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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 Jianpiliqi Yiliu Recipe combined with cytokine-induced killer (CIK) in the treatment of advanced hepatocellular carcinoma (HCC). Methods From January 2011 to January 2014, 60 patients with advanced HCC were enrolled and divided into treatment group and control group according to their willingness to take Jianpi Liqi Yiliu Decoction. Each group included 30 patients. Both groups were given CIK cell therapy: CIK cells 1 ~ 3 × 10 ~ 9 / times, 1 to 3 days for intravenous drip once a day; the same time treatment group Jianpi Liqi Yiliu decoction, control group To syndrome differentiation decoction, both groups received more than 2 cycles of treatment. Disease control rate (DCR), time to progress (TTP), overall su rvival (OS), performance status scale (PS), Child -Pugh score and adverse reactions, and for subgroup analysis. Results As of May 31, 2014, all patients in both groups reached the clinical end point. The TTP in the treatment group was 3.5 months (95% CI 3.30-4.10), which was better than that in the control group 2.5 months (95% CI 2.32-2.68), the difference was statistically significant (P <0.05); the treatment group and the control group (95% CI 4.53 ~ 5.87) and 4.6 months (95% CI 4.06 ~ 5.14). The difference was not statistically significant (P> 0.05). PS [(1.60 ± 0.10) points after treatment in treatment group was lower than that before treatment [(1.80 ± 0.09) points], the difference was statistically significant (P <0.05). The TTP of the treatment group was longer than that of the control group (P <0.05) at PS 0 ~ 1, 2 and Child-Pugh score of A grade. Two groups of patients during treatment showed no significant adverse reactions. Conclusion Jianpiqiqi Yiliu decoction combined with CIK cells can prolong the TTP and improve the physical status score of patients with CIK cells. And in the condition of 0 ~ 2 scores of physical status or Child-Pugh score of A level, it may be related to advanced HCC Patients with better treatment options.