BACKGROUND The diagnosis of primary biliary cholangitis(PBC)remains challenging,particularly in cases where anti-mitochondrial antibody(AMA),anti-mitochondrial E2 subunit antibody(AMA-M2),anti-glycoprotein 210(anti-gp...BACKGROUND The diagnosis of primary biliary cholangitis(PBC)remains challenging,particularly in cases where anti-mitochondrial antibody(AMA),anti-mitochondrial E2 subunit antibody(AMA-M2),anti-glycoprotein 210(anti-gp210),and anti-speckled protein 100(anti-Sp100)are all negative.In such instances,the condition is often confirmed through a liver needle biopsy.AIM To identify additional plasma biomarkers for non-invasive diagnostic methods of PBC.METHODS We utilized the Sengenics KREX^(TM)immunome protein array to identify potential biomarkers for the diagnosis of PBC.Subsequently,we validated the predictive capability of the RPL30 antibody through an ELISA and retrospectively analyzed its association with the clinical features of 17 autoantibody-negative PBC cases and 45 autoantibody-positive PBC cases.RESULTS In our study we observed that RPL30 demonstrated the highest fold-change difference in PBC,with a penetrance frequency of 40%and a penetrance fold change of 38.30147.The analysis of anti-RPL30 optical density values between patients with AMA/AMA-M2/anti-gp210/anti-Sp100-negative PBC(autoantibody-negative PBC)and healthy controls using a receiver operating characteristic curve yielded an area under the curve of 0.853.This analysis established an optimal cutoff value of 0.0708,achieving 100%specificity and 75%sensitivity.The combination of anti-RPL30 and other autoantibodies elevated the diagnosis rate of PBC from 61.29%to 79.00%(P=0.0489).Anti-RPL30 demonstrated a high positive rate in antibody-negative PBC cases,including AMA/AMAM2/anti-gp210/anti-Sp100-negative cases.Correlation analysis of anti-RPL30 optical density values with clinical data from patients with PBC revealed a positive association with both the international normalized ratio(P=0.008)and the Model for End-Stage Liver Disease score(P=0.003).CONCLUSION Our study highlighted the potential of anti-RPL30 as a promising biomarker for diagnosing PBC,particularly in autoantibody-negative cases.展开更多
The objective of this study was to prepare tamsulosin hydrochloride-sustained release(TSH-SR)pellets which showed good release stability with frame-controlled method.TSH was added to Eudragit~?NE30D and Eudragit~?L30D...The objective of this study was to prepare tamsulosin hydrochloride-sustained release(TSH-SR)pellets which showed good release stability with frame-controlled method.TSH was added to Eudragit~?NE30D and Eudragit~?L30D-55 polymers to form drug-loaded inner core.Afterwards,enteric Eudragit~?L30D-55 polymer was modified on the surface of it to the final product.Dissolution studies showed that TSH-SR pellets were more stable during the coating process,different curing temperatures and storage conditions compared with TSH pellets produced by film-controlled technique.Appearances and glass transition temperatures(Tgs)of free films and surface morphologies observed by scanning electron microscopy(SEM)of blank sustained release pellets prepared by different ratios of Eudragit~?NE30D and Eudragit~?L30D-55 further indicated that temperature and relative humidity(RH)were the key factors when Eudragit~?NE30D blended with Eudragit~?L30D-55 were applied to sustained/controlled release preparations.In addition,SEM identified the surface morphologies of TSH-SR pellets before and after dissolution,which showed intact surface structure and great correlation with release curve respectively.展开更多
基金Supported by National Natural Science Foundation of China,No.82172257Health Care Major Project of Guangzhou,No.202206080001Science and Technology Cooperation Program of Fujian Province,No.2021I0036。
文摘BACKGROUND The diagnosis of primary biliary cholangitis(PBC)remains challenging,particularly in cases where anti-mitochondrial antibody(AMA),anti-mitochondrial E2 subunit antibody(AMA-M2),anti-glycoprotein 210(anti-gp210),and anti-speckled protein 100(anti-Sp100)are all negative.In such instances,the condition is often confirmed through a liver needle biopsy.AIM To identify additional plasma biomarkers for non-invasive diagnostic methods of PBC.METHODS We utilized the Sengenics KREX^(TM)immunome protein array to identify potential biomarkers for the diagnosis of PBC.Subsequently,we validated the predictive capability of the RPL30 antibody through an ELISA and retrospectively analyzed its association with the clinical features of 17 autoantibody-negative PBC cases and 45 autoantibody-positive PBC cases.RESULTS In our study we observed that RPL30 demonstrated the highest fold-change difference in PBC,with a penetrance frequency of 40%and a penetrance fold change of 38.30147.The analysis of anti-RPL30 optical density values between patients with AMA/AMA-M2/anti-gp210/anti-Sp100-negative PBC(autoantibody-negative PBC)and healthy controls using a receiver operating characteristic curve yielded an area under the curve of 0.853.This analysis established an optimal cutoff value of 0.0708,achieving 100%specificity and 75%sensitivity.The combination of anti-RPL30 and other autoantibodies elevated the diagnosis rate of PBC from 61.29%to 79.00%(P=0.0489).Anti-RPL30 demonstrated a high positive rate in antibody-negative PBC cases,including AMA/AMAM2/anti-gp210/anti-Sp100-negative cases.Correlation analysis of anti-RPL30 optical density values with clinical data from patients with PBC revealed a positive association with both the international normalized ratio(P=0.008)and the Model for End-Stage Liver Disease score(P=0.003).CONCLUSION Our study highlighted the potential of anti-RPL30 as a promising biomarker for diagnosing PBC,particularly in autoantibody-negative cases.
文摘The objective of this study was to prepare tamsulosin hydrochloride-sustained release(TSH-SR)pellets which showed good release stability with frame-controlled method.TSH was added to Eudragit~?NE30D and Eudragit~?L30D-55 polymers to form drug-loaded inner core.Afterwards,enteric Eudragit~?L30D-55 polymer was modified on the surface of it to the final product.Dissolution studies showed that TSH-SR pellets were more stable during the coating process,different curing temperatures and storage conditions compared with TSH pellets produced by film-controlled technique.Appearances and glass transition temperatures(Tgs)of free films and surface morphologies observed by scanning electron microscopy(SEM)of blank sustained release pellets prepared by different ratios of Eudragit~?NE30D and Eudragit~?L30D-55 further indicated that temperature and relative humidity(RH)were the key factors when Eudragit~?NE30D blended with Eudragit~?L30D-55 were applied to sustained/controlled release preparations.In addition,SEM identified the surface morphologies of TSH-SR pellets before and after dissolution,which showed intact surface structure and great correlation with release curve respectively.
