RESUMEN
Objective To investigate the clinical effect of Bielong Ruangan decoction combined with transcatheter arterial chemoembolization (TACE) versus TACE alone in the treatment of hepatitis B virus (HBV)-related primary liver cancer.Methods The patients with HBV-related primary liver cancer who were hospitalized in Liver Research Center in The First Affiliated Hospital of Hunan University of Chinese Medicine from March 2014 to March 2016 were enrolled and randomly divided into study group and control group.The patients in the study group were treated with Bielong Ruangan decoction combined with TACE,and those in the control group were treated with TACE alone.The two groups were observed in terms of short-term therapeutic effect,traditional Chinese medicine (TCM) syndrome score,reduction in serum alpha-fetoprotein (AFP),incidence rate of post-TACE syndrome,and 1-year survival rate.The t-test was used for comparison of continuous data between groups;the chi-square test was used for comparison of categorical data between groups;the ridit analysis was used for comparison of ranked data between groups;the Kaplan-Meier method was used to calculate survival rate and plot survival curves;the log-rank test was used to compare survival rates between groups.Results There were significant differences between the study group and the control group in objective tumor response rate (77.4％ vs 56.4％,x2 =9.898,P =0.020) and reductions in TCM syndrome score and serum AFP level (t =2.194,P =0.030).As for the incidence rate of embolism syndrome after TACE,the study group had significantly lower incidence rates of pyrexia,nausea,vomiting,and poor appetite than the control group (all P ＜ 0.05).The study group had significantly higher quality of life and physical scores than the control group (t =-3.893 and-6.187,both P ＜ 0.001).There was also a significant difference in 1-year survival rate between the study group and the control group [77.4％ (48/62) vs 63.6％ (35/55),x2 =4.228,P =0.040].Conclusion In patients with HBV-related primary liver cancer,Bielong Ruangan decoction combined with TACE can improve their short-term clinical outcome and quality of life.