关键词: 肝肿瘤, 肝动脉化疗栓塞术, 癌痛消颗粒, 治疗结果, 预后, 自然杀伤T细胞

Abstract: Background　Hepatic arterial chemoembolization（TACE） is an important treatment for advanced primary liver cancer（PLC）．But some patients still have recent disease progression，low quality of life and functional ability for independent living after TACE treatment.Aitongxiao granules，a prescription developed by Professor WEI Ailing，the First Affiliated Hospital of Guangxi University of Chinese Medicine，has been clinically proved to be effective for PLC.But the efficacy of Aitongxiao granules combined with TACE for PLC and natural killer cell immune functions〔including interleukin（IL）-12，IL-10 and gamma interferon（IFN-γ）〕 is still unclear.Objective　To explore the clinical response and responses of IL-12，IL-10 and IFN-γ to Aitongxiao granules combined with TACE in PLC.Methods　This study was a randomized controlled single-blind，single-center test.According to the inclusion criteria，we enrolled 86 cases of PLC and 20 physical examinees（healthy group） from the First Affiliated Hospital of Guangxi University of Chinese Medicine，from June 2014 to February 2016.The PLC patients were equally divided into the experimental group and control group by a random number table.All PCL cases ate low-fat high-quality protein diet and were treated with TACE，the cases in the experimental group additionally took Aitongxiao granules，one dose per day.The treatment for PCL cases lasted for one course of treatment（8 weeks），and the follow-up for them ended on March 5，2018.Comparisons were made between the experimental and control groups in terms of clinical response，TCM syndrome score at baseline，by the end of the 7th day，4th and 8th weeks of treatment，and serum IL-12，IL-10 and IFN-γ levels,quality of life（assessed by EORTC QLQ-C30），before and after treatment，and long-term prognosis 〔total survival（OS） and time-to-progression（TTP）〕 and treatment-related side effects.Results　The overall response rate of the experimental group was much higher than that of the control group 〔83.72%（36/43） vs 65.12%（28/43）〕（χ2=3.909，P=0.048）．The TCM syndrome score decreased significantly in both the experimental and the control groups by the end of the 7th day，4th and 8th weeks of treatment（P<0.05）．The experimental group showed lower TCM syndrome score than the control group by the end of 4th，and 8th weeks of treatment（P<0.05）．At baseline and at the end of treatment，both the experimental and control groups had higher IL-10 levels and lower serum IL-12 and IFN-γ levels compared with the healthy group（P<0.05）．When the treatment ended， serum IL-10 was lower and serum IL-12 and IFN-γ were higher in the experimental group compared with the control group（P<0.05）.When the treatment ended，serum IL-10 decreased significantly but serum IL-12 and IFN-γ increased obviously in both the experimental and control groups（P<0.05）．At the end of treatment，both experimental and control groups had increased mean function score and decreased mean symptom score of EORTC QLQ-C30 compared with baseline（P<0.05）．Moreover，the experimental group showed higher mean function score and lower mean symptom score than the control group（P<0.05）．The median OS and TTP were 17（10，30），11（6，15） months for the control group，and 26（14，30），15（11，22） months for the experimental group.Both the risk of death and risk of disease progression of the experimental group were lower than those of the control group〔HR=0.529，95%CI（0.309，0.919），P=0.019；HR=0.568，95%CI（0.361，0.893），P=0.006〕.Conclusion　Aitongxiao granules combined with TACE has good clinical efficacy for PLC，which can significantly reduce the symptoms，effectively regulate the immune factor levels and improve the long-term prognosis.

Key words: Liver neoplasms, Transcatheter arterial chemoembolization, Aitongxiao granules, Treatment outcome, Prognosis, Natural killer T-cells