The rapid development of nanomaterials has brought groundbreaking opportunities for high-quality innovation in medical devices, but it has also become a new challenge for regulatory authorities. How to scientifically and rationally evaluate the risks of medical device products with nanomaterials and establish appropriate regulatory classifications have become critical research priorities. To solve this problem, this study focuses on medical devices with nanomaterials, conducts a comparative analysis of domestic and international regulatory classification policies, reviews the current registration status of related products, and provides recommendations on key considerations for the classification and regulation of medical devices with nanomaterials, which aims at promoting high-quality advancement in China's medical device regulation.
Nanostructures/classification* ; Equipment and Supplies/classification*

Objective To compare the clinical value of TruScreen,an artificial intelligence-based real-time cervical cancer screening system,combined with high-risk human papillomavirus(hr-HPV)test and Thinprep cytology test(TCT)combined with hr-HPV test in cervical cancer screening.Methods A total of 297 women undergoing cervical cancer screening at Panzhihua Central Hospital between June 2020 and December 2023 were enrolled.All participants underwent hr-HPV testing,TCT,and TruScreen test.The diagnostic performance of TruScreen combined with hr-HPV test and TCT combined with hr-HPV test for low-grade squamous intraepithelial lesion positive(LSIL+)and high-grade squamous intraepithelial lesion positive(HSIL+)cervical lesions was evaluated.Results Among the 297 enrolled women,pathology analysis identified 128(43.10%)LSI+cases and 67(22.56%)HSIL+cases.Additionally,there were 110(37.04%)HPV16/18 positive cases,177(59.60%)cases with TCT results≥atypical squamous cells of undetermined significance(ASCUS),and 176(59.26%)cases with abnormal TruScreen results.The area under the curve(AUC)of TruScreen combined with hr-HPV test in diagnosing LSIL+and HSIL+cervical lesions was higher than that of TCT combined with hr-HPV test(P<0.05).Conclusion TruScreen combined with hr-HPV test demonstrates superior performance in cervical cancer screening compared with TCT combined with hr-HPV test.TruScreen combined with hr-HPV test may serve as an alternative to conventional cytology-based methods for cervical cancer screening in China.

Humans ; Diabetes Mellitus, Type 1 ; Hypoglycemia/chemically induced* ; Hypoglycemic Agents/adverse effects* ; China ; Blood Glucose ; Insulin

Objective To explore the effects and influencing factors of traditional occupational health training on occupational health literacy (OHL) of employees in micro-, small- and medium-sized enterprises. Methods A total of 540 employees from 154 micro-, small- and medium-sized enterprises, who participated (347 employees) and not-participated (193 employees) in traditional occupational health training, and 171 community residents/students (not-participated in occupational health training) were selected as the research subjects using the convenient sampling method. The OHL level was investigated using Occupational Health Literacy Questionnaire of National Key Populations. Results The overall OHL level of employees was 43.3% (234/540). Among them, the overall OHL level of untrained and trained employees was 38.9% and 45.8%, respectively, and the overall OHL level of community residents/students was 43.3%. The results of multivariate logistic regression analysis showed that the higher the educational level, the higher the OHL level (all P<0.01). The OHL level of untrained and trained employees was higher than that of untrained community residents/students (all P<0.05). The interaction of education level and training status had no statistical difference on the OHL level of the research subjects (P>0.05). The results of factorial design analysis of variance showed that the overall OHL score rate of untrained employees and trained employees was higher than that of untrained community residents/students (all P<0.05). However, there was no significant difference in overall OHL score rate between untrained and trained employees (P>0.05). Conclusion The role of traditional occupational health training in improving the OHL level of employees in micro-, small- and medium-sized enterprises needs to be improved. The responsibility of enterprise occupational health training should be implemented, and multiple measures should be taken to enrich the ways and approaches of occupational health education for enterprise employees, to effectively improve the OHL of workers.

Objective:To assess the effect of flash glucose monitoring (FGM) compared with self-monitoring of blood glucose (SMBG) on glycemic control, residual islet function, and patient-reported outcomes in children and adolescents with newly diagnosed type 1 diabetes within 1 year.Methods:133 children and adolescents with newly diagnosed T1DM in the T1D clinic of the Second Xiangya Hospital of Central South University from January 2016 to January 2020 were divided into two groups: FGM group ( n=82) and SMBG group ( n=51). The observation indexes included hemoglobin A1c (HbA 1c), fasting and postprandial blood glucose (FBG and 2 h BG), C-peptide (FCP and 2 h CP) during the one-year follow-up, Δ CP (2 h CP-FCP), patient-reported hypoglycemia and questionnaires regarding self-management of diabetes and quality of life. Results:At 6 months, HbA 1c in 2 groups was significantly decreased (all P<0.05); at 6 to 12 months, HbA 1c in FGM group tended to be stable ( P>0.05); at 12 months, HbA 1c in SMBG group was significantly increased compared with 6 months ( P=0.001). At 12 months, HbA 1c in SMBG group was higher than that in FGM group ( P=0.001). At 12 months, FBG in FGM group was equivalent to the baseline level ( P>0.05), while FBG in SMBG group was significantly higher than the baseline level ( P=0.006). 2 h BG only decreased at the 6th and 12th month in FGM group (all P<0.05). The FCP of SMBG group was significantly decreased at 12 months ( P<0.05), and the 2 h CP, Δ CP in the two groups decreased gradually (all P<0.05). FGM group had more hypoglycemic events at 6 and 12 months (all P<0.05). At 6 months, the score of Self-Management of T1D for Adolescents (SMOD-A) in FGM group was significantly improved ( P=0.001). During the follow-up period, the quality of life score of FGM group was stable ( P>0.05), while the quality of life score of SMBG group had a downward trend ( P=0.052). Conclusions:In newly diagnosed children and adolescents with T1DM, early application of FGM for blood glucose management will help to improve HbA 1c and reduce postprandial blood glucose. In addition, the self-management ability of children with FGM was improved after 6 months.

Background: Clinical dexamethasone (DEX) treatment or stress in bovines results in extensive physiological changes with prominent hyperglycemia and neutrophils dysfunction. Objectives: To elucidate the effects of DEX treatment in vivo on cellular energy status and the underlying mechanism in circulating neutrophils. Methods: We selected eight-month-old male bovines and injected DEX for 3 consecutive days (1 time/d). The levels of glucose, total protein (TP), total cholesterol (TC), and the proinflammatory cytokines interleukin (IL)-1β, IL-6 and tumor necrosis factor (TNF)-α in blood were examined, and we then detected glycogen and adenosine triphosphate (ATP) content, phosphofructosekinase-1 (PFK1) and glucose-6-phosphate dehydrogenase (G6PDH) activity, glucose transporter (GLUT)1, GLUT4, sodium/glucose cotransporter (SGLT)1 and citrate synthase (CS) protein expression and autophagy levels in circulating neutrophils. Results: DEX injection markedly increased blood glucose, TP and TC levels, the Ca 2+ /P 5+ ratio and the neutrophil/lymphocyte ratio and significantly decreased blood IL-1β, IL-6 and TNF-α levels. Particularly in neutrophils, DEX injection inhibited p65-NFκB activation and elevated glycogen and ATP contents and SGLT1, GLUT1 and GR expression while inhibiting PFK1 activity, enhancing G6PDH activity and CS expression and lowering cell autophagy levels. Conclusions DEX induced neutrophils glucose uptake by enhancing SGLT1 and GLUT1 expression and the transformation of energy metabolism from glycolysis to pentose phosphate pathway (PPP)-tricarboxylic acid (TCA) cycle. This finding gives us a new perspective on deeper understanding of clinical anti-inflammatory effects of DEX on bovine.

OBJECTIVES: Patients with classical type 1 diabetes mellitus (T1DM) require lifelong dependence on exogenous insulin therapy due to pancreatic beta-cell destruction and absolute insulin deficiency. T1DM accounts for about 90% of children with diabetes in China, with a rapid increase in incidence and a younger-age trend. Epidemiological studies have shown that the overall glycated haemoglobin (HbA1c) and compliance rate are low in Chinese children with T1DM. Optimal glucose control is the key for diabetes treatment, and maintaining blood glucose within the target range can prevent or delay chronic vascular complications in patients with T1DM. Therefore, this study aims to investigate the glycemic control of children with T1DM from Hunan and Henan Province with flash glucose monitoring system (FGMS), and to explore factors associated with glycemic variability. METHODS: A total of 215 children with T1DM under 14 years old were enrolled continuously in 16 hospitals from August 2017 to August 2020. All subjects wore a FGMS device to collect glucose data. Correlation of HbA1c, duration of diabetes, or glucose scan rates with glycemic variability was analyzed. Glucose variability was compared according to the duration of diabetes, HbA1c, glucose scan rates and insulin schema. RESULTS: HbA1c and duration of diabetes were positively correlated with mean blood glucose, standard deviation of glucose, mean amplitude of glucose excursions (MAGE), and coefficient of variation (CV) of glucose (all P<0.01). The glucose scan rates during FGMS wearing was significantly positively correlated with time in range (TIR) (P=0.001) and negatively correlated with MAGE and mean duration of hypoglycemia (all P<0.01). Children with duration ≤1 year had lower time below range (TBR) and MAGE when compared with those with duration >1 year (all P<0.05). TIR and TBR in patients with HbA1c ≤7.5% were higher (TIR: 65% vs 45%, TBR: 5% vs 4%, P<0.05), MAGE was lower (7.0 mmol/L vs 9.4 mmol/L, P<0.001) than those in HbA1c >7.5% group. Compared to the multiple daily insulin injections group, TIR was higher (60% vs 52%, P=0.006), MAGE was lower (P=0.006) in the continuous subcutaneous insulin infusion group. HbA1c was lower in the high scan rates (≥14 times/d) group (7.4% vs 8.0%, P=0.046), TIR was significantly higher (58% vs 47%, P<0.001), and MAGE was lower (P<0.001) than those in the low scan rate (<14 times/d) group. CONCLUSIONS The overall glycemic control of T1DM patients under 14 years old in Hunan and Henan Province is under a high risk of hypoglycemia and great glycemic variability. Shorter duration of diabetes, targeted HbA1c, higher glucose scan rates, and CSII are associated with less glycemic variability.
Adolescent ; Blood Glucose ; Blood Glucose Self-Monitoring ; Child ; Diabetes Mellitus, Type 1/drug therapy* ; Glucose ; Glycated Hemoglobin A/analysis* ; Humans ; Hypoglycemia/prevention & control* ; Hypoglycemic Agents/therapeutic use* ; Insulin/therapeutic use*

Objective To investigate the effects of 5-aza-2'-deoxycytidine (5-Aza-dC) alone or combined with trichostatin A(TSA) on cell proliferation, promoter methylation and mRNA expression level of PDX-1 gene in pancreatic β cells induced by high glucose toxicity. Method NIT-1 cells were treated in vitro by high glucose (33.3 mmol/L), then divided into five groups, control group, HG grpup, 5-Aza-dC treatment group, TSA interfere group and 5-Aza-dC + TSA group. Proliferation of NIT-1 cells, insulin secretion, promoter methylation and mRNA expression of PDX-1 gene were detected respectively. Results 5-Aza-dC and TSA alone or in combination could promote cell proliferation and recover insulin secretion in NIT-1 cells , could also reduce PDX-1 gene methylation and enhance expression of PDX-1 mRNA. Compared with single-treatment group , combined group was significantly different (all P < 0.05). Conclusion 5-Aza-dC and TSA could activate the expression of PDX-1 and, then recover insulin secretion in NIT-1 cells induced by high glucose. Combination of them had synergistic effect.

Objective Analysis of clinical features and treatment of nasal type NK/T cell lymphoma, to improve the understanding of this special type of lymphoma.Method The clinical data of 34 patients with nasal type NK/T cell lymphoma confirmed by pathology were retrospectively analyzed.Result In 31 cases, 26 cases were EB virus (EBV) infection positive, recent Treatment Effectiveness in the positive group was significantly lower than the negative group (38.46%vs. 87.50%;P<0.05) . Follow up showed until October 2015, 19 of 34 patients died. Among them, 17 cases died of disease relapse or progression, 2 cases died of other diseases. 15 patients survived (11 of them were disease-free) and the median overall survival time was 37 months. The 2 year overall survival was related to clinical stage, B symptoms, EBV infection (the P values were 0.017/0.001, 0.005, and 0.039 respectively).Conclusion EBV infection is associated with patient's treatment response in NK/T-Cell Lymphoma; and the prognosis is associated with clinical features such as clinical stage, B symptom, and EBV infection.

Objective To explore the correlation between plasma Klotho and FGF23 levels with senile hypertension .Methods Totally 180 cases of hypertension aged more than 60 years old were selected as the research group and divided into the grade 1 hypertension group(60 cases) ,grade 2 hypertension group(60 cases) and grade 3 hypertension group(60 cases) .The age and pro‐portion of male to female were basically consistent .60 elderly people without hypertension were selected as the control group .The level of plasma Klotho and FGF23 protein were tested by ELISA .The lipid level was detected by the automatic biochemical analy‐zer .The detection results were compared with those in the control group for analyzing their correlation .Results Plasma Klotho protein level in each hypertension group was lower than that in the control group ,while plasma FGF23 protein level and BMI were significantly higher than those in the control group(P<0 .05) .With the blood pressure level increase ,plasma Klotho protein level was gradually decreased ,while FGF23 protein level was gradually increased .The negative correlation was found between plasma Klotho protein and FGF23 protein (r= -0 .282 ,P=0 .001) .Plasma Klotho protein and FGF23 protein had no obvious correlation with BMI (r= -0 .063 ,-0 .098 ,P>0 .05) .Conclusion Plasma Klotho protein and FGF23 protein levels have obvious correlation with the blood pressure level ,which may jointly participate in the occurrence and development of hypertension .