益气化瘀解毒方降低胃癌术后复发转移风险疗效评价的临床研究  

Clinical Study on the Efficacy of Yiqi Huayu Jiedu Decoction in Reducing the Risk of Recurrence and Metastasis of Postoperative Gastric Cancer

作　　者：张力[1] 舒鹏[1] 祁明浩[1] 壮雨雯 刘芹[2] 邵杰[1] 刘沈林[1] ZHANG Li;SHU Peng;QI Minghao;ZHUANG Yuwen;LIU Qin;SHAO Jie;LIU Shenlin(Affiliated Hospital of Nanjing University of Chinese Medicine,Nanjing 210029,China;Nanjing Drum Tower Hospital,Nanjing 210008,China)

机构地区：[1]南京中医药大学附属医院,江苏南京210029 [2]南京鼓楼医院,江苏南京210008

出　　处：《中国中医药信息杂志》2025年第3期144-149,共6页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：国家中医临床研究基地(江苏省中医院)开放课题(JD2019SZ11)。

摘　　要：目的评价益气化瘀解毒方联合化疗对胃癌Ⅱ、Ⅲ期根治术后患者的无病生存率、无病生存期(DFS)的影响。方法选择南京中医药大学附属医院、南京鼓楼医院胃癌Ⅱ、Ⅲ期根治术后患者102例,采用区组随机法分为对照组52例和试验组50例。对照组采用常规术后辅助化疗4~6周期,试验组在化疗基础上联用中药6个月,随访至患者复发转移或死亡。应用Kaplan-Meier法进行无病生存分析、估算2组平均DFS,采用Log Rank检验对组间生存分布差异进行显著性检验,应用Cox回归模型对影响预后的变量进行单因素及多因素分析。监测2组不良反应情况。结果试验组复发转移率为12.0%(6/50),对照组为34.6%(18/52),试验组低于对照组(P<0.05)。对照组1、2年无病生存率分别为86.5%、72.2%,平均DFS为25.8个月,试验组1、2年无病生存率分别为95.6%、84.1%,平均DFS为33.9个月,2组比较差异有统计学意义(P=0.012)。Cox多因素研究结果显示,影响胃癌患者无病生存时间的独立因素为:试验组(P=0.022)、胃次全切除手术方式(P=0.038)、临床分期Ⅱ期(P=0.040)。2组未见中药相关的不良反应报告。结论益气化瘀解毒方联合化疗可提高胃癌Ⅱ、Ⅲ期根治术后患者的1、2年无病生存率、延长DFS,降低复发转移率,改善预后。Objective To evaluate the effects of Yiqi Huayu Jiedu Decoction combined with chemotherapy on disease-free survival rate and disease-free survival(DFS)of patients with stageⅡandⅢpostoperative gastric cancer.Methods Totally 102 patients with stageⅡandⅢpostoperative gastric cancer treated by Affiliated Hospital of Nanjing University of Chinese Medicine and Nanjing Drum Tower Hospital were selected.The patients were divided into control group(52 cases)and test group(50 cases)with block random method.The control group received conventional postoperative adjuvant chemotherapy for 4-6 cycles.The test group was treated with Chinese materia medica for 6 months on the basis of chemotherapy.Continue follow-up until the patients had recurrence,metastasis or death.DFS was analyzed by Kaplan-Meier method,and the average DFS of the two groups was estimated.Log Rank test was used to test the significance of differences in survival distribution between groups.Univariate and multivariate analyses of variables affecting prognosis were conducted using the Cox regression model.Adverse reactions of both groups were monitored.Results The recurrence and metastasis rate of the test group was 12.0%(6/50),while that of the control group was 34.6%(18/52),which was lower in the test group than in the control group(P<0.05).The 1-year and 2-year DFS rates and DFS of the control group were 86.5%,72.2%and 25.8 months respectively,while those of the test group were 95.6%,84.1%and 33.9 months respectively,with statistical significance(P=0.012).Cox-regression analysis suggested:The independent factors influencing the disease-free survival time of patients with gastric cancer were the test group(P=0.022),surgical methods of subtotal gastrectomy(P=0.038)and clinical stagesⅡ(P=0.040).No adverse reactions related to Chinese materia medica were reported in the two groups.Conclusion Yiqi Huayu Jiedu Decoction combined with chemotherapy can improve the 1-year and 2-year DFS rate,prolong DFS,reduce the recurrence and metastasis rate,and improve

关 键 词：益气化瘀解毒方 胃癌术后 无病生存率 无病生存期 复发转移 临床研究 

分 类 号：R273.52[医药卫生—中西医结合]