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.Gut microbiota aids in differentiating proximal colorectal cancer in the combination of tumor markers
Tianchen HUANG ; Xiaodong HAN ; Yong ZHANG ; Kan LI ; Zhipeng GUO ; Lei LI ; Yachao WU ; Yanjun WANG ; Dongxiao BAI ; Jianan XIAO ; Jiangman ZHAO ; Fuyou ZHOU ; Weili LI
Chinese Journal of Laboratory Medicine 2024;47(4):444-450
Objective:To explore the differences in bacterial community structure between proximal colon cancer (PC), distal colon cancer (DC), and rectal cancer (RC), and the values of featured microbiota in differentiating PC with tumor markers.Methods:This case-control study enrolled 85 newly diagnosed colorectal cancer patients, including 22 PC, 15 DC and 48 RC patients, and 8 colorectal adenoma patients from May 2019 to July 2022 at the Department of General Surgery, Anyang Oncology Hospital. The blood and fecal samples were collected before surgery and then subjected to biochemical tests for tumor markers and 16S rDNA tests, respectively. SPSS (27.0.1) was applied to perform the t-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis H test, and Chi-Squared Test. Also, the receiver operating characteristic curve (ROC) was plotted on tumor markers and/or f_Bacteroidaceae with SPSS software .Results:All groups had significant differences in the CA125 ( F=3.543, P<0.05), CA72-4 ( F=3.596, P<0.05), and serum tumor-associated materials (TAM) levels ( F=5.787, P<0.01). In PC group, the levels of CA125 [PC vs RC, (36.84±6.30) kU/L vs (12.73±4.21) kU/L, P<0.01] and CA72-4 [PC vs RC, (45.56±10.86) kU/L vs (3.30±7.63) kU/L, P<0.01] were significantly higher than that of the RC group, while the level of TAM was remarkably elevated in PC group than in RC group [PC vs RC, (124.84±5.19) U/ml vs (102.44±3.63) U/ml, P<0.001] and CRA group [PC vs CRA, (124.84±5.19) U/ml vs (95.39±8.42) U/ml, P<0.01]. The LEfSe analysis showed that the featured microbiota in the PC group included f_Bacteroidaceae, f_Neisseriaceae, f_Clostridiaceae_1, f_Spirochaetaceae, and so on. The largest area under the ROC belonged to the combination of TAM and f_Bacteroidaceae, which reached 0.845 (95% CI 0.747-0.944), with sensitivity being 0.857 and specificity being 0.815. Conclusions:There is heterogeneity in gut microbiota composition among PC, DC, RC, and CRA. The combination of gut microbiota and tumor biomarkers demonstrated good differentiating effects in proximal colon cancers.
5.Analysis of safety recommendations in clinical practice guidelines and expert consensuses for Chinese patent medicine
Li ZHENG ; Jiangman SONG ; Dan GUO ; Yatong ZHANG
Adverse Drug Reactions Journal 2024;26(11):652-657
Objective:To explore the status and problems of safety recommendations in clinical practice guidelines and expert consensuses (guidelines/consensuses) on Chinese patent medicine (CPM) in China.Methods:Wanfang Med Online, CNKI, VIP, China Biology Medicine Database, Chinese Medical Journal Full Text Database, and the websites of Medlive, and China Association of Chinese Medicine were searched, and the guidelines/consensuses related to CPM were collected. The basic information, types, subject areas, evidence rating methods, safety reporting items, safety recommendation levels, and evidence sources of these guidelines/consensuses were extracted and analyzed by descriptive statistics.Results:A total of 138 guidelines/consensuses were included in the analysis, including 19 guidelines and 119 consensuses. The first guideline/consensus on CPM was published in 2004. Five, 3, 9, 15, 29, 32, 29, and 11 guidelines/consensuses were published respectively from 2016 to 2023. From 2020 to 2023, 101 guidelines/consensuses were published, which was 2.73 times the total number of those published in the past 16 years.(101/37). Among the 138 guidelines/consensuses, 59 (42.75%) were "disease-based" and 79 (57.25%) were "drug-based". The top 5 institutions in terms of the number of publications were National Administration of Traditional Chinese Medicine, China Association of Chinese Medicine, Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences, Chinese Association of Integrative Medicine, and Chinese Medical Association, of which National Administration of Traditional Chinese Medicine issued 19 guidelines. However, the issuing units of 26 guidelines/consensuses were medical colleges/medical institutions and the issuing units of 8 guildlines/consensuses were not clearly stated. Among the 138 guidelines/consensuses, 18 (13.04%) did not describe the safety of drugs and 120 (86.96%) described. Among the 120 guidelines/consensuses, none of the safety recommendations were graded according to The Grading of Recommendations Assessment, Development and Evaluation, and only 32.50% (39/120) of the evidence sources contained randomized controlled trials. A proportion of 50.72% (70/138) in 138 guidelines/consensuses did not report the funding situation, and 37.68% (52/138) did not disclose the conflict of interest.Conclusions:In recent years, the number of guidelines/consensuses on CPM has increased significantly in China, but the issuing agencies of some of them had poor authority. Most of the guidelines/consensuses are "drug-based", the descriptions of safety are insufficient, the evidence level is low, and there may be some bias.
6.Analysis of safety recommendations in clinical practice guidelines and expert consensuses for Chinese patent medicine
Li ZHENG ; Jiangman SONG ; Dan GUO ; Yatong ZHANG
Adverse Drug Reactions Journal 2024;26(11):652-657
Objective:To explore the status and problems of safety recommendations in clinical practice guidelines and expert consensuses (guidelines/consensuses) on Chinese patent medicine (CPM) in China.Methods:Wanfang Med Online, CNKI, VIP, China Biology Medicine Database, Chinese Medical Journal Full Text Database, and the websites of Medlive, and China Association of Chinese Medicine were searched, and the guidelines/consensuses related to CPM were collected. The basic information, types, subject areas, evidence rating methods, safety reporting items, safety recommendation levels, and evidence sources of these guidelines/consensuses were extracted and analyzed by descriptive statistics.Results:A total of 138 guidelines/consensuses were included in the analysis, including 19 guidelines and 119 consensuses. The first guideline/consensus on CPM was published in 2004. Five, 3, 9, 15, 29, 32, 29, and 11 guidelines/consensuses were published respectively from 2016 to 2023. From 2020 to 2023, 101 guidelines/consensuses were published, which was 2.73 times the total number of those published in the past 16 years.(101/37). Among the 138 guidelines/consensuses, 59 (42.75%) were "disease-based" and 79 (57.25%) were "drug-based". The top 5 institutions in terms of the number of publications were National Administration of Traditional Chinese Medicine, China Association of Chinese Medicine, Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences, Chinese Association of Integrative Medicine, and Chinese Medical Association, of which National Administration of Traditional Chinese Medicine issued 19 guidelines. However, the issuing units of 26 guidelines/consensuses were medical colleges/medical institutions and the issuing units of 8 guildlines/consensuses were not clearly stated. Among the 138 guidelines/consensuses, 18 (13.04%) did not describe the safety of drugs and 120 (86.96%) described. Among the 120 guidelines/consensuses, none of the safety recommendations were graded according to The Grading of Recommendations Assessment, Development and Evaluation, and only 32.50% (39/120) of the evidence sources contained randomized controlled trials. A proportion of 50.72% (70/138) in 138 guidelines/consensuses did not report the funding situation, and 37.68% (52/138) did not disclose the conflict of interest.Conclusions:In recent years, the number of guidelines/consensuses on CPM has increased significantly in China, but the issuing agencies of some of them had poor authority. Most of the guidelines/consensuses are "drug-based", the descriptions of safety are insufficient, the evidence level is low, and there may be some bias.
7.25-Hydroxyvitamin D and C-reactive protein levels in Patients with Vestibular Neuritis
Xiuhua LI ; Meng MENG ; Jiangman SONG
Journal of Apoplexy and Nervous Diseases 2021;38(9):829-832
Objective We evaluated serum levels of 25hydroxyvitamin D(25(OH)D)and Creactive protein(CRP)in patients presenting acutely with Vestibular neuritis(VN)and healthy controls and investigated the possible correlation of serum 25(OH)D and CRP levels with VN.Methods A total of 46 consecutive patients diagnosed with VN within 7 days of symptom onset and 66 ageand sexmatched healthy controls in NO731 Hospital,between March 2019 and August 2020 were recruited. Demographic and clinical data,such as age,sex,height,weight,living habits,ongoing health problems,and medication history,for all subjects were recorded,and levels of 25(OH)D and CRP were measured and compared. 〖WT5”HZ〗Results〖WT5”BZ〗Serum levels of 25(OH)D were significantly lower in patients with VN than in controls(18.30± 6.19 vs. 22.43±5.23 ng/ml,P<0.001).whereas serum levels of CRP were higher in patients with VN than in controls (15.86±8.37 vs. ng/ml,P<0.001)Regression analyses demonstrated that vitamin D and CRP were associated with VN,with an odds ratio of 1.187 (95%CI 1.046~1.093,P=0.001)and 1.223 (95%CI=1.10~1.36,P=0.000).Conclusion VN is associated with evidence of an acute inflammatory response,we found that serum 25(OH)D and CRP may be associated with VN occurrence.
8.Medication analysis of antiplatelet medication in a patient with recurrent stroke
Xi YANG ; Li LI ; Di CHEN ; Mengting YANG ; Jiangman SONG ; Yan LIU
Clinical Medicine of China 2020;36(6):564-567
A case of recurrent stroke with clopidogrel secondary prevention, CYP2C19 gene testing result of " clopidogrel slow metabolism" , platelet aggregation test result of " platelet aggregation significantly inhibited" as an example, the dialectical relationship among the above gene testing, platelet aggregation test, stroke recurrence were analyzed, and the choice of antiplatelet drugs was discussed.Clopidogrel gene testing has certain guiding significance for the secondary prevention of stroke patients.Platelet aggregation test results can not comprehensively evaluate the physiology and function of platelets in vivo.In order to find a more safe, effective and reasonable antiplatelet therapy, antiplatelet therapy should be further explored and optimized.
9. 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 (
10.FimA plasmid construction and protein purification of Porphyromonas gingivalis
Jiangman CHEN ; Yonggang LI ; Xin LI
Journal of Practical Stomatology 2018;34(2):168-171
Objective: To construct gine expression plasmid and to purify the protein of fimbriae(FimA) of Porphyromonas gingivalis (P. gingivalis). Methods: The bacteria DNA was extracted from P. gingivalis by using commercial kit. FimA gene was cloned after PCR. Plasmid was constructed and transformed into competent cells. Optimal conditions of protein induction were chosen. The fusionprotein was purified by Glutathione S-Transferase affinity chromatography. Fusion protein was confirmed by Western blot method. Results: The highest protein expression by the constructed plasmid was obtained at the low temperature and high concentration after 12 hours induction. The protein was confirmed by Western blot. Conclusion: A highly purified P. gingivalis FimA protein was successfully obtained.


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