原发性肝癌维持治疗中3种中成药的临床价值

The Clinical value of three Chinese patent medicine in Maintenance therapy of Primary liver cancer

目的:通过分析3种常见中成药在原发性肝癌维持治疗中的临床效果及预后,为原发性肝癌维持治疗方法的选择提供参考。方法:选择110例连续使用中成药的原发性肝癌患者,基于非干预性研究方法,根据治则分为参一胶囊组(健脾扶正法)、西黄丸组(解毒散结法)、紫龙金片组(化瘀抗癌法),应用Kaplan-Meier方法计算3组患者的中位生存时间,并纳入17个可能影响原发性肝癌预后的相关因子,应用时序检验(Log-rank test)进行组间生存率单因素比较,Cox回归模型进行多因素分析,筛选出影响各组患者预后的相关因素。结果:110例患者总体中位生存时间8.3月,其中参一胶囊组患者中位生存期最长,与其他两组比较差异具有统计学意义(P<0.05)。Child-Pugh分级、腹水情况、检出方式、门脉癌栓、AFP、总胆红素、白蛋白、胆碱酯酶、肿瘤类型、中药治疗时间、介入次数和BCLC分期对中成药治疗原发性肝癌的预后有影响。腹水情况、中药治疗时间、BCLC分期是影响参一胶囊组患者预后因素;Child-Pugh分级、腹水情况、胆碱酯酶、中药治疗时间、介入次数、BCLC分期是影响西黄丸组患者的预后因素;腹水情况、总胆红素、胆碱酯酶、BCLC分期是影响紫金龙片组患者的预后因素。结论:参一胶囊、西黄丸、紫龙金片在原发性肝癌维持与辅助治疗中均显示稳定积极效应;体现健脾扶正法的参一胶囊能够显著延长患者的中位生存期;3种治法的适应证各有侧重,预后影响因子不尽相同,为原发性肝癌中成药辨证治疗的合理实施提供参考。

Objective： To observe the the Clinical value of three Chinese patent medicine in Maintenance therapy of Primary liver cancer,and to provide reference for the selection of primary liver cancer maintenance treatment methods. Methods： One hundred and ten cases of primary liver cancer patients who used Chinese patent medicines continuously,based on the non intervention research method,according to the rule of treatment,were divided into Shen Yi capsule group（ Jianpi Fuzheng）,Xihuang Pill group（ removing toxic and dissipating mass）,and the Zilongjin tablet group（ removing blood stasis anti-cancer）,Kaplan-Meier method was used to calculate the median survival time of the three groups of patients,and include 17 related factors that may affect the prognosis of primary liver cancer,using Log-rank test to compare single-factor survival rates among groups and Cox regression model for multivariate analysis,finally screen out relevant factors affecting the prognosis of each group of patients. Results： The overall median survival time of 110 patients was 8. 3 months,among which the median survival time was the longest in the Shenyi Capsule group,and there was a statistically significant difference compared with the other two groups（ P〈0. 05）. Child-Pugh classification,ascites,detection methods,portal vein cancer thrombosis,AFP,total bilirubin,albumin,cholinesterase,tumor type,treatment time of Chinese herbal medicine,number of interventions,and BCLC staging would affect the prognosis of Primary liver cancer which treat by Chinese medicine. Ascites,Chinese medicine treatment time and BCLC staging were the prognostic factors of primary liver cancer treated by Jianpi Fuzheng method; Child-Pugh classification,ascites,cholinesterase,Chinese medicine treatment time,frequency of intervention,BCLC staging were the prognostic factors of primary liver cancer treated by removing toxic and dissipating mass method; Ascites,total bilirubin,cholinesterase and BCLC staging were the prognostic factors of primary liver cancer treated by removing blood stasis anti-cancer method. Conclusion： Shen Yi capsule,Xi Huang pill and Zi Long Jin tablet showed stable and positive effects in maintenance and adjuvant treatment of primary liver cancer; Shenyi capsules that embody spleen-strengthening and strengthening vital energy can significantly prolong the median survival of patients. The indications of the three treatment methods have different focuses,and the prognostic factors are not the same. It provides a reference for the rational implementation of syndrome differentiation and treatment of PLC Chinese patent medicine.