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.Therapeutic drug monitoring of antiepileptic drugs and analysis of its influencing factors in patients with epilepsy or bipolar affective disorder
Hailing YUAN ; Chunyan TIAN ; Xi CHEN ; Yi SU ; Yunsong ZHANG ; Yu ZHANG ; Liting XU
China Pharmacy 2026;37(18):2418-2423
OBJECTIVE To provide guidance for the individualized use of antiepileptic drugs (AEDs) in patients with epilepsy or bipolar affective disorder.METHODS Clinical data of patients with epilepsy or bipolar affective disorder who received AEDs treatment and underwent therapeutic drug monitoring (TDM) at Xi’an International Medical Center Hospital from January 2023 to December 2025 were retrospectively collected. The baseline information, characteristics of AEDs utilization, implementation status of TDM and laboratory parameters were summarized. Spearman correlation analysis, univariate analysis and multivariate linear regression analysis were performed to identify the independent influencing factors for blood concentrations of AEDs.RESULTS A total of 1 572 patients were enrolled, including 660 males and 912 females. The majority were aged ≥60 years (30.15%); 71.76% of patients were on monotherapy with AEDs, with valproic acid being the most commonly prescribed (51.97%); combination therapy was predominantly a two-drug regimen (26.21%), while three-drug regimens were rare (2.04%). A total of 2 901 blood samples for TDM were collected, with the highest number of samples for valproic acid and levetiracetam (1 987 and 684 samples, respectively). TDM for all five drugs was primarily conducted once; among which, the blood concentrations attainment rates exceeded 50% for patients taking valproic acid and levetiracetam, while the median blood concentrations for patients taking lamotrigine, oxcarbazepine, and carbamazepine were all below the lower limit of the therapeutic reference range. Based on the results of Spearman correlation analysis, univariate analysis, and multivariate linear regression analysis, patient gender, platelet count (PLT), alanine transaminase (ALT), aspartate transaminase (AST), and total bilirubin (TBil) were found to be independent factors influencing blood concentration of valproic acid (unstandardized coefficients were -6.770 7, -0.078 6, -0.099 4, 0.083 2, -0.578 9, P <0.05), while age and creatinine (CRE) were found to be independent factors influencing blood concentration of levetiracetam (unstandardized coefficients were 0.108 7, 0.047 8, P <0.05).CONCLUSIONS Female gender and elevated AST levels are risk factors for increased blood concentration of valproic acid, while elevated PLT, ALT and TBil levels are associated with decreased blood concentration of valproic acid. Patients of advanced age and those with renal insufficiency bear a relatively high risk of in vivo levetiracetam accumulation.
3.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.
4.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*
;
Antifungal Agents/isolation & purification*
;
Molecular Structure
;
Candida albicans/drug effects*
;
Ascomycota/genetics*
;
Magnetic Resonance Spectroscopy
;
Aspergillus niger/drug effects*
;
Genome, Fungal
;
Microbial Sensitivity Tests
5.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.
6.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.
7.Exploration and practice on Investigator-Initiated high-risk trial management at a pediatric hospital in Beijing
Yuguang LIANG ; Chunyan GUO ; Qian DING ; Qian WANG ; Meng ZHANG ; Yi ZHANG ; Peng GUO
Chinese Journal of Medical Science Research Management 2025;38(5):442-448
Objective:In response to the current situation where Investigator-Initiated Trial (IIT) management system of pediatric medical institutions in our country is inadequate and the management of high-risk projects needs to be strengthened, a pediatric hospital in Beijing has been selected as a pilot to develop a system and process suitable for IIT management. We aim to explore personalized management models for different types of research projects, especially high-risk ones, to improve the quality of pediatric IIT, reduce research risks, and enhance management efficiency.Methods:By analyzing the current management situation of high-risk pediatric IIT, optimization strategies were proposed to improve the internal IIT project management system and processes of the pilot unit, and effective management measures are promoted.Results:By revising the IIT project management system, improving the project application and approval processes, strengthening process quality control and personnel training, the risk control and quality supervision of such projects had been enhanced, thereby improving project quality and ensuring the rights and interests of research participants.Conclusions:After the pilot unit trialed a series of management measures for high-risk IIT projects, researchers' risk awareness has significantly increased, and project quality has been effectively improved. The Results provide a reference and model for peers in establishing management rules and also offer theoretical and practical foundations for improving the management system of high-risk clinical research.
8.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.
9.Study on the influence of field angle on the results of EPID dose verification in vivo
Jia FANG ; Wanli ZHU ; Chunyan DAI ; Yi ZHANG ; Yingjie MEI ; Jiaqian DAI ; Hongzhi ZHANG ; Fei ZHAO ; Shubo DING
Chongqing Medicine 2025;54(4):898-902
Objective To investigate the effect of field angle on the results of in vivo dose validation of electronic portal imaging device(EPID)in patients.Methods Design the mold test and analyze the influence of different mold thicknesses and different frame angles on the 2D γ pass rate.Twenty-three patients who un-derwent radiotherapy in the Department of Radiotherapy of Jinhua Municipal Central Hospital from January to June 2023 were selected as the research object.In vivo dose verification was carried out during treatment to obtain 2D γ pass rate using same-day sector beam CT(FBCT)of planned CT and executive image guided(IG-RT)as reference images,and the influence of field angle on pass rate was analyzed.Results When the frame angle was unchanged,the area of the shooting field was larger than 17 cm×17 cm,and the 2D γ passing rate decreased with the increase of the thickness.The frame angle had no effect on the 2D γ pass rate when the mold thickness was constant.In clinical treatment data,the passage rate of 2D γ near 0°/180° was higher than that near 90°/270°(P<0.05),and the passage rate near 90°/270° in the FBCT group was higher than that in the IGRT group(P<0.05).The median passing rate of 3 mm 2D γ was 97.97%in 3%of the 23 patients.The non-IGRT group was 96.81%,the IGRT group was 97.89%,the FBCT group was 98.94%.There was a statistically significant difference in 2D γ passing rate between the non-IGRT group and the IGRT group(Z=-5.083,P<0.05),and there was a statistically significant difference in 2D γ passing rate between the IGRT group and the FBCT group(Z=-10.657,P<0.05).Conclusion Clinically,the difference of pass rate in vi-vo dose verification at different rack angles is mainly due to the difference of images within and between ses-sions.Using same-day FBCT as the reference image for in-vivo dose verification can improve the accuracy of pass rate and eliminate the influence of image difference between sessions.
10.Report on the clinical application status and quality control directions of provocation/stress echocardiography in the diagnosis of hypertrophic cardiomyopathy in large grade A tertiary hospitals in China
Mingjun XU ; Yi WANG ; Haohui ZHU ; Chunyan MA ; Lixue YIN ; Mei ZHANG
Chinese Journal of Ultrasonography 2025;34(6):471-480
Objective:To assess the current clinical application status of provocation/stress echocardiography in hypertrophic cardiomyopathy(HCM)among echocardiography physicians from large grade A tertiary hospitals,located in 24 provinces or directly administered municipalities,and to achieve a relatively clear and comprehensive overview of the current clinical application status of provocation/stress echocardiography in HCM. This study was conducted by the Chinese Society of Ultrasound in Medicine(CSUM)and Chinese Society of Echocardiography(CSE).Methods:An online survey was anonymously conducted using Question Star application from 20 March to 30 September 2023. The survey covered the following topics including the echocardiographic diagnostic overview,the selection of views and measurement parameter of echocardiography,and the cognition and application,awareness and management of risk,and clinical demand of provocation/stress echocardiography.Results:A total of 337 valid responses were included in the final statistical analysis. The study revealed that the number of HCM patients seen by echocardiography physicians was very few(0-10%),with a low proportion of diagnosed obstructive HCM patients. There was incomplete mastery of the left ventricular outflow tract(LVOT)obstruction criteria(68.25%),insufficient awareness of the importance of LVOT pressure gradient measurement(7.12% echocardiographic doctors routinely performed LVOT gradient measurement for suspect HCM patients),non-standardized selection of echocardiographic views and measurement parameters for HCM,and significant deficiencies in knowledge and application of Valsalva provocation/stress echocardiography(17.21% and 79.23% doctors were quite aware of the principles of Valsalva provocation/stress echocardiography,respectively). The risk awareness of provocation/stress echocardiography(13.65% physicians were fully aware of the potential risk)and the ability to manage associated risks(19.29% physicians were able to handle all emergencies)were lacking. Existing guidelines did not sufficiently standardize the clinical practice of provocation/stress echocardiography(23.44%),and there was diversity in learning formats requirements and unmet clinical needs.Conclusions:This survey revealed insufficient fundamental theoretical knowledge and a need for further standardization and training in the application of provocation/stress echocardiography for HCM among echocardiography physicians. Additionally,risk awareness and adequate response skills need improvement. There is a need for more practical and guiding guidelines for clinical practice,as well as numerous unmet clinical needs.


Result Analysis
Print
Save
E-mail