[Bupleuri Radix-Paeoniae Radix Alba medicated plasma exerts effects on HepG2 hepatoma cells by regulating miR-1297/PTEN signaling axis].

The present study aimed to investigate the effect and mechanism of Bupleuri Radix-Paeoniae Radix Alba medicated plasma on HepG2 hepatoma cells by regulating the microRNA-1297(miR-1297)/phosphatase and tensin homologue deleted on chromosome 10(PTEN) signaling axis. Real-time quantitative PCR(RT-qPCR) was carried out to determine the mRNA levels of miR-1297 and PTEN in different hepatoma cell lines. The dual luciferase reporter assay was employed to verify the targeted interaction between miR-1297 and PTEN. The cell counting kit-8(CCK-8) was used to detect cell proliferation, and the optimal concentration and intervention time of the medicated plasma were determined. The cell invasion and migration were examined by Transwell assay and wound healing assay. Cell cycle distribution was detected by PI staining, and the apoptosis of cells was detected by Annexin V-FITC/PI double staining. The mRNA levels of miR-1297, PTEN, protein kinase B(Akt), and phosphatidylinositol 3-kinase(PI3K) were determined by RT-qPCR. Western blot was employed to determine the protein levels of PTEN, Akt, p-Akt, caspase-3, caspase-9, B-cell lymphoma-2(Bcl-2), and Bcl-2-associated X protein(Bax). The results showed that HepG2 cells were the best cell line for subsequent experiments. The dual luciferase reporter assay confirmed that miR-1297 could bind to the 3'-untranslated region(3'UTR) in the mRNA of PTEN. The medicated plasma inhibited the proliferation of HepG2 cells, and the optimal intervention concentration and time were 20% and 72 h. Compared with the blank plasma, the Bupleuri Radix-Paeoniae Radix Alba medicated plasma, miR-1297 inhibitor, miR-1297 inhibitor + medicated plasma all inhibited the proliferation, invasion, and migration of HepG2 cells, increased the proportion of cells in the G_0/G_1 phase, decreased the proportion of cells in the S phase, and increased the apoptosis rate. The medicated plasma down-regulated the mRNA levels of miR-1297, PI3K, and Akt and up-regulated the mRNA level of PTEN. In addition, it up-regulated the protein levels of PTEN, Bax, caspase-3, and caspsae-9 and down-regulated the protein levels of p-Akt, p-PI3K, and Bcl-2. In conclusion, Bupleuri Radix-Paeoniae Radix Alba medicated plasma can inhibit the expression of miR-1297 in HepG2 hepatoma cells, promote the expression of PTEN, and negatively regulate PI3K/Akt signaling pathway, thereby inhibiting the proliferation and inducing the apoptosis of HepG2 cells.

Radix Bupleuri-Radix Paeoniae Alba Inhibits the Development of Hepatocellular Carcinoma through Activation of the PTEN/PD-L1 Axis within the Immune Microenvironment.

OBJECTIVE: This study investigated how Radix Bupleuri-Radix Paeoniae Alba (BP) was active against hepatocellular carcinoma (HCC). METHODS: Traditional Chinese medicine systems pharmacology (TCMSP) database was employed to determine the active ingredients of BP and potential targets against HCC. Molecular docking analysis verified the binding activity of PTEN with BP ingredients. H22 cells were used to establish an HCC model in male balb/c mice. Immunofluorescence staining, immunohistochemistry, flow cytometry, western blotting, enzyme-linked immunosorbent assay, and real-time quantitative PCR were used to study changes in proliferation, apoptosis, PTEN levels, inflammation, and T-cell differentiation in male balb/c mice. RESULTS: The major active ingredients in BP were found to be quercetin, kaempferol, isorhamnetin, stigmasterol, and beta-sitosterol. Molecular docking demonstrated that these five active BP ingredients formed a stable complex with PTEN. BP exhibited an anti-tumor effect in our HCC mouse model. BP was found to increase the CD8+ and IFN-γ+/CD4+ T cell levels while decreasing the PD-1+/CD8+ T and Treg cell levels in HCC mice. BP up-regulated the IL-6, IFN-γ, and TNF-α levels but down-regulated the IL-10 levels in HCC mice. After PTEN knockdown, BP-induced effects were abrogated. CONCLUSION: BP influenced the immune microenvironment through activation of the PTEN/PD-L1 axis, protecting against HCC.

Network pharmacology-based prediction of active compounds in the Wenyang Jiedu Huayu formula acting on acute-on-chronic liver failure with experimental support in vitro and in vivo.

Acute-on-chronic liver failure (ACLF) is characterized by undermined liver function, massive necrosis/apoptosis of hepatocytes, and hepatic inflammatory cell recruitment, leading to multiorgan failure. Traditional Chinese medicine (TCM) has been widely applied in clinical and experimental studies of ACLF. In this study, 23 compounds with 6,386 drug targets were obtained from Wenyang Jiedu Huayu (WYJDHY), and 8,096 genes were identified as ACLF disease targets, among which 3,132 were overlapping co-targets. Expression profile analysis identified 105 DEGs among the co-targets, which were associated with biological activities such as lymphocyte activation, immune response regulation, and pathways such as Th17 cell differentiation and NF-κB signaling. After PPI analysis and network construction, atractylenolide I (AT-1) has been identified as the hub active ingredient of the WYJDHY formula. LPS stimulation inhibited rat hepatocytes' BRL 3A cell viability, promoted cell apoptosis, increased the levels of ALT, AST, IL-6, and VCAM-1 within the culture medium, and activated NF-κB signaling, whereas AT-1 treatment significantly attenuated LPS-induced toxicity on BRL 3A cells. Furthermore, the NF-κB signaling inhibitor PDTC exerted effects on LPS-stimulated BRL 3A cells similar to those of AT-1, and the combination of PDTC and AT-1 further attenuated LPS-induced toxicity on BRL 3A cells. In vivo, AT-1 alone or with PDTC improved the symptoms and local inflammation in ACLF model rats. In conclusion, 23 active ingredients of six herbs in the WYJDHY formula were retrieved, and 105 co-targets were differentially expressed in ACLF. AT-1 exerts protective effects on LPS-stimulated hepatocytes and ACLF rats, possibly by inhibiting the NF-κB pathway.

Efficacy and safety of Fuzheng Huayu tablet on persistent advanced liver fibrosis following 2 years entecavir treatment: A single arm clinical objective performance criteria trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Antiviral therapy can alleviate liver fibrosis in chronic hepatitis B, but it has a limited effect on advanced liver fibrosis/cirrhosis. Traditional Chinese medicine (TCM), particularly FuZheng HuaYu (FZHY) tablet, appears to have an antifibrotic effect, but its improving resolution of hepatitis b virus (HBV) -associated advanced fibrosis and experienced anti-viral treatment has not been investigated. AIM OF THE STUDY: To observe the safety and efficacy of adjunctive FZHY on the HBV-associated cirrhosis patients who received 2 years of entecavir but still with advanced fibrosis. METHODS: An open-label, multicentre, single arm trial. 251 patients were included and treated with TCM consisted of FZHY tablets 1.6 g and granules, three times a day in addition to entecavir 0.5 mg daily for an additional 48 weeks. Primary outcome was regression of fibrosis (the proportion of patients with a 1-point decrease in the Ishak liver fibrosis score from baseline to week 48). RESULTS: Fibrosis regression occurred in 94 of 184 patients with paired liver biopsy (51.09%, 95% CI: 43.9～58.0). In 132 compensated cirrhosis patients (Ishak score ≥5), 56.06% (74/132, 95% CI: 47.5～64.2) showed fibrosis regression and reached the goal of 54% (15% more than entecavir mono-therapy). 10 patients occurred adverse reaction, most of them were mild, and all recovered or achieved remission. CONCLUSIONS: The combination therapy of FZHY, TCM granules and ETV could regress the liver fibrosis in the patients with HBV cirrhosis, who experienced 2 years of ETV treatment, and it is safe and well tolerated.

Acupuncture combined with Chinese herbal medicine on non-alcoholic fatty liver disease: A protocol for systematic review and meta-analysis.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a global health burden. However, there are no approved drugs for NAFLD. A number of studies have shown that acupuncture combined with Chinese herbal medicine (CHM) can be beneficial for NAFLD. However, high-quality trials are still lacking. Therefore, we aimed to conduct a systematic review and meta-analysis to assess the effectiveness and safety of acupuncture combined with CHM for NAFLD. METHODS: Eight electronic databases including PubMed, the Cochrane Library, Web of Science, EMBASE, China National Knowledge Infrastructure, Chinese Scientific and Technical Journals Database, and Wan-fang Database from inception to November 2021 will be searched. We will also search for Clinical Trials Registry Platforms as a supplement. Randomized controlled trials on acupuncture combined with CHM for NAFLD will be included. Literature screening, data extraction, and risk of bias assessment were independently conducted by 2 reviewers. All differences between the 2 reviewers will be discussed and resolved by a third reviewer. Revman5.3 software will be used for meta-analysis. RESULT: This study aimed to evaluate the effectiveness and safety of acupuncture combined with CHM for NAFLD. CONCLUSION: The findings of this study will provide more evidence to determine whether acupuncture combined with CHM for NAFLD is an effective and safe intervention for NAFLD.

Traditional Chinese medicine, liver fibrosis, intestinal flora: is there any connection?-a narrative review.

This paper aims to analyze how intestinal flora regulates liver fibrosis pathogenesis and to evaluate the regulatory effect of traditional Chinese medicine (TCM) on the intestinal flora, providing new insights into liver fibrosis treatment. Destruction of the intestinal microbiome can lead to liver fibrosis development, accelerating the intestinal microbiome's disruption. TCM can effectively regulate the intestinal flora, helping prevent and treat liver fibrosis. This review discusses the mechanisms behind intestinal flora changes in liver fibrosis and how TCM can regulate these changes. We searched PubMed, the Wanfang database, and CNKI for "liver fibrosis", "intestinal microflora", and "intestinal microbiota" and reviewed the retrieved literature. We detail the prevention and treatment options for liver fibrosis though the use of TCM in regulating intestinal flora. We also highlight the influence of the intestinal flora on liver fibrosis and present the research regarding the prevention and treatment of liver fibrosis using TCM. We also describe the effects of TCM on the intestinal flora. TCM can effectively regulate the intestinal flora to prevent and treat liver fibrosis through the liver-intestine axis.

Gynura Segetum Related Hepatic Sinusoidal Obstruction Syndrome: A Liver Disease with High Mortality and Misdiagnosis Rate.

BACKGROUND AND AIM: Gynura segetum (Tusanqi or Jusanqi) is widely used in China as a herbal remedy, however, it has often been associated with hepatic sinusoidal obstruction syndrome (HSOS). Its extent in inducing hepatotoxicity is not sufficiently understood. Hence, we aimed to identify the characteristic features of Gynura segetum associated HSOS. METHODS: A total of 64 patients diagnosed with HSOS induced by gynura segetum were enrolled from eight Chinese tertiary care hospitals between 2008 and 2018. General information regarding diagnosis, disease history, suspected drug use, symptoms and signs, biochemical index, imaging data, liver histology, treatment methods, severity and prognosis were collected and analyzed. RESULTS: The mean age of the enrolled patients were 58.07±11.44 years. Male patients accounted for 64.1% of HSOS patients. The median latency period was 75 days. The number of patients with a definite diagnosis from the eight hospitals was 5 (7.81%), with a misdiagnosis rate of 92.18%. Hepatomegaly, splenomegaly, ascites and lower limbs edema were present in 89.1%, 76.6%, 81.3% and 43.8% of the patients, respectively. The imaging characteristic changes were liver parenchyma echo thickening, uneven density, and hepatic vein stenosis and occlusion. Liver biopsies had characteristic pathological changes. Except for ALT and D-Dimer, liver function and coagulation index at admission and before discharge were not significantly different (p>0.05). The 6-month mortality rate was 77.55%, with upper-gastrointestinal bleeding being the leading cause of death (42.11%). The second leading cause of death was a secondary infection (36.84%), while the third was hepatorenal syndrome (21.05%). CONCLUSION: Gynura segetum related HSOS often presents as progressive hepatic congestion, portal hypertension and liver failure, and has a high mortality and misdiagnosis rate.

Disruption of the gut-liver axis in the pathogenesis of acute-on-chronic liver failure.

Acute-on-chronic liver failure (ACLF) is characterized by organ failure mediated by acute decompensation of cirrhosis. Recent studies have highlighted the importance of the gut-liver axis (GLS) and its association with ACLF pathogenesis. In this review, we discuss the mechanisms related to the alteration of the GLA and their involvement in ACLF pathogenesis and suggest some possible therapeutic options that could modulate the GLA dysfunction. This knowledge may provide information useful for the design of therapeutic strategies for gut dysbiosis and its complications in ACLF.

Effect of Shuanghu Qinggan Granule () and Yigan Yiqi Jieyu Granule () plus lamivudine on chronic hepatitis B patients: A randomized double-blind placebo-controlled trial.

OBJECTIVE: To observe the clinical efficacy and safety of Shuanghu Qinggan Granule ( , SQG) plus Yigan Yiqi Jieyu Granule (, YYJG) combined with lamivudine (LAM) on chronic hepatitis B (CHB) patients. METHODS: The study was a multicenter, randomized, double-blinded and parallel controlled trial. A total of 320 patients were randomly allocated into 2 groups equally: 160 patients (treatment group) were given SQG and YYJG combined with LAM; and 160 patients (control group) were given LAM plus Chinese herb placebo, respectively. Liver functions, hepatitis B envelop antigen (HBeAg) titer levels, and hepatitis B virus DNA (HBV-DNA) load were monitored. RESULTS: (1) In the 48th week, the treatment group showed superior HBeAg seroconversion rate than that in the control group (38.0% vs. 24.0%, P<0.05). (2) In the 48th week, the treatment group demonstrated lower HBeAg titer than that in the control group (P<0.05). (3) In the 12th, 24th, 48th week, there was no statistical significance in HBV-DNA response rate between the two groups. (4) In the 12th week, the level of glutamyl transpeptidase (GGT) was significantly decreased in the treatment group compared with the control group (P<0.05); in the 36th week, the levels of alanine aminotransferase and aspartate transaminase were significantly lower in the treatment group than those in the control group (P<0.05). CONCLUSION: The protocol of SQG and YYJG combined with LAM to treat CHB showed superior efficacy than LAM monotherapy.

[Functions of T lymphocytes mediated by in vitro dendritic cells of chronic HBV infection patients in different immune states: a clinical research].

OBJECTIVE: To explore the improvement of dendritic cells' (DCs) functions in chronic hepatitis B (CHB) patients by two different drugs plasma, i.e., Shen supplementing and detoxification (SSD) and Pi invigorating and detoxification (PID), thus comparing which method was more effective to activate DCs to improve T lymphocyte functions. METHODS: Totally 30 CHB outpatients were recruited. They were assigned to the immune tolerant group and the immune clearance group, 15 in each group. Totally 60 mL peripheral blood was extracted to isolate and develop mature DCs. Chinese compound containing (Liuwei Ganlu Syrup for SSD) and (Sijun Ganlu Syrup for PID) plasma were added to promote the maturation of DCs on the 7th day. Besides, non-drug plasma was taken as the control. On the ninth day, HBV core 18-27 loaded core peptide and its own T lymphocyte were co-cultivated for 72 h. Then T lymphocytes were collected. The expression levels of CD3, CD28, CD4, and CD8, programmed death-1 (PD-1) were detected using flow cytometry. RESULTS: Compared with non-drug plasma, the expression levels of CD3, CD4, and CD28 could be improved, and the expression levels of CD8 and PD-1 could be reduced by the two methods, showing statistical difference (P < 0.05). Besides, SSD containing plasma showed better effect in improving the molecular CD28 expression rate, and reducing the molecular PD-1 expression rate on the T cell surface, showing statistical difference when compared with that of PID containing plasma (P < 0.05). CONCLUSIONS: In vitro intervention of DCs by SSD and PID containing plasmas combined co-cultivation of its own T lymphocytes could promote the activation of DCs to improve the function of T cells and the expression of T cell surface molecules. Besides, SSD showed more significant effect on infection immune of HBV patients in the tolerance stage.

[Effects of Bushen Jiedu Recipe and Jianpi Jiedu Recipe containing plasma on dendritic cells of chronic hepatitis B virus infection patients under different immune states].

OBJECTIVE: To compare the effects of Bushen Jiedu Recipe (BJR) and Jianpi Jiedu Recipe (JJR) containing plasma on dendritic cells (DCs) of chronic hepatitis B virus (HBV) infection patients under different immune states. METHODS: Recruited were 36 chronic HBV infection outpatients from First Affiliated Hospital of Hunan University of Traditional Chinese Medicine from April 2010 to January 2011. They were assigned to the immune tolerance group (18 cases) and the immune clearance group (18 cases).Another 10 healthy subjects were recruited as the healthy control group. Their anticoagulated peripheral venous blood was respectively collected. The peripheral blood mononuclear cells (PBMCs) were isolated and further extracted for incubating DCs. The DCs were intervened by BJR and JJR containing plasma. The morphology of DCs was identified. The expressions of CD1alpha, CD80, CD86, and HLA-DR were detected. The level of interferon-alpha (IFN-alpha) in the supernatant was observed by ELISA. RESULTS: The CD80 expression level was lower in the immune clear group than in the healthy control group before intervention (P < 0.05). The expression levels of CD80, CD86, and HLA-DR were lower in the immune tolerance group than in the healthy control group before intervention (P < 0.05).The IFN-alpha expression level was lower in the immune tolerance group and the immune clearance group than in the healthy control group before intervention (P < 0.05). The expression levels of CD80, HLA-DR, and IFN-alpha were lower in the immune tolerance group than in the immune clearance group before intervention (P < 0.05). Compared with the same group before intervention, the CD80 expression significantly increased in each treatment group (P < 0.05). After intervention the expression levels of CD80 and HLA-DR were higher in the immune tolerance group than in the immune clearance group in the same time phase, and the CD86 expression level was higher in the BJR group than in the immune clearance group in the same time phase, showing statistical difference (P < 0.05). CONCLUSIONS: The middle dose BJR and the small dose JJR both could promote the recovery of DCs in chronic HBV infection patients. Besides, BJR showed more prominent effects on the function of DCs in chronic HBV infection patients in the immune tolerance stage.

[Auxiliary treatment of HBV correlated hepatic failure by Chinese herbs: a systematic review of randomized controlled trials].

OBJECTIVE: To evaluate the effectiveness and safety of Chinese herbs as an adjuvant treatment for hepatitis virus B (HBV)-related hepatic failure. METHODS: Data were retrieved through the Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Library, PubMed, CNKI, VIP, Wanfang Database, and ChiCTR by key words or free words such as hepatic failure, severe hepatitis, HBV, Chinese medicine, randomization, and control. Appendix references of related papers were taken as supplementary indices. According to requirement for Cochrane systematic evaluation, randomized clinical trials on assessing the effectiveness and safety of Chinese herbs as main or adjuvant treatment in treating HBV-related hepatic failure were methodologically assessed, data extracted and analyzed. RESULTS: Totally 21 trials on Chinese herbal medicine therapy versus standard medical therapy (involving 1 881 patients) were included. Most trials had unclear risk bias. In 5 studies on the mortality, 3 trials showed that the mortality was lower in the test group than in the control group [RR 0.40, 95% CI (0.20, 0.79), P = 0.0002]. In 6 randomized control trials, totally 20 papers reported the control of complications. Eight results showed Chinese herbal medicine therapy had better effect in controlling complications. The recurrence rate and assessment of the survival quality were reported. Considering secondary indicators, four trials showed Chinese herbal medicine therapy had better effect in lowering the ineffective rate, decreasing total bilirubin (TBIL), and elevating prothrombin activity (PTA). Other prescriptive analyses found that the overall effect on secondary indicators was better in the test group than in the control group, but not all the indicators were statistically different. Adverse reactions were only reported in two papers, showing no severe adverse reaction. CONCLUSION: According to present evidence, till now, we could not judge whether Chinese herbs, as an adjuvant treatment, could do any favor for lowering the incidence and recurrence of hepatic failure patients, and improving their survival qualities.

[Effects of entecavir and Shenxian Yiganling combination therapy on patients with HBeAg-positive chronic hepatitis B for 48 weeks].

OBJECTIVE: To evaluate of the efficacy and safety of entecavir (ETV) combined with Shenxian Yiganling (SY) versus ETV therapy on patients with HBeAg-positive chronic hepatitis B (CHB) for 48 weeks. METHODS: One hundred and sixty-four CHB patients were assigned to two groups with the cohort study: the ETV combined with SY treatment group and the ETV control group. The alanine aminotransferase (ALT), the undetectable HBV DNA level, and HBeAg negative conversion rate, and HBeAg serological negative conversion rate were observed before and after treatment. RESULTS: At week 48, there was no significant difference in the normalization of ALT levels (70.00% vs 67.61%, P > 0.05) and undetectable HBV DNA levels (72.50% vs 73.24%, P > 0.05) between the two groups. There was significant difference in the HBeAg negative conversion rate (39.44% vs 23.75%) and HBeAg serological negative conversion rate (32.39% vs 15.00%) (both P < 0.05). CONCLUSION: ETV combined with SY promoted the HBeAg serological negative conversion rate possibly through the recovery of the immune functions.

[Study on the functions of peripheral dendritic cells in chronic hepatitis B virus infection patients of Gan-depression Pi-deficiency syndrome and Gan-Dan damp-heat syndrome under different immune states].

OBJECTIVE: To observe the functions of peripheral dendritic cells (DCs) in chronic hepatitis B virus (HBV) infection patients of Gan-depression Pi-deficiency syndrome (GPS) and Gan-Dan damp-heat syndrome (GDS) under different immune states, thus to study the features of the immune expressions of the two syndromes in chronic HBV infection, providing objective evidence for Chinese medicine syndrome typing. METHODS: The 40 chronic HBV patients were randomly assigned to two groups according to the immune state. Of them, there were 20 chronic HBV patients (under the condition of immune clearance; consisting of 10 patients of GPS and 10 of GDS) and 20 chronic HBV carriers (under the condition of immune tolerance; consisting of 10 patients of GPS and 10 of GDS). Besides, 10 healthy graduate volunteers of Hunan University of Traditional Chinese Medicine were recruited as the healthy control group. Their peripheral blood mononuclear cells (PBMCs) were cultured in vitro. The exterior morphological features and ultrastructure were observed by inverted microscope and electron microscope. The expressions of HLA-DR, CD80, CD86, and CDIa of the DCs surface were detected. The secretory levels of IL-12 in the supernate of DCs were detected by ELISA reagent kit. The proliferation capacities of allogeneic mixed lymphocyte were detected using MTT. The function features of DCs in the chronic HBV patients of two syndrome types under different immune states were compared, thus analyzing the difference of each index between the two syndrome types. RESULTS: Compared with the healthy control group, the expression rates of CD86, CD80, and HLA-DR decreased in the HBV carriers group (of the two syndrome types), showing statistical difference (P < 0.05). The expression rate of CD80 decreased in the HBV group (of the two syndrome types), showing statistical difference (P < 0.05). The expression rates of CD86 and HLA-DR were lower in the GPS group than in the GDS group. The expression rate of CD80 was lower in the GPS group than in the GDS group, showing statistical difference (P < 0.05). The proliferation capacities of IL-12 and T lymphocytes were lower in the HBV patients group than in the healthy control group (P < 0.05). The proliferation capacities of IL-12 and T lymphocytes were lower in the GPS group than in the GDS group, showing statistical difference (P < 0.05). CONCLUSIONS: The functions of peripheral DCs in chronic HBV infection of patients of the GPS and the GDS under different immune states were different. The phenotype and function tests of DCs provided objective evidence for Chinese syndrome typing of chronic hepatitis B, thus reflecting the features of immune expressions of the two syndrome types and the immunology connotation.

[Clinical observation on chronic severe hepatitis B treated by principles of cooling-blood and detoxicating combined with clearing-heat and resolving-damp or combined with strengthening-Pi and warming-yang].

OBJECTIVE: To observe the therapeutic efficacy on chronic severe hepatitis B (CSH) patients of Yanghuang and Yinhuang syndrome type by principles of cooling-blood and detoxicating combined with clearing-heat and resolving dampness (PA) or with strengthening-Pi and warming-yang (PB), respectively. METHODS: Forty-three patients with CSH were randomly divided into two groups, group A (22 cases) treated with PA and group B (21 cases) with PB. The therapeutic efficacy, laying stress on the effect in eliminating jaundice, was observed. RESULTS: The efficacy in group B was effective in 19 cases (90.5%), and ineffective in 2 (9.5%), while in group A, effective in 16 (72.7%) and ineffective in 6 (27.3%). Levels of TBIL and ALT were significantly lower in both groups (P < 0.05 or P < 0.01), and the descending extent was greater, the thrombinogen activity was higher in group B than that in group A after treatment (P < 0.05), no significant difference in ALT was found between the two groups. CONCLUSION: The efficacy of PB is better than that of PA on CSH with Yanghuang and Yinghuang syndrome.

Multicenter clinical study on Fuzhenghuayu capsule against liver fibrosis due to chronic hepatitis B.

AIM: To study the efficacy and safety of Fuzhenghuayu capsule (FZHY capsule, a capsule for strengthening body resistance to remove blood stasis) against liver fibrosis due to chronic hepatitis B. METHODS: Multicenter, randomized, double blinded and parallel control experiment was conducted in patients (aged from 18 to 65 years) with liver fibrosis due to chronic hepatitis B. Hepatic histologic changes and HBV markers were examined at wk 0 and 24 during treatment. Serologic parameters (HA, LM, P-III-P, IV-C) were determined and B ultrasound examination of the spleen and liver was performed at wk 0, 12 and 24. Liver function (liver function and serologic parameters for liver fibrosis) was observed at wk 0, 6, 12, 18 and 24. Blood and urine routine test, renal function and ECG were examined before and after treatment. RESULTS: There was no significant difference between experimental group (110 cases) and control group (106 cases) in demographic features, vital signs, course of illness, history for drug anaphylaxis and previous therapy, liver function, serologic parameters for liver fibrosis, liver histologic examination (99 cases in experimental group, 96 cases in control group), HBV markers, and renal function. According to the criteria for liver fibrosis staging, mean score of fibrotic stage(s) in experimental group after treatment (1.80) decreased significantly compared to the previous treatment (2.33, P<0.05), but there was no significant difference in mean score of fibrotic stage(s) (2.11 and 2.14 respectively). There was a significant difference in reverse rate between experimental group (52%) and control group (23.3%) in liver biopsy. With marked effect on decreasing the mean value of inflammatory activity and score of inflammation (P<0.05), Fuzhenghuayu capsule had rather good effects on inhibiting inflammatory activity and was superior to that of Heluoshugan capsule. Compared to that of pretreatment, there was a significant decrease in HA, LM, P-III-P and IV-C content in experimental group after 12 and 24 wk of treatment. The difference in HA, LM, P-III-P and IV-C content between 12 and 24 wk of treatment and pretreatment in experimental group was significantly greater than that in control group (P<0.01-0.05). The effect, defined as two of four parameters lowering more than 30% of the baseline, was 72.7% in experimental group and 27.4% in control group (P<0.01). Obvious improvement in serum Alb, ALT, AST and GGT was seen in two groups. Compared to that of control group, marked improvement in GGT and Alb was seen in experimental group (P<0.05). The effective rate of improvement in serum ALT was 72.7% in experimental group and 59.4% in control group. No significant difference was seen in blood and urine routine and ECG before and after treatment. There was also no significant difference in stable rate in ALT and serologic parameters for liver fibrosis between experimental group and control group after 12 wk of withdrawal. CONCLUSION: Fuzhenghuayu capsule has good therapeutic effects on alleviating liver fibrosis due to chronic hepatitis B without any adverse effect and is superior to that of Heluoshugan capsule.

[Multicenter clinical study about the action of Fuzheng Huayu Capsule against liver fibrosis with chronic hepatitis B].

OBJECTIVE: To study the efficacy and safety of Fuzheng Huayu Capsule (FZHY Capsule) against liver fibrosis with chronic hepatitis B. METHODS: Multicentric, randomized, double blinded and paralleled control led trial was conducted on patients (aged between 18 and 65) with liver fibrosis in chronic hepatitis B Indexes observed: (1) hepatic histological changes and HBV markers were observed at 0 and 24th week during the treatment; serological indexes (HA, LN, P-III-P, IV-C) were determined and B ultrasound examination of spleen and liver was taken at 0, 12th, 24th week; liver function (during the period of follow-up, liver function and serological indexes for liver fibrosis were evaluated) were observed at 0, 6th, 12th, 18th, 24th week; (2) indexes for safety: blood and urine routine tests, renal function and ECG were examined. RESULTS: (1) Enrollment and demographic data: There was no significant difference between the trial (110 cases) and control group (106 cases) in demographic feature, vital signs, course of illness, history for drug anaphylaxis, history of previous therapy, liver function, serological indexes for liver fibrosis, liver histological examination (99 cases for test group, 96 cases for control group), HBV markers, and renal function, etc. (2) Histological pathological examination: 93 cases of liver histological examination were taken, of these 50 cases for the trial group and 43 cases for control group which turned out to be at S mean value of 2.33 and 2.11 respectively pretreatment according to criteria for liver fibrosis staging. Post-treatment, the trial showed a significant decrease with S value of 1.80 compared to that of pretreatment; however, there was no significant improvement in control group before and after the treatment with S mean value of 2.14. There was significant difference in reversing rate (decrease at least 1 stage according to criteria for liver fibrosis staging) between the trial (52%) and control (23.3%) after liver biopsy. The trial had a rather good effect on improving inflammatory activity and was superior to control group with a marked decrease of mean value of inflammatory activity and score of inflammation (P<0.05). (3)Serological indexes for liver fibrosis: There was a significant decrease in HA, LN, P-III-P, IV-C content in test group after 12 and 24 weeks' treatment compared to that of pretreatment; the differences of HA, LN, P-III-P, IV-C between 12, 24 weeks' treatment and pretreatment were significantly greater than control group (P<0.01 or 0.05); the effectual was defined as 2 of 4 indexes lowered more than 30% of the baseline, according to this criteria, the trial was 72.7%, while control group 27.4% (P<0.01). (4)Liver function: Obvious improvement of serum Alb, ALT, AST, GGT was seen in 2 groups; compared with control group, marked improvement of GGT and Alb in the trial (P<0.05); the effective rate of serum ALT in the trial group was 72.7%, while control 59.4%. (5)No changes of significant difference between pre- and post-treatment in routine tests for blood and urine, renal function and ECG, etc. There was also no difference in the stable rate of ALT and serological indexes for liver fibrosis between the trial and control group 12 weeks after withdrawal (P<0.05). CONCLUSION: Fuzheng Huayu Capsule has good effect on alleviating liver fibrosis in chronic hepatitis B without any adverse effect and is superior to Heluo Shugan Capsule. Fuzheng Huayu Capsule is a safe and effective medicine for the treatment of liver fibrosis in chronic hepatitis B.