Objective:To evaluate the clinical utility of a novel quantitative assay named hepatitis B virus (HBV) simultaneous amplification and testing (SAT) using a kit for HBV RNA detection (RNA probes).Methods:HBV RNA was detected in 170 serum samples of chronic hepatitis B patients and 30 serum samples of patients without HBV infection collected by simple random sampling method from June 2017 to June 2018 in Huashan Hospital, Fudan University, Shanghai using HBV SAT and reverse transcription polymerase chain reaction (PCR) method. The sensitivity, specificity, kappa value and quantitative correlation of the two methods were analyzed and compared.The detection rates of HBV RNA from samples with different HBV DNA concentrations of the two methods were analyzed and compared. Statistical analysis was performed by chi-square test.Results:Based on the clinical diagnosis, the detection sensitivity, specificity, kappa value of HBV SAT were 97.06%(165/170), 100.00%(30/30) and 0.908, respectively, while the reverse transcription PCR were 92.94%(158/170), 100.00%(30/30) and 0.798, respectively. Among samples with lower concentration of HBV DNA (HBV DNA<100 IU/mL), the detection rates of HBV SAT and reverse transcription PCR were 77.27%(17/22) and 59.09%(13/22), respectively. The linear correlation coefficient of the two methods was r=0.987 8. Conclusions:Quantitation results of HBV RNA by HBV SAT and reverse transcription PCR method are consistent. HBV SAT is a rapid and accurate method for HBV RNA quantitative detection, which has a slightly higher detection rate than reverse transcription PCR in samples with low concentration of HBV DNA.

Objective: To study on the mRNA expression level of IN1 gene associated with the clinical efficacy and prognosis of hepatoblastoma(HB) in children and to elucidate the early warning value of IN1 gene for prognosis and chemotherapy sensitivity. Methods: Forty HB patients were selected based on primary diagnosis and treated from January 2015 to May 2018 in Tongren Hospital Affiliated to Capital Medical University. The expression level of INI1 gene was detected by using fluorescence immuno-PCR. Clinical data of children with HB were collected, including staging, grouping, risk, efficacy and prognosis of chemotherapy. The relationship between the mRNA expression of IN1 gene and clinical data was analyzed by SPSS 21.0 software. Results: (1)Clinical characters: the medium age of 40 HB patients was(30.50±2.39) months, male 29 cases (72.5%), and female 11 cases (27.5%). There was 1 case (2.5%) of stage Ⅱ HB, 13 cases (32.5%) of stage Ⅲ HB, and 26 cases (65.0%) of stage Ⅳ. The low-and intermediate- risk group had 12 cases (30.0%) of HB, and the high-risk group had 28 cases (70.0%) of HB.(2)Clinical efficacy and prognosis: by July 1^st, 2018, the medium following-up time was (12.2±10.1) months, 4 patients (10%) were treated by chemotherapy without surgery, and 36 patients (90%) were treated by surgery .All patients (100%) received chemotherapy.The average cycle of chemotherapy lasted(13.17±0.02). Ten patients were dead and 30 patients survived till following-up.The overall survival (OS) rates were 75% and the event-free survival rates were 50% (20 patients with HB). (3) IN1 gene mRNA expression: The average PCR quantitative of IN1 gene mRNA of 40 HB patients(2^-ΔCT)was 0.31±0.70.The average mRNA quantitative of HB patients (2^-ΔCT)with high-risk and low/intermediate-risk group was 0.23±0.43 and 0.48±1.13(t=6.363, P=0.05). According to histology diagnosis, the average mRNA quantitative of small cell undifferentiated (SCU) type (12 cases)and other type (25 cases) was 0.09±0.11 and 0.43±0.86(t=4.533, P=0.04). The average mRNA quantitative of patients with or without radical surgery was 0.04±0.03 and 0.34±0.74 (t=2.935, P=0.022). The data of children with poor chemotherapy sensitivity(19 cases)and those sensitive to chemotherapy (21 cases) were 0.03±0.04 and 0.30±0.82, and the difference was statistically significant (t=5.688, P=0.018). Conclusions Poor therapeutic effect results in low mRNA expression of IN1 gene in children of HB.The IN1 gene expression could be an early warning factor for treatment sensitivity and prognosis.

Objective:To take a broad overview of the current allocation of diagnosis and treatment resources and management for patients with tuberculous meningitis (TBM) in 49 hospitals in China.Methods:A cross-sectional survey about TBM was carried out in 49 hospitals from 27 provinces across China, by means of electronic questionnaire.The electronic questionnaire was filled by doctors in charge of the departments where TBM patients were routinely admitted from September to December 2018. The availability of medical resources, diagnosis, evaluation, treatment and surveillance in these hospitals were analyzed from the questionnaire. The count data were expressed as percentage.Results:Among the 49 participating hospitals, 37(75.5%) hospitals had less than 50 admissions of suspected TBM per year. Less than 20 TBM patients were confirmed by etiological diagnosis per year in 42(85.7%) participating hospitals.The availability of conventional medical imaging including computed tomography (CT), magnetic resonance imaging (MRI), enhanced MRI, cerebral angiography and magnetic resonance angiography (MRA) were 100.00%(49/49), 95.92%(47/49), 91.84%(45/49), 61.22%(30/49) and 67.35%(33/49), respectively. The rate of access to classic etiological diagnostic methods including acid-fast bacilli smear, mycobacterial culture and T cell spot test of tuberculosis infection were 77.55%(38/49), 95.92%(47/49) and 83.67%(41/49), respectively. Rifampin (100.0%, 49/49), isoniazid (100.0%, 49/49), pyrazinamide (98.0%, 48/49) and ethambutol (95.9%, 47/49) were most commonly used in initial anti-tuberculosis treatment of non-severe patients with TBM. The course of anti-tuberculosis treatment was 18 months in 25(51.0%) hospitals, and 12 months in 17(34.7%) hospitals. Intrathecal glucocorticoid and isoniazid were used in 39(79.6%) hospitals. Dexamethasone was used as part of treatment in 24(49.0%) hospitals, and the duration of glucocorticoid was about two months in 28(57.1%) hospitals. As for hyponatremia, 32(65.3%) hospitals didn′t investigate the cause, and hypertonic saline (83.7%, 41/49) and oral rehydration salts (71.4%, 35/49) were considered as the most common treatment strategy. Lumbar puncture was most commonly used for intracranial pressure surveillance in 48(98.0%) hospitals.Conclusions:The TBM cases admitted to the investigation hospitals are characterized by scattered sources and few confirmed cases of etiology. There are obvious heterogeneities in the diagnosis and treatment of TBM and the management of complications.The standardized plan for diagnosis and treatment of TBM are needed to improve the management.

Objective:To analyze the changes and efficacy of antiviral treatment regimens in patients with chronic hepatitis C.Methods:This was a single center retrospective study. A total of 157 patients with chronic hepatitis C in Huashan Hospital, Fudan University from January 2014 to February 2019 were included. Clinical informations of antiviral treatment and follow-up were collected. The sustained virologic response (SVR) rate and adverse events in patients receiving different antiviral regimens were compared. Chi-square test was used for statistical analysis.Results:Among the 157 patients, 133 patients had sufficient follow-up data. Seventy-one patients received treatment before 2017, among which 63 patients received interferon regimens and the SVR rate was 74.65%(53/71). Sixty-two patients received treatment after 2017, among which 61 patients received direct-acting antiviral agents (DAA) regimens and the SVR rate was 98.39%(61/62). The difference in SVR rate between the two groups was statistically significant ( χ2=15.230, P<0.01). In 69 patients who received DAA regimens from 2014 to 2019, the SVR at post-treatment week 12 (SVR12) was 95.65%(66/69). Among 43 patients who received DAA regimens containing sofosbuvir, the SVR12 rates of patients with hepatitis C virus genotype 1, 3 and other genotypes were 15/15, 5/6 and 90.91%(20/22), respectively. All the 26 patients who received DAA regimens non-containing sofosbuvir achieved SVR12. The SVR12 rates of patients with different hepatitis C virus genotypes and DAA regimens were not significantly different ( χ2=5.243, P=0.263). The incidences of adverse events in pre-2017 group and post-2017 group were 84.62%(77/91) and 6.06% (4/66), respectively. The difference was statistically significant ( χ2=94.520, P<0.01). The most common adverse events were decreases in neutrophil cell count, decreases in hemoglobin level and decreases in platelet count. Treatment was ceased in six patients due to adverse events. Conclusions:After 2017, the majority of patients with chronic hepatitis C received DAA regimens instead of interferon regimens. The SVR rate increases and the incidence of adverse events decreases along with the changes of leading treatment regimens.The SVR12 rate is higher in patients receiving DAA regimens, regardless of hepatitis C virus genotypes.

Objective:To analyze the hotspots and trends of global researches in the field of hepatitis B from 2016 to 2021.Methods:Based on the Web of Science Core Collection Database, the indexed "article" and "review" related to hepatitis B from January 1, 2016 to November 22, 2021 were collected. Using InCites and VOSviewer 1.6.8 to cluster the published features, highly cited papers, key research directions and subject headings.And combined with the specific content of the literature, a summary of research hotspots was formed and analyzed.Results:As of November 22, 2021, a total of 12 299 articles were retrieved. From 2016 to 2021, the numbers of global hepatitis B-related research publications were 2 045, 1 996, 2 039, 2 118, 2 186 and 1 915, respectively. China′s mainland published the most papers (4 422 pieces, 35.95%), with the average citation frequency of only 7.46, and the United States ranked second in terms of the number of papers published (1 949 pieces, 15.85%), with the average citation frequency of 13.78. The hotspots obtained after the clustering of keyword topics were hepatitis B virus (HBV) infection, coinfections of HBV and hepatitis C virus/human immunodeficiency virus, primary hepatocellular carcinoma, antiviral therapy and hepatitis B cure, HBV virology, HBV and immunology, HBV reactivation, HBV vaccine, etc.Conclusions:In the past six years, global researches in the field of hepatitis B have focused on hepatitis B epidemiology and management, prediction and prevention of hepatitis B-related liver cancer, hepatitis B cure and treatment optimization, HBV virology and host immune mechanism in the development of hepatitis B, etc.The number of published papers in the field of hepatitis B keeps relatively stable. The number of researches in China′s mainland is at the international leading level, but the influence of researches needs to be further improved.

Objective:To investigate the prevalence of positive hepatitis C virus (HCV) antibody, HCV RNA and genotype distribution of HCV in high-risk populations in Pudong New Area, Shanghai City, so that to provide evidence for making "hepatitis C micro elimination" strategies in Shanghai area.Methods:A survey with proportional sampling method was conducted among the high-risk populations, including people who inject drugs (PWID), voluntarily or compulsorily accepted drug detoxification or methadone treatment, human immunodeficiency virus voluntary counseling and testing (HIV VCT) outpatients, sexually transmitted disease (STD) outpatients, and commercial sex workers, who participated in the routine physical examination activities held by the community health service centers and public hospitals of Pudong New Area from July 2021 to November 2022. The residual plasma samples were collected from medical examinations. HCV antibody was tested in all samples. HCV RNA and HCV genotype were tested in samples with positive HCV antibody results.Results:A total of 1 000 HCV high-risk people were screened, including 453 PWID, 166 human immunodeficiency virus (HIV) infectors, 245 STD outpatients, and 136 commercial sex workers. The positive rates of HCV antibody in the four categories of personnel were 21.85%(99/453), 1.81%(3/166), 1.22%(3/245) and 0(0/136), respectively. The positive rate of HCV RNA was 42.68%(35/82) among HCV antibody positive people in high-risk populations. As much as 74.29%(26/35) of HCV RNA positive people had junior high school education or less, and 77.14%(27/35) of them were not married. Among the 12 samples tested for HCV genotype, five were genotype 3, five were genotype 6, and two were subtype 1b.Conclusions:PWID is the main high-risk HCV infection population, who should be the target of the following "hepatitis C micro elimination" strategies. The proportions of genotype 3 and genotype 6 are high in the high-risk HCV infection populations, and the pan-genotype direct-acting antiviral agent treatment may be more suitable in this situation. HCV infected persons in high-risk groups have low education level and marriage rate, which indicates that education and care in community are needed.