Objective： To investigate the efficacy and safety of the Fuzheng Huayu Tablet （扶正化瘀片, FZHYT）, which is used to reinforce qi and resolve stasis in patients with posthepatitic cirrhosis （PHC）. Methods： A mult...Objective： To investigate the efficacy and safety of the Fuzheng Huayu Tablet （扶正化瘀片, FZHYT）, which is used to reinforce qi and resolve stasis in patients with posthepatitic cirrhosis （PHC）. Methods： A multicenter, randomized, controlled clinical trial was conducted in 180 patients with PHC. The patients were randomly assigned using random numbers to a treatment group treated with FZHYT and a placebo group; the treatment course was 6 months for both groups. Overall response, adverse events （AEs）, and the 2-year survival rate were assessed after treatment. Evaluations were made on changes in liver function, liver fibrosis, coagulation, hemodynamics, degrees of esophagogastric varices, ascites, quality of life （QOL）, and scores of main symptoms. Results： The overall response was significantly higher in the treatment group than the placebo group （86.7% vs. 62.2%, P〈0.01）. Patients in both groups had significant improvements in liver function [total bilirubin （TBIL）, albumin （ALB）], liver fibrosis [hyaluronic acid （HA）, type 1V collagen （CIV）], coagulation [prothrombin time （PT）, activated partial thromboplastin time （APTT）, fibrinogen （FIB）, and thrombin time （TT）], hemodynamics portal venous flow （PVF）, and splenic vein flow （SVF） after treatment. Between-group comparisons showed that compared with the placebo group patients in the treatment group achieved significantly greater improvements in TBIL, ALB, HA, C IV, PT, AP＇I-r, PVF, SVF, time to ascites resolution, 2-year survival, QOL, and symptom scores （P〈0.05 or P〈0.01）. There were no significant AEs during the treatment. Conclusion： FZHYT is effective and safe for the treatment of hepatic cirrhosis as it is associated with improved liver function, liver fibrosis, coagulation, portal hypertension state, QOL, 2-year survival rate, and fewer AEs.展开更多
Background Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B(CHB),but it has a limited effect on cirrhosis.Chinese medicines(CMs),particularly Fuzheng Huayu Tablet(扶正化瘀片,FZHY),have an an...Background Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B(CHB),but it has a limited effect on cirrhosis.Chinese medicines(CMs),particularly Fuzheng Huayu Tablet(扶正化瘀片,FZHY),have an antifibrotic effect in patients with CHB.Objective To observe the safety and efficacy of adjunctive FZHY in patients with hepatitis B virus(HBV)cirrhosis,this study was designed as a randomized,placebo-controlled,double-blind,parallel assignment,multicenter trial at 20 centers in China.The total 700 naive patients will be enrolled with compensate cirrhosis due to HBV,and randomly assigned into 2 groups,receiving entecavir(0.5 mg,daily)and FZHY placebo(1.6 g,3 times a day),or entecavir(0.5 mg,daily)and FZHY(1.6 g,3 times a day),respectively.The primary endpoint was histological improvement at week 48.The secondary outcome is the decline values of liver fibrosis using the noninvasive methods from baseline to week 48 in each arm of the study.Adverse events such as stomach upset,headache,fatigue,dizziness,nausea will be strictly recorded.Discussion Through this study,we hope to generate a solid evidence for the therapeutic strategy of HBV cirrhosis with a combination of anti-viral such as ETV and anti-fibrotic herbal product such as FZHY.Protocol version:Version 1.3,Date:2014.12.4.Trial registration number:NCT02241590.展开更多
Objective： To observe the influence of Fuzheng Huayu Tablet （扶正化瘀片, FZHYT） on mental state and social activity of patients with post-hepatitis B liver cirrhosis （LC-HB）. Methods： Adopting grouped randomized...Objective： To observe the influence of Fuzheng Huayu Tablet （扶正化瘀片, FZHYT） on mental state and social activity of patients with post-hepatitis B liver cirrhosis （LC-HB）. Methods： Adopting grouped randomized double-blinded control method, 180 LC-HB patients in 3 research centers were distributed to 2 groups, the treated group and the control group, 90 in each group. Patients in the treated group were administered with FZHYT; while those in the control group treated with conventional therapy combined with placebo, the course for all patients were 6 months. Their mental state and social activity were evaluated before treatment, after 3 months＇ treatment and at terminal of the 6-month therapeutic course by estimating with Zung self-rating anxiety scale （SAS）, self-rating depression scale （SDS） and social deficit screening scale （SDSS）. Additionally, the basic demographic materials, liver function, cirrhosis index, hepatic and splenic images, blood coagulation function, etc. in the patients were tested and compared as well. Results： As compared with before treatment, the normal rate of SAS and SDS scores increased and the social deficit rate decreased in the treated group significantly after treatment, showing statistical significance （P〈0.05 or P〈0.01）; while in the control group, change was only shown in the social deficit （P〈0.01）, inter-group comparisons after treatment showed significant differences in all the three indexes （P〈0.05 or P〈0.01）. Additionally, after treatment, levels of liver function, cirrhosis, blood coagulation function and splenomegaly in the treated group were all improved significantly （P〈0.05 or P〈0.01）, and the improvements were better than those in the control group （P〈0.01） in levels of total bilirubin （TBIL）, albumin （ALB）, type 1V collagen （1V-C）, prothrombin time （PT）, prothrombin activity （PTA）. Conclusion： Most patients of LC-HB have mental disturbance and social activity deficit, which could definitely be improved by intervention with Chinese FZHYT.展开更多
Publications>Journals>Journal of Clinical and Translational Hepatology>Article Full Text ORIGINAL ARTICLE OPEN ACCESS Histological Outcome of Fuzheng Huayu plus Entecavir Combination Therapy in Chronic Hepati...Publications>Journals>Journal of Clinical and Translational Hepatology>Article Full Text ORIGINAL ARTICLE OPEN ACCESS Histological Outcome of Fuzheng Huayu plus Entecavir Combination Therapy in Chronic Hepatitis B Patients with Significant Liver Fibrosis Hong-Lian Gui#,1,Chang-Qing Zhao#,2,Yan Wang3,Hong-Tu Gu2,Wei-Jing Wang1,4,Wei Cai1,Qing Guo1,Shi-San Bao5,Lie-Ming Xu*,2 and Qing Xie*,1 Author information Journal of Clinical and Translational Hepatology 2020;8(3):277-284DOI:10.14218/JCTH.2020.00004 Abstract Background and Aims:To evaluate the efficacy of Fuzheng Huayu(FZHY),a Chinese herbal formula,plus entecavir(ETV)in regression of liver fibrosis in chronic hepatitis B(CHB)patients with significant fibrosis/cirrhosis.Methods:The current study was a two-center,randomized,double-blind and placebo-controlled pilot study.Fifty-two currently untreated chronic hepatitis B patients with Ishak fibrosis score≥3 points were identified and 1:1 randomized into FZHY plus ETV combination and placebo plus ETV groups.The second liver biopsy was performed after 48-week treatment.Necroinflammatory improvement and regression of fibrosis were assessed.Fine changes in different collagen features in paired liver biopsies were evaluated by dual-photon microscopy for both groups.Results:Forty-nine patients completed the full course of treatment;forty-six of them underwent second liver biopsy(for which twenty-two were in the combination group and twenty-four were in the control group).Compared to those in the control group,patients in the combination group had significantly higher rate of fibrosis regression(82%vs.54%)(p<0.05).Furthermore,the necroinflammatory improvement was greater in the combination group than in the control group(59%vs.25%,p<0.05).Among the more than 80 collagen parameters in the dual-photon analysis,5 decreased significantly in the combination group compared to the control group(p<0.05).However,no significant improvement was detected in either biochemical,virologic or serologic responses between these two groups at week 48.Conclusions:The combination therapy of FZHY plus ETV for 48 weeks resulted in a higher rate of necroinflammatory improvement and fibrosis regression than ETV alone in chronic hepatitis B patients with significant fibrosis/cirrhosis.The clinical trial number is ChiCTR-TRC-11001377.展开更多
目的探讨替比夫定片联合扶正化瘀片治疗慢性乙型肝炎肝纤维化的疗效。方法选择本院2011年7月至2012年11月收治的慢性乙型肝炎(CHB)患者120名,随机分为2组,治疗组与对照组各60例。治疗组和对照组常规应用替比夫定片抗病毒及护肝等治疗;...目的探讨替比夫定片联合扶正化瘀片治疗慢性乙型肝炎肝纤维化的疗效。方法选择本院2011年7月至2012年11月收治的慢性乙型肝炎(CHB)患者120名,随机分为2组,治疗组与对照组各60例。治疗组和对照组常规应用替比夫定片抗病毒及护肝等治疗;治疗组在上述治疗同时,联合应用扶正化瘀片治疗6个月。观测肝功能、肝纤维化四项指标、患者的症状体征等变化。计数资料采用χ2检验,计量资料采用t检验。结果经过6个月治疗,治疗组AST(33.1±15.5 vs 39.5±18.4)、白蛋白/球蛋白比例(A/G)(1.78±0.41 vs 1.64±0.32)、TBil(13.8±6.6 vs 17.9±8.3)复常,ALT(55.3±23.4 vs 64.7±27.6)降低,与对照组比较差异皆有统计学意义(t值分别为2.060、2.085、3.172、2.012,P值均<0.05);治疗组血清透明质酸(HA)(107.7±82.3 vs141.6±91.4)、层黏连蛋白(LN)(125.4±73.2 vs 154.9±76.5)、Ⅲ型前胶原(PⅢP)(0.61±0.56 vs 0.96±0.44)、Ⅵ型胶原(Ⅳ-C)(90.6±78.3 vs 134.3±67.9)有较大程度改善,与对照组比较差异均有统计学意义(t值分别为2.155、2.135、3.266、3.807,P值均<0.05);治疗组患者疲乏感减轻(71.7%vs 53.3%)、食欲增加(83.3%vs 65.0%)、腹胀减轻(80.0%vs 58.3%),与对照组比较差异皆有统计学意义(P<0.05)。结论 CHB患者存在着不同程度肝纤维化,应用替比夫定片联合扶正化瘀片治疗,患者在症状改善、肝功能恢复及肝纤维化改善方面明显优于单用替比夫定。展开更多
基金Supported by the National Natural Science Foundation of China (No.81160433)the Guangxi Natural Science Foundation (No.2011GXNSFD018035 and GZKZZ1103)
文摘Objective： To investigate the efficacy and safety of the Fuzheng Huayu Tablet （扶正化瘀片, FZHYT）, which is used to reinforce qi and resolve stasis in patients with posthepatitic cirrhosis （PHC）. Methods： A multicenter, randomized, controlled clinical trial was conducted in 180 patients with PHC. The patients were randomly assigned using random numbers to a treatment group treated with FZHYT and a placebo group; the treatment course was 6 months for both groups. Overall response, adverse events （AEs）, and the 2-year survival rate were assessed after treatment. Evaluations were made on changes in liver function, liver fibrosis, coagulation, hemodynamics, degrees of esophagogastric varices, ascites, quality of life （QOL）, and scores of main symptoms. Results： The overall response was significantly higher in the treatment group than the placebo group （86.7% vs. 62.2%, P〈0.01）. Patients in both groups had significant improvements in liver function [total bilirubin （TBIL）, albumin （ALB）], liver fibrosis [hyaluronic acid （HA）, type 1V collagen （CIV）], coagulation [prothrombin time （PT）, activated partial thromboplastin time （APTT）, fibrinogen （FIB）, and thrombin time （TT）], hemodynamics portal venous flow （PVF）, and splenic vein flow （SVF） after treatment. Between-group comparisons showed that compared with the placebo group patients in the treatment group achieved significantly greater improvements in TBIL, ALB, HA, C IV, PT, AP＇I-r, PVF, SVF, time to ascites resolution, 2-year survival, QOL, and symptom scores （P〈0.05 or P〈0.01）. There were no significant AEs during the treatment. Conclusion： FZHYT is effective and safe for the treatment of hepatic cirrhosis as it is associated with improved liver function, liver fibrosis, coagulation, portal hypertension state, QOL, 2-year survival rate, and fewer AEs.
基金Supported by Ministry of Science and Technology of the People’s Republic of China(No.2014ZX10005001)。
文摘Background Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B(CHB),but it has a limited effect on cirrhosis.Chinese medicines(CMs),particularly Fuzheng Huayu Tablet(扶正化瘀片,FZHY),have an antifibrotic effect in patients with CHB.Objective To observe the safety and efficacy of adjunctive FZHY in patients with hepatitis B virus(HBV)cirrhosis,this study was designed as a randomized,placebo-controlled,double-blind,parallel assignment,multicenter trial at 20 centers in China.The total 700 naive patients will be enrolled with compensate cirrhosis due to HBV,and randomly assigned into 2 groups,receiving entecavir(0.5 mg,daily)and FZHY placebo(1.6 g,3 times a day),or entecavir(0.5 mg,daily)and FZHY(1.6 g,3 times a day),respectively.The primary endpoint was histological improvement at week 48.The secondary outcome is the decline values of liver fibrosis using the noninvasive methods from baseline to week 48 in each arm of the study.Adverse events such as stomach upset,headache,fatigue,dizziness,nausea will be strictly recorded.Discussion Through this study,we hope to generate a solid evidence for the therapeutic strategy of HBV cirrhosis with a combination of anti-viral such as ETV and anti-fibrotic herbal product such as FZHY.Protocol version:Version 1.3,Date:2014.12.4.Trial registration number:NCT02241590.
基金Supported by Project of Guangxi Science and Technology Department(No.2010 GXNSFA 013217)Key Project of Guangxi Health Department(No.201 0095)Guangxi Provincial Fund of Natural Science(No.Gui Ke Zi 0832174)
文摘Objective： To observe the influence of Fuzheng Huayu Tablet （扶正化瘀片, FZHYT） on mental state and social activity of patients with post-hepatitis B liver cirrhosis （LC-HB）. Methods： Adopting grouped randomized double-blinded control method, 180 LC-HB patients in 3 research centers were distributed to 2 groups, the treated group and the control group, 90 in each group. Patients in the treated group were administered with FZHYT; while those in the control group treated with conventional therapy combined with placebo, the course for all patients were 6 months. Their mental state and social activity were evaluated before treatment, after 3 months＇ treatment and at terminal of the 6-month therapeutic course by estimating with Zung self-rating anxiety scale （SAS）, self-rating depression scale （SDS） and social deficit screening scale （SDSS）. Additionally, the basic demographic materials, liver function, cirrhosis index, hepatic and splenic images, blood coagulation function, etc. in the patients were tested and compared as well. Results： As compared with before treatment, the normal rate of SAS and SDS scores increased and the social deficit rate decreased in the treated group significantly after treatment, showing statistical significance （P〈0.05 or P〈0.01）; while in the control group, change was only shown in the social deficit （P〈0.01）, inter-group comparisons after treatment showed significant differences in all the three indexes （P〈0.05 or P〈0.01）. Additionally, after treatment, levels of liver function, cirrhosis, blood coagulation function and splenomegaly in the treated group were all improved significantly （P〈0.05 or P〈0.01）, and the improvements were better than those in the control group （P〈0.01） in levels of total bilirubin （TBIL）, albumin （ALB）, type 1V collagen （1V-C）, prothrombin time （PT）, prothrombin activity （PTA）. Conclusion： Most patients of LC-HB have mental disturbance and social activity deficit, which could definitely be improved by intervention with Chinese FZHYT.
基金supported by the Shanghai Three-Year Plan of the Key Subjects Construction in Public Health-Infectious Diseases and Pathogenic Microorganism(15GWZK0102)the Shanghai Three-Year Plan of the Clinical Skills and Innovations(16CR1002A)+1 种基金the Shanghai Municipal Key Clinical Specialty(shslczdzk01103)Key Projects in the National Science and Technology Pillar Program during the Thirteen Five-year Plan Period(2017ZX10203202,2017ZX10203201-008,2017ZX10202202-005-004,2018ZX09201016-003-001).
文摘Publications>Journals>Journal of Clinical and Translational Hepatology>Article Full Text ORIGINAL ARTICLE OPEN ACCESS Histological Outcome of Fuzheng Huayu plus Entecavir Combination Therapy in Chronic Hepatitis B Patients with Significant Liver Fibrosis Hong-Lian Gui#,1,Chang-Qing Zhao#,2,Yan Wang3,Hong-Tu Gu2,Wei-Jing Wang1,4,Wei Cai1,Qing Guo1,Shi-San Bao5,Lie-Ming Xu*,2 and Qing Xie*,1 Author information Journal of Clinical and Translational Hepatology 2020;8(3):277-284DOI:10.14218/JCTH.2020.00004 Abstract Background and Aims:To evaluate the efficacy of Fuzheng Huayu(FZHY),a Chinese herbal formula,plus entecavir(ETV)in regression of liver fibrosis in chronic hepatitis B(CHB)patients with significant fibrosis/cirrhosis.Methods:The current study was a two-center,randomized,double-blind and placebo-controlled pilot study.Fifty-two currently untreated chronic hepatitis B patients with Ishak fibrosis score≥3 points were identified and 1:1 randomized into FZHY plus ETV combination and placebo plus ETV groups.The second liver biopsy was performed after 48-week treatment.Necroinflammatory improvement and regression of fibrosis were assessed.Fine changes in different collagen features in paired liver biopsies were evaluated by dual-photon microscopy for both groups.Results:Forty-nine patients completed the full course of treatment;forty-six of them underwent second liver biopsy(for which twenty-two were in the combination group and twenty-four were in the control group).Compared to those in the control group,patients in the combination group had significantly higher rate of fibrosis regression(82%vs.54%)(p<0.05).Furthermore,the necroinflammatory improvement was greater in the combination group than in the control group(59%vs.25%,p<0.05).Among the more than 80 collagen parameters in the dual-photon analysis,5 decreased significantly in the combination group compared to the control group(p<0.05).However,no significant improvement was detected in either biochemical,virologic or serologic responses between these two groups at week 48.Conclusions:The combination therapy of FZHY plus ETV for 48 weeks resulted in a higher rate of necroinflammatory improvement and fibrosis regression than ETV alone in chronic hepatitis B patients with significant fibrosis/cirrhosis.The clinical trial number is ChiCTR-TRC-11001377.
文摘目的探讨替比夫定片联合扶正化瘀片治疗慢性乙型肝炎肝纤维化的疗效。方法选择本院2011年7月至2012年11月收治的慢性乙型肝炎(CHB)患者120名,随机分为2组,治疗组与对照组各60例。治疗组和对照组常规应用替比夫定片抗病毒及护肝等治疗;治疗组在上述治疗同时,联合应用扶正化瘀片治疗6个月。观测肝功能、肝纤维化四项指标、患者的症状体征等变化。计数资料采用χ2检验,计量资料采用t检验。结果经过6个月治疗,治疗组AST(33.1±15.5 vs 39.5±18.4)、白蛋白/球蛋白比例(A/G)(1.78±0.41 vs 1.64±0.32)、TBil(13.8±6.6 vs 17.9±8.3)复常,ALT(55.3±23.4 vs 64.7±27.6)降低,与对照组比较差异皆有统计学意义(t值分别为2.060、2.085、3.172、2.012,P值均<0.05);治疗组血清透明质酸(HA)(107.7±82.3 vs141.6±91.4)、层黏连蛋白(LN)(125.4±73.2 vs 154.9±76.5)、Ⅲ型前胶原(PⅢP)(0.61±0.56 vs 0.96±0.44)、Ⅵ型胶原(Ⅳ-C)(90.6±78.3 vs 134.3±67.9)有较大程度改善,与对照组比较差异均有统计学意义(t值分别为2.155、2.135、3.266、3.807,P值均<0.05);治疗组患者疲乏感减轻(71.7%vs 53.3%)、食欲增加(83.3%vs 65.0%)、腹胀减轻(80.0%vs 58.3%),与对照组比较差异皆有统计学意义(P<0.05)。结论 CHB患者存在着不同程度肝纤维化,应用替比夫定片联合扶正化瘀片治疗,患者在症状改善、肝功能恢复及肝纤维化改善方面明显优于单用替比夫定。
