By collecting inspection results from medical device clinical trials from 2016 to 2023,to analyze and discuss common problems of clinical trials from both in vitro diagnostic reagents and medical devices,and propose the suggested mea-sures taken by participants in the clinical trial,so as to avoid similar problems occur and ensure the quality of clinical trials.

By collecting inspection results from medical device clinical trials from 2016 to 2023,to analyze and discuss common problems of clinical trials from both in vitro diagnostic reagents and medical devices,and propose the suggested mea-sures taken by participants in the clinical trial,so as to avoid similar problems occur and ensure the quality of clinical trials.

Objective To evaluate the applicability of a modified U-shaped forearm flap for the repair of small-and medium-sized defects in the oral and maxillary areas to provide a reference for clinicians.Methods This study was re-viewed and approved by the Ethics Committee,and informed consent was obtained from the patients.Ten patients with small-and medium-sized defects in the oral and maxillary areas underwent surgical repair using modified U-shaped fore-arm flaps.There were 8 males and 2 females aged 43-72 years.The donor site was apposed primarily after harvesting the modified U-shaped forearm skin flap.The flaps ranged from 6 cm × 4 cm to 8 cm × 5 cm in size.Six months after the operation,hand movements(finger extension,fist clenching,wrist rotation upward and wrist rotation downward),the forearm donor site,hand sensations and the satisfaction score for the postoperative quality of the scar at the donor site were evaluated(0 to 10;0:very unattractive,10:very satisfactory).Results A total of 10 patients with modified U-shaped forearm flaps survived.One patient developed venous crisis 24 hours after surgery and survived after surgical ex-ploration.Delayed healing occurred at the donor site of the forearm in 1 patient,and the wounds at the donor site of the forearm in the other patients all healed in the first stage.One patient presented with dysesthesia in the hand 2 weeks af-ter surgery and recovered within 3 months.Six months after surgery,all patients had no limited hand movement and no paresthesia at the forearm donor site or hand.The patients were basically satisfied with the appearance of the donor site,and the average satisfaction score of the subjective questionnaire was 8.4 points.Conclusion Modified U-shaped fore-arm flaps can directly close forearm donor site wounds,which avoids surgical trauma to the secondary donor site and sig-nificantly reduces related complications.Modified U-shaped forearm flaps provide an alternative to conventional forearm flaps for the repair of small-and medium-sized defects in the oral and maxillary areas.

Objective:To explore the effects of the immune responses mediated by topological structures of three-dimensional bioprinted scaffolds on hair follicle cycle in mice.Methods:The study was an experimental research. The alginate-gelatin composite hydrogels were printed into scaffolds using a three-dimensional bioprinter and named T45 scaffolds, T60 scaffolds, and T90 scaffolds according to the 3 topological structures of the scaffolds (the rotation angles of the printhead during printing were 45°, 60°, and 90°, respectively), and the morphology of the three scaffolds was observed after cross-linking by naked eyes. Nine 8-week-old female C57BL/6J mice were divided into T45 group, T60 group, and T90 group, according to the random number table, with three mice in each group, and the T45, T60, and T90 scaffolds were subcutaneously implanted on the back of mice, respectively. On post implantation day (PID) 7, the hair growth in the dorsal depilated area of mice was observed, the thickness of the fiber capsule around the scaffolds was observed by hematoxylin-eosin staining, and the expression levels of CD68, bone morphogenetic protein-2 (BMP-2), and tumor necrosis factor (TNF) protein in the tissue surrounding the scaffolds were observed by immunofluorescence staining. The samples of the above experiments were all 3.Results:The topological structures of the three scaffolds were all clear with high fidelity after cross-linking. On PID 7, the hair growth was obvious in the dorsal depilated area of mice in T45 group and T90 group, while hair growth was slow in the scaffold implantation area of mice in T60 group, which was significantly different from that of the unimplanted area. On PID 7, compared with (18±4) μm in T90 group, the thickness of both the fiber capsule around the scaffolds ((39±4) and (55±8) μm) of mice in T45 group and T60 group was significantly increased ( P<0.05); the thickness of the fiber capsule around the scaffolds of mice in T60 group was also significantly increased compared with that in T45 group ( P<0.05). On PID 7, the expression level of CD68 protein in the tissue surrounding the scaffolds of mice in T60 group was significantly higher than the levels in T45 group and T90 group (with both P values <0.05). The expression level of BMP-2 protein in the tissue surrounding the scaffolds of mice in T60 group was significantly higher than the levels in T45 group and T90 group (with both P values <0.05), and the expression level of BMP-2 protein in the tissue surrounding the scaffolds of mice in T45 group was significantly higher than that in T90 group ( P<0.05). The expression level of TNF protein in the tissue surrounding the scaffolds of mice in T60 group was significantly lower than the levels in T45 group and T90 group (with both P values <0.05). Conclusions:Three-dimensional bioprinted scaffolds with different topological structures mediate different degrees of immune responses after being implanted in mice. A moderate immune response promotes hair growth in depilated area of mice, while an excessive immune response results inhibits the hair follicle entering into the anagen phase.

Objective Pertussis cases have increased markedly since 2018 in Guangxi.The aim of this study was to evaluate antibody levels and the infection status of pertussis in the resident population. Method A total of 10,215 serum samples from residents were collected from August-November 2018 and tested for anti-pertussis IgG and toxin IgG using the enzyme-linked immunosorbent assay(ELISA). Results Of the collected samples,1,833(17.94%)tested positive for anti-pertussis IgG,with the median concentration of 16.06 IU/mL.Antibody level<10 IU/mL accounted for more than 60%in children under 4 years of age,but declined with age,whereas the percentages of the other three levels(10-40,40-50,and≥50 IU/mL)increased almost with age(P<0.001).Moreover,7,924 samples were selected for anti-pertussis toxin IgG,of which 653(8.24%)tested positive(≥40 IU/mL)with the median concentration of 5.89 IU/mL,and 204 participants(2.56%)had recent pertussis infection(≥100 IU/mL).Among the different age groups,the highest rates of positivity and recent infection were observed at 11-20 years of age,the lowest positivity rate at 5 years of age,and the lowest recent infection rate at 4 years of age(P<0.001,P=0.005,respectively). Conclusion The survey results showed that all age groups in Guangxi lacked immunity against pertussis,which was one of the main factors contributing to the resurgence of pertussis in 2018.In addition,the prevalence of pertussis is relatively high in Guangxi,and its incidence is seriously underestimated,especially in adolescents and adults.

Objective: To investigate the current status and influencing factors of knowledge, attitude, and practice of hypertension prevention and control among rural residents in Shanxi Province, so as to provide insights into implementation of health education pertaining to hypertension control in rural areas. Methods: A total of 7 403 residents were sampled using a multi-stage cluster random sampling method from rural areas of Yangqu, Daning, and Yonghe counties of Shanxi Province from November 2020 to July 2021 for face-to-face questionnaire surveys and physical examinations. Residents' basic characteristics, knowledge, attitude, and practice of hypertension prevention and control, and height, weight, blood pressure were collected, and factors affecting knowledge, attitude, and practice of hypertension prevention and control were identified using a generalized linear model. Results: A total of 7 403 questionnaires were allocated, and 7 031 effective questionnaires were recovered, with an effective response rate of 94.98%. The respondents included 3 035 men (43.17%) and 3 996 women (56.83%), and had a mean age of (58.45±13.75) years. The median scores of hypertension prevention and control knowledge, attitude and practice were 5 (interquartile range, 4), 16 (interquartile range, 5) and 14 (interquartile range, 7) points, with scoring percentages of 48.40%, 80.55% and 54.41%, respectively. Generalized linear model analysis showed that an educational level of junior high school and above, annual family income per capita of ≥4 000 RMB, family history of hypertension, development of hypertension among family members or friends, overweight/obesity and presence of depression resulted in high scores for hypertension prevention and control knowledge; annual family income per capita of ≥10 000 RMB, family history of hypertension, presence of hypertension among family members or friends, mild/severe insomnia and presence of depression resulted in high scores for hypertension prevention and control attitude, while age of ≥65 years and blood pressure of ≥140/≥90 mmHg resulted in low scores for attitude; females, age of ≥45 years, an educational level of junior high school and above, blood pressure of ≥140/≥90 mmHg, family history of hypertension, presence of hypertension among family members or friends and overweight/obesity resulted in high scores for hypertension prevention and control practice, and residents had a low body weight had a low score for practice (all P<0.05). Conclusions The hypertension prevention and control attitude is satisfactory among rural residents in Shanxi Province; however, the hypertension prevention and control knowledge and practice are poor. Health education pertaining to hypertension prevention and control should be strengthened, and personalized health education is needed targeting individuals with a low educational level and low income.

Objective:To summarize and analyze the clinical data of Chinese patients with colony-stimulating factor 1 receptor (CSF1R)-related leukoencephalopathy, and clarify the phenotypic and genetic characteristics of Chinese patients.Methods:Medical history of patients with CSF1R-related leukoencephalopathy diagnosed from April 1, 2018 to January 31, 2021 in the department of neurology of 22 hospitals in China was collected, and scores of Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment Scale (MoCA), magnetic resonance severity scale were evaluated. Group comparison was performed between male and female patients.Results:A total of 62 patients were included, and the male-female ratio was 1∶1.95. The age of onset was (40.35±8.42) years. Cognitive impairment (82.3%, 51/62) and motor symptoms (77.4%,48/62) were the most common symptoms. The MMSE and MoCA scores were 18.79±7.16 and 13.96±7.23, respectively, and the scores of two scales in male patients (22.06±5.31 and 18.08±5.60) were significantly higher than those in females (15.53±7.41 , t=2.954, P=0.006; 10.15±6.26, t=3.328 , P=0.003). The most common radiographic feature was bilateral asymmetric white matter changes (100.0%), and the magnetic resonance imaging severity scale score was 27.42±11.40, while the white matter lesion score of females (22.94±8.39) was significantly higher than that of males (17.62±8.74 , t=-2.221, P<0.05). A total of 36 CSF1R gene mutations were found in this study, among which c.2381T>C/p.I794T was the hotspot mutation that carried by 17.9% (10/56) of the probands. Conclusions:The core phenotypic characteristics of CSF1R-related leukoencephalopathy in China are progressive motor and cognitive impairment, with bilateral asymmetrical white matter changes. In addition, there exist gender differences clinically, with severer cognitive impairment and imaging changes in female patients. Thirty-six CSF1R gene mutations were found in this study, and c.2381T>C/p. I794T was the hotspot mutation.

Betacoronavirus ; isolation & purification ; pathogenicity ; Bile Acids and Salts ; metabolism ; Bile Ducts, Intrahepatic ; pathology ; virology ; Cell Culture Techniques ; Coronavirus Infections ; complications ; pathology ; Cytokine Release Syndrome ; etiology ; physiopathology ; Cytopathogenic Effect, Viral ; Epithelial Cells ; enzymology ; pathology ; virology ; Humans ; Hyperbilirubinemia ; etiology ; Liver ; pathology ; Organoids ; pathology ; virology ; Pandemics ; Peptidyl-Dipeptidase A ; analysis ; Pneumonia, Viral ; complications ; pathology ; Receptors, Virus ; analysis ; Serine Endopeptidases ; analysis ; Viral Load

Objective:To observe the healing morphology, macular microstructure and visual function of idiopathic macular hole (IMH) after pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) flap.Methods:Retrospective case study. From 2016 to 2018, 39 eyes of 39 patients with IMH diagnosed in Tianjin Eye Hospital were included in the study. Among them, there were 4 eyes in 4 males and 35 eyes in 35 females, with an average age of 64.56±7.2 years. BCVA, OCT, OCT angiography (OCTA) and MAIA microperimetry examination were performed in all patients. BCVA examination was performed with the international standard visual acuity chart, which was converted to logMAR visual acuity when recording. All patients underwent PPV combined with ILM flap covering and air tamponade. According to the characteristics of OCT images postoperatively, the eyes were divided into U-shaped closed group, V-shaped closed group, irregular closed group and flat closed group, with 26, 5, 7 and 1 eyes respectively. There was a significant difference in the minimum hole diameter ( F=5.118, P=0.005) and macular hole classification ( F=3.608, P=0.024). The shallow capillary layer (SCP) blood flow density in the U-shaped closure group was significantly higher than that in the V-shaped closure group, the irregular closure group and the flat closure group (t=2.079, 2.368; P=0.047, 0.025). At 1, 3, 6 months after the operation, the same equipment and methods were used for relevant examination. The blood flow density of BCVA, SCP, perimeter of foveal avascular zone (PERIM) and mean sensitivity (MS) were compared before and after operation. Independent sample t-test was used for quantitative data comparison between different groups, and χ2 test was used for counting data comparison. Results:Six months after operation, the logMAR of the eyes in the U-shaped closure group was -0.75±0.29 higher than that before operation, and was better than that in the V-shaped closure group, the irregular closure group and the flat closure group ( t=-2.974, -2.518; P=0.006, 0.018). The integrity of external limiting membrane (ELM) and ellipsoid in U-shaped closed group was significantly higher than that in V-shaped closed group, irregular closed group and flat closed group ( χ2=15.229, 10.809; P=0.020, 0.013). The percentage of macular central fovea reflex mass in the U-shaped closed group was significantly lower than that in the V-shaped closed group, irregular closed group and flat closed group ( χ2=20.107, P=0.000). PERIM in U-shaped closure group was smaller than that in V-shaped closure group, irregular closure group and flat closure group, and the difference was statistically significant ( t=-3.391, -2.427; P=0.002, 0.022). The total MS of macular area 10° in the U-shaped closure group was significantly higher than that in the other V-shaped closure group, irregular closure group and flat closure group ( t=2.939, 2.811; P=0.001, 0.001). Conclusion:After IMH operation, the U-shaped closure showed better BCVA and macular light sensitivity, the proportion of ELM and ellipsoid to restore structural integrity are higher, PERIM is smaller, and there are fewer macular fovea strong reflex masses.

Objective:To observe the changes of microperimeter and OCT angiography (OCTA) in idiopathic macular hole (IMH) before and after operation, and to explore the correlation between the changes and visual acuity.Methods:From January 2018 to January 2019, 41 patients (41 eyes) with IMH who underwent pars plana vitrectomy (PPV) with or without internal limiting membrane (ILM) flap surgery in Tianjin Eye Hospital were included in this study. Among them, 8 patients (8 eyes) were male and 33 patients (33 eyes) were female. The average age was 64.02±6.46 years. The average course of disease was 7.00±8.85 months. BCVA, microperimeter and OCTA were performed. The retinal mean sensitivity (RMS) at 10 ° and fovea 2 ° fixation rate (P1) and binary contour ellipse area (63% BCEA) were measured by macular integrity assessment instrument. The central retinal thickness (CRT), choroidal blood flow area (CFA), superficial and deep retinal blood flow density (FAVD, FDVD), foveal avascular zone (FAZ) and blood flow densitywithin the width of FAZ 300 μm (FD-300) were measured by OCTA. Twenty one and 19 eyes with or without ILM flap operation were treated with 25G standard three incision PPV. The follow-up time was more than 6 months. Paired t-test was used to compare the indexes before and after operation. Pearson correlation analysis was performed for the correlation between logMAR visual acuity and microperimeter variables and OCTA variables. Nonparametric test was performed for paired comparison between affected eyes and contralateral eyes before and after operation.Results:At 6 months after operation, logMAR visual acuity ( t=-12.33), RMS ( t=7.94), P1 ( t=3.21), 63% BCEA ( t=-3.98), CRT ( t=-9.17), CFA ( t=8.14), FSVD ( t=3.75), FDVD ( t=3.88) were significantly improved compared with those before operation ( P<0.001). The difference of FAZ area ( t=-1.40) and FD-300 ( t=1.95) before and after operation were not statistically significant ( P>0.05). The results of correlation analysis showed that logMAR visual acuity 6 months after surgery was correlated with preoperative logMAR visual acuity, MIN, RMS, P1, 63% BCEA, FSVD, FDVD and FAZ ( r=0.432、0.527、-0.410、-0.383、0.349、-0.406、-0.373、0.407; P<0.05). At 6 months after operation, the indexes of the affected eyes were significantly improved compared with those before operation, but worse than those of the contralateral eyes ( P<0.05). Conclusions:PPV for IMH can effectively improve the visual acuity, retinal function and foveal microvascular circulation. Retinal function and blood circulation changes have a significant impact on postoperative visual acuity.