AIM To investigate potential effects of poly I:C on mucosal injury and epithelial barrier disruption in dextran sulfate sodium (DSS)-induced acute colitis. METHODS Thirty C57BL/6 mice were given either regular drinkin...AIM To investigate potential effects of poly I:C on mucosal injury and epithelial barrier disruption in dextran sulfate sodium (DSS)-induced acute colitis. METHODS Thirty C57BL/6 mice were given either regular drinking water (control group) or 2% (w/v) DSS drinking water (model and poly I:C groups) ad libitum for 7 d. Poly I:C was administrated subcutaneously (20 mu g/mouse) 2 h prior to DSS induction in mice of the poly I:C group. Severity of colitis was evaluated by disease activity index, body weight, colon length, histology and myeloperoxidase (MPO) activity, as well as the production of proinflammatory cytokines, including tumor necrosis factor-a (TNF-alpha), interleukin 17 (IL-17) and interferon-. (IFN-gamma). Intestinal permeability was analyzed by the fluorescein isothiocyanate labeled-dextran (FITC-D) method. Ultrastructural features of the colon tissue were observed under electron microscopy. Expressions of tight junction (TJ) proteins, including zo-1, occludin and claudin-1, were measured by immunohistochemistry/immunofluorescence, Western blot and real-time quantitative polymerase chain reaction (RT-qPCR). RESULTS DSS caused significant damage to the colon tissue in the model group. Administration of poly I:C dramatically protected against DSS-induced colitis, as demonstrated by less body weight loss, lower disease activity index score, longer colon length, colonic MPO activity, and improved macroscopic and histological scores. It also ameliorated DSS-induced ultrastructural changes of the colon epithelium, as observed under scanning electron microscopy, as well as FITC-D permeability. The mRNA and protein expressions of TJ protein, zo-1, occludin and claudin-1 were also found to be significantly enhanced in the poly I:C group, as determined by immunohistochemistry/immunofluorescence, Western blot and RT-qPCR. By contrast, poly I:C pretreatment markedly reversed the DSS-induced up-regulated expressions of the inflammatory cytokines TNF-alpha, IL-17 and IFN-gamma. CONCLUSION Our study suggested that poly I:C may protect against DSS-induced colitis through maintaining integrity of the epithelial barrier and regulating innate immune responses, which may shed light on the therapeutic potential of poly I:C in human colitis.展开更多
Objective: The objective is to evaluate the effectiveness of chemotherapy as postoperative adjuvant therapy for stage IB-IIB cervical cancer with intermediate-risk factors. Methods: We retrospectively reviewed the med...Objective: The objective is to evaluate the effectiveness of chemotherapy as postoperative adjuvant therapy for stage IB-IIB cervical cancer with intermediate-risk factors. Methods: We retrospectively reviewed the medical records of 119 cervical cancer patients with intermediate-risk factors treated with radical hysterectomy and pelvic lymphadenectomy from December 1997 to September 2010. The intermediate-risk factors included bulky tumor (≥4 cm), lymphovascular space invasion, and deep stromal invasion. Sixteen patients did not receive adjuvant therapy (observation group);73 were treated with chemotherapy (CT group);30 were treated with adjuvant radiation therapy (RT group). The significance of the clinical parameters, 3- and 5-year overall survival (OS) rates of each group, was analyzed. Results: The 3- and 5-year OS rates between the observation group and adjuvant therapy group (CT plus RT groups) were not statistically different (3-year OS: 100% and 94.4%, respectively;5-year OS: 100% and 92.3%, respectively;p > 0.05). The 3- and 5-year OS rates between the CT group and RT group were also not statistically different (3-year OS: 93.6% and 96.4%, respectively;5-year OS: 80.7% and 96.4%, respectively;p < 0.05). Univariate and multivariate analysis of survival indicated that different adjuvant therapies were not independent prognostic indicators for IB-IIB cervical cancer patients with intermediate-risk factors. Conclusions: CT may have equivalent therapeutic effect as RT for stage IB-IIB cervical cancer patients with intermediate-risk factors after radical surgery, and prospective randomized trial is needed to study the effect of CT in these patients.展开更多
Some patients with chronic hepatitis B virus(HBV)infection failed to clear HBV,even persistently continue to produce antibodies to HBV.Here we performed a two stage genome wide association study in a cohort of Chinese...Some patients with chronic hepatitis B virus(HBV)infection failed to clear HBV,even persistently continue to produce antibodies to HBV.Here we performed a two stage genome wide association study in a cohort of Chinese patients designed to discover single nucleotide variants that associate with HBV infection and clearance of HBV.The first stage involved genome wide exome sequencing of 101 cases(HBsAg plus anti-HBs positive)compared with 102 control patients(antiHBs positive,HBsAg negative).Over 80%of individual sequences displayed 209 sequence coverage.Adapters,uncertain bases[10%or low-quality base calls([50%)were filtered and compared to the human reference genome hg19.In the second stage,579 chronic HBV infected cases and 439 HBV clearance controls were sequenced with selected genes from the first stage.Although there were no significant associated gene variants in the first stage,two significant gene associations were discovered when the two stages were assessed in a combined analysis.One association showed rs506121-“T”allele[within the dedicator of cytokinesis 8(DOCK8)gene]was higher in chronic HBV infection group than that in clearance group(P=0.002,OR=0.77,95%CI[0.65,0.91]).The second association involved rs2071676—A allele within the Carbonic anhydrase(CA9)gene that was significantly elevated in chronic HBV infection group compared to the clearance group(P=0.0003,OR=1.35,95%CI[1.15,1.58]).Upon replication these gene associations would suggest the influence of DOCK8 and CA9 as potential risk genetic factors in the persistence of HBV infection.展开更多
BACKGROUND Data that assess maternal and infant outcomes in hepatitis C virus(HCV)-infected mothers are limited.AIM To investigate the frequency of complications and the associated risk factors.METHODS We performed a ...BACKGROUND Data that assess maternal and infant outcomes in hepatitis C virus(HCV)-infected mothers are limited.AIM To investigate the frequency of complications and the associated risk factors.METHODS We performed a cohort study to compare pregnancy and fetal outcomes of HCVviremic mothers with those of healthy mothers.Risk factors were analyzed with logistic regression.RESULTS Among 112 consecutive HCV antibody-positive mothers screened,we enrolled 79 viremic mothers.We randomly selected 115 healthy mothers from the birth registry as the control.Compared to healthy mothers,HCV mothers had a significantly higher frequency of anemia[2.6%(3/115)vs 19.0%(15/79),P<0.001]during pregnancy,medical conditions that required caesarian section[27.8%(32/115)vs 48.1%(38/79),P=0.004],and nuchal cords[9.6%(11/115)vs 34.2%(27/79),P<0.001].In addition,the mean neonatal weight in the HCV group was significantly lower(3278.3±462.0 vs 3105.1±459.4 gms;P=0.006),and the mean head circumference was smaller(33.3±0.6 vs 33.1±0.7 cm;P=0.03).In a multivariate model,HCV-infected mothers were more likely to suffer anemia[adjusted odds ratio(OR):18.1,95%confidence interval(CI):4.3-76.6],require caesarian sections(adjusted OR:2.6,95%CI:1.4-4.9),and have nuchal cords(adjusted OR:5.6,95%CI:2.4-13.0).Their neonates were also more likely to have smaller head circumferences(adjusted OR:2.1,95%CI:1.1-4.3)and lower birth weights than the average(≤3250 gms)with an adjusted OR of 2.2(95%CI:1.2-4.0).The vertical transmission rate was 1%in HCV-infected mothers.CONCLUSION Maternal HCV infections may associate with pregnancy and obstetric complications.We demonstrated a previously unreported association between maternal HCV viremia and a smaller neonatal head circumference,suggesting fetal growth restriction.展开更多
Objective:To explore the effect of hydromorphone hydrochloride postoperative analgesia on the inflammatory cytokines, S-100β, and NSE in elderly patients after total hip replacement (THR).Methods: A total of 100 pati...Objective:To explore the effect of hydromorphone hydrochloride postoperative analgesia on the inflammatory cytokines, S-100β, and NSE in elderly patients after total hip replacement (THR).Methods: A total of 100 patients who were admitted in our hospital from January, 2015 to July, 2016 for THR were included in the study and randomized into the observation group and the control group with 50 cases in each group. After operation, the patients in the two groups were immediately given patient-controlled analgesia. The patients in the observation group were given hydromorphone hydrochloride (0.3 mg) + dexamethasone (5 mg) + normal saline (100 mL), while the patients in the control group were given sufentanil (150 μg) + dexamethasone (5 mg) + normal saline (100 mL). The morning fasting peripheral venous blood before operation, 24 h and 3 d after operation in the two groups was collected. ELISA was used to detect the serum CRP, IL-6, and TNF-α, and the plasma S-100β and NSE levels.Results:The serum CRP, TNF-α, and IL-6 levels 24 h and 3 d after operation in the two groups were significantly elevated when compared with before operation, and were reduced 3d after operation. CRP, TNF-α, and IL-6 levels at each timing point after operation in the observation group were significantly lower than those in the control group. The plasma S-100βand NSE levels 24 h and 3 d after operation in the two groups were significantly elevated when compared with before operation, and were reduced 3 d after operation. The plasma S-100β and NSE levels at each timing point after operation in the observation group were significantly lower than those in the control group.Conclusions:Hydromorphone hydrochloride can relieve the postoperative pain in elderly patients with THR, effectively alleviate the inflammatory reaction, reduce the plasma S-100β and NSE levels, and alleviate the cerebral injury, whose pathogenesis remains a further deep study.展开更多
Background:The diagnosis of tuberculous pleurisy(TP)presents a significant challenge due to the low bacterial load in pleural effusion(PE)samples.Cell-free Mycobacterium tuberculosis DNA(cf-TB)in PE samples is conside...Background:The diagnosis of tuberculous pleurisy(TP)presents a significant challenge due to the low bacterial load in pleural effusion(PE)samples.Cell-free Mycobacterium tuberculosis DNA(cf-TB)in PE samples is considered an optimal biomarker for diagnosing TP.This study aimed to evaluate the applicability of cf-TB testing across diverse research sites with a relatively large sample size.Methods:Patients suspected of TP and presenting with clinical symptoms and radiological evidence of PE were consecutively enrolled by treating physicians from 11 research sites across 6 provinces in China between April 2020 and August 2022.Following centrifugation,sediments obtained from PE were used for Xpert MTB/RIF(Xpert)and mycobacterial culture,while the supernatants were subjected to cf-TB testing.This study employed a composite reference standard to definite TP,which was characterized by any positive result for Mycobacterium tuberculosis(MTB)through either PE culture,PE Xpert,or pleural biopsy.Results:A total of 1412 participants underwent screening,and 1344(95.2%)were subsequently enrolled in this study.Data from 1241(92.3%)participants were included,comprising 284 with definite TP,677 with clinically diagnosed TP,and 280 without TP.The sensitivity of cf-TB testing in definite TP was 73.6%(95%CI 68.2%-78.4%),significantly higher than both Xpert(40.8%,95%CI 35.3%-46.7%,P<0.001)and mycobacterial culture(54.2%,95%CI 48.4%-59.9%,P<0.001).When clinically diagnosed TP was incorporated into the composite reference standard for sensitivity analysis,cf-TB testing showed a sensitivity of 46.8%(450/961,95%CI 43.7%-50.0%),significantly higher than both Xpert(12.1%,116/961,95%CI 10.2%-14.3%,P<0.001)and mycobacterial culture(16.0%,154/961,95%CI 13.8%-18.5%,P<0.001).The specificities of cf-TB testing,Xpert,and mycobacterial culture were all 100.0%.Conclusions:The performance of cf-TB testing is significantly superior to that of Xpert and mycobacterial culture methods,indicating that it can be considered as the primary diagnostic approach for improving TP detection.Trial registration:The trial was registered on Chictr.org.cn(ChiCTR2000031680,https://www.chictr.org.cn/showproj.html?proj=49316).展开更多
BACKGROUND Hepatitis B is a major public health problem in China. Accurate liver injury assessment is essential for clinical evidence-based treatment. Liver biopsy is considered the gold standard method to stage liver...BACKGROUND Hepatitis B is a major public health problem in China. Accurate liver injury assessment is essential for clinical evidence-based treatment. Liver biopsy is considered the gold standard method to stage liver disease, but it is not widely used in resource-limited settings. Therefore, non-invasive liquid biopsy tests are needed. AIM To assess liver injury in hepatitis B patients using quantified cell free DNA combined with other serum biomarker as a liquid biopsy-based method. METHODS A cohort of 663 subjects including 313 hepatitis B patients and 350 healthy controls were enrolled. Ultrasound-guided liver biopsies followed by histopathological assessments were performed for the 263 chronic hepatitis B patients to determine the degree of liver injury. Cell-free DNA was quantified using a novel duplex real-time polymerase chain reaction assay. RESULTS Compared with healthy controls, patients with hepatitis B virus (HBV) infection had significantly higher plasma DNA, serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and HBV DNA levels (P<0.01). Serum ALT, AST, bilirubin, and plasma DNA levels of patients with markedsevere inflammation were significantly higher than those with mild-moderate inflammation (P<0.01). There was a statistically significant correlation between hepatocyte inflammation severity and serum bilirubin (R^2=0.673, P<0.01) or plasma DNA (R^2=0.597, P<0.01) levels. The areas under the curves of serum ALT, bilirubin, plasma DNA, and their combination to distinguish between patients with mild–moderate and marked-severe inflammation were 0.8059, 0.7910, 0.7921, and 0.9564, respectively. CONCLUSION The combination of plasma DNA, serum ALT, and bilirubin could be a candidate liquid biopsy for non-invasive assessment of liver injury in hepatitis B patients.展开更多
Background:Fuzheng Huayu tablet is a traditional Chinese medicine(TCM)used for the treatment of liver fibrosis and cirrhosis.However,whether the combination with Fuzheng Huayu tablet could affect the antiviral efflcac...Background:Fuzheng Huayu tablet is a traditional Chinese medicine(TCM)used for the treatment of liver fibrosis and cirrhosis.However,whether the combination with Fuzheng Huayu tablet could affect the antiviral efflcacy of nucleos(t)ide remains a concern.The objective of this trial was to explore the impact of Fuzheng Huayu tablet on antiviral effect of entecavir in patients with hepatitis B cirrhosis.Methods:A prospective,randomized control trial was conducted.Patients with compensated hepatitis B cirrhosis were randomly divided into the treatment group(entecavir capsule plus Fuzheng Huayu tablet)and the control group(entecavir capsule plus simulant of Fuzheng Huayu),and followed up for 48 weeks.The dynamic changes of HBV DNA load,the rate of serological conversion of HBeAg,liver function,renal function and liver stiffness measurement(LSM)were monitored.The general clinical data and adverse events were also recorded.Results:There was no significant difference in the rate of virological response and cumulative virological response between the treatment group and the control group(P>0.05).After 48 weeks of treatment,the HBeAg seroconversion rate,biochemical response rate and LSM value were 21.05%and 4.76%(P=0.164),86.96%and 65.96%(P=0.017),9.5 kpa and 10.6 kpa(P=0.827)in the treatment group and the control group,respectively.No serious adverse events related to the study therapy occurred during the trial.Conclusions:The antiviral entecavir combined with Fuzheng Huayu tablet did not affect the antiviral efflcacy of entecavir,but could improve the rate of biochemical response,and had a tendency to improve the rate of serological conversion of HBeAg and liver fibrosis in patients with hepatitis B cirrhosis.Fuzheng Huayu tablet is clinically safe for patients with hepatitis B cirrhosis.展开更多
Background:The ultimate goal of hepatitis B treatment is hepatitis B surface antigen(HBsAg)seroclearance.Several factors have been suggested to be associated with the rate of HBsAg reduction in antiviral-naive or lami...Background:The ultimate goal of hepatitis B treatment is hepatitis B surface antigen(HBsAg)seroclearance.Several factors have been suggested to be associated with the rate of HBsAg reduction in antiviral-naive or lamivudine therapy cohorts.However,there are few studies evaluating the factors during long-term entecavir(ETV)therapy.In the present study,we aimed to evaluate the factors to predict the outcome of ETV therapy for 7 years.Methods:A total of 47 chronic hepatitis B(CHB)patients treated with ETV monotherapy were included in this study.Liver biochemistry,hepatitis B virus(HBV)serological markers,serum HBV DNA,and HBsAg titers were tested at baseline,3 months,6 months,and yearly from 1 to 7.The associations between factors and HBsAg reduction were assessed using multivariate tests with repeated measure analysis of variance.Results:At baseline,serum HBsAg levels showed a positive correlation with baseline HBV DNA levels(r=0.625,P〈0.001).The mean HBsAg titers after ETV treatment were significantly lower than the baseline titers(P ranges from 0.025 to 0.000,000,6).The HBsAg reduction rate during the 1st year was greater compared to after 1 year of treatment(P〈0.05).Multivariate test showed that hepatitis B e antigen(HBeAg)seroclearance and/or HBsAg reduction≥0.5 log10 IU/ml at 6 months had a high negative predictive value(96.77%)for HBsAg seroclearance(P=0.002,P=0.012,respectively).Conclusions:The HBsAg reduction rate during the 1st year was greater than that after 1 year of treatment.Further,HBeAg status and HBsAg levels at month 6 are the optimal factors for the early prediction of HBsAg seroclearance after long-term ETV therapy in CHB patients.展开更多
Chronic liver disease(CLD)entails elevated risk of COVID-19 severity and mortality.The effectiveness of the booster dose of inactivated SARS-CoV-2 vaccine in stimulating antibody response in CLD patients is unclear.Th...Chronic liver disease(CLD)entails elevated risk of COVID-19 severity and mortality.The effectiveness of the booster dose of inactivated SARS-CoV-2 vaccine in stimulating antibody response in CLD patients is unclear.Therefore,we conducted a cross-sectional study involving 237 adult CLD patients and 170 healthy controls(HC)to analyze neutralizing antibodies(NAbs)against SARS-CoV-2 prototype and BA.4/5 variant,anti-receptor binding domain(RBD)IgG,and total anti-SARS-CoV-2 antibodies.Serum levels of the total anti-SARS-CoV-2 antibodies,anti-RBD IgG and inhibition efficacy of NAbs were significantly elevated in CLD patients after the booster dose compared with the pre-booster dose,but were relatively lower than those of HCs.Induced humoral responses decreased over time after booster vaccination.The neutralization efficiency of the serum against BA.4/5 increased but remained below the inhibition threshold.All four SARS-CoV-2 antibodies,including total anti-SARS-CoV-2 antibodies,anti-RBD IgG and NAbs against prototype and BA.4/5,were lower in patients with severe CLD than those with non-severe CLD.After booster shot,age and time after the last vaccine were the risk factors for seropositivity of NAb against BA.4/5 in CLD patients.Additionally,white blood cell counts and hepatitis B core antibodies were the protective factors,and severe liver disease was the risk factor associated with seropositivity of total anti-SARS-CoV-2 antibodies.Overall,our data uncovered that antibody responses were improved in CLD patients and peaked at 120 days after the booster vaccines.All antibodies excepting total anti-SARS-CoV-2 antibodies declined after peak.CLD patients exhibited impaired immunologic responses to vaccination and weakened NAbs against BA.4/5,which hindered the protective effect of the booster shot against Omicron prevalence.Cellular immune responses should be further evaluated to determine the optimal vaccine regimen for CLD patients.展开更多
Background and Aims: Chronic hepatitis B virus(HBV)in-fection remains a major public health problem globally.Here,we describe the baseline characteristics and treatment pro-files of HBV-infected patients recruited to ...Background and Aims: Chronic hepatitis B virus(HBV)in-fection remains a major public health problem globally.Here,we describe the baseline characteristics and treatment pro-files of HBV-infected patients recruited to the China Registry of Hepatitis B.Methods: Inclusion criteria were patients with different stages of chronic HBV infection and complete key data.Exclusion criteria were patients with hepatocellular car-cinoma.The baseline clinical,laboratory and treatment pro-files were analyzed.Results: Finally,40,431 patients were included.The median age was 43 years,with 65.2%being men and 51.3%being positive for hepatitis B e antigen(HBeAg).The most common initial diagnosis was chronic hep-atitis B(81.0%),followed by cirrhosis(9.3%),inactive carrier of hepatitis B surface antigen(HBsAg)(6.7%),and immune tolerant phase of hepatitis B infection(3.0%).Among the 21,228 patients who were on treatment,88.0%,10.0%and 2.0%received nucleos(t)ide analogues(NAs),interferon or combination of NAs and interferon,respectively.The propor-tion of patients who received preferred NAs(entecavir or te-nofovir disoproxil fumarate)had increased from 13.5%in 2003 to 79.7%in 2016.Conclusions: We concluded that middle-aged men accounted for most of the patients with chronic hepatitis B in this cross-sectional study.About half of the patients were HBeAg-positive.NAs were the most com-monly used therapy,and use of the preferred NAs had steadily increased in the past decade.展开更多
While some individuals infected by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)present mild-to-severe disease,many SARS-CoV-2-infected individuals are asymptomatic.We sought to identify the distinction ...While some individuals infected by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)present mild-to-severe disease,many SARS-CoV-2-infected individuals are asymptomatic.We sought to identify the distinction of immune response between asymptomatic and moderate patients.We performed single-cell transcriptome and T-cell/B-cell receptor(TCR/BCR)sequencing in 37 longitudinal collected peripheral blood mononuclear cell samples from asymptomatic,moderate,and severe patients with healthy controls.Asymptomatic patients displayed increased CD56^(bri)CD16^(-) natural killer(NK)cells and upregulation of interferon-gamma in effector CD4^(+) and CD8^(+) T cells and NK cells.They showed more robust TCR clonal expansion,especially in effector CD4^(+) T cells,but lack strong BCR clonal expansion compared to moderate patients.Moreover,asymptomatic patients have lower interferon-stimulated genes(ISGs)expression in general but large interpatient variability,whereas moderate patients showed various magnitude and temporal dynamics of the ISGs expression across multiple cell populations but lower than a patient with severe disease.Our data provide evidenee of different immune signatures to SARS-CoV-2 in asymptomatic infections.展开更多
Background:Coronavirus disease 2019(COVID-19),caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2),continues to impose a significant global health burden.Limited data exist regarding antibody response...Background:Coronavirus disease 2019(COVID-19),caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2),continues to impose a significant global health burden.Limited data exist regarding antibody responses to breakthrough infections caused by the Delta and Omicron variants of SARS-CoV-2.This study aimed to compare antibody levels and their relationships with clinical features in patients with breakthrough infections.Methods:Sera from patients with breakthrough infections were analyzed for IgG,IgM,IgA,and neutralizing antibodies(NAbs)using a fully automated chemiluminescence immunoassay analyzer.Antibody levels were then compared and correlated with clinical features.Results:Booster COVID-19 vaccination was associated with higher levels of NAb and IgG in breakthrough-infected individuals(β=0.51,95%confidence interval[CI]:0.12-0.90,andβ=0.84,95%CI:0.35-1.33,respectively).Individuals infected with the Delta variant exhibited higher IgM and IgA levels compared with those infected with the Omicron variant(β=0.80,95%CI:0.46-1.14,and β=0.55,95%CI:0.13-0.98,respectively).The SARS-CoV-2 RNA clearance time was negatively correlated with NAb and IgG levels in Delta infections(correlation coefficient r_(s)=−0.31 and−0.26,respectively)and Omicron infections(r_(s)=−0.29 and−0.32,respectively).Conclusions:Patients with breakthrough infections of the Delta variant exhibited higher IgM and IgA levels than those with breakthrough infections of the Omicron variant.Elevated NAb and IgG levels,associated with booster COVID-19 vaccination,correlated with shorter SARS-CoV-2 RNA clearance times.These findings underscore the enhanced immunogenicity of booster vaccination in mitigating the duration of viral RNA positivity.展开更多
Background and Aims:Data are limited on the use of pegylated-interferon alpha-2a(peg-IFNα)in Chinese patients with chronic hepatitis B virus(HBV)infection(CHB).We evaluated the effectiveness and safety of peg-IFNαin...Background and Aims:Data are limited on the use of pegylated-interferon alpha-2a(peg-IFNα)in Chinese patients with chronic hepatitis B virus(HBV)infection(CHB).We evaluated the effectiveness and safety of peg-IFNαin Chinese patients with hepatitis B envelope antigen-negative CHB in routine clinical practice.Methods:In this prospective,multicenter,observational,non-interventional cohort study,patients were assessed for up to 1 year after peg-IFNαtreatment cessation.Treating physicians established the dosing and treatment duration according to Chinese clinical practice.Effectiveness of peg-IFNαtreatment was measured by the percentage of:patients with HBV DNA<2000 IU/mL and loss of hepatitis B surface antigen(commonly known as HBsAg);HBV DNA level at end of treatment(EOT),and 6 months and 1 year posttreatment;and time course change in quantitative HBV DNA and HBsAg.Results:At EOT,6 months posttreatment,and 1 year posttreatment,the percentage of patients with HBV DNA<2000 IU/mL was 90.0%,81.8%,and 82.2%,and that of patients with HBsAg loss was 6.5%,9.4%,and 9.5%,respectively.The HBV DNA level decreased from 5.61 log IU/mL at baseline to 2.48 log IU/mL at EOT and 2.67 log IU/mL at 1 year posttreatment.The HBsAg level decreased from 3.08 log IU/mL at baseline to 2.24 log IU/mL at EOT and 2.10 log IU/mL at 1 year posttreatment.The incidence of adverse events was 52.0%.Conclusions:Peg-IFNαhas the potential to provide functional cure(HBsAg loss)for CHB and is well tolerated in hepatitis B envelope antigen-negative CHB patients in routine clinical practice in China.展开更多
基金the Scientific Research Foundation of HealthDepartment of Hebei Province,No.20160483
文摘AIM To investigate potential effects of poly I:C on mucosal injury and epithelial barrier disruption in dextran sulfate sodium (DSS)-induced acute colitis. METHODS Thirty C57BL/6 mice were given either regular drinking water (control group) or 2% (w/v) DSS drinking water (model and poly I:C groups) ad libitum for 7 d. Poly I:C was administrated subcutaneously (20 mu g/mouse) 2 h prior to DSS induction in mice of the poly I:C group. Severity of colitis was evaluated by disease activity index, body weight, colon length, histology and myeloperoxidase (MPO) activity, as well as the production of proinflammatory cytokines, including tumor necrosis factor-a (TNF-alpha), interleukin 17 (IL-17) and interferon-. (IFN-gamma). Intestinal permeability was analyzed by the fluorescein isothiocyanate labeled-dextran (FITC-D) method. Ultrastructural features of the colon tissue were observed under electron microscopy. Expressions of tight junction (TJ) proteins, including zo-1, occludin and claudin-1, were measured by immunohistochemistry/immunofluorescence, Western blot and real-time quantitative polymerase chain reaction (RT-qPCR). RESULTS DSS caused significant damage to the colon tissue in the model group. Administration of poly I:C dramatically protected against DSS-induced colitis, as demonstrated by less body weight loss, lower disease activity index score, longer colon length, colonic MPO activity, and improved macroscopic and histological scores. It also ameliorated DSS-induced ultrastructural changes of the colon epithelium, as observed under scanning electron microscopy, as well as FITC-D permeability. The mRNA and protein expressions of TJ protein, zo-1, occludin and claudin-1 were also found to be significantly enhanced in the poly I:C group, as determined by immunohistochemistry/immunofluorescence, Western blot and RT-qPCR. By contrast, poly I:C pretreatment markedly reversed the DSS-induced up-regulated expressions of the inflammatory cytokines TNF-alpha, IL-17 and IFN-gamma. CONCLUSION Our study suggested that poly I:C may protect against DSS-induced colitis through maintaining integrity of the epithelial barrier and regulating innate immune responses, which may shed light on the therapeutic potential of poly I:C in human colitis.
文摘Objective: The objective is to evaluate the effectiveness of chemotherapy as postoperative adjuvant therapy for stage IB-IIB cervical cancer with intermediate-risk factors. Methods: We retrospectively reviewed the medical records of 119 cervical cancer patients with intermediate-risk factors treated with radical hysterectomy and pelvic lymphadenectomy from December 1997 to September 2010. The intermediate-risk factors included bulky tumor (≥4 cm), lymphovascular space invasion, and deep stromal invasion. Sixteen patients did not receive adjuvant therapy (observation group);73 were treated with chemotherapy (CT group);30 were treated with adjuvant radiation therapy (RT group). The significance of the clinical parameters, 3- and 5-year overall survival (OS) rates of each group, was analyzed. Results: The 3- and 5-year OS rates between the observation group and adjuvant therapy group (CT plus RT groups) were not statistically different (3-year OS: 100% and 94.4%, respectively;5-year OS: 100% and 92.3%, respectively;p > 0.05). The 3- and 5-year OS rates between the CT group and RT group were also not statistically different (3-year OS: 93.6% and 96.4%, respectively;5-year OS: 80.7% and 96.4%, respectively;p < 0.05). Univariate and multivariate analysis of survival indicated that different adjuvant therapies were not independent prognostic indicators for IB-IIB cervical cancer patients with intermediate-risk factors. Conclusions: CT may have equivalent therapeutic effect as RT for stage IB-IIB cervical cancer patients with intermediate-risk factors after radical surgery, and prospective randomized trial is needed to study the effect of CT in these patients.
基金supported by grant from the International Science&Technology Cooperation Program of China(No.2014DFR31200)the National Infrastructure of Chinese Genetic Resources(YCZYPT[2017]01-6)+1 种基金federal funds from the National Cancer Institute,National Institutes of Health,USA(No.N01-CO12400)the National Natural Science Foundation of China(No.30671855)。
文摘Some patients with chronic hepatitis B virus(HBV)infection failed to clear HBV,even persistently continue to produce antibodies to HBV.Here we performed a two stage genome wide association study in a cohort of Chinese patients designed to discover single nucleotide variants that associate with HBV infection and clearance of HBV.The first stage involved genome wide exome sequencing of 101 cases(HBsAg plus anti-HBs positive)compared with 102 control patients(antiHBs positive,HBsAg negative).Over 80%of individual sequences displayed 209 sequence coverage.Adapters,uncertain bases[10%or low-quality base calls([50%)were filtered and compared to the human reference genome hg19.In the second stage,579 chronic HBV infected cases and 439 HBV clearance controls were sequenced with selected genes from the first stage.Although there were no significant associated gene variants in the first stage,two significant gene associations were discovered when the two stages were assessed in a combined analysis.One association showed rs506121-“T”allele[within the dedicator of cytokinesis 8(DOCK8)gene]was higher in chronic HBV infection group than that in clearance group(P=0.002,OR=0.77,95%CI[0.65,0.91]).The second association involved rs2071676—A allele within the Carbonic anhydrase(CA9)gene that was significantly elevated in chronic HBV infection group compared to the clearance group(P=0.0003,OR=1.35,95%CI[1.15,1.58]).Upon replication these gene associations would suggest the influence of DOCK8 and CA9 as potential risk genetic factors in the persistence of HBV infection.
基金Supported by The Ministry of Science and Technology of China for the National Five-Year Key Projects in Infectious Diseases,No. 2015ZX10004801
文摘BACKGROUND Data that assess maternal and infant outcomes in hepatitis C virus(HCV)-infected mothers are limited.AIM To investigate the frequency of complications and the associated risk factors.METHODS We performed a cohort study to compare pregnancy and fetal outcomes of HCVviremic mothers with those of healthy mothers.Risk factors were analyzed with logistic regression.RESULTS Among 112 consecutive HCV antibody-positive mothers screened,we enrolled 79 viremic mothers.We randomly selected 115 healthy mothers from the birth registry as the control.Compared to healthy mothers,HCV mothers had a significantly higher frequency of anemia[2.6%(3/115)vs 19.0%(15/79),P<0.001]during pregnancy,medical conditions that required caesarian section[27.8%(32/115)vs 48.1%(38/79),P=0.004],and nuchal cords[9.6%(11/115)vs 34.2%(27/79),P<0.001].In addition,the mean neonatal weight in the HCV group was significantly lower(3278.3±462.0 vs 3105.1±459.4 gms;P=0.006),and the mean head circumference was smaller(33.3±0.6 vs 33.1±0.7 cm;P=0.03).In a multivariate model,HCV-infected mothers were more likely to suffer anemia[adjusted odds ratio(OR):18.1,95%confidence interval(CI):4.3-76.6],require caesarian sections(adjusted OR:2.6,95%CI:1.4-4.9),and have nuchal cords(adjusted OR:5.6,95%CI:2.4-13.0).Their neonates were also more likely to have smaller head circumferences(adjusted OR:2.1,95%CI:1.1-4.3)and lower birth weights than the average(≤3250 gms)with an adjusted OR of 2.2(95%CI:1.2-4.0).The vertical transmission rate was 1%in HCV-infected mothers.CONCLUSION Maternal HCV infections may associate with pregnancy and obstetric complications.We demonstrated a previously unreported association between maternal HCV viremia and a smaller neonatal head circumference,suggesting fetal growth restriction.
文摘Objective:To explore the effect of hydromorphone hydrochloride postoperative analgesia on the inflammatory cytokines, S-100β, and NSE in elderly patients after total hip replacement (THR).Methods: A total of 100 patients who were admitted in our hospital from January, 2015 to July, 2016 for THR were included in the study and randomized into the observation group and the control group with 50 cases in each group. After operation, the patients in the two groups were immediately given patient-controlled analgesia. The patients in the observation group were given hydromorphone hydrochloride (0.3 mg) + dexamethasone (5 mg) + normal saline (100 mL), while the patients in the control group were given sufentanil (150 μg) + dexamethasone (5 mg) + normal saline (100 mL). The morning fasting peripheral venous blood before operation, 24 h and 3 d after operation in the two groups was collected. ELISA was used to detect the serum CRP, IL-6, and TNF-α, and the plasma S-100β and NSE levels.Results:The serum CRP, TNF-α, and IL-6 levels 24 h and 3 d after operation in the two groups were significantly elevated when compared with before operation, and were reduced 3d after operation. CRP, TNF-α, and IL-6 levels at each timing point after operation in the observation group were significantly lower than those in the control group. The plasma S-100βand NSE levels 24 h and 3 d after operation in the two groups were significantly elevated when compared with before operation, and were reduced 3 d after operation. The plasma S-100β and NSE levels at each timing point after operation in the observation group were significantly lower than those in the control group.Conclusions:Hydromorphone hydrochloride can relieve the postoperative pain in elderly patients with THR, effectively alleviate the inflammatory reaction, reduce the plasma S-100β and NSE levels, and alleviate the cerebral injury, whose pathogenesis remains a further deep study.
基金supported by the Beijing Municipal Science and Technology Project(Z191100006619079)the General Program of the National Natural Science Foundation of China(82072381).
文摘Background:The diagnosis of tuberculous pleurisy(TP)presents a significant challenge due to the low bacterial load in pleural effusion(PE)samples.Cell-free Mycobacterium tuberculosis DNA(cf-TB)in PE samples is considered an optimal biomarker for diagnosing TP.This study aimed to evaluate the applicability of cf-TB testing across diverse research sites with a relatively large sample size.Methods:Patients suspected of TP and presenting with clinical symptoms and radiological evidence of PE were consecutively enrolled by treating physicians from 11 research sites across 6 provinces in China between April 2020 and August 2022.Following centrifugation,sediments obtained from PE were used for Xpert MTB/RIF(Xpert)and mycobacterial culture,while the supernatants were subjected to cf-TB testing.This study employed a composite reference standard to definite TP,which was characterized by any positive result for Mycobacterium tuberculosis(MTB)through either PE culture,PE Xpert,or pleural biopsy.Results:A total of 1412 participants underwent screening,and 1344(95.2%)were subsequently enrolled in this study.Data from 1241(92.3%)participants were included,comprising 284 with definite TP,677 with clinically diagnosed TP,and 280 without TP.The sensitivity of cf-TB testing in definite TP was 73.6%(95%CI 68.2%-78.4%),significantly higher than both Xpert(40.8%,95%CI 35.3%-46.7%,P<0.001)and mycobacterial culture(54.2%,95%CI 48.4%-59.9%,P<0.001).When clinically diagnosed TP was incorporated into the composite reference standard for sensitivity analysis,cf-TB testing showed a sensitivity of 46.8%(450/961,95%CI 43.7%-50.0%),significantly higher than both Xpert(12.1%,116/961,95%CI 10.2%-14.3%,P<0.001)and mycobacterial culture(16.0%,154/961,95%CI 13.8%-18.5%,P<0.001).The specificities of cf-TB testing,Xpert,and mycobacterial culture were all 100.0%.Conclusions:The performance of cf-TB testing is significantly superior to that of Xpert and mycobacterial culture methods,indicating that it can be considered as the primary diagnostic approach for improving TP detection.Trial registration:The trial was registered on Chictr.org.cn(ChiCTR2000031680,https://www.chictr.org.cn/showproj.html?proj=49316).
基金the National Natural Science Foundation of China,No.81672100 and No.81371894the Key Laboratory for Laboratory Medicine of Jiangsu Province of China,No.ZDXKB2016005Jiangsu Provincial Commission of Health and Family Planning,No.H201609
文摘BACKGROUND Hepatitis B is a major public health problem in China. Accurate liver injury assessment is essential for clinical evidence-based treatment. Liver biopsy is considered the gold standard method to stage liver disease, but it is not widely used in resource-limited settings. Therefore, non-invasive liquid biopsy tests are needed. AIM To assess liver injury in hepatitis B patients using quantified cell free DNA combined with other serum biomarker as a liquid biopsy-based method. METHODS A cohort of 663 subjects including 313 hepatitis B patients and 350 healthy controls were enrolled. Ultrasound-guided liver biopsies followed by histopathological assessments were performed for the 263 chronic hepatitis B patients to determine the degree of liver injury. Cell-free DNA was quantified using a novel duplex real-time polymerase chain reaction assay. RESULTS Compared with healthy controls, patients with hepatitis B virus (HBV) infection had significantly higher plasma DNA, serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and HBV DNA levels (P<0.01). Serum ALT, AST, bilirubin, and plasma DNA levels of patients with markedsevere inflammation were significantly higher than those with mild-moderate inflammation (P<0.01). There was a statistically significant correlation between hepatocyte inflammation severity and serum bilirubin (R^2=0.673, P<0.01) or plasma DNA (R^2=0.597, P<0.01) levels. The areas under the curves of serum ALT, bilirubin, plasma DNA, and their combination to distinguish between patients with mild–moderate and marked-severe inflammation were 0.8059, 0.7910, 0.7921, and 0.9564, respectively. CONCLUSION The combination of plasma DNA, serum ALT, and bilirubin could be a candidate liquid biopsy for non-invasive assessment of liver injury in hepatitis B patients.
基金supported by grants from the Beijing Municipal Science and Technology Project of Traditional Chinese Medicine(JJ2014-25)the Capital Funds for Health Improvement and Research(CFH-2018-2-2173 and CFH-2020-1-2171)。
文摘Background:Fuzheng Huayu tablet is a traditional Chinese medicine(TCM)used for the treatment of liver fibrosis and cirrhosis.However,whether the combination with Fuzheng Huayu tablet could affect the antiviral efflcacy of nucleos(t)ide remains a concern.The objective of this trial was to explore the impact of Fuzheng Huayu tablet on antiviral effect of entecavir in patients with hepatitis B cirrhosis.Methods:A prospective,randomized control trial was conducted.Patients with compensated hepatitis B cirrhosis were randomly divided into the treatment group(entecavir capsule plus Fuzheng Huayu tablet)and the control group(entecavir capsule plus simulant of Fuzheng Huayu),and followed up for 48 weeks.The dynamic changes of HBV DNA load,the rate of serological conversion of HBeAg,liver function,renal function and liver stiffness measurement(LSM)were monitored.The general clinical data and adverse events were also recorded.Results:There was no significant difference in the rate of virological response and cumulative virological response between the treatment group and the control group(P>0.05).After 48 weeks of treatment,the HBeAg seroconversion rate,biochemical response rate and LSM value were 21.05%and 4.76%(P=0.164),86.96%and 65.96%(P=0.017),9.5 kpa and 10.6 kpa(P=0.827)in the treatment group and the control group,respectively.No serious adverse events related to the study therapy occurred during the trial.Conclusions:The antiviral entecavir combined with Fuzheng Huayu tablet did not affect the antiviral efflcacy of entecavir,but could improve the rate of biochemical response,and had a tendency to improve the rate of serological conversion of HBeAg and liver fibrosis in patients with hepatitis B cirrhosis.Fuzheng Huayu tablet is clinically safe for patients with hepatitis B cirrhosis.
基金This study was supported by the grants from the 12th Five-Year Plan,the National Natural Science Foundation of China,the Beijing Municipal Science and Technology Commission of Major Projects
文摘Background:The ultimate goal of hepatitis B treatment is hepatitis B surface antigen(HBsAg)seroclearance.Several factors have been suggested to be associated with the rate of HBsAg reduction in antiviral-naive or lamivudine therapy cohorts.However,there are few studies evaluating the factors during long-term entecavir(ETV)therapy.In the present study,we aimed to evaluate the factors to predict the outcome of ETV therapy for 7 years.Methods:A total of 47 chronic hepatitis B(CHB)patients treated with ETV monotherapy were included in this study.Liver biochemistry,hepatitis B virus(HBV)serological markers,serum HBV DNA,and HBsAg titers were tested at baseline,3 months,6 months,and yearly from 1 to 7.The associations between factors and HBsAg reduction were assessed using multivariate tests with repeated measure analysis of variance.Results:At baseline,serum HBsAg levels showed a positive correlation with baseline HBV DNA levels(r=0.625,P〈0.001).The mean HBsAg titers after ETV treatment were significantly lower than the baseline titers(P ranges from 0.025 to 0.000,000,6).The HBsAg reduction rate during the 1st year was greater compared to after 1 year of treatment(P〈0.05).Multivariate test showed that hepatitis B e antigen(HBeAg)seroclearance and/or HBsAg reduction≥0.5 log10 IU/ml at 6 months had a high negative predictive value(96.77%)for HBsAg seroclearance(P=0.002,P=0.012,respectively).Conclusions:The HBsAg reduction rate during the 1st year was greater than that after 1 year of treatment.Further,HBeAg status and HBsAg levels at month 6 are the optimal factors for the early prediction of HBsAg seroclearance after long-term ETV therapy in CHB patients.
基金This work was supported by the Beijing Natural Science Foundation(M23008)the National Key Research and Development Program of China(2018YFE0207300)+2 种基金Beijing Municipal Science&Technology Commission(Z211100002521021)the National High Level Hospital Clinical Research Funding(2022-PUMCH-B-124)Key Research and Development Plan of Hebei Province,Special Health Innovation Project(22377744D).
文摘Chronic liver disease(CLD)entails elevated risk of COVID-19 severity and mortality.The effectiveness of the booster dose of inactivated SARS-CoV-2 vaccine in stimulating antibody response in CLD patients is unclear.Therefore,we conducted a cross-sectional study involving 237 adult CLD patients and 170 healthy controls(HC)to analyze neutralizing antibodies(NAbs)against SARS-CoV-2 prototype and BA.4/5 variant,anti-receptor binding domain(RBD)IgG,and total anti-SARS-CoV-2 antibodies.Serum levels of the total anti-SARS-CoV-2 antibodies,anti-RBD IgG and inhibition efficacy of NAbs were significantly elevated in CLD patients after the booster dose compared with the pre-booster dose,but were relatively lower than those of HCs.Induced humoral responses decreased over time after booster vaccination.The neutralization efficiency of the serum against BA.4/5 increased but remained below the inhibition threshold.All four SARS-CoV-2 antibodies,including total anti-SARS-CoV-2 antibodies,anti-RBD IgG and NAbs against prototype and BA.4/5,were lower in patients with severe CLD than those with non-severe CLD.After booster shot,age and time after the last vaccine were the risk factors for seropositivity of NAb against BA.4/5 in CLD patients.Additionally,white blood cell counts and hepatitis B core antibodies were the protective factors,and severe liver disease was the risk factor associated with seropositivity of total anti-SARS-CoV-2 antibodies.Overall,our data uncovered that antibody responses were improved in CLD patients and peaked at 120 days after the booster vaccines.All antibodies excepting total anti-SARS-CoV-2 antibodies declined after peak.CLD patients exhibited impaired immunologic responses to vaccination and weakened NAbs against BA.4/5,which hindered the protective effect of the booster shot against Omicron prevalence.Cellular immune responses should be further evaluated to determine the optimal vaccine regimen for CLD patients.
文摘Background and Aims: Chronic hepatitis B virus(HBV)in-fection remains a major public health problem globally.Here,we describe the baseline characteristics and treatment pro-files of HBV-infected patients recruited to the China Registry of Hepatitis B.Methods: Inclusion criteria were patients with different stages of chronic HBV infection and complete key data.Exclusion criteria were patients with hepatocellular car-cinoma.The baseline clinical,laboratory and treatment pro-files were analyzed.Results: Finally,40,431 patients were included.The median age was 43 years,with 65.2%being men and 51.3%being positive for hepatitis B e antigen(HBeAg).The most common initial diagnosis was chronic hep-atitis B(81.0%),followed by cirrhosis(9.3%),inactive carrier of hepatitis B surface antigen(HBsAg)(6.7%),and immune tolerant phase of hepatitis B infection(3.0%).Among the 21,228 patients who were on treatment,88.0%,10.0%and 2.0%received nucleos(t)ide analogues(NAs),interferon or combination of NAs and interferon,respectively.The propor-tion of patients who received preferred NAs(entecavir or te-nofovir disoproxil fumarate)had increased from 13.5%in 2003 to 79.7%in 2016.Conclusions: We concluded that middle-aged men accounted for most of the patients with chronic hepatitis B in this cross-sectional study.About half of the patients were HBeAg-positive.NAs were the most com-monly used therapy,and use of the preferred NAs had steadily increased in the past decade.
基金supported by grants from the Beijing Natural Science Foundation(L202038)the Natural Science Foundation of China(81773494,81621005)the Emergency Science and Technology Project for Prevention and Control of COVID-19(20277734D).
文摘While some individuals infected by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)present mild-to-severe disease,many SARS-CoV-2-infected individuals are asymptomatic.We sought to identify the distinction of immune response between asymptomatic and moderate patients.We performed single-cell transcriptome and T-cell/B-cell receptor(TCR/BCR)sequencing in 37 longitudinal collected peripheral blood mononuclear cell samples from asymptomatic,moderate,and severe patients with healthy controls.Asymptomatic patients displayed increased CD56^(bri)CD16^(-) natural killer(NK)cells and upregulation of interferon-gamma in effector CD4^(+) and CD8^(+) T cells and NK cells.They showed more robust TCR clonal expansion,especially in effector CD4^(+) T cells,but lack strong BCR clonal expansion compared to moderate patients.Moreover,asymptomatic patients have lower interferon-stimulated genes(ISGs)expression in general but large interpatient variability,whereas moderate patients showed various magnitude and temporal dynamics of the ISGs expression across multiple cell populations but lower than a patient with severe disease.Our data provide evidenee of different immune signatures to SARS-CoV-2 in asymptomatic infections.
基金funded by the Key Research and Development Program of Hebei Province(Grant number:22377744D)the Research and Development Program of Shijiazhuang Science and Technology(Grant number:211200443).
文摘Background:Coronavirus disease 2019(COVID-19),caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2),continues to impose a significant global health burden.Limited data exist regarding antibody responses to breakthrough infections caused by the Delta and Omicron variants of SARS-CoV-2.This study aimed to compare antibody levels and their relationships with clinical features in patients with breakthrough infections.Methods:Sera from patients with breakthrough infections were analyzed for IgG,IgM,IgA,and neutralizing antibodies(NAbs)using a fully automated chemiluminescence immunoassay analyzer.Antibody levels were then compared and correlated with clinical features.Results:Booster COVID-19 vaccination was associated with higher levels of NAb and IgG in breakthrough-infected individuals(β=0.51,95%confidence interval[CI]:0.12-0.90,andβ=0.84,95%CI:0.35-1.33,respectively).Individuals infected with the Delta variant exhibited higher IgM and IgA levels compared with those infected with the Omicron variant(β=0.80,95%CI:0.46-1.14,and β=0.55,95%CI:0.13-0.98,respectively).The SARS-CoV-2 RNA clearance time was negatively correlated with NAb and IgG levels in Delta infections(correlation coefficient r_(s)=−0.31 and−0.26,respectively)and Omicron infections(r_(s)=−0.29 and−0.32,respectively).Conclusions:Patients with breakthrough infections of the Delta variant exhibited higher IgM and IgA levels than those with breakthrough infections of the Omicron variant.Elevated NAb and IgG levels,associated with booster COVID-19 vaccination,correlated with shorter SARS-CoV-2 RNA clearance times.These findings underscore the enhanced immunogenicity of booster vaccination in mitigating the duration of viral RNA positivity.
基金The authors wish to thank all of the investigators and participating study sites,which are listed in Supplemental Table 1,as well as all the patients who participated in this studyThe authors also wish to thank Michelle Belanger,MD,of Edanz Medical Writing for providing medical writing assistance,which was funded by Shanghai Roche Pharmaceuticals Ltd.The study was funded by Shanghai Roche Pharmaceuticals Ltd
文摘Background and Aims:Data are limited on the use of pegylated-interferon alpha-2a(peg-IFNα)in Chinese patients with chronic hepatitis B virus(HBV)infection(CHB).We evaluated the effectiveness and safety of peg-IFNαin Chinese patients with hepatitis B envelope antigen-negative CHB in routine clinical practice.Methods:In this prospective,multicenter,observational,non-interventional cohort study,patients were assessed for up to 1 year after peg-IFNαtreatment cessation.Treating physicians established the dosing and treatment duration according to Chinese clinical practice.Effectiveness of peg-IFNαtreatment was measured by the percentage of:patients with HBV DNA<2000 IU/mL and loss of hepatitis B surface antigen(commonly known as HBsAg);HBV DNA level at end of treatment(EOT),and 6 months and 1 year posttreatment;and time course change in quantitative HBV DNA and HBsAg.Results:At EOT,6 months posttreatment,and 1 year posttreatment,the percentage of patients with HBV DNA<2000 IU/mL was 90.0%,81.8%,and 82.2%,and that of patients with HBsAg loss was 6.5%,9.4%,and 9.5%,respectively.The HBV DNA level decreased from 5.61 log IU/mL at baseline to 2.48 log IU/mL at EOT and 2.67 log IU/mL at 1 year posttreatment.The HBsAg level decreased from 3.08 log IU/mL at baseline to 2.24 log IU/mL at EOT and 2.10 log IU/mL at 1 year posttreatment.The incidence of adverse events was 52.0%.Conclusions:Peg-IFNαhas the potential to provide functional cure(HBsAg loss)for CHB and is well tolerated in hepatitis B envelope antigen-negative CHB patients in routine clinical practice in China.
