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    30 June 2026, Volume 41 Issue 6
    Standardization of clinical blood lipid testing:from guidelines to practice
    LI Benbo, YAN Shengkai
    2026, 41(6):  517-520.  DOI: 10.3969/j.issn.1673-8640.2026.06.001
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    Dyslipidemia,especially elevated low-density lipoprotein cholesterol (LDL-C),is a pathogenic risk factor for atherosclerotic cardiovascular disease (ASCVD). As the primary link in blood lipid management,the quality of clinical blood lipid testing directly determines the accuracy of clinical decision-making for ASCVD and the overall level of comprehensive management. Therefore,it is recommended to conduct comprehensive and systematic quality management throughout the blood lipid testing process,including pre-examination processes,examination processes and post-examination processes,so as to promote the standardization of clinical blood lipid profile testing and provide reliable support for precise blood lipid management across the whole life cycle. Meanwhile,further communication between clinical laboratories and clinical departments should be strengthened to comprehensively improve the quality of clinical blood lipid management.

    Consistency of the estimation results of LDL-C based on formula method and the direct determination results of LDL-C by homogeneous enzymatic method in patients with ASCVD
    WANG Xiaoling, SHI Qingyu, ZHOU Jiaye, WANG Kouqiong, ZHU Jing, SHEN Yifeng, SHAO Wenqi, PAN Baishen, WANG Beili, GUO Wei
    2026, 41(6):  521-529.  DOI: 10.3969/j.issn.1673-8640.2026.06.002
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    Objective To evaluate the correlation between the results of low-density lipoprotein cholesterol(LDL-C) calculated using different estimation formulas and the homogeneous enzymatic method(direct method) in patients with atherosclerotic cardiovascular disease(ASCVD). Methods A total of 101 144 newly diagnosed ASCVD patients from Zhongshan Hospital of Fudan University from January 1,2020 to December 31,2022 were enrolled. The total cholesterol(TC),triglyceride(TG),high-density lipoprotein cholesterol(HDL-C) and LDL-C levels were determined using the homogeneous enzymatic method,and non-high-density lipoprotein cholesterol(non-HDL-C) was calculated. LDL-C results were calculated using the Friedewald formula,Martin-Hopkins formula,Martin-Hopkins extended formula and Sampson formula. All the patients were classified based on the TG determination results:≤1.70 mmol·L-1 group,>1.70-≤4.52 mmol·L-1 group,>4.52-≤9.04 mmol·L-1 group and >9.04 mmol·L-1 group. The determination coefficient(r2),root mean square error(RMSE) and mean absolute difference(MAD),as well as the proportion of patients whose classification changed at the LDL-C treatment target values(1.4,1.8 and 2.6 mmol·L-1),were used to evaluate the differences in LDL-C estimation results between the formula method and the direct method. Results Among the 101 144 ASCVD patients,the Sampson formula,Martin-Hopkins formula,Martin-Hopkins extended formula and Friedewald formula were all correlated with the direct method,with r2 values of 0.956 6,0.948 1,0.949 3 and 0.904 5,respectively,and RMSE values of 0.29,0.27,0.27 and 0.44 mmol·L-1,respectively. As the TG level of patients increased,the r2 values of each estimation formula and the direct method decreased,and the RMSE and MAD increased. According to different LDL-C treatment target values,the classification of ASCVD patients based on the direct method LDL-C results was used as the standard,and the proportion of patients whose classification changed was the lowest for the Martin-Hopkins formula and Martin-Hopkins extended formula(23.10% and 23.11%),and the highest for the Friedewald formula(34.27%). The 1.4‰ of patients had a classification change amplitude exceeding 3 LDL-C treatment target values. Conclusions In ASCVD patients,the correlation between LDL-C estimation results of the Sampson formula and LDL-C determination results of the direct method is the highest,followed by the Martin-Hopkins formula and Martin-Hopkins extended formula,and the lowest is the Friedewald formula. As the TG level increases,the correlation between estimation formula and direct method results decreases. Therefore,when making treatment decisions based on LDL-C treatment target values in clinical practice,the differences in LDL-C estimation results among different formulas should be fully considered.

    Analysis of postprandial sd-LDL,sd-LDL% and conventional blood lipid parameter reference cut-off values in healthy adults
    HU Hao, XU Xiaoping, YU Wenting, WANG Haijun, CHEN Shengjiao, LIU Weiqun
    2026, 41(6):  530-537.  DOI: 10.3969/j.issn.1673-8640.2026.06.003
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    Objective To investigate the postprandial blood lipid levels [total cholesterol(TC),triglyceride(TG),high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C),small and dense low-density lipoprotein cholesterol(sd-LDL-C),non-high-density lipoprotein cholesterol(non-HDL-C),remnant lipoprotein cholesterol(RLP-C),the percentage of small and dense low-density lipoprotein(sd-LDL%)and the ratio of TG/HDL-C] in healthy adults under normal dietary conditions,and to establish the reference cut-off values. Methods A total of 1 417 healthy subjects who underwent routine physical examinations from June 2024 to April 2025 at Jiangwan Hospital in Hongkou District,Shanghai,were enrolled. They were classified by gender and age. For males,the groups were 18-40 years old,41-60 years old and >60 years old. For females,the groups were 18-30 years old,31-45 years old,46-55 years old and ≥56 years old. The samples were collected from all the subjects for 2-4 h after lunch. TC,TG,HDL-C,LDL-C and sd-LDL-C were determined,and non-HDL-C,RLP-C,sd-LDL% and the ratio of TG/HDL-C were calculated. The 90th percentile (P90)of each item was statistically analyzed,and the upper limits of reference intervals were established. Results There was statistical significance in postprandial TC,TG,HDL-C,non-HDL-C,sd-LDL% and the ratio of TG/HDL-C among males and females(P<0.05),while there was no statistical significance in postprandial LDL-C,sd-LDL-C and RLP-C levels(P>0.05). The levels of sd-LDL-C and sd-LDL% were increased with age in both males and females(P<0.05). The levels of TC,TG,LDL-C,non-HDL-C,sd-LDL-C and sd-LDL% and the TG/HDL-C ratio in postprandial blood of females increased with age (P<0.001). The levels of postprandial sd-LDL-C and TG and the ratio of TG/HDL-C,non-HDL-C were positively correlated(r values were 0.512,0.505 and 0.421,respectively,P<0.01),and negatively correlated with HDL-C(r=-0.276,P<0.01). Among healthy subjects≤45 years old,the blood lipid levels of males,except for HDL-C,were lower than those of females in the same age group(P<0.01),and the other blood lipid levels were higher than those of females(P<0.01). Among healthy subjects>55 years old,the TC,TG,HDL-C,LDL-C,non-HDL-C,RLP-C,sd-LDL-C levels and the ratio of TG/HDL-C were higher in females than in males(P<0.05). After excluding the subjects with TG >5 mmol·L-1,the upper limits of the 90% reference interval for postprandial sd-LDL-C and sd-LDL% were as follows:for males ≤60 years old,<1.61 mmol·L-1 and <52.1%;for males >60 years old,<1.71 mmol·L-1 and <65.7%;for females ≤45 years old,<1.39 mmol·L-1 and <43.3%;for females >45 years old,<1.71 mmol·L-1 and <52.7%. Conclusions The 90% reference upper limit values of blood lipid indicators after daily ordinary meals for healthy adults of different genders and ages have initially established. In a non-fasting state,sd-LDL-C and sd-LDL% are indicators reflecting the blood lipid metabolism changes with aging in males. There are differences in blood lipid metabolism among females of different age groups.

    Analysis of the trend of lipoprotein(a) concentration from 2005 to 2024 based on the data from over 1.5 million cases
    XIONG Ying, WANG Yini, ZHU Jing, SHAO Wenqi, PAN Baishen, WANG Beili, GUO Wei
    2026, 41(6):  538-546.  DOI: 10.3969/j.issn.1673-8640.2026.06.004
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    Objective To investigate the distribution of lipoprotein(a) [Lp(a)] concentration and the trend of abnormal rate changes. Methods The Lp(a) concentration data of 1 540 949 cases who visited or underwent examinations at Zhongshan Hospital of Fudan University from November 2005 to December 2024 were collected. After datum cleaning,Mann-Kendall trend test was used to analyze the distribution of Lp(a) concentration and the abnormal rate >300 mg·L-1. The individuals with ≥2 Lp(a) concentration tests was selected,and the changes in the first and last results were analyzed. Results The 50th percentile(P50) of Lp(a) concentration was relatively stable,being 111.0 mg·L-1 in 2005 and 110.2 mg·L-1 in 2024. While the 25th percentile(P25) increased from 56.0 mg·L-1 to 62.5 mg·L-1,and the 75th percentile(P75) increased from 226.5 mg·L-1 to 248.7 mg·L-1. The overall abnormal rate of Lp(a) slightly increased,and it was higher in females than in males. The abnormal rate is the highest among population over 80 years old. The changes in Lp(a) between the first and last tests in the population were not significant,and the proportions of Lp(a) concentrations <300 mg·L-1 and ≥300 mg·L-1 in the 2 tests were 95.5% and 85.8%,respectively. Conclusions From 2005 to 2024,the P50 of Lp(a) concentration in the tested population from zhongshan Hospital of Fudan University remained stable,while the P25P75 and abnormal rate showed an upward trend. Among them,the increase in Lp(a) concentration in females was more significant than that in males. It is notable that the abnormal rate of Lp(a) in males and females aged 40-59 years showed a significant upward trend,and continuous early monitoring of Lp(a) is of significance for the discovery,prevention and treatment of cardiovascular diseases.

    Correlation between the single nucleotide polymorphism of PLA2G7 gene and the activity and concentration of Lp-PLA2
    SHAO Wenqi, ZHOU Yan, XIONG Ying, ZHU Jing, GUO Jiajie, PAN Baishen, WANG Beili, GUO Wei
    2026, 41(6):  547-553.  DOI: 10.3969/j.issn.1673-8640.2026.06.005
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    Objective To investigate the relationship between PLA2G7 gene single nucleotide polymorphisms(SNP)and the activity and concentration of lipoprotein-associated phospholipase A2 (Lp-PLA2). Methods A total of 100 patients with coronary artery disease (CAD) diagnosed by coronary angiography at Zhongshan Hospital of Fudan University from January 2024 to December 2024 and 100 healthy subjects (healthy control group) were enrolled. The serum total cholesterol (TC),triglyceride (TG),high-density lipoprotein cholesterol (HDL-C),low-density lipoprotein cholesterol (LDL-C) and Lp-PLA2 activity and concentration were determined,as well as the SNP of PLA2G7 gene at rs1805017,rs1805018,rs76863441 and rs1051931 loci. Spearman correlation analysis was used to evaluate the correlation between different SNP sites of PLA2G7 gene. Multiple linear models were used to analyze the influencing factors of Lp-PLA2 activity and concentration. Results There was statistical significance in serum TC,TG,LDL-C,HDL-C levels and Lp-PLA2 activity between CAD group and healthy control group (P<0.05),while there was no statistical significance in Lp-PLA2 concentration between the 2 groups (P>0.05). The genotype distribution of PLA2G7 gene at rs1051931 locus had statistical significance between CAD group and healthy control group (P=0.036). The genotypes at other loci showed no statistical significance between the 2 groups (P>0.05). Among all the subjects,the PLA2G7 gene I198T locus mutation was positively correlated with V279F locus mutation (r=0.706,P<0.001),and V379A locus mutation was positively correlated with R92H and I198T locus mutations(r values were 0.256 and 0.140,P<0.05). In CAD group and healthy control group,the carriers of V279F and I198T locus mutation (including heterozygous and homozygous mutations) had lower Lp-PLA2 activity and concentration than wild-type (P<0.05). After adjusting for age,gender and blood lipid indicators,V279F and I198T were locus independent influencing factors for the decrease in Lp-PLA2 concentration (P<0.05),and V279F mutation was an independent influencing factor for the decrease in Lp-PLA2 activity (P<0.001). Conclusions The SNP of PLA2G7 gene at rs1805018 and rs76863441 loci are related to Lp-PLA2 activity and concentration,and they are independent influencing factors for the decrease in Lp-PLA2 level.

    Application value of a novel serum biomarker P85 antibody for nasopharyngeal carcinoma in high-risk populations of Epstein-Barr virus infection in low-incidence areas
    GE Donghua, CHENG Cheng, SHEN Lilin, QIN Xin, GAO Chunfang, GAO Zhiyuan, XU Xuewen
    2026, 41(6):  554-559.  DOI: 10.3969/j.issn.1673-8640.2026.06.006
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    Objective To investigate the value of the novel nasopharyngeal carcinoma(NPC) biomarker P85 antibody in screening high-risk individuals in low-incidence areas and its diagnostic efficacy for NPC. Methods A total of 156 high-risk patients(140 non-NPC and 16 NPC cases) were enrolled from Yueyang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai University of Traditional Chinese Medicine from January 2024 to December 2025. High-risk individuals were defined as those with positive plasma Epstein-Barr virus(EBV) DNA(≥400 copies·mL-1) and positive serum EBV viral capsid antigen(VCA) IgA antibody and/or nuclear antigen 1(NA1) IgA antibody. The clinical data and EBV infection-related indicators(plasma EBV DNA load and serum EBV-related antibodies) were collected,and P85 antibody levels were determined. The diagnostic efficacy of each indicator for NPC was evaluated using receiver operating characteristic(ROC) curve. To avoid overfitting in small samples,5 cross-validation methods(K-fold,leave-one-out,leave-group-out,bootstrap and stratified K-fold) were used to internally validate the diagnostic efficacy,and the corrected area under curve(AUC) and 95% confidence interval(CI) were calculated. Results The serum P85 antibody level in NPC group was higher than that in control group(P<0.001),while there was no statistical significance in plasma EBV DNA load,NA1 IgA antibody and VCA IgA antibody levels between the 2 groups(P>0.05). The AUC for diagnosing NPC by EBV DNA,NA1 IgA antibody,VCA IgA antibody and P85 antibody were 0.514,0.587,0.633 and 0.916,respectively. After validation by 5 cross-validation methods(K-fold,leave-one-out,leave-group-out,bootstrap and stratified K-fold),the corrected AUC of P85 antibody were 0.879,0.874,0.919,0.910 and 0.898,respectively,with small fluctuations among different methods. The AUC of EBV DNA,NA1 IgA antibody and VCA IgA antibody ranged from 0.543 to 0.770,0.542 to 0.860 and 0.482 to 0.654,respectively,with large fluctuations among different methods. Conclusions P85 antibody has high specificity in high-risk individuals in low-incidence areas of NPC and can be used as a novel diagnostic marker for NPC in such areas.

    Role of combined determination of anti-phospholipase A2 receptor antibody and urine protein markers in the diagnosis of primary membranous nephropathy
    WANG Wenjuan, JIN Jizhi, ZHANG Chunxu, LIU Hua
    2026, 41(6):  560-565.  DOI: 10.3969/j.issn.1673-8640.2026.06.007
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    Objective To investigate the role of combined determination of serum anti-phospholipase A2 receptor antibody(PLA2R-Ab) and urine protein markers in the diagnosis of primary membranous nephropathy(PMN). Methods Totally,61 patients with PMN at the Sixth Affiliated Hospital of Shanghai Jiao Tong University from July 2023 to March 2024,49 patients with immunoglobulin A nephropathy(IgAN),156 patients with diabetic nephropathy(DN) and 42 patients with other glomerular diseases were enrolled. Serum PLA2R-Ab,IgG4,urine alpha1-microglobulin(α1-MG),immunoglobulin G(IgG),transferrin(TF),microalbumin(mAlb),creatinine(Cr),red blood cell(RBC) count,urine protein and urine albumin-to-creatinine ratio(ACR),24 h urine mAlb and 24 h urine protein were determined and calculated. Spearman correlation analysis was used to evaluate the correlation between PLA2R-Ab and renal function indicators. Logistic regression analysis was used to evaluate the influencing factors of PMN occurrence. Receiver operating characteristic(ROC) curve was used to evaluate the efficacy of each indicator in diagnosing PMN. Results There was statistical significance in serum PLA2R-Ab,urine mAlb,urine TF,urine IgG,ACR and urine RBC count among PMN group,IgAN group,DN group and other glomerular disease group(P<0.05),while there was no statistical significance in serum IgG4 levels(P>0.05). In PLA2R-Ab-positive PMN patients,serum PLA2R-Ab level was positively correlated with ACR and urine IgG(r values were 0.239 and 0.228,P<0.05). Urine IgG,urine TF and serum PLA2R-Ab were independent risk factors for PMN occurrence [odds ratios(OR) were 0.994,1.012 and 1.358,95% confidence intervals(CI) were 0.990-0.999,1.006-1.017 and 1.039-1.774,P<0.05]. The areas under curves(AUC) of single and combined determinations of urine IgG,urine TF and serum PLA2R-Ab for diagnosing PMN were 0.650,0.814,0.858 and 0.953,respectively. Conclusions Serum PLA2R-Ab,urine IgG and urine TF are related to the occurrence of PMN,and the combined determination of the 3 indicators can improve the diagnostic efficacy of PMN.

    Prognostic evaluation role of 21-gene recurrence score based on different risk stratification criteria in ER-positive,HER-2-negative Luminal type early IDC patients
    LIN Jiafei, CHEN Xiaosong, WU Beiying, JIN Lilan, LIN Lin
    2026, 41(6):  566-574.  DOI: 10.3969/j.issn.1673-8640.2026.06.008
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    Objective To evaluate the value of 21-gene recurrence score(RS) based on different risk stratification criteria in the prognosis assessment of estrogen receptor(ER)-positive,human epidermal growth factor receptor 2(HER-2)-negative Luminal type early invasive ductal carcinoma(IDC) patients. Methods A total of 771 ER-positive,HER-2-negative female IDC patients who underwent surgical treatment at Ruijin Hospital,Shanghai Jiao Tong University School of Medicine from January 2013 to December 2019 were enrolled. The clinical data were collected,and 16 tumor-related genes and 5 reference genes were determined to calculate the 21-gene RS. All the patients were classified into low-risk,intermediate-risk and high-risk groups according to the 21-gene RS grouping criteria of the NSABP B-14 study(low-risk <18 points,intermediate-risk 18-30 points,high-risk >30 points) and the 21-gene RS grouping criteria of the TAILORx trial(low-risk<11 points,intermediate-risk 11-25 points,high-risk>25 points). The follow-up period was 5 years,and the disease-free survival(DFS) endpoint events were recorded. Multivariate ordinal Logistic regression analysis was used to evaluate the influencing factors of different grouping criteria for IDC patients. The survival situation of IDC patients was evaluated using the Kaplan-Meier survival curve. Results There was statistical significance in PR expression,Ki67 expression,molecular typing,menstrual status and histological grade among the low-risk,intermediate-risk and high-risk groups based on the NSABP B-14 study criteria(P<0.05). Low PR expression,histological grade Ⅲ and high Ki67 expression were independent risk factors for high-risk 21-gene RS(P<0.05). There was statistical significance in age,tumor size,PR expression,Ki67 expression,molecular typing,menstrual status,histological grade and clinical stage among the low-risk,intermediate-risk and high-risk groups based on the TAILORx trial criteria(P<0.05). Low PR expression and histological grade Ⅲ were independent risk factors for high-risk 21-gene RS(P<0.001). After 5-year follow-up,65 of the 771 IDC patients had DFS endpoint events. There was no statistical significance in 5-year DFS rate among the low-risk,intermediate-risk and high-risk groups based on the NSABP B-14 study criteria(P>0.05). There was statistical significance in 5-year DFS rate among the low-risk,intermediate-risk and high-risk groups based on the TAILORx trial criteria(P<0.05). There was statistical significance in 5-year DFS rates among different tumor sizes,histological grades,Ki67 expression,molecular typing and clinical stages(P<0.05). The intermediate-high-risk and tumor>2 cm based on the TAILORx trial criteria were independent risk factors for poor prognosis in IDC patients(P<0.05). Conclusions The 21-gene RS is related to PR expression and histological grade in IDC patients. The risk stratification criteria based on the TAILORx trial are more effective for prognosis assessment of IDC patients than those based on the NSABP B-14 study,and it can provide more valuable clinical decision-making basis for ER-positive,HER-2-negative IDC patients.

    Salmonella typhimurium T3SS effector protein AvrA enhances its intracellular survival by inhibiting itaconate transfection
    ZHAO Hongyu, ZHONG Mengjiao, LI Yirong, LIAN Huan
    2026, 41(6):  575-582.  DOI: 10.3969/j.issn.1673-8640.2026.06.009
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    Objective To screen and identify type Ⅲ secretion system(T3SS) effector protein of Salmonella typhimurium that affect the transfection of host cell itaconate. Methods A stable HeLa cell line expressing the key enzyme immune responsive gene 1(IRG1) for itaconate synthesis was constructed. After transfection with the effector protein of Salmonella,bacterial infection was performed. The transfection level of itaconate into Salmonella-containing vesicles(SCV) was determined by plate colony counting and the luciferase reporter system for itaconate. A mutant strain of Salmonella with effector protein gene knockout was constructed by homologous recombination using suicide plasmids. Combined with colony counting,luciferase reporter experiments and confocal imaging,the changes in itaconate transfection were further analyzed. Real-time fluorescence quantitative polymerase chain reaction(qPCR) and western blotting were used to determine the effect of effector protein AvrA on the expression of IRG1 at the mRNA and protein levels. Confocal imaging was used to determine the localization of AvrA in the cells. Liquid chromatography-tandem mass spectrometry(LC-MS/MS) was used to screen potential host-interacting proteins of AvrA. Results The effector protein AvrA significantly inhibited itaconate transfection into SCV(P<0.01). After overexpression of AvrA in HeLa-IRG1 cells,the transfection efficiency of itaconate decreased(P<0.001). In cells infected with the AvrA knockout strain,the transfection level increased(P<0.001),and the survival ability of bacteria in macrophages decreased(P<0.001). The real-time fluorescence quantitative PCR and western blotting showed that AvrA did not affect the expression of IRG1. Subcellular localization analysis showed that AvrA was simultaneously located in the host cytoplasm and nucleus. LC-MS/MS initially screened multiple potential host-interacting proteins of AvrA. Conclusions Salmonella typhimurium secretes the effector protein AvrA through its T3SS to inhibit the itaconate transfection into the SCV,thereby escaping the host cell's autonomous immune response and enhancing the survival ability of bacteria in the host cell. This process does not rely on the regulation of IRG1 expression.

    Treponema pallidum upregulates prostaglandin E2 through BiP-PERK-COX-2 signaling pathway in vitro to inhibit the phagocytosis of macrophages
    YI Dongyu, CHEN Rong, LI Na, SHEN Zhenhua
    2026, 41(6):  583-589.  DOI: 10.3969/j.issn.1673-8640.2026.06.010
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    Objective To analyze the effect of Treponema pallidum on the phagocytosis of macrophages and whether this effect is achieved through the regulation of prostaglandin E2 secretion pathway. Methods Human monocytic cell line THP-1 was differentiated into macrophages by phorbol myristate acetate(PMA) as the main cell experimental model. The phagocytosis of macrophages was determined by fluorescent microsphere phagocytosis assay. The secretion level of prostaglandin E2 in the cell supernatant was determined by enzyme-linked immunosorbent assay(ELISA). The expression of endoplasmic reticulum stress marker proteins(BiP,PERK and COX-2) was determined by western blotting. BiP inhibitor,PERK inhibitor,COX-2 inhibitor and prostaglandin E2 antibody were used for intervention experiments to verify whether Treponema pallidum inhibited the phagocytosis of macrophages by upregulating prostaglandin E2 through the activation of BiP-PERK-COX-2 signaling pathway. Results Treponema pallidum inhibited the phagocytosis of fluorescent microspheres by macrophages in a concentration-dependent manner. Treponema pallidum induced the secretion of prostaglandin E2 by macrophages,and the use of prostaglandin E2 antibody could reverse the phagocytosis inhibition caused by Treponema pallidum. BiP inhibitor,PERK inhibitor and COX-2 inhibitor could all effectively inhibit the production of prostaglandin E2 and restore the phagocytosis of macrophages. Conclusions Treponema pallidum inhibits the phagocytosis of macrophages in vitro by upregulating prostaglandin E2 through the activation of BiP-PERK-COX-2 signaling pathway.

    Molecular characteristics,virulence genes and drug resistance changes of clinical isolates of hypermucoviscous Klebsiella pneumoniae of a Grade 2 general hospital in Shanghai from 2018 to 2024
    CAI Xiaoyao, CHENG Yang, JIN Shu, FENG Yiming, HU Yiwen, ZHANG Li, ZHU Qing, ZHANG Ji, YAN Peiyi
    2026, 41(6):  590-596.  DOI: 10.3969/j.issn.1673-8640.2026.06.011
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    Objective To investigate the molecular characteristics,virulence genes and drug resistance of hypermucoviscous Klebsiella pneumoniae(hmKp) isolated clinically before and after the coronavirus disease 2019 pandemic in Putuo District People's Hospital of Shanghai,and to provide a reference for dealing with hmKp in clinical practice. Methods The clinical isolates of Klebsiella pneumoniae from January 2018 to December 2020(before the pandemic) and from January 2023 to December 2024(after the pandemic) were collected. Positive isolates of hmKp were screened out through latex agglutination test. The capsular serotypes(K1,K2,K5,K20,K54 and K57) and virulence genes(rmpArmpA2,iroNmagAiucAkfu and allS) of hmKp were determined by polymerase chain reaction(PCR). Multilocus sequence typing(MLST) was performed on the hmKp isolates,and their drug resistance was evaluated through in vitro drug susceptibility test. The capsular serotypes,virulence genes and drug resistance before and after the pandemic were compared. Results Totally,64 isolates of hmKp were determined. The determination rate of hmKp was 14.16% before the pandemic,and it was 11.68% after the pandemic. The isolates mainly were collected from respiratory tract samples. The distribution of capsular serotypes showed significant changes before and after the pandemic,with the dominant serotype shifting from K20 to K2,and the K57 serotype decreased from 25.0% to 0. The ST type diversity of hmKp had increased,with the K2 type mainly being ST86,and new subtypes such as ST25 had emerged. After the pandemic,the recombination of virulence genes was significant:iroN increased from 0 to 100% in K1,K2 and K20 types,rmpA2 reached 100% in K1 type,and iucA was completely lost in K1 and K2 types. The overall drug resistance rate decreased,with a significant reduction in cefotaxime(from 18.75% to 9.38%) and levofloxacin(from 18.75% to 6.25%),and the carbapenems maintained a low drug resistance rate(6.25% for imipenem). Conclusions It suggests that hmKp may exhibit characteristics of serotype substitution(rise of K2 type) and recombination of virulence genes(universalization of iroN) after the pandemic. Although the K2 type is not a traditional highly virulent serotype,it carries the rmpA+rmpA2+iroN complex virulence genes,and its clinical risk should be vigilant. It is recommended to assess the virulence potential of the isolates using multiple indicators rather than a single serotype.

    Application of plasma AT in renal injury and prognosis evaluation of multiple myeloma patients
    SUN Changming, WANG Liping, ZHAO Weichuan, PIAO Zongfang, GUO Yiqun
    2026, 41(6):  597-602.  DOI: 10.3969/j.issn.1673-8640.2026.06.012
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    Objective To analyze the clinical role of plasma antithrombin(AT) activities in patients with multiple myeloma(MM) with renal injury. Methods The data of 60 newly diagnosed MM patients(MM group) and 60 newly diagnosed patients with kidney disease(control group) from the Affiliated Hospital of Chengde Medical College from January 2018 to October 2020 were collected. The differences in AT activity among different immunological types of MM patients were compared. According to serum creatinine(SCr) level,the MM group and the control group were further classified into normal renal function,impaired renal function,normal renal function control group and impaired renal function control group. Pearson correlation analysis was used to evaluate the correlation between AT activity and cystatin C(Cys C) in MM patients. Receiver operating characteristic(ROC) curve was used to evaluate the efficacy of AT and Cys C in diagnosing renal injury in MM patients. Follow-up was conducted for MM patients,and the differences in survival time after chemotherapy among patients with different AT activities and Cys C levels were compared. Results There was statistical significance in AT activity among patients with different immune types of MM(F=13.144,P<0.05). The AT activity increased in the order of light chain type,IgG type,IgA type and non-secretory type MM patients. The plasma AT activity of MM patients with normal renal function was better than that of MM patients with impaired renal function(P<0.05),and the plasma AT activity of impaired renal function control group was lower than that of normal renal function control group(P<0.05). The plasma AT activity in impaired renal function group was higher than that in impaired renal function control group(P<0.05). The AT activity and Cys C of MM patients with renal injury were negatively correlated(r=-0.554,P=0.004). The areas under curves(AUC) of AT activity and Cys C for diagnosing renal injury in MM patients were 0.887 and 0.625,respectively. The survival time after treatment was longer in MM patients with normal AT activity and normal Cys C than in MM patients with reduced AT activity and increased Cys C,and also longer than in MM patients with normal AT activity and increased Cys C(P<0.05). Conclusions The plasma AT activity in MM patients is related to the immunological type of the patients. The AT activity can be used to assess renal injury in MM patients.

    Construction of a nomogram prediction model for secondary diabetic kidney disease in patients with type 2 diabetes mellitus
    HUANG Zhengju, CHEN Yabin, WANG Wanni, CHEN Jintu
    2026, 41(6):  603-608.  DOI: 10.3969/j.issn.1673-8640.2026.06.013
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    Objective To construct a nomogram model for predicting secondary diabetic kidney disease(DKD) in patients with type 2 diabetes mellitus(T2DM),and to evaluate its effectiveness. Methods A total of 143 patients with T2DM secondary to DKD(DKD group) and 190 patients with single T2DM(T2DM group) were enrolled from Quanzhou First Hospital of Fujian Medical University from January 2024 to June 2025. The clinical data and determination results were collected. The data of 235 patients in 2024 were included in the training set,and the data of 98 patients in 2025 were included in the test set. The differences in clinical data,fasting blood glucose(FBG),glycated hemoglobin A1c(HbA1c),urinary microalbumin-to-creatinine ratio(UACR),urinary chemical tests and formed element tests between patients with secondary DKD and patients with single T2DM in the training set were compared. Logistic regression analysis was used to evaluate the risk factors for DKD occurrence in the training set and to construct a nomogram model. Receiver operating characteristic(ROC) curve was used to evaluate the efficacy of the nomogram model and its single measurement indicators in diagnosing DKD. Based on the test set data,the ROC curve and decision curve were used to validate the nomogram model. Results In the training set,there was statistical significance in hypertension history,disease duration,FBG,HbA1c,urinary chemical tests and urinary formed element tests between DKD and T2DM groups(P<0.05). The prolongation of disease duration,elevated FBG level,positive urinary protein(PRO) were independent risk factors for DKD occurrence. Each risk factor and the 2 constructed nomogram models based on risk factors(nomogram 1)and independent risk factors(nomogram 2)could effectively screen for DKD. The areas under curves(AUC) were 0.598-0.949. The AUC of the 2 nomogram models for diagnosing DKD was higher than each single indicator. The AUC for screening DKD in the test set by the 2 nomogram models was >0.900. when the risk threshold was 10%,the clinical net benefits of nomogram 1 and nomogram 2 were 0.231 and 0.221,respectively. Conclusions The constructed nomogram model can provide a reference for clinicians to quickly and intuitively assess whether T2DM patients have secondary DKD.

    Application effect evaluation of automatic quality control in biochemical and immunological production line
    ZHENG Wenbin, HUANG Rong, GUO Weiquan, WANG Siqi, ZHANG Shichang
    2026, 41(6):  609-614.  DOI: 10.3969/j.issn.1673-8640.2026.06.014
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    Objective To evaluate the application effect of automatic quality control mode in the biochemical and immunological production line. Methods The manual and automatic internal quality control(IQC) results were analyzed by collecting 32 biochemical items and 22 immunological items of production line in Shenzhen Hospital of Southern Medical University from 2023 to 2024. The differences in precision,stability,consumption of quality control specimens,review time of the first report and control failure rate were analyzed. Results Among the 108 quality control data,82 showed statistical significance between the 2 quality control modes(P<0.05). Under the automatic quality control mode,for the 47 items with industry standards,except for the low-value quality control sample of free prostate speeific antigen whose coefficient of variation(CV) exceeded the industry standard requirements,the CV of the 2-level quality control samples for the other items all met the quality requirements. Totally,7 items had a CV of the low-value quality control sample,and 1 item had a CV of the high-value quality control sample higher than that of the manual quality control mode. There were 12 items with periodic changes related to the storage of quality control specimens. The consumption of quality control samples under the automatic quality control mode was at least 31.51% less than that under the manual quality control mode. Under the automatic quality control mode,the review time of the first report was approximately 10.47 min earlier than that under the manual quality control mode. The out-of-control rates of the automatic quality control mode and the manual quality control mode were 0.07% and 0.06%,respectively. Under the manual quality control mode,there was no out-of-control caused by the quality control specimens,while under the automatic quality control mode,the out-of-control caused by the quality control specimens accounted for 35.71% of the total out-of-control. Conclusions The automatic quality control mode of the biochemical and immunological production line can meet the clinical quality control requirements and has advantages in precision improvement,cost saving and efficiency optimization.