IAIH-PG consensus for histological criteria of AIH: Multicentre validation with focus on chronic liver diseases in China.

BACKGROUND AND AIMS: The International AIH Pathology Group (IAIH-PG) put forward the new histological criteria of autoimmune hepatitis (AIH) in 2022, which have not undergone adequate verification. In this study, we verified the applicability of the new histological criteria in the population of Chinese patients with chronic liver disease, comparing it with the simplified criteria. METHODS: The gold standard for diagnosis in all patients was based on histological findings, combined with clinical manifestations and laboratory tests and determined after a follow-up period of at least 3 years. A total of 640 patients with various chronic liver diseases from multiple centres underwent scoring using the new histological criteria and the simplified criteria, comparing their diagnostic performance. RESULTS: In this study, the new histological criteria showed a sensitivity of 73.6% and 100% for likely and possible AIH, with specificities of 100% and 69.0% respectively. The coincidence rates of possible AIH for the new histological criteria, simplified histological criteria and simplified score were 81.7%, 72.8% and 69.7% respectively. For likely AIH, the rates were 89.2%, 75.9% and 65.6% respectively. Based on the new histological criteria, all patients with AIH were correctly diagnosed. Specifically, 73.6% were diagnosed with likely AIH and 26.4% were possible AIH. Additionally, the simplified histological criteria achieved a diagnosis rate of 98.6% for AIH, while the simplified score could only diagnose 53.8% of AIH. CONCLUSIONS: Compared with the simplified score and simplified histological criteria, the sensitivity and specificity of the new histological criteria for AIH were significantly improved. The results indicate that the new histological criteria exhibit high sensitivity and specificity for diagnosing AIH in China.

Development and validation of a noninvasive prediction model of autoimmune hepatitis in patients with liver diseases.

BACKGROUND AND AIMS: There is no golden standard for the diagnosis of autoimmune hepatitis which still dependent on liver biopsy currently. So, we developed a noninvasive prediction model to help optimize the diagnosis of autoimmune hepatitis. METHODS: From January 2017 to December 2019, 1739 patients who had undergone liver biopsy were seen in the second hospital of Nanjing, of which 128 were here for consultation. Clinical, laboratory, and histologic data were obtained retrospectively. Multivariable logistic regression analysis was employed to create a nomogram model that predicting the risk of autoimmune hepatitis. Internal and external validation was both performed to evaluate the model. RESULTS: A total of 1288 patients with liver biopsy were enrolled (1184 from the second hospital of Nanjing, the remaining 104 from other centers). After the univariate and multivariate logistic regression analysis, nine variables including ALT, IgG, ALP/AST, ALB, ANA, AMA, HBsAg, age, and gender were selected to establish the noninvasive prediction model. The nomogram model exhibits good prediction in diagnosing autoimmune hepatitis with AUROC of 0.967 (95% CI: 0.776-0.891) in internal validation and 0.835 (95% CI: 0.752-0.919) in external validation. CONCLUSIONS: ALT, IgG, ALP/AST, ALB, ANA, AMA, HBsAg, age, and gender are predictive factors for the diagnosis of autoimmune hepatitis in patients with unexplained liver diseases. The predictive nomogram model built by the nine predictors achieved good prediction for diagnosing autoimmune hepatitis.

Study on pain control of continuous adductor block analgesia after primary knee replacement / 中国骨伤

OBJECTIVE@#To investigate the effect of continuous adductor block on pain control after bilateral knee joint Ⅰ stage replacement.@*METHODS@#A retrospective analysis was made of the data of 24 patients with bilateral knee joint I stage replacement who were treated in our hospital from January 2018 to January 2019, and who underwent continuous adductor block analgesia. There were 6 males and 18 females, aged 60 to 72 (65.05±5.82) years old. The patients underwent continuous block of adductor canal with patient-controlled analgesia system. At 4, 6, 12, 24, 36 and 48 hours after operation, visual analogue score(VAS) of resting state and passive motion state was performed;the knee joint activity was followed up for 1 week, 1, 3 and 6 months after operation;the knee joint function was scored at 6 months after operation, using the knee joint scoring standard of American Special Surgery Hospital(HSS);adverse reactions and complications were recorded.@*RESULTS@#The VAS scores under resting state and passive motion state at each time point were less than 3 points in patients with continuous adductor block. The patients had better postoperative exercise of knee joint activity. The score of HSS was excellent in 20 cases, good in 2 cases, fair in 1 case and poor in 1 case. There were only 4 cases of nausea and vomiting, none of them had serious adverse reactions and complications such as bradycardia and deep vein thrombosis.@*CONCLUSION@#Continuous adductor block has a significant effect on pain control and less adverse reactions after bilateral knee jointⅠ -stage replacement.

Effects of different decocting methods on quality of Mahuang Xixin Fuzi decoction / 中国中药杂志

To compare the quality difference between Mahuang Xixin Fuzi decoction(MXF) prepared by traditional decocting method and that prepared by two commonly used decocting methods, and explore the scientific nature of the traditional decocting method. By taking effect-toxic components in MXF as the research object, this article investigated these three different decocting methods from the quantitative determination of effect-toxic components in MXF. By using multivariate statistical analysis methods, three characteristic constituents were identified as kakoul, mesaconitine (MA) and hypaconitine (HA) respectively. As compared with two commonly used decocting methods, MXF decoction prepared by traditional decocting method had the shortest boiling time, but with the lowest dissolution rates of MA and AC and the higher dissolution rates of mono-ester aconitum alkaloids. In addition, the traditional decocting method increased the dissolution of ephedra alkaloid and accelerated the hydrolysis of diester diterpenoid alkaloids. There were differences in the content of effect-toxic components in MXF decoctions prepared by three different decocting methods, which can provide a reference for use of the classical prescriptions.

[Survey on seroepidemiological status and vaccine coverage of hepatitis B among children in Chaoyang district of Beijing in 2010].

OBJECTIVE: To explore seroepidemiological status and vaccine coverage of hepatitis B in children aging under 15 years old in Chaoyang district of Beijing. METHODS: A total of 1602 children aging under 15 years old, residents or floating population who had lived here more than six months, were randomly selected by multistage cluster sampling, from Chaoyang district of Beijing in year 2010. The demographic information and vaccine coverage of hepatitis B vaccine (HepB) were collected by self-designed questionnaire.5 ml blood was collected from each subject and the serum HBsAg, anti-HBs and anti-HBc were detected by Abbott microparticle enzyme-linked immunoassay. Those whose HBsAg was positive were then tested HBeAg and anti-HBe. The positive rate of hepatitis B indicators and coverage rate of HepB in different population were compared. RESULTS: The positive rate of HBsAg, anti-HBs and anti-HBc were 0.56% (9/1602), 64.17% (1028/1602) and 2.12% (34/1602), respectively; while the age standardized rates were separately 0.57%, 66.36% and 1.98%; and the gender-adjusted rates were 0.56%, 64.23% and 2.12% respectively. The positive rate of anti-HBs was statistically significant (χ(2) = 165.445, P = 0.000). The positive rate of anti-HBs was up to 90.73% (235/259) among 1-2 years old children, followed by 76.22% (141/185) among 13 - 15 years old children, 67.21% (166/247) among 3 - 4 years old children, 61.22% (150/245) among 9 - 10 years old children, 60.68% (142/234) among 11 - 12 years old children, 49.05% (103/210) among 5 - 6 years old children and 40.99% (91/222) among 7 - 8 years old children. The average coverage rate of HepB was 90.44% (1371/1516), separately 93.76% (661/705) in residents and 87.55% (719/811) in floating population. The difference was statistically significant (χ(2) = 16.829, P = 0.000). CONCLUSION: HBsAg positive rate in children under 15 years old in Chaoyang district of Beijing dropped to less than 1% and the coverage rate of HepB had reached over 90%. It is suggested that we should pay more attention to increase the coverage rate of HepB among floating children under 15 years old.

[Study on family aggregation and risk factors of hepatitis B virus transmission in Chaoyang district, Beijing].

OBJECTIVE: To explore the family aggregation and risk factors of hepatitis B virus (HBV) transmission in Chaoyang district of Beijing. METHODS: A total of 5266 families were randomly selected for the multi-stage cluster sampling study in Chaoyang district of Beijing in 2010. The family members who aged between 1 and 70 years old and lived constantly in Beijing for over half a year, were recruited as subjects. There were 14 491 subjects in total, including temporary residents who did not have Beijing household account, except foreigners. 5 ml venous blood was drawn from every subject. A self-designed questionnaire was used to collect the basic information of the population and the risk factors of the hepatitis B transmission. Microparticle enzyme-linked immunoassay was applied to test five indicators of hepatitis B. Negative binomial distribution test was used among the HBsAg positive families to calculate the family aggregation rate of hepatitis B. Single factor analysis and multi-factor logistic regression model were used to analyze the risk factors of HBV transmission. RESULTS: In all, 308 out of 5266 families had HBsAg positive members, accounting for 5.85%.383 out of 14 410 subjects were HBsAg positive, rating at 2.66%. The HBsAg positive rate among subjects under 14 years old was the lowest, at 0.56% (9/1603); and the positive rate among subjects aging between 35 and 44 years old was the highest, at 4.27% (47/1029). Negative binomial distribution test showed that the family aggregation rate of HBV infection was 7.66% (χ² = 15.10, P < 0.05). The analysis of family aggregation of HBsAg positive showed that 17.39% (8/46) of the transmission was from father to child, 13.04% (6/46) was from mother to child, 30.44% (14/46) was between couples, and another 39.13% (18/46) was between siblings or other relatives. Both single factor analysis and multi-factor logistic regression analysis showed that hepatitis B positive family members (OR = 5.40, 95%CI: 5.24 - 5.55), hepatitis B positive friends and colleagues (OR = 1.55, 95%CI: 1.11 - 1.99) and blood donation and transfusion history (OR = 1.96, 95%CI: 1.76 - 2.15) were the risk factors of HBV infection. CONCLUSION: HBV transmission showed family aggregation in Beijing, however, the risk factors needed further studies.

[Prevalence of hepatitis B in Chaoyang district, Beijing in 2010].

OBJECTIVE: To study the prevalence of hepatitis B infections and carrier status among general population in Chaoyang district, Beijing in 2010. METHODS: From May to December 2010, 14 491 subjects over 12 months old were selected by multistage random cluster sampling method from residents in Chaoyang district, Beijing. Five millilitre venous blood specimens were collected from these subjects to test hepatitis B virus antigens and antibodies. Status of hepatitis B infections were analyzed in different age, sex and registered permanent residence groups. RESULTS: The overall positive rate of surface antigen (HBsAg) was 2.66% (383/14 410). The lowest rate of 0.56% (9/1603) was found in the 1 to 14 years old group and the 35 to 44 years old group had the highest rate of 4.27% (92/2154). The rate in subjects younger than 24 years old was 1.03% (31/2986). The overall positive rate of surface antibody (anti-HBs) was 40.21% (5798/14 421). The highest positive rate of anti-HBs (80.59%, 407/505) was found in the 1 to 4 years old group. The overall positive rate of core antibody (anti-HBc) was 30.26% (4364/14 424). The overall hepatitis B virus infection rate was 30.32% (4364/14 393). For male and female groups, the positive rates of HBsAg were 2.93% (179/6108) and 2.44% (202/8287) respectively (χ² = 3.32, P > 0.05); anti-HBs were 41.93% (2563/6113) and 38.96% (3231/8293) respectively (χ² = 12.88, P < 0.01); and anti-HBc were 31.39% (1919/6114) and 29.39% (2438/8295) respectively (χ² = 6.65, P = 0.01). For local residents group and mobile population group, the positive rates of HBsAg were 2.46% (283/11 510) and 3.60% (98/2719) respectively (χ² = 11.08, P < 0.01); anti-HBs were 37.11% (4293/11 568) and 53.07% (1445/2723) respectively (χ² = 233.51, P < 0.01); and anti-HBc were 30.83% (3567/11 570), and 28.41% (774/2724) respectively (χ² = 6.08, P < 0.05). CONCLUSION: The positive rate of HBsAg in population younger than 24 years old has reached a relatively low level. The mobile population has significantly higher positive rate of HBsAg than local residents, indicating the need for enhancing prevention and control measures for hepatitis B for the mobile population and local residents over 25 years old.

[Comparison on the antibody response after primary immunization of 5 µg and 10 µg hepatitis B vaccine made by recombinant DNA techniques among newborns].

OBJECTIVE: To compare the antibody response induced by primary immunization with 5 µg and 10 µg hepatitis B vaccine made by recombinant DNA techniques among the newborns. METHODS: Healthy infants who had completed primary immunization with 5 µg hepatitis B vaccine made by recombinant dexyribonucleic acid techniques in Saccharomyces (Hep-SC) or 10 µg hepatitis B vaccine made by recombinant dexyribonucleic acid techniques in Hansenula polymorpha (HepB-HP) were included in the study. Kids under study were 7-12 months of age and had been on 0-1-6 schedule. Standardized questionnaire was used and blood samples were collected. The titer of antibody to hepatitis B surface antigen (anti-HBs) was detected by Chemiluminescence Microparticle Imunoassay (CMIA). If anti-HBs happened to be under 10 mIU/ml, HBV DNA was further detected by nested-PCR to distinguish occult hepatitis B virus infection. Sero-conversion rate and titer of anti-HBs were compared between the two kinds of hepatitis B vaccines. Multivariate analysis was used to find the relationship between the kind of hepatitis B vaccine as well as the antibody response after debugging the other influencing factors including month-age, gender, birth-weight, premature birth and mother's HBsAg status. RESULTS: 8947 infants vaccinated with 5 µg HepB-SC and 4576 infants vaccinated with 10 µg HepB-HP were investigated. In the 5 µg group, the rates of non-, low-, normal- and high-response were 1.88%, 15.18%, 61.42% and 21.52% respectively. In the 10 µg group, the corresponding rates were 0.15%, 2.16%, 29.42% and 68.26% respectively. The non-, low-, normal-response rates were all higher in 5 µg group than in 10 µg group (P<0.01), while the high-response rate was much higher in 10 µg group than in 5 µg group (P<0.01). The geometric mean concentration (GMC) of anti-HBs were 354.81 mIU/ml (95%CI: 338.84-363.08 mIU/ml) and 1778.28 mIU/ml (95%CI: 1698.24-1819.70 mIU/ml) in the 5 µg group and 10 µg group respectively. The GMC was statistically higher in the 10 µg group than in the 5 µg group (P<0.001). The sero-conversion rate and GMC were significantly different between the two groups even after debugging the other influencing factors. CONCLUSION: Better anti-HBs response could be achieved by primary immunization with 10 µg HepB-HP than with 5 µg HepB-SC among newborns.

[Multi-center matching study on antibody response between preterm and full-term infants after primary immunization of hepatitis B vaccine].

OBJECTIVE: To compare the antibody response between preterm and full-term infants after primary immunization of hepatitis B vaccine (HepB). METHODS: Infants who were aged 7 - 12 months and had completed primary immunization with 5 µg HepB made by recombinant deoxyribonucleic acid techniques in saccharomyces cerevisiae (HepB-SC) or 10 µg HepB made by recombinant deoxyribonucleic acid techniques in Hansenula polymorpha (HepB-HP) on 0-1-6 schedule were investigated in four provinces (municipality) including Beijing, Shandong, Jiangsu and Guangxi of China. Among them, all preterm infants were selected to form the preterm group and the 1:1 matching full-term infants with the same month-age, gender and residence were randomly selected to form the full-term group. Their HepB history was determined by immunization certificate and all of their parents were interviewed with standard questionnaire to get their birth information. Blood samples were obtained from all anticipants and were tested for Anti-HBs by chemiluminescence microparticle immuno-assay (CMIA). RESULTS: Total anticipants were 648 pairs of infants. The rates of non-response, low-response, normal-response and high-response after the primary immunization were 1.39%, 8.64%, 45.83% and 44.14% in the preterm group, respectively. The corresponding rates were 1.08%, 9.26%, 44.91% and 44.75% in the full-term group. The above four rates did not show significant differences between the two groups (P > 0.05). The geometric mean concentrations (GMC) of anti-HBs in the pre-term and full-term group were 755.14 and 799.47 mIU/ml respectively. There was no significantly difference in the GMCs between the two groups (P > 0.05). Results from multivariable conditional logistic analysis showed that preterm was not an influencing factor to the antibody response after HepB primary immunization among newborns even after debugging the other influencing factors. CONCLUSION: The antibody response after HepB primary immunization were similar among the preterm and full-term infants. The preterm newborns could be immunized under the same HepB immunization strategy.

[Study on the cellular and humoral immunity effect of recombinant Chinese hamster ovary cell hepatitis B vaccine in adults].

OBJECTIVE: To evaluate the cellular and humoral immunity effect of 10 µg and 20 µg recombinant Chinese hamster ovary (CHO) cell hepatitis B vaccine in adults by randomized double-blind controlled trials. METHOD: A total of 642 adults aged 18 - 45 years old, non-vaccinated against hepatitis B, and hepatitis B five blood indicators negative were selected as the study subjects. The study subjects were randomly divided into two groups and each group had 321 subjects. The subjects were given 10 µg and 20 µg recombinant CHO hepatitis B vaccination respectively by 0, 1st, 6th month schedule. Blood sample was collected from each study subject one month after the second dose vaccination. The anti-HBs level was detected by Abbott chemiluminescence detection method (I2000) to evaluate humoral immunity status. Of all the study objects, 153 cases were randomly selected by the Excel random function. Their blood samples were collected and Lymphocyte were separated to detect the IL-4 and IFN-γ levels in vitro by enzyme-linked immunospot (ELISPOT) method to evaluate the cellular immunity status. RESULTS: The anti-HBs seroconversion rates in 10 µg and 20 µg dose group were 88.8% (285/321) and 95.3% (306/321) respectively, and 95%CI were 85.4% - 92.2% and 93.0% - 97.6% respectively. The spot forming cell (SFC) of IL-4 of the 20 µg-dose group (x(-) = 20.31) were significantly higher than the 10 µg-dose group (x(-) = 8.19, t = 3.27, P < 0.01). With the increasing of anti-HBs titer, the SFC of IL-4 also went up significantly. There was a positive correlation between SFC of IL-4 and anti-HBs (Spearman correlation coefficient = 0.538, P < 0.0001). No significant difference was found for IFN-γ SFC in two groups (10 µg group: x(-) = 1.49; 20 µg group: x(-) = 0.86; t = 1.83, P > 0.05). CONCLUSION: The humoral and cellular immune effects of 20 µg recombinant CHO hepatitis B vaccine are better than that of the 10 µg recombinant CHO hepatitis B vaccine.20 µg recombinant CHO hepatitis B vaccine should be chosen as the adult's hepatitis B prevention vaccine.

[Study on the immuno-effects and influencing factors of Chinese hamster ovary (CHO) cell hepatitis B vaccine among adults, under different dosages].

OBJECTIVE: To evaluate the immuno-effect and related influencing factors on 10 µg and 20 µg Chinese hamster ovary (CHO) cell hepatitis B vaccine, using the randomized double-blind controlled trials in adult population. METHODS: A total of 642 adults aged 18 - 45 years old, non-vaccinated against hepatitis B, and negative on five blood indicators for hepatitis B, were selected as the study objects from four districts in Beijing. The study objects were randomly divided into two groups, and then accepted 10 µg and 20 µg recombinant CHO hepatitis B vaccination by 0 - 1 - 6 month schedule. Influencing factors were investigated by means of questionnaire. Blood samples were collected one month after the third dose of vaccination. Anti-HBs level was detected by Abott chemiluminescence detection method. For the anti-HBs negative person, fluorescent quantitative PCR method was used to find out if the person had been infected with HBV. Logistic regression analysis was used to find out the influencing factors of anti-HBs seroconversion on every studied subject. RESULTS: The anti-HBs seroconversion rates on 10 µg and 20 µg dose groups were 88.8% (95%CI: 85.4% - 92.2%) and 95.3% (95%CI: 93.0% - 97.6%) respectively. Taking the anti-HBs level < 100 mIU/ml as the low/non-response standard, the low response and non-response rates were 34.3% and 17.4% respectively. The geometric mean titers (GMT) of anti-HBs were 173.42 mIU/ml for the 10 µg dose group and 588.51 mIU/ml for the 20 µg dose group. Data from the Multivariate analysis showed that:diabetes, spouses infected with hepatitis B virus and old age were unfavorable factors for anti-HBs Seroconversion. 20 µg dose of the vaccine was conducive to seroconversion. CONCLUSION: 20 µg CHO hepatitis B vaccine seemed better than 10 µg CHO hepatitis B vaccine while many factors need to be taken into account for evaluation on hepatitis B vaccines.