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*

BACKGROUND: Observational research has reported that systemic lupus erythematosus (SLE) is related to common female hormone-dependent cancers, but the underlying causal effect remains undefined. This study aimed to explore the causal association of these conditions by Mendelian randomization (MR) analysis. METHODS: We selected instrumental variables for SLE from genome-wide association studies (GWASs) conducted in European and East Asian populations. The genetic variants for female malignant neoplasms were obtained from corresponding ancestry GWASs. We utilized inverse variance weighted (IVW) as the primary analysis, followed by sensitivity analysis. Furthermore, we conducted multivariable MR (MVMR) to estimate direct effects by adjusting for the body mass index and estradiol. Finally, we implemented reverse direction MR analysis and gave a negative example to test the reliability of MR results. RESULTS: We found SLE was significantly negatively associated with overall endometrial cancer risk (odds ratio [OR] = 0.961, 95% confidence interval [CI] = 0.935-0.987, P  = 3.57E-03) and moderately inversely related to endometrioid endometrial cancer (ENEC) (OR = 0.965, 95% CI = 0.936-0.995, P  = 0.024) risk in the European population by IVW. We replicated these results using other MR models and detected a direct effect by MVMR (overall endometrial cancer, OR = 0.962, 95% CI = 0.941-0.983, P  = 5.11E-04; ENEC, OR = 0.964, 95% CI = 0.940-0.989, P  = 0.005). Moreover, we revealed that SLE was correlated with decreased breast cancer risk (OR = 0.951, 95% CI = 0.918-0.986, P  = 0.006) in the East Asian population by IVW, and the effect was still significant in MVMR (OR = 0.934, 95% CI = 0.859-0.976, P  = 0.002). The statistical powers of positive MR results were all >0.9. CONCLUSION This finding suggests a possible causal effect of SLE on the risk of overall endometrial cancer and breast cancer in European and East Asian populations, respectively, by MR analysis, which compensates for inherent limitations of observational research.
Female ; Humans ; Genome-Wide Association Study ; Mendelian Randomization Analysis ; Neoplasms, Hormone-Dependent ; Reproducibility of Results ; Endometrial Neoplasms ; Lupus Erythematosus, Systemic/genetics* ; Carcinoma, Endometrioid ; Breast Neoplasms ; Polymorphism, Single Nucleotide

OBJECTIVE: To explore the clinical phenotype and genetic basis of a neonate with Au-Kline syndrome (AKS). METHODS: Clinical data and result of genetic testing of a neonate with AKS who was admitted to the Affiliated Provincial Children's Hospital of Anhui Medical University in January 2021 were retrospectively analyzed. Relevant literature was searched from the Wanfang Data Knowledge Service Platform, China National Knowledge Infrastructure and PubMed databases using key words "Au Kline syndrome", "Au-Kline syndrome", "HNRNPK" and "AKS". The research period was set as from January 1, 2000 to December 31, 2020. RESULTS: The male newborn has manifested feeding difficulties, hypotonia, absence of the upper jaw to the uvula and facial dysmorphism. Trio-whole exome sequencing revealed that he has harbored a frameshift c.478dupA (p.Ile160AsnfsTer7) variant of the HNRNPK gene, which was varified by Sanger sequencing to have a de novo origin. The variant has not been included in the databases. Based on the guidelines from the American College of Medical Genetics and Genomics, the variant was rated as pathogenic (PVS1+PS2+PM2_Supporting). Literature retrieval has identified 14 children with AKS and de novo mutations of the HNRNPK gene. Their clinical manifestations have included growth and motor retardation, various degree of mental retardation, facial dysmorphism and a high frequency of congenital heart malformations. CONCLUSION The AKS in this child may be attributed to the c478dupA frameshifting variant of the HNRNPK gene. Diagnosis of AKS should be suspected for children with mental retardation and multiple congenital malformation syndromes including Kabuki syndrome.
Humans ; Male ; Abnormalities, Multiple/genetics* ; Genetic Testing ; Heterogeneous-Nuclear Ribonucleoprotein K/genetics* ; Intellectual Disability/genetics* ; Mutation ; Retrospective Studies ; Infant, Newborn

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 explore the curative effect and nursing of enhanced external counterpulsation (EECP) on patients with ischemic cerebral apoplexy. Methods In September 2013 to March 2013 in Shenzhen Futian District People′s Hospital neurology hospital, toally 286 patients with ischemic cerebral apoplexy were randomly divided into two groups, control group and treatment group with 143 cases in each group. The control group used conventional treatment and the treatment group used EECP. The score of clinical nerve function and defect improved Barthel index were compared. Result The score of clinical nerve function defect and improved Barthel index of the treatment group before the treatment were without difference (all P>0.05). The score of clinical nerve function defect and improved Barthel index of the treatment group were less than those of control group after the treatment (all P < 0.05). Conclusion Ischemic stroke patients with positive EECP can significantly increase clinical neural function and life ability , improve patient′s quality of life.

Objective To confirm the main pathway of chemokine-chemokine receptor which mediates the accumulation of regulatory T cell ( Treg) in pancreatic cancer .Methods The concentrations of protein of FOXP3 and chemokines of CCL2, CCL3, CCL5, CCL17, CXCL8 in human and mouse pancreatic cancer and adjacent normal pancreatic tissue were measured by the method of enzyme-linked immunosorbent assay (ELISA).The receptor of chemokine CCL5 (CCR5) in human and mouse pancreatic cancer were determined by the immunofluorescent stain .Results The concentration of FOXP 3 protein in human pancreatic cancer and adjacent normal pancreatic tissue as (487.5 ±534.1) and (162.6 ±42.0) pg/mg, respectively, while they were (84.6 ±54.1) and (14.4 ±7.6) pg/mg, respectively in mouse.The concentration of FOXP3 protein were significantly higher in pancreatic cancer than those in adjacent normal pancreatic tissue .The concentration of CCL2 in human pancreatic cancer and adjacent normal pancreatic tissue as (76.9 ±37.5), (40.8 ±25.5) pg/mg, and the concentration of CCL3 as (38.0 ±22.6), (21.3 ±16.5) pg/mg, and the concentration of CCL5 were (390.2 ±158.5), (59.1 ±22.8) pg/mg, and the concentration of CCL17 as (7.2 ±2.0), (4.1 ±2.4)pg/mg, and the concentration of CXCL8 as (9.3 ±5.5), (6.3 ±5.2)pg/mg.The concentration of CCL2, CCL5, CCL17 in pancreatic cancer was significantly higher than those in adjacent normal pancreatic tissue (P<0.05).The concentration of CCL2 in mouse pancreatic cancer and adjacent normal pancreatic tissue as (77.9 ±30.5), (43.6 ±16.6) pg/mg, and the concentration of CCL3 was (27.4 ±18.2), (14.0 ±4.5)pg/mg, and the concentration of CCL5 was (302.2 ±55.8), (64.5 ±30.3) pg/mg; and the concentration of CCL17 was (4.4 ±1.4), (2.2 ±1.0)pg/mg;and the concentration of CXCL8 was (55.1 ± 55.1), ( 93.4 ±7.3 ) pg/mg.The concentration of CCL2, CCL5, CCL17 in pancreatic cancer were significantly higher than those in adjacent normal pancreatic tissue , and the difference between the two groups was statistically significant (P<0.05).The level of FOXP3 in pancreatic cancer was positively correlated with the concentration of chemokine CCL 5 both in human and mouse pancreatic cancer .Immunofluorescent staining indicated that the FOXP3 +cells also expressed CCR5.Conclusions The CCL5-CCR5 is the main chemokine-chemokine receptor pathway mediating the accumulation of Treg cells in pancreatic cancer .

OBJECTIVE: To evaluate the relationship between human papilloma virus (HPV) infection and the occurrence, recurrence and malignant transformation of nasal inverted papilloma (NIP). METHOD: With comprehensive retrieval of related literature that had been published in databases included Pubmed (1990--2011), Cochrane Library, CNKI (1979-2011), VIP (1989-2011), CBM (1990-2011) and WANFANG Meta-analysis software Rev-Man 5.0 was used to analyze the raw data and to calculate the value of combined odd ratio (OR) and 95% confidence interval (CI). RESULT: According to Meta-analysis, the occurrence group between HPV and NIP, the OR was 34.44 and 95% CI was 12.96-91.56; the recurrence group, the OR was 3.66 and 95% CI was 1.77-7.56, to the high-risk HPV, the OR was 1.94 and 95% CI was 0.30-12.58; the malignant transformation group, the OR was 1.79 and 95% CI was 0.94-3.40 to the high-risk HPV, the OR was 49.35 and 95% (CI was 0.45-11.23. CONCLUSION HPV may play an important role in the occurrence and recurrence of NIP and high-risk HPV was closely related to the progress of NIP.
DNA, Viral ; Humans ; Nose Neoplasms ; virology ; Papilloma, Inverted ; virology ; Papillomaviridae ; Papillomavirus Infections ; pathology

Purpose:To study the apoptosis and proliferation in ovarian cancer and the relationship between gene and the histological grading as well as response to chemotherapy. Methods:In our study apoptosis in fifty fresh samples of epithelial ovarian carcinomas were evaluated by TDT (terminal deoxynucleotidyl transferase) assay. We used the techniques of immunohistochemistry to detect the proliferation and the protein expression of bcl-2,bax and p53 gene.Results:In 66% (30/50) samples of fresh epithelial ovarian carcinoma apoptosis was observed in different degrees. Our results showed that PCAN and p53 expression in poorly differentiated ovarian carcinoma is higher than that in well middle differentiated (P