1.Physicochemical properties and biocompatibility of hydroxyapatite/graphene oxide/interleukin-4 composite coating materials
Congcong LI ; WUFANBIEKE·BAHETI ; Li ZHAO ; Xiaotao CHEN ; Chuifan KONG ; Min YU
Chinese Journal of Tissue Engineering Research 2026;30(2):404-413
BACKGROUND:Pure titanium and titanium alloy implants are widely used in the field of implant restoration due to their excellent biocompatibility and elastic modulus.However,the biological inertness of the surface of titanium-based implants leads to poor integration with surrounding bone tissues,and surface modification is required to improve the bone integration ability of titanium-based implants.OBJECTIVE:To fabricate hydroxyapatite/graphene oxide/interleukin-4 composite coatings on pure titanium substrates,and to investigate their physicochemical properties and biocompatibility of the coating materials.METHODS:Hydroxyapatite/graphene oxide/interleukin-4 composite coatings were prepared on pure titanium substrates by electrochemical deposition and freeze-drying.Titanium sheets loaded with interleukin-4 and titanium sheets loaded with hydroxyapatite/graphene oxide coatings were prepared at the same time,and the physicochemical properties of pure titanium sheets and the above three titanium sheets were characterized.MC3T3-E1 cells were inoculated on the surfaces of pure titanium sheets and the above three titanium sheets,respectively.Cell proliferation was detected by CCK-8 assay and DAPI staining.Cell activity was detected by Calcein-AM/PI staining.Cell morphology and adhesion were observed by scanning electron microscopy.RESULTS AND CONCLUSION:(1)Scanning electron microscopy,energy-dispersive X-ray spectroscopy,X-ray photoelectron spectroscopy,X-ray diffraction,and Raman spectroscopy confirmed the successful fabrication of the hydroxyapatite/graphene oxide/interleukin-4 composite coating on the titanium surface.The water contact angle of hydroxyapatite/graphene oxide/interleukin-4 group was larger than that of pure titanium group and hydroxyapatite/graphene oxide group,and smaller than that of interleukin-4 group.(2)CCK-8 assay and DAPI staining results showed that hydroxyapatite/graphene oxide/interleukin-4 coating could promote the proliferation of MC3T3-E1 cells.Calcein-AM/PI staining results showed that MC3T3-E1 cells in hydroxyapatite/graphene oxide/interleukin-4 coating group had higher activity and fewer dead cells.Scanning electron microscopy showed that MC3T3-E1 cells adhered to the surfaces of the four groups of materials with good cell morphology.Compared with the pure titanium group,the MC3T3-E1 cells in the interleukin-4 group extended more pseudopodia,the cell-cell connections were closer,and the adhesion area was larger;compared with the hydroxyapatite/graphene oxide group,the MC3T3-E1 cells in the hydroxyapatite/graphene oxide/interleukin-4 group extended more pseudopodia,the cell-cell connections were closer,and the adhesion area was larger.(3)These findings indicate that the hydroxyapatite/graphene oxide/interleukin-4 composite coating possesses favorable physicochemical and biological properties.
2.Establishment of graded management standards for off-label use of Shenqi fuzheng injection
Min WU ; Mei YU ; Shengnan YIN ; Dongmei LIU
China Pharmacy 2026;37(5):650-654
OBJECTIVE To establish the graded management standards for off-label use of Shenqi fuzheng injection. METHODS Systematic searches were conducted in databases including CNKI, PubMed and the Cochrane Library to retrieve guidelines/consensuses, systematic reviews/meta-analyses, and randomized controlled trials (RCTs) of Shenqi fuzheng injection. The quality of evidence was evaluated using AGREE Ⅱ, AMSTAR Ⅱ, and the Risk of Bias 1.0 tool recommended by Cochrane Collaboration, and the graded management standard for off-label use of Shenqi fuzheng injection was developed by using the Thomson grading system. RESULTS A total of 534 articles were involved, including 11 guidelines, 22 systematic reviews/meta-analysis, and 501 RCTs. They covered 79 off-label indications for Shenqi fuzheng injection: cancer-related fatigue, colorectal cancer and breast cancer, all with high-quality evidence were classified under grade A management (grade Ⅰ commendation), allowing all physicians across the hospital to prescribe relevant treatments; five diseases, such as ovarian cancer, liver cancer, leukemia, heart failure and cerebral infarction, were classified under grade B management (grade Ⅱa commendation), with prescription restricted to physicians with intermediate or higher professional titles in specific departments; eleven diseases, including sepsis, cervical cancer, esophageal cancer, etc., were classified under grade C management (grade Ⅱb commendation), requiring strict evaluation by senior physicians before prescription; the use of Shenqi fuzheng injection for other conditions was explicitly prohibited due to a lack of sufficient evidence. CONCLUSIONS Off-label use of Shenqi fuzheng injection is prevalent. The graded management standard established by evidence-based medical approach provides a scientific basis for standardizing the clinical application of traditional Chinese medicine injections and offers an operable paradigm for implementing differentiated drug use supervision in medical institutions.
3.Mechanism of Shenqi Dihuangtang in Blocking Renal Fibrosis Injury in Diabetic Kidney Disease Mediated by Epithelial-mesenchymal Transition Through Inhibiting TGF-β1/Smad Signaling Axis
Liangjing LIU ; Haolan LIU ; Xiaoling MAO ; Min YU ; Weitong YAN ; Chao LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):32-45
ObjectiveThis paper aims to study the potential active compound components and action mechanism of Shenqi Dihuangtang in the treatment of diabetic kidney disease (DKD) through network pharmacology and in vivo experimental verification. MethodsUltra-high-performance liquid chromatography-Q-exactive orbitrap mass spectrometry (UPLC-Q-Exactive Orbitrap MS) technology was used to clarify the main active chemical components of Shenqi Dihuangtang, and it was combined with network pharmacology methods such as gene ontology (GO) functional annotations and Kyoto encyclopedia of genes and genome (KEGG) to predict the potential action mechanism of Shenqi Dihuangtang in treating DKD. Subsequently, the DKD model of db/db male mice was established, and the mice were randomly divided into model group, low-dose Shenqi Dihuangtang group (6.10 g·kg-1), medium-dose Shenqi Dihuangtang group (12.19 g·kg-1), high-dose Shenqi Dihuangtang group (24.38 g·kg-1), and daplizin group (1.25 mg·kg-1). During the same period, C57BL/6J male mice were selected into normal group and received drug intervention for 8 weeks, respectively. During this period, the body weight and fasting blood glucose (FBG) of the mice were dynamically monitored, and oral glucose tolerance test (OGTT) and insulin tolerance test (ITT) were performed at the end of dosing. The levels of serum creatinine (SCr), blood urea nitrogen (BUN), uric acid (UA), albumin (ALB), and total protein (TP) were measured by an automatic biochemical analyzer, and 24-hour urine protein was measured by a urine protein quantitative kit. Hematoxylin-eosin (HE), periodic-acid Schiff (PAS), and Masson staining were employed to observe the renal histopathology. The expression of nephrotic protein Nephrin was observed by immunohistochemistry. Western blot was used to detect the expression of epithelial-mesenchymal transition (EMT)-related proteins such as TGF-β1, Smad2/3, α-smooth muscle actin (α-SMA), neural-cadherin (N-Cadherin), and snail protein. ResultsUPLC-Q-Exactive Orbitrap MS identified 384 active compounds in the aqueous extract of Shenqi Dihuangtang. According to oral bioavailability≥30% and the five drug-like principles, 44 key active ingredients were screened out, and 169 intersection targets highly correlated with DKD were matched. Among them, there was a significant interaction relationship between tumor necrosis factor(TNF), interleukin(IL)-6, protein kinase B(Akt)1, Caspase-3, Jun proto-oncogene (JUN), hypoxia inducible factor-1α(HIF-1α), B cell lymphoma-2(Bcl-2), matrix metallopeptidase-9(MMP-9), IL-1β, and TGF-β1. GO functional annotations were significantly enriched in cellular components such as membrane rafts, membrane microdomains, and collagen-containing extracellular matrix, molecular functions such as DNA-binding transcription factor binding, R-Smad binding, and Smad protein binding, as well as biological processes such as reactions to lipopolysaccharides(LPS), reactions to bacteria-derived molecules, and wound healing. The KEGG pathway was significantly enriched in lipids and atherosclerosis, TGF-β signaling pathway, phosphatidylinositol 3 kinase (PI3K)/Akt signaling pathway, etc. In vivo experimental results showed that the high-dose Shenqi Dihuangtang group could significantly reduce FBG levels in db/db mice (P<0.01), improve OGTT (P<0.01) and ITT (P<0.01) levels, reduce SCr (P<0.01), BUN (P<0.01), UA (P<0.01) and 24-hour BUN (P<0.01), and increase ALB (P<0.01) and TP (P<0.01) levels. Pathological staining confirmed that the high-dose Shenqi Dihuangtang group could significantly reduce the glomerular mesangial matrix area and collagen deposition (P<0.01) and upregulate the positive expression rate of Nephrin (P<0.01). Western blot results showed that the high-dose Shenqi Dihuangtang group significantly downregulated the expression of TGF-β1 (P<0.01) and Smad2/3 (P<0.01) signal molecules and inhibited the protein levels of α-SMA (P<0.01), N-Cadherin (P<0.01), and Snail (P<0.01). ConclusionShenqi Dihuangtang can inhibit the TGF-β1/Smad signaling axis and block the renal EMT process, thereby improving DKD renal fibrosis damage. Further analysis of its key active components and clinical transformation pathways is needed in the future.
4.The Structure and Function of The YopJ Family Effectors in The Bacterial Type III Secretion System
Ao-Ning LI ; Wen-Bo LI ; Yu-Ying LU ; Min-Hui ZHU ; Yu-Long QIN ; Yong ZHAO ; Zhao-Huan ZHANG
Progress in Biochemistry and Biophysics 2026;53(3):516-533
The Type III Secretion System (T3SS) serves as a pivotal virulence apparatus for numerous Gram-negative bacterial pathogens, enabling them to infect both animal and plant hosts. Functioning as a molecular syringe, the T3SS directly translocates bacterial effector proteins from the bacterial cytoplasm into the interior of eukaryotic host cells. These effectors are central weapons that precisely manipulate a wide spectrum of host cellular physiological processes, ranging from cytoskeletal dynamics to immune signaling, to establish a favorable niche for bacterial survival and proliferation. Among the diverse arsenal of T3SS effectors, the YopJ family constitutes a critical group of virulence factors. Members of this family are characterized by a conserved catalytic triad structure—a hallmark of the CE clan of cysteine proteases that has been evolutionarily repurposed to confer acetyltransferase activity. A defining and intriguing feature of these enzymes is their stringent dependence on a host-derived eukaryotic cofactor, inositol hexakisphosphate (IP6), for allosteric activation. This requirement acts as a sophisticated molecular safeguard, ensuring enzymatic activity only within the appropriate host environment, thereby preventing detrimental effects on the bacterium itself. While seminal studies on individual members such as Yersinia’s YopJ and Salmonella’s AvrA have provided deep mechanistic insights, a systematic and integrative understanding of the structure-function relationships across the entire family remains fragmented. Key questions persist regarding how a conserved catalytic core has diverged to recognize distinct host substrates in different kingdoms of life. To address this gap, this article provides a systematic review of the YopJ family, focusing on three interconnected aspects: their structural features, their catalytic mechanism, and their divergent immunosuppressive strategies in animal versus plant hosts. By conducting a comparative analysis of the sequences and resolved three-dimensional structures of three representative members (e.g., HopZ1a, PopP2, AvrA), we elucidate regions of significant variation embedded within the conserved core catalytic architecture. These variable regions, often involving surface loops and substrate-binding interfaces, are crucial determinants of target specificity and functional specialization. The functional divergence of this effector family is most apparent when comparing their modes of action in different hosts. In animal hosts, YopJ-family effectors primarily sabotage innate immune signaling pathways. They achieve this by acetylating key serine and threonine residues within the activation loops of critical kinases in the MAPK and NF‑κB pathways. This post-translational modification blocks the phosphorylation and subsequent activation of these kinases, leading to potent suppression of inflammatory cytokine production. Conversely, in plant hosts, the strategy broadens to dismantle the two-tiered plant immune system. YopJ homologs target a more diverse set of substrates, including immune-associated receptor-like cytoplasmic kinases (RLCKs), microtubule networks via tubulin acetylation (which disrupts cellular trafficking and signaling), and transcription factors central to defense gene regulation. This multi-target approach effectively suppresses both Pattern-Triggered Immunity (PTI) and Effector-Triggered Immunity (ETI). In conclusion, this synthesis aims to deepen the mechanistic understanding of YopJ family-mediated pathogenesis by integrating structural biology with cellular function across host kingdoms. Elucidating the precise molecular basis for substrate selection—how conserved platforms achieve target diversity—is a major frontier. Furthermore, this knowledge provides a vital theoretical foundation for developing novel anti-virulence strategies. Targeting the conserved IP6-binding pocket or the catalytic acetyltransferase activity itself represents a promising avenue for designing broad-spectrum inhibitors that could disarm this critical family of bacterial effectors, potentially offering new therapeutic approaches against a range of pathogenic bacteria.
5.Effectiveness of generative large language model MedGo in nursing decision-making for elderly patients with multimorbidity
Qiaoyun YAN ; Min LI ; Yawen YAN ; Yaqing NI ; Yun GU ; Jiawen QIN ; Haiping YU ; Haitao ZHANG ; Liming ZHAO
Chinese Journal of Clinical Medicine 2026;33(1):16-23
Objective To explore the effectiveness of the generative large language model MedGo in nursing decision-making for elderly patients with multimorbidity. Methods A quasi-randomized controlled trial study was conducted involving 6 junior nurses, 6 senior nurses and the MedGo model from January 1, 2025 to March 31, 2025 at the Emergency Internal Medicine Ward of Shanghai East Hospital Affiliated to Tongji University. Clinical data of 120 elderly patients with multimorbidity were analyzed to compare the performance of the three groups in four tasks (nursing diagnosis assessment, nursing intervention formulation, complication identification, and complication prevention) from three evaluation dimensions: decision-making time consumption, decision accuracy, and decision-making quality. Results In terms of decision-making time, the senior nurse group completed all four tasks faster than the junior nurse group (P<0.01), and the MedGo group completed all four tasks faster than the junior nurse group (P<0.001) and the senior nurse group (P<0.001). In terms of decision-making accuracy, senior nurse group scored higher than junior nurse group in all four tasks (P<0.001), while the MedGo group outperformed the senior nurse group only in complication identification (P<0.001). In terms of decision-making quality, the MedGo group scored higher than junior nurse group (P<0.001) and senior nurse group (P<0.001) in all four tasks. Conclusions The MedGo model demonstrates advantages of high efficiency, accuracy, and quality in nursing decision-making for elderly patients with multimorbidity; senior nurses outperform junior nurses in decision-making, providing diverse references for clinical nursing decision-making.
6.Physicochemical properties and biocompatibility of hydroxyapatite/graphene oxide/interleukin-4 composite coating materials
Congcong LI ; WUFANBIEKE·BAHETI ; Li ZHAO ; Xiaotao CHEN ; Chuifan KONG ; Min YU
Chinese Journal of Tissue Engineering Research 2026;30(2):404-413
BACKGROUND:Pure titanium and titanium alloy implants are widely used in the field of implant restoration due to their excellent biocompatibility and elastic modulus.However,the biological inertness of the surface of titanium-based implants leads to poor integration with surrounding bone tissues,and surface modification is required to improve the bone integration ability of titanium-based implants.OBJECTIVE:To fabricate hydroxyapatite/graphene oxide/interleukin-4 composite coatings on pure titanium substrates,and to investigate their physicochemical properties and biocompatibility of the coating materials.METHODS:Hydroxyapatite/graphene oxide/interleukin-4 composite coatings were prepared on pure titanium substrates by electrochemical deposition and freeze-drying.Titanium sheets loaded with interleukin-4 and titanium sheets loaded with hydroxyapatite/graphene oxide coatings were prepared at the same time,and the physicochemical properties of pure titanium sheets and the above three titanium sheets were characterized.MC3T3-E1 cells were inoculated on the surfaces of pure titanium sheets and the above three titanium sheets,respectively.Cell proliferation was detected by CCK-8 assay and DAPI staining.Cell activity was detected by Calcein-AM/PI staining.Cell morphology and adhesion were observed by scanning electron microscopy.RESULTS AND CONCLUSION:(1)Scanning electron microscopy,energy-dispersive X-ray spectroscopy,X-ray photoelectron spectroscopy,X-ray diffraction,and Raman spectroscopy confirmed the successful fabrication of the hydroxyapatite/graphene oxide/interleukin-4 composite coating on the titanium surface.The water contact angle of hydroxyapatite/graphene oxide/interleukin-4 group was larger than that of pure titanium group and hydroxyapatite/graphene oxide group,and smaller than that of interleukin-4 group.(2)CCK-8 assay and DAPI staining results showed that hydroxyapatite/graphene oxide/interleukin-4 coating could promote the proliferation of MC3T3-E1 cells.Calcein-AM/PI staining results showed that MC3T3-E1 cells in hydroxyapatite/graphene oxide/interleukin-4 coating group had higher activity and fewer dead cells.Scanning electron microscopy showed that MC3T3-E1 cells adhered to the surfaces of the four groups of materials with good cell morphology.Compared with the pure titanium group,the MC3T3-E1 cells in the interleukin-4 group extended more pseudopodia,the cell-cell connections were closer,and the adhesion area was larger;compared with the hydroxyapatite/graphene oxide group,the MC3T3-E1 cells in the hydroxyapatite/graphene oxide/interleukin-4 group extended more pseudopodia,the cell-cell connections were closer,and the adhesion area was larger.(3)These findings indicate that the hydroxyapatite/graphene oxide/interleukin-4 composite coating possesses favorable physicochemical and biological properties.
7.Mechanism of Action of Kaixinsan in Ameliorating Alzheimer's Disease
Xiaoming HE ; Xiaotong WANG ; Dongyu MIN ; Xinxin WANG ; Meijia CHENG ; Yongming LIU ; Yetao JU ; Yali YANG ; Changbin YUAN ; Changyang YU ; Li ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):20-29
ObjectiveTo investigate the mechanism of action of Kaixinsan in the treatment of Alzheimer's disease (AD) based on network pharmacology, molecular docking, and animal experimental validation. MethodsThe Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform(TCMSP) and the Encyclopedia of Traditional Chinese Medicine(ETCM) databases were used to obtain the active ingredients and targets of Kaixinsan. GeneCards, Online Mendelian Inheritance in Man(OMIM), TTD, PharmGKB, and DrugBank databases were used to obtain the relevant targets of AD. The intersection (common targets) of the active ingredient targets of Kaixinsan and the relevant targets of AD was taken, and the network interaction analysis of the common targets was carried out in the STRING database to construct a protein-protein interaction(PPI) network. The CytoNCA plugin within Cytoscape was used to screen out the core targets, and the Metascape platform was used to perform gene ontology(GO) functional enrichment analysis and Kyoto encyclopedia of genes and genomes(KEGG) pathway enrichment analysis. The “drug-active ingredient-target” interaction network was constructed with the help of Cytoscape 3.8.2, and AutoDock Vina was used for molecular docking. Scopolamine (SCOP) was utilized for modeling and injected intraperitoneally once daily. Thirty-two male C57/BL6 mice were randomly divided into blank control (CON) group (0.9% NaCl, n=8), model (SCOP) group (3 mg·kg-1·d-1, n=8), positive control group (3 mg·kg-1·d-1 of SCOP+3 mg·kg-1·d-1 of Donepezil, n=8), and Kaixinsan group (3 mg·kg-1·d-1 of SCOP+6.5 g·kg-1·d-1 of Kaixinsan, n=8). Mice in each group were administered with 0.9% NaCl, Kaixinsan, or Donepezil by gavage twice a day for 14 days. Morris water maze experiment was used to observe the learning memory ability of mice. Hematoxylin-eosin (HE) staining method was used to observe the pathological changes in the CA1 area of the mouse hippocampus. Enzyme linked immunosorbent assay(ELISA) was used to determine the serum acetylcholine (ACh) and acetylcholinesterase (AChE) contents of mice. Western blot method was used to detect the protein expression levels of signal transducer and activator of transcription 3(STAT3) and nuclear transcription factor(NF)-κB p65 in the hippocampus of mice. ResultsA total of 73 active ingredients of Kaixinsan were obtained, and 578 potential targets (common targets) of Kaixinsan for the treatment of AD were screened out. Key active ingredients included kaempferol, gijugliflozin, etc.. Potential core targets were STAT3, NF-κB p65, et al. GO functional enrichment analysis obtained 3 124 biological functions, 254 cellular building blocks, and 461 molecular functions. KEGG pathway enrichment obtained 248 pathways, mainly involving cancer-related pathways, TRP pathway, cyclic adenosine monophosphate(cAMP) pathway, and NF-κB pathway. Molecular docking showed that the binding of the key active ingredients to the target targets was more stable. Morris water maze experiment indicated that Kaixinsan could improve the learning memory ability of SCOP-induced mice. HE staining and ELISA results showed that Kaixinsan had an ameliorating effect on central nerve injury in mice. Western blot test indicated that Kaixinsan had a down-regulating effect on the levels of NF-κB p65 phosphorylation and STAT3 phosphorylation in the hippocampal tissue of mice in the SCOP model. ConclusionKaixinsan can improve the cognitive impairment function in SCOP model mice and may reduce hippocampal neuronal damage and thus play a therapeutic role in the treatment of AD by regulating NF-κB p65, STAT3, and other targets involved in the NF-κB signaling pathway.
8.Distribution characteristics of smoking behavior among adult twins in China
Shunkai LIU ; Wenjing GAO ; Weihua CAO ; Jun LYU ; Canqing YU ; Shengfeng WANG ; Tao HUANG ; Dianjianyi SUN ; Chunxiao LIAO ; Yuanjie PANG ; Ruqin GAO ; Min YU ; Jinyi ZHOU ; Xianping WU ; Zhong DONG ; Fan WU ; Dezheng WANG ; Zhihua XU ; Yu LIU ; Jianrui WANG ; Jie YIN ; Shengli YIN ; Liming LI
Chinese Journal of Preventive Medicine 2025;59(7):1090-1096
This study aims to describe the population and regional distribution characteristics of smoking behavior among adult twins in the China Twin Registry (CNTR), as well as the concordance rates for smoking behavior in monozygotic and dizygotic twins, and estimate the heritability. The study population included adult twins in CNTR who had smoking questionnaire data. A random-effects regression model was used to describe the distribution of smoking behavior among different subgroups based on various characteristics. The concordance of smoking behavior between different zygosity groups was calculated, and heritability was estimated. A total of 28 444 twin pairs were included in this study, with an average age of (36.6±12.0) years. Among male twins, 41.2% were current smokers, while only 1.2% of females smoked. Higher smoking rates were observed among male smokers in the 50-59 age group ( z=23.0, P<0.001), northern regions ( z=2.9, P<0.01), rural areas ( z=-5.2, P<0.001), those who were divorced/widowed ( z=3.8, P<0.001), and first-born twins ( z=-4.3, P<0.001), while lower smoking rates were found in those with higher education ( z=-16.1, P<0.001) and unmarried individuals ( z=-16.0, P<0.001). The smoking concordance rate for male monozygotic twins was 69.6%, significantly higher than the 57.3% concordance rate for dizygotic twins ( χ 2=105.0, P<0.05). The heritability of smoking behavior in male twins was estimated at 28.9% (95% CI: 24.3%-33.4%). Stratified analyses showed differences in heritability across regions and age groups: the heritability in northern regions was 32.6% (95% CI: 27.3%-38.0%), higher than the 21.0% (95% CI: 12.4%-29.5%) observed in southern regions; the highest heritability of 35.1% (95% CI: 26.3%-43.9%) was found in the 18-29 age group, with heritability decreasing with age. In conclusion, the smoking rate and influencing factors in the twin population are similar to those in the general population, with unique characteristics, such as higher smoking rates in first-born twins. Genetic factors have a significant impact on smoking behavior.
9.Proficiency testing for 11 clinical biobanks in Beijing City: simulation study and result analysis
Qian ZHANG ; Yun ZHANG ; Lu HAN ; Min LIU ; Yongbo YU ; Yan WANG ; Ying HU ; Hui ZHONG ; Dan GUO ; Shipeng SUN ; Jinxi LIN ; Siyuan XU ; Xiaokun TANG ; Gaoyuan SUN ; Chuanbao ZHANG ; Hexin LI
Chinese Journal of Preventive Medicine 2025;59(9):1590-1596
Objective:To evaluate the sample preparation proficiency and storage proficiency of 11 clinical biobanks in Beijing through simulated experiments, and to establish an assessment method for the quality comparability of biological samples.Methods:An exploratory research design was adopted. In November 2023, artificial composite serum quality control materials containing six recombinant human protein markers—recombinant human alanine aminotransferase (rhALT), recombinant human aspartate aminotransferase (rhAST), recombinant human creatine kinase (rhCK), recombinant human creatine kinase-MB (rhCK-MB), recombinant human B-type natriuretic peptide (rhBNP), and recombinant human troponin I (rhTNI)—were distributed to 11 clinical biobanks in Beijing City. Sample preparation and storage followed the standardized operating procedures. Proficiency differences were assessed through statistical analysis.Results:Three-way repeated measures ANOVA revealed all six protein markers showed a declining trend over storage time in ultra-low-temperature environments ( F values 11.68-4 179.66, all P<0.01). However, neither long-term/temporary refrigerator types ( F values 0.01-1.23, all P>0.05)nor placement locations within refrigerators significantly affected the stability of these six proteins ( F valus 0.03-1.47, all P>0.05). The biases in detection results for rhALT, rhAST, rhTNI, and rhBNP at different storage time points were within the allowable bias limits for each item, supporting their use as markers for protein stability in biobank samples. All 11 institutions passed the storage proficiency assessment. In the preparation proficiency assessment, deviations were observed in post-preparation sample results, with a notably high out-of-control rate for rhCK (36.36%). Conclusion:Sample preparation proficiency can serve as a quality control metric for clinical biobanks. Future external quality assessment systems for biobanks should focus on sample preparation rather than storage processes.
10.Clinical characteristics and outcomes of elderly patients with stage Ⅰ diffuse large B-cell lymphoma: a study by the Jiangsu Cooperative Lymphoma Group (JCLG)
Yi XIA ; Jing HE ; Weiying GU ; Tao JIA ; Tingxun LU ; Yongle LI ; Jiahao ZHOU ; Bingzong LI ; Haiying HUA ; Ping LIU ; Yuqing MIAO ; Yuexin CHENG ; Xiaoyan XIE ; Yunping ZHANG ; Wenzhong WU ; Zhuxia JIA ; Xuzhang LU ; Chunling WANG ; Liang YU ; Min XU ; Jinning SHI ; Weifeng CHEN ; Wanchuan ZHUANG ; Zhen QIAN ; Jun QIAN ; Haiwen NI ; Yifei CHEN ; Qiudan SHEN ; Jianyong LI ; Wenyu SHI
Chinese Journal of Internal Medicine 2025;64(6):504-513
Objective:To summarize the clinical characteristics of elderly patients with stage Ⅰ diffuse large B-cell lymphoma (DLBCL) and analyze the factors associated with prognosis.Methods:A case series study was conducted by retrospectively collecting clinical data from patients aged over 60 years with newly diagnosed stage Ⅰ DLBCL across 20 medical centers in Jiangsu Province, China, between June 2010 and April 2023. The involved site, classification and treatment plan were summarized. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Statistical analyses were performed using the Kaplan-Meier method, and Cox regression model.Results:The study included 255 patients with a median age of 69 years, of whom 130 (51.0%) were male, 66 (25.9%) were aged ≥75 years and 26 (10.1%) had a high Charlson Comorbidity Index (CCI) score of ≥2. Extranodal involvement was observed in 163 (63.9%) patients, with the stomach (37.4%, 61/163), intestine (19.0%, 31/163), testes (11.0%, 18/163), and breast (7.4%, 12/163) being the most frequently affected sites. The non-germinal center B-cell (non-GCB) subtype was prevalent in 63.7% of patients (142/223), with no significant difference between the nodal and extranodal groups ( P=0.681). Furthermore, 73.9% (184/249) and 11.7% (29/249) of patients received the R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) and R-miniCHOP regimen, respectively. The overall 3-year PFS rate was 81.5%, and the 3-year OS rate was 85.6%. Patients aged ≥75 years ( HR=2.910, 95% CI 1.565-5.408, P=0.001) and/or with a CCI score ≥2 ( HR=2.324, 95% CI 1.141-4.732, P=0.020) had a significantly poorer PFS. Incorporating age ≥75 years and CCI score ≥2 into the stage-modified international prognostic index (sm-IPI) can better stratify the prognosis of elderly patients with stage Ⅰ DLBCL. The 3-year PFS rate was 48.7% in the high-risk group versus 85.7% in the low-risk group ( P<0.001). Conclusions:Our findings show that the elderly patients with stage Ⅰ DLBCL were predominantly characterized by extranodal involvement (particularly in the stomach and intestinal tract) and non-GCB subtype. Age ≥75 years and CCI ≥2 were identified as independent prognostic factors. The newly established sm-IPI-75-CCI incorporating these factors demonstrated superior prognostic discrimination compared to conventional risk assessment systems.

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