Objective To explore the structural changes and potential improvement in the reporting system,and to provide reference for improving the efficiency of drug safety supervision.Methods Descriptive statistical analysis and structural analysis were used to analyze the source of adverse drug reaction(ADR)reports,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China from 2014 to 2023.Results The structural variation of the source of ADR report,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China were 20.00%,6.20%,27.20%,9.40%and 16.62%,respectively.Among them,patients aged 65 and over(VSV=13.20)had the largest change value and positive change;the source of drug business enterprises(VSV=-9.70),intravenous injection route(VSV=-6.51)and traditional Chinese medicine category(VSV=-4.70)showed negative changes.Conclusions It is necessary to improve the laws and regulations of the industry,enhance the ability of enterprises to implement the main responsibility,improve the public's awareness and participation awareness of ADR,strengthen the monitoring and guidance strategies of drug safety in specific age groups,improve the monitoring level of adverse reactions of traditional Chinese medicine,and strengthen the supervision of adverse reactions of intravenous injection.

Objective To observe the value of prenatal ultrasound evaluation on morphology of Sylvian fissure(SF)during the second and third trimesters for screening fetal abnormal cerebral cortical development.Methods Totally 876 fetuses in the second and third trimesters were retrospectively included.Prenatal ultrasound was performed to observe the morphology of fetal SF and whether there was complicated abnormalities of the development of cerebral cortical and other structures.Then prenatal ultrasound was regularly reexamined,and the pregnancy outcome,while the growth and development of newborns were followed up.Results Among 876 fetuses,normal SF morphology was observed in 861 fetuses(861/876,98.29％),while 11 fetuses(11/876,1.26％)had delayed SF development(normal SF morphology but inconsistent with gestational week)and 4 fetuses(4/876,0.46％)had abnormal SF morphology,all complicated with abnormal cerebral cortical development and/or intracranial and extracranial structural malformations,and reexamination of prenatal ultrasound showed that SF morphology was consistent with the gestational week in 4 fetuses,SF morphology still did not match the gestational week in 4 fetuses,and SF morphology was still abnormal in 2 fetuses.Among these 15 fetuses,6 were successfully born and grew well after followed up until 10-15 months,4 were induced labor,while the rest 4(3 with delayed SF development and 1 with abnormal SF morphology)complicated with other severe malformations and 1 with abnormal SF morphology were induced labor or lost to follow-up,hence not undergoing ultrasound re-examination.Conclusion Prenatal ultrasound evaluation on SF morphology during the second and third trimesters had important value for screening fetal abnormal cerebral cortical development.

Objective To explore the structural changes and potential improvement in the reporting system,and to provide reference for improving the efficiency of drug safety supervision.Methods Descriptive statistical analysis and structural analysis were used to analyze the source of adverse drug reaction(ADR)reports,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China from 2014 to 2023.Results The structural variation of the source of ADR report,the occupation of the reporter,the age of the patient,the type of drug and the route of administration in China were 20.00%,6.20%,27.20%,9.40%and 16.62%,respectively.Among them,patients aged 65 and over(VSV=13.20)had the largest change value and positive change;the source of drug business enterprises(VSV=-9.70),intravenous injection route(VSV=-6.51)and traditional Chinese medicine category(VSV=-4.70)showed negative changes.Conclusions It is necessary to improve the laws and regulations of the industry,enhance the ability of enterprises to implement the main responsibility,improve the public's awareness and participation awareness of ADR,strengthen the monitoring and guidance strategies of drug safety in specific age groups,improve the monitoring level of adverse reactions of traditional Chinese medicine,and strengthen the supervision of adverse reactions of intravenous injection.

Objective To observe the value of prenatal ultrasound evaluation on morphology of Sylvian fissure(SF)during the second and third trimesters for screening fetal abnormal cerebral cortical development.Methods Totally 876 fetuses in the second and third trimesters were retrospectively included.Prenatal ultrasound was performed to observe the morphology of fetal SF and whether there was complicated abnormalities of the development of cerebral cortical and other structures.Then prenatal ultrasound was regularly reexamined,and the pregnancy outcome,while the growth and development of newborns were followed up.Results Among 876 fetuses,normal SF morphology was observed in 861 fetuses(861/876,98.29％),while 11 fetuses(11/876,1.26％)had delayed SF development(normal SF morphology but inconsistent with gestational week)and 4 fetuses(4/876,0.46％)had abnormal SF morphology,all complicated with abnormal cerebral cortical development and/or intracranial and extracranial structural malformations,and reexamination of prenatal ultrasound showed that SF morphology was consistent with the gestational week in 4 fetuses,SF morphology still did not match the gestational week in 4 fetuses,and SF morphology was still abnormal in 2 fetuses.Among these 15 fetuses,6 were successfully born and grew well after followed up until 10-15 months,4 were induced labor,while the rest 4(3 with delayed SF development and 1 with abnormal SF morphology)complicated with other severe malformations and 1 with abnormal SF morphology were induced labor or lost to follow-up,hence not undergoing ultrasound re-examination.Conclusion Prenatal ultrasound evaluation on SF morphology during the second and third trimesters had important value for screening fetal abnormal cerebral cortical development.

OBJECTIVE: To identify phytochemical constituents present in the extract of flowers of Xanthoceras sorbifolia and evaluate their anti-oxidant and anti-hyperglycemic capacities. METHODS: The AlCl₃ colorimetric method and Prussian Blue assay were used to determine the contents of total flavonoids and total phenolic acids in extraction layers, and the bioactive layers was screened through anti - oxidative activity in vitro. The Waters ACQUITY UPLC system and a Waters ACQUITY UPLC BEH C₁₈ column (2.0 mm × 150 mm, 5 μm) were used to identify the ingredients. And anti-oxidative ingredients were screened by off-line UPLC-QTOF-MS/MS-free radical scavenging. The ameliorative role of it was further evaluated in a high-fat, streptozotocin-induced type 2 diabetic rat model and the study was carried out on NADPH oxidase (PDB ID: 2CDU) by molecular docking. RESULTS: Combined with the results of activity screening in vitro, the anti - oxidative part was identified as the ethyl acetate layer. A total of 24 chemical constituents were identified by liquid chromatography-mass spectrometry in the ethyl acetate layer and 13 main anti-oxidative active constituents were preliminarily screened out through off-line UPLC-QTOF-MS/MS-free radical scavenging. In vivo experiments showed that flowers of X. sorbifolia could significantly reduce the blood glucose level of diabetic mice and alleviate liver cell damage. Based on the results of docking analysis related to the identified phytocompounds and oxidase which involved in type 2 diabetes, quercetin 3-O-rutinoside, kaempferol-3-O-rhamnoside, isorhamnetin-3-O-glucoside, and isoquercitrin showed a better inhibitory profile. CONCLUSION The ethyl acetate layer was rich in flavonoids and phenolic acids and had significant anti-oxidant activity, which could prevent hyperglycemia. This observed activity profile suggested X. sorbifolia flowers as a promising new source of tea to develop alternative natural anti-diabetic products with a high safety margin.

Objective:To explore the ovarian function and its influencing factors in women of child-bearing age with systemic lupus erythematosus(SLE).Methods:A total of 107 female patients diag-nosed with SLE at Peking University People's Hospital from January 2017 to May 2024,aged between 20 and 40 years,were included in the study.At the same time,40 matched healthy women aged between 20 and 40 years were selected as controls.Serum levels of anti-Müllerian hormone(AMH)were measured using the chemiluminescence method in both the control group and the SLE patients.The general clinical characteristics and medication history(including hormones,immunosuppressants,and biological agents)of the SLE patients were obtained through case retrieval.Changes in serum AMH levels before and after treatment with biological agents in the SLE patients were analyzed.Results:(1)The AMH levels in the SLE patients were significantly lower than those in the healthy control group[1.475(0.344,3.030)μg/L vs.2.934(1.893,4.761)μg/L,P＜0.001].(2)The level of AMH in the SLE patients with normal menstruation was significantly higher than that in the patients with irregular menstruation[1.931(0.638,3.414)μg/L vs.0.335(0.159,1.527)μg/L,P=0.004].No statistical differences were found in clinical characteristics and laboratory indicators between the groups with decreased AMH group and normal AMH group.(3)The multivariate logistic regression analysis revealed that age(OR=1.124,95％CI:1.033-1.224,P=0.007)and disease duration(OR=1.100,95％CI:1.017-1.190,P=0.018)were identified as significant risk factors for the decline in AMH levels.(4)After 6 months of treatment with telitacicept,the AMH level was significantly higher than that before treatment[2.050(0.763,4.259)μg/L vs.1.988(0.473,2.822)μg/L,P=0.043].There was no signifi-cant difference in AMH level between patients receiving rituximab treatment for 6 months[2.026(0.376,2.267)μg/L vs.1.545(0.503,3.414)μg/L,P=0.127].Conclusion:Ovarian function is decreased in SLE patients of childbearing age,and age and disease duration are the risk factors.The utilization of biological agents demonstrates favorable safety profiles regarding ovarian function in child-bearing-age patients with SLE.

Objective:To study the expression of peripheral blood NKT-like cells in patients with systemic sclerosis (SSc), to explore the correlation between NKT-like cells and laboratory and clinical indicators of systemic sclerosis, and investigate the role of NKT-like cells in the occurrence and development of Systemic sclerosis.Methods:Forty-six SSc patients (SSc group) were enrolled from Department of Rheumatology and Immunology of Peking University People 's Hospital during December 2018 to December 2019. Thirty healthy subjects with matched age and sex were selected as healthy control group (HC group). The cell count and percentage of NKT-like cells and other lymphocyte subsets in peripheral blood were detected by flow cytometry. At the same time, other laboratory indexes were determined by different methods. Spearman's correlation analysis, Pearson's correlation analysis, Man-Whitney U test and Fisher's exact test were used to analyze the difference and correlation between NKT-like cells and other clinical and laboratory indicators. Results:Compared with HC group [165(72, 226)cells/μl], the cell count of NKT-like cells in peripheral blood of SSc group[30(19, 58)cells/μl] was significantly decreased ( Z=-5.69, P<0.001). Correlation analysis showed that the cell count of NKT-like cells was positively correlated with total T lymphocytes ( r=0.56, P<0.001), CD4 +T cells ( r=0.42, P=0.004), CD8 +T cells ( r=0.60, P<0.001), B cells ( r=0.50, P<0.001) and NK cells ( r=0.33, P=0.024), respectively. The percentage of NKT-like cells in lymphocytes was also positively correlated with the percentage of CD8 +T cells ( r=0.34, P=0.020), but not significantly correlated with other subset of lymphocytes. The ESR of the NKT-like cell decreased group was significantly higher than that of the NKT-like normal group[15(9, 28) mm/1 h vs 8 (4, 16) mm/1 h, Z=-2.04, P=0.042]. Moreover, the cell count of NKT-like cells was negatively correlated with ESR ( r=-0.34, P=0.019). Conclusion:The cell count and percentage of NKT-like cells in peripheral blood of SSc patients decreased significantly. NKT-like cells were not only positively correlated with a variety of lymphocyte subpopulations, but also negatively correlated with ESR. NKT-like cells may be used as an indicator to monitor the disease activity in patients with SSc.

BACKGROUND: Human neutrophil lipocalin (HNL) has been used extensively to differentiate acute bacterial infection from febrile diseases as a biomarker to reflect the activation of the neutrophil. The serum HNL levels in the adult-onset Still's disease (AOSD) patients with and without infection, as well as the healthy controls (HCs), were analyzed statistically in this study to evaluate the value of HNL for the diagnosis of AOSD. METHODS: A total of 129 AOSD patients were enrolled, from whom blood samples were drawn and the AOSD diagnosis was confirmed through the review of the medical records, where the systemic score, demographic characteristics, clinical manifestations, and laboratory parameters were also collected for the patients; in addition, a total of 40 HCs were recruited among the blood donors from the healthcare center with the relevant information collected. The HNL test was done for the blood samples with the enzyme-linked immunosorbent assay and the analyses were done for the correlations of HNL with clinical manifestations and diagnostic effectiveness. RESULTS: The serum HNL increased significantly in the patients with only AOSD as compared with that in the HCs (139.76 ± 8.99 ng/mL vs . 55.92 ± 6.12 ng/mL; P  < 0.001). The serum HNL level was correlated with the white blood cell (WBC) count ( r  = 0.335, P  < 0.001), neutrophil count ( r  = 0.334, P  < 0.001), erythrocyte sedimentation rate ( r  = 0.241, P  = 0.022), C-reactive protein ( r  = 0.442, P  < 0.0001), and systemic score ( r  = 0.343, P  < 0.0001) in the AOSD patients significantly. Patients with fever, leukocytosis ≥15,000/mm 3 , and myalgia in the HNL-positive group were observed relatively more than those in the HNL-negative group ( P  = 0.009, P  = 0.023, and P  = 0.007, respectively). HNL was a more sensitive indicator than ferritin and C-reactive protein (CRP) to differentiate the AOSD patients with bacterial infection from AOSD-only patients, and the Youden index was 0.6 for HNL and 0.29 for CRP. CONCLUSION Serum HNL can be used as a biomarker for the diagnosis of the AOSD, and HNL is also observed to be associated with the disease activity.
Adult ; Humans ; Still's Disease, Adult-Onset/diagnosis* ; C-Reactive Protein/metabolism* ; Neutrophils/metabolism* ; Clinical Relevance ; Biomarkers ; Bacterial Infections

0bjective To analyze the clinical characteristics, pathological types, treatment and prognosis in children with steroid resistant nephrotic syndrome (SRNS) in Northwest China, in order to provide reference for the treatment of SRNS. Methods:The clinical data, renal pathological results, treatment plan and efficacy of 102 children diagnosed with SRNS in the Department of Nephrology, Xi'an Children's Hospital of Shaanxi Province from January 1st, 2018 to December thirty-first, 2020 were analyzed retrospectively. All children were divided into groups according to age, clinical classification, pathological type, treatment scheme and treatment outcome, and the risk factors affecting the prognosis of children with SRNS were discussed. The measurement datas conforming to normal distribution were expressed as xˉ± s, and t test was used for comparison between groups. Measurement datas that did not conform to normal distribution were represented by M ( Q1, Q3), and Kruskall-Wallis test was used for comparison between groups.Enumeration datas were compared by χ 2 test. Risk factors were analyzed by multiple factor Logistic regression analysis. Results:The median age of onset of 102 children with SRNS was 3.0 years. Focal segmental glomerulosclerosis (FSGS) accounted for 36.3% (37/102), minimal lesions accounted for 33.3% (34/102), and mesangial proliferative glomerulonephritis accounted for 23.5% (24/102). The prevalence rates of hypertension (35.1% (13/37)), 24-h urine protein quantification (130.5 (91.5, 159.6) mg/(kg·24 h) and renal insufficiency (21.6% (8/37)) in FSGS group were higher than those in non-FSGS group (13.8% (9/65), 65.8 (51.2,85.5) mg/(kg·24 h), 4.6% (3/65)). The differences between the two groups were statistically significant (statistical values were χ 2=6.32, Z=5.90, χ 2=7.09; P values were 0.012, <0.001, 0.008). Logistic multivariate regression analysis showed that the hypertension ( OR=4.055, 95% CI 1.178-3.962) and 24 hour urinary protein ( OR=1.036, 95% CI 1.020-1.053) were associated with the increased risk of FSGS ( P values were 0.026 and <0.001). ROC curve ananlysis showed that the optimal critical value of 24 hour urinary protein was 85.65 mg/(kg·24 h) in FSGS. After treatment, complete remission was 61.8%(63/102), partial remission was 14.7%(15/102), and no remission was 23.5%(24/102). By the end of follow-up the treatment effective rate in the small lesion group (94.1%(32/34)) was higher than that in the FSGS Group (51.3%(19/37)), and the difference between the two groups was statistically significant (χ 2=16.02, P<0.001). In the initial immunosuppressive treatment, the complete remission rate of hormone combined with calcineurin inhibitor group (77.1%(37/48)) was higher than that of hormone combined with cyclophosphamide Group (11.1%(3/27)). There was significant difference between the two groups ( Z=32.28, P<0.001). Conclusion:The most common pathological type in children with SRNS was FSGS, and the age of onset was generally small. The prognosis of patients with pathological type FSGS was the worst, and the prognosis of small lesions was better. Hypertension and 24-hour urinary protein quantification were the risk factors of FSGS. Calcineurin inhibitors were the first choice for the second-line immunosuppressants of SRNS in children.

Objective:To investigate the level and the influencing factors of blood uric acid in monks and nuns in Wutai Mountain area, and to explore the relationship between blood uric acid level and BMI and blood lipids levels.Methods:Physical examinations and laboratory tests were performed on monks and nuns in Wutai Mountain area. There were 207 males and 261 females. Physical examination includes height, weight, blood pressure, blood uric acid, blood lipid, blood glucose and other indicators. The blood uric acid level was measured using the uricase method. Chi-square test for trend, and t test were utilized for statistical analysis. Results:The average blood uric acid level of the monk and the nun was (372±6) μmol/L and (290±4) μmol/L, respectively. Obviously, the average blood uric acid level of the monk was significantly higher than it in the nun ( t=11.636, P<0.01). The total incidence rate of hyperuricemia, which was diagnosed when the blood uric acid level was higher than 420 μmol/L in males and the blood uric acid level was higher than 360 μmol/L in females. In particular, the incidence rate of hyperuricemia was much higher in the monk (24.3%, 50/207) than in the nuns (13.4%, 35/261) ( χ2=8.966, P<0.01) . Analysis by age, the prevalence of hyperuricemia in men was 20.3%(42/207) before the age of 50, which was higher than that after the age of 50 (3.9%, 8/207) ( χ2=26.3, P< 0.01); The prevalence of hyperuricemia in women before the age of 50 was 2.7%(7/261), which was lower than that after the age of 50 (10.7%, 28/261) ( χ2=13.51, P<0.01). The uric acid level of men and women between 50-60 years old, showed the opposite trend. The level of uric acid in men decreased and increased in women. In addition, the prevalence of triglyceride abnormalities and overweight was more significantly in monks and nuns with high uric acid than those with the normal uric acid level [71.8%(61/85) vs 45.2%(173/383), χ2=19.68, P<0.01; 54.1%(46/85) vs 19.8%(76/383), χ2=42.4, P<0.01]; while no significant difference of total cholesterol and blood glucose levels was observed between these two groups. Conclusion:There are differences in blood uric acid levels among Wutai Mountain area monks and nuns of different ages and genders. The level of blood uric acid in male is significantly higher than that in female. Lipid metabolism and over weight are closely related to elevated level of the uric acid, which might be the risk factors of uric acid abnormality in Wutai Mountain population.