健脾为主中药复方联合化疗延长晚期胃癌复治患者生存期的前瞻性同期对照研究

Prospective Concurrent Control Study of Traditional Chinese Herbal Medicine Based on Invigorating Spleen Combined With Chemotherapy as Second-line Therapy for Advanced Gastric Cancer

目的：评价以健睥为主中药复方辨证治疗在晚期胃癌复治患者（二线治疗）中的疗效。方法：采用多中心、前瞻性同期对照研究，将晚期胃癌一线治疗失败病例，以是否自愿接受基于健脾为主中药复方辨证治疗分为中药治疗组和非中药治疗组。主要研究终点为总生存期（overall survival，OS）。通过Cox比例风险回归模型对影响0S的预后因素进行多因素分析，应用Kaplan—Meier法估算中位生存时间。结果：共有181例晚期胃癌二线治疗的病例纳入本项研究，其中中药治疗组101例，非中药治疗组80例，Cox多因素研究结果显示，姑息手术（相对危险度HR=0.497，95％CI：0.345～0.718，P：0.000）、健脾为主的中药复方（HR=0．600，95％CI：0．423～0．849，P=0．004）是影响初治化疗失败晚期胃癌OS独立的预后因素。中药组的中位OS为8．6个月，较非中药组的7．4个月延长（P=0．002）。结论：健脾为主中药复方辨证治疗是影响晚期胃癌二线治疗预后的独立保护性因素。健脾为主中药复方辨证治疗可延长晚期胃癌复治患者的生存期。

Objective ： To evaluate the effect of traditional Chinese herbal medicine based on invigorating spleen combined with chemotherapy as second - line therapy for advanced gastric cancer. Methods ： Patients with advanced gastric cancer who failed in first - line chemotherapy were prospectively enrolled, with the multi - center and prospective concurrent control study. All Patients were assigned to either traditional Chinese herbal medicine based on invigorating spleen （TCHM） group or non - TCHM group by their own wills. The primary endpoint was overall survival （OS）. Multivariate Cox - regression a- nalysis was performed to determine survival trends adjusted for clinical and demographic factors. Kaplan - Meier curves were used to assess the differences in OS. Result： 181 patients with advanced gastric cancer were assigned to the study （TCHM group n = 101, and non -TCHM group n = 80）. Cox -regression analysis suggested that palliative surgery （hazard ratio [ HR ] = 0. 497, 95% confidence interval [ CI ] ： 0. 345 - 0. 718, P = 0. 000 ） and TCHM treatment （ HR = 0. 600, 95% CI： 0.423 -0.849, P =0. 004） were independent prognostic factors for OS. Overall survival time was 8.6 months in the TCHM group compared with 7.4 months in non - TCHM group （ P = 0. 002 ）. Conclusion ： Chinese traditional herbal med- icine based on invigorating spleen was an independent protective factor for patients with advanced gastric cancer who failed in first - line chemotherapy. It could prolong the overall survival time of advanced gastric cancer.