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    30 November 2024, Volume 39 Issue 11
    Clinical roles of miR-21,miR-222,miR-146b and miR-7 in diagnosis of papillary thyroid carcinoma
    LIANG Liang, YANG Haiqing, LI Yashan, WANG Jian, MAN Baohua, TANG Haixian, ZHANG Xiaojun, HE Sai, YIN Yan
    2024, 39(11):  1027-1034.  DOI: 10.3969/j.issn.1673-8640.2024.11.001
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    Objective To investigate the diagnostic roles of miR-21,miR-222,miR-146b and miR-7 for papillary thyroid carcinoma (PTC). Methods From December 2020 to December 2021,150 patients with PTC(PTC group),50 patients with benign thyroid nodules (benign nodule group) and 50 healthy subjects(healthy control group)were enrolled from the Third People's Hospital of Yunnan Province. All the clinical data of the research subjects were collected,and miR-21,miR-222,miR-146b and miR-7 were determined. The efficacy of each index in diagnosing PTC was evaluated by receiver operating characteristic(ROC)curve. Results The relative expression levels of miR-21,miR-222 and miR-146b in PTC group,benign nodule group and healthy control group were decreased successively (P<0.001),while the relative expression level of miR-7 was increased successively (P<0.001). There was statistical significance in the relative expression level of miR-222 among patients with different tumor stages(P<0.05). The relative expression level of miR-146b differed between patients with and without lymphatic metastasis (P<0.05). The relative expression levels of miR-21 and miR-7 were not statistically significant among patients with different genders,ages,tumor sizes, tumor stages and lymphatic metastasis(P>0.05).The areas under curves(AUC) of miR-21,miR-222,miR-146b and miR-7 single determinations in the differential diagnosis of PTC and benign nodules were 0.743,0.828,0.708 and 0.777,respectively. The AUC (0.933) of the combined determination of the 4 indicators was higher than those of the other three-three combinations,except for miR-222+miR-146b+miR-7 (0.917)(P>0.05),and it was also higher than those of the other two-two combinations and single determinations (P<0.05). The AUC of miR-222+miR-146b+miR-7 and the combined determination of the 4 indicators for the differential diagnosis of early (stage Ⅰ-Ⅱ) PTC and benign nodules were 0.914 and 0.925,respectively (P>0.05). For the differential diagnosis of middle-late (stage Ⅲ-Ⅳ) PTC and benign nodules,the AUC were 0.938 and 0.992,respectively (P>0.05). Conclusions MiR-146b and miR-222 are associated with the condition of PTC. The combined determination of miR-222,miR-146b and miR-7 has a relatively high efficacy in differentiating benign and malignant thyroid nodules in both the early and advanced stages of thyroid carcinoma.

    Roles of serum exosomal CEA,CA15-3 and CA125 in the differential diagnosis of non-small cell lung cancer and benign lung diseases
    CUI Xiaoyang, LIU Guodong, GUO Huijuan, LIAO Zhihong, LIU Yunhong, ZHANG Weifen, CHEN Zirao, WEI Xiaozhu
    2024, 39(11):  1035-1041.  DOI: 10.3969/j.issn.1673-8640.2024.11.002
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    Objective To investigate the roles of serum exosomal carcinoembryonic antigen(CEA),carbohydrate antigen(CA)15-3 and CA125 determinations in the differential diagnosis of non-small cell lung cancer(NSCLC)and benign lung diseases. Methods A total of 152 patients with NSCLC (28 cases of early-stage NSCLC and 124 cases of advanced NSCLC)and 86 patients with benign lung diseases were enrolled from Shenzhen Longhua District People's Hospital from January 2019 to December 2023. The exosomes in serum were extracted,serum and exosomal levels of CEA,CA15-3 and CA125 were determined. The diagnostic performance was assessed by receiver operating characteristic(ROC)curve. Logistic regression analysis was used to evaluate the risk factors of NSCLC. A combined determination model for differentiating NSCLC from benign lung diseases was constructed based on the 3 tumor markers in exosomes. Calibration curve and decision curve were used to evaluate the role of combined determination model. Results Compared with benign group,serum and exosomal levels of CEA,CA15-3 and CA125 in NSCLC group were increased (P<0.000 1). The serum levels of CEA,CA15-3 and CA125 were higher than exosomal levels (P<0.05). The serum levels and exosomal levels in NSCLC group showed a positive correlation (P<0.000 1). The serum levels of CEA,CA15-3 and CA125 in early-stage NSCLC group were higher than those in benign group (P<0.05). Compared with early-stage NSCLC group,serum CEA level in advanced NSCLC group was increased (P<0.05),while serum CA15-3,serum CA125,exosomal CEA,exosomal CA15-3 and exosomal CA125 levels were slightly increased(P>0.05). The areas under curves (AUC) for serum CEA,CA15-3 and CA125 in differentiating NSCLC from benign lung diseases were 0.788 3,0.789 6 and 0.678 6,respectively,while the AUC for exosomal CEA,CA15-3 and CA125 were 0.852,0.918 and 0.891,respectively. The combined determination model had good discrimination (AUC=0.970). The accuracy of the combined determination model was high (χ2=5.280 7,P=0.503),and the net benefit rate was >0 within the high-risk threshold range(0.00-1.00),with the maximum net benefit rate being 0.703. Conclusions The combined determination of exosomal CEA,CA15-3 and CA125 in serum samples has a high clinical value for the differential diagnosis of NSCLC and benign lung diseases.

    Etiology and molecular analysis of Streptococcus suis type 14 causing sepsis, meningitis and pneumonia
    ZHOU Ning, MAO Min, JI Xin, HE Jiale, YE Xiuyun, LIN Yubo, ZHONG Wei, LIU Yang
    2024, 39(11):  1042-1047.  DOI: 10.3969/j.issn.1673-8640.2024.11.003
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    Objective To identify and analyze the pathogenic bacteria isolated from blood samples of patients,and to understand the etiology and molecular characteristics of Streptococcus suis type 14. Methods Mass spectrometry analysis and serum agglutination test were used for identification. The drug resistance was analyzed by microbroth dilution method,and polymerase chain reaction (PCR)was used to determine 7 main virulence genes. Genomic information was obtained by next generation sequencing,and average nucleotide identity(ANI),ST typing and drug resistance gene analysis were performed. Results The isolates showed agglutination reaction with Streptococcus suis type 14,but no agglutination reaction with Streptococcus suis type 2. PCR showed positive 16S rRNA,negative cps2J and positive cps14J. The isolate were sensitive to all 9 antibiotics,including vancomycin,except for erythromycin,azithromycin,tetracycline and clindamycin,which were resistant. Except for gapdh virulence gene negative,the 6 main virulence genes,mrp,fbps,sly,orf2,ef and gdh,were all positive. The sequencing results showed ST 1 type,and phylogenetic tree analysis showed that this isolate had a relationship with previous isolates from Shenzhen City and Guangxi Zhuang Autonomous Region. Conclusions The isolated pathogen is highly virulent isolate Streptococcus suis type 14 ST 1,which can cause complications such as sepsis,meningitis and pneumonia in patients. Currently,there are no relevant reports. Epidemic prevention and monitoring should be strengthened in epidemic areas to avoid the recurrence of cases.

    Effect of different preservation methods on stability of samples in external quality assessment of paroxysmal nocturnal hemoglobinuria by flow cytometry
    ZHAO Qiang, XU Xiuwen, HAN Jiaojiao, SONG Ying, MIAO Yingbo, ZHU Peichao, ZHOU Wei, LIN Shiyang, TONG Lanfei, CHE Yiming, JIN Lei, XU Chong
    2024, 39(11):  1048-1052.  DOI: 10.3969/j.issn.1673-8640.2024.11.004
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    Objective To investigate the effect of different preservation methods on the stability of samples in external quality assessment (EQA)of paroxysmal nocturnal hemoglobinuria(PNH)by flow cytometry,and to lay the foundation for establishing an EQA system for PNH flow cytometry determination. Methods Totally,9 PNH positive fresh ethylenediaminetetracetic acid anticoagulated samples were collected. For each sample,the sample was mixed and then classified into 4 parts. The 3 parts of them were treated with 3 different cell preservation solutions,domestic company's cell preservation solution(Group A),foreign company's cell preservation solution(Group B)and acid-citrate-dextrose(ACD)cell preservation solution (Group C). The remaining 1 part was used as control without adding cell preservation solution (Group D). After the samples were treated,they were thoroughly mixed and divided into 5 parts and placed at 2-6℃. The sample stability under different preservation methods for 1,3,5,7 and 14 d was determined by standard flow cytometry recommended by the Clinical and Laboratory Standards Institute(CLSI) H52-A2. Results Compared with that at 2-6℃ for 1 d,the red blood cell PNH clone ratio exhibited a decreasing trend in Group A,B and D at 3,5,7 and 14 d(P<0.05),while Group C showed no statistical significance(P>0.05). The white blood cell PNH clone ratio remained stable in Group B and C. There was statistical significance between 7,14 d and 1 d for Group A and D(P<0.05),and there was no statistical significance for Group A and D at 3 and 5 d as well as for Group B and C at 3,5,7 and 14 d compared to 1 d (P>0.05). Conclusions In PNH determination,whether it is red blood cell PNH clone or white blood cell PNH clone,the samples with ACD preservation can meet the requirement of EQA sample stability within 14 d,ensuring the sample stability to the maximum extent possible.

    Roles of urinary exosome miR-27a,miR-27b,miR-29c,miR-200c in diagnosis of early diabetic nephropathy
    LIU Junru, LI Meng, XU Yang, ZHENG Weiying
    2024, 39(11):  1053-1059.  DOI: 10.3969/j.issn.1673-8640.2024.11.005
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    Objective To investigate the roles of urinary exosome miR-27a,miR-27b,miR-29c and miR-200c in the diagnosis of early diabetic nephropathy(DN). Methods A total of 260 type 2 diabetes mellitus(T2DM)patients were enrolled from Jinhua People's Hospital from January 2021 to December 2022. According to urinary albumin excretion rate(UAER),T2DM patients were classified into simple T2DM group(135 cases),early DN group(82 cases) and clinical DN group(43 cases). Another 50 healthy subjects from Jinhua People's Hospital were enrolled as control group. The general data of all the subjects were collected,and the expressions of urinary exosome miR-27a,miR-27b,miR-29c,miR-200c,urinary creatinine(UCr),urinary urea nitrogen(UUN),urinary transforming growth factor-beta 1(TGF-β1;corrected by UCr),glycated hemoglobin A1c(HbA1c),serum uric acid(UA)were determined. Pearson correlation analysis was used to evaluate the correlation between each index. Multiple stepwise regression analysis was used to evaluate the influencing factors for urinary TGF-β1. Receiver operating characteristic(ROC) curve was used to evaluate the efficacy of miR-27a,miR-27b,miR-29c and miR-200c in the diagnosis of early DN. Results The relative expression levels of urinary exosome miR-27a,miR-27b and miR-200c in healthy control group,simple T2DM group,early DN group and clinical DN group were increased successively(P<0.001),while the relative expression levels of miR-29c were decreased successively(P<0.001). The levels of UUN,UCr,corrected TGF-β1,HbA1c and UA in simple T2DM group,early DN group and clinical DN group were higher than those in healthy control group(P<0.05). The levels of UUN,UCr,UA,corrected TGF-β1 and UAER in simple T2DM group,early DN group and clinical DN group were increased successively(P<0.001). Urinary exosome miR-27a,miR-27b and miR-200c were positively correlated with UCr and corrected TGF-β1(P<0.01),while miR-29c was negatively correlated with UCr and corrected TGF-β1(P<0.001),and there was no correlation with UUN and UA(P>0.05). HbA1c,UCr and urinary exosome miR-27a,miR-27b,miR-29c and miR-200c were independent influencing factors for corrected TGF-β1(P<0.01). The areas under curves(AUC) of urinary exosome miR-27a,miR-27b,miR-29c and miR-200c for the diagnosis of early DN by single determinations and combined determination were 0.823,0.855,0.799,0.557 and 0.923,respectively. Conclusions The combined determination of urinary exosome miR-27a,miR-27b,miR-29c and miR-200c has good diagnostic value for early DN.

    Relationship between serum miR-9-5p,miR-185-5p expressions and cardiac function and ventricular remodeling in patients with ischemic heart failure
    LIU Ru, ZHANG Feifei, WANG Yu, LI Xin
    2024, 39(11):  1060-1065.  DOI: 10.3969/j.issn.1673-8640.2024.11.006
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    Objective To investigate the relationship between the expressions of serum miR-9-5p and miR-185-5p in patients with ischemic heart failure(IHF)and cardiac function and ventricular remodeling. Methods From February 2021 to February 2023,108 patients with IHF who received treatment at Nanyang Central Hospital were enrolled. According to New York Heart Association(NYHA)cardiac function classification,the patients with IHF were classified into grade Ⅰ-Ⅱ group(35 cases),grade Ⅲ group(42 cases) and grade Ⅳ group(31 cases). In addition,50 patients with mild coronary heart disease in remission period without heart failure were randomly enrolled as control group. The levels of serum miR-9-5p,miR-185-5p,B-type natriuretic peptide(BNP),left ventricular ejection fraction(LVEF),left atrial diameter(LAD)and left ventricular end diastolic diameter(LVEDD)were determined and measured. Pearson correlation analysis was used to evaluate the correlation of serum miR-9-5p,miR-185-5p and cardiac function,ventricular remodeling. Receiver operating characteristic(ROC)curve was used to analyze the diagnostic values of serum miR-9-5p,miR-185-5p for the diagnosis of IHF. Results The miR-9-5p and miR-185-5p relative expressions,LAD,LVEDD and BNP in IHF group were higher than those in control group(P<0.05),and LVEF was lower than that in control group(P<0.05). The levels of LAD,LVEDD,BNP,miR-9-5p and miR-185-5p relative expressions were increased in grade Ⅰ-Ⅱ,Ⅲ,Ⅳ groups(P<0.001),and LVEF was decreased(P<0.001). LAD,LVEDD,BNP and miR-9-5p,miR-185-5p had positive correlation(P<0.05). LVEF had negative correlation(P<0.05). The miR-9-5p and miR-185-5p were risk factors for IHF[odds ratios(OR)were 2.114 and 2.224,95% confidence intervals(CI)were 1.129-3.958 and 1.297-3.813,P<0.05]. The areas under curves (AUC) of miR-9-5p,miR-185-5p,LVEF,BNP were 0.806,0.789,0.734 and 0.751,respectively. The AUC of miR-9-5p+miR-185-5p+LVEF,miR-9-5p+miR-185-5p+BNP,miR-9-5p+miR-185-5p+LVEF+BNP were 0.879,0.876,0.936,respectively. Conclusions The expression levels of miR-9-5p and miR-185-5p in serum of patients with IHF are increased,they are related to cardiac dysfunction and may be involved in ventricular remodeling. The combination of serum miR-9-5p,miR-185-5p,LVEF and BNP has high efficacy in the diagnosis of IHF.

    Combined determination of anti-U1-RNP and anti-RNPA/RNP68 antibodies in diagnosis of autoimmune diseases
    WANG Ying, ZHANG Yihao, JI Wei, FU Yan, YU Xueying, ZHANG Hui, HU Tingting, SHEN Wei, MAN Qiuhong
    2024, 39(11):  1066-1071.  DOI: 10.3969/j.issn.1673-8640.2024.11.007
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    Objective To investigate the roles of anti-U1-ribonucleoprotein(RNP)antibody and anti-RNPA/RNP68 antibodies in the diagnosis of autoimmune diseases(AID). Methods From October 2021 to March 2024,136 AID patients from Shanghai Fourth People's Hospital of Tongji University and Renji Hospital of Shanghai Jiao Tong University School of Medicine were enrolled [AID group,including 23 cases of mixed connective tissue disease (MCTD),49 cases of systemic lupus erythematosus (SLE),14 cases of Sjögren's syndrome (SS),14 cases of lupus nephritis,17 cases of autoimmune hepatitis (AIH),19 cases of rheumatoid arthritis (RA)],and 136 non-AID patients (non-AID group) and 100 healthy subjects(healthy control group)were enrolled as well. The anti-RNPA /RNP68 antibodies were determined by flow dot matrix immunoluminescence,and anti-U1-RNP antibodies were determined by western blotting. Kappa test was used to evaluate the consistency of different methods. Receiver operating characteristic (ROC) curve was used to evaluate the efficacy of each index in diagnosing AID. Results The positive rates of anti-U1-RNP antibody and anti-RNPA/RNP68 antibody in AID group were higher than those in non-AID group and healthy control group (P<0.016 7),and the positive rates of the 2 antibodies in non-AID group were also higher than those in healthy control group (P<0.0167). There was no statistical significance in the positive rate of anti-U1-RNP antibody and anti-RNPA /RNP68 antibody among all the groups (P>0.05). The consistency of the 2 antibodies was better in healthy control group (Kappa=0.92),and it was poor in AID group (Kappa=0.10). The area under curve (AUC)of the combined determination of anti-U1-RNP antibody and anti-RNPA /RNP68 antibody (both positive) was 0.80,which was higher than those of single determinations (0.70,0.73) (P<0.01). For MCTD and SLE,the AUC of anti-U1-RNP antibody and anti-RNPA/RNP68 antibody combined determination were 0.81 and 0.75,respectively,which were higher than those of single determinations of anti-U1-RNP antibody (AUC were 0.73 and 0.70,respectively) (P<0.01). The AUC of the combined determination of the 2 antibodies for SLE was higher than that of the single determination of anti-RNPA/RNP68 antibody (0.67) (P<0.01). For lupus nephritis,the AUC of the combined determination of anti-U1-RNP antibody and anti-RNPA/RNP68 antibody was 0.52,which was lower than those of the single determinations of the 2 antibodies (0.62,0.69)(P<0.05). For SS,the AUC of anti-RNPA/RNP68 antibody single determination was 0.72,which was higher than that of anti-U1-RNP antibody single determination (0.51) (P<0.05). There was no statistical significance between the AUC of anti-U1-RNP antibody,anti-RNPA/RNP68 antibody and combined determination in diagnosing other AID (P>0.05). Conclusions Anti-U1-RNP antibody and anti-RNPA/RNP68 antibody have relatively high efficacy in the diagnosis of lupus nephritis and SS,respectively. The combined determination of 2 antibodies can improve the diagnostic ability of SLE and MCTD,and has certain value in clinical diagnosis.

    Clinical roles of indirect immunofluorescence assay,line immunoassay,chemiluminescent assay for determining antinuclear antibodies singly and in combination
    HU Chuanxi, LIU Lingyan, LI Man
    2024, 39(11):  1072-1077.  DOI: 10.3969/j.issn.1673-8640.2024.11.008
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    Objective To investigate the clinical roles of indirect immunofluorescence assay(IFA),line immunoassay(LIA) and chemiluminescent assay(CLIA) singly and in combination for determining antinuclear antibodies(ANA). Methods Totally,4 722 patients who underwent ANA determination at Shanghai Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine from August 2022 to July 2023 were enrolled,which included 935 patients with autoimmune diseases(AID) and 3 787 patients without AID. IFA was used to determine ANA,while LIA and CLIA were used to determine ANA specific spectra. The consistency analysis between different methods was conducted using Kappa test. The efficacy of different methods for diagnosing AID was evaluated by receiver operating characteristic(ROC) curve. Results The positive determination rates of IFA,LIA and CLIA in AID group were 67.5%,52.1% and 44.8%,respectively,which were all higher than those in non-AID group(36.9%,20.1% and 17.4%,respectively)(P<0.05). The consistency between IFA and LIA was average(Kappa=0.609),while the consistency between IFA and CLIA was poor(Kappa=0.276). Among patients with different types of diseases,AID patients had the highest consistency(Kappa values of 0.628 and 0.444 for IFA with LIA and CLIA,respectively),while patients with other diseases had the lowest consistency(Kappa values of 0.120 and 0.194 for IFA with LIA and CLIA,respectively). The areas under curves(AUC) for diagnosing AID using IFA,LIA and CLIA single determinations were 0.707,0.662 and 0.655,respectively. The AUC of parallel determinations of IFA+LIA and IFA+CLIA were 0.711 and 0.699,respectively,and those of series determinations IFA+LIA and IFA+CLIA were 0.677 and 0.647,respectively. Conclusions The consistency between IFA and LIA or CLIA is not high,and inconsistent results are more likely to occur in non-AID patients. When using a single determination for AID screening,IFA should be prioritized. If ANA and ANA specific spectrum are used for combined determination,parallel determination should be preferred.

    Correlation between serum ESM1,DHEA-S and cardiac autonomic neuropathy in patients with type 2 diabetes mellitus
    LI Sirui, XU Junyue
    2024, 39(11):  1078-1083.  DOI: 10.3969/j.issn.1673-8640.2024.11.009
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    Objective To investigate the correlation between serum endothelial cell-specific molecule 1(ESM1),dehydroepiandrosterone sulfate(DHEA-S)and cardiac autonomic neuropathy(CAN)in patients with type 2 diabetes mellitus(T2DM). Methods From August 2021 to August 2023,198 T2DM patients who were diagnosed and treated in Beijing Electric Power Hospital were enrolled. They were classified into CAN group (96 cases) and non-CAN group (102 cases) based on the standard cardiovascular autonomic reflex test(CART). The clinical data of all patients were collected. Serum ESM1,DHEA-S,inflammatory factors [high-sensitivity C-reactive protein (hs-CRP),interleukin-17 (IL-17)] and routine biochemical indicators [total cholesterol (TC),triglyceride (TG),high-density lipoprotein cholesterol (HDL-C),low-density lipoprotein cholesterol(LDL-C),serum creatinine (SCr),fasting blood glucose,glycated hemoglobin A1c(HbA1c),albumin(Alb),homocysteine (Hcy),cardiac troponin T (cTnT),hemoglobin (Hb)] were determined. Logistic regression analysis was used to evaluate the influencing factors of CAN in T2DM patients. The diagnostic efficacy of serum ESM1 and DHEA-S for CAN in T2DM patients was evaluated by receiver operating characteristic (ROC)curve. Results The serum ESM1 level in CAN group was higher than that in non-CAN group (P<0.05),and the serum DHEA-S level was lower than that in non-CAN group (P<0.05). ESM1,HbA1c,hs-CRP and cTnT were the risk factors for CAN in T2DM patients [odds ratios(OR)were 1.584,1.799,1.391 and 1.679,95% confidence intervals(CI)were 1.023-2.452,1.087-2.977,1.013-1.911 and 1.027-2.746,respectively,P<0.05]. DHEA-S and Alb were protective factors for CAN in T2DM patients (OR=0.793 and 0.907,95%CI 0.694-0.906 and 0.849-0.970,respectively,P<0.05). The areas under curves (AUC) of serum ESM1 and DHEA-S single and combined determinations for the diagnosis of CAN in T2DM patients were 0.889,0.848 and 0.947,respectively. The sensitivity and specificity of the combined determination were 90.6% and 76.4%,respectively. Conclusions Serum ESM1 and DHEA-S may serve as biomarkers for the diagnosis of CAN in patients with T2DM.

    Diagnostic efficacy evaluation of t-PSA and its derived indicator PHI and PI-RADS score for prostate cancer
    ZHANG Qin, YAO Hanxin, WANG Boyu, JU Xinwei, XU Wei
    2024, 39(11):  1084-1090.  DOI: 10.3969/j.issn.1673-8640.2024.11.010
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    Objective To investigate the diagnostic efficacy of total prostate-specific antigen (t-PSA),the percentage of free prostate-specific antigen(f-PSA)to t-PSA (f-PSA/t-PSA%),prostate health index (PHI) and prostate imaging reporting and data system (PI-RADS) score in the diagnosis of prostate cancer. Methods Totally,277 patients with prostate diseases diagnosed by pathological examination from July 2022 to February 2024 in the First Hospital of Jilin University were classified into benign disease group (143 cases) and prostate cancer group (134 cases). They were classified into t-PSA < 20 ng·mL-1 group (147 cases,including 100 cases of benign disease and 47 cases of prostate cancer) and t-PSA ≥ 20 ng·mL-1 group (130 cases,including 43 cases of benign disease and 87 cases of prostate cancer) according to t-PSA level. The serum t-PSA,f-PSA and isoform[-2] prostate-specific antigen(p2PSA)of all the patients were determined,and the f-PSA/t-PSA% was calculated. The PI-RADS score was evaluated. Logistic regression analysis was used to assess the factors for prostate cancer. The diagnostic efficacy of each indicator was evaluated by receiver operating characteristic (ROC) curve. Results The t-PSA and PHI in prostate cancer group were higher than those in benign disease group (P<0.001),and f-PSA/t-PSA% was lower than that in benign disease group (P<0.001). The proportion of PI-RADS score ≥4 was higher than that of benign disease group (P<0.001). The areas under curves(AUC)of t-PSA,f-PSA/t-PSA%,PHI and PI-RADS for the diagnosis of prostate cancer were 0.752,0.633,0.913 and 0.881,respectively. PHI and PI-RADS score were independent risk factors for prostate cancer [odds ratios (OR) were 1.035 and 2.520,95% confidence intervals (CI) were 1.021-1.049 and 1.672-3.800,respectively,P<0.001]. In t-PSA <20 ng·mL-1 group,compared with benign disease patients,PHI and PI-RADS score≥4 proportion in prostate cancer patients were increased (P<0.001),f-PSA/t-PSA% was decreased (P<0.05),and there was no statistical significance in t-PSA level (P>0.05). In t-PSA≥20 ng·mL-1 group,compared with benign disease patients,t-PSA,PHI and PI-RADS score≥4 proportion in prostate patients were increased (P<0.001),while f-PSA/t-PSA% had no statistical significance (P>0.05). The AUC of t-PSA,f-PSA/t-PSA%,PHI and PI-RADS in the diagnosis of prostate cancer with t-PSA < 20 ng·mL-1 were 0.561,0.611,0.836 and 0.834,respectively. The AUC of the combined determination was the highest (0.900). The AUC for the diagnosis of t-PSA≥20 ng·mL-1 prostate cancer were 0.822,0.520,0.963 and 0.875,respectively. The AUC of t-PSA+f-PSA/t-PSA%+PHI and t-PSA+f-PSA/t-PSA%+PHI+PI-RADS score were 0.970 and 0.972,respectively. Conclusions For patients with t-PSA< 20 ng·mL-1,the combined determination of t-PSA,f-PSA/t-PSA%,PHI and PI-RADS score can improve the determination rate of prostate cancer. For patients with t-PSA≥20 ng·mL-1,PHI is a good indicator for diagnosing prostate cancer,and the combined determination of t-PSA,f-PSA/t-PSA% and PHI can improve diagnostic efficacy.

    Prognostic roles of Lp-PLA2,HDAC3 and TAFI levels in patients with large-scale cerebral infarction
    WU Shaohua, XI Junnan, LIU Liang, WU Yating, ZHANG Meng, CHEN Liwei, XUE Meng, LIU Shifu
    2024, 39(11):  1091-1096.  DOI: 10.3969/j.issn.1673-8640.2024.11.011
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    Objective To evaluate the prognostic roles of lipoprotein-associated phospholipase A2(Lp-PLA2),histone deacetylase(HDAC)3 and thrombin activable fibrinolysis inhibitor (TAFI) levels in patients with large-scale cerebral infarction. Methods A total of 120 patients with large-scale cerebral infarction in Henan University of Science and Technology Affiliated Yellow River Hospital from March 2020 to March 2023 were enrolled as large-scale cerebral infarction group,and 120 healthy subjects during the same period were enrolled as control group. Lp-PLA2,HDAC3 and TAFI levels were determined by enzyme-linked immunosorbent assay. All the patients with large-scale cerebral infarction were followed up for 90 d,which included 45 patients with poor prognosis and 75 patients with good prognosis. Spearman correlation analysis was used to evaluate the relationship between Lp-PLA2,HDAC3,TAFI levels and the National Institute of Health Stroke Scale(NIHSS)score. The prognostic roles of Lp-PLA2,HDAC3 and TAFI levels in patients with large-scale cerebral infarction was analyzed by receiver operating characteristic(ROC)curve. Multivariate Logistic regression analysis was used to evaluate the factors affecting the poor prognosis of patients with large-scale cerebral infarction. Results Compared with control group,Lp-PLA2,HDAC3 and TAFI levels in large-scale cerebral infarction group were increased (P<0.001). Lp-PLA2,HDAC3 and TAFI levels were positively correlated with NIHSS score in patients with large-scale cerebral infarction(rs=0.542,0.620 and 0.597,P<0.05). Compared with good prognosis group,NIHSS score,Lp-PLA2,HDAC3 and TAFI levels in poor prognosis group were increased (P<0.001). NIHSS score,Lp-PLA2,HDAC3 and TAFI levels were the factors for poor prognosis in patients with large-scale cerebral infarction (P<0.01). The areas under curves of Lp-PLA2,HDAC3,TAFI and NIHSS score single determinations and combined determination were 0.790,0.795,0.780,0.908 and 0.964,respectively. Conclusions Lp-PLA2,HDAC3 and TAFI in patients with large-scale cerebral infarction are increased,and the Lp-PLA2,HDAC3,TAFI and NIHSS score combined determination is of certain value in evaluating the prognosis of patients with large-scale cerebral infarction.

    Correlation of HPV combined with lower genital tract pathogen infection and cervical lesion
    ZHU Jieke, ZHOU Peng, LUO Ying, WU Maofeng, XUAN Shuxia, CHEN Chen, QI Huaxin, OUYANG Yu, YIN Weiguo
    2024, 39(11):  1097-1100.  DOI: 10.3969/j.issn.1673-8640.2024.11.012
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    Objective To investigate the relationship between human papillomavirus (HPV) infection with Chlamydia trachomatis(CT)and Ureaplasma urealyticum(UU)lower genital tract pathogen infections and cervical lesion. Methods From August 2019 to January 2021,935 female patients,aged 17-73 years old,were enrolled from Qingyuan Hospital of Guangzhou Medical University. There were 241 cases of menelipsis(25.78%),453 cases of cervicitis (48.45%),92 cases of cervical cancer (9.84%),184 cases of cervical intraepithelial neoplasia (CIN)Ⅰ(19.68%),68 cases of CIN Ⅱ(7.27%) and 138 cases of CIN Ⅲ(14.76%). CT and UU of vaginal or cervical secretions were determined by fluorescence quantitative polymerase chain reaction(PCR). HPV genotyping and CT and UU determinations were performed in 235 patients. Pearson correlation analysis was used to evaluate the correlation between HPV combined with lower genital tract pathogen infection and cervical lesion. Results CT and UU infections were correlated with HPV infection,and the odds ratio(OR)was 1.16(P<0.001). The infection rates of high-risk HPV and low-risk HPV had statistical significance between CT and UU infected and uninfected subjects(P<0.05). The cervical lesion caused by high-risk HPV combined CT and UU infections had statistical significance from those caused by low-risk HPV combined CT and UU infections (P<0.05). Conclusions High-risk HPV combined with CT and UU infections may be related to the occurrence and development of cervical lesion.

    Application of metagenomic next-generation sequencing and traditional methods in central nervous system infection
    SHANG Yuanjiang, ZHU Guoqing, ZHANG Lei, SHEN Dandan, PAN Qiuhui
    2024, 39(11):  1101-1107.  DOI: 10.3969/j.issn.1673-8640.2024.11.013
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    Objective To investigate the diagnostic value of metagenomic next-generation sequencing (mNGS) in central nervous system infection(CNSI),and to study the distribution of common pathogens of CNSI in Shanghai Tenth People's Hospital. Methods A total of 81 patients in Shanghai Tenth People's Hospital from November 2021 to June 2023 were enrolled. The patients were classified into CNSI group (34 cases) and non-CNSI group (47 cases),and all the patients were tested with cerebrospinal fluid routine test,biochemistry determination,mNGS and traditional methods (cerebrospinal fluid smear and microbial culture),and the differences between mNGS and traditional methods were compared. Receiver operating characteristic(ROC)curve was used to evaluate the efficiency of mNGS and traditional methods in diagnosing CNSI. Results For pathogen identification,there was no statistical significance in the determination of bacteria and fungi between mNGS and traditional methods (P>0.05),but there was statistical significance in the determination of viruses(P<0.05). At the level of pathogen species,both mNGS and traditional methods determined the most bacteria as Acinetobacter baumannii,without statistical significance(P>0.05). The most commonly determined viruses by mNGS were human herpes virus 4 and human herpes virus 5. The positive determination rate of mNGS pathogens in cerebrospinal fluid of CNSI group(64.7%)was higher than that of non-CNSI group(14.9%)(P<0.05). The consistency between mNGS and traditional methods was moderate(Kappa=0.412,P=0.001). The sensitivity of cerebrospinal fluid mNGS in diagnosing CNSI(64.7%)was higher than that of traditional methods(23.5%),and the specificity(85.1%)was lower than that of traditional methods(100.0%)(P<0.05). The area under curve of mNGS for diagnosing CNSI(0.749)was larger than that of traditional methods (0.618)(P<0.05). Conclusions Cerebrospinal fluid mNGS is recommended for screening patients suspected with CNSI. The most common pathogen of CNSI in Shanghai Tenth People's Hospital is Gram-negative bacteria.

    Clinical application of different determination methods for influenza A virus
    LI Teng, JIA Qin, SUN Pingping, WEN Donghua, XUAN Qiankun
    2024, 39(11):  1108-1112.  DOI: 10.3969/j.issn.1673-8640.2024.11.014
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    Objective To investigate the clinical application value of nucleic acid point-of-care testing (POCT) and colloidal gold immunoassay(antigen assay)for influenza A virus (FluA). Methods Nasal swab samples from 56 patients with suspected influenza A with fever and cough in East Hospital of Tongji University(South Branch) from February 20,2023 to April 5,2023 were collected. FluA was determined by colloidal gold immunoassay,nucleic acid POCT and polymerase chain reaction(PCR)-fluorescent probe assay(fluorescent PCR),and the determination efficiency of colloidal gold immunoassay and nucleic acid POCT was compared with fluorescent PCR as standard. The clinical data of FluA determined by colloidal gold immunoassay and nucleic acid POCT were analyzed retrospectively. Results Among the 56 samples,the positive rates of colloidal gold immunoassay,fluorescent PCR and nucleic acid POCT were 32.14%,60.71% and 62.50%,respectively. The determination rate of FluA by colloidal gold immunoassay was lower than that by fluorescent PCR(P<0.05),and nucleic acid POCT had good consistency with fluorescent PCR(Kappa=0.962,P>0.05). The turn-around time(TAT) of colloidal gold immunoassay and nucleic acid POCT was <60 min,and the TAT of fluorescent PCR was 240 min. From February 20,2023 to April 5,2023,a total of 12 107 nasal swab samples were determined by colloidal gold immunoassay with a positive rate of 34.92%. Totally,7 924 clinical samples were determined by nucleic acid POCT with a positive rate of 71.02%. The positive rate of nucleic acid POCT for FluA was higher than that of colloidal gold immunoassay of the same age group. Conclusions The sensitivity of nucleic acid POCT is higher than that of colloidal gold immunoassay. Nucleic acid POCT could be used as a rapid determination method for FluA,which is worthy of further promotion and usage in clinical practice.

    Roles of serum miR-129-3p and miR-144-3p in drug-resistant pulmonary tuberculosis patients
    LIU Jian, XU Hui, YANG Yongqiong, DENG Zhengbo
    2024, 39(11):  1113-1117.  DOI: 10.3969/j.issn.1673-8640.2024.11.015
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    Objective To investigate the roles of serum miR-129-3p and miR-144-3p in drug-resistant pulmonary tuberculosis patients. Methods A total of 140 drug-resistant pulmonary tuberculosis patients who underwent neoadjuvant radiotherapy and chemotherapy in Santai Hospital of North Sichuan Medical University from January 2021 to June 2022 were enrolled. According to the therapeutic effect after 6 months of treatment,they were classified into effective group (92 cases) and ineffective group (48 cases). Totally,140 healthy subjects who matched the general information of drug-resistant pulmonary tuberculosis patients during the same period were enrolled as control group. The expression levels of serum miR-129-3p and miR-144-3p were compared. Multivariate Logistic regression analysis was used to analyze the influencing factors of therapeutic effect in drug-resistant pulmonary tuberculosis patients. Receiver operating characteristic (ROC) curve analysis was used to analyze the predictive values of serum miR-129-3p,miR-144-3p,albumin and white blood cell count on the therapeutic effect of drug-resistant pulmonary tuberculosis after 2 months of treatment. Results Compared with control group,the levels of serum miR-129-3p and miR-144-3p in drug-resistant pulmonary tuberculosis group were decreased (P<0.05). After 2 months of treatment,the levels of serum miR-129-3p and miR-144-3p in ineffective group were lower than those in effective group (P<0.05). Serum miR-129-3p,miR-144-3p,albumin and white blood cell count were influencing factors for the therapeutic effect of drug-resistant pulmonary tuberculosis patients (P<0.05). After 2 months of treatment,the area under curve of the combination of serum miR-129-3p,miR-144-3p,albumin and white blood cell count in predicting the therapeutic effect of drug-resistant pulmonary tuberculosis patients was 0.956,with the sensitivity of 87.50% and the specificity of 92.39%,which was better than their single determinations (P<0.05). Conclusions The expression levels of miR-129-3p and miR-144-3p in serum of drug-resistant pulmonary tuberculosis patients are decreased,and the combination with miR-129-3p,miR-144-3p,albumin and white blood cell count play a role in predicting the therapeutic effect of drug-resistant pulmonary tuberculosis patients.

    Application of total protein standard reference material in frozen human serum in value transfer of reference method
    SUN Jiangman, LI Min, MENG Xiangzhao, MA Li, ZHAO Guanglun, YU Hongyuan
    2024, 39(11):  1118-1121.  DOI: 10.3969/j.issn.1673-8640.2024.11.016
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    Objective To evaluate the accuracy of the measurement results in reference method using total protein standard reference material in frozen human serum as calibrator. Methods SRM927e,SRM927f and GBW09186-188 were used as calibrators to measure RELA 22A and 22B,appropriate calibrators were selected,and then RELA 23A,23B,18A,18B,17A,17B and 53 individual serum samples were measured,and the results were compared with the Clinical and Laboratory Standards Institute (CLSI) EP09-A3. Results The measurement results of RELA 22A and 22B using SRM927f as calibrator exceeded the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC)equivalent limit,while the measurement results using SRM927e as calibrator were within the equivalent limit. The measurement results using GBW09186-188 as calibrators were all within the equivalent limit,and the bias of GBW09188 was the least. The bias range of the 3-year international comparison samples measured with GBW09188 as calibrator was -0.45%-0.45%,all of which were within the equivalent limit. The Bland-Altman results using SRM927e and GBW09188 as calibrators were all within 95% confidence interval (CI),indicating good consistency in the measurement results of the 2 calibrators. The bias at the medical decision level of the 4 regression analyses was within the clinically acceptable range. Conclusions The measurement results of serum total protein reference method with GBW09188 as calibrator are accurate and reliable.