Table of Content

30 January 2022, Volume 37 Issue 1

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Establishment and validation of a plasma exosome-derived circular RNA model for HCC diagnosis

MENG Jun, WANG Junqing, FEI Xiaochun, GU Zhidong

2022, 37(1):  1-10.  DOI: 10.3969/j.issn.1673-8640.2022.01.001

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Objective To investigate plasma exosome-derived circular RNA（exo-circRNA） with diagnostic potential for hepatocellular carcinoma（HCC）. Methods A total of 256 patients with HCC who received curative resection（25 cases belonged to discovery cohort,126 cases belonged to training cohort and 105 cases belonged to validation cohort）,100 patients with liver cirrhosis（50 cases belonged to training cohort and 50 cases belonged to validation cohort） and 125 healthy subjects（healthy control group,25 individuals belonged to discovery cohort,50 individuals belonged to training cohort and 50 individuals belonged to validation cohort）were enrolled. The plasma exosome was isolated by precipitation,and the expression level of exo-circRNA was determined by real-time quantitative polymerase chain reaction（RT-qPCR）. The new exo-circRNA model for HCC diagnosis was constructed using Logistic regression analysis,and the diagnostic performance of this exo-circRNA model was evaluated by receiver operating characteristic（ROC） curve. Results Compared with normal liver cell line L02,102 exo-circRNA expression in liver cancer cell line Hep3B were increased（P<0.05）. After conducting integrative analysis with exoRBase database,4 circRNA with increased expression in HCC patients were identified（circ_0000690,circ_0001359,circ_0000396 and circ_0000722）. The expressions of circ_0000690,circ_0001359 and circ_0000396 were increased in HCC group compared with those in healthy control group（P<0.05）. There was no statistical significance in the expression of circ_0000722 between the 2 groups（P>0.05）. The expression of circ_0000690 was higher in HCC group compared to those in liver cirrhosis group and healthy control group in both training and validation cohorts（P<0.001）. The expression of circ_0001359 showed escalating pattern in healthy control group,liver cirrhosis group and HCC group（P<0.05）. There was no statistical significance in the expression of circ_0000396 between HCC group and liver cirrhosis group（P>0.05）,but they were still higher than those in healthy control group（P<0.05）. The established diagnostic model was Logit（P）=1.110×circ_0000690+0.822×circ_0001359+0.622×circ_0000396-4.153. ROC curve analysis results showed that,in the training cohort,the areas under curves（AUC）for diagnosing HCC of circ_ 0000690,circ_ 0001359,circ_0000396 and integrated model were 0.802,0.726,0.621 and 0.859,respectively. Meanwhile,the AUC for diagnosing early HCC（defined as Barcelona stage 0+A） of circ_ 0000690,circ_ 0001359,circ_0000396 and integrated model were 0.767,0.698,0.611 and 0.847,respectively. The AUC for diagnosing alpha-fetoprotein（AFP）-negative（<20 ng/mL） HCC were 0.810,0.695,0.588 and 0.894,respectively. In the validation cohort,the AUC for diagnosing HCC of circ_ 0000690,circ_0001359,circ_0000396 and integrated model were 0.752,0.663,0.615 and 0.847,respectively. The AUC for diagnosing early HCC of circ_ 0000690,circ_ 0001359,circ_0000396 and integrated model were 0.763,0.673,0.591 and 0.845,respectively. Moreover,the AUC for diagnosing AFP-negative HCC of circ_ 0000690,circ_ 0001359,circ_0000396 and integrated model were 0.702,0.670,0.641 and 0.840,respectively. Conclusions The plasma exo-circRNA model established in this study has potential diagnostic value for HCC,especially AFP-negative and early HCC.

Analysis of diagnostic efficacy of serum MMP-9 with or without Xpert MTB/RIF assay in alveolar lavage fluid and INF-γ release test for pulmonary tuberculosis

LI Xiaoqian, WANG Zhihui, CHI Yuepeng, WANG Yuhong, XIE Lanpin, LIANG Yachong

2022, 37(1):  11-15.  DOI: 10.3969/j.issn.1673-8640.2022.01.002

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Objective To investigate the diagnostic efficacy of serum matrix metalloproteinase-9（MMP-9） combined with Xpert MTB/RIF assay in alveolar lavage fluid and interferon gamma（INF-γ） release test for pulmonary tuberculosis. Methods Totally,200 patients with suspected pulmonary tuberculosis in Hebei Chest Hospital from May 2019 to May 2020 were enrolled. According to the examination results,pulmonary tuberculosis group was subclassified into mycotic-positive pulmonary tuberculosis group（62 cases）,mycotic-negative pulmonary tuberculosis group（88 cases） and non-pulmonary tuberculosis group（50 cases）. The result differences of serum MMP-9,interleukin（IL）-15,tumor necrosis factor-alpha（TNF-α）,C-reactive protein（CRP）,erythrocyte sedimentation rate（ESR）,INF-γ release test,culture of sputum Mycobacterium tuberculosis（MTB）,Xpert MTB/RIF assay in alveolar lavage fluid were compared among the 3 groups on the day of admission. Logistic regression analysis was used to draw receiver operating characteristic（ROC） curve to evaluate the diagnostic efficacy of serum MMP-9,Xpert MTB/RIF assay in alveolar lavage fluid and INF-γ release test for pulmonary tuberculosis. Results There was statistical significance for MMP-9 and INF-γ among the 3 groups（P<0.05）,and there was no statistical significance for the other indicators（P>0.05）. The levels of MMP-9 and INF-γ in pulmonary tuberculosis group were higher than those in non-pulmonary tuberculosis group（P<0.05）. The positive rate of Xpert MTB/RIF in mycotic-positive pulmonary tuberculosis group was higher than that in mycotic-negative pulmonary tuberculosis group（P<0.05）. Between mycotic-positive and mycotic-negative pulmonary tuberculosis groups,there was no statistical significance for the positive rate of INF-γ release test and INF-γ level（P>0.05）. The positive rate of INF-γ had no statistical significance between mycotic-positive and mycotic-negative pulmonary tuberculosis groups（P>0.05）. Logistic regression analysis showed that MMP-9 [odds ratio（OR）=1.687,P=0.004],INF-γ（OR=2.511,P=0.005） and Xpert MTB/RIF（OR=1.340,P=0.005） were the risk factors of pulmonary tuberculosis. The sensitivity,specificity and accuracy of Xpert MTB/RIF assay in pulmonary tuberculosis diagnosis were 86.7%,96.0% and 89.0%,respectively. The sensitivity,specificity and accuracy of INF-γ release test in the diagnosis of pulmonary tuberculosis were 80.0%,62.0% and 75.5%,respectively. The sensitivity of MMP-9 in the diagnosis of pulmonary tuberculosis was 80.7%,the specificity was 60.0%,and the accuracy was 75.0%. The sensitivity,specificity and accuracy of the combined determination for the diagnosis of pulmonary tuberculosis were 90.7%,78.0% and 87.5%,respectively. Conclusions The high expressions of MMP-9 and INF-γ and the positivity of Xpert MTB/RIF are the risk factors of pulmonary tuberculosis. The sensitivity and specificity of the combined determination of the 3 indicators in the diagnosis of pulmonary tuberculosis are increased,which has certain clinical significance.

Relationship between Helicobacter pylori virulence genotypes and early renal damage in patients with peptic ulcer

YAN Xisheng, LEI Lei, WANG Jian

2022, 37(1):  16-22.  DOI: 10.3969/j.issn.1673-8640.2022.01.003

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Objective To investigate the relationship between Helicobacter pylori（Hp） virulence genotypes and early renal damage in patients with peptic ulcers. Methods A total of 504 patients with peptic ulcer were enrolled and classified into Hp（-） group and Hp（+） group according to the presence or absence of Hp infection,and 100 healthy subjects were enrolled as healthy control group. The changes of renal function indicators in different groups were analyzed. The relationship between Hp virulence genes,inflammatory factors and immune response factors and early renal damage was evaluated. Logistic regression analysis was used to evaluate the influence factors for early renal damage in patients with peptic ulcers. Receiver operating characteristic（ROC） curve was used to evaluate the efficiency of these indicators for the diagnosis of early renal damage in patients with peptic ulcers. Results Retinol binding protein（RBP）,urinary beta₂-microglobulin（β₂-MG）,urinary alpha₁-microglobulin（α₁-MG）,urinary transferrin（TF）,cystatin C（Cys C）,high-sensitivity C-reactive protein（hs-CRP）,immunoglobulin（Ig） A1 and vicia vilosa lectin（VVL）-IgA1 binding capacity in Hp（+） group had statistical significance compared with Hp（-） group and healthy control group（P<0.05）. The determination rate of cagA+vacA in patients with early renal damage in Hp（+） group was higher than that without early renal damage（P<0.05）. Logistic regression analysis showed that the course of disease,α₁-MG,RBP,Cys C,hs-CRP,IgA1,VVL-IgA1 binding capacity and the positive expression of cagA+vacA were influence factors for early renal damage in patients with peptic ulcer infected with Hp. The areas under curves of IgA1 and VVL-IgA1 binding capacity in the diagnosis of Hp-positive peptic ulcer with early renal damage were 0.792 and 0.773,respectively. The α₁-MG,RBP,Cys C,hs-CRP and VVL-IgA1 binding capacity in cagA+vacA group with Hp infection and early renal damage had statistical significance compared to that in non-cagA+vacA group（P<0.05）. Conclusions There is a certain proportion of early renal damage in patients with Hp infection and peptic ulcer,while the early renal damage is obvious in patients with cagA+vacA co-expression,which may be caused by inflammation and immune response.

Establishment of reference intervals of serum PGⅠ,PGⅡ and PGR for apparently healthy subjects in Zigong

YU Jianhong, PENG Qingyuan, YIN Minggang

2022, 37(1):  23-27.  DOI: 10.3969/j.issn.1673-8640.2022.01.004

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Objective To establish the reference intervals of serum pepsinogenⅠ（PGⅠ）, pepsinogenⅡ（PGⅡ） and the ratio of pepsinogenⅠ/pepsinogenⅡ（PGR） for apparently healthy subjects in Zigong,and to provide a reference for clinical diagnosis and treatment. Methods The levels of PGⅠ and PGⅡ were determined by latex enhanced immunoturbidimetry,¹³C urea breath test was used to screen Helicobacter pylori（HP） infection in 2 880 apparently healthy subjects from Zigong First People's Hospital,and PGR was calculated. The reference interval was established by percentile method（P_2.5-P_97.5）. The efficacy of PGⅠand PG Ⅱin judging HP positivity was evaluated by receiver operating characteristic（ROC） curve. Kendall's tau-b correlation analysis was used to evaluate the correlation between PGⅠ,PGⅡ and HP positivity. Results The levels of serum PGⅠand PGⅡin males were higher than those in females（P<0.05）,and PGR was lower（P<0.05）. The levels of serum PGⅠand PGⅡ in 18-44-year-old group,45-59-year-old group and >59-year-old group increased in turn（P<0.05）. There was no statistical significance for PGR among the age groups（P>0.05）. The reference intervals of serum PGⅠand PGⅡ were established according to sex and age,and the reference intervals of PGR were established according to sex. Taking the positive ¹³C urea breath test as the basis for HP positivity,the areas under curves for HP positivity judged by PGⅠ,PGⅡ and PGR were 0.712,0.825 and 0.799,respectively. There were correlations between PGⅠ,PGⅡ and HP positivity（r=0.286 and 0.440,respectively,P<0.01）,while PGR was negatively correlated with HP positivity（r=-0.403,P<0.01）. Conclusions The reference intervals of serum PGⅠ,PGⅡ and PGR in apparently healthy subjects in Zigong have been established.

Relationship between plasma omentin-1 level and metabolic clearance rate in type 2 diabetes mellitus patients

QU Yuanqing, ZHAO Fan, YE Ailian, LI Lifeng, ZHAO Haitao, LI Huizhen, LIANG Zhuohui, LI Liang

2022, 37(1):  28-31.  DOI: 10.3969/j.issn.1673-8640.2022.01.005

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Objective To investigate the relationship between plasma omentin-1 level and metabolic clearance rate（MCR） in type 2 diabetes mellitus（T2DM）patients. Methods Totally,126 patients with T2DM and 102 healthy subjects were enrolled. The levels of plasma omentin-1,fasting blood glucose,glycated hemoglobin A_1c（HbA_1c）,total cholesterol（TC）,triglyceride（TG）,high-density lipoprotein cholesterol（HDL-C） and low-density lipoprotein cholesterol（LDL-C） were determined. MCR and homeostasis model assessment for insulin resistance（HOMR-IR） were calculated. According to MCR,126 patients were classified into high MCR group and low MCR group. Pearson correlation analysis was used. Multivariate stepwise regression analysis was used to analyze the influencing factors of MCR and HOMA-IR. Results The plasma omentin-1 and MCR levels in T2DM group were lower than those in healthy control group（P<0.01）. Compared with high MCR group,the levels of TC,TG,LDL-C,HbA_1c and HOMA-IR were higher,and the levels of HDL-C and plasma omentin-1 were lower in low MCR group（P<0.001）. Pearson correlation analysis showed that there were positive correlations between plasma omentin-1 and MCR,HDL-C（r=0.589 and 0.236,respectively,P<0.05）,and there were negative correlations between MCR and HbA_1c,TC,TG（r=-0.689,-0.120 and -0.420,respectively,P<0.05）. There was a negative correlation between HOMA-IR and plasma omentin-1（r=-0.752,P<0.001） and a positive correlation between HOMA-IR and TG（r=0.265,P<0.05）. The results of multivariate stepwise regression analysis showed that the main variables affecting MCR were HbA_1c and plasma omentin-1,and the main variable affecting HOMA-IR was plasma omentin-1. Conclusions There is a positive correlation between plasma omentin-1 and MCR in T2DM patients,which could be used as indicators to reflect the level of glycolipid metabolism.

Relationship between serum 25（OH）D and disease control in children with allergic rhinitis-asthma syndrome

LI Dingfu, HUANG Jian, CAI Meiling, WANG Lizhen, JIAN Kaigan, YANG Feifei

2022, 37(1):  32-35.  DOI: 10.3969/j.issn.1673-8640.2022.01.006

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Objective To investigate the relationship between serum 25-hydroxyvitamin D [25（OH）D] level and disease severity,hormone responsiveness in children with allergic rhinitis-asthma syndrome. Methods Totally,50 healthy subjects were enrolled as control group,and 150 patients were enrolled in allergic rhinitis group（50 cases）,asthma group（50 cases） and allergic rhinitis-asthma syndrome group（50 cases）. Lung function [forced vital capacity（FVC）,forced expiratory volume in one second（FEV1）,forced expiratory flow rate 25%-75%（FEF25%-75%） and peak expiratory flow（PEF）] and serum 25（OH）D were determined. The situation of disease control was evaluated by modified British medical research council（mMRC） score,score for allergic rhinitis（SFAR） and asthma control test（ACT） score. According to hormone usage doses,allergic rhinitis-asthma syndrome group was subclassified into low-dose hormone group,middle-dose hormone group and high-dose hormone group. Linear regression analysis was used to evaluate the influence of 25（OH）D level on lung function and disease control. Results The serum 25（OH）D levels of asthma group,allergic rhinitis group and allergic rhinitis-asthma syndrome group were lower than that in control group（P<0.01）,and the difference among asthma group,allergic rhinitis group and allergic rhinitis-asthma syndrome group had statistical significance（P<0.01）. There was statistical significance in serum 25（OH）D levels among low-dose hormone group,middle-dose hormone group and high-dose hormone group（P<0.01）. Linear regression analysis showed that 25（OH）D in children with allergic rhinitis-asthma syndrome influenced on FEV1,FVC,FEF25%-75%,PEF,ACT score,mMRC score and SFAR（P<0.01）. Conclusions Serum 25（OH）D level is related to lung function and disease control in children with allergic rhinitis-asthma syndrome.

Correlation between serum C peptide and insulin-like growth factor binding protein 3 and the risk of breast cancer patient death

ZHANG Xinyue, CHEN Liang, ZHENG Yu

2022, 37(1):  36-40.  DOI: 10.3969/j.issn.1673-8640.2022.01.007

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Objective To investigate the correlation between serum C peptide and insulin-like growth factor binding protein 3（IGFBP-3） and the risk of breast cancer patient death. Methods Totally,339 patients with breast cancer were enrolled and followed up for 2-4 years. The general clinical data（age,sex,physical activity,smoking history,drinking history,height,body mass and waist circumference） of all the patients were collected,the body mass index（BMI） was calculated,and the levels of C peptide,fasting insulin（FINS）,fasting blood glucose（FBG）,serum creatinine（SCr） and IGFBP-3 were determined. Cox regression analysis was used to assess the relationship between the indicators and the risk of breast cancer patient death. Results BMI,waist circumference,C peptide and IGFBP-3 levels in death group were higher than those in survival group（P<0.05）. There was no statistical significance in the other indicators between the 2 groups（P>0.05）. According to the four percentiles of C peptide,the patients were classified into 4 groups. Compared with those of C peptide≤0.39 nmol/L,serum IGFBP-3 levels of C peptide 0.40-0.62 nmol/L group,C peptide 0.63-1.02 nmol/L group,C peptide≥1.03 nmol/L group were increased（P<0.05） with the trend of P<0.000 1,indicating that it was related to C peptide. According to FINS's four percentiles,4 subgroups of breast cancer patients were grouped. There was no statistical significance in serum IGFBP-3 level among the 4 groups（P>0.05） with the trend of P>0.05,indicating that serum IGFBP-3 had no relation with FINS level. Cox regression analysis showed that C peptide and IGFBP-3 were related to the risk of breast cancer patient death after fully correcting the confounding factors. The hazard ratios（HR） were 1.58 and 1.02,respectively,the 95% confidence intervals（CI） ranged from 1.09 to 2.66 and from 1.01 to 1.91,and the P values were 0.02 and 0.01. Conclusions C peptide and serum IGFBP-3 are related to the risk of breast cancer patient death.

Correlation between E-Cad,G-17,HER-2 and postoperative recurrence risk of gastric cancer

MAO Zheng, QIAN Zengkun, YING Fei, WANG Zhaoli, XIAO Qun, CUI Fan

2022, 37(1):  41-46.  DOI: 10.3969/j.issn.1673-8640.2022.01.008

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Objective To investigate the correlation between serum epithelial cadherin（E-Cad）and gastrin-17（G-17）levels and human epidermal growth factor receptor-2（HER-2） expression in tumor tissues and the risk of postoperative recurrence in patients with gastric cancer. Methods Totally,92 patients with gastric cancer who underwent radical gastric cancer treatment were enrolled,and the serum E-Cad and G-17 levels and the tumor tissue HER-2 expression were determined before the operation. All the patients were followed up for 5 years,with gastric cancer recurrence or 5 years of follow-up as the follow-up endpoint. Totally,92 patients with benign gastric lesions were enrolled as control group. The clinical data（sex,age,clinical stage,degree of differentiation,recurrence and so on） of all the gastric cancer patients were collected. Receiver operating characteristic（ROC） curve was used to evaluate the efficiency of various indicators in judging the recurrence of gastric cancer. Cox regression analysis was used to evaluate the risk factors affecting the recurrence of gastric cancer. Kaplan-Meier survival curve was used to evaluate the 5-year recurrence of gastric cancer. Results The serum G-17 level and the positive rate of HER-2 in gastric cancer group were higher than those in control group（P=0.000）,and the serum E-Cad level was lower than that in control group（P=0.000）. The levels of serum E-Cad and G-17 and the positive rate of HER-2 were correlated with TNM stage,differentiation and recurrence of gastric cancer（P<0.05）,but there was no correlation with sex（P>0.05）. ROC curve analysis showed that the areas under curves（AUC） of single determinations of E-Cad,G-17 and HER-2 and combined determination were 0.775,0.822,0.603 and 0.950,respectively. Kaplan-Meier survival curve analysis showed that the recurrence rate of low expression of E-Cad was higher than that of high expression group（P<0.05）,while the recurrence rate of low expression of G-17 and low expression of HER-2 was lower than that of high expression of G-17 and high expression of HER-2（P<0.05）. Cox regression analysis showed that decreased E-Cad level,increased G-17 level and increased HER-2 expression were risk factors for gastric cancer recurrence [hazard ratios（HR） were 0.835,1.568 and 3.981,95% confidence intervals（CI） were 0.767-0.909,1.292-1.904 and 1.504-10.538,respectively]. Conclusions E-Cad,G-17 and HER-2 play roles in the prediction of gastric cancer recurrence after radical gastric cancer treatment.

Analysis of serum SARS-CoV-2 IgM,IgG and neutralizing antibody levels in an adult population vaccinated with SARS-CoV-2

GE Yanmei, HAN Jianxiang, JI Wenli, GAO Daqing, TONG Huacheng

2022, 37(1):  47-50.  DOI: 10.3969/j.issn.1673-8640.2022.01.009

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Objective To evaluate the formation of severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） IgM,IgG and neutralizing antibodies of the adult population who injected with the vaccine of SARS-CoV-2. Methods A total of 80 adults who received the vaccine of SARS-CoV-2（vaccination group） were enrolled,and the serum levels of SARS-CoV-2 IgM,IgG and neutralizing antibodies were determined within 7 d and 14 d after the completion of vaccination. Totally,80 healthy adults who did not receive the vaccine of SARS-CoV-2 were enrolled as control group. They were classified according to age and sex. Results On the 14th day after the completion of vaccination,the positive rate of SARS-CoV-2 IgM,IgG and neutralizing antibodies of vaccination group were 37.5%,98.8% and 95.0%,respectively. The false-positive rate of IgM or IgG antibody was 3.8%,and the false-positive rate of neutralizing antibody was 8.8%. The positive rate of SARS-CoV-2 neutralizing antibody in males was higher than that in females（P<0.05）. There was no statistical significance in the positive rates of the 3 antibodies between those aged 20 to 39 and those aged 40 to 60 in vaccination group（P>0.05）. The serum SARS-CoV-2 IgG antibody level on the 14th day of vaccination was higher than that within 7 d of vaccination（P=0.007）. There was no statistical significance in serum SARS-CoV-2 IgM and neutralizing antibody levels at the 2 time points（P>0.05）. The positive rates of serum SARS-CoV-2 IgG and neutralizing antibodies within 7 d of vaccination were lower than those on the 14th day（P<0.01）. There was no statistical significance between the 2 time points of SARS-CoV-2 IgM antibody（P>0.05）. Conclusions For 2 weeks after adults who completed the SARS-CoV-2 vaccination,the positive rate of SARS-CoV-2 IgG antibody reaches 95.0%,and that of neutralizing antibody reaches 86.2%.

Clinical roles of SAA and CRP in pathological staging and metastasis of gastrointestinal cancer

XIONG Zhongbo, WANG Lei, YIN Beiqi, DAI Yue, WEI Xiaoqing, LU Pei

2022, 37(1):  51-55.  DOI: 10.3969/j.issn.1673-8640.2022.01.010

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Objective To investigate the clinical roles of serum amyloid A（SAA） and C-reactive protein（CRP） in gastrointestinal cancer staging. Methods Totally,400 patients with gastrointestinal cancer（157 gastric cancer cases and 243 colorectal cancer cases）,97 polyp patients and 104 healthy subjects were recruited. The levels of SAA,CRP,carcinoembryonic antigen（CEA）,carbohydrate antigen（CA） 242,CA19-9 and CA50 were determined,and the patients' pathological stage data were collected postoperatively. The role of tumor stage was judged by each index using receiver operating characteristic（ROC） curve. Results The levels of SAA,CRP,CA242,CA19-9,CEA and CA50 were higher in gastrointestinal cancer group than those in healthy control and polyp groups（P<0.01）. There was no statistical significance for all the indicators in polyp group and healthy control group（P>0.05）. SAA levels had statistical significance among different clinical stages,different T stages and different N stages in gastrointestinal cancer patients（P<0.05）,and there was no statistical significance between different M stages（P>0.05）. CRP levels had no statistical significance among different pathological stages in patients with gastrointestinal cancer（P>0.05）. The areas under curves（AUC） of SAA,CRP,CA242,CA19-9,CEA and CA50 single determinations for the evaluation of lymph node metastasis in gastrointestinal cancer were 0.732,0.505,0.626,0.631,0.604 and 0.625,respectively. The highest efficacy of the SAA+CRP+CA242 combined determination was observed. The combined determination model was Logit（P）=-0.988+0.013×SAA+0.003×CRP+0.010×CA242,and the AUC for judging lymph node metastasis of gastrointestinal cancer was 0.769. Conclusions SAA and CRP can be considered clinically useful in pathological staging and lymph node metastasis judging of gastrointestinal cancer.

Application of thioredoxin reductase in monitoring the curative effect of lung cancer

MAN Xianfeng, HE Xiaoting, ZHANG Ying, YU Weiwei, WANG Qi, YIN Hanwei, WANG Runjie

2022, 37(1):  56-59.  DOI: 10.3969/j.issn.1673-8640.2022.01.011

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Objective To investigate the role of plasma thioredoxin reductase（TR） in monitoring the efficacy of chemotherapy in lung cancer. Methods Totally,482 lung cancer patients were classified into 2 groups according to the efficacy of chemotherapy,which were unbenefited group（211 cases） and benefited group（271 cases）. TR,carcinoembryonic antigen（CEA）,squamous cell carcinoma antigen（SCC-Ag）,cytokeratin 19 fragment（CYFRA 21-1）,neuron-specific enolase（NSE） and gastrin-releasing peptide precursor（ProGRP） levels were determined. Receiver operating characteristic（ROC） curve was used to evaluate the roles of single and combined determinations of each indicator in judging the efficacy of chemotherapy. Results TR,CEA and NSE levels in unbenefited group were higher than those in benefited group（P<0.05）,and there was no statistical significance in SCC-Ag,CYFRA 21-1 and ProGRP levels between the 2 groups（P>0.05）. The positive rate of TR in unbenefited group was 56.40%,which was higher than that in benefited group（13.16%）（P<0.05）. ROC curve analysis showed that the areas under curves（AUC） of TR,CEA,CYFRA 21-1,SCC-Ag,NSE and ProGRP single determinations to judge the efficacy of chemotherapy were 0.759,0.667,0.579,0.530,0.619 and 0.544,respectively. The AUC of combined determinations of TR+CEA,TR+CEA+CYFRA 21-1,TR+CEA+CYFRA 21-1+NSE and TR+CEA+CYFRA 21-1+NSE+ProGRP were 0.757,0.749,0.752 and 0.788,respectively. TR did not correlate with CEA,NSE,SCC-Ag,CYFRA 21-1 and ProGRP（r=0.05,0.02,-0.15,0.05 and 0.10,P>0.05）. Conclusions TR may serve as a biomarker for monitoring lung cancer curative effect.

Clinical role of high-fluorescent cell and serum ascites albumin gradient in the diagnosis of malignant ascites

SUN Jingfang, LIU Yun, JIANG Qingqing, SONG Shuang, LI Shibao, MA Ping, DING Shuang

2022, 37(1):  60-62.  DOI: 10.3969/j.issn.1673-8640.2022.01.012

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Objective To investigate the clinical role of high-fluorescent cell（HFC） and serum ascites albumin gradient（SAAG） in the diagnosis of malignant ascites. Methods Totally,202 patients with ascites were enrolled. The patients were classified into malignant group（36 cases）and benign group（166 cases）according to the results of exfoliative cytology. The distribution of HFC and SAAG in the 2 groups was analyzed,and the efficiency of single and combined determinations was evaluated. Results The levels of the absolute value of high-fluorescent cell（HF#） and the percentage of high-fluorescent cell（HF%） in malignant group were higher than those in benign group（P=0.000 0、P=0.000 1）,and the level of SAAG was lower than that in benign group（P=0.000 0）. The areas under curves of HF#,HF% and SAAG for the diagnosis of malignant ascites were 0.797,0.704 and 0.770,respectively. The sensitivities,specificities and accuracies of HF# and SAAG single determinations were 83.3%,66.9%,69.8% and 88.9%,62.1%,66.8%,respectively. The sensitivity,specificity and accuracy of HF# and SAAG combined determination in series were 77.8%,80.1%,79.7%,respectively. The sensitivity,specificity and accuracy of HF# and SAAG combined determination in parallel were 94.4%,48.8%,56.9%,respectively. Conclusions Although the sensitivity decreases after HFC and SAAG combined determination,the specificity and accuracy are both increased,which is more conducive to the diagnosis of malignant ascites.

Roles of serum interleukin-6 and D-dimer levels in predicting the risk of cerebral hemorrhage in patients with hypertension

HU Bing, LI Gai, ZHANG Huimin

2022, 37(1):  63-67.  DOI: 10.3969/j.issn.1673-8640.2022.01.013

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Objective To study the roles of serum interleukin-6（IL-6） and D-dimer（DD） levels in predicting the risk of cerebral hemorrhage in patients with hypertension. Methods A total of 400 hypertensive patients were enrolled and followed up for 5 years. The serum IL-6 and DD levels were determined and compared between cerebral hemorrhage occurring group and non-occurring group. Logistic regression analysis was used to evaluate the risk factors for cerebral hemorrhage in patients with hypertension. Receiver operating characteristic（ROC） curve was used to evaluate the predictive roles of serum IL-6 and DD levels for cerebral hemorrhage. Results After 5 years of follow-up,62 cases of 400 hypertensive patients were lost to follow-up,and 32（9.47%） cases of cerebral hemorrhage occurred in the remaining 338 cases. The carotid atherosclerosis ratio,cerebral microhemorrhage ratio,serum IL-6 level,serum DD level and the course of hypertension were 87.50%,25.00%,（19.02±2.51） pg/mL,（318.40±57.85） μg/L and（12.54±2.34） years,respectively. Compared with non-occurring group,the carotid atherosclerosis and cerebral microhemorrhage ratios,serum IL-6 and DD levels and the course of hypertension were higher（χ²=15.317,P<0.001;χ²=5.872,P=0.015;t=7.915,P<0.001;t=24.694,P<0.001;t=14.753,P<0.001）. The carotid atherosclerosis,cerebral microhemorrhage,the course of hypertension,IL-6 and DD were risk factors of cerebral hemorrhage in hypertensive patients（P<0.05）. The optimal cut-off values of serum IL-6 and DD levels to predict cerebral hemorrhage in hypertensive patients were 18.35 pg/mL and 287.51 μg/L,respectively,and the areas under curves of single and combined determinations were 0.706,0.731 and 0.795,respectively. Conclusions The combined determination of serum IL-6 and DD plays a role in predicting the risk of cerebral hemorrhage in patients with hypertension,which can provide a reference for the prevention of cerebral hemorrhage.

Evaluation of colloidal gold immunochromatography assay for the rapid determination of carbapenemase in CRE isolates

YAO Lifeng, ZHENG Qiaoping, YANG Meng, LUO Qingqiong, CHEN Xu, CHEN Fuxiang

2022, 37(1):  68-71.  DOI: 10.3969/j.issn.1673-8640.2022.01.014

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Objective To evaluate the clinical application role of colloidal gold immunochromatography assay（GICA） for the rapid determination of carbapenemase in carbapenem-resistant Enterobacteriaceae（CRE） isolates. Methods Totally,73 non-reduplicative isolates of CRE were isolated. The expression of carbapenemase gene was identified by polymerase chain reaction（PCR）,and the rapid determination of carbapenemase was performed by GICA. PCR was used as reference method to evaluate the accuracy of GICA in the rapid determination of carbapenemase. Results The results of PCR for the 73 CRE isolates showed that there were 51 bla_KPC positive isolates（69.9%）,19 bla_NDM positive isolates（26.0%）,2 bla_IMP positive isolates（2.7%） and 1 bla_VIM positive isolate（1.4%） with no bla_OXA positive isolate determined. The accuracy of GICA for the determination of the carbapenemase types of bla_KPC,bla_NDM,bla_IMP and bla_VIM positive isolates was 100%. The consistency of GICA and PCR in the determination of carbapenemase types of CRE isolates is 100%. Conclusions GICA with the characteristics of simple,rapid and high accuracy has a potential clinical application role in early monitoring of carbapenem-resistant isolates and providing a reference for anti-infection therapy.

Clinical role of HBV RNA detection in chronic hepatitis B

MA Yanting, SU Xi, HUANG Fei, WANG Mengxian, SHEN Minna, ZHANG Chunyan, WANG Beili, PAN Baishen, GUO Wei

2022, 37(1):  72-77.  DOI: 10.3969/j.issn.1673-8640.2022.01.015

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Objective To evaluate the performance of a method for the detection of hepatitis B virus（HBV） RNA,to compare serum HBV RNA levels in patients with different results of serological markers of HBV infection,and to evaluate the relationship between HBV RNA and HBV DNA. Methods The performance of the method for HBV RNA detection was evaluated,which included precision,sensitivity and linearity. The sera of 81 patients with hepatitis B surface antigen（HBsAg）-positive chronic hepatitis B were collected,and the levels of HBV RNA,HBV DNA and serological markers were detected simultaneously. The patients were classified according to the different results of hepatitis B e antigen（HBeAg）,serological markers of HBV infection and medication. Results The intra-assay precisions of high and low HBV RNA values were 0.56% and 2.30%,and the inter-assay precisions were 3.13% and 6.03%,respectively,which all met the clinical requirements. The sensitivity of the assay was achieved by repeating the assay 20 times for samples close to the lower limit of detection stated by the manufacturer,and the detection rate was 100%,which met the clinical requirement. It was linear in the range of HBV RNA 1.0×10²-1.0×10⁷ copies/mL. Serum HBV RNA and HBV DNA loads in HBeAg-positive group were higher than those in HBeAg-negative group（P<0.01,P<0.05）,and the HBeAg-positive and hepatitis B e antibody（HBeAb）-negative group had the highest HBV RNA loads among all the groups with different results of serological markers of HBV infection（P<0.01）. Serum HBV DNA and HBV RNA loads were higher in untreated group than those in treated group（P<0.01,P<0.05）. In 81 patients with chronic hepatitis B,HBV RNA loads were positively correlated with HBV DNA load and HBeAg positive titer（r=0.348 and 0.544,respectively,P<0.05） and without HBsAg titer（r=0.04,P>0.05）. In HBeAg-positive patients with chronic hepatitis B,serum HBV RNA loads were positively correlated with serum HBV DNA load（r=0.338,P<0.05）. In HBeAg-negative patients with chronic hepatitis B,serum HBV RNA levels did not correlate with serum HBV DNA load（r=0.14,P>0.05）. Conclusions Serum HBV RNA level is a potential new marker for monitoring the viral activity and therapeutic efficacy of HBV infection.

Establishment and evaluation of Wuhan Glycohemoglobin Harmonization Program

YUE Daoyuan, CHEN Wei, LIAO Qing, YU Weiting, LI Huijun

2022, 37(1):  78-82.  DOI: 10.3969/j.issn.1673-8640.2022.01.016

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Objective To improve the harmonization of glycated hemoglobin A_1c（HbA_1c）measurements among the clinical laboratories in Wuhan of China by establishing Wuhan Glycohemoglobin Harmonization Program（WHGHP）. Methods Laboratories were voluntarily enrolled in WHGHP through questionnaires. Three laboratories with good quality assurance constituted a core reference network to determine the target values of comparison samples. These samples were then assigned to the participating laboratories for HbA_1c determination. The results reported by each participating laboratory were obtained and analyzed. The passing rates and the inter-laboratory coefficients of variation（CV） in 2018 and 2019 were estimated. The mean values and deviations of each method group were calculated based on the measurements of samples with HbA_1c target values from 5.5% to 6.0% in 2019. Results The number of laboratories participating in WHGHP increased from 23 in 2018 to 43 in 2019. The passing rates of all the participating laboratories increased from 81.8%-82.6% in 2018 to 83.7%-90.7% in 2019,and the maximum imprecisions（CV） were decreased from 7.9% to 3.6%,which were getting close to the results from the College of American Pathologists（CAP）,the National Glycohemoglobin Standardization Program（NGSP） and the National Center for Clinical Laboratories（NCCL）. Among the 4 quarters of 2019,the biggest deviation within each method group was found in the second quarter,and the maximum CV was 10.2%. Among the 4 quarters of 2019,the maximum CV fell to 3.1%. Conclusions Based on the establishment and implementation of WHGHP,the quality of HbA_1c determination has been enhanced,which would further promote the harmonization and standardization process of HbA_1c determination in Wuhan.

Establishment and application of intelligent structured medical laboratory knowledge base under ISO 15189 quality system

CHEN Ping, CHEN Tingting

2022, 37(1):  83-86.  DOI: 10.3969/j.issn.1673-8640.2022.01.017

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Objective According to ISO 15189 quality system,an intelligent structured medical laboratory knowledge base covering the whole process of inspection has been established to meet the requirements of each medical link for the medical laboratory knowledge base. Methods Under ISO 15189 quality system,artificial intelligence was introduced to establish an intelligent structured medical laboratory knowledge base covering the extraction and mining of medical laboratory knowledge sources,user-defined knowledge points and medical laboratory quality manual generation. Results The established intelligent structured medical laboratory knowledge base can collect knowledge from each business point. Service manuals,project,books project operation procedures and instrument operation procedures and collection manuals can be automatically generated through rich text editing and then fragment of each point in the program file were distributed in medical laboratory information system（LIS） to support workstation and mobile terminal to browse the medical laboratory knowledge base,access and datum sharing. Conclusions Through the establishment of intelligent structured medical laboratory knowledge base,the basic information will be classified and arranged to make the information and knowledge orderly,shorten the search time,speed up the flow of knowledge and information,which is conducive to the sharing and exchange of medical laboratory knowledge.

Progress on the enrichment technology of circulating tumor cells

SHEN Suya, HUANG Jianzhao, LI Xiaohuai

2022, 37(1):  91-96.  DOI: 10.3969/j.issn.1673-8640.2022.01.019

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Circulating tumor cells（CTC）are a few tumor cells that are shed from the site of a primary or metastatic tumor into the circulatory system. As such,the isolation of CTC from blood samples and their subsequent analysis are of importance not only for understanding cancer metastasis at the cellular level but also for clinical management of the disease. Since the content of CTC in blood is too scarce to be enriched,which has become the bottleneck restricting its clinical application. In recent years,with the development of separation and enrichment techniques,CTC as a tumor biomarker for disease prognosis evaluation has become a hot topic. This review aims to review the latest advances of CTC isolation technology in cancer diagnosis,introduces the application examples of this technology,and discusses its advantages and disadvantages,prospects and technical challenges,to provide a reference for follow-up research.

Research progress on a gene editing and molecular diagnostic system CRISPR-Cas13a

CHEN Jialing, HUANG Yinger, DENG Hao, WU Hongfeng, ZHANG Jing, ZHAO Yijun, LUO Jiahao, HAO Wenbo

2022, 37(1):  97-100.  DOI: 10.3969/j.issn.1673-8640.2022.01.020

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Clustered regularly interspaced short palindromic repeats（CRISPR）-CRISPR-associated protein（Cas） system is a powerful tool for gene editing. Compared with Cas9,Cas13a targeted multiple gene transcription products and regulated gene function expression,filling Cas9 with defects such as editing and missing effect only limited to DNA level. Moreover,using the characteristics of Cas13a targeting RNA,the system has been successfully transformed into the next generation of nucleic acid diagnostic tools. In this review,the latest research progress of CRISPR-Cas13 system in the field of gene editing and molecular diagnosis is summarized,and the application prospect of this system has prospected.