In recent years,China has made great progress in basic nanomedicine,nanotoxicology and nanobiology research.Nanotechnology has been continuously applied in biomaterial and medical device,more and more medical devices applying nanomaterials are developed and manufactured.In order to gain more comprehension and accurate understanding of the research and industrial development in nanobiomaterial medical devices,this study reviewed the common nanomaterial in medical devices and the regulatory situation of nanomaterial medical devices at home and abroad,and discussed the current challenges in biological evaluation of nanomaterial medical devices,with a view to providing ideas for the safety evaluation and research of related products.

BACKGROUND:Rapid developments in the field of bioinformatics have provided new methods for the diagnosis of osteoarthritis.Artificial neural networks have powerful data computing and classification capabilities,which have shown better performance in disease diagnosis. OBJECTIVE:To establish a new diagnostic predictive model of osteoarthritis based on artificial neural network and to verify the diagnostic value of the model in osteoarthritis with an external dataset. METHODS:The eligible osteoarthritis-related data sets were downloaded through GEO database search and divided into Train group and Test group.The gene expression matrix of the Train group was analyzed to screen the differentially expressed genes.GO and KEGG enrichment analyses were performed on the differentially expressed genes.Through Lasso regression model,support vector machine model and random forest tree model,the key genes of osteoarthritis were further identified from the differentially expressed genes.The R software"Neuralnet"package was then used to construct the osteoarthritis diagnosis model based on artificial neural network,and the model performance was evaluated by the five-fold cross-validation.Two independent data sets in the Test group were used to verify their diagnostic results. RESULTS AND CONCLUSION:A total of 90 differentially expressed genes related to osteoarthritis were obtained by differential analysis,of which 33 were down-regulated and 57 were up-regulated.GO enrichment analysis showed that the differentially expressed genes were mainly involved in the following biological processes,including leukocyte-mediated immunity,leukocyte migration in bone marrow and chemokine production.KEGG enrichment analysis showed that these genes were mainly enriched in rheumatoid arthritis,interleukin-17 signaling pathway and osteoclast differentiation pathway.Five key genes for the diagnosis of osteoarthritis,HMGB2,GADD45A,SLC19A2,TPPP3 and FOLR2,were identified by three machine learning methods.The artificial neural network model of five key genes in the Train group showed that the accuracy was 96.36%and the area under the curve was 0.997.The five-fold cross validation of the neural network model showed that the average area under the curve was greater than 0.9 and the model was of robustness.Two independent data sets in the Test group showed its area under the curve was 0.814 and 0.788 respectively.Therefore,the establishment of an artificial neural network model for the diagnosis of osteoarthritis has a certain diagnostic value.

Objective To develop a method for rapid determination of the dissolution of cefixime capsules,to explore the consistency of the dissolution curves of the generic and reference preparations in different media,and to assess the reliability of the in vitro dissolution evaluation method according to the results of bioequivalence studies.Methods The dissolution test was performed by the paddle method at 50 r·min-1,using pH1.2 hydrochloric acid solution,pH6.8 phosphate buffer solution,pH7.5 phosphate buffer solution,and water as the dissolution media.And a high-performance liquid chromatography(HPLC)method with a core-shell column was established to determine the dissolution curves of the generic and reference preparations respectively.The bioequivalence of the generic and reference preparations was evaluated through the bioequivalence(BE)test.Results The similarity factors(f2)of the three batches of the generic and reference preparations in the four media were greater than 60.The fasting and postprandial pharmacokinetic parameters(Cmax,AUC0-t,AUC0-∞)of the generic and reference preparations in hu-mans were all in line with the bioequivalence standard.Conclusion The in vitro dissolution behavior of the generic and refer-ence preparations was consistent,and the two preparations were bioequivalent.The method is simple and quick,and it can be em-ployed to measure the dissolution of cefixime capsules,which can provide references for the consistency evaluation of cefixime capsules.

Objective:To investigate the influencing factors of surgical site infection (SSI) after abdominal surgery.Methods:The retrospective cross-sectional study was conducted. The clinical data of 567 patients undergoing abdominal surgery in 6 medical centers, including 445 cases in the Zhengzhou Central Hospital Affiliated to Zhengzhou University, 54 cases in the the First Affiliated Hospital of Zhengzhou University, 49 cases in the Shangqiu First People's Hospital, 10 cases in the Luoyang Central Hospital, 5 cases in the First Affiliated Hospital of Henan University of Science and Technology and 4 cases in the Henan Provincial People's Hospital, from June 1 to June 30, 2020 were collected. There were 284 males and 283 females, aged (51±18)years. Observation indicators: (1) incidence of SSI after surgery; (2) influencing factors of SSI. Follow-up was conducted using outpatient examination and telephone interview to detect the incidence of SSI. Patients without implant were followed up within postoperative 30 days, and patients with implant were followed up within postoperative 1 year. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Measure-ment data with skewed distribution were represented as M(range), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers or percentages, and comparison between groups was performed using the chi-square test or Fisher exact probability. Univariate analysis was performed using the corresponding statistical methods. Multivariate analysis was performed using the Logistic stepwise regression model advance method. Results:(1) Incidence of SSI after surgery. All the 567 patients were followed up after surgery as planned. There were 27 cases with SSI after surgery including 9 cases with superficial incision infection, 9 cases with deep incision infection, 9 cases with organ/gap infection. Of the 27 cases with SSI after surgery, 18 cases with positive results of incisional microbial culture including 8 cases with positive results of Escherichia coli, 6 cases with positive results of Klebsiella pneumonia, 3 cases with positive results of Enterococcus faecium and 1 case with positive result of Pseudomonas aeruginosa. (2) Influencing factors of SSI. Results of univariate analysis showed that age, preoperative hemoglo-bin, preoperative albumin, preoperative fasting blood glucose, preoperative intestinal preparation, surgical type, surgical site, surgical incision type, duration of intensive cure unite, duration of post-operative hospital stay, duration of total hospital stay, operation time, hospital expense were related factors affecting the incidence of SSI of patients undergoing abdominal surgery ( χ2=40.12, Z=?4.22, ?2.21, ?4.75, χ2=7.07, 16.43, 38.06, 17.50, Z=?4.43, ?4.42, ?7.14, ?7.15, ?5.90, P<0.05) and the American Association of Anesthesiologists Classification, preoperative oral antibiotics, surgical methods and postoperative intensive care unit stay were related factors affecting the incidence of SSI of patients undergoing abdominal surgery ( P<0.05). Results of multivariate analysis showed that age, preopera-tive fasting blood glucose, preoperative intestinal preparation, surgical type, surgical site as appendix and rectum, surgical methods, surgical incision type as infective incision and polluted incision, operation time were independent factors affecting the incidence of SSI of patients undergoing abdo-minal surgery ( odds ratio=7.69, 1.21, 0.27, 5.82, 5.19, 19.08, 0.23, 27.76, 4.97, 1.01, 95% confidence intervals as 2.04?28.95, 1.04?1.41, 0.08?0.94, 1.36?24.85, 1.10?24.43, 4.48?81.25, 0.06?0.87, 2.54?303.53, 1.12?22.14, 1.01?1.02, P<0.05). Conclusion:Age, preoperative fasting blood glucose, preoperative intestinal preparation, surgical type, surgical site as appendix and rectum, surgical methods, surgical incision type as infective incision and polluted incision, operation time are independent factors affecting the incidence of SSI of patients undergoing abdominal surgery.

Objective:To study the illumination for distance vision evaluation of the pilots wearing night vision goggles (NVGs).Methods:The distance vision was tested by circular visual acuity chart for flying personnel 5 m apart from subjects. The Illuminance on the surface of chart was set 300 lx for naked eye and 1×10 -1 lx and 1×10 -3 lx for NVG aided eyes. The naked and NVG distance visions of 15 healthy male volunteers were tested under all illuminations. The differences of NVG distance vision were compared between the illuminations of 1×10 -1 lx and 1×10 -3 lx to determine the proper level for evaluation. The naked and NVG distance visions of 20 male pilots were tested to verify the feasibility and necessity of the test, but NVG tests were only at 1×10 -1 lx level. Results:Volunteers′ left distance vision was 0.67±0.39, the right was 0.67±0.38 and the binocular was 0.80±0.40. Their NVG distance vision under 1×10 -1 lx was 0.53±0.22, 0.59±0.25 and 0.63±0.24 respectively, comparing with the vision of 0.30±0.11, 0.34±0.11 and 0.36±0.11 under 1×10 -3 lx. The difference showed statistical significance ( P<0.05). In verification test, the left, right and binocular NVG distance vision of 20 pilots under 1×10 -1 lx was 0.63±0.16, 0.64±0.14 and 0.73±0.12 respectively, comparing with their left, right and binocular naked vision of 1.12±0.32, 1.08±0.37, and 1.37±0.37 respectively. Conclusions:The tests indicated that 1×10 -1 lx would be the appropriate illumination level for pilot′s NVG distance vision evaluation. And it is necessary to evaluate pilot′s NVG distance vision before night flight mission.

Objective:To study the illumination for distance vision evaluation of the pilots wearing night vision goggles (NVGs).Methods:The distance vision was tested by circular visual acuity chart for flying personnel 5 m apart from subjects. The Illuminance on the surface of chart was set 300 lx for naked eye and 1×10 -1 lx and 1×10 -3 lx for NVG aided eyes. The naked and NVG distance visions of 15 healthy male volunteers were tested under all illuminations. The differences of NVG distance vision were compared between the illuminations of 1×10 -1 lx and 1×10 -3 lx to determine the proper level for evaluation. The naked and NVG distance visions of 20 male pilots were tested to verify the feasibility and necessity of the test, but NVG tests were only at 1×10 -1 lx level. Results:Volunteers′ left distance vision was 0.67±0.39, the right was 0.67±0.38 and the binocular was 0.80±0.40. Their NVG distance vision under 1×10 -1 lx was 0.53±0.22, 0.59±0.25 and 0.63±0.24 respectively, comparing with the vision of 0.30±0.11, 0.34±0.11 and 0.36±0.11 under 1×10 -3 lx. The difference showed statistical significance ( P<0.05). In verification test, the left, right and binocular NVG distance vision of 20 pilots under 1×10 -1 lx was 0.63±0.16, 0.64±0.14 and 0.73±0.12 respectively, comparing with their left, right and binocular naked vision of 1.12±0.32, 1.08±0.37, and 1.37±0.37 respectively. Conclusions:The tests indicated that 1×10 -1 lx would be the appropriate illumination level for pilot′s NVG distance vision evaluation. And it is necessary to evaluate pilot′s NVG distance vision before night flight mission.

Objective To evaluate the efficacy of dexmedetomidine mixed with sufentanil for patient-controlled intravenous analgesia (PCIA) after double lung transplantation.Methods Thirty-two patients of both sexes,aged 33-64 yr,of American Society of Anesthesiologists physical status Ⅲ or Ⅳ,with body mass index of 18-29 kg/m2,were divided into 2 groups (n=16 each) using a random number table:sufentanil group (group S) and dexmedetomidine mixed with sufentanil group (group DS).PCIA was performed after operation in both groups.The PCIA solution contained sufentainl 3.0 μg/kg and tropisetron 10 mg (diluted to 100 ml in normal saline) in group S and sufentainl 3.0 μg/kg,dexmedetomidine 1.0 μg/kg and tropisetron 10 mg (diluted to 100 ml in normal saline) in group DS.Visual analogue scale score was maintained less than or equal to 3 during postoperative analgesia period,and sufentainl 5 μg was intravenously injected when visual analogue scale score was more than or equal to 4.The requirement for rescue analgesics and development of adverse reactions were recorded.The pulmonary arterial pressure was recorded at the end of surgery (T0) and at 2,4,8,24 and 48 h after surgery (T1-5).Results Compared with group S,the requirement for rescue analgesics,incidence of nausea and vomiting and pulmonary arterial pressure at T1-5 were significantly decreased in group DS (P＜0.05).Conclusion Dexmedetomidine mixed with sufentanil produces better efficacy for PCIA with fewer adverse reactions and decreases the pulmonary arterial pressure after double lung transplantation.

Objective To build an analytic hierarchy process (AHP) of the medical selection for the high performance fighter pilot. Methods According to the consulting results from aeromedical experts ,an AHP model and expert′s judgment matrix were built and checked upon the consistency. Then ,the relative weights of evaluation indexes were calculated.The method was preliminarily applied in the medical selection of high performance fighter pilot. Results An AHP evaluation model of medical selection for high performance fighter pilot was constructed ,including 5 first level indexes of basic physiological function , flight physiological endurance , psychological basis , mental ability , physical fitness and ergonomics ,and 23 second level indexes.The relative weights of 5 first level indexes were 0.172 8 ,0.224 1 ,0.178 5 ,0.289 1 and 0.135 5 corresponding to basic physiological function ,flight physiological endurance , psychological basis , mental ability , physical fitness and ergonomics.The model was applied to comprehensively evaluate the physiological and psychological indexes of 16 hight performance fighter pilot candidates.The scores in turn from high to low were 7.79 ,7.45 ,7.24 ,7.17 ,7.15 ,6.92 ,6.81 ,6.59 ,6.24 ,6.02 ,5.96 ,5.85 ,5.83 ,5.71 ,5.26 and 5.20. Conclusions The AHP provides new method and reference to high performance fighter pilot selection and the application accumulates data and experience for other objective evaluation researches.

Objective To build an analytic hierarchy process (AHP) of the medical selection for the high performance fighter pilot. Methods According to the consulting results from aeromedical experts ,an AHP model and expert′s judgment matrix were built and checked upon the consistency. Then ,the relative weights of evaluation indexes were calculated.The method was preliminarily applied in the medical selection of high performance fighter pilot. Results An AHP evaluation model of medical selection for high performance fighter pilot was constructed ,including 5 first level indexes of basic physiological function , flight physiological endurance , psychological basis , mental ability , physical fitness and ergonomics ,and 23 second level indexes.The relative weights of 5 first level indexes were 0.172 8 ,0.224 1 ,0.178 5 ,0.289 1 and 0.135 5 corresponding to basic physiological function ,flight physiological endurance , psychological basis , mental ability , physical fitness and ergonomics.The model was applied to comprehensively evaluate the physiological and psychological indexes of 16 hight performance fighter pilot candidates.The scores in turn from high to low were 7.79 ,7.45 ,7.24 ,7.17 ,7.15 ,6.92 ,6.81 ,6.59 ,6.24 ,6.02 ,5.96 ,5.85 ,5.83 ,5.71 ,5.26 and 5.20. Conclusions The AHP provides new method and reference to high performance fighter pilot selection and the application accumulates data and experience for other objective evaluation researches.

Objective To investigate the relationship between QRS wave terminal distortion with coronary arterial lesion and serum high-sensitivity cardiac troponin I (hs-cTnI) in early stage of acute ST-segment elevation myocardial infarction (STEMI).Methods One hundred and twenty patients with STEMI were classified into the QRS wave distortion positive group(QRS+,n=81) and non-QRS wave distortion group(QRS-group,n=39) according to EKG on admission.The two groups all conducted the coronary angiography and hs-cTnI detection.The coronary arterial lesion occurrence situation and hs-cTnI level were compared between the two groups.Results (1) In the QRS+ group:68 cases (83.59％) were male and 13 cases (16.05％) were females;in the QRS-group:27 cases(69.23％) were male and 12 cases (30.77％) were female.The sex difference had statistical significance (P＜0.05).(2) The occurrence rate of left anterior descending artery (LAD) lesion in the QRS+ group was higher than that in the QRS-group,the difference was statistically significant (P＜0.05).But the occurrence rate of left circumflex coronary artery (LCX) lesion in the QRS-group was higher than that in the QRS+ group,the difference was statistically significant (P＜0.01).(3) The hs-cTnI level in the QRS+ group was higher than that in the QRS-group,the difference was statistically significant (P ＜0.01).Conclusion The patients with QRS wave distortion positive have a higher occurrence rate of LAD lesion,while the patients with out QRS wave distortion negative have higher occurrence rate of LCX lesion;the QRS wave terminal distortion has relationship with serum hs-cTnI level.