OBJECTIVE To understand the healthcare-seeking behavior of patients with AIDS co-infected with tu-berculosis and analyze the factors influencing delayed consultation and diagnosis,and to provide a theoretical basis for the implementation of interventional tuberculosis control measures.METHODS Two hundred and two patients with AIDS complicated with tuberculosis who were first admitted to Yunnan Infectious Diseases Hospital from Jan.2020 to Dec.2023 were selected,and their clinical data were collected through the inpatient medical record system.Multivariate logistic regression model was used to analyze the factors influencing delayed consultation and diagnosis.RESULTS Time of admission,place of residence,presence of lung cavities,distribution of lung lesions,intermediate hospital visited,sputum culture results,etiological situation,CD4+/CD8+cell ratio,and CD8+cell counts were the factors influencing delayed consultation(P<0.05).The initial diagnosis and Gene-Xpert results were the factors influencing delayed diagnosis(P<0.05).Multivariate logistic regression analysis showed that ad-mission in 2021(OR=3.842,95%CI:1.651-8.966),and presence of lung cavity(OR=8.007,95%CI:1.381-6.436),single lung lesion accumulation(OR=0.637,95%CI:0.049-8.267)were risk factors for delayed consultation.A 10%reduction in body mass(OR=2.070,95%CI:1.056-4.059)and negative Gene-Xpert re-sults(OR=1.667,95%CI:0.688-4.038)were risk factors for delayed diagnosis.CONCLUSIONS The issues of delayed medical consultation and diagnosis in patients with AIDS complicated with tuberculosis remain severe,with different factors influencing the delay.Special attention should be paid to the screening for latent tuberculosis infection in people infected with HIV.When experiencing suspicious symptoms,patients should go be encouraged to take exams at designated tuberculosis hospitals,repeatedly collect sputum samples and monitor changes in body mass,all of which are positively significant in reducing delays.

OBJECTIVE To understand the healthcare-seeking behavior of patients with AIDS co-infected with tu-berculosis and analyze the factors influencing delayed consultation and diagnosis,and to provide a theoretical basis for the implementation of interventional tuberculosis control measures.METHODS Two hundred and two patients with AIDS complicated with tuberculosis who were first admitted to Yunnan Infectious Diseases Hospital from Jan.2020 to Dec.2023 were selected,and their clinical data were collected through the inpatient medical record system.Multivariate logistic regression model was used to analyze the factors influencing delayed consultation and diagnosis.RESULTS Time of admission,place of residence,presence of lung cavities,distribution of lung lesions,intermediate hospital visited,sputum culture results,etiological situation,CD4+/CD8+cell ratio,and CD8+cell counts were the factors influencing delayed consultation(P<0.05).The initial diagnosis and Gene-Xpert results were the factors influencing delayed diagnosis(P<0.05).Multivariate logistic regression analysis showed that ad-mission in 2021(OR=3.842,95%CI:1.651-8.966),and presence of lung cavity(OR=8.007,95%CI:1.381-6.436),single lung lesion accumulation(OR=0.637,95%CI:0.049-8.267)were risk factors for delayed consultation.A 10%reduction in body mass(OR=2.070,95%CI:1.056-4.059)and negative Gene-Xpert re-sults(OR=1.667,95%CI:0.688-4.038)were risk factors for delayed diagnosis.CONCLUSIONS The issues of delayed medical consultation and diagnosis in patients with AIDS complicated with tuberculosis remain severe,with different factors influencing the delay.Special attention should be paid to the screening for latent tuberculosis infection in people infected with HIV.When experiencing suspicious symptoms,patients should go be encouraged to take exams at designated tuberculosis hospitals,repeatedly collect sputum samples and monitor changes in body mass,all of which are positively significant in reducing delays.

Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.

Objective:To investigate the effect of sodium tanshinone ⅡA sulfonate (STS) on pyroptosis of human umbilical vein endothelial cells (HUVECs) induced by H 2O 2 and its possible mechanism. Methods:From November 2021 to September 2022, HUVECs were used as the research subjects at Wuxi Ninth People’s Hospital. The experiment was divided into four groups: the blank control group (normal condition), blank + STS group, H 2O 2 group and H 2O 2 + STS group. When the cells reached 80% fusion, 500.00 μmol/L of H 2O 2 was added to H 2O 2 group and H 2O 2 + STS group for 3 hours, and then the medium containing 500.00 μmol/L H 2O 2 was removed. After that, the blank+ STS group and the H 2O 2+ STS group were each supplemented with 5.00 μg/ml of STS and co-cultured with HUVECs for 24 hours. CCK-8 was used to assess the impact of STS at various concentrations (0.00, 0.05, 0.50, 5.00, 50.00, 500.00 μg/ml) on the proliferation of HUVECs. DNA damage-positive cells were detected with TUNEL staining. The expression of NOD-like receptor protein 3 (NLRP3) was detected using real-time PCR (RT-PCR) to investigate the optimal concentration of pyroptosis induced by H 2O 2. A detection kit was used to measure the expression of reactive oxygen species (ROS) induced by H 2O 2. The effect of STS on the migration and tube formation of HUVECs during pyroptosis was examined using a cell scratch test and a matrix gel tube formation test. The expressions of NLRP3, caspase-1, interleukin-18, and interleukin-1β were detected using RT-PCR and Western blotting. Repeated measures ANOVA was used to compare the concentrations at different time points, t-tests were used to compare data between two groups, and one-way ANOVA was used to compare data between multiple groups. P<0.05 was considered statistically significant. Results:STS below 50.00 μg/ml had no effect on the proliferation of HUVECs, while 500.00 μmol/L H 2O 2 had the most significant effect on inducing pyroptosis in HUVECs. TUNEL staining showed that compared with the control group, the number of TUNEL-positive cells in H 2O 2 group was significantly increased, and the difference was statistically significant ( P<0.01). However, there was no significant difference in the number of TUNEL-positive cells in the H 2O 2+ STS group ( P>0.05). The results of ROS detection showed that compared with the H 2O 2 group, intracellular ROS levels in the H 2O 2+ STS group was significantly decreased, and the difference was statistically significant ( P<0.01). Cell scratch and tube formation in vitro experiments showed that compared with the control group, cell mobility and tube formation ability were significantly decreased in the H 2O 2 group (all P<0.01), and there was no statistical significance in the H 2O 2+ STS group (all P>0.05). RT-PCR and Western blotting results showed that, compared with the H 2O 2 group, the expression of pyroptosis-related factors in the H 2O 2+ STS group was significantly decreased (all P<0.05). Conclusion:STS can inhibit the excessive production of ROS, promote the cell migration and tubular formation of HUVECs after pyroptosis induction, and alleviate H 2O 2-induced pyroptosis of HUVECs, thereby promoting angiogenesis.

Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.

Objective To establish a gene sequencing method for ABO blood group,to analyze the mu-tation sites at the DNA level in order to accurately identify ABO blood group.Methods Twenty blood sam-ples were selected,in which 18 samples were ABO normal blood group and 2 samples were the ABO subtype. Exons 6 and 7 of ABO blood group gene were amplified by sequence-specific primer PCR (PCR-SSP),and then the gene sequence was directly sequenced and analyzed by PCR,and the ABO blood group was identified by comparing with the ABO reference sequence.Results The gene sequencing results of 20 blood samples were consistent with the serological results.In 2 subtype samples,the genotype in 1 sample was BA.02/O.01 and its phenotype was B(A) subtype.C>G mutation occurred at position 700 of the 7th exon,which resulted in proline changing to alanine at position 234 during amino acid translation.The genotype of the other sample was AW.37/B.01 and the phenotype was AxB subtype.The position 940 of the 7th exon mutates from ade-nine to guanine,resulting in the mutation of lysine changing to glutamic acid at position 314 during protein translation.Conclusion A method of ABO blood group gene sequencing suitable for laboratory is estab-lished,which could accurately identify ABO blood group.

Objective:To investigate the effect of sodium tanshinone ⅡA sulfonate (STS) on pyroptosis of human umbilical vein endothelial cells (HUVECs) induced by H 2O 2 and its possible mechanism. Methods:From November 2021 to September 2022, HUVECs were used as the research subjects at Wuxi Ninth People’s Hospital. The experiment was divided into four groups: the blank control group (normal condition), blank + STS group, H 2O 2 group and H 2O 2 + STS group. When the cells reached 80% fusion, 500.00 μmol/L of H 2O 2 was added to H 2O 2 group and H 2O 2 + STS group for 3 hours, and then the medium containing 500.00 μmol/L H 2O 2 was removed. After that, the blank+ STS group and the H 2O 2+ STS group were each supplemented with 5.00 μg/ml of STS and co-cultured with HUVECs for 24 hours. CCK-8 was used to assess the impact of STS at various concentrations (0.00, 0.05, 0.50, 5.00, 50.00, 500.00 μg/ml) on the proliferation of HUVECs. DNA damage-positive cells were detected with TUNEL staining. The expression of NOD-like receptor protein 3 (NLRP3) was detected using real-time PCR (RT-PCR) to investigate the optimal concentration of pyroptosis induced by H 2O 2. A detection kit was used to measure the expression of reactive oxygen species (ROS) induced by H 2O 2. The effect of STS on the migration and tube formation of HUVECs during pyroptosis was examined using a cell scratch test and a matrix gel tube formation test. The expressions of NLRP3, caspase-1, interleukin-18, and interleukin-1β were detected using RT-PCR and Western blotting. Repeated measures ANOVA was used to compare the concentrations at different time points, t-tests were used to compare data between two groups, and one-way ANOVA was used to compare data between multiple groups. P<0.05 was considered statistically significant. Results:STS below 50.00 μg/ml had no effect on the proliferation of HUVECs, while 500.00 μmol/L H 2O 2 had the most significant effect on inducing pyroptosis in HUVECs. TUNEL staining showed that compared with the control group, the number of TUNEL-positive cells in H 2O 2 group was significantly increased, and the difference was statistically significant ( P<0.01). However, there was no significant difference in the number of TUNEL-positive cells in the H 2O 2+ STS group ( P>0.05). The results of ROS detection showed that compared with the H 2O 2 group, intracellular ROS levels in the H 2O 2+ STS group was significantly decreased, and the difference was statistically significant ( P<0.01). Cell scratch and tube formation in vitro experiments showed that compared with the control group, cell mobility and tube formation ability were significantly decreased in the H 2O 2 group (all P<0.01), and there was no statistical significance in the H 2O 2+ STS group (all P>0.05). RT-PCR and Western blotting results showed that, compared with the H 2O 2 group, the expression of pyroptosis-related factors in the H 2O 2+ STS group was significantly decreased (all P<0.05). Conclusion:STS can inhibit the excessive production of ROS, promote the cell migration and tubular formation of HUVECs after pyroptosis induction, and alleviate H 2O 2-induced pyroptosis of HUVECs, thereby promoting angiogenesis.

AIM:One of the important characteristics of the occurrence and development of triple-negative breast cancer(TNBC)is dysregulated cell metabolism.The aim of this study is to investigate the mechanism of pyruvate dehydrogenase E1 subunit alpha 1(PDHA1),a key enzyme component in aerobic glycolysis,affecting the proliferation,metastasis and invasion of TNBC.METHODS:(1)The expression levels of PDHA1 in breast cancer tissues and adja-cent tissues were analyzed by UALCAN database,KM-plotter database,Gene MANIA database and TCGA database.The expression of PDHA1 was compared according to tumor pathological stage,subtype classification and breast cancer bio-markers.The function of PDHA1 in TNBC was explored by gene enrichment analysis.(2)Immunohistochemistry assays were used to detect the expression of PDHA1 in human TNBC tissue and adjacent tissue samples.(3)Stable PDHA1 knockout and PDHA1 rescue TNBC MDA-MB-231 cells were constructed.The proliferation of MDA-MB-231 cells was de-tected by colony formation assay and cell counting assay.The regulatory effect of PDHA1 on the invasion and migration of MDA-MB-231 cells was detected by in vitro scratch assay and Transwell migration assay.RESULTS:Database analysis showed that the group with high PDHA1 expression in breast cancer had shorter survival and worse prognosis.In clinical specimens,the expression of PDHA1 in cancer tissues was higher than that in adjacent normal tissues.Knockout of PDHA1 inhibited the proliferation,metastasis,invasion and epithelial-mesenchymal transition of MDA-MB-231 cells.CONCLUSION:PDHA1 is overexpressed in TNBC,and it promotes cell proliferation and facilitates TNBC metastasis through the epithelial-mesenchymal transition pathway.

Cancer has become a major life-threatening disease globally.In recent years,precision therapy for cancer has gradually emerged,and significant success has been achieved with targeted therapies,immune checkpoint inhibitors,and the newly emerging antibody-drug conjugates(ADC).The development of ADC has been rapid,with up to 15 ADC drugs currently approved worldwide.However,the hepatotoxicity of ADC has gained increasing attention,with reports of fatal hepatotoxic events.In this article,we briefly reviewed the ADC approved globally,summarized the liver-related adverse events and hepatotoxic manifestations reported in current clinical trials of ADC,and compiled research on possible hepatotoxicity mechanisms.Our aim is to assist clinicians in understanding and managing the hepatotoxicity characteristics of ADC,enabling timely identification of patients at risk of hepatotoxicity and implementing effective measures to manage these risks,thus reducing and preventing serious adverse events.

Cancer has become a major life-threatening disease globally.In recent years,precision therapy for cancer has gradually emerged,and significant success has been achieved with targeted therapies,immune checkpoint inhibitors,and the newly emerging antibody-drug conjugates(ADC).The development of ADC has been rapid,with up to 15 ADC drugs currently approved worldwide.However,the hepatotoxicity of ADC has gained increasing attention,with reports of fatal hepatotoxic events.In this article,we briefly reviewed the ADC approved globally,summarized the liver-related adverse events and hepatotoxic manifestations reported in current clinical trials of ADC,and compiled research on possible hepatotoxicity mechanisms.Our aim is to assist clinicians in understanding and managing the hepatotoxicity characteristics of ADC,enabling timely identification of patients at risk of hepatotoxicity and implementing effective measures to manage these risks,thus reducing and preventing serious adverse events.