1. 上海中医药大学附属龙华医院肿瘤一科,上海,200032
2. 上海中医药大学附属第七人民医院肿瘤科,上海,200137
3. 上海市第八人民医院中医科,上海,200235
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陶丽, 朱莹杰, 顾缨, 等. 基于生存分析的胃肠安方辨证治疗对不可切除性结直肠癌肝转移预后影响的双向队列研究[J]. 上海中医药杂志, 2017,51(1):42-49.
TAO Li, ZHU Ying-jie, GU Ying, et al. Bidirectional cohort study on the influence of syndrome differentiation treatment of Weichang’an Prescription on prognosis of unresectable colorectal liver metastases based on survival analysis[J]. Shanghai Journal of Traditional Chinese Medicine, 2017,51(1):42-49.
陶丽, 朱莹杰, 顾缨, 等. 基于生存分析的胃肠安方辨证治疗对不可切除性结直肠癌肝转移预后影响的双向队列研究[J]. 上海中医药杂志, 2017,51(1):42-49. DOI:
TAO Li, ZHU Ying-jie, GU Ying, et al. Bidirectional cohort study on the influence of syndrome differentiation treatment of Weichang’an Prescription on prognosis of unresectable colorectal liver metastases based on survival analysis[J]. Shanghai Journal of Traditional Chinese Medicine, 2017,51(1):42-49. DOI:
目的:观察中药胃肠安方辨证治疗对不可切除性结直肠癌肝转移患者总生存期(overall survival,OS)和无进展生存期(progression free survival,PFS)的影响。 方法:收集131例不可切除性结直肠癌肝转移患者的临床资料,采用双向队列同期对照方法,将其分为中西医结合组(65例)与西医组(66例)。运用Microsoft Excel及SPSS 21.0软件建立数据库,采用寿命表法统计患者的1、2、3、4、5年生存率;采用Kaplan-Meier法计算中位OS及PFS,并进行单因素分析,差异经Log-rank检验进行组间比较;将经单因素分析有统计学意义的因素纳入Cox回归模型进行多因素分析,筛选出不可切除性结直肠癌肝转移患者的预后相关因素。 结果:①西医组中位OS为18.5个月,中西医结合组中位OS为23.2个月,两组中位OS比较差异有统计学意义(P=0.006<0.05)。②西医组与中西医结合组的1、2、3、4、5年生存率分别为69.7% vs 87.2%、33.3%vs47.4%、14.5%vs28.4%、1.3%vs23.7%、0%vs 0%,提示中西医结合组5年内的生存率明显优于西医组(P<0.05)。③影响本病患者OS的独立保护因素是原发灶切除(P=0.003)、化疗(P=0.000)、中药辨证治疗(P=0.004);原发灶切除的风险比为0.433(95%CI:0.251~0.748),化疗的风险比为0.148(95%CI:0.060~0.365),服用中药的风险比为0.532(95% CI:0.347~0.816)。④西医组中位PFS为6.1个月,中西医结合组中位PFS为9.2个月,两组中位PFS比较差异有统计学意义(P=0.049<0.05)。⑤影响本病患者PFS的独立保护因素是原发灶切除(P=0.022)、肝转移灶局部治疗(P=0.020);原发灶切除的风险比为0.466(95%CI:0.242~0.895),肝转移灶局部治疗的风险比为0.576(95%CI:0.362~0.918)。 结论:胃肠安方为主的中医药辨证治疗是改善不可切除性结直肠癌肝转移预后的有效保护性因子;中西医结合治疗在延长不可切除性结直肠癌肝转移OS和PFS方面均显示出一定的优势。
Objective:To observe the influence of syndrome differentiation treatment of Weichang’an Prescription on the overall survival (OS) and the progression free survival (PFS) of patients with unresectable colorectal liver metastases. MethodsThe clinical data on a total of 131 patients with unresectable colorectal liver metastases were collected and divided into the integrated Chinese and western medicine group(65 cases)and western medicine group(66 cases)by the bidirectional cohort and concurrent control method.The database was established by Microsoft Excel and SPSS 21.0 software.The survival rates of patients within 1,2,3,4,5 years were counted by life-table method;the median OS and PFS were calculated by Kaplan-Meier method and then carried on the univariate analysis,the difference was compared between groups by Log-rank test;the factors with statistically significance in univariate analysis were enrolled in Cox regression analysis and conducted the multivariate analysis.The prognosis related factors of patients with unresectable colorectal liver metastases were screened out. Results:①The median OS of the western medicine group was 18.5 months and the median OS of the integrated therapy group was 23.2months. There was significant difference on the median OS between the two groups (P=0.006<0.05). ②Within 1,2,3,4,5 years the survival rates of the western medicine group and integrated therapy group were 69.7% vs 87.2%, 33.3%vs 47.4%, 14.5%vs 28.4%, 1.3%vs 23.7%, 0%vs 0% respectively,which suggested that the survival rate of the integrated therapy group in 5 years was obviously better than that of the western medicine group(P<0.05).③The Cox regression analysis suggested that resection of primary tumor (P=0.003) , chemotherapy (P=0.000) and syndrome differentiation treatment of Chinese medicine(P=0.004) were independent prognostic factors which affected the OS of patients with this disease. The hazard ratio of resection of primary tumorwas 0.433(95%CI:0.251-0.748),chemotherapy was 0.148(95%CI:0.060-0.365),administration with Chinese medicine was 0.532(95% CI:0.347-0.816). ④The median PFS of the western medicine group were 6.1 months,and the median PFS of the integrated therapy group were 9.2 months. There was significant difference on the median PFS between the two groups (P=0.049<0.05). ⑤The Cox regression analysis suggested that resection of primary tumor (P=0.022) and local treatment of liver metastases(P=0.020) were independent prognostic factors which affected PFS of patients with this disease. The hazard ratio of resection of primary tumor was 0.466(95%CI:0.242-0.895), and local treatment of liver metastases was 0.576(95%CI:0.362-0.918). Conclusion:The syndrome differentiation treatment of traditional Chinese medicine based on Weichang’an Prescription are effectively protective factors of prognosis;integrated therapy of Chinese and western medicine show a certain advantage on prolonging OS and PFS of patients with unresectable colorectal liver metastases,which needs to be further evaluated by follow-up.
结直肠癌肝转移不可切除中医药疗法辨证论治总生存期无进展生存期
colorectal cancerliver metastasesunresectabletherapy of traditional Chinese medicinesyndrome differentiation treatmentoverall survivalprogression free survival
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