1.Effect evaluation of pharmaceutical service based on root cause analysis combined with KAP theory on decreasing the protocol violations of investigational medicinal products rate in pediatric clinical trials
Chunyan GUO ; Yi ZHANG ; Yuxin YANG ; Yuguang LIANG ; Qian DING ; Qian WANG ; Chengyue ZHANG ; Yu SUN ; Peng GUO
China Pharmacy 2026;37(9):1206-1210
OBJECTIVE To investigate the effect of pharmaceutical services guided by root cause analysis (RCA) in a problem-oriented manner combined with knowledge-attitude-practice (KAP) theory on reducing the incidence of protocol violations of investigational medicinal products in pediatric clinical trials. METHODS A total of 617 participants from 69 drug clinical trial projects conducted in our hospital from January 2016 to December 2020 were selected as the control group, and 868 participants from 72 drug clinical trial projects from January 2022 to December 2025 as the observation group. RCA was performed on the protocol violations of investigational medicinal product in the control group to identify the types and underlying causes. The control group received routine pharmaceutical services for drug clinical trials, while the observation group was provided with precision pharmaceutical services from the three dimensions of knowledge, attitude and practice on the basis of routine pharmaceutical services, according to the root causes identified by RCA. The occurrence of investigational medicinal products protocol violations was compared between the two groups. RESULTS The total incidence of protocol violations of investigational medicinal products, as well as the incidences of minor and major protocol violations, were all significantly lower in the observation group than in the control group ( P <0.001). The main types of protocol violations in both groups included missed/under-/over-dosing of medications, non-adherence to administration time, failure to adjust dosage as required, and combined medication/vaccination in violation of the protocol. Regarding the responsible subjects of protocol violations, the incidences of protocol violations attributed to participants and their guardians as well as investigators and accidental factors were significantly lower in the observation group than in the control group ( P <0.001, P <0.001, P =0.025). However, there were no statistically significant differences in the incidences of protocol violations caused by sponsor-related reasons between the two groups ( P >0.05). CONCLUSIONS Pharmaceutical services led by pharmacists, based on problem-oriented RCA and combined with KAP theory, can effectively reduce the protocol violations of investigational medicinal products rate in pediatric clinical trials, thereby safeguarding the safety and rights of study participants.
2.Correlations between Helicobacter pylori infection and osteoporosis:a Meta-analysis
Chunyan YUE ; Yi PENG ; Luling DONG
Military Medical Sciences 2025;49(3):198-206
Objective To study the relationships between Helicobacter pylori(Hp)infection and the occurrence of osteoporosis via Meta-analysis.Methods Two researchers independently retrieved related literature related to the association between Hp infection and osteoporosis and published in such databases as PubMed,EMBASE and Cochrane Library,China Science and Technology Journal Database,China National Knowledge Infrastructure(CNKI),and Wanfang Database as of February 2024.STATA 11.0 software was used for Meta-analysis before the combined OR value and its 95%CI were calculated.Results Twenty-four studies involving 24 936 participants were included in the study.Meta-analysis showed that Hp infection was significantly associated with the risk of osteoporosis(OR:1.52,95%CI:1.17-1.99).Those infected with the CagA-positive Hp strain were more likely to develop osteoporosis(OR:2.42,95%CI:1.32-4.43).Hp infection was significantly associated with decreased bone mass(OR=1.32,95%CI:1.08-1.62),but the decrease of bone mineral density in Hp-positive patients was not significant compared with Hp negative controls.Conclusion Infection with Hp,particularly the CagA-positive strain,has been associated with an increased risk of osteoporosis.The bone health of Hp-positive patients deserves more attention.
3.Discovery of fernane-type triterpenoids from Diaporthe discoidispora using genome mining and HSQC-based SMART technology.
Yajing WANG ; Yongfu LI ; Yan DONG ; Chunyan YU ; Chengwei LIU ; Chang LI ; Yi SUN ; Yuehu PEI
Chinese Journal of Natural Medicines (English Ed.) 2025;23(3):368-376
In this study, we employed a combination of genome mining and heteronuclear single quantum coherence (HSQC)-based small molecule accurate recognition technology (SMART) technology to search for fernane-type triterpenoids. Initially, potential endophytic fungi were identified through genome mining. Subsequently, fine fractions containing various fernane-type triterpenoids were selected using HSQC data collection and SMART prediction. These triterpenoids were then obtained through targeted isolation and identification. Finally, their antifungal activity was evaluated. As a result, three fernane-type triterpenoids, including two novel compounds, along with two new sesquiterpenes and four known compounds were isolated from one potential strain, Diaporthe discoidispora. Their structures were elucidated through analysis of high-resolution electrospray ionization mass spectrometry (HR-ESI-MS) and nuclear magnetic resonance (NMR) spectroscopic data. The absolute configurations were determined using single-crystal X-ray diffraction analysis and electron capture detector (ECD) analysis. Compound 3 exhibited moderate antifungal activity against Candida albicans CMCC 98001 and Aspergillus niger.
Triterpenes/isolation & purification*
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Antifungal Agents/isolation & purification*
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Molecular Structure
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Candida albicans/drug effects*
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Ascomycota/genetics*
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Magnetic Resonance Spectroscopy
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Aspergillus niger/drug effects*
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Genome, Fungal
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Microbial Sensitivity Tests
4.Comparison of small-sample multi-class machine learning models for plasma concentration prediction of valproic acid
Xi CHEN ; Shen’ao YUAN ; Hailing YUAN ; Jie ZHAO ; Peng CHEN ; Chunyan TIAN ; Yi SU ; Yunsong ZHANG ; Yu ZHANG
China Pharmacy 2025;36(11):1399-1404
OBJECTIVE To construct three-class (insufficient, normal, excessive) and two-class (insufficient, normal) models for predicting plasma concentration of valproic acid (VPA), and compare the performance of these two models, with the aim of providing a reference for formulating clinical medication strategies. METHODS The clinical data of 480 patients who received VPA treatment and underwent blood concentration test at the Xi’an International Medical Center Hospital were collected from November 2022 to September 2024 (a total of 695 sets of data). In this study, predictive models were constructed for target variables of three-class and two-class models. Feature ranking and selection were carried out using XGBoost scores. Twelve different machine learning algorithms were used for training and validation, and the performance of the models was evaluated using three indexes: accuracy, F1 score, and the area under the working characteristic curve of the subject (AUC). RESULTS XGBoost feature importance scores revealed that in the three-class model, the importance ranking of kidney disease and electrolyte disorders was higher. However, in the two-class model, the importance ranking of these features significantly decreased, suggesting a close association with the excessive blood concentration of VPA. In the three-class model, Random Forest method performed best, with F1 score of 0.704 0 and AUC of 0.519 3 on the test set; while in the two-class model, CatBoost method performed optimally, with F1 score of 0.785 7 and AUC of 0.819 5 on the test set. CONCLUSIONS The constructed three-class model has the ability to predict excessive VPA blood concentration, but its prediction and model generalization abilities are poor; the constructed two-class model can only perform classification prediction for insufficient and normal blood concentration cases, but its model performance is stronger.
5.Implementing standardized school desks and chairs to promote the healthy development of primary and secondary school students
ZHANG Fengyun, SONG Yi, ZHANG Lin, LUO Chunyan, DU Wei, DONG Bin
Chinese Journal of School Health 2025;46(3):305-309
Abstract
In order to understand and analyze the current standards and application of school desks and chairs for primary and secondary schools, and to promote the healthy growth of primary and secondary school students. The article conducts a comprehensive review of the functional and dimensional standards for school furniture both domestically and internationally, and objectively analyzes the current utilization and existing issues concerning desks and chairs in schools. It further explores the multifaceted factors that influence the allocation of desks and chairs, and proposes effective countermeasures, so as to provide a reference for the risk factors of common diseases related to desks and chairs, such as myopia and abnormal spinal curvature.
6.Relationship between stressors and job burnout: Moderating role of job well-being
Jie WU ; Fengmin CHENG ; Ruotong YI ; Weiqian YU ; Chunyan LIU ; Mengyu OU
Journal of Environmental and Occupational Medicine 2025;42(7):833-839
Background Enhancing the sense of honor and belonging among medical staff is a key component of establishing a modern hospital management system. Compared to medical staff at general hospitals, medical staff at oncology hospitals are more prone to job burnout, yet few studies in China have focused on job burnout among employees in oncology hospitals. Objective To propose a hypothetical model in which job well-being moderates the relationship between stressors and occupational burnout, to explore how stressors influence burnout and potential moderating role of job well-being, and to provide better understanding of job burnout and motivate employees based on the double-edge sword effect of stressors. Methods A cross-sectional survey was conducted in May 2022 at a tertiary oncology specialty hospital in Chongqing, China. A total of 1 898 medical staff were recruited. Data were collectedthrough four scales including a general information questionnaire, Maslach Burnout Inventory-Human Service Survey, Work Stressor Scale, and Occupational Well-being Scale for Medical Staff. Independent sample t-tests and one-way ANOVA were used for univariate comparisons of job burnout. Pearson correlation analysis was employed to examine the relationships between job burnout, stressors, and job well-being. Hierarchical linear regression was conducted to identify factors influencing job burnout and to examine potential moderating role of job well-being in the relationship between stressors and job burnout. Results A total of 2 123 questionnaires were distributed, with 1 898 valid responses, yielding an effective response rate of 89.4%. The prevalence of job burnout was 60.1%. The correlation coefficient was 0.717 (P<0.001) between stressors and burnout, −0.784 (P<0.05) between job well-being and burnout, and −0.744 (P<0.001) between stressors and job well-being. The quadratic stressors showed a statistically significant effect on burnout (β=0.404, P<0.01). Job well-being positively moderated the relationship between the linear stressors and burnout (β=1.289, P<0.001) and negatively moderated the relationship between the quadratic stressors and job burnout (β=−0.571, P<0.01), explaining 7.1% of the variance. Conclusion Job burnout prevalence is relatively high among employees in oncology hospitals. There is a curvilinear relationship between stressors and job burnout, with job well-being moderating this relationship. From a practical perspective, it is recommended to establish a tiered stress alert system to monitor employees’ stress levels and prevent prolonged exposure to high-pressure conditions. Additionally, improving employees’ job well-being through institutional incentives and developmental support can enhance its moderating role in mitigating the adverse effects of stressors on job burnout. Meanwhile, fostering coordinated responses between organizations and individuals is crucial for strengthening mental health management systems, thereby supporting a healthy, stable, and sustainable development of the healthcare workforce.
7.Analysis of the influencing factors for pruritus and construction of a nomogram prediction model in peritoneal dialysis patients
Rui YANG ; Shu ZHOU ; Jianxiong LIN ; Chunyan YI ; Xiao YANG ; Wei CHEN ; Haiping MAO
Chinese Journal of Nephrology 2025;41(4):258-265
Objective:To explore the influencing factors for skin pruritus and to construct a nomogram prediction model in peritoneal dialysis (PD) patients.Methods:It was a retrospective cross-sectional investigation study. The PD patients who were regularly followed up between July, 2023 and April, 2024 in PD center of the First Affiliated Hospital of Sun Yat-sen University were enrolled in this study. The pruritus status was evaluated by the 14-Item UP-Dial Scale. The general demographic data and clinical data were collected. The patients were divided into pruritus group and non-pruritus group according to the presence or absence of skin itching. The differences of clinical data and laboratory results were compared between the two groups. Logistic regression was used to analyze the associated factors for pruritus in PD patients. The nomogram model was constructed by R software. The receiver operating characteristic (ROC) curve analysis and the Hosmer-Lemeshow goodness-of-fit test were used to evaluate the performance of the model, and its clinical effectiveness was evaluated using the calibration curve.Results:A total of 315 PD patients were enrolled in this study, with age of (48.0±12.9) years, including 134 females (42.5%). Among them, 161 patients (51.1%) experienced skin pruritus. Of whom, 111 patients (68.9%) had mild pruritus, 34 patients (21.1%) had moderate pruritus, 16 patients (9.9%) had severe pruritus. The age ( t=-2.266, P=0.024), proportion of diabetes mellitus ( χ2=3.910, P=0.048), Charson comorbidity index ( Z=-2.458, P=0.014), blood eosinophil percentage ( Z=-2.385, P=0.017), C-reactive protein ( Z=-2.590, P=0.010), serum phosphorus ( Z=-3.233, P=0.001) and β2 microglobulin ( Z=-2.756, P=0.006) level in the pruritus group were higher than those in the non-pruritus group, and the measured glomerular filtration rate (mGFR) level ( Z=-3.708, P<0.001) of patients in the pruritus group was lower than that in the non-pruritus group. There were 262 patients in the training set and 53 patients in the validation set. The multivariate logistic regression analysis in the training set revealed that advanced age ( OR=1.032, 95% CI 1.010-1.054, P=0.004), lower mGFR ( OR=0.758, 95% CI 0.648-0.886, P<0.001), higher serum phosphorus ( OR=2.761, 95% CI 1.282-6.024, P=0.010), and elevated blood eosinophil percentage ( OR=1.098, 95% CI 1.012-1.191, P=0.025) were independent factors associated with pruritus in PD patients. The nomogram model constructed based on these indicators demonstrated good discrimination and calibration. In the training set, the area under the ROC curve ( AUC) was 0.757 (95% CI 0.699-0.816), with Hosmer-Lemeshow test χ2=4.979, P=0.760. In the validation set, the AUC was 0.779 (95% CI 0.651-0.907), and Hosmer-Lemeshow test χ2=12.938, P=0.114. Conclusions:The prevalence of skin pruritus is 51.1% in PD patient. Advanced age, lower mGFR, higher serum phosphorus and higher blood eosinophil percentage are the independent influencing factors for pruritus in PD patients. The nomogram model constructed based on these indicators shows excellent predictive performance for skin pruritus in PD patients.
8.Cross-sectional study of drug resistance in newly diagnosed HIV-1 infected patients in Shanghai
Qianru LIN ; Xuqin WANG ; Wenqi TANG ; Yuan DONG ; Qing YUE ; Chunyan HE ; Xiaolei YU ; Changhe LIU ; Yiqing HAN ; Wanqing FENG ; Zhen NING ; Xin SHEN ; Xin CHEN ; Yi LIN
Chinese Journal of Experimental and Clinical Virology 2025;39(1):69-74
Objective:To investigate the drug resistance of newly diagnosed HIV-1 infected patients in Shanghai and to provide reference value for clinical antiretroviral therapy (ART).Methods:The peripheral venous blood plasma of 196 newly diagnosed HIV-1 infected patients screened according to the inclusion and exclusion criteria at the Shanghai Public Health Clinical Center from April to June 2023 was collected, HIV-1 RNA was extracted, the pol region was amplified by reverse transcription-polymerase chain reaction (RT-PCR) for sequencing, the mutation sites and ART drug resistance were analyzed.Results:The plasma of 196 newly diagnosed HIV-1 infected patients was amplified successfully in 162 cases (amplification success rate was 82.65%). The subtypes consisted of CRF07_BC(51.23%), CRF01_AE (27.78%), and others (6.79%), CRF55_01B (5.56%), B (3.70%), CRF01_AE/B (3.70%) and CRF08_BC (1.23%). The overall transmitted drug resistance rate was 7.41%, the protease inhibitors (PIs), non-nucleoside/nucleotide reverse transcriptase inhibitors (NNRTIs), nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), integrase inhibitors (INSTIs) resistance rates were 3.09%, 3.70%, 0.00% and 0.62%, respectively. The proportion of NNRTIs-related mutation sites in B (66.67%) and CRF55_01B (88.89%) was higher than that in CRF07_BC (13.25%); the proportion of NNRTIs-related mutation sites in CRF55_01B (88.89%) was higher than that in CRF01_AE (22.22%) and other subtypes (18.18%), the difference was statistically significant (all P<0.05). Multivariate logistic regression analysis showed that the probability of PIs-related mutation sites in CRF01_AE/B was 21.71 times that of CRF07_BC[odds ratio ( OR)=21.71, 95% confidence interval ( CI): 3.36-140.27, P=0.001]. Conclusions:The transmitted drug resistance among newly diagnosed HIV-1 infected patients in Shanghai is at the moderate epidemic level, mainly NNRTIs and PIs-related drug resistance, and the INSTIs resistance rate is low, the use of INSTIs in ART regimens should be considered.
9.Relationship between social function and family support in young and middle-aged patients undergoing peritoneal dialysis
Shan LYU ; Chunyan YI ; Shuchao LU ; Xiao YANG ; Haiping MAO ; Wei CHEN ; Jianxiong LIN
Chinese Journal of Nephrology 2025;41(11):811-816
Objective:To analyze the relationship between social function and family support in young and middle-aged patients undergoing peritoneal dialysis (PD).Methods:In this cross-sectional study, the patients undergoing maintenance PD therapy for more than 3 months at the Department of Nephrology, the First Affiliated Hospital of Sun Yat-sen University, from May to October 2023 were recruited retrospectively. The social dysfunction screening scale and family support self-rating scale were used to evaluate the social dysfunction and family support of PD patients, respectively. The social demographic and clinical data of the patients were collected. Logistic regression analysis model was used to identify associated factors of social dysfunction in PD patients.Results:A total of 359 PD patients were recruited with age of (42.6±9.5) years old. Among them, 197 patients (54.9%) were males, and 33 patients (9.2%) were complicated with diabetes. The dialysis age was 28.8 (13.5, 56.3) months. The score of social function was 2 (1, 4), and the score of family support was (10.5±2.2). There were 199 patients (55.4%) having social dysfunction. There were 224 patients (62.4%) employed after PD. Compared with the normal social function group, the social dysfunction group had significantly lower score in family support ( Z=-2.613, P=0.009), serum potassium ( t=-2.725, P=0.007), urea clearance index ( Z=-2.346, P=0.019) and proportions of married status ( χ2=6.847, P=0.009), pre-dialysis employment ( χ2=3.996, P=0.046) and post-dialysis employment ( χ2=8.331, P=0.004), and higher serum creatinine ( Z=2.175, P=0.030), and proportions of annual household income < 100 000 yuan ( χ2=6.270, P=0.012) and diabetes mellitus ( χ2=4.400, P=0.036). Multivariate logistic regression analysis revealed that family support ( OR=0.828, 95% CI 0.733-0.935, P=0.002), diabetes mellitus ( OR=3.551, 95% CI 1.456-8.658, P=0.005) and serum potassium ( OR=0.559, 95% CI 0.374-0.835, P=0.005) were independent correlated factors of social dysfunction in young and middle-aged PD patients. Conclusions:The prevalence of social dysfunction is 55.4%, and the employment rate is 62.4% in young and middle-aged PD patients. Poor family support, diabetes mellitus and decreased serum potassium level are independently associated with social dysfunction in young and middle-aged PD patients.
10.Exploration and practice on construction of clinical research integrated management system of a pediatric hospital in Beijing
Yuguang LIANG ; Qian WANG ; Qian DING ; Chunyan GUO ; Meng ZHANG ; Yi ZHANG ; Xiaoling WANG ; Peng GUO
Chinese Journal of Medical Science Research Management 2025;38(1):69-74
Objective:This study starts from the main problems existing in the current stage of the development of pediatric clinical research in China and focuses on the construction of a clinical research management system. By innovating the platform management model and enhancing personnel skills, we can provide support and assurance for improving the clinical research platform and its sustainable development in the future.Methods:This study established an integrated management platform for Industry-Sponsored Initiated Clinical Research Trial (IST) and Investigator Initiated Clinical Research (IIT) and implement integrated management of IST and IIT projects. At the same time, in response to the weak links in quality management, synchronous training of management and research talents should be implemented to achieve dual improvement in project management quality and platform service efficiency throughout the process.Results:We had optimized the clinical research organization structure, improved the management system, and strengthened the quality supervision of IIT projects by establishing rules and systems to improve the quality and efficiency of project management.Conclusions:Based on analyzing the current situation in China and referring to international experience, we have built a clinical research management platform in line with the development of the hospital, and implemented centralized management of the entire process of IST and IIT projects, strengthened project process quality control, which is expected to provide a reference for peers.


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