OBJECTIVE:To investigate the effect of the decoction of Fuzheng Jiedu Xiaoji formula(扶正解毒消积方,FJXF)plus chemoembolization(TACE)on primary liver cancer(PLC)in patients,and study the underlying mechanism.METHODS:P...OBJECTIVE:To investigate the effect of the decoction of Fuzheng Jiedu Xiaoji formula(扶正解毒消积方,FJXF)plus chemoembolization(TACE)on primary liver cancer(PLC)in patients,and study the underlying mechanism.METHODS:Patients with PLC who met the inclusion criteria were randomized into case group and control group.The case group was treated with FJXF combined with TACE.The control group was treated with TACE alone.The short-term clinical effect was evaluated;liver biochemistry,liver function index and multidrug resistance-associated indicators were detected.RESULTS:FJXF combined with TACE in the case group significantly increased the disease control rate than TACE alone in the control group(83.3%vs 61.1%).There was a reduction in the serum alpha-fetoprotein at 8 weeks after treatment in each group,while no difference between the two groups.The same trend can be observed for transaminase and direct bilirubin in both groups.In the case group,it showed a significant increase for albumin at 8 weeks after treatment,while no change in the control group.Multidrug resistanceassociated indicators for multidrug resistance protein 1 and p-glycoprotein were upregulated in the case group but remained stable in the control group.CONCLUSIONS:FJXF combined TACE had a better short-term effect than TACE alone in patients with PLC.The potential mechanism was probably associated with alleviated multidrug resistance induced by FJXF.Additionally,FJXF didn’t increase the risk of liver damage in the combined therapy.展开更多
Objective: To evaluate whether adding Fuzheng Jiedu Xiaoji(FZJDXJ) therapy improves survival in advanced hepatitis B virus-related hepatocellular carcinoma(HBV-HCC) patients. Methods: This prospective, randomized cont...Objective: To evaluate whether adding Fuzheng Jiedu Xiaoji(FZJDXJ) therapy improves survival in advanced hepatitis B virus-related hepatocellular carcinoma(HBV-HCC) patients. Methods: This prospective, randomized controlled study was performed at a major academic medical center in Beijing, China from October 2020 to October 2022. Eligible patients with advanced HBV-HCC were randomly divided equally(1:1) to receive either the combination of FZJDXJ and conventional Western medical therapy(63 cases, FZJDXJ group) or solely Western medicine(66 cases, control group). The study endpoints consisted of overall survival(OS) as the primary outcome, with progression-free survival(PFS), disease control rate(DCR), and adverse events(AEs) as secondary measures. Results: The median OS was significantly prolonged in the FZJDXJ group at 8.9 months(95% CI: 6.0–11.9) vs. 4.4 months(95% CI: 3.2–7.3) in the control group(P<0.05). The hazard ratio for mortality in the FZJDXJ group was 0.59(95% CI: 0.40–0.89), suggesting a 41% lower risk of death compared to the control group. The results revealed that patients receiving FZJDXJ therapy achieved a PFS of 5.1 months(95% CI: 4.1 to 7.2 months), compared to only 2.9 months(95% CI: 2.0 to 4.6 months) in the control group(P<0.05). Additionally, DCR was significantly elevated in the FZJDXJ group(20.6%) compared to the control group(10.6%, P<0.05). Subgroup analysis demonstrated that FZJDXJ significantly improved OS in patients with alpha-fetoprotein levels <400 ng/m L, age <60 years, Barcelona Clinic Liver Cancer(BCLC) stage C, and compensated liver function(Child-Pugh A and B, P<0.05). Multivariate analysis revealed that FZJDXJ therapy acted as an independent factor protecting against mortality within 1 year. Gastrointestinal symptoms are rare side effects, and no fatalities associated with the treatment were reported. Conclusion: This randomized controlled trial demonstrated that FZJDXJ combined Western conventional therapy significantly improves OS and PFS in patients with advanced HBV-HCC.展开更多
基金Supported by Beijing Municipal Administration of Hospitals Incubating Program(No.pz2017029)
文摘OBJECTIVE:To investigate the effect of the decoction of Fuzheng Jiedu Xiaoji formula(扶正解毒消积方,FJXF)plus chemoembolization(TACE)on primary liver cancer(PLC)in patients,and study the underlying mechanism.METHODS:Patients with PLC who met the inclusion criteria were randomized into case group and control group.The case group was treated with FJXF combined with TACE.The control group was treated with TACE alone.The short-term clinical effect was evaluated;liver biochemistry,liver function index and multidrug resistance-associated indicators were detected.RESULTS:FJXF combined with TACE in the case group significantly increased the disease control rate than TACE alone in the control group(83.3%vs 61.1%).There was a reduction in the serum alpha-fetoprotein at 8 weeks after treatment in each group,while no difference between the two groups.The same trend can be observed for transaminase and direct bilirubin in both groups.In the case group,it showed a significant increase for albumin at 8 weeks after treatment,while no change in the control group.Multidrug resistanceassociated indicators for multidrug resistance protein 1 and p-glycoprotein were upregulated in the case group but remained stable in the control group.CONCLUSIONS:FJXF combined TACE had a better short-term effect than TACE alone in patients with PLC.The potential mechanism was probably associated with alleviated multidrug resistance induced by FJXF.Additionally,FJXF didn’t increase the risk of liver damage in the combined therapy.
基金Supported by the High-Level Chinese Medicine Key Discipline Construction Project(No.zyyzdxk-2023005)Capital Health Development Research Project(No.2024-1-2173)National Natural Science Foundation of China(Nos.82474426,82474419 and 82204848)。
文摘Objective: To evaluate whether adding Fuzheng Jiedu Xiaoji(FZJDXJ) therapy improves survival in advanced hepatitis B virus-related hepatocellular carcinoma(HBV-HCC) patients. Methods: This prospective, randomized controlled study was performed at a major academic medical center in Beijing, China from October 2020 to October 2022. Eligible patients with advanced HBV-HCC were randomly divided equally(1:1) to receive either the combination of FZJDXJ and conventional Western medical therapy(63 cases, FZJDXJ group) or solely Western medicine(66 cases, control group). The study endpoints consisted of overall survival(OS) as the primary outcome, with progression-free survival(PFS), disease control rate(DCR), and adverse events(AEs) as secondary measures. Results: The median OS was significantly prolonged in the FZJDXJ group at 8.9 months(95% CI: 6.0–11.9) vs. 4.4 months(95% CI: 3.2–7.3) in the control group(P<0.05). The hazard ratio for mortality in the FZJDXJ group was 0.59(95% CI: 0.40–0.89), suggesting a 41% lower risk of death compared to the control group. The results revealed that patients receiving FZJDXJ therapy achieved a PFS of 5.1 months(95% CI: 4.1 to 7.2 months), compared to only 2.9 months(95% CI: 2.0 to 4.6 months) in the control group(P<0.05). Additionally, DCR was significantly elevated in the FZJDXJ group(20.6%) compared to the control group(10.6%, P<0.05). Subgroup analysis demonstrated that FZJDXJ significantly improved OS in patients with alpha-fetoprotein levels <400 ng/m L, age <60 years, Barcelona Clinic Liver Cancer(BCLC) stage C, and compensated liver function(Child-Pugh A and B, P<0.05). Multivariate analysis revealed that FZJDXJ therapy acted as an independent factor protecting against mortality within 1 year. Gastrointestinal symptoms are rare side effects, and no fatalities associated with the treatment were reported. Conclusion: This randomized controlled trial demonstrated that FZJDXJ combined Western conventional therapy significantly improves OS and PFS in patients with advanced HBV-HCC.
