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[目的]评价以健脾为基础的中药复方辨证治疗对老年胃癌生存期的影响。[方法]采用前瞻性的同期对照研究,分层分析、Cox多因素回归分析方法,在临床病理分期、手术和化疗等因素基线均衡的条件下,比较接受健脾为基础的中药治疗组和未接受中药的同期对照组老年胃癌病例的生存期,Kaplan-Meier法估算中位生存时间(OS),组间生存分布差异采用Log-rank进行显著性检验。[结果]共有404例≥60岁老年胃癌病例纳入研究,包括203例晚期胃癌和201例Ⅰb～Ⅳ(M0)接受根治术(R0)后胃癌病例。203例晚期胃癌的同期对照研究:中药组共78例,对照组共125例。Cox多因素回归分析示,中药(P=0.000)、化疗(P=0.000)、放疗(P=0.021)是影响老年晚期胃癌患者OS独立的保护性因素。以化疗因素分层:化疗亚组中,中药组(51例)的中位OS19.9个月,较对照组(45例)的14.0个月延长(P=0.015),服用中药的相对危险度为0.544(95%CI:0.331～0.896);非化疗亚组中,中药组(27例)的中位OS17.9个月较对照组(80例)的7.5个月延长(P=0.000),服用中药的相对危险度0.244(95%CI:0.132～0.451)。201例Ⅰb～Ⅳ(M0)期根治术(R0)后老年胃癌的同期对照研究:中药组共80例,对照组共121例。Cox多因素回归分析示,临床病理分期(P=0.000)、中药(P=0.000)是老年胃癌根治术后患者OS独立的影响因素。临床病理分期(P=0.001)、中药(P=0.000)是老年胃癌根治术后患者无病生存(DFS)独立的影响因素。以临床病理分期分层:Ⅲ～Ⅳ(M0)期亚组中,中药组(53例)的OS未达到中位数,对照组(102例)的中位OS31.9个月,生存分布差异有统计学意义(P=0.000)。服用中药的相对危险度为0.316(95%CI:0.171～0.585)。1年、3年、5年生存率,中药组分别为:100%、79%、67%,对照组则分别为:89%、45%、32%。中药组的DFS未达到中位数,对照组的中位DFS25.7个月,无病生存分布差异有统计学意义(P=0.000)。服用中药的相对危险度0.367(95%CI:0.206～0.656)。1年、3年、5年无病生存率,中药组分别为:98%、66%、66%,对照组则分别为:81%、43%、35%。[结论]以健脾为基础的中药复方辨证治疗是老年晚期胃癌预后的独立的保护性因素,可延长老年晚期胃癌的生存期;延长Ⅲ～Ⅳ(M0)期老年胃癌根治术后的无病生存期和总生存期。中医药治疗在改善老年胃癌总体预后方面的作用值得进一步作随机对照研究评价。
[Objective] To evaluate the effect of spleen-based TCM syndrome differentiation on the survival of elderly patients with gastric cancer. [Methods] A prospective cohort study, stratified analysis and Cox regression analysis were used to compare the effects of spleen-based Chinese herbal medicine treatment group and untreated group on the condition of baseline equalization of clinicopathologic staging, surgery and chemotherapy. The survival of elderly patients with gastric cancer in the control group receiving the traditional Chinese medicine, the median survival time (OS) by the Kaplan-Meier method, and the differences in survival distribution between groups were tested by Log-rank. [Results] A total of 404 cases of gastric cancer aged ≥60 years were enrolled in the study, including 203 cases of advanced gastric cancer and 201 cases of gastric cancer after Ⅰb ~ Ⅳ (M0) radical operation (R0). Control study of 203 cases of advanced gastric cancer: a total of 78 cases of Chinese medicine group, a control group of 125 cases. Cox multivariate regression analysis showed that Chinese medicine (P = 0.000), chemotherapy (P = 0.000) and radiotherapy (P = 0.021) were independent protective factors for elderly patients with advanced gastric cancer. In the chemotherapy subgroup, the median OS of the TCM group (51 cases) was 19.9 months, which was 14.0 months longer than that of the control group (45 cases) (P = 0.015). The relative risk of taking traditional Chinese medicine (95% CI: 0.331-0.896). In the non-chemotherapy subgroup, the median OS of the Chinese medicine group (27 cases) was prolonged by 7.5 months (P = 0.000) compared with the control group (80 cases) The relative risk of taking Chinese medicine was 0.244 (95% CI: 0.132-0.451). A prospective cohort study of 201 elderly patients with stage Ⅰb-Ⅳ (M0) radical resection (R0): 80 cases in Chinese medicine group and 121 cases in control group. Cox multivariate regression analysis showed that the clinical pathological stage (P = 0.000) and traditional Chinese medicine (P = 0.000) were the independent factors of OS in the elderly patients with gastric cancer after radical operation. Clinicopathologic stage (P = 0.001), traditional Chinese medicine (P = 0.000) were independent factors influencing disease-free survival (DFS) in elderly patients with gastric cancer after radical operation. In the clinical stage of staging, the OS of the TCM group (53 cases) did not reach the median, and the median OS of the control group (102 cases) was 31.9 months, the difference of the survival distribution There was statistical significance (P = 0.000). The relative risk of taking Chinese medicine was 0.316 (95% CI: 0.171 ~ 0.585). 1 year, 3 years, 5 years survival rate, the Chinese medicine group were: 100%, 79%, 67%, respectively, the control group were: 89%, 45%, 32%. The median DFS of Chinese medicine group did not reach the median. In the control group, median DFS was 25.7 months, the difference of disease-free survival was statistically significant (P = 0.000). The relative risk of taking Chinese medicine 0.367 (95% CI: 0.206 ~ 0.656). 1 year, 3 years, 5 years disease-free survival rate, the Chinese medicine group were: 98%, 66%, 66%, respectively, the control group were: 81%, 43%, 35%. [Conclusion] The dialectical treatment of traditional Chinese medicine compound prescription based on spleen-strengthening is an independent protective factor of the prognosis of advanced gastric cancer, prolonging the survival of elderly patients with advanced gastric cancer and prolonging the disease-free after gastric cancer of stage Ⅲ ~ Ⅳ (M0) Survival and overall survival. Chinese medicine treatment in improving the overall prognosis of elderly patients with gastric cancer should be further evaluated as a randomized controlled study.