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Objective:To explore the therapeutic effect of Fuzheng Huayu capsule on nonalcoholic fatty liver fibrosis induced by high trans fatty acid and high sugar diet in mice. Method:Forty SPF male C57/B6 mice were randomly divided into 4 groups （normal group， model group， Obelcholinic acid group， and Fuzheng Huayu capsule group）， with 10 mice in each group. Except 10 mice in the normal group， nonalcoholic fatty liver fibrosis was induced by high-fat and high-sugar diet for 24 weeks in the other 30 mice. From the 25th week of modeling， 4 groups received intragastric administration for 4 weeks， once a day： Fuzheng Huayu capsule group 4.8 g·kg<sup>-1</sup>. Oxycholic acid group 10 mg·kg<sup>-1</sup>. Model control group and normal group received the same volume of normal saline. Liver tissue and serum samples were collected at the end of the 28th week. The pathological changes of liver tissue of mice in each group were observed by hematoxylin-eosin （HE） staining， the degree of liver fibrosis was observed by Sirius red staining， the degree of lipid deposition was observed by oil red O staining， the content of hydroxypropylamine （Hyp） in liver tissue was determined by alkaline hydrolysis， and the change of triglyceride （TG） in liver tissue was detected by enzyme method. Serum alanine aminotransferase （ALT）， aspartate aminotransferase （AST） activities and fasting blood glucose （FBG） were detected by kit method， enzyme-linked immunosorbent assay （ELISA） was used to detect fasting Insulin （INS） level and calculate the changes of insulin resistance index （HOMA-IR）， liver fibrosis related mRNA and proteins of were detected by Real-time fluorescence quantitative polymerase chain reaction （Real-time PCR）， Western blot and Immunohistochemistry. Result:Compared with the normal group， the liver tissue in the model group showed significant collagen fiber deposition， at mostly F2-F3 fibrosis stages， with increased number of inflammatory foci in liver tissue， obvious balloon degeneration and fatty degeneration of liver cells， significantly increased contents of Hyp and TG in liver tissue （<italic>P</italic><0.01）， significantly increased activities of ALT and AST in serum and levels of FBG， INS and HOMA-IR （<italic>P</italic><0.01）， and increased type I collagen （Col-Ⅰ）， Col-Ⅳ， <italic>α</italic>-smooth muscle agonist protein （<italic>α</italic>-SMA） and transforming growth factor-<italic>β</italic> （TGF-<italic>β</italic>） protein and mRNA in liver tissue. Compared with the model group， the collagen fiber deposition in liver tissue of mice in Fuzheng Huayu capsule group was significantly reduced， at mostly F0-F1 fibrosis stages， with significantly improved balloon-like change of hepatocytes， and significantly reduced number of inflammatory foci in lobules （<italic>P</italic><0.05，<italic>P</italic><0.01）. Compared with the model group， Fuzheng Huayu capsule can significantly reduce the content of Hyp in liver tissue， the levels of serum ALT and AST， and the expression of Col-Ⅰ， Col-Ⅳ， <italic>α</italic>-SMA and TGF-<italic>β</italic> genes and proteins in mice （<italic>P</italic><0.05，<italic>P</italic><0.01）. Conclusion:Fuzheng Huayu capsule has a good therapeutic effect on nonalcoholic fatty liver fibrosis induced by high trans fatty acid and high sugar diet in mice.
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Objective To identify the blood components of Fuzheng Huayu capsule by ultra performance liquid chromatography-high resolution time-of-flight mass spectrometry (UHPLC-Q-TOF/MS). Methods ACQUITY UPLCHSS T3 (2.1 mm × 100 mm, 1.8 μm) was used to chromatographic separation; mobile phase was 0.1% formic acid aqueous solution (A) −0.1% formic acid acetonitrile solution (B). The gradient elution conditions included: 0−3 min, 2% B; 3−18 min, 2%−50% B; 18−22 min, 50%−95% B; 22−25 min, 95% B. The equilibration time was 10 min, the flow rate was 0.40 ml/min, and the analysis time was 25 min. The mass spectrometry was characterized by electrospray ionization by a positive-negative ion mode scan with a range of 100-1 100 m/z. Results 49 components were identified in the serum samples at one time, of which 4 were positive and negative ion modes. Conclusion The blood components of Fuzheng Huayu capsule were clarified by this method, which enriched the scientific connotation of Fuzheng Huayu capsule, and laid the foundation for the in-depth study of the compound.
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Objective To explore the clinical efficacy of entecavir combined with Fuzheng Huayu capsule in patients with chronic hepatitis B cirrhosis. Methods A total of 102 decompensated patients with chronic hepatitis B cirrhosis were enrolled in our hospital from May 2015 to May 2017. The patients were divided into study group and control group by random number method. The patients were treated with routine symptom and liver Treatment group, based on this line of entecavir treatment, the study group in the conventional therapy based on entecavir combined with Fuzheng Huayu capsule treatment, compared the two groups of patients with HBV DNA negative rate, inflammatory factors, fibrosis indicators and liver function indicators. Results However, the improvement of inflammatory factors, fibrosis indexes and liver function indexes in the study group was more significant than that in the control group, and the difference was significant, but there was no significant difference between the two groups There was statistical significance (P<0.05). Conclusion The efficacy of entecavir combined with Fuzheng Huayu capsule in patients with chronic hepatitis B liver cirrhosis is accurate and worthy of clinical application in clinical practice.
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To systemically review the efficacy and safety of Fuzheng Huayu Capsule (FHC) combined with Adefovir Dipivoxil in treatment of chronic hepatitis B with hepatic fibrosis. Wanfang, CNKI, VIP, CBM, PubMed, Cochrane and Embase were retrieved by computers to collect the RCTs of FHC combined with Adefovir Dipivoxil in treatment of chronic hepatitis B with hepatic fibrosis from their inception to March 2017. After two reviewers separately screened literature according to the inclusion and exclusion criteria, extracted data and assessed the quality of the included studies, data were analyzed with RevMan 5.3 sofware. Totally 14 RCTs were included with 1 400 patients involved. According to Meta-analysis, compared with Adefovir Dipivoxil alone, FHC combined with Adefovir Dipivoxil was more efficiently in reducing the liver fibrosis indexes HA [MD = -99.66, CI = -129.94 - -69.37], P < 0.000 01]; LN [MD = -40.99, CI = -58.56 - -23.41, P < 0.000 01]; PCIII [MD = -76.40, CI = -108.15 - -44.66, P < 0.000 01]; IV-C [MD = -55.24, CI = -79.19 - -31.29, P < 0.000 01], in improving the liver function ALT [MD = -21.05, CI = -22.58 - -19.52, P < 0.000 01]; AST [MD = -16.74, CI = -25.14 - -8.33, P < 0.000 1]; TBIL [MD = -10.38, CI = 14.17 - 6.59, P < 0.000 01]; ALB [MD = 4.35, CI = -3.48 - 5.23, P < 0.000 01], and improving the ultrasound imaging results. Also, no significant adverse reaction was reported. FHC combined with Adefovir Dipivoxil could significantly improve liver function, reduce liver fibrosis indexes, and had less adverse reactions, but more large sample, high quality clinical trial are required to verify the curative effect.
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Objective@#To investigate the effect of Fuzheng Huayu capsules on the survival rate of patients with liver cirrhosis.@*Methods@#A retrospective analysis was performed for the clinical data of the patients with various types of liver cirrhosis who were hospitalized in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from January 1, 2006 to December 31, 2008. The data collected for these patients included their basic information, diagnosis and treatment, and results of laboratory examination. The Kaplan-Meier method was used to analyze the effect of Fuzheng Huayu capsules on the survival rate of patients with liver cancer. The starting point of observation was the first day of the patient’s admission and the ending point of follow-up observation was the date of death or the end of follow-up April 1, 2014. The cut-off value was obtained if the patient did not experience any outcome event (death) at the end of follow-up. With reference to the outcome, the time when the outcome occurred, and the cut-off value, the life-table method was used to calculate survival rates and survival curves were plotted. The Kaplan-Meier product-limit method was used to calculate the arithmetic mean of survival time and median survival time, and the log-rank test was used to compare the survival data.@*Results@#A total of 430 patients with liver cirrhosis were enrolled, among whom 191 died and 239 survived or were censored. The average constituent ratio of death was 55.6% and the average constituent ratio of survival was 44.4%. The life-table method showed that the half-, 1-, 2-, and 5-year survival rates were 70%, 64%, 58%, and 48%, respectively. The median survival time was 112.1 weeks for the patients who did not take Fuzheng Huayu capsules and 351.6 weeks for those who did, and there was a significant difference in survival rate between the two groups (P = 0.000). Among 313 patients who had an etiology of hepatitis B, 164 did not take Fuzheng Huayu capsules and had a median survival time of 195.9 weeks and a 5-year survival rate of 44%, and 149 took Fuzheng Huayu capsules and had a median survival time of 336.9 weeks and a 5-year survival rate of 59%; there was a significant difference in survival rate between the two groups (P = 0.038). Among 117 patients who did not have hepatitis B, 68 did not take Fuzheng Huayu capsules and had a median survival time of 78.1 weeks and a 5-year survival rate of 32%, and 49 took Fuzheng Huayu capsules and had a median survival time of 277.4 weeks and a 5-year survival rate of 53%; there was a significant difference in survival rate between the two groups (P = 0.013). Among 92 patients with compensated liver cirrhosis, 47 did not take Fuzheng Huayu capsules and had a 5-year survival rate of 65%, and 45 took Fuzheng Huayu capsules and had a 5-year survival rate of 82%; both groups of patients had a median survival of 440 weeks; there was a significant difference in survival rate between the two groups (P = 0.027). Among 338 patients with decompensated liver cirrhosis, 185 did not take Fuzheng Huayu capsules and had a median survival time of 60.3 weeks and a 5-year survival rate of 33%, and 153 took Fuzheng Huayu capsules and had a median survival time of 267.7 weeks and a 5-year survival rate of 51%; there was a significant difference in survival rate between the two groups (P = 0.001).@*Conclusion@#Fuzheng Huayu capsules can improve the prognosis of patients with liver cirrhosis and increase their survival rates and have good long-term efficacy.
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Objective To explore the clinical efficacy of entecavir combined with Fuzheng Huayu capsule in patients with chronic hepatitis B cirrhosis. Methods A total of 102 decompensated patients with chronic hepatitis B cirrhosis were enrolled in our hospital from May 2015 to May 2017. The patients were divided into study group and control group by random number method. The patients were treated with routine symptom and liver Treatment group, based on this line of entecavir treatment, the study group in the conventional therapy based on entecavir combined with Fuzheng Huayu capsule treatment, compared the two groups of patients with HBV DNA negative rate, inflammatory factors, fibrosis indicators and liver function indicators. Results However, the improvement of inflammatory factors, fibrosis indexes and liver function indexes in the study group was more significant than that in the control group, and the difference was significant, but there was no significant difference between the two groups There was statistical significance (P<0.05). Conclusion The efficacy of entecavir combined with Fuzheng Huayu capsule in patients with chronic hepatitis B liver cirrhosis is accurate and worthy of clinical application in clinical practice.
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ObjectiveTo investigate the clinical effect of entecavir (ETV) combined with Fuzheng Huayu capsules in the treatment of patients with compensated chronic hepatitis B-related cirrhosis. MethodsA total of 142 patients with compensated chronic hepatitis B-related cirrhosis who visited the Sixth People′s Hospital Qingdao from January 2013 to December 2015 were randomly divided into treatment group and control group, with 71 patients in each group. Both groups were given conventional treatment such as liver-protecting and symptomatic treatment. The patients in the control group were given ETV 0.5 mg/day, while those in the treatment group received oral administration of Fuzheng Huayu capsules 1.5 g twice a day in addition to the treatment in the control group. Both groups were treated for 12 months. The changes in inflammatory factors and fibrosis markers were observed. The t-test was used for comparison of continuous data between groups, and the chi-square test was used for comparison of categorical data between groups. ResultsAfter the 12-month treatment, the treatment group and the control group showed no significant difference in the serum HBV DNA clearance rate ［91.5% (65/71) vs 90.1% (64/71), P=0.771］. Compared with the control group, the treatment group showed significant reductions in serum hyaluronic acid, laminin, procollagen type III, collagen type IV, alanine aminotransferase, aspartate aminotransferase, liver stiffness measurement, tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), interleukin-8 (IL-8), and hypersensitive C-reactive protein (hs-CRP) (t=16187，5343，13697，17121，7409，27371，7973，5471，7885，9057，8171，all P＜0.001). ConclusionCompared with ETV alone, ETV combined with Fuzheng Huayu capsules exerts a better anti-fibrotic effect and can inhibit the release of TNF-α, IL-6, IL-8 and hs-CRP in patients with compensated chronic hepatitis B-related cirrhosis.
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Objective To observe the effects of Fuzheng Huayu Capsule on the expressions of the main roles, Rock1 and Rock2, in RhoA/Rock signal transduction pathway in rats with myocardial infarction (MI);To explore the possible mechanism of Fuzheng Huayu Capsule to improve ventricular remodeling in myocardial fibrosis. Methods The MI model was induced by ligation of the left coronary artery. Rats with MI were randomly divided into the model group, Fuzheng Huayu group and Fasudil hydrochloride group. A sham-operation group threading without ligation was setting as a control group, with eight rats in each group. The rats were treated with corresponding medicine for 4 weeks from the second day after modeling. The expression of Rock1, Rock2 and its mRNA were detected by immunohistochemical and real-time PCR method. Results The protein expression of Rock1 and Rock2 in model group were significantly higher than those in the sham-operation group (P<0.05). The protein expression of Rock1 and Rock2 in the Fuzheng Huayu group and Fasudil hydrochloride group were lower than those in the model group. The mRNA expression of Rock2 was significantly higher in the model group than that in the sham-operation group (P<0.05). The mRNA expression of Rock1 in the Fasudil hydrochloride group was lower than that in the model group (P<0.05). The mRNA expression of Rock2 in the Fuzheng Huayu group and Fasudil hydrochloride group was lower than that in the model group (P<0.05). Conclusion Fuzheng Huayu Capsule can decrease the expression of Rock1, Rock2 and Rock2 in the marginal zone of myocardial infarction in rats with MI. The anti ventricular remodeling mechanism of Fuzheng Huayu Capsule maybe related with this.
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Objective To investigate the clinical efficacy of Fuzheng Huayu Capsule in the treatment of liver cirrhosis (decompensated) and its impact on quality of life in patients with TCM therapy research.Methods 160 cases of liver cirrhosis (decompensated) patients were chosen as research subjects.They were divided into experimental groupand control group according to random number table.Both groups used routine liver antiviral therapy,the experimental group was given Fuzhenghuayu tablets therapy,the control group only received conventional therapy.After 6 months of treatment,and treatment for the two groups of patients were evaluated quality of life conditions.Results Compared with before treatment,HA,LN,PC Ⅲ,Ⅳ-C of the indicators were significantly decreased,and the difference was statistically significant (t =10.89,15.88,10.42,12.38,4.41,9.27,4.97,6.55,all P ＜ 0.05).After the two groups of patients for the treatment of fibrotic indicators analysis found more significant decline in the observation group,the difference was statistically significant (t =5.32,3.88,5.25,5.01,all P ＜ 0.05).2 Compared with before treatment,ALT,AST levels of the two groups were significantly decreased,the difference had statistically significant (t =2.02,17.87,2.62,7.96,all P ＜0.05).for two groups of patients was compared with that total efficiency (87.50％ vs 66.25 ％),the difference was statistically significant (x2 =10.16,P ＜ 0.05).Compared with pre-treatment,two patients in the field of physiology,psychology field,the field of social relations,environmental areas and total score was significantly higher,the difference was statistically significant (t =13.94,12.37,11.12,10.71,16.45,8.60,6.54,8.35,4.86,8.04,all P ＜ 0.05) ; The two groups of patients after treatment compare the scores and scores found in the observation group was significantly more elevated,compared with the control group,the difference was statistically significant (t =4.97,3.81,4.98,2.56,5.05,all P ＜ 0.05).Conclusion In the treatment of hepatitis cirrhosis,Fuzheng Huayu Capsule can significantly improve the degree of liver fibrosis,improve the quality of life of patients and improve clinical outcomes.
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Objective To investigate the efficacy and safety of Fuzheng huayu capsule in combination With anti-viral drugs in the treatment of hepatitis B-mediated liver cirrhosis.Methods One hundred and twentysix patients with liver cirrhosis resulting from hepatitis B were randomized into group A (38 cases receiving conventional therapy),group B (41 cases receiving conventional therapy + entecavir)and group C (47 cases receiving conventional therapy + entecavir and anti-fibrosis treatment ).The Fuzheng Huayu capsule was administrated for 24 weeks and all the patients were observed for 48 weeks.Results The liver cirrhosis-related parameters in Group C were more remarkably improved than that of Group A and Group B:HA( [ 152.3 ± 72.3 ]μg/L vs.[212.3 ± 86.9] μg/L,[325.6 ± 153.1 ] μg/L,F =30.18,P ＜ 0.01 ),LN( [ 104.7 ± 23.9 ] μg/L vs.[ 139.9 ±28.9] μg/L,[ 127.7 ±76.0] μg/L,F =36.99,P ＜0.01 ),Pc Ⅲ ( [ 167.8 ±61.4] μg/L vs.[207.5 ±78.1 ] μg/L,[ 263.1 ± 113.2 ] μg/L,F =30.34,P ＜ 0.01 ) and Child-Pugh scale ( [ 6.94 ± 1.31 ] vs.[ 7.53 ±1.24 ],[ 8.77 ± 1.36 ],F =14.45,P ＜ 0.01 ).The liver function-related parameters in Group C were significantly different from that of Group A and Group B:ALT( [58 ±41 ] U/L vs.[ 147 ±96] U/L,[75 ± 19]U/L,F =16.82,P ＜0.01 ),ALB( [38.1 ± 1.7]g/L vs.[26.5 ±3.5 ] g/L,[35.4 ± 1.8 ] g/L,F =4.69,P ＜0.01),TBil ([31.9 ± 12.7] μmol/L vs.[85.2 ±58.3] μmol/L,[46.1 ± 17.8] μmol/L,F.=15.10,P ＜0.01)and PTA improvement ([76 ±24]％ vs.[57 ± 12]％,[73 ± 18]％,F =79.26,P ＜0.01).Conclusion Entecavir can rapidly and effectively inhibit the replication of HBV in patients with decompensated hepatitis Bmediated cirrhosis and improve the liver function.When combined with fuzheng huayu capsule,entecavir will effectively improve the cirrhosis and elevate the serum albumin level.
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OBJECTIVE:To analyze the cost-effectiveness of 4 kinds of Chinese patent drugs in the treatment of hepatic fibrosis. METHODS:84 patients with hepatic fibrosis were treated with Dahuang Zhechong capsule(group A) ,Fuzheng Huayu capsule(group B) ,Fufang Biejia Ruangan tablet(group C) and Biejia Jian pill(group D) ,respectively. Then cost-effectiveness was analyzed with pharmacoeconomic method. RESULTS:The total costs(C) were 835.2 yuan for group A,1228.5 yuan for group B,1922.4 yuan for group C and 488 yuan for group D. The total effective rates(E) were 76.19%,80.95%,85.71%,80.95%,respectively(P