茯苓四逆汤联合索拉菲尼治疗晚期原发性肝癌的疗效观察  

Effect of Fuling Sini Decoction Combined with Sorafenib on Advanced Primary Liver Cancer

作　　者：余静芳 李泽鹏 周晓玲[1] 李灿 刘莹 张悦 韦宛华 YU Jingfang;LI Zepeng;ZHOU Xiaoling;LI Can;LIU Ying;ZHANG Yue;WEI Wanhua(Liuzhou Hospital of Traditional Chinese Medicine,Liuzhou 545000,China;Guangzhou University of Chinese Medicine,Guangzhou 510000,China)

机构地区：[1]柳州市中医医院,广西柳州545000 [2]广州中医药大学,广东广州510000

出　　处：《中医药学报》2021年第6期76-80,共5页Acta Chinese Medicine and Pharmacology

基　　金：国家自然科学基金项目(81760855);柳州市应用技术研究与开发计划项目(2018AF10503);柳州市科协软科学研究课题(20190109号)。

摘　　要：目的:观察茯苓四逆汤联合索拉菲尼治疗晚期原发性肝癌的疗效及对患者免疫功能的影响。方法:选取2017年1月1日—2018年12月31日在柳州市中医医院消化科门诊或住院治疗的晚期原发性肝癌患者,将纳入病例随机分为西药组(单纯索拉非尼治疗)、中药组(单纯中药茯苓四逆汤治疗)和联合组(索拉非尼联合茯苓四逆汤治疗)。治疗4周后进行近期疗效评价和远期疗效评价;同时观察三组患者治疗前后外周血T淋巴细胞亚群变化情况。结果:治疗4周后,基于改良版实体肿瘤疗效评价标准mRECIST的近期疗效评价结果显示,联合组患者的疾病控制率为84.85%(28/33),显著高于西药组的53.13%(17/32)及中药组的55.00%(22/40)(P<0.05);生存分析表明,联合组患者拥有更好的生存获益,且联合组12个月的生存率亦明显优于西药组和中药组(P<0.05);治疗4周后,联合组及中药组患者CD4^(+)/CD8^(+)比值明显上升,CD8^(+)细胞比例下降,治疗前后差异有统计学意义(P<0.05);经治疗后两组患者CD3^(+)、CD8^(+)细胞百分率和CD4^(+)/CD8^(+)比值的变化与西药组比较,差异均有统计学差异(P<0.05),提示中药治疗可改善肝癌患者的免疫功能,从而提高机体自身抗肿瘤作用。结论:索拉非尼联合茯苓四逆汤与单纯索拉非尼、单纯中药治疗相比能显著改善晚期原发性肝癌患者的生存结局,这可能与调节肿瘤患者免疫功能有关,但仍需要大样本的前瞻性随机对照研究去证实。Objective:To observe the curative effect of Fuling Sini Decoction combined with Sorafenib in the treatment of advanced primary liver cancer and its influence to immune function of the patients.Methods:Patients with advanced primary liver cancer were randomly divided into the western medication group(Sorafenib),the TCM medication group(Fuling Sini Decoction)and the combined group(Sorafenib combined with Fuling Sini Decoction).After 4 weeks of the treatment,the short-term and long-term effect evaluation were carried out,and the changes of peripheral blood T lymphocyte subsets were observed before and after the treatment in the three groups.Conclusion:After 4 weeks of the treatment,the results of short-term evaluation based on mRECIST criteria showed that the disease control rate was 84.85%(28/33)in the combined group,which was significantly higher than 53.13%(17/32)in the western medication group and 55.00%(22/40)in the TCM medication(P<0.05).Survival analysis showed that the patients in the combined group had better survival benefits,and the 12-month survival rate in the combined group was significantly higher than that in the western medication group and the TCM medication group(P<0.05).The ratio of CD4^(+)/CD8^(+)was significantly increased and the proportion of CD8 cells was significantly decreased after four weeks of the treatment compared to those before the treatment in the combined group and the TCM medication group(P<0.05).There were statistical differences in the cell percentage of CD3^(+)and CD8^(+),as well as in the ratio of CD4^(+)/CD8^(+)between the western medication group and the TCM medication group,as well as between the western medication group and the combined group,which suggested that TCM medication could improve the immune function of the patients with liver cancer and improve the anti-tumor effect of the body itself.Conclusion:Sorafenib combined with Fuling Sini Decoction may significantly improve survival outcomes in the patients with advanced primary liver cancer when compared to single ap

关 键 词：茯苓四逆汤 索拉菲尼 原发性肝癌 临床观察 

分 类 号：R273.57[医药卫生—中西医结合]