A series of laws and regulations are the essential legal requirement in the field of clinical trial of medical device currently in China, especially the Provision for Clinical Trial of Medical Device. On the basis of current situation of medical device clinical trial, systemic analysis on the hot spot topics in the regulations was conducted to explore the way of improving the control system of clinical trial of medical device in China, which will provide the reference for medical device industry and the investigators of the clinical trial of medical device.
China ; Device Approval ; legislation & jurisprudence

Objective Analysis of the results through nine kinds of Immunoglobulin M (IgM) in children with respiratory tract infection test ,and then investigate infant′s characteristics about gender ,geographical and seasonal ,provide a reference for clinical di‐agnosis .Methods Firstly ,collection the 2 736 children′s blood in our hospital and centrifuged serum ,use indirect immunofluores‐cence (ILF) method and IgM antibody reagents to detect Legionella pneumophlia 1(LP1) ,Mycoplasma pneumoniae(MP) ,Coxiella burnetii(COX) ,Chlamydia pneumoniae(CP) ,Adenovirus(ADV) ,Respiratory syncytial virus(RSV) ,Influenza A virus(IFA) ,Influ‐enza B virus(IFB) ,Parainfluenza virus(PIV) and record the children′s information ever months ,and use the card square test to a‐nalysis .Results A total of 2 736 cases of children were detected in 918 cases (33 .5% ) with IgM antibodies ,the detection rate in descending order MP ,FluB ,PIV ,ADV ,RSV ,COX ,FluX ,CP and LP1 ,124 cases of mixed infection ,it′s 13 .51% of the total num‐ber of infections .The total number of infections in men positive 21 .02% ,12 .54% for women ,with statistical significance (P<0 . 05) ,between different sexes .The highest in age groups was the 13 years old group detection rate was 13 .49% ,followed by 35 years old group(7 .79% ) ,and there was a significant difference(P<0 .05) between the groups .The analyzed about seasonal viral infection in children ,the winter(14 .07% ) and spring(7 .79% ) higher incidence ,and prevalence of each season statistically significant (P<0 .05) .Conclusion Children in the region are mostly M P pathogen infection ,and exist differences in seasonal ,gender and age .

OBJECTIVE: To investigate the effect of electroacupuncture (EA) at different time-points on postoperative gastrointestinal function in patients undergoing colorectal cancer surgery. METHODS: Eighty patients with colorectal cancer undergoing laparotomy were randomly assigned to intravenous anesthesia, EA A, EA B, and EA C groups (n＝20 cases in each group). All the patients in the four groups received intravenous anesthesia with midazolam, sufentanil, cisatracurium besylate and Propofol, postoperative gastrointestinal decompression and drug analgesia. EA (2－3 mA, 2 Hz) was applied to Zhongwan (CV 12) and Tianshu (ST 25), Neiguan (PC 6), Zusanli (ST 36), Shangjuxu (ST 37), Xiajuxu (ST 39) on the right side for 30 min, once (one day before surgery) in the EA A group, twice (one day and 30 min before surgery) in the EA B group, and 3 times (one day, 30 min before and one day after surgery) in the EA C group. The acupoints used after surgery were PC 6, ST 36, ST 37 and ST 39. The time of postoperative ventilation, defecation, food-intake and water drinking, stomach tube removal and abdominal drainage tube removal, the volumes of stomach tube drainage and abdominal drainage, and postoperative adverse reactions were recorded. RESULTS: The first ventilation time, after surgery in the EA C group was significantly earlier than those in the intravenous anesthesia, EA A and EA B groups (P<0.05); and the water intake and abdomicnal drainage tube removal time after surgery in the EA C group were significantly earlier than those in the intravenous anesthesia group (P<0.05). No significant differences were found among the 4 groups in the time of defecation, food intake, stomach tube removal, stomach tube drainage and abdominal drainage volumes, and numbers of patients with nausea, vomiting, fever and other adverse reactions (P>0.05)．. CONCLUSION: EA treatment combined with intravenous anesthesia conducted before and after surgery is effective in promoting the recovery of gastrointestinal function in patients undergoing colorectal cancer laparotomy, and is obviously better than simple pre-operative EA.

OBJECTIVE: To explore the association of mental health,job burnout and mental fatigue in mental workers.METHODS: A total of 276 mental workers in 11 research institutes in Ningxia were selected as research subjects by convenient sampling method. The questionnaire survey was carried out using the scales of Self-Reporting Inventory( SCL-90),Maslach Burnout Inventory-General Survey and Mental Fatigue subscale of Fatigue Scale-14 to investigate the workers' mental health,job burnout and mental fatigue. RESULTS: The scores of SCL-90 and job burnout in mental workers were( 142. 4 ± 42. 2) and( 41. 8 ± 10. 5). The medium( P25,P75) mental fatigue total score was [3. 0( 2. 0,4. 0) ].The correlation analysis showed that the total score of SCL-90 was positively correlated with that of mental fatigue and job burnout( P < 0. 01). The job burnout was the intermediate variable between mental fatigue and mental health( 43. 4% of the total effect). The dimension of low sense of accomplishment was the regulating variable. CONCLUSION: Job burnout plays an intermediate role between mental fatigue and mental health in mental workers. The low sense of accomplishment plays a regulatory role.

AIM:To evaluate the application effect of artificial intelligence(AI)assisted diagnosis system in screening diabetic retinopathy(DR)in Yinchuan Community, Ningxia Hui Autonomous Region.METHODS:From July 2020 to July 2021, fundus photograph of 2 707 eyes from 1 358 diabetic patients with type 2 diabetes in two communities of Ningxia and Yinchuan were included in this study. The Eye Wisdom AI assisted screening and diagnosis system was used to analyze automatically and detect the characteristic changes of DR, such as hemorrhage, microaneurysms and retinal microvascular abnormalities. The results of fundus photograph were automatically graded according to the standard of DR international stage standard. The manual analysis group gave feedback after image interpretation, analyzed the sensitivity, specificity, misdiagnosis rate and missed diagnosis rate of the AI-assisted screening system for DR diagnosis, and compared the consistency between AI and manual analysis. Kappa consistency test was performed for the results of AI screening system and manual analysis.RESULTS:Compared with manual analysis, the sensitivity, specificity, missed diagnosis rate and misdiagnosis rate of AI were 91.84%, 99.06%, 8.16% and 0.94% respectively. The Kappa value of consistency analysis of the two diagnosis results was 0.817(P<0.001). Compared with manual analysis, the sensitivity and specificity of AI group to diagnose non-DR were 99.06% and 91.84% respectively. The sensitivity and specificity of mild NPDR were 85.36% and 98.52% respectively. The sensitivity and specificity of moderate NPDR were 81.53% and 98.55% respectively. The sensitivity and specificity of severe NPDR were 70% and 99.51% respectively. The sensitivity and specificity of PDR were 86.67% and 99.63% respectively. The Kappa value of the consistency analysis of DR staging diagnosis was 0.878(P<0.01).CONCLUSION: The AI remote screening system adopted in this study showed good consistency with the results of manual analysis, which can meet the needs of DR screening and provide a new effective prevention and treatment mode for DR patients in the community.

OBJECTIVE: To explore biomarkers for early auxiliary diagnosis of pneumoconiosis in coal workers(CWP) and its clinical significance. METHODS: Sixty-nine male coal miners exposed to dust were selected as control group, and sixty-seven CWP male patients were chosen as CWP group by purposive sampling method. Serum samples were collected from subjects of the two groups. The levels of malonaldehyde(MDA) and superoxide dismutase(SOD) were determined by colorimetric method. The enzyme-linked immunosorbent assay was used to measure the level of interleukin-6(IL-6) and tumor necrosis factor alpha(TNF-α). The acetylcholinesterase(AChE) activity was determined by modified Ellman method. The logistic regression model was used to analyze the risk factors of CWP. The receiver operating characteristic(ROC) curve was established to analyze the sensitive indicators in the pathogenesis of CWP. RESULTS: The serum SOD activity decreased(median: 65.1 vs 59.2 kU/L, P<0.05), and the MDA, IL-6 and TNF-α levels increased in the CWP group(median: 4.92 vs 6.68 μmol/L, 129.82 vs 163.18 ng/L, 63.90 vs 70.93 ng/L, P<0.05) compared with the control group. The logistic regression analysis results showed that AChE was the protective factor of CWP, while age, chronic respiratory symptoms, IL-6 and MDA were the risk factors of CWP(P<0.05). The ROC curve showed that IL-6 and MDA can be used as early indicators for the diagnosis of CWP in dust-exposed workers. CONCLUSION: The serum IL-6 and MDA levels can be used as biomarkers for early auxiliary diagnosis of CWP.

Background Long-term exposure to free silica particles will lead to fibrosis of lung tissue, and abnormal expression of microRNA (miRNA) may affect the occurrence and process of fibrosis. Objective To observed possible intervention effect of miR-204-3p overexpression adenovirus on silicosis fibrosis induced by silica dust using a silicosis rat model via non-exposed intratracheal instillation. Methods Forty SD rats were randomly divided into four groups: control group, silicosis model group, miRNA-NC group, and miR-204-3p intervention group. Under ether anesthesia, rats in the silicosis model group, miRNA-NC group, and miR-204-3p intervention group were injected with 1 mL (50 mg·mL⁻¹) of free silica dust suspension into the trachea, while the control group was injected with the same volume of normal saline. After 30 d of dust exposure, the miR-204-3p intervention group was injected with rno-mir-204 adenovirus vector to overexpress miR-204-3p, and the miRNA-NC group was given empty virus vector. After 30 d of normal feeding, the animals were sacrificed by chloral hydrate anesthesia, and the lung tissue was taken for subsequent experiments. The relative expression level of miR-204-3p in lung tissue of rats in each group was detected by real-time fluorescence quantitative PCR (RT-qPCR). HE staining, Masson staining, and Sirius red staining were used for pathological observation. Immunohistochemistry was used to detect the expression of Fibronectin and Collagen I in lung tissue of rats in each group. RT-qPCR was used to detect the relative gene expression levels of fibrosis markers Fibronectin, Vimentin, Collagen I, and Collagen III in lung tissue of rats in each group. Western blot was used to detect the protein expression levels of fibrosis markers Fibronectin, Vimentin, Collagen I, and Collagen III in lung tissue of rats in each group. Results The anatomical features of lung tissue in the control group were pink lung tissue with soft texture and smooth surface, while those in the silicosis model were grayish white tissue with hard texture and scars and grayish white silicon nodules on the surface. Compared with the silicosis model group, the color of lung tissue in the miR-204-3p intervention group became ruddy, the surface was smooth, and the texture became soft. The staining results showed that the alveolar wall of the control group was thin, there were a small number of capillaries in the alveoli, and the alveolar structure was clear and complete. In the silicosis model group, the alveolar wall became thicker, the pulmonary septum was partially broken, the alveolar structure was defective, and a large amount of collagen fibers were deposited. The alveolar structure of the miR-204-3p intervention group was relatively clear and there was a small amount of collagen fiber deposition. RT-qPCR results showed that compared with the control group, the relative expression levels of miR-204-3p in lung tissue of the silicosis model group and the miRNA-NC group were decreased (P<0.05), and the relative expression level of miR-204-3p in lung tissue of the miR-204-3p intervention group was increased (P＜0.05). The results of immunohistochemistry showed that compared with the control group, the expression levels of Fibronectin and Collagen I in lung tissue of the silicosis model group were increased (P＜0.05). Compared with the silicosis model group, the relative expression levels of Fibronectin and Collagen I in lung tissue of the rats in the miR-204-3p intervention group were significantly decreased (P<0.05). The results of RT-qPCR and Western blot showed that compared with the control group, the relative protein and gene expression levels of fibrosis factors Fibronectin, Vimentin, Collagen I, and Collagen III in lung tissue of the silicosis model group increased (P＜0.05). Compared with the silicosis model group, the relative gene and protein expression levels of fibrosis factors Fibronectin, Vimentin, Collagen I, and Collagen III in lung tissue of rats in the miR-204-3p intervention group were decreased (P＜0.05). Conclusion Silica dust can cause lung fibrosis in rats, and overexpression of miR-204-3P in vivo can reduce silicosis fibrosis in rats caused by silica dust.

Through phage display, we tried to find out whether the N-terminal fragment of glucogan-like peptide 1 receptor (nGLP-1R) still had binding activity to Exendin-4 after missing one or two gene segments. By error-prone PCR, We constructed a randomly mutated phage display peptide library with different length of the N-terminal (21-145 residues) extracellular domain of glucogan-like peptide 1 receptor (GLP-1R) from rat lung. A mutant named EP16 without binding activity was found by ELISA. Through sequence alignment we found that EP16 missed the first 20 and last 10 amino acids and the 52nd tryptophan was mutated to arginine. In order to determine why Ep16 did not show its binding ability to Exendin-4, a wild type EP16 without the first 20 and last 10 amino acids and nGLP-1R(W52R) was constructed in which the 52nd tryptophan was mutated to arginine. The contrastive analysis showed that the substitution of W52R led to a markedly reduced binding ability of EP16. The mutation of the conserved W52 could change the biologic activity of the protein. The lack of the first 20 and last 10 amino acids had no effect on its biologic activity. Therefore, the mutation of a single amino acid residue of the key sequence could change the biologic activity of the nGLP-1R.
Amino Acid Sequence ; Amino Acid Substitution ; Animals ; Binding Sites ; Glucagon-Like Peptide-1 Receptor ; Molecular Sequence Data ; Mutagenesis, Site-Directed ; Mutation ; Peptide Fragments ; chemistry ; genetics ; metabolism ; Peptides ; metabolism ; Protein Binding ; Rats ; Receptors, Glucagon ; chemistry ; genetics ; metabolism ; Venoms ; metabolism

【Objective】 To explore the effects of anti-inflammatory of short-chain fatty acids in human peripheral blood mononuclear cells （THP-1） and chronic obstructive pulmonary （COPD） mice. 【Methods】 We adopted the methods of qRT-PCR， ELISA， Western blotting， HE staining and Sirius staining to detect the changes of inflammatory factors in THP-1 cells and COPD with or without short-chain fatty acids. 【Results】 The ELISA and qRT-PCR experiments showed that the serum inflammatory factors， including interleukin-6 （IL-6）， interleukin-1β （IL-1β） and tumor necrosis factor-α （TNF-α）， were higher in clinical COPD patients than in healthy people. And the THP-1 cells expressed these inflammatory factors highly after LPS stimulation. Among three short-chain fatty acids treated， butyrate could reduce the levels of inflammatory factors better than acetate and propionate. After COPD mice were treated with butyrate in the drinking water， the mRNA expressions of inflammatory factors IL-6， IL-1β and TNF-α in the lung tissue decreased， and the concentrations of IL-6 and IL-1β in plasma decreased. The protein detection results showed that the phosphorylation expression of NF-κB decreased， and butyrate might inhibit the expressions of inflammatory factors by inhibiting the NF-κB signaling pathway. 【Conclusion】 The SCFA butyrate can inhibit LPS-induced inflammatory response of THP-1 cells and have an inhibitory effect on inflammation in COPD mice.

Objective: To investigate the effects of antimicrobial peptides merecidin on the biological functions of human lung adenocarcinomaA549 cells and the potential signaling pathways and targets that involved in promoting apoptosis, by studying the changes of phosphorylation levels of proteins in A549 cells after merecidin treatment. Methods: The antibacterial peptide mericidin (9 μmol/L) was applied to treat A549 cells for 6 h, and the total protein was collected and extracted. The peptide was digested by trypsin and labeled with TMT, and then fractionated by HPLC. The phosphorylated peptides were enriched with IMAC-Fe, and finally subjected to mass spectrometry analysis. Library identification and quantification of phosphorylated peptides obtained by mass spectrometry were processed using MaxQuant software, to further analyze the functions and pathways of differentially expressed phosphorylated proteins by combining with bioinformatic analysis. Results: Through IPA analysis of phosphorylated proteins in the normal control group and the antibacterial peptide merecidin treatment group, 753 differentially phosphorylated proteins in mericidin treatment group were screened out under the conditions of |Fold Change|≥2 and P<0.05, including 229 significantly up-regulated genes and 417 down-regulated genes. Among them, the differentially expressed proteins related to apoptosis included RB1, MAPK1, ARAF, PTK2, FOXO, MARCKSandsoon.Theresultsofbiologicalprocessanalysisshowedthatdifferentiallyexpressed phosphorylated proteins were mainly concentrated in cell signal transduction, degradation and transport of nucleic acid, and cellular energy metabolism, protein translation and synthesis, and cytoskeleton formation etc. The enrichment results showed that the differentially expressed phosphorylated proteins were mainly involved in apoptosis-related MAPK, ErbB, PI3K-Akt, and Ras signaling pathways. Protein-protein interaction analysis indicated the associations among apoptosis-related proteins PTK2, PRKCA, MA2PK2, MAPK1, and LMNA. Conclusion: The antibacterial peptide merecidin may induce apoptosis and alteration of other cell functions by affecting a variety of genes and signaling pathways such as RB1, MAPK1,ARAF, PTK2, FOXO and MARCKS etc.