Objective:To investigate the relationship between intestinal flora and acute respiratory distress syndrome in patients with severe acute pancreatitis.Methods:One hundred and six patients with severe acute pancreatitis admitted to a hospital from March 2019 to February 2021 were selected as the observation group for prospective analysis. They were divided into concurrent group (52 cases) and non-concurrent group (54 cases) according to whether they were complicated with acute respiratory distress syndrome. In addition, 100 healthy people in the same period were selected as the control group to analyze the relationship between intestinal flora and acute respiratory distress syndrome in patients with severe acute pancreatitis.Results:There were significant differences in the number of intestinal flora ( Lactobacillus, Bifidobacterium, Escherichia coli) between the observation group and the control group ( t = 49.69, 73.28 and 46.32; P<0.05). There were significant differences in the number of intestinal flora ( Lactobacillus, Bifidobacterium, Escherichia coli) between the concurrent group and the non-concurrent group ( t = 34.85, 39.71 and 23.47; P<0.05). The levels of serum endotoxin, diamine oxidase and D-lactic acid in the concurrent group were significantly higher than those in the non-concurrent group: (0.63 ± 0.16) EU/ml vs. (0.45 ± 0.08) EU/ml, (6.29 ± 1.18) U/ml vs. (4.89 ± 0.91) U/ml, (11.63 ± 2.84) mmol/L vs. (9.33 ± 2.61) mmol/L ( t = 7.37, 6.85 and 4.34, P<0.05). Spearman analysis showed that severe acute pancreatitis complicated with acute respiratory distress syndrome was negatively correlated with the number of intestinal Lactobacillus and Bifidobacterium ( r = - 0.342 and - 0.291, P = 0.011 and 0.021), which was positively correlated with the number of intestinal Escherichia coli flora ( r = 0.263, P = 0.033). Conclusions:Intestinal colony imbalance is common in patients with severe acute pancreatitis, and the imbalance of intestinal colony and the impairment of intestinal mucosal barrier function are more serious in patients with acute respiratory distress syndrome. There is a significant correlation between severe acute pancreatitis complicated with acute respiratory distress syndrome and its intestinal colony.

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.

Objective:We conducted a real-world multi-center clinical study with a large sample size to comprehensively evaluate the performance of three commercial hepatitis C virus (HCV) core antigen assays. The study aimed to evaluate the performance for their use in HCV infection screening, and to provide clues for further improving the sensitivity and specificity of the assays.Methods:Key performance indicators including the lower limit of detection (LOD), diagnostic sensitivity, and specificity of three HCV antigen assays (the Architect, Laibo, and ChemClin HCV core antigen assays) were evaluated using commercial seroconversion panels reflecting early HCV infection and clinical routine serum samples of outpatients and inpatients from 3 tertiary hospitals from January 2018 to April 2022. Factors that affect the performance indicators were further investigated.Results:The window period for detecting HCV infection with the three antigen assays was equal to or slightly longer than that of the RNA assay, but all are shorter than that of the anti-HCV assay. There was a good linear positive correlation between HCV core antigen and HCV RNA levels in treatment naive patients with hepatitis C ( r=0.90, P<0.01). For the most common genotype 1b strain in China, the LOD of the three HCV assays were equivalent to 531 IU/ml (Architect), 3,698 IU/mL (Laibo), and 4,624 IU/mL (ChemClin) HCV RNA, respectively. Due to the skewed distribution of HCV RNA levels in treatment-naive hepatitis C patients, more than 95% of the patients had viral loads higher than 6 166 IU/ml. Therefore, the three HCV antigens assays still maintained a satisfactory diagnostic sensitivity (94.33%-99.40%). Among 54 immunodeficient patients (leukemia patients) with HCV infection, 9% (5/54) had negative anti-HCV results, while the HCV antigen assays found all these infectors. Through further experiments, we revealed the amino acid polymorphism in the core region of genotype 3 strain impaired the sensitivity of all three HCV antigen assays. In addition, the sensitivity of the two domestic assays was impaired by anti-HCV antibodies in the serum. The specificity of HCV antigen assays for diagnosing hepatitis C is 99.94% to 99.98%. The rheumatoid factors, autoantibodies, and other unknown interference substances can lead to a small number of low level, "false positive" antigen results. Conclusions:HCV core antigen assay may be used as a satisfactory approach of infection screening, especially for the immunodeficient patents. However, the sensitivity and specificity of the assays are influenced by multiple factors, which should be further improved.

Objective:To investigate the clinical value of peripheral blood T lymphocytes in the diagnosis and prognosis of patients with hepatocellular carcinoma (HCC) recurrence after liver transplantation.Methods:The clinical and laboratory data of 50 HCC patients, who received liver transplantation and were followed up in the Liver transplantation Center of Beijing Youan Hospital from January 2014 to December 2016, were retrospectively analyzed. The differences on clinical laboratory indicators and five-year survival were compared between HCC recurrence group ( n=29) and non-recurrence group ( n=21). Spearman correlate analysis was used to analyze the correlation between clinical laboratory indicators and HCC recurrence after liver transplantation. Receiver operator characteristic (ROC) curve was used to analyze the diagnostic value of CD4+T lymphocytes in HCC recurrence after liver transplantation. Kaplan-Meier survival curve was used to compare the survival time of patients with different CD4+T lymphocytes levels post liver transplantation. Results:Compared to non-recurrence group, the level of alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, albumin, lymphocytes, alpha-fetoprotein, protein induced by vitamin K deficiency or antagonist-Ⅱ, CD3+, CD4+and CD8+T lymphocytes were significantly different (all P<0.05). The median recurrence time after liver transplantation was 13.0 (6.0, 24.0) months, and the mortality rate was 100%. The 5-year mortality rate was 0 in the non-recurrence group. During 5-year follow-up, the median survival time of patients in the HCC recurrence group was 18.0 (9.0, 36.0) months, which was significantly lower than that of non-recurrence group [60.0 (60.0, 60.0) months, ( P<0.05)]. Compared with non-recurrence group, the CD3+, CD4+, and CD8+T lymphocytes were significantly lower in the recurrence group (all P<0.05). Spearman correlate analysis showed that HCC recurrence after liver transplantation was negatively correlated with the CD3+, CD8+and CD4+T lymphocytes ( r=-0.43, -0.38, -0.44, all P<0.05). ROC analysis showed that CD4+T lymphocytes at cutoff of≤265.50 cells/μl was valuable for the diagnosis of HCC recurrence after liver transplantation (specificity 100%, sensitivity 48.30%). Survival curve analysis showed that the survival time was significantly lower in the CD4≤265.50 cells/μl group [15.0 (10.0, 36.8) months] than that in the CD4>265.50 cells/μl group [53.0 (19.5, 60.0) months] ( P<0.05). Conclusion:There is a significant negative correlation between CD4+T lymphocytes and HCC recurrence after liver transplantation. CD4+T lymphocytes at cutoff value of≤265.50 cells/μl is valuable for the clinical diagnosis and prognosis evaluation of HCC recurrence after liver transplantation.

Objective:To understand the characteristics of serological detection indicators of patients with hepatitis B virus (HBV) infection in three hospitals in Beijing from 2018 to 2021.Methods:The five markers of hepatitis B, liver function tests, HBV DNA load, AFP and PT test results and basic clinical information of HBsAg positive HBV infected patients in three hospitals in Beijing from 2018 to 2021 were collected. Then the diagnosis of HBV infection, the positive patterns of serological indicators for five markers of hepatitis B and the clinical characteristics of hepatitis B patients were analyzed by SAS 9.4 statistical software.Results:Among the 1 026 604 patients who were tested for the five markers of hepatitis B or hepatitis B surface antigen quantification (HBsAg-QN) in three hospitals in Beijing from 2018 to 2021, the positive detection rate of HBsAg was 53.50%. The annual positive detection rate of HBsAg was 57.22%, 55.05%, 53.64% and 47.69% successively, showing a downward trend year by year. 111 709 hepatitis B patients were divided into 1-30, 31-60 and>60 years old groups according to their age. The main diseases of the three groups of HBV infected patients was chronic hepatitis B (CHB), and the proportion of patients with acute hepatitis B (AHB) and CHB decreased with age, while the proportion of patients with HBV-related liver cirrhosis, HBV-related liver cancer, liver cancer surgery and liver transplantation increased with age, the difference of which was statistically significant (all P<0.05). In this research, a total of 24 positive patterns of the five markers of hepatitis B were detected, including 7 common patterns (the main pattern was 145), 14 rare patterns (the main pattern was 1345), and 3 unusual patterns (the main pattern was 12345). The age, male ratio, HBeAg positive detection rate, HBV DNA positive detection rate and load, TBIL, ALT, AFP and PT results in the HBsAg positive group (90 011cases) were higher than those in the HBsAg negative group (21 698 cases), and the above results of the two groups of hepatitis B patients were higher than those of the healthy control group (20 623 cases). The albumin (ALB) results were the lowest in the HBsAg positive group and the highest in the healthy control group. And the differences were statistically significant (all P<0.05). Conclusions:From 2018 to 2021, the positive rate of HBsAg among the patients who received the five markers of hepatitis B or HBsAg-QN test in three hospitals in Beijing decreased year by year. Age was associated with disease progression in patients with hepatitis B. The positive patterns of five markers of hepatitis B in HBV infected people showed diversity.

Objective:To explore the clinical and laboratory characteristics of acquired immunodeficiency syndrome (AIDS) patients complicated with disseminated nontuberculous mycobacterial (NTM) disease, in order to provide basis for clinical therapy.Methods:The clinical findings, imaging and etiological data of the 71 AIDS patients complicated with disseminated NTM disease admitted to Beijing You′an Hospital from June 2016 to June 2021 were retrospectively analyzed.Results:Among 71 patients with disseminated NTM disease, the most common initial symptom was fever, followed with cough, expectoration, fatigue, poor appetite, abdominal pain and diarrhea. Seventy point four percent (50/71) of these patients had at least two comorbidities, with oral candida infection, cytomegalovirus infection, syphilis, pneumocystis pneumonia and bacterial pneumonia being the most common. Hemoglobin ((87.8±24.2) g/L) and albumin ((27.3±7.0) g/L) levels significantly decreased, while erythrocyte sedimentation rate ((59.8±28.6) mm/1 h) and C-reactive protein ((74.7±50.8) mg/L) levels increased in most cases. The median CD4 + T lymphocyte count was 7×10 6/L. The median time of positive blood culture of NTM was 260 h. Among the 71 patients, 40 cases (56.3%) were infected with Mycobacterium avium, 15 cases (21.1%) with Mycobacterium intracellulare, 10 cases (14.1%) with Mycobacterium colombiense, three cases (4.2%) with Mycobacterium marseillense and three cases (4.2%) with Mycobacterium kansasii.The frequent imaging findings were patchy and nodular shadows in lungs, and most patients had mediastinal or hilar lymph node enlargement and splenomegaly. Conclusions:AIDS complicated with disseminated NTM disease is prevalently occurred in patients with severe immune deficiency, and most of the bacteria belong to the Mycobacterium avium- intracellulare complex. Early obtaining positive etiological results of NTM is essential to guide the correct clinical diagnosis and accurate treatment.

Objective:To analyze the characteristics of clinical and laboratory indexes in patients with liver disease with positive anti-liver cytosol antibody type 1 (anti-LC1), in order to provide references for clinical and differential diagnosis.Methods:The clinical data of 23 832 inpatients and outpatients with positive anti-LC1 autoantibodies detected in routine autoantibody test from January 2010 to January 2020 were retrospectively analyzed, and their clinical and laboratory indexes were compared. Western blotting was used to detect anti-LC1, anti-soluble liver antigen antibody (anti-SLA), anti-glycoprotein 210 antibodies and anti-nucleosome 100 antibodies. Indirect immunofluorescence assay was used to detect anti-nuclear antibody (ANA), anti-mitochondrial antibody, anti-Smooth muscle antibody (ASMA), anti-liver and kidney microsomal antibody (anti-LKM) and other autoantibodies. Normally distributed measurement data between the two groups were compared by independent-sample t-test, and the multiple groups comparison were compared by one-way analysis of variance. Non-normally distributed measurement data were compared by non-parametric rank sum test.Results:38 anti-LC1 positive patients were detected in 23832 autoantibody tests. The age of initial diagnosis ranged from 11.0 to 84.0 (50.6 ± 16.0) years. There were 8 males (21.1%) and 30 females (78.9%). A total of 31 cases (81.6%) were positive for anti-LC1 and ANA, and the dominant karyotype was speckled pattern, accounting for 54.8%. Five cases (13.2%) were positive for ASMA, and no simultaneous positive with anti-LKM or anti-SLA. Among the 38 anti-LC1 positive patients, 9 were diagnosed with autoimmune hepatitis (AIH), 6 with possible AIH, 6 with primary biliary cholangitis (PBC), 8 with hepatitis B, 2 with hepatitis C, 1 with alcoholic liver disease, 2 with non-alcoholic fatty liver disease, 1 with drug-induced liver injury, 1 with hepatolenticular degeneration, and 2 with tumor. Confirmed and probable AIH cases accounted for 39.5% (15/38) of anti-LC1 positive cases. Among anti-LC1 positive patients, 47.4% (18/38) had entered the stage of liver cirrhosis. AIH group globulin level was higher than HBV group ( P = 0.006) and other disease groups ( P = 0.001). AIH group IgG level was higher than PBC group ( P = 0.027), HBV group ( P = 0.009) and other disease groups ( P = 0.004). the of the PBC group IgM level was higher than AIH group ( P = 0.003), HBV group ( P = 0.003) and other disease groups ( P = 0.006). Conclusion:Anti-LC1 is not only detected in AIH, but also observed in patients with primary biliary cholangitis, hepatitis B and C, alcoholic and non-alcoholic liver disease, drug-induced liver injury, hereditary metabolic liver disease and tumor. In addition, it is mainly female gender dominance and nearly half of ANA-positive young, middle-aged and elderly patients develop liver cirrhosis. For the diagnosis of type 2 autoimmune hepatitis, whether anti-LC1 is a specific antibody needs further research, but if AIH is highly suspected, this antibody can be used as a substitute.

Emerging infectious diseases are a common type of public health emergencies, which occur frequently around the world in recent years, seriously threatening the safety of human life and property. In the process of dealing with epidemic situation, medical laboratories have played an important role in disease diagnosis, treatment, efficacy evaluation and prognosis judgment and so on. Beijing Youan Hospital, as the designated hospital of the coronavirus disease 2019 (COVID-19), has set up an emergency laboratory in the capital for the prevention and control of the COVID-19 by carrying out routine tests and virus nucleic acid tests, it provides timely and effective evidence for clinical diagnosis and treatment. To provide ideas and references for the building of the Emergency Laboratory in infectious hospitals. This article discuss how to set up an independent emergency laboratory efficiently, strengthen the cooperation with the Center for Disease Control and Prevention, make the best use of all resources, and share the enlightenment gained in the process of construction.

Emerging infectious diseases are a common type of public health emergencies, which occur frequently around the world in recent years, seriously threatening the safety of human life and property. In the process of dealing with epidemic situation, medical laboratories have played an important role in disease diagnosis, treatment, efficacy evaluation and prognosis judgment and so on. Beijing Youan Hospital, as the designated hospital of the coronavirus disease 2019 (COVID-19), has set up an emergency laboratory in the capital for the prevention and control of the COVID-19 by carrying out routine tests and virus nucleic acid tests, it provides timely and effective evidence for clinical diagnosis and treatment. To provide ideas and references for the building of the Emergency Laboratory in infectious hospitals. This article discuss how to set up an independent emergency laboratory efficiently, strengthen the cooperation with the Center for Disease Control and Prevention, make the best use of all resources, and share the enlightenment gained in the process of construction.

Objective: To analyze the serological characteristics of anti-mitochondrial antibody M2 subtype (AMA-M2) in patients with drug-induced liver injury (DILI) and primary biliary cholangitis (PBC), in order to provide reference for clinical differential diagnosis. Methods: Laboratory data of 2802 DILI cases who visited the hospital between January 2011 and December 2017 were retrospectively collected. AMA-M2 positive patients were analyzed with respect to laboratorical findings, and serum data of 120 patients with primary biliary cholangitis (PBC) at the same period was taken as a control. A chi-square test was used for group comparisons. One-way ANOVA and rank sum tests was used for ALT, AST, ALP, GGT and three groups of immunoglobulin M. Results: Among 2802 DILI patients, AMA-M2 positive rate was 5.1% (144/2 802), 77.1% (111/144) was DILI alone, 22.2% (32/144) was DILI with PBC, and 0.7% (1/144) was DILI with Sjogren's syndrome. An AMA-M2 level in DILI alone group was mostly mild and moderate than the PBC group and the DILI combined with the PBC group. There was significant difference between the two groups (P < 0.05).There was no significant difference in AMA-M2 levels between DILI group combined with PBC group and PBC group (P > 0.05). ALT and AST levels of DILI alone group and DILI combined with PBC were (585.92 ± 653.04) U/L, (501.45 ± 512.67) U/L and (373.47 ± 502.60) U/L, (335.97 ± 513.96) U/L, respectively, which were significantly higher than PBC group [(106.33 + 134.08) U/L, (112.59 + 152.20) U/L]. There were statistically significant differences between the two groups (P < 0.05).The ALP level of DILI alone group was (152.58 + 81.46) U/L, which was lower than PBC group (237.86 + 215.09). The difference was statistically significant (P < 0.05). The level of immunoglobulin M in the DILI alone group was (1.76 ± 1.16) g/L, which was lower than PBC group (4.74 ± 5.74) g/L and the DILI combined with the PBC group (3.31 ± 1.68) g/L. There was significant difference between the two groups. During follow-up, 2.7% of patients with DILI had cirrhosis, 42.3% had lower AMA-M2 titer, 14.4% had lower AMA-M2 titer, 13.5% had higher AMA-M2 titer and five cases developed PBC. Conclusion AMA-M2 is not only positive in patients with PBC, but also low-to-medium or even high-level AMA-M2 may be detected in DILI patients. For AMA-M2-positive DILI patients, it is necessary to identify whether they are associated with PBC. Secondly, the levels of ALT, AST and ALP should be analyzed, and the patients should be on regular follow up for early and timely detection of drug-induced PBC.