Table of Content

28 March 2023, Volume 38 Issue 3

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Consensus on androgen testing in polycystic ovary syndrome

Expert Group on the Consensus on Androgen Testing in Polycystic Ovary Syndrome China Association for Promotion of Health Science and Technology-Fertility Protection and Preservation Committee

2023, 38(3):  203-208.  DOI: 10.3969/j.issn.1673-8640.2023.03.001

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Polycystic ovary syndrome（PCOS） is one of the most common endocrine disorders in reproductive-age females，frequently leading to female infertility. Hyperandrogenemia plays a role in the pathogenesis of PCOS. Hyperandrogenemia can be evaluated by biochemical tests or clinical signs. At present，there are some limitations of immunology-based testing methods for androgen，such as cross-reaction，poor accuracy in low-concentration samples and lack of comparability among different reagent manufacturers，leading to false positivity. With the advantages of high sensitivity，high specificity，wide linear range and the capability of simultaneous determination of multiple molecules，liquid chromatography-tandem mass spectrometry（LC-MS/MS） becomes a good choice for androgen testing. On the basis of published clinical and laboratory evidence，Beijing Obstetrics and Gynecology Hospital of Capital Medical University，China Association for Promotion of Health Science and Technology-Fertility Protection and Preservation Committee，along with the experts in the clinical laboratory，gynecological endocrinology and mass spectrometry application relevant field made this consensus，in order to provide professional guidance in PCOS androgen testing in clinical laboratories. The consensus includes recommendations on types and methods of androgen testing for PCOS and challenges of androgen testing with LC-MS/MS.

Significance of minimal residual disease dynamic monitoring in the prognosis of acute B-lymphoblastic leukemia children with positive and negative ETV6/RUNX1 fusion genes

LIU Junshan, GUO Mingfa, SUN Jia, SHI Lihuan, LIU Wei, DUAN Yongtao

2023, 38(3):  209-214.  DOI: 10.3969/j.issn.1673-8640.2023.03.002

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Objective To analyze the significance of minimal residual disease（MRD）dynamic monitoring in the prognosis of acute B-lymphoblastic leukemia（B-ALL） children with positive and negative ETV6/RUNX1 fusion genes. Methods The clinical data of 234 children with B-ALL in the Children's Hospital of Zhengzhou University from January 2018 to June 2021 were collected. There were 78 children with ETV6/RUNX1 fusion gene（positive group） and 156 children without ETV6/RUNX1 fusion gene（negative group）. The differences in relapse-free survival（RFS） between positive and negative groups were compared. The results of MRD in the 2 groups on the 15th day（MRD1） and the 33rd day（MRD2） of induction chemotherapy and before the start of consolidation therapy（the 12th week，MRD3） were calculated，and the significance of MRD1，MRD2 and MRD3 in the prognosis of B-ALL children was analyzed. Results Compared with negative group，the RFS in positive group were prolonged（P=0.029）. In negative group，there was no statistical significance in RFS between MRD1 negative and positive children（P>0.05），but the RFS of MRD2 and MRD3 negative children were longer than those of MRD2 and MRD3 positive children（P<0.05），and MRD3 was an independent risk factor for RFS odds ratio was 3.678， 95% confidence interval 1.254-10.785，P=0.018）. In positive group，there was no statistical significance in RFS between MRD1 and MRD2 positive and negative children（P>0.05），but the RFS of MRD3 negative children was longer than those of MRD3 positive children，but MRD3 was not an independent risk factor for RFS（P>0.05）. Conclusions MRD dynamic monitoring has prognostic significance for B-ALL children with negative ETV6/RUNX1 fusion gene，and MRD dynamic monitoring should be carried out. For positive ETV6/RUNX1 fusion gene children，the significance of MRD dynamic monitoring is weak. Clinic can decide whether to use according to actual situation.

Establishment and performance evaluation of candidate reference measurement procedure for the determination of immunosuppressive drugs in human whole blood by ID-LC-MS/MS

YANG Xiaodong, LI Quanle, PAN Qingqing, ZHOU Jing, XIE Yangmin, ZOU Jihua, SHEN Min, ZHANG Man

2023, 38(3):  215-222.  DOI: 10.3969/j.issn.1673-8640.2023.03.003

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Objective To establish a candidate reference measurement procedure for immunosuppressive drugs（tacrolimus，sirolimus，everolimus and cyclosporine A） in human whole blood by isotope-dilution liquid chromatography-tandem mass spectrometry（ID-LC-MS/MS），and to evaluate its analytical performance. Methods Human whole blood samples were prepared by a simple protein precipitation method，and ID-LC-MS/MS was used to determine tacrolimus，sirolimus，everolimus and cyclosporine A quantitatively. The performance，including linearity，limit of quantitation，relative matrix effect，precision and trueness，were evaluated. Results ID-LC-MS/MS allowed the determination of the 4 immunosuppressive drugs within a total runtime of 4.5 min. ID-LC-MS/MS allowed the determination of cyclosporine A in the range of 10-500 ng/mL. Tacrolimus，sirolimus and everolimus were analyzed in the range of 1-50 ng/mL. The limit of quantitation was 10 ng/mL for cyclosporine A and 1 ng/mL for the others. The relative matrix effects were ≤8.64%. The precisions for intra-day and inter-day coefficients of variation（CV） were ≤5%. The average recovery rates were found to be 98.84%-100.99% for the 4 immunosuppressive drugs. Expanded measurement uncertainties were found to be ≤7.91 % for tacrolimus（k=2），≤7.97 % for sirolimus（k=2），≤7.14 % for everolimus（k=2） and ≤7.91 % for cyclosporine A（k=2）. Conclusions The candidate reference measurement procedure for tacrolimus，sirolimus，everolimus and cyclosporine A in human whole blood by ID-LC-MS/MS has been established successfully，which can be used in value traceability and standardization.

Identification of plasma differential peptids in PLA2R1-related membranous nephropathy patients

WANG Yajie, ZU Bailing, GAN Chenxin, WU Jiaoxiang, SHU Jie, HANG Chen, CHEN Minghui, LIN Fujun, HU Zhigang, HUANG Biao, SHENG Huiming

2023, 38(3):  223-229.  DOI: 10.3969/j.issn.1673-8640.2023.03.004

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Objective To investigate the changes of plasma peptide profiles of M-type phospholipase A2 receptor（PLA2R1） -related membranous nephropathy. Methods Totally，28 patients with primary membranous nephropathy（PMN） and positive anti-PLA2R1 antibody（PMN group） and 28 healthy subjects（healthy control group） were enrolled. The plasma peptides were determined by nano-high performance liquid chromatography tandem mass spectrometry（nano-HPLC-MS/MS），and the differentially expressed peptides between PMN and healthy control groups were screened. The differentially expressed peptides were analyzed bioinformatically，and liquid chromatography tandem mass spectrometry（LC-MS/MS）was used to verify them. Spearman correlation analysis was used to evaluate the correlation between plasma C4b and anti-PLA2R1-IgG antibodies in PMN patients.Results A total of 903 peptides were found，and 31 of them were expressed differentially between PMN and healthy control groups，with 15 being down-regulated and 16 being up-regulated. Totally，8 of them were from C4b. Kyoto Encyclopedia of Genes and Genomes（KEGG） pathway analysis revealed that the complement and coagulation cascade were primarily involved in the precursor proteins of differentially expressed peptides. According to the verification results，the plasma C4b level in PMN group was lower than that in healthy control group（P<0.001）. The results of Spearman correlation analysis showed that plasma C4b in PMN patients had no correlation with anti-PLA2R1-IgG antibodies（r=0.03，P=0.877）. Conclusions C4b could be a promising new biomarker in patients with PLA2R1-related membranous nephropathy.

Relationship between EOS%，CCR3，eotaxin and disease severity in children with acute bronchopneumonia

WANG Yaling, HUANG Yunli, TIAN Mi, WANG Shunlan, XIAO Li

2023, 38(3):  230-234.  DOI: 10.3969/j.issn.1673-8640.2023.03.005

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Objective To investigate eosinophil percentage（EOS%），serum CC chemokine receptor 3（CCR3） and eotaxin of children with acute bronchopneumonia and their relationship with disease severity. Methods A total of 126 children with acute bronchopneumonia（bronchopneumonia group） were enrolled. According to the clinical pulmonary infection score（CPIS）of children with acute bronchopneumonia on admission，they were classified into mild group（81 cases，CPIS≤6）and severe group（45 cases，CPIS>6）. Totally，60 healthy children were enrolled as healthy control group. The EOS% and serum CCR3 and eotaxin levels of all the subjects were determined，the lung function indicators [tidal volume（VT），respiratory rate（RR），the ratio of volume to peak expiratory flow to total expiratory volume（VPTEF/VE）and the ratio of time to peak tidal expiratory flow to total expiratory time（TPTEF/TE）] of children with acute bronchopneumonia were determined. Pearson correlation analysis was used to evaluate the correlation between various indicators，and receiver operating characteristic（ROC） curve was used to evaluate the diagnostic values of EOS%，serum CCR3 and eotaxin levels in children with severe acute bronchopneumonia. Results The levels of EOS%，serum CCR3 and eotaxin in bronchopneumonia group were higher than those in healthy control group（P=0.000）. Compared with mild group，the levels of serum CCR3，eotaxin，EOS% and RR in severe group were higher（P<0.01），and VT，VPTEF/VE，TPTEF/TE were lower（P<0.01）. The levels of EOS%，serum CCR3 and eotaxin in children with acute bronchopneumonia were positively correlated with RR（P<0.05），and they were negatively correlated with VPTEF/VE and TPTEF/TE（P<0.05），but without VT（P>0.05）. ROC curve analysis results showed that the areas under curves（AUC）of single determinations and combined determination of EOS%，serum CCR3 and eotaxin levels for the diagnosis of severe acute bronchopneumonia were 0.861，0.762，0.826 and 0.931，respectively. Conclusions Serum CCR3，eotaxin and EOS% are related to the severity of acute bronchopneumonia in children，and they can reflect the status of lung function to a certain extent，or they can be used as serological indicators for clinical judgment of the development of acute bronchopneumonia.

Relationship of XPC rs2228000 polymorphisms and breast cancer

LI Mu, GONG Dongliang, XU Liming, PENG Rong

2023, 38(3):  235-239.  DOI: 10.3969/j.issn.1673-8640.2023.03.006

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Objective To study the relationship between DNA damage repair gene xeroderma pigmentosum group C（XPC） rs2228000 polymorphisms and breast cancer risk. Methods Totally，562 breast cancer patients and 572 healthy subjects were enrolled. The general data of all the subjects and the clinicopathologic data of breast cancer patients were collected. Polymerase chain reaction（PCR）-restriction fragment length polymorphism（RFLP） was used to determine XPC. Using Logistic regression analysis，the correlation between XPC rs2228000 polymorphisms and breast cancer was evaluated. Results The distribution frequencies of XPC rs2228000 CC genotype（wild type），CT genotype（heterozygous type） and TT genotype（homozygous type） in breast cancer group were 33.2%，50.9% and 15.9%，respectively. Those in control group were 43.2%，48.4% and 8.4%，respectively. There was statistical significance in the frequency distribution of each genotype between the 2 groups（χ²=14.59，P<0.01）. The frequencies of allele C and T had statistical significance between the 2 groups（χ²=10.5，P<0.01）. Individuals with allele T had a 1.52 times greater risk than those with allele C [odds ratio（OR）=1.52，95% confidence interval（CI）1.37-1.94]. The XPC rs2228000 genotype distribution in breast cancer patients with estrogen receptor（ER）positivity and invasive ductal carcinoma had statistical significance compared with those with ER negative and other pathological types （P<0.05）. There was no statistical significance in XPC rs2228000 genotype distribution among breast cancer patients with different ages，menopausal status，progesterone receptor （PR） expression and BRCA1 gene expression（P>0.05）. Conclusions XPC rs2228000 polymorphisms are related to breast cancer.

Expression of long non-coding RNA ZFAS1 in osteosarcoma tissues

ZHANG Yinlong, YANG Hong

2023, 38(3):  240-244.  DOI: 10.3969/j.issn.1673-8640.2023.03.007

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Objective To investigate the expression of long non-coding RNA （lncRNA）zine finger antisense 1（ZFAS1） in osteosarcoma tissues and its influence on patient prognosis. Methods A total of 101 patients with osteosarcoma who were hospitalized in Shangqiu Hospital of Traditional Chinese Medicine for surgical treatment were enrolled from June 2009 to June 2015. Osteosarcoma and adjacent tissues（>5 cm from tumors） were collected. The expressions of ZFAS1 were determined by real-time fluorescence quantitative polymerase chain reaction（RT-qPCR）. All the patients were followed up for 5 years until June 30，2020. The survival time of the patients were recorded. Kaplan-Meier method was used for survival analysis，and Cox regression model was used for prognostic influencing factor analysis. Results The relative expression level of ZFAS1 in osteosarcoma tissues was 2.74±0.23，which was higher than 1.01±0.09 in adjacent tissues（t=71.876，P<0.001）. The relative expression levels of ZFAS1 in osteosarcoma tissues of patients with different Enneking stages，KPS scores，degrees of differentiation and metastasis had statistical significance（P<0.05）. Kaplan-Meier survival analysis results showed that the survival time of patients in low expression group was（46.24±2.55） months，and the 5-year survival rate was 61.11%，which were higher than those in high expression group，which were（26.09±2.76） months and 21.28%，respectively（Log-rank χ²=22.059，P<0.001）. The results of Cox proportional hazard regression model showed that Enneking stage，the degree of differentiation，metastasis and ZFAS1 expression were independent risk factors affecting patients' prognosis [hazard ratios（HR）were 2.620，0.384，2.197 and 1.978，95% confidence intervals（CI）were 1.203-5.706，0.186-0.791，1.131-4.270 and 1.034-3.784]. Conclusions The expression of ZFAS1 in osteosarcoma tissues is related to the pathological indicators of malignant progression of patients and prognosis，which is an independent risk factor affecting the prognosis of patients.

Role of serum progranulin in type Ⅰ autoimmune hepatitis prognosis evaluation

REN Huirong, XU Tingjuan, WU Tao, HUANG Mei, YANG Liang

2023, 38(3):  245-250.  DOI: 10.3969/j.issn.1673-8640.2023.03.008

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Objective To investigate the expression of serum progranulin（PGRN） in the prognosis evaluation of patients with type Ⅰ autoimmune hepatitis（AIH）. Methods Totally，39 active type Ⅰ AIH patients were enrolled as AIH group，and 35 healthy subjects were enrolled as control group. The general data and the determination results of white blood cell（WBC） count，serum liver enzymes，immunoglobulins and autoantibodies were collected. Serum levels of PGRN，interleukin（IL）-17 and IL-10 were determined. The changes in serum PGRN before and after treatment and its correlation with recurrence were analyzed. Spearman correlation analysis was used to analyze the correlations of serum PGRN with IL-17，IL-10 and clinical parameters. Receiver operating characteristic （ROC） curve was used to evaluate the efficiency of serum PGRN in the diagnosis of type Ⅰ AIH recurrence. Results Compared with healthy control group，serum PGRN and IL-17 were increased in AIH group（P<0.05），while IL-10 was decreased（P<0.05）. Serum PGRN was positively correlated with IL-17，gamma-glutamyltransferase（GGT），immunoglobulin G（IgG） and immunoglobulin M（IgM）（r values were 0.410，0.489，0.596 and 0.525，P<0.05）. Serum PGRN level in AIH group after treatment was lower than that before treatment（P<0.01）. Serum PGRN was higher in recurrence patients than that in non-recurrence patients（P<0.05）. ROC curve results showed that the area under curve of serum PGRN was 0.78 for predicting type Ⅰ AIH recurrence. When the optimal cut-off value was 80.75 pg/mL，the sensitivity was 62.50%，and the specificity was 83.33%. Conclusions Serum PGRN is increased in type Ⅰ AIH patients，it is related to AIH treatment efficiency and recurrence，and it can be used as an indicator to evaluate liver inflammation，injury severity and recurrence.

Relationship between serum miR-326 and chemotherapy sensitivity and prognosis in patients with treatment-related hematological malignancy

CHEN Zhe, ZHANG Ling, LIU Jie, WANG Xia, ZHANG Bin, GAO Binghua

2023, 38(3):  251-256.  DOI: 10.3969/j.issn.1673-8640.2023.03.009

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Objective To investigate the relationship between serum microRNA-326（miR-326） and chemotherapy sensitivity and prognosis in patients with treatment-related hematological malignancy. Methods Totally，50 patients with treatment-related hematological malignancy in the First Affiliated Hospital of Hebei North University from January 2012 to January 2021 were enrolled（study group），and 40 patients with hematological malignancy without primary solid tumors during the same period were enrolled as control group. Serum miR-326 levels were determined by real-time fluorescence quantitative polymerase chain reaction（RT-qPCR）. Study group received chemotherapy after admission，and they were classified into chemotherapy effective and chemotherapy ineffective groups according to the tumor assessment results. Serum miR-326 levels before and after chemotherapy were compared between the 2 groups，and the correlation between serum miR-326 levels and chemotherapy sensitivity in patients with treatment-related hematological malignancy was analyzed by Spearman correlation analysis. All the research subjects were followed up. The patients in study group were classified into survival and death groups according to the follow-up endpoint event（all-cause death），and the clinical data of the patients in the both groups were collected to analyze the factors influencing the prognosis of patients with treatment-related hematological malignancy using Logistic regression analysis. Receiver operating characteristic（ROC） curve was used to assess the effect of serum miR-326 on prognostic predictive value in patients with treatment-related hematological malignancy. Results Serum miR-326 level in study group was lower than that in control group（P<0.001）. Serum miR-326 levels were higher in chemotherapy effective group after chemotherapy compared with those before chemotherapy（P<0.05），and the difference between serum miR-326 levels before and after chemotherapy in chemotherapy ineffective group was not statistically significant（P>0.05）. Serum miR-326 levels were positively correlated with chemotherapy sensitivity in patients with treatment-related hematological malignancy（r=0.641，P<0.05）. The proportions of hypertension，infection，coagulation abnormalities，recurrent tumor chemotherapy cycles（≥5） and impairment of organ function were higher in death group than those in survival group，and serum miR-326 levels were lower than those in survival group（P<0.05）. Infection，coagulation abnormalities，impairment of organ function and low serum miR-326 levels were risk factors for poor prognosis in patients with treatment-related hematological malignancy（P<0.05）. The area under curve for serum miR-326 levels to predict the prognosis of patients with treatment-related hematological malignancy was 0.868，with the optimal cut-off value of 0.44，the sensitivity of 86.80% and the specificity of 78.10%. Conclusions Serum miR-326 shows abnormally low expression in patients with treatment-related hematological malignancy，which is related to chemotherapy sensitivity and is one of the relevant factors affecting patients' prognosis. It has a high predictive value for patients' prognosis.

Role of chemiluminescence interferon gamma release assay in auxiliary diagnosis of pulmonary tuberculosis

GAI Linlin, LI Haibo, CHU Jinjin, SUN Jiamei, YAN Xinyi, DU Jinke, DAI Wenqing, XU Donghua

2023, 38(3):  257-260.  DOI: 10.3969/j.issn.1673-8640.2023.03.010

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Objective To investigate the clinical application value of chemiluminescence interferon gamma release assay in the auxiliary diagnosis of pulmonary tuberculosis. Methods Totally，183 pulmonary tuberculosis patients and 33 healthy subjects in Weifang People's Hospital from March 1，2019 to December 31，2020 were enrolled. They were classified into active pulmonary tuberculosis group（109 cases）and inactive pulmonary tuberculosis group（74 cases）. The performance of chemiluminescence interferon gamma release assay，tuberculin skin allergy test，T-SPOT TB test and blood routine test were evaluated. The difference of blood routine test positive and negative results in chemiluminescence interferon gamma release assay for active pulmonary tuberculosis group was compared. Results The positive rates of active pulmonary tuberculosis group，inactive pulmonary tuberculosis group and healthy control group were 92.66%，62.16% and 9.09% by chemiluminescence interferon gamma release assay，respectively（P<0.05）. The sensitivities of chemiluminescence interferon gamma release assay，tuberculin skin allergy test and T-SPOT TB test had statistical significance（P<0.05），and the specificities，positive predictive values and negative predictive values had no statistical significance（P>0.05）. The sensitivity，specificity，positive predictive value and negative predictive value of chemiluminescence interferon gamma release assay were slightly higher than those of T-SPOT TB test（P>0.05）. There was no statistical significance in the absolute value of white blood cell，the absolute value of lymphocyte and the percentage of lymphocyte in peripheral blood between chemiluminescence interferon gamma release assay positive and negative patients in active pulmonary tuberculosis group（P>0.05）. Conclusions Chemiluminescence interferon gamma release assay is convenient and rapid and has certain guiding significance for the auxiliary diagnosis of pulmonary tuberculosis.

Determination limits of a severe acute respiratory syndrome coronavirus 2 nucleic acid determination reagent in 4 determination systems

ZENG Yanfen, WU Quanming, ZHOU Huan, ZHANG Qiuqin, KANG Yanli, LI Yao, CHEN Xijun, HUANG Jiangang, CHEN Falin

2023, 38(3):  261-266.  DOI: 10.3969/j.issn.1673-8640.2023.03.011

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Objective To verify and analyze the determination limits of a severe acute respiratory syndrome coronavirus 2 nucleic acid determination reagent in 4 determination systems，and to improve the quality of severe acute respiratory syndrome coronavirus 2 nucleic acid determination. Methods One matched determination system and 3 unmatched determination systems were selected，and the determination limit performance was verified by the severe acute respiratory syndrome coronavirus 2 nucleic acid reference material of the National Institute of Metrology，China. The reasons of failed verification systems were analyzed. Results The determination ability of unmatched system 1 was strong，followed by matched system 1 and unmatched system 2. Shortening the time of cell lysis，nucleic acid release and magnetic bead binding and reducing the number of nucleic acid washing affected the determination limit. Conclusions The severe acute respiratory syndrome coronavirus 2 nucleic acid determination reagent selected in this study could pass the determination limit verification. It is urgent for relevant departments to issue production standards and calibration standards for corresponding instruments. Laboratories should pay attention to sample addition amount，the optimization of unmatched systems and the maintenance and calibration of instruments.

Clinical characteristics and epidemiological of enterovirus infection in children with acute diarrhea in Tianjin

WU Jinying, FANG Yulian, WANG Wei, HOU Mengzhu, WANG Lu, ZHAO Yu

2023, 38(3):  267-271.  DOI: 10.3969/j.issn.1673-8640.2023.03.012

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Objective To investigate the clinical characteristics and epidemiological of enterovirus in children with acute diarrhea in Tianjin，and to provide a reference for the prevention and treatment of viral diarrhea. Methods The 1 102 stool samples of hospitalized children with acute diarrhea admitted in Tianjin Children's Hospital from August 2019 to July 2020 were collected，and there were 680 boys and 422 girls，aged 1-148 months. Rotavirus and adenovirus were determined by colloidal gold immunochromatography，and norovirus was determined by reverse transcription polymerase chain reaction（PCR）. The determination results and clinical data were collected and analyzed. Results Totally，421（38.2%）children were positive for viruses，and the determination rates of norovirus，rotavirus and adenovirus were 24.9%，11.0% and 2.4%，respectively. Norovirus and rotavirus had high determination rates in winter and spring，while adenovirus had high determination rates in summer and autumn. There was statistical significance in the determination rates of the 3 enteroviruses in different age groups（P<0.05），and there was statistical significance in the determination rates of norovirus and adenovirus between boys and girls（P<0.05）. The incidence rates of associated symptoms such as fever，cough，vomiting and abdominal pain of acute diarrhea caused by different enteroviruses were different（P<0.05）. The incidence rates of water，electrolyte and acid-base disturbance were higher in adenovirus infected children（P<0.05）. The incidence rate of fat droplets in stool routine examination and the incidence rate of leukopenia in peripheral blood were higher in rotavirus infected children（P<0.05）. Conclusions Norovirus and rotavirus are the main etiological factors of diarrhea among children in Tianjin and mostly occur in infants and young children with obvious seasonality. The clinical characteristics and laboratory examination results of diarrhea caused by different viral infections are different，which may provide a reference for the clinical treatment of diarrhea.

Microecological characteristics of vaginitis patients in Xi'an

LI Jiao, ZHANG Qian, GAO Juanjuan, LI Na, GAO Li, PEI Meili, GOU Wenli

2023, 38(3):  272-275.  DOI: 10.3969/j.issn.1673-8640.2023.03.013

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Objective To study the pathogenic characteristics of female vaginal microecology and mixed vaginitis in Xi'an，and to provide a reference for clinical diagnosis and treatment. Methods A total of 20 218 outpatients in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of Xi'an Jiao Tong University from January 2021 to May 2022 were enrolled. The bacterial morphology and function of vaginal secretions were determined. The results of vaginal microecological tests of these patients were analyzed. Results The 50.6% females were with vaginal dysbiosis. The main diseases were bacterial vaginitis（BV）（28.3%），vulvovaginal candidiasis（VVC）（20.0%） and aerobic vaginitis（AV）（15.2%）. In the 10 222 vaginal dysbiosis females，61.6% cases were simple vaginitis（6 293 cases），and 38.4% cases were mixed vaginitis（3 929 cases）. The proportions of mixed infection BV+AV，BV+VVC，AV+BV+VVC and AV+BV+trichomonal vaginitis（TV） were 54.98%，16.14%，13.01% and 8.00%，respectively. Vaginitis recurred in 1 119 cases，with simple vaginitis accounting for 47.6%（533 cases） and mixed vaginitis accounting for 52.4%（586 cases）. Conclusions Mixed vaginitis has a high incidence of clinical infection. Using vaginal microecological tests for the identification of vaginal infection may provide a reference for the diagnosis and treatment of refractory vaginal infection.

Screening hub genes and diagnostic analysis of gestational diabetes mellitus based on GEO database

CHEN Hui, CHEN Guanghui, LIANG Yingliang, WANG Wandang, YIN Zhijun

2023, 38(3):  276-281.  DOI: 10.3969/j.issn.1673-8640.2023.03.014

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Objective To screen hub genes for gestational diabetes mellitus（GDM） by bioinformatics. Methods Microarray data related to GDM were downloaded from gene expression omnibus（GEO）database（GSE103552）. Limma package was used to screen the differentially expressed genes of control group and GDM group. Clusterprofiler was used for Gene Ontology（GO） and Kyoto Encyclopedia of Genes and Genomes（KEGG） enrichment analysis. WGCNA outputed module genes were used，and the intersection with modular genes and differentially expressed genes was used to determine the characteristic difference genes. The online website STRING and Cytoscape software were used to construct the protein interaction network for the characteristic difference genes，and the hub genes were screened. R software was used to analyze the expression and diagnostic value of hub genes. Receiver operating characteristic（ROC） curve was used to evaluate the diagnostic performance of hub genes. Results The GDM-related microarray matrix GSE103552 included 17 controls and 20 GDM samples. There were 118 differentially expressed genes，including 65 up-regulated cases and 53 down-regulated cases. Differentially expressed genes were enriched in extracellular matrix tissues，extracellular structural tissues and DNA conformation change response，and they regulated RNA transport and taste transduction. Totally，33 characteristic difference genes. Protein interaction network construction identified 5 hub genes（ANKRD36C，CLK1，LUC7L3，NKTR and RSRP1），the 5 hub genes were highly expressed in differentially expressed genes，and the area under curve for diagnosing GDM was >0.8. Conclusions Based on GEO database，the 5 hub genes are highly expressed in differentially expressed genes，providing potential diagnostic，prognostic markers and therapeutic targets for GDM.

Changes and clinical significance of HbA_1c，NT-proBNP，Hcy，SOD and TC levels in patients with diabetes cardiomyopathy

ZHENG Zhiyou, LI Xingzhao, XIE Yage

2023, 38(3):  282-286.  DOI: 10.3969/j.issn.1673-8640.2023.03.015

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Objective To investigate glucose metabolism [glycated hemoglobin A_1c（HbA_1c）]，lipid metabolism [total cholesterol（TC） and triglyceride（TG）]，oxidative stress [homocysteine（Hcy），beta-hydroxybutyric acid（beta-hydroxybutyrate，β-HB），superoxide dismutase（SOD）]，inflammation [C-reactive protein（CRP）] and myocardial injury [amino-terminal B-type natriuretic peptide（NT-proBNP）] indicators in diabetes cardiomyopathy（DCM）. Methods From December 2018 to January 2022，60 patients with DCM（DCM group） and 60 patients with simple diabetes（control group） from Binhu Hospital of Hefei First People's Hospital were enrolled，and the general data of all the patients were collected. HbA_1c，NT-proBNP，Hcy，TC，TG，CRP，β-HB and SOD levels were determined. Logistic regression analysis was used to evaluate the risk factors of DCM. Receiver operating characteristic（ROC） curve was used to evaluate the value and predictive efficacy of various influencing factors in the auxiliary diagnosis of DCM. Results HbA_1c，NT-proBNP，Hcy，TC，TG，CRP and β-HB levels were higher than those in control group（P<0.05）. The level of SOD was lower than that in control group（P<0.05）. Logistic regression analysis showed that HbA_1c [odds ratio（OR）=3.092，95% confidence interval（CI）1.187-8.051]，NT-proBNP（OR=1.003，95% CI 1.000-1.006），Hcy（OR=1.349，95% CI 1.088-1.673），SOD（OR=0.969，95% CI 0.943-0.995） and TC（OR=2.947，95% CI 1.159-7.494） were risk factors for DCM. The areas under curves of HbA_1c，NT-proBNP，Hcy，SOD and TC single determinations and the combined determination were 0.615，0.613，0.650，0.608，0.603 and 0.683 in the differential diagnosis of DCM，respectively. Conclusions HbA_1c，NT-proBNP，Hcy，SOD and TC are related to the occurrence of DCM.

Influence of disease types and clinical indexes on the CMIA determination results of anti-HCV antibody

HE Xin, LI Yanping

2023, 38(3):  287-290.  DOI: 10.3969/j.issn.1673-8640.2023.03.016

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Objective To investigate the influencing factors of grey-zone results in anti-hepatitis C virus（HCV） antibody determination by chemiluminescence microparticle immunoassay（CMIA）. Methods Totally，183 patients in the grey-zone（S/CO value was 1.0-5.0）（grey-zone group） were enrolled for anti-HCV antibody determination by CMIA. There were 33 cases of malignant tumors，16 cases of hepatitis B，16 cases of cholecystitis，13 cases of gallstones，13 cases of benign tumors，11 cases of liver cirrhosis，9 cases of bile duct stones，9 cases of cholangitis and 63 cases of other diseases. Totally，33 healthy subjects with negative results of anti-HCV antibody（S/CO value <1.0） were enrolled as control group. Reverse transcription-polymerase chain reaction（RT-PCR） was used to determine HCV RNA. The clinical data of all the patients and the laboratory determination results of all the subjects were collected，and the anti-HCV antibody determination results by enzyme-linked immunosorbent assay（ELISA） and electrochemiluminescence immunoassay were recorded. Multiple linear regression analysis was used to investigate the influencing factors of anti-HCV antibody determination results. Results The results of HCV RNA determination in grey-zone group were negative. The consistency of CMIA and electrochemiluminescence immunoassay with RT-PCR was 100.00%，and the consistency of ELISA with RT-PCR was 97.81%. The results of multiple linear regression analysis showed that the S/CO value of anti-HCV antibody determined by CMIA could be increased by benign tumors（t=2.080，P=0.039） and be decreased by osmolality（t=-2.238，P=0.027）. The other indicators had no effect on the determination of anti-HCV antibody by CMIA（P>0.05）. There was no statistical significance in serum osmolality between grey-zone group and control group（P>0.05）. Conclusions When using CMIA to determine the samples from patients with a history of benign tumors，the S/CO value may increase，resulting in grey-zone results.

Role of brown adipose tissue in insulin resistance and its research progress

SUN Wenyuan, WANG Pan, CUI Liyan

2023, 38(3):  297-300.  DOI: 10.3969/j.issn.1673-8640.2023.03.019

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Brown adipose tissue is a kind of special fat in mammals，which is composed of brown adipocytes and stromal vascular fraction. It is involved in glucose and lipid metabolism and plays a role in insulin resistance（IR）. The thermogenic effect of brown adipocytes increases energy consumption，and secretary factors from brown adipocytes act in autocrine or paracrine forms in multiple tissues to regulate energy consumption，feeding behavior and insulin sensitivity. In this review，the function and secretion factors of brown adipose tissue are summarized. The research progress of brown adipose tissue in animal model and human body is summarized. The effect brown adipose tissue on IR improvement is discussed.