Study on the effect of Xiaotan Sanjie Decoction treatment based on the progression-free survival of patients with intermediate and advanced gastric cancer
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摘要: [目的]探讨消痰散结方干预中晚期胃癌患者无进展生存期的临床疗效。[方法]本研究根据非随机临床同期对照研究及患者自愿原则，分为2组，中药组和化疗组，中药组以消痰散结方为基础，随证加减，每日1剂，连续服用6个月。对照组化学治疗采用氟尿嘧啶为基础的方案，疗程为3~6个周期。采用单因素生存曲线比较法，COX多因素回归分析方法，比较2组患者无进展生存期的时间。[结果]采用Kaplan-Metier方法，Log-rank检验各个单因素与转移的影响，其中年龄、手术方式、体重、治疗方式、卡氏评分等5个因素与中晚期胃癌的无进展生存期相关，对9个变量进行多因素COX比例风险模型分析，结果显示中药治疗（P=0.00）、手术方式（P=0.00）、体重（P=0.014）为影响中晚期胃癌的生存期的独立性相关因素。服用中药的相对危险度为0.302（95%CI：0.176~0.521），手术方式的相对危险度为2.459（95%CI：1.436~4.208），体重的相对危险度为0.965（95%CI：0.937~0.993）。服用消痰散结方组患者无进展生存期（29.513±9.40）个月，化疗组平均无进展时间为（22.0259±8.01）个月，2组比较差异有统计学意义（P<0.05）。[结论]以消痰散结方为基础的中药复方辨证治疗可以延长中晚期胃癌患者无进展生存期，是中晚期胃癌预后的独立保护性因素，可使患者生存受益。Abstract: [Objective] To investigate the clinical efficacy of "Dispersing Phlegm and Eliminating Stagnation" Decoction on the progression-free survival time of patients with intermediate and advanced gastric cancer.[Methods] According to the voluntary principle, patients were divided into TCM group and chemotherapy group.TCM group were treated with modified "Dispersing Phlegm and Eliminating Stagnation" Decoction according to symptoms for 6 months.Chemotherapy group were treated with fluorouracil-based chemotherapy for 3 to 6 cycles.After the treatment, the two groups were followed up.Progression free survival were recorded and compared by Kaplan-Merier and COX multiple factors regression analysis.[Results] Five factors, such as, age, operation method, weight, treatment, KPS, were associated with the progression free surial time of intermediate and advanced gastric cancer.By COX proportional hazards model analysis, the results showed that the body weight(P=0.014), Chinese medicine treatment(P=0.00), surgical procedures(P=0.00) were the independent factors related to the survival time of advanced gastric cancer.The relative risk of the Chinese medicine was 0.302(95% CI:0.176-0.521), the relative risk of surgical approach was 2.459(95% CI:1.436-4.208), the relative risk of weight was 0.965(95% CI:0.937-0.993).The time of progression free survival in the observation group was 29.513±9.40 months, compared with 22.0259±8.01 months in the control group, the difference was statistically significant(P<0.05).[Conclusion] On the basis of the clinical efficacy of "Dispersing Phlegm and Eliminating Stagnation" Decoction of traditional Chinese medicine syndrome differentiation treatment was the independent protective factors of middle-late gastric cancer prognosis, and the recipe can significantly prolong the survival time of patients with advance d gastric cancer.
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