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ObjectiveTo investigate the serum level of HBV RNA in untreated or treatment-experienced patients with chronic hepatitis B （CHB） and the correlation between serum HBV RNA level and the duration of antiviral therapy with nucleos（t）ide analogues （NAs）. MethodsA total of 300 patients with CHB who attended Department of Infectious Diseases in The First Affiliated Hospital of Shihezi University School of Medicine from February to July， 2022， were enrolled as subjects. Related clinical data were collected， and according to the duration of antiviral therapy， they were divided into untreated group with 73 patients， treatment duration ≤1 year group with 91 patients， and treatment duration >1 year group with 136 patients. Serum HBV RNA load， HBV DNA load， and HBsAg concentration were measured for all patients. The Mann-Whitney U test was used for comparison of continuous data between two groups， and the Kruskal-Wallis H test was used for comparison between multiple groups， further pairwise comparison using Bonferroni method； the chi-square test was used for comparison of categorical data； a Spearman correlation analysis was used to investigate the degree of correlation between various indicators. ResultsThe positive rate of HBeAg was 18.3%， and among the patients with negative HBV DNA， the patients with positive HBV RNA accounted for 44.1% （86/195）. There was a significant difference in the distribution of the serum levels of HBV RNA， HBV DNA， and HBsAg between the positive HBeAg group and the negative HBeAg group （Z=10.740， 6.300， and 7.280， all P<0.05）. There was a significant difference in the distribution of DNA level between the untreated group and the treatment duration ≤1 year group （P<0.05）； there was a significant difference in the distribution of HBV RNA and HBV DNA levels between the untreated group and the treatment duration >1 year group （P<0.05）； there was a significant difference in the distribution of HBV RNA， HBV DNA， and HBsAg levels between the treatment duration ≤1 year group and the treatment duration >1 year group （P<0.05）. The correlation analysis between the duration of antiviral therapy and the levels of HBV RNA， HBV DNA， and HBsAg showed that the duration of antiviral therapy had an extremely weak negative correlation with the levels of HBV RNA and HBsAg （r=-0.247 and -0.138， both P<0.05） and a strong negative correlation with the level of HBV DNA （r=-0.771， P<0.001）. There was a low degree of correlation between the serum level of HBV RNA and the serum levels of HBV DNA and HBsAg （r=0.360 and 0.442， both P<0.001）. Further stratified analysis showed that in the untreated group， there was a strong positive correlation between HBV RNA and HBV DNA （r=0.752， P<0.001） and a moderate positive correlation between HBV RNA and HBsAg （r=0.559， P<0.001）； in the treatment duration ≤1 year group， there was a low degree of positive correlation between HBV RNA and HBV DNA/HBsAg （r=0.396 and r=0.388， both P<0.001）； in the treatment duration >1 year group， there was a low degree of positive correlation between HBV RNA and HBsAg （r=0.352， P<0.001）. ConclusionSerum HBV RNA is negatively correlated with the duration of treatment with NAs， and the correlation of HBV RNA with HBV DNA and HBsAg gradually decreases with the increase in the duration of treatment. Therefore， it can be used as a supplementary indicator for monitoring the level of virologic response in CHB patients to a certain extent， with a relatively high accuracy in reflecting the level of viral replication in untreated patients.
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ObjectiveTo investigate the change and potential role of Mindin protein in the treatment of chronic hepatitis B （CHB） with PEG-IFNα-2b. MethodsA total of 29 CHB patients who received the treatment with PEG-IFNα-2b in The Second Affiliated Hospital of Xi’an Jiaotong University from January 2018 to December 2019 were enrolled， and according to their clinical outcome， they were divided into cured group with 17 patients and uncured group with 12 patients. Peripheral blood samples were collected from both groups at baseline， 12 weeks， and 24 weeks to measure blood routine indices， liver function parameters， hepatitis B markers， and Mindin protein. HBsAg， alanine aminotransferase （ALT）， aspartate aminotransferase （AST）， and Mindin protein at different time points were compared between the two groups. The independent-samples t test was used for comparison of normally distributed continuous data between two groups， and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups； a Spearman correlation analysis was used to investigate correlation； a multiple linear regression analysis was used to investigate the influence of HBsAg and ALT on the content of Mindin protein. ResultsThe analysis of baseline data showed that there were significant differences in the levels of HBsAg， HBeAb， albumin， and albumin/globulin ratio between the cured group and the uncured group （all P<0.05）. The cured group tended to have a gradual increase in the level of Mindin， and the level of Mindin at 24 weeks was significantly higher than that at baseline （P<0.05）. The cured group had a significantly higher level of Mindin protein than the uncured group at 24 weeks （P=0.019）. The cured group had a significantly lower level of HBsAg than the uncured group （P<0.05）， with a significant change from baseline to each time point within the cured group （P<0.05）. In addition， the levels of ALT and AST in the cured group tended to first increase and then decrease， and the expression levels at 12 weeks were significantly higher than those at baseline （P<0.05）. At 12 weeks， there was a strong linear correlation between Mindin protein levels and ALT in the untreated group （r=0.760 8， P<0.05）， and further multiple linear regression analysis also demonstrated a linear relationship between the two （b=1.571， P=0.019）. ConclusionThere is a significant difference in the level of Mindin protein between the cured group and the non-cured group after 24 weeks of PEG-IFNα-2b antiviral treatment， and therefore， detecting the dynamic changes of Mindin protein can better predict the treatment outcome of CHB， which provides a reference for clinical practice.
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ObjectiveTo investigate the application value of liver/spleen CT value （CTL/S）， controlled attenuation parameter （CAP）， and magnetic resonance imaging-proton density fat fraction （MRI-PDFF） in chronic hepatitis B （CHB） patients with hepatic steatosis. MethodsA retrospective analysis was performed for the clinical data of 213 CHB patients who underwent liver CT， CAP， and MRI-PDFF examinations in Affiliated Hospital of Yan’an University from October 2018 to December 2022. According to MRI-PDFF， the 213 patients were divided into CHB group with 111 patients （MRI-PDFF<5%） and CHB+hepatic steatosis group with 102 patients （MRI-PDFF≥5%）， among whom there were 69 patients with mild hepatic steatosis and 33 patients with moderate to severe hepatic steatosis. The independent-samples t test was used for comparison of normally distributed continuous data between groups， and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups. The Bland-Altman plot was used to evaluate the consistency in MRI-PDFF measurement between two physicians. The Spearman’s correlation coefficient was used to analyze the correlation between CTL/S and MRI-PDFF and between CAP and MRI-PDFF. The receiver operating characteristic （ROC） curve was plotted and the area under the ROC curve （AUC） was calculated to investigate the value of CTL/S and CAP in the diagnosis of different degrees of hepatic steatosis， and the DeLong test was used to compare the AUCs of the two radiological examinations. ResultsMRI-PDFF had relatively high repeatability and stability in CHB patients. There is a significant negative correlation between CTL/S and MRI-PDFF （r=-0.800， P<0.001） and a significant positive correlation between CAP and MRI-PDFF （r=0.692， P<0.001）. Both CTL/S and CAP had a relatively high accuracy in the diagnosis of hepatic steatosis in CHB patients， with an AUC of 0.951 and 0.902， respectively， and CTL/S had a better accuracy than CAP （P<0.05）. In the diagnosis of mild and moderate-to-severe hepatic steatosis， CTL/S had an AUC of 0.921 and 0.895， respectively， and CAP had an AUC of 0.859 and 0.825， respectively， suggesting that CTL/S had a slightly higher diagnostic efficiency than CAP. ConclusionMRI-PDFF has high repeatability and stability in CHB patients， and CTL/S and CAP have a high diagnostic value for different degrees of hepatic steatosis in CHB patients.
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ObjectiveTo investigate the potential effect of ursodeoxycholic acid （UDCA） in the prevention and treatment of COVID-19 in patients with chronic hepatitis B. MethodsClinical data were collected from 324 patients with chronic hepatitis B who were treated in Beijing Ditan Hospital， Capital Medical University， from January to December 2022， and according to whether UDCA was administered， they were divided into UDCA group and control group. The propensity score matching （PSM） method was used to balance the confounding factors such as age， sex， and chronic complications， and the two groups were compared in terms of SARS-CoV-2 infection rate， symptoms， and recovery time after COVID-19. The two groups were also compared in terms of related laboratory markers （white blood cell count ［WBC］， hemoglobin ［Hb］， platelet count ［PLT］， alanine aminotransferase ［ALT］， aspartate aminotransferase ［AST］， albumin ［Alb］， alkaline phosphatase ［ALP］， total bilirubin ［TBil］， triglyceride ［TG］， and total cholesterol ［TC］）， vaccination， and the incidence rate of liver disease symptoms after COVID-19. The independent-samples t test was used for comparison of normally distributed continuous data between two groups， and the Mann-Whitney U test was used for comparison of data with skewed distribution between the two groups； the chi-square test and the continuously corrected chi-square test were used for comparison of categorical data between two groups. The binary Logistic regression model was used for univariate and multivariate analyses to investigate the influencing factors for COVID-19 after matching. ResultsThere were 87 patients in the UDCA group and 237 patients in the control group， and after PSM， there were 78 patients in the UDCA group and 137 patients in the control group， with good balance between the two groups. There was a significant difference in SARS-CoV-2 infection rate between the UDCA group and the control group ［82.1% （64/78） vs 95.6% （131/137）， χ2=10.847， P=0.001］. After COVID-19， compared with the control group， the UDCA group had a significantly lower proportion of the patients with chill （10.9% vs 38.9%， χ2=16.124， P<0.001） and cough （56.3% vs 74.8%， χ2=6.889， P=0.009）. There was a significant difference between the UDCA group and the control group in the proportion of the patients with a recovery time of ≤7 days after COVID-19 （79.7% vs 61.1%， χ2=6.760， P=0.009）. Both univariate and multivariate logistic regression analyses showed that UDCA was an independent influencing factor for COVID-19 （odds ratio=0.21 and 0.17， both P<0.05）. ConclusionUDCA is an protective factor against COVID-19 in patients with chronic hepatitis B and can alleviate related symptoms to some extent and shorten the recovery time， and therefore， it has an important value in the prevention and treatment of COVID-19.
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ObjectiveTo investigate the significance of high-sensitive polymerase chain reaction （PCR） in detecting hepatitis B virus （HBV） among the population with a very low viral load （HBV DNA 10 — 99 IU/mL）. MethodsThis study was conducted among the chronic hepatitis B （CHB） patients who were treated with nucleos（t）ide analogues for ≥48 weeks in The Fifth Affiliated Hospital of Guangzhou Medical University from September 2019 to February 2022 and had an HBV DNA load below the lower limit of ordinary-sensitivity detection （100 IU/mL）. Then high-sensitivity HBV DNA detection was performed for all patients， and according to these results， the patients were divided into very low viral load group （VLVL group with an HBV DNA load of 10 — 99 IU/mL） and complete virologic response group （CVR group with an HBV DNA load of <10 IU/mL or without HBV DNA detected）. The two groups were compared in terms of general characteristics， serum virological indicators， biochemical parameters， and noninvasive fibrosis markers； the value of related serum virological indicators in predicting the results of high-sensitivity HBV DNA above the lower limit of detection were assessed； the influencing factors for failure to achieve CVR were analyzed. The independent-samples t test was used for comparison of normally distributed continuous data between two groups， and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups； the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups. The receiver operating characteristic （ROC） curve was used to investigate the value of related serum virological indicators in predicting the results of high-sensitivity HBV DNA above the lower limit of detection， and a binary logistic regression analysis was used to investigate the influencing factors for failure to achieve CVR. ResultsA total of 106 CHB patients were enrolled， with 24 in the VLVL group and 82 in the CVR group. Compared with the CVR group， the VLVL group had a significantly younger age （P=0.004） and significantly higher quantitative hepatitis B surface antigen （qHBsAg） level （P=0.002）， HBeAg positive rate （P=0.002）， pgRNA positive rate （P=0.010）， and alanine aminotransferase level （P=0.017）. The qHBsAg level had an area under the ROC curve of 0.717 （P=0.002） in predicting the results of high-sensitivity HBV DNA above the lower limit of detection （>10 IU/mL）， with an optimal cut-off value of 1 214.5 IU/mL， a sensitivity of 95.5%， and a specificity of 53.9%. Positive HBeAg （odds ratio ［OR］=3.654， 95% confidence interval ［CI］： 1.162 — 11.489， P=0.027） and qHBsAg （OR=2.985， 95%CI： 1.058 — 8.422， P=0.039） were independent influencing factors for failure to achieve CVR. ConclusionSome CHB patients have an HBV DNA load of <100 IU/mL by ordinary-sensitivity detection， but with the presence of VLVL determined by high-sensitivity PCR. The VLVL group had significantly higher level of inflammatory damage and positive rates of pgRNA and HBeAg. Positive HBeAg and high qHBsAg level are independent influencing factors for failure to achieve CVR. Clinicians should not ignore the presence of VLVL in CHB patients， and high-sensitivity HBV DNA detection should be performed in a timely manner.
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Chronic hepatitis B virus （HBV） infection is the main cause of the disease burden of viral hepatitis worldwide， and meanwhile， due to changes in lifestyle and dietary habits， the incidence rate of metabolic associated fatty liver disease （MAFLD） is constantly increasing， making MAFLD the leading chronic liver disease around the world. Chronic HBV infection comorbid with MAFLD is becoming more and more common in clinical practice. Metabolic factors， rather than viral factors， are the main cause of chronic HBV infection comorbid with MAFLD. During disease progression， steatohepatitis and fibrosis， rather than steatosis， are the main influencing factors for the progression to liver cirrhosis and hepatocellular carcinoma. For patients with chronic HBV infection and MAFLD， integrated management of virus and metabolic factors is of great importance. This article reviews the tissues regarding the interaction， prognosis， and clinical management of chronic HBV infection and MAFLD.
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Objective:To investigate the efficacy of peginterferon alfa-2a (Peg-IFNα-2a) combined with entecavir in sequential treatment of chronic hepatitis B.Methods:A total of 106 patients with chronic hepatitis B who received treatment in Affiliated Hangzhou Xixi Hospital of Zhejiang University School of Medicine from January 2020 to February 2022 were included in this study. They were divided into a control group (entecavir treatment, n = 53) and a study group (sequential therapy with Peg-IFNα-2a followed by entecavir, n = 53). Liver function indicators, liver fibrosis indicators, clinical treatment efficacy, and incidence of adverse reactions were compared between the two groups before and after treatment. Results:After treatment, total bilirubin, alanine aminotransferase and aspartate transaminase in the control and study groups were (94.79 ± 8.71) μmol/L and (67.67 ± 9.19) μmol/L, (256.93 ± 44.07) U/L and (186.56 ± 48.37) U/L, (256.47 ± 43.73) U/L and (200.69 ± 41.34) U/L, and they were (140.05 ± 26.15) μmol/L and (141.32 ± 25.35) μmol/L, (433.66 ± 77.16) U/L and (429.77 ± 73.73) U/L, (352.34 ± 65.19) U/L and (354.05 ± 66.13) U/L before the treatment. After treatment, these indexes in each group were decreased compared with before treatment ( t = 19.19, -12.13, -28.85, -20.96, -19.27, -12.03, all P < 0.05). After treatment, these indexes in the study group were significantly lower than those in the control group ( t = -6.49, -7.30, -6.74, all P < 0.001). After treatment, the levels of hyaluronic acid, laminin, type III procollagen peptide, and type IV collagen in the control and study groups were (124.91 ± 22.99) μg/L and (101.29 ± 22.67) μg/L, (132.71 ± 25.37) μg/L and (110.56 ± 25.49) μg/L, (116.93 ± 20.29) μg/L and (93.14 ± 20.39) μg/L, (63.14 ± 12.19) μg/L and (50.81 ± 11.63) μg/L, and they were (175.73 ± 48.56) μg/L and (177.61 ± 48.51) μg/L, (163.43 ± 41.52) μg/L and (165.57 ± 41.59) μg/L, (139.71 ± 31.75) μg/L and (141.72 ± 31.78) μg/L, (106.97 ± 32.24) μg/L and (104.02 ± 34.12) μg/L before treatment. After treatment, the levels of these indexes in each group were significantly decreased compared with before treatment ( t = -13.04, -8.68, -10.43, -5.82, -13.35, -6.26, -13.02, -10.72, all P < 0.05). After treatment, the levels of these indexes in the study group were significantly lower than those in the control group ( t = -5.32, -4.48, -6.02, -5.32, all P < 0.001). The total response rate in the study group was 88.68% (47/53), which was significantly higher than 62.26% (33/53) in the control group ( χ2 = 9.98, P < 0.05). The HBsAg conversion rate in the study group was 33.96% (18/53), which was significantly higher than 1.32% (6/53) in the control group ( χ2 = 7.75, P < 0.05). There was no statistically significant difference in the incidence of adverse reactions between the study and control groups [26.42% (14/53) vs. 30.19% (16/53), χ2 = 0.81, P > 0.05]. Conclusion:Sequential therapy with Peg-IFNα-2a followed by entecavir can effectively improve liver function,reduce liver fibrosis , improve clinical treatment efficacy, and will not increase adverse reactions.
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Objective:To investigate the relationship between peripheral blood lipid levels and hepatitis B-related liver cancer, and to provide a theoretical basis for the early prevention and treatment of liver cancer.Methods:A total of 188 patients with hepatitis B-related liver cancer who received treatment in The First Hospital of Shanxi Medical University from June 2018 to June 2021 met the inclusion and exclusion criteria and had complete data, were included in this study. They were divided into three groups: chronic hepatitis B group ( n = 72), hepatitis B cirrhosis group ( n = 62), and hepatitis B-related liver cancer group ( n = 54) according to different stages of the disease. All patients' medical records were obtained from the medical data room. Fasting venous blood was collected in all patients on the second day after admission to detect peripheral blood lipid, liver function, and other relevant indicators. General data and biochemical indicators were collected. The Kruskal-Wallis test was performed to compare the measurement data among groups. The chi-squared test was performed to compare the count data among groups. Spearman's correlation (bivariate) was performed. Binary logistic regression was performed to analyze the influential factors of liver cancer. Results:There were significant differences in the levels of total cholesterol (TC), triacylglycerol (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) among the three groups ( F = 32.14, 27.59, 10.88, 34.09, all P < 0.05). TC and LDL-C levels in the hepatitis B-related liver cancer group were significantly higher than those in the hepatitis B cirrhosis group ( F = -32.31, -50.19, both P < 0.05). There were no significant differences in TG and HDL-C levels between hepatitis B-related liver cancer and hepatitis B cirrhosis groups ( F = -10.69, 4.46, both P > 0.05). TC, TG, HDL-C and LDL-C levels in the hepatitis B cirrhosis group were significantly lower than those in the chronic hepatitis B group ( F = 53.30, 46.98, 24.61, 48.57, all P < 0.05). LDL-C level was positively correlated with the occurrence of liver cancer ( r = 0.20, P < 0.05). HDL-C level was negatively correlated with the occurrence of liver cancer ( r = -0.15, P < 0.05). LDL-C was an independent risk factor for liver cancer ( OR = 3.35, P < 0.05), and HDL-C was a protective factor for liver cancer ( OR = 0.12, P < 0.05). Conclusion:Compared with patients with chronic hepatitis B and hepatitis B cirrhosis, patients with hepatitis B-related liver cancer had abnormal peripheral blood lipid levels, which may be related to the abnormal lipid metabolism of tumor cells. Moreover, peripheral blood lipid levels may affect the occurrence and development of tumor cells.
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Objective:To analyze the diagnostic and prognostic values of the red blood cell distribution width-to-platelet count ratio (RPR) for hepatitis B and liver cirrhosis.Methods:The clinical data of 80 patients with hepatitis B and liver cirrhosis who were diagnosed and treated in Yiwu Central Hospital from June 2020 to August 2021 were retrospectively analyzed. These patients were included in the hepatitis B and liver cirrhosis group. They were subdivided into survival ( n = 69) and death ( n = 11) groups according to their prognosis outcomes. Eighty patients with chronic hepatitis B were included in the chronic hepatitis B group. Eighty healthy controls who concurrently underwent physical examination were included in the control group. The diagnostic and prognostic values of RPR, aspartate aminotransferase-to-platelet ratio index (APRI), and fibrosis index based on four factors (FIB-4) for hepatitis B and liver cirrhosis were analyzed. Results:Red blood cell distribution width, alanine transaminase, and aspartate transaminase in the hepatitis B and liver cirrhosis group and chronic hepatitis B group were significantly higher compared with the control group (all P < 0.05). Platelet count in the hepatitis B and liver cirrhosis group and chronic hepatitis B group was significantly lower than that in the control group (both P < 0.05). Red blood cell distribution width in the hepatitis B and liver cirrhosis group was significantly higher than that in the chronic hepatitis B group [(18.25 ± 3.28)% vs. (14.67 ± 2.15)%, t = 8.16, P < 0.05]. Platelet count, alanine transaminase, and aspartate transaminase levels in the hepatitis B and liver cirrhosis group were (78.47 ± 11.43) × 10 9/L, (49.48 ± 6.85) U/L, (45.86 ± 6.28) U/L, respectively, which were significantly lower than (133.36 ± 18.42) × 10 9/L, (128.36 ± 15.40) U/L, (98.67 ± 14.41) U/L in the chronic hepatitis B group ( t = -22.65, -41.86, -30.05, all P < 0.05). PRP, APRI, and FIB-4 in the hepatitis B and liver cirrhosis group were (0.23 ± 0.05), (1.85 ± 0.44), (4.25 ± 0.81) respectively, which were significantly higher than (0.11 ± 0.02), (1.46 ± 0.33), (3.38 ± 0.63) in the chronic hepatitis B group ( t = 19.93, 6.34, 7.58, all P < 0.001). The RPR, APRI, and FIB-4 in the death group were (0.25 ± 0.08), (1.97 ± 0.48), (4.52 ± 1.31), respectively, which were significantly higher than (0.18 ± 0.05), (1.68 ± 0.40), (3.69 ± 1.21) in the survival group ( t = 3.94, 2.17, 2.09, all P < 0.05). The receiver operating characteristic curve revealed that PRP has an extremely high value in diagnosing hepatitis B and liver cirrhosis and predicting the death of patients with hepatitis B and liver cirrhosis. Conclusion:RPR has an extremely high value in diagnosing hepatitis B and liver cirrhosis and predicting the prognosis of this disease.
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Chronic hepatitis B （CHB） is still a malignant infectious disease that seriously threatens human health， and currently nucleos（t）ide analogues and interferon are the main treatment methods for CHB， but they cannot achieve functional cure. The development and progression of CHB are closely associated with immune function dysregulation in the host， and therefore， regulating host immunity has become a key link in the treatment of CHB. Recent studies have shown that traditional Chinese medicine exerts a therapeutic effect on CHB by regulating host immune function. This article introduces the relationship between traditional Chinese medicine theory and immunity and summarizes the theoretical basis and related studies for traditional Chinese medicine in the immune regulation of CHB， in order to provide new ideas for integrated traditional Chinese and Western medicine therapy for CHB.
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ObjectiveTo establish an early predictive model using serological markers based on LASSO regression for predicting the possibility of HBsAg clearance in HBeAg-negative chronic hepatitis B （CHB） patients treated with pegylated interferon α-2b （PEG-IFNα-2b）， and to investigate the diagnostic value of the model. MethodsA total of 136 HBeAg-negative CHB patients who received PEG-IFNα-2b treatment in the Affiliated Hospital of Xuzhou Medical University from April 2020 to October 2021 were enrolled， among whom 47 received PEG-IFNα-2b for the first time （previously untreated） and 89 received PEG-IFNα-2b after 48 weeks of treatment with nucleos（t）ide analogues （treatment-experienced）. The patients were randomly assigned to a training set with 95 patients and a validation set with 41 patients at a ratio of 7∶3， and related data were collected for both groups， including virological markers， routine blood test results， and liver function at baseline and week 12 of treatment. According to HBsAg status at week 48 of treatment， the patients were divided into seroconversion group with 38 patients and non-seroconversion group with 98 patients. The independent-samples t test was used for comparison of normally distributed continuous data between two groups， and the Wilcoxon rank-sum test was used for comparison of non-normally distributed continuous data between two groups； the chi-square test was used for comparison of categorical variables between two groups. The LASSO regression analysis and univariate and multivariate logistic regression analyses were used to establish a nomogram model； the receiver operating characteristic （ROC） curve was used to assess its predictive ability， and the area under the ROC curve （AUC） was used for comparison of predictive value. ResultsIn the training set， 95 HBeAg-negative CHB patients were treated with PEG-IFNα-2b for 48 weeks， among whom there were 27 patients in the seroconversion group and 68 in the non-seroconversion group. The univariate Logistic regression analysis， with P<0.2 as the criterion for screening， showed that 9 indicators were included in the LASSO regression analysis， i.e.， sex， baseline HBV DNA level， the reduction in HBV DNA in 0 — 12 weeks， baseline HBsAg level， the reduction in HBsAg in 0 — 12 weeks， baseline aspartate aminotransferase （AST） level， the reduction in AST in 0 — 12 weeks， baseline alanine aminotransferase （ALT） level， and the reduction in ALT in 0 — 12 weeks. The LASSO regression analysis showed that sex， baseline HBsAg level， the reduction in HBsAg in 0 — 12 weeks， and the reduction in ALT in 0 — 12 weeks were non-zero variables and were included in the multivariate Logistic regression analysis. The multivariate Logistic regression analysis obtained 4 independent predictive factors， i.e.， sex （odds ratio ［OR］=5.38， 95% confidence interval ［CI］： 1.11 — 34.21， P=0.049）， baseline HBsAg level （OR=0.12， 95%CI： 0.04 — 0.26， P<0.001）， the reduction in HBsAg in 0 — 12 weeks （OR=5.54， 95%CI： 1.97 — 19.18， P=0.003）， and the reduction in ALT in 0 — 12 weeks （OR=0.99， 95%CI： 0.97 — 1.00， P=0.039）. A nomogram model was established based on the results of the multivariate Logistic regression analysis， and the ROC curve was used to assess the predictive value of this nomogram model. This nomogram model had an AUC of 0.934 （95%CI： 0.886 — 0.981） in the training set and an AUC of 0.921 （95%CI： 0.838 — 1.000） in the validation set. In addition， the results of calibration curve and decision curve analyses showed that the model had good consistency and accuracy. ConclusionBased on general information and serological markers， the LASSO regression analysis is used to establish a nomogram model using sex， baseline HBsAg level， the reduction in HBsAg in 0 — 12 weeks， and the reduction in ALT in 0 — 12 weeks， and this model can be used to predict the probability of achieving HBsAg clearance in HBeAg-negative CHB patients treated with PEG-IFNα-2b， which provides important reference and theoretical support for the clinical treatment of patients.
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Guidelines for the prevention and treatment of chronic hepatitis B (2022 edition) are updated and revised based on the research advances in chronic hepatitis B virus infection in China and globally and the previous editions of the guidelines. This article introduces the updates in natural history and the noninvasive diagnosis and treatment of fibrosis. In particular, the guidelines further expand the indications for patients with chronic hepatitis B virus infection, clearly defines the selection of the population benefiting from interferon therapy, and strictly limits the standard of oral nucleos(t)ide analogues. Meanwhile, the guidelines also recommend more active treatment of patients with low-level viremia and children in the immune-tolerant phase. The new edition of the guidelines will provide an important basis for expanding the screening for hepatitis B virus infection, improving diagnostic rate, optimizing treatment regimens, and standardizing clinical management in China.
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In recent years, monotherapy and combination therapy with immune checkpoint inhibitors (ICIs) have achieved good efficacy in a variety of malignancies from solid tumors to lymphomas and have become a standardized and systematic treatment modality for many cancers. However, there is still a lack of studies on the safety of ICIs in hepatitis B virus (HBV)-infected patients with malignancies, and early studies have reported HBV reactivation due to ICI antitumor therapy in clinical practice. With reference to related literature, this article reviews the recent clinical trials and application of ICIs in cancer patients with chronic viral infection and clarifies the efficacy and safety of ICIs in this special population, in order to provide a reference for clinical medication.
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Objective To investigate the possible influence of long-term antiviral therapy with entecavir on renal function in patients with chronic hepatitis B (CHB) and the sensitive indicators for early identification of renal injury. Methods A cross-sectional real-world study was conducted for the clinical data of 125 CHB patients treated with entecavir for more than 1 year (treatment group) and 44 patients with chronic HBV infection who did not receive antiviral therapy (control group), including the changes in serum creatinine (SCr), estimated glomerular filtration rate (eGFR), and the levels of urinary α1 microglobulin (α1-MG), β2 microglobulin (β2-MG), and N-acetyl-β-D-glucosaminidase (NAG). The chi-square test or the Fisher's exact test was used for comparison of categorical data between groups. The independent-samples t test was used for comparison of normally distributed continuous data between groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups. The Logistic regression analysis was used to investigate independent influencing factors for abnormal urinary α1-MG, β2-MG, and NAG in the treatment group. Results There were no significant differences in SCr and eGFR between the treatment group and the control group ( t =0.999 and -1.259, P > 0.05), and both indices were within the normal range in these two groups. The treatment group had significantly higher abnormal rates of urinary α1-MG and β2-MG than the control group (47.2%/42.4% vs 13.6%/13.6%, χ 2 =15.693 and 12.567, both P 2×upper limit of normal (18.4%/21.6% vs 2.3%/4.5%, both P 0.05) and the proportion of patients with urinary NAG > 2×upper limit of normal (8.8% vs 6.8%, P > 0.05). Compared with the control group, the treatment group had a significantly higher proportion of patients with abnormalities in two or more indicators for renal tubular injury (33.6% vs 11.4%, χ 2 =8.519, P 0.05). Conclusion Long-term treatment of CHB with entecavir may be associated with the risk of renal tubular dysfunction, and abnormalities in more than two indicators for renal injury may help to identify renal tubular dysfunction in patients, so as to adjust related treatment in time.
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Objective To investigate liver inflammation and fibrosis in patients with chronic HBV infection with a low viral load. Methods Among the HBsAg-positive patients who attended Ganzhou Fifth People's Hospital from April 2019 to June 2022, 41 patients with 20 IU/mL 200-2 000 IU/mL and 4 (26.67%) had an HBV DNA level of 20-200 IU/mL; the patients with G2 liver inflammation accounted for 73.33% (11/15), and those with S2 liver fibrosis accounted for 46.67% (7/15); the patients with ALT ≤30 U/L accounted for 46.67% (7/15); the patients aged ≥30 years accounted for 86.66% (13/15); the patients with LSM > 17 kPa accounted for 6.67% (1/15), those with an LSM value of 12.4-17 kPa accounted for 46.67% (7/15), and those with an LSM value of 9.4-12.4 kPa accounted for 33.33% (5/15). Conclusion Patients with chronic HBV infection and low-level viremia have a relatively high risk of progression of inflammation and fibrosis. ALT level cannot be used as a basis for antiviral therapy in HBV-infected people with a low viral load. LSM based on transient elastography can be used as a noninvasive test to screen for CHB patients with a low viral load, and antiviral therapy should be considered when HBV-infected patients with a low viral load have an age of > 30 years and an LSM value of > 9.4 kPa persistently.
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In order to reduce the disease burden of chronic hepatitis B (CHB) and improve the treatment rate of CHB, the indications for anti-viral therapy have been gradually expanded and simplified in guidelines for the prevention and treatment of CHB released by Chinese Medical Association from 2005 to 2022. This article elaborates on the evolution in the indications for anti-viral therapy in CHB from the five aspects of converging indications of HBeAg-positive and HBeAg-negative CHB, reduction in the treatment threshold of HBV DNA, reduction in the treatment threshold of serum alanine aminotransferase, emphasis on the risk factors for disease progression, and gradual loosening of the requirements for virological indicators in patients with liver cirrhosis.
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This article introduces the debates on the natural history of chronic hepatitis B virus (HBV) infection during the update of Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Version), including nomenclature and definition, HBV infection, HBV DNA threshold for patients in the immune-tolerant phase, indeterminate phase and natural history, clinical diagnosis and natural history, and HBV DNA threshold for patients in the inactive phase.
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In recent years, significant breakthroughs have been made in the research on the role of traditional Chinese medicine (TCM) in the prevention and treatment of chronic hepatitis B liver fibrosis. In terms of clinical research, several multicenter randomized double-blind controlled studies have been conducted with liver pathological changes as the main efficacy evaluation indicator, which have improved the level of evidence in clinical research on the TCM prevention and treatment of liver fibrosis. As for basic research, in-depth studies have been conducted on the mechanism of action of TCM in intervening against liver fibrosis at various levels, including the effect on HSC activation, apoptosis and autophagy, inhibition of liver inflammatory injury, immunoregulation, and inhibition of hepatic sinusoidal capillarization, thereby highlighting the advantages and research difficulties of TCM through "multiple components, targets, and pathways". Under the guidance of Implementation Plan for the Major Projects of Revitalizing and Developing TCM, it is crucial to conduct high-quality clinical and basic research on TCM in the treatment of liver fibrosis, produce high-quality industry achievements, and thus help TCM to be recognized around the world.
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Chronic hepatitis B is a public health issue worldwide. Nucleotide analogues and interferon therapy can effectively inhibit HBV replication, but they still have the shortcomings such as inability to achieve the clearance of HBV cccDNA and low HBsAg clearance rate. The academic viewpoint of "kidney-tonifying therapy for chronic hepatitis B" provides new ideas and methods for the treatment of hepatitis B. During long-term clinical practice, Department of Hepatology in Shuguang Hospital has identified that "deficiency of spleen and kidney with damp heat remaining" is the key pathogenesis of the continuous progression of chronic hepatitis B and has established the treatment regimen for chronic hepatitis B with the basic treatment method of tonifying the kidney, strengthening the spleen, and promoting diuresis. The clinical research of National Science and Technology Major Project from The 11th Five Year Plan to The 13th Five Year Plan has validated the clinical efficacy of this regimen and clarified that regulating the immune function of the body is the main mechanism of the kidney-tonifying, spleen-strengthening, and diuresis-promoting therapy in the treatment of chronic hepatitis B.
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Chronic hepatitis B and its related diseases remain important public health problems and tough medical issues in China and even around the world, and now there is still a lack of effective radical treatment methods. This article reviews the traditional Chinese Medicine treatment regimens, the integrated traditional Chinese and Western Medicine treatment regimens, and related research highlights formed for hepatitis B (including various disease stages such as HBV carriers, chronic hepatitis B, liver fibrosis, liver cirrhosis, precancerous lesions of hepatocellular carcinoma, liver cancer, and liver failure) under the support of National Science and Technology Major Project from "The 11th Five-Year Plan" to "The 13th Five-Year Plan" (Prevention and Treatment of Major Infectious Diseases such as AIDS and Viral Hepatitis), and it also summarizes the role of traditional Chinese Medicine in the comprehensive prevention and treatment of chronic hepatitis B and its related diseases.