1.Efficacy and safety of ferric derisomaltose injection versus iron sucrose injection in the treatment of iron deficiency anemia in patients with inflammatory bowel disease
Changqin LIU ; Xiaomin SUN ; Cui ZHANG ; Liang CHEN ; Zhanju LIU
Chinese Journal of Digestion 2025;45(4):241-246
Objective:To compare and analyze the clinical efficacy and safety of ferric derisomaltose injection (FDI) and iron sucrose injection (ISI) in the treatment of iron deficiency anemia (IDA) in patients with inflammatory bowel disease (IBD).Methods:From January 1, 2023 to August 31, 2024, 89 IBD patients complicated with IDA hospitalized and treated at the Department of Gastroenterology, Tenth People′s Hospital of Tongji University were enrolled and divided into the FDI group (44 cases) and ISI group (45 cases). Patients in the FDI group and ISI group were treated with FDI and ISI, respectively, and the treatment course were both 8 weeks. The iron supplementation dose, number of injections, and efficacy (response rate) were compared between the 2 groups. Hemoglobin (Hb) levels were measured before treatment and at the 2nd, 4th, and 8th week after treatment. After 8 weeks of treatment, the changes in serum iron, C-reactive protein (CRP), Crohn′s disease activity index (CDAI), modified Mayo score, inflammatory bowel disease questionnaire (IBDQ) score, and serum phosphorus levels were compared with those before treatment. Chi-square test, paired t-test, independent sample t-test, Wilcoxon signed-rank test, and Mann-Whitney U test were used for statistical analysis. Results:The difference between required and actual iron supplementation and number of injections of the FDI group were both less than those of the ISI group ((466±264) mg vs. (571±302) mg, 1.0 (1.0, 1.0) vs. 3.0 (2.0, 5.5)), and the differences were statistically significant ( t=3.69, U=104.50; both P<0.001). After 8 weeks of treatment, the efficacy and increase in serum iron of the FDI group were both higher than those of the ISI group (81.8% (36/44) vs. 60.0% (27/45), 7.35 (4.53, 12.68) μmol/L vs. 3.60 (1.10, 8.20) μmol/L), and the differences were statistically significant ( χ2=5.12, U=545.40; P=0.024, <0.001). After 2, 4, and 8 weeks of treatment, the increase in Hb from before treatment of the FDI group were higher than those of the ISI group (22.5 (8.5, 29.0) g/L vs. 7.0 (2.0, 23.5) g/L; 29.5 (22.0, 49.8) g/L vs. 14.0 (6.0, 32.0) g/L; 36.5 (25.5, 60.5) g/L vs. 21.0 (7.0, 42.0) g/L), and the differences were statistically significant ( U=590.00, 518.00, and 584.00; all P<0.001). The reductions in CDAI, modified Mayo score, and CRP, as well as the improvement in IBDQ score before and after treatment were comparable between the FDI group and the ISI group (130.7±70.3 vs. 128.8±74.6, 7.3±2.3 vs. 5.8±3.2, 26.73 (2.44, 63.44) mg/L vs. 7.41 (1.86, 47.39) mg/L, 38.5±28.4 vs. 37.0±28.1), and the differences were not statistically significant (all P>0.05). In the FDI group serum phosphorus levels after 4 and 8 weeks of treatment were both higher than that before treatment (1.27(1.13, 1.45), 1.23(1.13, 1.40) mmol/L vs. 1.21 (1.03, 1.28) mmol/L), and the differences were statistically significant ( Z=539.00 and 454.00, both P<0.001). During the treatment, mild to moderate adverse reactions occurred in 13.6% (6/44) patients of the FDI group and 11.1% (5/45) patients of the ISI group, there were no serious adverse events. Conclusion:FDI can rapidly, effectively, and safely improve IDA in IBD patients without affecting blood phosphate metabolism.
2.Interpretation of"Guideline 9213 for validation,verification,and transfer of microbiological analytical methods"in Chinese Pharmacopoeia 2025 Edition
Yan YANG ; Hong SHAO ; Shujuan WANG ; Rong FU ; Qian YANG ; Junhao CHEN ; Zhen SHEN ; Chunyan AN ; Yiling FAN ; Meicheng YANG ; Jun ZHANG ; Changqin HU
Drug Standards of China 2025;26(5):462-467
The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.
3.Interpretation of"Guideline 9213 for validation,verification,and transfer of microbiological analytical methods"in Chinese Pharmacopoeia 2025 Edition
Yan YANG ; Hong SHAO ; Shujuan WANG ; Rong FU ; Qian YANG ; Junhao CHEN ; Zhen SHEN ; Chunyan AN ; Yiling FAN ; Meicheng YANG ; Jun ZHANG ; Changqin HU
Drug Standards of China 2025;26(5):462-467
The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.
4.Efficacy and safety of ferric derisomaltose injection versus iron sucrose injection in the treatment of iron deficiency anemia in patients with inflammatory bowel disease
Changqin LIU ; Xiaomin SUN ; Cui ZHANG ; Liang CHEN ; Zhanju LIU
Chinese Journal of Digestion 2025;45(4):241-246
Objective:To compare and analyze the clinical efficacy and safety of ferric derisomaltose injection (FDI) and iron sucrose injection (ISI) in the treatment of iron deficiency anemia (IDA) in patients with inflammatory bowel disease (IBD).Methods:From January 1, 2023 to August 31, 2024, 89 IBD patients complicated with IDA hospitalized and treated at the Department of Gastroenterology, Tenth People′s Hospital of Tongji University were enrolled and divided into the FDI group (44 cases) and ISI group (45 cases). Patients in the FDI group and ISI group were treated with FDI and ISI, respectively, and the treatment course were both 8 weeks. The iron supplementation dose, number of injections, and efficacy (response rate) were compared between the 2 groups. Hemoglobin (Hb) levels were measured before treatment and at the 2nd, 4th, and 8th week after treatment. After 8 weeks of treatment, the changes in serum iron, C-reactive protein (CRP), Crohn′s disease activity index (CDAI), modified Mayo score, inflammatory bowel disease questionnaire (IBDQ) score, and serum phosphorus levels were compared with those before treatment. Chi-square test, paired t-test, independent sample t-test, Wilcoxon signed-rank test, and Mann-Whitney U test were used for statistical analysis. Results:The difference between required and actual iron supplementation and number of injections of the FDI group were both less than those of the ISI group ((466±264) mg vs. (571±302) mg, 1.0 (1.0, 1.0) vs. 3.0 (2.0, 5.5)), and the differences were statistically significant ( t=3.69, U=104.50; both P<0.001). After 8 weeks of treatment, the efficacy and increase in serum iron of the FDI group were both higher than those of the ISI group (81.8% (36/44) vs. 60.0% (27/45), 7.35 (4.53, 12.68) μmol/L vs. 3.60 (1.10, 8.20) μmol/L), and the differences were statistically significant ( χ2=5.12, U=545.40; P=0.024, <0.001). After 2, 4, and 8 weeks of treatment, the increase in Hb from before treatment of the FDI group were higher than those of the ISI group (22.5 (8.5, 29.0) g/L vs. 7.0 (2.0, 23.5) g/L; 29.5 (22.0, 49.8) g/L vs. 14.0 (6.0, 32.0) g/L; 36.5 (25.5, 60.5) g/L vs. 21.0 (7.0, 42.0) g/L), and the differences were statistically significant ( U=590.00, 518.00, and 584.00; all P<0.001). The reductions in CDAI, modified Mayo score, and CRP, as well as the improvement in IBDQ score before and after treatment were comparable between the FDI group and the ISI group (130.7±70.3 vs. 128.8±74.6, 7.3±2.3 vs. 5.8±3.2, 26.73 (2.44, 63.44) mg/L vs. 7.41 (1.86, 47.39) mg/L, 38.5±28.4 vs. 37.0±28.1), and the differences were not statistically significant (all P>0.05). In the FDI group serum phosphorus levels after 4 and 8 weeks of treatment were both higher than that before treatment (1.27(1.13, 1.45), 1.23(1.13, 1.40) mmol/L vs. 1.21 (1.03, 1.28) mmol/L), and the differences were statistically significant ( Z=539.00 and 454.00, both P<0.001). During the treatment, mild to moderate adverse reactions occurred in 13.6% (6/44) patients of the FDI group and 11.1% (5/45) patients of the ISI group, there were no serious adverse events. Conclusion:FDI can rapidly, effectively, and safely improve IDA in IBD patients without affecting blood phosphate metabolism.
5.Galangin inhibits the pyroptosis of macrophages mediated by NOD-like receptor proteins 3
Lingzhi SHEN ; Li LI ; Zhouxin YANG ; Dongyang GUO ; Changqin CHEN ; Jing YAN
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2024;31(1):28-33
Objective To investigate the effect of Galangin on pyroptosis of bone marrow derived macrophages(BMDMs).Methods BMDMs were cultured in vitro and divided into blank control group,model group and Galangin group with different concentrations.Lipopolysaccharide(LPS)and adenosine triphosphate(ATP)were used to construct the pyroptosis model.The effect of different concentrations of Galangin on the proliferation of BMDMs was detected by cell counting Kit-8(CCK-8).The level of cysteinyl aspartate specific proteinase-1 p10 subunit(caspase-1 p10),interleukin-1β(IL-1β)in supernatant and intracellular nucleotide NOD-like receptor protein 3(NLRP3)were detected by Western blotting.IL-1β in supernatant was detected by enzyme-linked immunosorbent assay(ELISA).The cell death was observed by propidium iodide(PI)staining.High-throughput sequencing was used to compare the gene expression in the model group and Galangin groups at 20 μmol/L.Results There was no statistically significant difference between the 5,10,20,40,60,80 μmol/L Galangin groups on the proliferation level of BMDMs(all P>0.05),indicating that no significant effect of Galangin at 5,10,20,40,60,80 μmol/L was observed on the proliferation of BMDMs.So we selected Galangin at 5,10,20 μmol/L and treatment for 1,2 and 4 hours as the effects of different concentrations and time on the pyroptosis of BMDMs.Compared with blank control group,the expression of caspase-1 p10 and mature IL-1β protein and IL-1β in supernatant in model group were significantly increased(all P<0.05).Compared with model group,the expression of caspase-1 p10 and mature IL-1β protein and IL-1β in supernatant of Galangin at 5,10 and 20 μmol/L were significantly decreased[IL-1β protein expression(gray value):0.155±0.006,0.113±0.006,0.111±0.007 vs.1.000±0.000,caspase-1 p10 protein expression(gray value):0.207±0.044,0.160±0.008,0.082±0.008 vs.1.000±0.000,IL-1β(μg/L):99.80±10.36,85.21±8.78,26.53±4.56 vs.494.10±35.47,all P<0.05].There was no significant difference between the different concentration groups(all P>0.05),but with the extension of treatment time of Galangin,the inhibitory effect was enhanced.The inhibitory effect of Galangin at 20 μmol/L for 4 hours was the most obvious[IL-1β protein expression(gray value):0.186±0.004 vs.1.000±0.000,caspase-1 p10 protein expression(gray value):0.247±0.009 vs.1.000±0.000,IL-1β(μg/L):173.80±10.56 vs.653.80±76.02,all P<0.05].Treatment with 20 μmol/L Galangin for 4 hours could reduce the number of pyroptotic cell deaths(number of view:23.00±3.61 vs.67.67±15.63,P<0.05)and inhibited the expression of NLRP3 protein(gray value:0.178±0.025 vs.0.406±0.066,P<0.05).High-throughput sequencing showed that,compared with the model group,Galangin down-regulated the genes of Nlrp3,Nod2,IL-1β and up-regulated genes of Skp2(also known as Fbxl1),Fbxl20,Fbxl4,Fbxo32 and Fbxw7.Conclusion Galangin inhibited pyroptosis mediated by NLRP3 inflammasome in macrophages.
6.Quality of urodynamics: a national cross-sectional study in China.
Xiao ZENG ; Ziyuan XIA ; Liao PENG ; Jiapei WU ; Jiayi LI ; Jianhui YANG ; Juan CHEN ; Changqin JIANG ; Dewen ZHONG ; Yang SHEN ; Jumin NIU ; Xiao XIAO ; Li WEN ; Hong SHEN ; Deyi LUO
Chinese Medical Journal 2023;136(2):236-238
7.A case of glycogen storage disease Ib with Crohn′s disease-like enterocolitis
Lu LU ; Changqin LIU ; Wei WU ; Meiying ZENG ; Mengling SHA ; Chunqiu CHEN ; Zhanju LIU ; Xiaomin SUN
Chinese Journal of Inflammatory Bowel Diseases 2023;07(2):201-203
Glycogen storage disease (GSD) - type Ib is an autosomal recessive disease, often accompanied by inflammatory bowel disease. A case of GSD -Ib combined with Crohn′s disease-like enterocolitis is reported. The diagnosis and treatment of this patient is helpful to improve the understanding of this rare disease.
8.A case of glycogen storage disease Ib with Crohn′s disease-like enterocolitis
Lu LU ; Changqin LIU ; Wei WU ; Meiying ZENG ; Mengling SHA ; Chunqiu CHEN ; Zhanju LIU ; Xiaomin SUN
Chinese Journal of Inflammatory Bowel Diseases 2023;07(2):201-203
Glycogen storage disease (GSD) - type Ib is an autosomal recessive disease, often accompanied by inflammatory bowel disease. A case of GSD -Ib combined with Crohn′s disease-like enterocolitis is reported. The diagnosis and treatment of this patient is helpful to improve the understanding of this rare disease.
9.Analysis of sepsis-related genes through weighted gene co-expression network
Changqin CHEN ; Li LI ; Changyun ZHAO ; Junhai ZHEN ; Jing YAN
Chinese Critical Care Medicine 2021;33(6):659-664
Objective:To identify the Key genes in the development of sepsis through weighted gene co-expression network analysis (WGCNA).Methods:The gene expression dataset GSE154918 was downloaded from the public database Gene Expression Omnibus (GEO) database, which containes data from 105 microarrays of 40 control cases, 12 cases of asymptomatic infection, 39 cases of sepsis, and 14 cases of follow-up sepsis. The R software was used to screen out differentially expressed genes (DEG) in sepsis, and the distributed access view integrated database (DAVID), search tool for retrieval of interacting neighbouring genes (STRING) and visualization software Cytoscape were used to perform gene function and pathway enrichment analysis, Protein-protein interaction (PPI) network analysis and key gene analysis to screen out the key genes in the development of sepsis.Results:Forty-six candidate genes were obtained by WGCNA and combined with DEG expression analysis, and these 46 genes were analyzed by gene ontology (GO) and Kyoto City Encyclopedia of Genes and Genomes (KEGG) pathway enrichment to obtain gene functions and involved signaling pathways. The PPI network was further constructed using the STRING database, and 5 key genes were selected by the PPI network visualization software Cytoscape, including the mast cell expressed membrane protein 1 gene (MCEMP1), the S100 calcium-binding protein A12 gene (S100A12), the adipokine resistance factor gene (RETN), the c-type lectin structural domain family 4 member gene (CLEC4D), and peroxisome proliferator-activated receptor gene (PPARG), and differential expression analysis of each of these 5 genes showed that the expression levels of the above 5 genes were significantly upregulated in sepsis patients compared with healthy controls.Conclusion:In this study, 5 key genes related to sepsis were screened by constructing WGCNA method, which may be potential candidate targets related to sepsis diagnosis and treatment.
10.Association of serum Fetuin-B with metabolic syndrome in obese Chinese adults
Yongwen LIU ; Dongmei WANG ; Zhibin LI ; Mingzhu LIN ; Changqin LIU ; Zheng CHEN ; Xiulin SHI ; Shuyu YANG ; Xuejun LI
Chinese Journal of Endocrinology and Metabolism 2018;34(3):217-222
Objective To investigate the independent association of serum Fetuin-B with metabolic syndrome in obese Chinese adults.Methods Cross-sectional data on socio-demographic,lifestyle,clinical characteristics, and serum Fetuin-B were collected for 1 318 Chinese adults with central obesity.Associations of serum Fetuin-B with metabolic syndrome and insulin resistance were analyzed using multivariable Logistic regression analysis.Results A total of 820(62.2%)individuals were identified as metabolic syndrome.Subjects with metabolic syndrome showed significantly increased levels of serum Fetuin-B than those with non-metabolic syndrome[(4.18 ±1.39 vs 4.02 ± 1.35)μg/ml,P=0.043].Increased serum Fetuin-B were significantly associated with increased fasting plasma glucose and insulin levels, as well as prevalences of non-alcoholic fatty liver disease(NAFLD)and insulin resistance.After adjustment for potential confounders, serum Fetuin-B was significantly associated with increased risks of metabolic syndrome and insulin resistance(OR=1.19,95%CI 1.06-1.34,P=0.004;OR=1.15,95%CI 1.01-1.30,P=0.031 respectively).Conclusion Serum Fetuin-B level was significantly associated with NAFLD;and elevated serum Fetuin-B was significantly associated with increased risk of metabolic syndrome.

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