Hepatitis E virus infection in liver transplant recipients / 器官移植

Hepatitis E virus infection is a common cause of acute viral hepatitis. In recent years, the incidence of hepatitis E has shown an increasing trend, which has gradually become an important cause of acute viral hepatitis worldwide. Age, sex, intensity of immunosuppression and socio-economic factors are all risk factors for hepatitis E virus infection. Liver transplant recipients require long-term use of immunosuppressive drugs for anti rejection treatment, prone to hepatitis E virus infection and at the risk of liver fibrosis and cirrhosis due to immunosuppression status. Therefore, special attention should be paid to liver transplant recipients in clinical practice. Meantime, related risk factors should be identified to assist diagnosis and take stricter preventive measures. According to literature review, the etiological characteristics of hepatitis E virus and the epidemiological characteristics, clinical manifestations, diagnosis and treatment of hepatitis E virus infection in liver transplant recipients were reviewed, aiming to properly monitor, treat and prevent hepatitis E virus infection in liver transplant recipients in clinical practice, improving the prognosis of liver transplant recipients.

Laboratory diagnosis and clinical applications of hepatitis E / 中华检验医学杂志

Hepatitis E virus (HEV) is the major pathogen responsible for acute viral hepatitis in China. Recently, there have been new advances in the methodologies and novel discoveries in the laboratory diagnosis of HEV, including various diagnostic markers such as HEV RNA, HEV antigen, anti-HEV IgM, and anti-HEV IgG. A multi-indicator diagnostic approach should be applied across different populations, including patients with acute or chronic hepatitis E, individuals with extra-hepatic clinical symptoms, asymptomatic carriers, and specific occupational groups undergoing health assessments. The clinical significance of test results for each marker varies among these different groups.

Study on epidemiological prevalence and serological marker characteristics of hepatitis E infection / 中华检验医学杂志

Objective:This study aims to explore the prevalence of hepatitis E virus (HEV) infection in patients and the screening value of serological indicators for HEV infection patients.Methods:Retrospective analysis was conducted on 97 440 cases of anti-HEV IgM and IgG simultaneously tested in two Beijing hospitals from January 1, 2018 to August 31, 2023. Among them, there were 61 005 males and 36 435 females, with an average age of 51.65±13.05 years old. According to the positivity of anti HEV specific antibodies, they were divided into anti-HEV IgM positive group (3 588 cases), anti-HEV IgG positive group (18 083 cases), and anti-HEV antibody negative group (78 892 cases). Results of HEV RNA, liver function, AFP, PIVKA-Ⅱ and PT were collected, and their basic clinical information were recorded. The prevalence of HEV infection in patients, as well as the relationship between the positivity of anti-HEV specific antibodies and the patient′s age group, HEV RNA, and clinical characteristics were analyzed.Results:Among 97 440 patients who tested anti-HEV IgM and IgG simultaneously, the positivity rate of anti-HEV IgM was 3.68% (3 588/97 440), and was 18.56% for anti-HEV IgG (18 083/97 440). The overall positivity rates of anti-HEV IgM in two Beijing hospitals from 2018 to 2023 were 2.51%, 2.53%, 3.02%, 4.59%, 5.72%, and 4.26% ( χ2=1 401.73, P<0.001), while the positivity rates of anti-HEV IgG were 12.56%, 12.32%, 12.85%, 22.65%, 27.42%, and 26.66% ( χ2=1 058.29, P<0.001). These rates showed a gradual increase until 2023 when a decline was observed. The positivity rates of anti-HEV IgM (2.28%, 3.60%, 4.47%) ( χ2=89.62, P<0.001) and IgG (4.71%, 17.86%, 25.94%) ( χ2=2 017.32, P<0.001) increased with age in patients who aged 1-30, >30-60, and over 60 years old. The age and ALB values of patients in the anti-HEV IgM positive group were lower than the IgG-positive group, while the proportion of males, TBIL, ALT, AFP and PT values were higher than the IgG-positive group, and the differences were statistically significance ( P<0.05). Furthermore, patients in both the anti-HEV IgM and IgG positive groups had higher age, male proportion, TBIL, ALT, AFP, PIVKA-Ⅱ, and PT values than the anti-HEV negative group. Additionally, both groups had lower ALB values than the anti-HEV negative group, all of which were statistically significant ( P<0.05). 2 162 HEV infected patients were grouped based on HEV RNA positivity. The proportion of anti-HEV IgM single positive, IgG single positive, IgM+IgG double positive, and antibody negative patients in the HEV RNA positive group were 5.42% (18/332), 3.62% (12/332), 90.36% (300/332), and 0.60% (2/332), respectively. Among them, the proportion of anti-HEV IgM+IgG double positive patients in the HEV RNA positive group was higher than that in the HEV RNA negative group ( χ2=302.87, P<0.001), while the proportion of anti-HEV IgG single positive ( χ2=174.36, P<0.001) and anti-HEV antibody negative patients ( χ2=59.28, P<0.001) were lower than that in the HEV RNA negative group, both of which were statistically significant ( P<0.001). In addition, the positive rates of HEV RNA in anti-HEV IgM positive, IgG positive, and antibody negative patients were 29.23% (318/1 088), 17.59% (312/1 774), and 0.65% (2/306), respectively. Conclusion:The HEV infection rate among patients declined in 2023. HEV infection is age-related, with older individuals being more susceptible. Abnormal liver function and jaundice were commonly observed during HEV infection. It is crucial to note that the absence of anti-HEV specific antibodies cannot rule out HEV infection; therefore, additional testing for HEV RNA and/or HEV Ag is necessary for accurate diagnosis.

Hepatitis E virus prevalence among blood donors in Wuhan urban agglomeration / 中国输血杂志

【Objective】 To investigate the prevalence of Hepatitis E virus (HEV) among blood donors in Wuhan urban agglomeration, aimed at providing data support for the development of HEV screening strategies for blood donors. 【Methods】 A total of 3 329 blood samples were collected from four centralized testing areas (Ezhou, Tianmen, Xiantao and Qianjiang) and screened at Wuhan Blood Center from January to December 2021. Among them, 2 737 were eligible blood samples with normal ALT (ALT normal group) and 592 were with elevated ALT (ALT elevated group). Enzyme linked immunosorbent assay (ELISA) was used to detect anti-HEV IgG, anti-HEV IgM and HEV-Ag, and Real-time PCR was used to perform single HEV RNA detection on blood samples with elevated ALT and normal ALT anti-HEV IgM+ blood samples. A two-sided Pearson’s chi-squared test or Fisher's exact test was used to evaluate the differences in the positive rates of anti-HEV IgG and anti-HEV IgM in different regions and ALT groups. 【Results】 The overall positive rates of anti-HEV IgG, anti-HEV IgM, and HEV-Ag in 3 329 blood samples from four regions were 21.63%, 1.29%, and 0%, respectively. There was a significant difference in the positive rates of anti-HEV IgG among blood donors in different regions (P<0.05). The highest positive rate of anti-HEV IgG was found in Tianmen 29.44% (136/462), followed by Qianjiang 22.69% (236/1 040), Xiantao 22.66% (230/1 015), and Ezhou 14.53% (118/812). The positive rates of anti-HEV IgG and anti-HEV IgM in blood samples with elevated ALT were significantly higher than that in normal ALT samples (25.68% vs 20.75%, 2.53% vs 1.02%, both P<0.05). However, none of the samples was HEV RNA positive. 【Conclusion】 HEV is prevalent among blood donors in Wuhan urban agglomeration with extremely low current infection rates, and the prevalence of anti-HEV IgG serum varies among different regions. The prevalence of anti-HEV antibodies in blood donors with elevated ALT is significantly higher than that in normal ALT donors.

Lack of evidence of acute HEV infections as a sexually transmitted disease: Data from a German cohort of PrEP users

Abstract Background While the sexual transmissibility of HAV in MSM has been extensively described, the potential for sexual transmission of HEV has not been definitively established. Although HEV has been detected in the ejaculate of chronically infected men, studies among MSM PrEP users in France did not observe an elevated anti-HEV seroprevalence as an indicator of increased exposure risk by sexual intercourse. Patients and methods A total of 111 unselected PrEP users and 111 age- and sex-matched blood donors were tested for anti-HEV IgG, IgM and HEV (PCR). Of the participants 79/111 (71 %) responded to a questionnaire covering topics as sexual preferences, previous sexually transmitted diseases, profession, food consumption, and pet ownership. Results The anti-HEV IgG seroprevalence in PrEP users (22 %) did not differ significantly from the rate in controls (17 %). While one PrEP user and three controls tested positive for anti-HEV IgM, all PrEP users and controls tested PCR negative. Conclusion In immunocompetent individuals with frequent changes of sexual partners, the epidemiology of Hepatitis E Virus does not significantly involve the sexual transmission route.

Trends in seroprevalence of enteric transmitted hepatitis virus infections at a tertiary care hospital in Delhi: a 4-year review

Background: Hepatitis A virus (HAV) and hepatitis E virus (HEV), both enteric hepatitis viruses, are transmitted through the feco-oral route. These infections can range from asymptomatic or subclinical cases to acute viral hepatitis, occasionally leading to mortality. To gain an understanding of the disease and develop effective management strategies, comprehending the disease burden is essential. This study aimed to provide insights into the prevalence of enteric transmitted hepatitis viruses among individuals with acute hepatitis in the Delhi region. Methods: A retrospective investigation was conducted at a prominent tertiary care super specialty hospital in Delhi, spanning from February 2019 to December 2022. Serum samples from patients suspected of having hepatitis and sent for HAV and HEV testing were included. The samples underwent enzyme-linked immunosorbent assay to detect HAV and HEV immunoglobulin (Ig)M antibodies. Collected data was analyzed using SPSS software version 21, employing Chi-square and Fischer exact tests where applicable. Results: Throughout the study period, a total of 1275 samples were incorporated. Viral etiology was evident in 197 patients (15.45%). Among these, IgM HAV was identified in 142 patients (11.13%), and IgM HEV was present in 55 patients (4.31%). HAV infection was notably more prevalent in the pediatric age group (20.89% or 89/426; p<0.001), while HEV was significantly more common among adolescents and adults (5.77% or 49/849; p<0.001). Conclusions: Regular surveillance of enteric transmitted viruses causing hepatitis should encompass both hospital and community levels to accurately gauge disease burden and evolving epidemiology.

Expert consensus on the process of in-hospital screening and management of viral hepatitis E in China (2023) / 临床肝胆病杂志

Hepatitis E caused by hepatitis E virus (HEV) infection is an acute /chronic infectious disease with significant morbidity and mortality, which has become an important global health issue. Our understanding of HEV has changed completely over the past decade. Every year 20 million people are infected with HEV, among whom hepatitis E occur in 3.3 million cases and 70 thousands die from HEV infection-related diseases globally. However, a majority of HEV infections, especially fulminant or chronic hepatitis E, are missed diagnosed or misdiagnosed in China. According the goal of eliminating viral hepatitis as a public health threat by 2030 set by the World Health Organization and based on the fact that medical institutions are the main facilities for diagnosis and treatment of Hepatitis E in China, we developed the Expert Consensus on the process of in - hospital screening and management of viral hepatitis E in China. The consensus intends to promote multi-disciplinary and multi-departmental collaboration in health care institutions, including hospital administration, infection control division, clinical departments and laboratory, to strengthen the screen, diagnosis, consultation, referral and treatment of patients with hepatitis E. Meanwhile, the consensus also intends to raise the awareness of hepatitis E among non-infectious and non-hepatic specialists, which would be conducive to timely detection and early diagnosis of hepatitis E.

HPV B19, HAV and HEV infection among voluntary blood donors in Nantong / 中国输血杂志

【Objective】 To evaluate the viability of nucleic acid test(NAT) of human parvovirus B19 (HPV B19), hepatitis A virus (HAV) and hepatitis E virus (HEV) along with routine NAT for voluntary blood donors, and to analyze HPV B19, HAV and HEV prevalence in Nantong, so as to provide reference for rational blood screening programs. 【Methods】 HPV B19 DNA, HAV RNA and HEV RNA of blood donors in Nantong from November 2021 to May 2022 were detected using NAT, and serological antibody testing was performed on NAT reactive samples. 【Results】 Three HPV B19 DNA was yielded out of 3 440 blood donors, with a positive rate of 0.09%, among which 2 were negative for HPV B19-IgM and 1 was undetermined due to insufficient sample size. HAV RNA and HEV RNA were not detected in 3 440 blood donors. HPV B19, HAV, and HEV NAT were conducted simultaneously with routine HBV, HCV and HIV screening, prolonging the test reports by 20 minutes. 【Conclusion】 Although the HPV B19 DNA, HAV RNA and HEV RNA prevalence among voluntary blood donors in Nantong is low, the risk of transfusion transmitted infection still exsits and can be reduced by NAT.

Prevalence of HEV infection markers in Chinese blood donors: a meta-analysis / 中国输血杂志

【Objective】 To analyze the serological markers and RNA prevalence of HEV infection in Chinese voluntary blood donors in different regions of China, so as to provide basis for the necessity of HEV screening and the formulation of screening strategies for voluntary blood donors. 【Methods】 Databases such as CNKI, Wanfang medicine and PubMed were searched for eligible literature, and the literature data meeting the inclusion criteria were extracted for meta-analysis using R4.1.3 software. 【Results】 A total of 26 studies were included, involving 97 928, 117 831 and 82 673 cases, respectively, for anti-HEV IgG, anti-HEV IgM and HEV RNA. The pooled estimated prevalence of anti-HEV IgG, anti-HEV IgM and HEV RNA among Chinese voluntary blood donors was 23.0% [95% CI (18%, 29%)] vs 1.13% [95% CI (0.94%, 1.36%)] vs 0.028%[95%CI(0.006%, 0.059%)], and there were significant differences among different cities and regions. 【Conclusion】 The past infection rate of HEV among voluntary blood donors in China was somewhat high and with significant regional differences. The current infection rate was relatively low and had decreased compared with that in the past decade, but there was still residual risk of blood transfusion. It is necessary to pay more attention to blood HEV screening of voluntary blood donors.

Strengthening the study of chronic hepatitis E / 中华肝脏病杂志

This paper summarizes the incidence, modes of transmission, diagnosis, treatment and prevention of chronic hepatitis E.

Advances in hepatitis E epidemiology / 中华肝脏病杂志

Hepatitis E is a viral hepatitis that the hepatitis E virus (HEV) causes. In the early 1980s, the hepatitis E virus was first discovered and identified, and it is one of the important pathogens that cause acute viral hepatitis globally. HEV infection is usually self-limiting, but in some groups of populations, such as pregnant women, patients with chronic liver disease, and the elderly, the prognosis is poor and may result in acute or subacute liver failure or even death. In addition, HEV infection can occur in chronically immunocompromised populations. At present, some regions and countries are not paying enough attention to hepatitis E prevention, diagnosis, and treatment, which suggests that we should study the epidemiology of HEV infection.

Research progress in the etiology of hepatitis type E virus / 中华肝脏病杂志

Hepatitis type E virus (HEV) is a significant infectious zoonotic disease that causes hepatitis E. The disease is primarily transmitted via the fecal-oral route through contaminated water or food and is transmissible between species and genera. The causative agent for the disease is the hepatitis type E virus, which is a member of the Hepadnaviridae family and a single-stranded RNA virus. Its 7.2 kb genome mainly contains three open reading frames (ORFs): ORF1 encodes a non-structural polyprotein that mediates viral replication and transcription; ORF2 encodes a capsid protein and free antigen that induce neutralizing antibodies; ORF3 partially overlaps with ORF2 and encodes a small multifunctional protein involved in virion formation and release. HEV has a unique dual life cycle: it is excreted into feces in the form of naked virions but circulates in the blood in the form of "quasi-enveloped" particles. The two kinds of virus particles adsorb and penetrate the host cell in distinct ways, then internalize and decapsulate to replicate the genome, thereby producing more virion and releasing it outside the cell to mediate the virus's spread. This paper reviews the morphological characteristics, genome structure, encoded proteins, and function of HEV virus-like particles in order to provide a theoretical basis for basic research and comprehensive disease prevention and control.

Laboratory diagnosis of hepatitis type E / 中华肝脏病杂志

Hepatitis type E virus (HEV) infection is a common cause of acute viral hepatitis in China, and its etiological diagnosis relies on laboratory detection. Therefore, this article introduces the HEV RNA, HEV antigen, anti-HEV IgM, and IgG detection methods and their diagnostic application value. In addition, it also discusses the current international diagnostic standard and HEV infection presentation.

Intrahepatic and extrahepatic clinical manifestations and treatment progress for hepatitis type E / 中华肝脏病杂志

Hepatitis type E virus (HEV) is one of the main causes of acute hepatitis globally and has thus gained attention as a public health issue. The diverse clinical manifestations of hepatitis type E are typically acute and self-limiting with mild symptoms, but populations with underlying liver disease or immunocompromised patients can have severe and chronic symptoms. Severity and chronicity can arise and manifest as fulminant hepatitis, chronic hepatitis, or even hepatic failure. HEV infection-induced hepatic failure (acute-on-chronic liver failure), based on the different backgrounds of chronic liver disease, is a clinical phenotype of severe HEV infection that requires attention. In addition, HEV infection can exhibit extrahepatic clinical manifestations of multi-system and organ involvement like neurological diseases (Guillain-Barré syndrome), renal diseases (membranous/membranous proliferative glomerulonephritis, cryoglobulinemia), and blood diseases (thrombocytopenia). At home or abroad, there are no antiviral drugs approved, particularly for HE treatment. Since most acute HE can resolve spontaneously, no special treatment is required clinically. However, in patients with severe or chronic HE, ribavirin (RBV) monotherapy and/or pegylated interferon-combination therapy have achieved certain antiviral effects. Combined small-molecule drugs and RBV have been attempted to treat HEV, but high-level evidence-based treatment is still lacking. Thus, new, highly effective anti-HEV drugs are clinical priorities to address these concerns. Severe and chronic HEV infections' clinical phenotype, early detection, mechanism, intervention, and outcome need additional study.

Prophylactic vaccines for hepatitis type E / 中华肝脏病杂志

Over the past few years, hepatitis type E has been increasingly recognized as an underestimated global disease burden. Populations with severe infection-related injuries or deaths include pregnant women, patients with underlying liver disease, and the elderly. Vaccines are the most effective means to prevent hepatitis type E virus (HEV) infection. However, the development of inactivated or attenuated vaccines is not feasible due to the lack of an efficient HEV cell culture system, so researchers have conducted in-depth research on recombinant vaccines. The capsid protein (pORF2), which the virion's open reading frame 2 encodes, contains almost exclusively the HEV neutralization site. Several candidate vaccines based on pORF2 have demonstrated potential for primate protection, with two being well tolerated and highly effective in preventing hepatitis type E in adults. Hecolin® (HEV 239 vaccine), the world's first hepatitis type E vaccine, was approved for marketing in China in 2012.

Epidemiological characteristics of hepatitis A and hepatitis E in Jiaxing City from 2005 to 2021 / 预防医学

Objective@#To investigate the epidemiological characteristics of hepatitis A and hepatitis E in Jiaxing City, Zhejiang Province from 2005 to 2021, so as to provide insights into prevention and control of hepatitis A and hepatitis E.@*Methods@#Data of hepatitis A and hepatitis E reported in Jiaxing City from 2005 to 2021 were collected from the Chinese Disease Prevention and Control Information System. The temporal, spatial and population distribution of hepatitis A and hepatitis E were analyzed using a descriptive epidemiological method, and the trends in incidence of hepatitis A and hepatitis E were evaluated using annual percent change (APC). @*Results@# Totally 1 830 hepatitis A cases were reported in Jiaxing City from 2005 to 2021, with an annual average incidence of 2.44/105, and 2 deaths were reported, with a fatality rate of 0.11%. The incidence of hepatitis A appeared a tendency towards a decline from 2005 to 2012 (APC=-37.807%, P<0.05) and was relatively stable from 2012 to 2021 (APC=-1.277%, P>0.05), and the incidence peaked from July to September, with a monthly average incidence of 0.30/105. Higher annual average incidence of hepatitis A was seen in urban areas than in rural areas (3.91/105 vs. 1.92/105; P<0.05), among people at ages of 30 to 39 years (4.19/105), and among men than among women (3.00/105 vs. 1.93/105; P<0.05). Farmers were the predominant occupation (759 cases, 41.31%). Totally 2 176 hepatitis E cases were reported in Jiaxing City from 2005 to 2021, with an annual average incidence of 2.91/105, and 7 deaths were reported, with a fatality rate of 0.32%. The incidence of hepatitis E was relatively stable from 2005 to 2011 (APC=3.421%, P>0.05) and appeared a tendency towards a decline from 2011 to 2021 (APC=-4.294%, P<0.05), and the incidence peaked from January to March, with a monthly average incidence of 0.38/105. Higher annual average incidence of hepatitis E was seen in urban areas than in rural areas (3.50/105 vs. 2.70/105; P<0.05), among people at ages of 70 to 79 years (6.20/105), and among men than among women (3.74/105 vs. 2.05/105; P<0.05). Farmers were the predominant occupation (1 079 cases, 49.59%).@*Conclusions@#The incidence of hepatitis A and hepatitis E appeared a tendency towards a decline in Jiaxing City from 2005 to 2021. The incidence of hepatitis A was high in summer, and cases were mainly males, young and middle-aged people and farmers. The incidence of hepatitis E was high in winter, and cases were mainly males, elderly people and farmers.

Prognostic value of serum carbamoyl phosphate synthase 1 in patients with hepatitis E-related acute liver failure / 中华检验医学杂志

Objective:To explore the impact of serum carbamoyl phosphate synthase 1 (CPS1) level on prognosis of patients with hepatitis E-related acute liver failure (HEV-ALF).Methods:This retrospective analysis included 100 HEV-ALF patients, 100 patients with acute hepatitis E (AHE) and 100 healthy controls who admitted or underwent health checkup from December 2018 to June 2019 in six hospitals, including the First Affiliated Hospital, Zhejiang University School of Medicine. HEV-ALF patients were divided into non-survial ( n=21) and survival ( n=79) subgroups according to results of 30-day follow-up results. HEV-ALF patients were also divided into the high ( n=50) and low ( n=50) serum CPS1 level groups. HEV-ALF patients were further divided into the improvement ( n=55), fluctuation ( n=32) and deterioration ( n=13) subgroups. The general clinical data from all participants were collected. Serum CPS1 levels were detected by enzyme linked immunosorbent assay. The survival time in the high and low serum CPS1 level groups were presented in the Kaplan-Meier curve. The correlation between serum CPS1 level and HEV-ALF related conventional parameters was also analyzed by linear regression. The efficacy of serum CPS1 level on predicting the 30-day mortality of HEV-ALF patients was estimated by the receiver operating characteristic curve and area under curve (AUC). Results:Serum CPS1 level was significantly higher in HEV-ALF patients than in AHE patients [958.59 (665.52, 1 105.83) pg/ml vs 549.38 (495.02, 649.08) pg/ml, P<0.001], and serum CPS1 level was significantly higher in AHE patients than in healthy controls [549.38 (495.02, 649.08) pg/ml vs 469.89 (373.32, 564.53) pg/ml, P<0.001]. The level of serum CPS1 was significantly lower in the HEV-ALF survival group than in the HEV-ALF non-survival group [922.6 (652.7, 1, 042.3) pg/ml vs 1 252.8 (933.3, 1 555.8) pg/ml, P<0.001]. In addition, the survival time was shorter in the high serum CPS1 level group than in the low serum CPS1 level group [24.59 (22.11, 27.06) d vs 28.16 (26.25, 30.07) d, P=0.045]. Serum CPS1 levels were increased in the fluctuation and deterioration groups [Fluctuation: 1 328.3 (1 184.3, 1 964.0) pg/ml vs 1 245.7 (1 102.0, 1 937.6) pg/ml, P<0.01; Deterioration: 1 483.6 (1 275.9, 1 656.8) pg/ml vs 1 332.2 (1 197.4, 1 509.8) pg/ml, P<0.01], while decreased in the improvement group [810.3 (599.7, 904.5) pg/ml vs 922.6 (679.5, 1 039.6) pg/ml, P<0.01] over time. Besides, a linear positive correlation was found between serum CPS1 level and alanine aminotransferase (ALT) and total bilirubin (TBIL) (ALT: r=0.339, P<0.001; TBIL: r=0.304, P=0.002). The AUC of serum CPS1 level to predict the 30-day mortality of HEV-ALF patients was 0.803 (95% CI 0.666-0.941), the sensitivity and specificity were 66.67% and 97.47%, respectively. Conclusion:Serum CPS1 level was significantly increased in HEV-ALF patients, and closely related to the prognosis of patients with HEV-ALF.

Preparation of Chinese national potency reference for hepatitis E vaccine / 中国生物制品学杂志

@#ObjectiveTo prepare the hepatitis E vaccine national potency reference for the quality control of hepatitis E vaccine.MethodsA batch of hepatitis E vaccine was selected as the row material,and the screened lyoprotectant was added. After aliquot and freeze-drying,it was prepared as candidate reference material,and the homogeneity and stability were investigated,which was distributed to four laboratories for collaborative calibration and applicability study.Results The 5% trehalose + 2% dextran was selected as the lyoprotectant to prepare the candidate reference material. The aliquot accuracy of candidate reference material was 0. 7%;The coefficient of variation(CV)of antigen content homogeneity was9. 0%;The CV of aluminum content homogeneity was 4. 0%. Moisture content was 1. 7%. The candidate reference material showed good acceleration stability and reconstituted stability. A total of 18 valid data were obtained from the collaborative calibration. The results showed that the average value of median effective dose(ED50)was 0. 15 μg(95% confidence interval of 0. 12 ～ 0. 18 μg)with the intra-laboratory CV of 30. 8% ～ 64. 2%,and the inter-laboratory CV of 32. 6%. Two hepatitis E vaccines produced by two laboratories themselves and the candidate reference material showed good dose-response relationship,of which the seroconversion rate decreased with the decrease of vaccine antigen content and the curve change trend was similar.ConclusionThe first Chinese national potency reference for hepatitis E vaccine(300031-201801)was prepared,which can be used for the quality control of potency ED50detection of hepatitis E vaccine.

Epidemiological characteristics of viral hepatitis E in Fujian Province from 2012 to 2021 / 中国热带医学

@#Abstract: Objective To analyze the epidemiological characteristics of viral hepatitis E in Fujian Province from 2012-2021, and to provide scientific evidence for the prevention and control of hepatitis E in the future. Methods Descriptive epidemiological method was used to analyze hepatitis E cases in Fujian Province from 2012 to 2021. Results From 2012 to 2021, a total of 8 877 cases of hepatitis E were reported in Fujian Province from 2012-2021. The overall incidence rate showed a decreasing trend (χ2trend =458.14, P<0.001), with the lowest incidence rate of 1.32/100 000 in 2020 and an annual average incidence rate of 2.29/100 000 per year. The incidence was higher in winter and spring, with the months of March and April having the highest number of reported cases (2 146, 24.17%) and the fewest cases were reported in September (571, 6.43%). The difference in reported incidence rates between cities was statistically significant (χ2=1 877.75, P<0.01). The comprehensive experimental zone of Pingtan had the highest average reported incidence rate of 6.03/100 000, while Zhangzhou had the lowest at 0.94/100 000. The number of male cases was higher than the number of female cases, with a male to female ratio of 2.04∶1. The disease was most prevalent among middle-aged and elderly individuals, with the age group of 40-<65 years having the highest number of reported cases, accounting for 57.44% (5 099/8 877) of all cases. The age group of 50-<55 years had the highest reported incidence, with the number of reported cases increasing with age below 50 years, but decreasing with age over 50 years. As for occupational distribution, peasants had the highest proportion of the disease, accounting for 34.49% (3 062 cases) of the total cases. Conclusions The reported incidence rate of hepatitis E in Fujian showed a downward from 2012 to 2021. Due to the impact of COVID-19, incidence of the lowest was 2020, but it did not reflect the true situation of the disease, which may have affected trend of hepatitis E. In order to control and reduce the incidence of hepatitis E, efforts should be made to increase publicity and education on health knowledge and vaccination among key areas and populations, strengthen monitoring and diagnostic capability, and implement comprehensive prevention and control measures.

Research advances in hepatitis E virus infection in pregnancy / 临床肝胆病杂志

Previous studies have shown that hepatitis E virus （HEV） infection in pregnancy can cause liver failure and adverse pregnancy outcomes such as miscarriage， stillbirth， and vertical transmission， especially in countries where HEV genotypes 1 and 2 are prevalent. In recent years， HEV infection in China is sporadic and is mainly caused by HEV genotype 4， and although studies have shown that most pregnant women with HEV infection in China have no signfinicant clinical symptoms， there is still a high incidence rate of adverse pregnancy outcomes. This article reviews the recent studies on HEV infection in pregnancy， including the advances in pathogenesis， epidemiology， prognosis， mechanism of severe exacerbation， treatment， and prognosis， and puts forward recommendations for the screening and evaluation of HEV infection in pregnancy.