As cardiac magnetic resonance imaging technology advances,T1 mapping has emerged as a non-invasive method offering visual and quantitative insights into myocardial fibrosis,edema,and infiltration associated with cardiac dis-eases.The application of T1 mapping in myocardial diseases allows for evaluating both focal and diffuse myocardial fibro-sis,playing a crucial clinical role in the differentiation,treatment,and prognostic risk assessment of diseases.This arti-cle aims to provide a thorough overview of the clinical applications of T1 mapping in patients with cardiomyopathy,summa-rizing the commonly employed scanning techniques and imaging principles.

Objective:To analyze the relationship between 24-hour urinary calcium (24 h UCa) level and the risk of end-stage kidney disease (ESKD), cardiovascular disease (CVD), and all-cause mortality.Methods:In the Chinese Cohort Study of Chronic Kidney Disease, we examined 3 375 patients aged 18-74 years with CKD stages 1-4. Kaplan-Meier survival and Cox proportional hazard regression models were used to test a time-to-event association between levels of 24 h UCa and incidence of ESKD, CVD, and all-cause mortality.Results:During a follow-up of 4.17 (3.37, 5.20) years, 179, 145, 104 and 38 ESKD events occurred in <0.60, 0.60-, 1.20-, ≥2.32 mmol 24 h UCa groups. Higher levels of 24 h UCa (1.20-,≥2.32 mmol) were independently associated with a lower incidence of ESKD events in patients with CKD, with HR (95% CI) of 0.71 (0.54-0.93) and 0.43 (0.29-0.64), respectively. No significant associations with CVD and all-cause mortality endpoints were detected. Conclusion:Among patients with CKD, levels of 24 h UCa displayed an association with the risk of ESKD among patients with CKD stages 1-4.

Objective:To investigate the feasibility and value of nomogram based on base line clinical and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) characteristics for pretreatment predicting the depth of myometrial invasion and tumor grade of endometrioid endometrial carcinoma (EEC).Methods:Preoperative baseline clinical characteristics and DCE-MRI characteristics of 194 EEC patients were prospectively collected at Obstetrics and Gynecology Hospital, Fudan University from October 2020 to January 2022 and used as a training set. Univariate analysis was conducted to compare baseline clinical characteristics and DCE-MRI quantitative parameters [including tumor volume, and mean, median, and standard deviation of volume transfer constant (K trans), rate constant (K ep), extravascular extracellular volume fraction (V e), and initial area under the enhancement curve (iAUC)] between patients with deep myometrial invasion (DMI) and those with superficial myometrial invasion (SMI), as well as between high-grade and low-grade EEC. Multivariate logistics regression analysis was used to identify independent predictors for the construction of nomogram. An independent external testing set comprising 127 EEC patients was retrospectively collected from Zhongshan Hospital, Fudan University and Zhongshan Hospital, Fudan University (Xiamen Branch). The area under the receiver operating characteristic curve (AUC) and decision curve analysis (DCA) were used for evaluating the model′s predictive performance and clinical net benefit, respectively. Results:(1) The depth of myometrial invasion: univariate analysis showed that in the training set, the EEC patients with DMI differed significantly from those with SMI in clinical characteristics including higher proportion of postmenopausal state and overweight [body mass index (BMI)≥25 kg/m2], and abnormal levels of serum cancer antigen (CA) 125, CA 199, and human epididymis protein 4 (HE4), and in DCE-MRI quantitative parameters including tumor volume, and median, mean, and standard deviation of K trans, median of V e, as well as median, mean, and standard deviation of iAUC (all P<0.05). Multivariate analysis showed that the patient′s menstrual status, BMI, CA 199, tumor volume, and mean of iAUC were independent predictors of the depth of myometrial invasion, and constructed the nomogram (recorded as Nomogram_1), achieving an AUC of 0.861 (95% CI: 0.803-0.919) in the training set. In the independent external testing set, the AUC was 0.876 (95% CI: 0.815-0.938), with corresponding sensitivity of 82.0%, specificity of 80.7%, accuracy of 81.1%, positive predictive value (PPV) of 65.3%, and negative predictive value (NPV) of 91.0% for predicting DMI. (2) The EEC grade: univariate analysis showed that in the training set, high-grade EEC patients differed significantly from low-grade EEC in clinical characteristics including patient′s age, the proportion of postmenopausal state and overweight, and abnormal levels of serum CA 125, and in DCE-MRI quantitative parameters including tumor volume, median, mean, and standard deviation of K trans, median and mean of V e, as well as median, mean, and standard deviation of iAUC (all P<0.05). Multivariate analysis showed that the patient′s menstrual status, BMI, tumor volume, and median of V e emerged as independent predictors of EEC grade, and constructed the nomogram (recorded as Nomogram_2), achieving an AUC of 0.845 (95% CI: 0.786-0.893) in the training set. While in the external testing set, the AUC was 0.819 (95% CI: 0.744-0.894), with corresponding sensitivity of 72.4%, specificity of 72.4%, accuracy of 72.4%, PPV of 43.8%, and NPV of 89.9% for predicting high-grade EEC. (3) The DCA curves demonstrated that both Nomogram_1 and Nomogram_2 yielded obvious positive clinical net benefits across a wide range of threshold probabilities. Conclusion:The nomogram based on pretreatment clinical and DCE-MRI characteristics has the potential to noninvasive predict the depth of myometrial invasion and grade of EEC, providing valuable reference information for clinical management decision-making.

As cardiac magnetic resonance imaging technology advances,T1 mapping has emerged as a non-invasive method offering visual and quantitative insights into myocardial fibrosis,edema,and infiltration associated with cardiac dis-eases.The application of T1 mapping in myocardial diseases allows for evaluating both focal and diffuse myocardial fibro-sis,playing a crucial clinical role in the differentiation,treatment,and prognostic risk assessment of diseases.This arti-cle aims to provide a thorough overview of the clinical applications of T1 mapping in patients with cardiomyopathy,summa-rizing the commonly employed scanning techniques and imaging principles.

Objective:To analyze the relationship between 24-hour urinary calcium (24 h UCa) level and the risk of end-stage kidney disease (ESKD), cardiovascular disease (CVD), and all-cause mortality.Methods:In the Chinese Cohort Study of Chronic Kidney Disease, we examined 3 375 patients aged 18-74 years with CKD stages 1-4. Kaplan-Meier survival and Cox proportional hazard regression models were used to test a time-to-event association between levels of 24 h UCa and incidence of ESKD, CVD, and all-cause mortality.Results:During a follow-up of 4.17 (3.37, 5.20) years, 179, 145, 104 and 38 ESKD events occurred in <0.60, 0.60-, 1.20-, ≥2.32 mmol 24 h UCa groups. Higher levels of 24 h UCa (1.20-,≥2.32 mmol) were independently associated with a lower incidence of ESKD events in patients with CKD, with HR (95% CI) of 0.71 (0.54-0.93) and 0.43 (0.29-0.64), respectively. No significant associations with CVD and all-cause mortality endpoints were detected. Conclusion:Among patients with CKD, levels of 24 h UCa displayed an association with the risk of ESKD among patients with CKD stages 1-4.

Objective:To investigate the feasibility and value of nomogram based on base line clinical and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) characteristics for pretreatment predicting the depth of myometrial invasion and tumor grade of endometrioid endometrial carcinoma (EEC).Methods:Preoperative baseline clinical characteristics and DCE-MRI characteristics of 194 EEC patients were prospectively collected at Obstetrics and Gynecology Hospital, Fudan University from October 2020 to January 2022 and used as a training set. Univariate analysis was conducted to compare baseline clinical characteristics and DCE-MRI quantitative parameters [including tumor volume, and mean, median, and standard deviation of volume transfer constant (K trans), rate constant (K ep), extravascular extracellular volume fraction (V e), and initial area under the enhancement curve (iAUC)] between patients with deep myometrial invasion (DMI) and those with superficial myometrial invasion (SMI), as well as between high-grade and low-grade EEC. Multivariate logistics regression analysis was used to identify independent predictors for the construction of nomogram. An independent external testing set comprising 127 EEC patients was retrospectively collected from Zhongshan Hospital, Fudan University and Zhongshan Hospital, Fudan University (Xiamen Branch). The area under the receiver operating characteristic curve (AUC) and decision curve analysis (DCA) were used for evaluating the model′s predictive performance and clinical net benefit, respectively. Results:(1) The depth of myometrial invasion: univariate analysis showed that in the training set, the EEC patients with DMI differed significantly from those with SMI in clinical characteristics including higher proportion of postmenopausal state and overweight [body mass index (BMI)≥25 kg/m2], and abnormal levels of serum cancer antigen (CA) 125, CA 199, and human epididymis protein 4 (HE4), and in DCE-MRI quantitative parameters including tumor volume, and median, mean, and standard deviation of K trans, median of V e, as well as median, mean, and standard deviation of iAUC (all P<0.05). Multivariate analysis showed that the patient′s menstrual status, BMI, CA 199, tumor volume, and mean of iAUC were independent predictors of the depth of myometrial invasion, and constructed the nomogram (recorded as Nomogram_1), achieving an AUC of 0.861 (95% CI: 0.803-0.919) in the training set. In the independent external testing set, the AUC was 0.876 (95% CI: 0.815-0.938), with corresponding sensitivity of 82.0%, specificity of 80.7%, accuracy of 81.1%, positive predictive value (PPV) of 65.3%, and negative predictive value (NPV) of 91.0% for predicting DMI. (2) The EEC grade: univariate analysis showed that in the training set, high-grade EEC patients differed significantly from low-grade EEC in clinical characteristics including patient′s age, the proportion of postmenopausal state and overweight, and abnormal levels of serum CA 125, and in DCE-MRI quantitative parameters including tumor volume, median, mean, and standard deviation of K trans, median and mean of V e, as well as median, mean, and standard deviation of iAUC (all P<0.05). Multivariate analysis showed that the patient′s menstrual status, BMI, tumor volume, and median of V e emerged as independent predictors of EEC grade, and constructed the nomogram (recorded as Nomogram_2), achieving an AUC of 0.845 (95% CI: 0.786-0.893) in the training set. While in the external testing set, the AUC was 0.819 (95% CI: 0.744-0.894), with corresponding sensitivity of 72.4%, specificity of 72.4%, accuracy of 72.4%, PPV of 43.8%, and NPV of 89.9% for predicting high-grade EEC. (3) The DCA curves demonstrated that both Nomogram_1 and Nomogram_2 yielded obvious positive clinical net benefits across a wide range of threshold probabilities. Conclusion:The nomogram based on pretreatment clinical and DCE-MRI characteristics has the potential to noninvasive predict the depth of myometrial invasion and grade of EEC, providing valuable reference information for clinical management decision-making.

Objective To investigate the basic information of human immunodeficiency virus/acquired immune deficiency syndrome(HIV/AIDS)patients who infected with Epstein-Barr virus(EBV)or human Cytomegalovirus(HCMV),collect the relevant clinical immunological data and analyze the influencing factors.Method A total of 1 093 HIV/AIDS patients treated in the First Hospital of Changsha from January to December 2022 and underwent EBV and HCMV screening were collected.Flow cytometry was used to detect the CD4+T lymphocytes.Fluorescence quantitative PCR was applied for HIV-RNA,EBV-DNA,and HCMV-DNA testing.Statistical analysis was carried out by using SPSS 27.0,and logistic regression was used to analyze the risk factors of HIV/AIDS patients complicated with viral infection.Results Among 1 093 HIV/AIDS patients,the positive rates of EBV-DNA and HCMV-DNA were 48.22%(527/1 093)and 19.03%(208/1 093),respectively.As the number of CD4+T lymphocytes increased,the positive rates of EBV-DNA and HCMV-DNA decreased,and the differences was statistically significant(χ2=39.50,143.0,all P<0.001).As the level of HIV-RNA increased,the positive rates of EBV-DNA and HCMV-DNA increased,and the differences were statistically significant(χ2=46.18,124.3,all P<0.001).The patients receiving antiretroviral therapy(ART)significantly decreased the positive rates of EBV-DNA and HCMV-DNA(χ2=30.60,96.59,all P<0.001).There was a significant negative correlation between the number of CD4+T lymphocytes and the level of HIV-RNA(r=-0.49,P<0.001).Logistic regression analysis showed that the CD4+T lymphocyte count<200/μl(OR=1.46,95%CI:1.02～2.08,P=0.037),HIV-RNA load>200 copies/ml(OR=1.70,95%CI:1.18～2.44,P=0.004)and the age>30 years old(OR=2.15,95%CI:1.44～3.19,P<0.001)were risk factors for HIV/AIDS patients infected with EBV.Without regularly receiving ART(OR=1.83,95%CI:1.10～3.02,P=0.019),HIV-RNA load>200 copies/ml(OR=2.56,95%CI:1.50～4.35,P<0.001)and the CD4+T lymphocyte count<200/μl(OR=4.61,95%CI:2.57～8.28,P<0.001)were risk factors for HCMV infection in HIV/AIDS patients.Conclusion To reduce the possibility of opportunistic infection in HIV/AIDS patients,the surveillance of EBV and HCMV and regular ART should be strengthened,especially when the number of CD4+T lymphocytes decreases(<200/μl),the level of HIV RNA increases(>200 copies/ml)or the age>30 years old.

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.

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 observe the effect of Zuogui Jiangtang Shuxin Decoction on diabetes atherosclerosis in ApoE-/-mice induced by streptozotocin combined with high-fat diet;To explore its mechanism of diabetes atherosclerosis by regulating intestinal flora and glucose and lipid metabolism.Methods Diabetic atherosclerosis model was constructed by intraperitoneal streptozotocin 40 mg/kg combined with a high-fat diet in 8-week-old male ApoE-/-mice,which were randomly divided into model group,Zuogui Jiangtang Shuxin Decoction group and metformin group,with 5 mice in each group,another 5 C57BL/6 mice were set as the blank control group.Zuogui Jiangtang Shuxin Decoction group were given Zuogui Jiangtang Shuxin Decoction 28.86 g/kg for gavage,the metformin group was given metformin 0.065 g/kg for gavage,and the model group and blank control group were given same volume of distilled water for gavage for consecutive 8 weeks.Fasting blood glucose(FBG)was detected,automatic biochemical analyzer was used to detect serum triglycerides(TG)and total cholesterol(TC)contents,morphology of pancreas,aorta and colonic tissue were observed by HE staining.Intestinal contents were collected to detect the changes of intestinal flora by sequencing with 16S rRNA amplicon.Results Compared with the blank control group,the FBG,TG,TC content in the model group significantly increased(P<0.01);the pancreatic lobules had an unclear lobe structure and a large number of atrophied glandular follicles;the intima-media of the aorta was hyperplastic,exhibiting visible atheromatous plaques and lumen stenosis;the structure of colonic tissue was unclear,and the intestinal mucosa in certain parts was vesiculously eroded,accompanied by inflammatory cells infiltration.Compared with the model group,the FBG,TG,TC content in Zuogui Jiangtang Shuxin Decoction group and metformin group significantly decreased(P<0.01);the pancreatic tissue structure was improved,atherosclerotic plaque and lipid deposition reduced,the colonic mucosal epithelium repaired,and inflammatory cell infiltration reduced.Alpha and Beta diversity analyses showed that the groups of samples were able to separate significantly,with the total number and abundance of intestinal flora species being lower in the model group.Compared with the blank control group,the relative abundance of the model group increased in Firmicutes,Desulfobacterota,Clostridia,Desulfovibrionia and Lachnospiraceae,decreased in Bacteroidota,Bacteroidia,Muribaculaceae and Muribaculaceaes(P<0.01).Compared with the model group,the relative abundance of Zuogui Jiangtang Shuxin Decoction group decreased in Firmicutes,Desulfobacterota,Clostridia,Desulfovibrionia and Lachnospiraceae,and increased in Bacteroidota,Bacteroidia,Muribaculaceae and Muribaculaceaes(P<0.05,P<0.01).Conclusion Zuogui Jiangtang Shuxin Decoction can regulate the intestinal microecology,thereby inhibiting the formation of diabetic atherosclerotic plaque.The mechanism may be related to its regulation of intestinal flora structure,improvement of glucose and lipid metabolism,protection of pancreatic tissues,and repair of the intestinal mucosal barrier.