OBJECTIVE To establish a core competency evaluation system for drug clinical trial quality management personnel in China and validate its application. METHODS Based on the scope of work， responsibilities， and role positioning of quality management personnel in drug clinical trials， a preliminary draft of the core competency evaluation system was constructed through literature analysis and expert consultation. The draft was refined through a Delphi method involving 17 experts who provided feedback and revisions， ultimately forming a complete evaluation system. The developed system was applied to conduct electronic surveys from March to May 2024 among 110 quality management personnel from 38 drug clinical trial institutions， comparing their scores on indicator importance and self-assessed capabilities. RESULTS The response rate of both rounds of questionnaire survey was 100%， with Kendall’s W coefficients of 0.256 and 0.277 （P＜0.001 for both）， and an expert authority coefficient of 0.946. The finalized evaluation system for core competencies of clinical trial quality management personnel comprised 9 primary indicators， covering individual professional competence， communication skills， implementation condition verification， informed consent process review， clinical trial execution monitoring， adverse event disposal， reporting and documentation， trial record examination， trial report auditing， and inspection of other tasks， and 107 secondary indicators. Empirical research revealed significant discrepancies between importance scores and self-assessed competency scores across 70 indicators among 110 respondents （P＜0.05）. Indicators with relatively notable gaps between importance scores and self-assessed competency scores included in-depth understanding of Good Clinical Practice （GCP） requirements （0.34-point gap）， familiarity with national and institutional clinical trial inspection priorities （0.24-point gap），etc. CONCLUSIONS The indicator system constructed in this study has good scientificity and reliability. Clinical trial quality management personnel demonstrate deficiencies in multiple critical competencies， highlighting the urgent need for targeted training programs to enhance their overall professional capabilities.

To better promote the development of film-coated formulations and membrane agents, the present study was carried out to investigate the critical material attributes (CMAs) of different sources and models of HPMC in terms of film-coating performance and the correlation between each of the CMAs and the film-coating-related properties, using 2910 HPMC as the research target. Firstly, various analytical techniques were used to characterize the CMAs and film coating-related properties of HPMC. Secondly, the CMAs and film coating-related properties of HPMC were systematically evaluated by principal component analysis (PCA) and orthogonal partial least-squares discrimination analysis (OPLS-DA). The CMAs and film-coating-related properties of HPMC were systematically evaluated to elucidate the intrinsic relationship between the CMAs and film-coating-related properties of HPMC. The results showed that there were significant differences in viscosity, weight-average molecular weight, film tensile strength, elongation, elastic modulus, dissolution time, and flexibility of HPMCs from different manufacturers. The results of PCA and OPLS-DA analyses indicated that these 11 variables showed some correlations with each other. Both mathematical models showed better differentiation and classification of HPMC samples, and the OPLS-DA model had a better classification effect than the PCA model. Therefore, in this study, the physicochemical properties and the film-forming characteristic of HPMC were comprehensively evaluated, and the correlation between them was further established using PCA and OPLS-DA. The impact degree of different CMAs on the film coating performance of HPMC was clarified, which can be used as an important reference for the selection of excipient quality control programs in excipient production and formulation research and development.

Objective: To investigate the hygienic status of the central air conditioner ventilation system in public places in urban areas of Ma'anshan City, Anhui Province, so as to provide insights into formulation of supervision and management interventions. Methods: A total of 15 public places with the central air conditioner ventilation system were randomly sampled from main urban areas in Ma'anshan City in 2022. Sampling and detection were performed following the standard GB/T 18204.5—2013 Examination methods for public places Part 5: Central air conditioning ventilation system, including total number of bacteria and total number of fungus on the inner surface of wind pipes, total number of bacteria and fungus, particulate matter (PM10) and β-hemolytic streptococci in the air supply system, and Legionella pneumophila in the cooling water, and the detection indicators were assessed following the WS 394—2012 Guideline for hygiene of the central air conditioner ventilation system in public places. The eligible rate of samples, the detection rate of L. pneumophila were analyzed. Results: A total of 368 samples were collected from 15 public places, and the qualified rate was 50.54%, no places had all eligible measurement indicators. The qualified rates of total bacteria and fungus numbers on the inner surface of wind pipes were 52.67% and 59.33%. The qualified rates of total bacterium number, total fungus number, PM10 and β-hemolytic streptococci were 12.00%, 28.00%, 90.00% and 96.00% in the air supply system. The qualified rates of samples in administrative workplaces, hotels, bathing places and malls (supermarkets) were 32.50%, 59.24%, 61.09% and 68.92%, the qualified rates of total bacteria on the inner surface of air ducts were 8.33%, 72.46%, 66.67% and 61.90%, and the qualified rates of total fungus numbers in air supply were 0, 21.70%, 33.30% and 71.40%, respectively, with statistical significance (P<0.05). A total of 18 cooling water samples were collected, and L. pneumophila was detected in three samples (16.67%). Conclusions Poor hygiene is seen in the central air conditioning ventilation systems in public places in main urban areas of Ma'anshan City. High attention needs to be paid to contamination of bacterium, fungus and L. pneumophila, and expansion of supervision coverage and improved supervision intensity are recommended.

The central nervous system is one of the most sensitive targets of microwave radiation. Microwave radiation can affect spatial learning and memory and neural information transmission. The effects of microwave radiation on neurotransmitters in the hippocampus and the underlying mechanisms are still unclear. This paper reviews the effects of microwave radiation on learning/memory and neurotransmitters as well as the mechanisms of action on neurotransmitters. This paper aims to provide a scientific basis for future research in this area.

Objective:To evaluate the clinical outcome of Robot-assisted sacroiliac screw fixation in the treatment of fragility fracture of the sacrum in the elderly.Methods:From March 2016 to June 2022, a retrospective analysis was performed on 30 patients with fragility fractures of the sacrum in the elderly who accepted robot-assisted sacroiliac screw to treat fragility fractures of the sacrum in our hospital. There were 12 males and 18 females with average age 71.03±8.25 years (range, 60-89 years). According to the classification of fragility fractures of the pelvis (FFP) in the elderly, there were 22 patients with FFP II, 2 patients with FFP III, and 6 patients with FFP IV. Surgical planning was based on the average CT value of S 1 channel and whether there is a transsacral screw channel. Robot-assisted sacroiliac screw fixation was performed during surgery. The pain of pre-operation and post-operation was evaluated using the visual analogue scale (VAS), the position of sacroiliac screws was evaluated by Gras grading, and the degree of functional recovery after surgery was evaluated using the Majeed function score. Results:All 30 patients successfully completed the operation. The mean operation time was 27.00±6.68 min (range, 18-35 min), the mean fluoroscopy times were 27.13±5.16 (range, 18-34), and the mean blood loss was 30.53±6.61 ml (range, 23-38 ml). All patients were followed up, and the mean follow-up time was 19.03±7.8 months (range, 8-25 months). The VAS was 5(5, 6), 4(3, 4), 3(2, 3), 0(0, 1) points before surgery, 1 week, 2 months and 6 months after surgery, respectively, and the difference was statistically significant ( H=103.26, P<0.001). After the surgery of 2 months, 6 months and the last follow-up time, the Majeed function scores were 88(83, 90), 91(87, 92), 92(90, 93) points, respectively, and the difference was statistically significant ( H=19.59, P<0.001). Screw position was evaluated according to Gras grading at 3 days after surgery, including 28 cases of level I, 2 cases of level II, and no screw penetrated the cortical bone or entered the sacral canal or sacral foramen. No vascular or nerve injury occured during the operation. 28 patients with FFS met the fracture healing criteria, and the healing time was 4.54±1.57 months (range, 3-7 months). Two patients had bone nonunion, one of whom underwent anterior ring plate removal due to infection of the pelvic anterior wound, and one month later, pelvic CT scan revealed loosening of the sacroiliac screw; the other one is considered to be related to too early weight bearing. Conclusion:For fragility fractures of the sacrum in elderly, Robot-assisted sacroiliac screw is an effective minimally invasive treatment, with high accuracy of screw placement, effective pain reduction, improved fracture healing rate, and achieve the satisfactory clinical efficacy.

The purpose of this study is to describe the principles in selection and application of antidepressants in patients with depression complicating glaucoma or at high risk of glaucoma. With the aim of providing a partial reference for relevant issues， this paper elaborated a case of major depression after glaucoma surgery receiving 6 weeks of treatment with escitalopram oxalate and sulpiride achieved significant improvement in depressive and psychotic symptoms without triggering or exacerbating glaucoma.

Objective: To analyze the relationship between family behaviors and overweight/obesity in primary and junior school students aged 6-14 years in Xuzhou, and to provide a reference for a targeted measure to prevent and control overweight and obesity. Methods: Using multistage stratified cluster random sampling, a total of 6 220 students aged 6-14 years old from 10 primary schools and 10 junior schools were investigated by a self-designed questionnaire. Chi-square and multivariate Logistic regression models were used to explore the relationship between family behaviors and overweight/obesity in primary and junior school students. Results: The rate of overweight/obesity in primary and junior boys was higher than that in primary and junior girls. The rate of overweight/obesity in urban students was higher than that of rural students(P<0.05). The Chi-square analysis showed that overweight of parents, irregular breakfast, eating fast food, eating sweets, drinking sweetened beverage, long screen time and short sleep duration were risk family behavior factors of overweight/obesity in primary and junior boy students(P<0.05). The risk family behavior factors of overweight/obesity in primary and junior girl students were overweight of parents, irregular breakfast, eating fast food and eating sweets(P<0.05). The risk family behavior factors of overweight/obesity, such as drinking sweetened beverage and short sleep duration, were also related to primary girls(P<0.05), and long screen time was related to junior girls(P<0.05). The multivariate Logistic regression showed that such family behavior factors as irregular breakfast(OR-boy=1.58, OR-girl=1.74), eating fast food(OR-boy=1.37, OR-girl=1.11), eating sweets(OR-boy=1.85, OR-girl=1.52), drinking sweetened beverage(OR-boy=1.64, OR-girl=1.33) and short sleep duration(OR-boy=1.56, OR-girl=1.69) were positively correlated with the prevalence of overweight/obesity in primary students. Long screen time was also correlated to overweight/obesity primary boy students(OR=1.18). Family behavior factors for child overweight and obesity induded overweight of parents(OR-boy=1.29, OR-girl=1.23) and eating sweets(OR-boy=1.44, OR-girl=1.51). Irregular breakfast(OR=1.51), eating fast food(OR=1.22), drinking sweetened beverage (OR=1.75) and long visual screen time (OR=1.15) were also positively correlated with the prevalence of overweight/obesity in junior boy students. Conclusion Family behavior factors were positively correlated with the prevalence of overweight/obesity in primary and junior students. The influence of family behavior factors were different between primary and junior students. Behavioral interventions based on family should be adopted to prevent and control the overweight/obesity of children.

Objective To analyze the relationship between sleep duration, screen viewing time, and the prevalence of overweight/obesity among primary school students in Xuzhou. Methods Using a cluster sampling method, a total of 3 228 students (including 1 679 boys and 1 549 girls with an average age of 10.78±0.69 years) from grade one to six from 10 primary schools in Xuzhou underwent interview using a self?designed questionnaire containing basic characteristics, sleep duration, and screen viewing time. Data on height and weight were also collected. The relationship between sleep duration, screen viewing time, and overweight/obesity was analyzed using a logistic regression analysis. Results The prevalence rates of overweight among boys and girls were 16.56% and 11.94%, respectively (χ2=13.59, P<0.05). The prevalence rates of obesity among boys and girls were 14.47% and 10.07%, respectively (χ2=14.01, P<0.05). In total, 74.41% students reported a lack of sleep; the average sleeping time was (9.24±1.07) h. The average sleeping time among boys was (9.35 ± 1.12) h and among girls was (9.13 ± 1.03) h. The difference in sleep duration between boys and girls was significant (t=5.79, P<0.05). The differences in sleep duration and overweight/obesity were significant between both boys (χ2=18.62, P<0.05) and girls (χ2=21.14, P<0.05). Regarding screen viewing time, 17.29% of students spent more than 2 hours per day viewing a screen. The difference in screen viewing time between boys and girls was significant (Z=3.02, P=0.014). The proportion of children with screen viewing time of more than 2 h/d among overweight/obese and healthy weight male students was 29.50% (82/278) and 22.56% (316/1401), respectively, which was significantly different (χ2=6.18, P=0.01). However, there was no significant difference when examining the same groups among girls (12.98% (24/185;obese/overweight) vs . 9.97% (136/1364; healthy weight); χ2=1.59, P=0.21). After adjusting for parental obesity, eating sweets, and physical activity, logistic regression analysis showed that students who had a sleep duration less than 10 h/d had an odds ratio of 1.4 (95% CI: 1.15-1.71), the odds ratio for boys and girls was 1.56 (95% CI: 1.13-2.14) and 1.69 (95% CI: 1.15-2.46). The students who had a screen viewing time of more than 2 h/d had an odds ratio of 1.14 (95% CI: 1.05-1.80); the odds ratio for boys in this group was 1.18 (95% CI: 1.03-1.67). Conclusion Short sleep duration is a risk factor for being overweight/obese in both boys and girls. However, long screen viewing times were associated with being overweight/obese only in boys.

Objective To explore the influence of interleukin-2 receptor antagonists(IL-2Ra) on the morbidity and prognosis of new onset diabetes after transplantation(NODAT)in liver transplant recipients. Methods Pre-and post-operative clinical data of 879 nondiabetic patients who underwent a liver transplantation between April 2001 and December 2016 were retrospectively studied. All the enrolled patients were divided into IL-2Ra and non-IL-2Ra groups according to the use of IL-2Ra. Transient-NODAT(T-NODAT)and Persistent-NODAT(P-NODAT)were defined according to whether NODAT would be existed continuously. The impacts of IL-2Ra on the cumulative incidence as well as the risk of NODAT and T-NODAT were analyzed through comparison between patients who used IL-2Ra or not. And influence of IL-2Ra on the long-term survival of NODAT patients was further analyzed. Results Among 879 patients,177(32.24%)from the IL-2Ra group(n=549)developed NODAT and 29.38%(n=52)of the NODAT reversed,while 131(39.70%)from the non-IL-2Ra group(n=330)developed NODAT and 26.72%(n=35)of the NODAT reversed. After adjusting for 18 possible confounding factors,the IL-2Ra group had significantly decreased cumulative incidence of NODAT over the non-IL-2Ra group(adjusted P=0.028). COX regression analyses showed that IL-2Ra was a protective factor against NODAT development(HR 0.774;95% CI 0.616-0.973; P=0.028), while the use of IL-2Ra and the reverse of NODAT did not significantly related. In addition, long-term survival of the NODAT patients were far better in the IL-2Ra group(adjusted P=0.001). Conclusion IL-2Ra significantly reduces the risk of NODAT in liver transplant recipients and is beneficial to the long-term survival of NODAT patients.

Objective: To verify the accuracy of oxygen concentration (FiO₂) of modified oxygen treatment with Venturi and humidity system. Methods: Patients just after ventilator weaning and before the removal of tracheal intubation/tracheotomy tube, who admitted to the intensive care unit (ICU) of Henan Provincial People's Hospital from May 1st to December 15th in 2017, were enrolled. All patients were given a modified oxygen treatment with Venturi and humidity system, and the oxygen flow rate (Flow) of the Venturi device and the oretical value of FiO₂ were adjusted according to the patient's condition. Patients were divided into five groups based on doctor's orders: Flow 3 L/min FiO₂ 0.24, Flow 3 L/min FiO₂ 0.26, Flow 6 L/min FiO₂ 0.28, Flow 6 L/min FiO₂ 0.30, Flow 9 L/min FiO₂ 0.35. The value of FiO₂ at the inhalation end of patients of each group was measured by TSI airflow analyzer, and the consistency between the measured value of FiO₂ at the inhalation end and the FiO₂ marked value of Venturi was compared and analyzed. Results: When the FiO₂ theoretical value of Venturi were adjusted to 0.24, 0.26, 0.28, 0.30, and 0.35, the measured values of FiO₂ at the inhalation end of patients were 0.38±0.05, 0.38±0.05, 0.40±0.04, 0.41±0.04, and 0.77±0.11, respectively, which were all significantly higher than the theoretical value of FiO₂ (all P < 0.01). The difference between the measured value of FiO₂ at the inhalation side and the FiO₂ value of the Venturi annotated and the difference rate were both "V"-shaped, both of which decreased with the increase in theoretical value of FiO₂ to a Flow of 9 L/min and a theoretical value of FiO₂ 0.35, the accuracy was the worst, with the FiO₂ difference of 0.42±0.11, and the FiO₂ difference rate of (121.6±36.5)%. Conclusion There is a difference between the measured value and the theoretical value of FiO₂ at the inhalation end of the modified Venturi oxygen therapy humidification system, which needs to be paid attention to during clinical oxygen therapy.