基于倾向性评分匹配研究参麦注射液对Ⅱ~Ⅲ期胃癌患者生存期的影响

Effect of Shenmai Injection on survival of patients with gastric cancer in phaseⅡtoⅢbased on propensity score matching

目的探讨参麦注射液在真实世界环境下对Ⅱ~Ⅲ期胃癌患者生存期的影响。方法收集2012年1月1日—2022年12月1日符合纳入标准的433例胃癌患者为研究对象,将其分为参麦组(中西医联合治疗)和对照组(单纯西医治疗)。应用倾向性评分匹配(PSM)均衡组间混杂因子;采用Cox回归模型评估胃癌预后风险因子;采用Kaplan-Meier法和Log-rank检验比较2组患者的总生存期(OS)和无进展生存期(PFS)。结果共纳入433例符合纳入标准的患者,PSM后2组各有65例患者。PSM后,参麦组中位OS、中位PFS分别为35.27、22.63个月,均长于对照组的17.83、14.97个月,差异有统计学意义(P<0.001、P=0.003)。PSM后,参麦组1、3、5年生存率分别为90.7%、49.3%、34.8%,高于对照组的67.7%、19.8%、4.9%,差异有统计学意义(χ^(2)=21.983,P<0.001)。生存预后的多因素分析显示,影响胃癌的独立危险因素为侵犯脉管(P=0.046),腺癌含印戒细胞癌(P=0.001),TNM分期Ⅲa期(P=0.012)、Ⅲb期(P=0.035)、Ⅲc期(P=0.046)。参麦注射液联合艾迪注射液(P<0.001)、鸦胆子注射液(P=0.001)、根治性手术(P=0.004)、化疗(P=0.005)可以使胃癌患者生存获益。结论参麦注射液联合西医方法治疗Ⅱ、Ⅲ期胃癌较单纯西医治疗更具优势。

Objective To explore the effect of Shenmai Injection on survival of patients with gastric cancer in phaseⅡtoⅢin a real-world environment.Methods From January 1,2012 to December 1,2022,433 patients with gastric cancer who met the inclusion criteria were collected as research objects and divided into the Shenmai group(treated with traditional Chinese and western medicine)and the control group(treated with western medicine).Propensity score matching(PSM)was used to balance the confounding factors between groups;the Cox regression model was used to evaluate the risk factors for prognosis of gastric cancer;the Kaplan-Meier method and Log-rank test were used to compare the overall survival(OS)and progression free survival(PFS)of patients in both groups.Results A total of 433 patients met the inclusion criteria were enrolled in this study,and were assigned into two groups after PSM,with 65 cases in each group.After PSM,the median OS and PFS in the Shenmai group were 35.27 and 22.63 months respectively,which were significantly longer than 17.83 and 14.97 months in the control group(P<0.001,P=0.003).After PSM,the 1-,3-and 5-year survival rates in the Shenmai group were 90.7%,49.3%and 34.8%respectively,which were significantly higher than 67.7%,19.8%and 4.9%in the control group(χ^(2)=21.983,P<0.001).Multivariable analysis of survival prognosis showed that the independent risk factors influencing gastric cancer were vascular invasion(P=0.046),adenocarcinoma with signet-ring cell carcinoma(P=0.001),phaseⅢa(P=0.012),phaseⅢb(P=0.035)and phaseⅢc(P=0.046)of TNM staging.Shenmai Injection combined with Aidi injection(P<0.001),Yadanzi Injection(P=0.001),radical surgery(P=0.004)and chemotherapy(P=0.005)were able to benefit the survival of gastric cancer patients.Conclusion The combination of Shenmai Injection and western medicine has more advantages than simple western medicine treatment in treating patients with gastric cancer in phaseⅡtoⅢ.