健脾为主的中药复方改善女性晚期胃癌预后的临床评价

Clinical evaluation on effects of Chinese medicine compound recipe for invigorating spleen on prognosis of female patients with advanced gastric cancer

目的:评价健脾为主的中药复方对女性晚期胃癌预后的影响。方法:多中心采集女性晚期胃癌患者,采用回顾性非随机同期对照研究方法,以总生存期(OS)作为主要的观察指标,用Kaplan-Meier生存分析计算中位OS,各因素组间用Log-rank进行显著性检验生存分布差异,并用Cox风险比例回归模型进行预后多因素的分析。结果:依据病例选择标准共收集初治女性晚期胃癌患者457例,单因素分析提示,中药(P=0.00)、姑息化疗(P=0.02)是影响女性晚期胃癌生存的预后因素,而原发部位(P=0.71)、组织学分型(P=0.07)、腹膜转移(P=0.17)、靶向治疗(P=0.71)、放疗(P=0.54)则不是。Cox风险比例模型分析亦提示,中药(P=0.00,相对危险度为0.62,95%CI:0.48~0.78)、姑息化疗(P=0.01,相对危险度为0.72,95%CI:0.57~0.92)为影响女性晚期胃癌生存的独立预后因素;而发病年龄(P=0.58)、原发部位(P=0.63)、组织学分型(P=0.18)、腹膜转移(P=0.16)、放疗(P=0.98)、靶向治疗(P=0.58)则为非影响因素。中药组中位生存期为17.6个月、非中药组为11.4个月,差异具统计学意义(P=0.00);中药组的1、2、3、5年生存率分别为72%、36%、19%、14%,而非中药组1、2、3、5年生存率分别为48%、23%、15%、10%。结论:健脾为主的中药复方可改善女性晚期胃癌的预后,联合姑息化疗是目前我国治疗女性晚期胃癌的主要方法。

Objective： To evaluate the effects of Chinese medicine compound recipe for invigorating spleen on the prognosis of female patients with advanced gastric cancer. Methods： Female patients with advanced gastric cancer were collected in multi centre. A retrospective non-randomized concurrent control study was conducted. The overall survival（ OS） was taken as the primary endpoint.Kaplan-Meier survival analysis was used to calculate the median OS. The difference of survival distribution among the groups was analyzed by Log-rank. The cox proportional hazard model was used to analyze the multivariate prognostic factors. Results： According to the criteria of case selection,457 female cases of advanced gastric cancer were collected. Single factor analysis suggested that Chinese medicine（ P =0.00）,palliative chemotherapy（ P = 0.02） were the prognostic factors which affected the survival of female patients with advanced gastric cancer,while the primary site（ P = 0. 71）,histological type（ P = 0. 07）,peritoneal metastasis（ P = 0. 17）,target therapy（ P = 0. 71） and radiotherapy（ P = 0.54） were not the prognostic factors. Cox regression analysis suggested that Chinese medicine（ P = 0. 00,hazard ratio[HR]= 0.62,95%CI： 0. 48-0.78）,palliative chemotherapy（ P = 0. 01,HR = 0. 72,95% CI： 0.57-0. 92） were independent prognostic factors.,while age of onset（ P = 0.58）,primary site（ P = 0.63）,histological type（ P = 0.18）,peritoneal metastasis（ P = 0.16）,radiotherapy（ P = 0.98） and targete therapy（ P = 0.58） were not the risk factors. The median overall survival of Chinese medicine group was 17.6 months and that of non-Chinese medicine group was 11.4 months,with statistically significant difference（ P = 0.00）. The one-year,twoyear,three-year and five-year survival rates of Chinese medicine group were 72%,36%,19% and 14% respectively,while the one-year,two-year,three-year and five-year survival rates of non-Chinese medicine group were 48%,23%,15% and 10% respectively. Conclusion：Chinese medicine compound recipe for invigorating spleen can improve the prognosis of female patients with advanced gastric cancer.Combined palliative chemotherapy is the main therapy for female patients with advanced gastric cancer in China.