健脾理气抑瘤方联合细胞因子介导的杀伤细胞治疗晚期肝细胞癌的临床研究

Combination of Jianpi Liqi Yiliu Formula with Cytokine-induced Killer Cell Treatment for Advanced Hepatocellular Carcinoma

目的评价健脾理气抑瘤方联合细胞因子介导的杀伤细胞（cytokine-induced killer,CIK）治疗晚期肝细胞癌（hepatocellular carcinoma,HCC）的临床疗效。方法自2011年1月—2014年1月共纳入60例晚期HCC患者,根据是否愿意服用健脾理气抑瘤方,分为治疗组和对照组,每组30例。两组均给予CIK细胞治疗：CIK细胞1~3×10~9个/次,第1~3天进行静脉滴注,每天1次;同时治疗组予健脾理气抑瘤方汤剂,对照组予辨证中药汤剂,两组均接受2周期以上的治疗。观察两组患者的疾病控制率（disease control rate,DCR）、疾病进展时间（time to progress,TTP）、总生存期（overall su rvival,OS）、体能状态评分（performance status scale,PS）、Child-Pugh评分及不良反应,并作亚组分析。结果截至2014年5月31日,两组所有患者均达到临床终点。治疗组TTP为3.5个月（95%CI 3.30~4.10）,优于对照组2.5个月（95%CI 2.32~2.68）,差异有统计学意义（P〈0.05）;治疗组和对照组DCR分别为36.7%和30.0%,OS为5.2个月（95%CI 4.53~5.87）和4.6个月（95%CI 4.06~5.14）,差异均无统计学意义（P〉0.05）。治疗组治疗后PS[（1.60±0.10）分]低于治疗前[（1.80±0.09）分],差异有统计学意义（P〈0.05）。在PS 0~1、2分和Child-Pugh评分为A级时,治疗组TTP均长于对照组（P〈0.05）。治疗期间两组患者未见明显不良反应。结论健脾理气抑瘤方联合CIK细胞较辨证中药治疗组可延长患者TTP及改善体力状态评分,且在体力状态评分0~2分或Child-Pugh评分为A级的情况下,可能是晚期HCC患者的更优治疗方案。

Objective To evaluate the clinical efficacy of Jianpi Liqi Yiliu Formula（JLYF） combined with cytokine-induced killer（CIK） cells for treating patients with advanced hepatocellular carcinoma（HCC）.Methods Between January 2011 and January 2014,60 advanced HCC patients were enrolled in this study,who were assigned to the treatment group and the control group according to their willingness for taking JLYF,30 cases in each group.All patients received CIK cell treatment：1×10~9-3×10~9 each time,by intravenous dripping from the 1st day to the 3rd day,once per day.Besides,patients in the treatment group took JLYF decoction,while those in the control group took Chinese medical decoction by syndrome typing.All patients received treatment of at least two cycles.The time to progression（TTP）,overall survival（OS）,disease control rate（DCR）,performance status scale（PS）,Child-Pugh scale,and adverse reactions were observed,and subgroup analyzed.Results To May 31,2014,all patients reached the clinical endpoint.TTP was 3.5 months（95%CI：3.30-4.10） in the treatment group,better than that（2.5 months,95%CI：2.32-2.68） of the control group（P 〈0.05）.DCR was 36.7%in the treatment group and 30.0%in the control group（P〉0.05）.OS was 5.2 months（95%CI：4.53-5.87） in the treatment group and 4.6 months（95%CI：4.06-5.14） in the control group（P〉0.05）.The PS scale was 1.60 ±0.10 after treatment,lower than that（1.80 ±0.09） before treatment in the treatment group（P 〈0.05）.When the PS scale was 0-2 or Child-Pugh scale was class A,TTP was longer in the treatment group than in the control group（P〈0.05）.No adverse reaction occurred in the two groups during the treatment course.Conclusions The combination of JLYF with CIK cell treatment could prolong advanced HCC patients’ TTP,improve PS scale,as compared with syndrome typed Chinese medical decoction treatment group.Besides,when the PS scale was 0-2 or Child-Pugh scale was class A,it was a better treatment program for advanced HCC patients.