方案可使晚期胃癌患者生存获益。

Objective To evaluate clinical efficacy of traditional Chinese medicine (TCM) plus oxaliplatin and fluorouracil-based chemotherapy in advanced gastric cancer. Methods A total of 250 patients with advanced gastric cancer were treated with oxaliplatin and fluorouracil. According to whether or not to receive TCM, they were divided into TCM group and simultaneous non-TCM group. Under the condition of balanced baseline, overall survival (OS) and 1, 2, 3 and 5-year OS ratios were compared. Cox multi-factor regression model was performed to analyze independent factors affecting prognosis of advanced gastric cancer. Kaplan-Meier was used to assess the median of OS. Results There were 205 eligible patients enrolled in the study, including 87 cases in the TCM group and 118 cases in the non-TCM group. Cox multi-factor analysis suggested that gender (P = 0.002), chemotherapy cycles (P = 0.000), targeted therapy (P = 0.043) and TCM of invigorating spleen (P = 0.003) were independent factors affecting OS of advanced gastric cancer. Log-rank test in the subgroup of non-targeted therapy indicated that the median of OS in the TCM group was 21.271 months, significantly longer than 10.849 months in the control group (P = 0.001), relative risk of taking TCM was 0.549 (95%CI: 0.384 - 0.782). The 1, 2, 3 and 5-year OS ratios in the TCM group were 76%, 40%, 27% and 22% respectively, and they were 46%, 22%, 13% and 7% in the non-TCM group respectively. Conclusion TCM of invigorating spleen is an independent protective factor affecting the prognosis of advanced gastric cancer. Its early intervention combined with oxaliplatin and fluorouracil-based chemotherapy shows survival benefit for patients with advanced gastric cancer.

科技部国家重点研发计划，中医药现代化研究（2017YFC1700605）：基于健脾为主的中医药辨证方案提高胃癌根治术后无病生存率的临床及机制研究，负责人：赵爱光；国家中医药管理局国家中医临床研究基地业务建设科研专项（JDZX2015068）：中医药规范化辨证治疗方案对晚期胃癌临床结局影响的登记研究，负责人：赵爱光；上海中医药大学附属龙华医院龙医学者（育苗计划）（LYTD-44）：中药复方WCA-P及其拆方对人胰腺癌BxPC-3皮下移植瘤裸小鼠模型及STAT3调控的影响，负责人：曹妮达。