1.Research Progress on the Clinical Efficacy and Safety of Telitacicept in the Treatment of IgA Nephropathy
Jiangman SONG ; Xuelin SUN ; Zhe XU ; Li ZHENG
Medical Journal of Peking Union Medical College Hospital 2025;16(6):1413-1418
Immunoglobulin A nephropathy (IgAN) is the most common primary glomerular disease worldwide, accounting for 20%-40% of primary glomerulonephritis cases. Approximately 40% of patients progress to end-stage renal disease within 20 years. Traditional treatments primarily involve renin-angiotensin system inhibitors and glucocorticoids, but some patients show limited response and face infection risks. In recent years, the dual-target biologic agent Telitacicept, which targets B cell-activating factor/B lymphocyte stimulator(BAFF/BLyS) and a proliferation-inducing ligand (APRIL), has demonstrated significant potentialin the treatment of IgAN. By simultaneously neutralizing BAFF/BLyS and APRIL, Telitacicept suppresses abnormal B-cell activation and the production of pathogenic IgA1, significantly reducing urinary protein levels and preserving renal function. This article systematically reviews its mechanism of action, clinical efficacy, and safety, aiming to provide insights for the clinical management of IgAN.
2.Application of Cystatin C International Primary and National Secondary Reference Materials in Dissemination of Quantity Value for Seven Routine Detection Reagent Systems in Clinical Laboratories
Jiangman SUN ; Min LI ; Xiangzhao MENG ; Hongyuan YU ; Baorong CHEN ; Yan SHAO
Journal of Modern Laboratory Medicine 2025;40(5):189-193
Objective To evaluate the application of Cystatin C(Cys C)international primary reference material and national secondary reference materials for quantity transfer in seven conventional systems.Methods Seven Cys C reagents from different manufacturers commonly used in clinical laboratories were used to simultaneously measure two standard substances[ERM-DA471/IFCC,GBW(E)091173~6]and 42 individual serum samples.The theoretical and measured values of the standard substances were linearly fitted,and the measured values of the single serum samples were substituted into the fitting equation to obtain the calibrated values,and the measured values and calibrated values were compared with CLSI EP9-A3 file.Results The theoretical and measured values of ERM-DA471/IFCC and GBW(E)091173~6 were linearly fitted,and the regression equations were Y=0.941X+0.159,Y=0.963X+0.162,respectively,with correlation coefficients of 1.000(taking system B as an example).All system analysis models were analyzed using Passing-Bablok regression analysis.The comparison bias between the calibration values and measurement values of two standards in seven systems were-20.38%~10.58%and-16.76%~9.90%,respectively,with the same bias trend.The comparison bias of the calibrated values of the two standard substances was-4.18%~2.31%.The calibration of the standards had a significant improvement for the bias between calibration value and measurement value exceeding±4%.The bias of the measured values in the pairwise combinations of each system at each medical decision level was-17.87%~14.97%and the bias range of GBW(E)091173~6 calibration values at each medical decision level was-4.96%~4.51%,with most values being less than 3%.The bias of ERM-DA471/IFCC calibration values was-3.92%~6.30%,with most values being less than 4%.Among them,the most common situation was that the bias of ERM-DA471/IFCC calibration value was less than that of measurement value,and the bias of GBW(E)091173~6 calibration value was less than that of ERM-DA471/IFCC calibration value,with 51.19%(43/84)of the comparison bias bata at the level of medical decisionmaking.Conclusion Both reference materials can improve the alignment bias of conventional system,and GBW(E)091173~6 calibration effect is better than ERM-DA471/IFCC.
3.Application of Cystatin C International Primary and National Secondary Reference Materials in Dissemination of Quantity Value for Seven Routine Detection Reagent Systems in Clinical Laboratories
Jiangman SUN ; Min LI ; Xiangzhao MENG ; Hongyuan YU ; Baorong CHEN ; Yan SHAO
Journal of Modern Laboratory Medicine 2025;40(5):189-193
Objective To evaluate the application of Cystatin C(Cys C)international primary reference material and national secondary reference materials for quantity transfer in seven conventional systems.Methods Seven Cys C reagents from different manufacturers commonly used in clinical laboratories were used to simultaneously measure two standard substances[ERM-DA471/IFCC,GBW(E)091173~6]and 42 individual serum samples.The theoretical and measured values of the standard substances were linearly fitted,and the measured values of the single serum samples were substituted into the fitting equation to obtain the calibrated values,and the measured values and calibrated values were compared with CLSI EP9-A3 file.Results The theoretical and measured values of ERM-DA471/IFCC and GBW(E)091173~6 were linearly fitted,and the regression equations were Y=0.941X+0.159,Y=0.963X+0.162,respectively,with correlation coefficients of 1.000(taking system B as an example).All system analysis models were analyzed using Passing-Bablok regression analysis.The comparison bias between the calibration values and measurement values of two standards in seven systems were-20.38%~10.58%and-16.76%~9.90%,respectively,with the same bias trend.The comparison bias of the calibrated values of the two standard substances was-4.18%~2.31%.The calibration of the standards had a significant improvement for the bias between calibration value and measurement value exceeding±4%.The bias of the measured values in the pairwise combinations of each system at each medical decision level was-17.87%~14.97%and the bias range of GBW(E)091173~6 calibration values at each medical decision level was-4.96%~4.51%,with most values being less than 3%.The bias of ERM-DA471/IFCC calibration values was-3.92%~6.30%,with most values being less than 4%.Among them,the most common situation was that the bias of ERM-DA471/IFCC calibration value was less than that of measurement value,and the bias of GBW(E)091173~6 calibration value was less than that of ERM-DA471/IFCC calibration value,with 51.19%(43/84)of the comparison bias bata at the level of medical decisionmaking.Conclusion Both reference materials can improve the alignment bias of conventional system,and GBW(E)091173~6 calibration effect is better than ERM-DA471/IFCC.
4. Retrospectively analysis of characteristics and risk factors of immune treatment-related hepatic adverse events in malignant tumor
Shuluan LI ; Xiaoping GAO ; Qianqi CHEN ; Xiaohong FU ; Yan ZHAO ; Jiangman DUAN ; Yueqiang TANG ; Jie SUN ; Junling LI ; Qiming ZHOU
Chinese Journal of Oncology 2020;42(1):50-54
Objective:
To explore the clinical features and risk factors of hepatic injury due to immune checkpoint inhibitors (CPI) therapy in malignant tumor.
Methods:
Data of 112 patients (64 men and 48 women) who received CPI between January 2016 and March 2019 in Chinese Academy of Medical Sciences and Peking Union Medical College Shenzhen Hospital, and Huazhong University of Science and Techology Union Shenzhen Hospital were retrospectively collected. The median age of these patients was 60 years.
Results:
Hepatic adverse events were observed in 30 patients out of 112 patients (26.8%). Among them, the incidence of grade 3-5 hepatic adverse events were 7.14% (8/112). The median time of hepatic adverse event occurrence was 3 weeks (2-30) after undergoing therapy. The results of univariate and multivariate analyses showed that liver cancer was attributed to the CPI induced hepatitis (
5.Detection of serum autoantlbodies for cyclinB1,p62,Koc,IMP1 and Survivin in the subjects with esophageal and gastric cardia carcinoma and precancerous lesions and their expressions in the esophageal and gastric cardia Cancer tissue
Fang DU ; Lidong WANG ; Zhe SUN ; Zongmin FAN ; Shanshan GAO ; Xin HE ; Yijun QI ; Yanan JIANG ; Tao GUO ; Zhiwei CHANG ; Xiaodong LV ; Pingjuan LI ; Yanchun YIN ; Mu NIU ; Jiangman LI ; Jilin LI ; Xinying JIAO ; Fubao CHANG ; Jianying ZHANG ; Kaijuan WANG ; Liping DAI
Clinical Medicine of China 2008;24(10):970-974
Objective To characterise the alterations of serum autoantibodies for cyclinB1,p62,Koc-IMP1 and survivin in the subjects with esophgeal and gastric cardia carcinoma and precancerous lesion and their expres-sions in the esophageal and gastric cardia cancer tissue.Methods Enzyme-linked immunoassay and tumor-associated antigen mini-array (consisting of five full-length recombinant proteins,including eyefinB1-p62-Koc,IMP1 and Survivin)were applied to determine the serum level of the autoantibodies of these antigens on 376 subjects with e-sephageal and gastric cardia carcinoma and precancerous lesions.At the same time,the expression of these antigens was detected by immunohistochemical method(ABC)on 13 patients with esophageal cancer and 16 with gastric car-dia cancer.Results All of the 5 antigens determined,the linear correlation Was observed for the detection frequency of cyclinB1,IMPI and p62 in esophageal carcinogenesis,and for p62 in gastric cardia multi-stage progression from normal to precancerous and cancerous lesions(P<0.05).The detection rale with single positive antoantibody im-munoreactivity for both esophageal and gastric cardia cancers were low.However.the positive detection mte for both esophageal and gastric cardia cancer increased apparently when the multiple positive markers were combined together for analysis,which increased tO 3~5 and 3~4 folds respectively.Furthermore,the difference in autoantibody immu-noreactive rate was significant with the lesion progressed from mild tO severe precancerous lesions and to cancer both in esophageal and gastric cardia cancers(P<0.05).The positive immunoreactions of the 5 antigens were detected in cancer tissues.The positive immunostaining rates for cyclinB1,Koc,IMP1 and Survivin both in esophageal and gastric cardia cancers were higher compared to their serllin positive rate of autoantibodies I P<0.05).Of the pa-tients with positive immunostaining in the two cancer tissues,the autoantibodies in the serum for the corresponding antigens could be detected in the same patient.Conclusion The production of the tumor-associated autoantibodies is related tO antigens.The screening rate through serum tumor-associated antigen mini-array for the patients with e-sophageal and gastric cardia carcinoma and precancerous lesions has been increased apparently with combined analy-sis of multiple autoantibodies than with single one.

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