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.Teaching and practice exploration on the integration of multi-disciplines in teaching of operative dentistry
Chunyan WAN ; Keqing PAN ; Jing DENG ; Shuai WANG ; Lingshuang LIU ; Haiping XU ; Xiaofei YU ; Lei MA ; Jing FU ; Mengdong LIU ; Wen SU
Chinese Journal of Medical Education Research 2025;24(4):529-534
Objective:In order to effectively educate students on tooth defect diseases and restoration techniques, the teaching and research team at the School of Stomatology of Qingdao University developed an integrated course operative dentistry. This course is specifically designed to align with the undergraduate curriculum reform requirements of "Three Early, Two Multiple and One Integration".Methods:The teaching practice of operative dentistry was conducted with the stomatology undergraduates of grade 2020 and 2021. The course group redesigned the curriculum by reorganizing teaching content, rebuilding teaching resources, reconstructing teaching mode, and reshaping the evaluation system. Evaluation of the curriculum design included test scores, satisfaction questionnaires, and teacher self-evaluation. Statistical analysis was performed using SPSS 27.0 software, including independent sample t-tests for numerical variables and Fisher's exact test or Wilcoxon rank sum test for categorical variables. Results:Through the integrated course learning, 92.68% (38/41) of the students of grade 2020 and 97.44% (38/39) of the students of grade 2021 can basically or completely master various dental defect repair schemes and understand the importance of preserving natural tooth. 82.93% (34/41) of the students of grade 2020 and 100.00% (39/39) of the students of grade 2021 could basically or completely master the key points of various dental defect restorations.Conclusions:Through the practice of teaching, it has been confirmed that the integrated course of operative dentistry is beneficial to students' mastering the knowledge and skills of dental defect diseases and their restoration in a more comprehensive way, and is conducive to the cultivation of clinical thinking, hands-on ability and the patient-centered, comprehensive problem-solving thinking, which is in line with the guidance on the innovation and development of medical education.
3.Improve self-management behaviour of the patients with glaucoma after day surgery:an online-to-offline health education based on timing theory
Chunyan YANG ; Weixin ZHENG ; Wenmin HUANG ; Huiming XIAO ; Bomin LIN ; Xiaoye XU ; Xinyan LI ; Yu ZHANG
Modern Clinical Nursing 2025;24(8):46-53
Objective To evaluate the efficacy of an online-to-offline(O2O)health education guided by the'Timing Theory'in improving self-management behaviours among the patients with glaucoma after day surgery.Methods In this randomised controlled study conducted between July and December 2022,70 patients with glaucoma after day surgery in our hospital were assigned to a control group and an experimental group,with 35 patients per group.Patients in control group received routine nursing care,while those in experimental group received O2O health education based on timing theory in addition to the routine nursing care.Outcomes were evaluated using the glaucoma awareness and knowledge questionnaire(GAKQ),self-efficacy to manage chronic disease scale(SEMCD)and glaucoma self-management questionnaire(GSMQ)at baseline,at 1 month and 3 months after surgery.Results A total of 32 patients in the experimental group and 27 in the control group completed the study.The generalised estimating equation(GEE)analysis showed a significant difference,respectively,in total score of GSMQ in interaction effect(F=8.408,P=0.015)and SEMC in time main effect(F=54.660,P<0.001).There were significant differences in total scores of GAKQ in time main effect,inter-group main effect and interaction effect(F=128.483,P<0.001;F=7.991,P<0.05;F=32.652,P<0.001,respectively).At one-month after intervention,the experimental group showed significantly higher GAKQ and SEMCD scores than the control group(Z=-2.004,P<0.05;Z=-2.029,P<0.05,respectively).At 1-and 3-months after intervention,the experimental group demonstrated significantly higher GAKQ scores(Z=-3.987,P<0.001;Z=-4.505,P<0.001,respectively).Conclusion The timing theory based O2O health education significantly improves knowledge of glaucoma,self-efficacy and self-management behaviours among day surgery patients and helps patients better cope with perioperative self-management over day surgery.
4.Research progress on kinesiophobia in school-aged children with asthma and nursing enlightenment
Zhixiang SUN ; Jing FU ; Pingpin WEN ; Xiaoli ZHANG ; Xinyu YANG ; Chunyan LIU ; Yu XIAO
Chinese Journal of Nursing 2025;60(19):2419-2425
Kinesiophobia is prevalent among school-aged children with asthma,and severe kinesiophobia can hinder their participation in physical activities and disease control,adversely affecting their physical and mental health.This paper reviews the concept,development,assessment tools,influencing factors,and intervention strategies of kinesiophobia in school-aged children with asthma,analyzes existing challenges,and proposes directions for future research.It aims to provide insights for developing scientific and personalized intervention plans to enhance children's exercise levels and improve their quality of life.
5.Effect evaluation of Kushen Huangqi decoction combined with Aidi injection in the treatment of primary liver cancer
Guanghua YU ; Chunyan SONG ; Xue SONG
Tianjin Medical Journal 2025;53(4):429-433
Objective To investigate the therapeutic effect of Kushen Huangqi decoction combined with Aidi injection on primary liver cancer and its impacts on immune function and quality of life.Methods A total of 110 patients with primary liver cancer were randomly divided into the combined group(n=55)and the control group(n=55).The control group was treated with Aidi injection(50 mL)on the basis of routine treatment,and the combined group was treated with Kushen Huangqi decoction on the basis of the control group.The healing effects,traditional Chinese medicine(TCM)symptom scores,quality of life[Karnofsky Performance Status(KPS)score,the MOS 36-item short-form health survey(SF-36)],liver function indicators[total bilirubin(TBIL),aspartate aminotransferase(AST),alanine aminotransferase(ALT)]and immune function indicators before and after treatment were compared between the two groups.Results After treatment,the KPS score,SF-36 score,CD4+and CD4+/CD8+were increased in the two groups,and those in the combined group were higher than the control group.The TCM symptom scores,AST,TBIL,ALT and CD8+were decreased in the two groups,and those in the combined group were lower than those in the control group(P<0.05).Conclusion The combination of Kushen Huangqi decoction and Aidi injection is beneficial for enhancing immune function,reducing Chinese medicine syndrome scores and liver function damage,improving efficacy and quality of life in treating primary liver cancer.
6.Advances in prenatal imaging assessment of fetal malformation of cortical development
Simin ZHANG ; Changqing SHENG ; Yu ZHANG ; Chunyan ZHANG ; Xiaoxue YANG ; Yuanyuan MAN ; Yingying CAI ; Rui YAN ; Xinru GAO
Chinese Journal of Medical Imaging Technology 2025;41(3):377-381
Fetal malformation of cortical development(MCD)is a group of structural neurological disorders caused by abnormalities in development of cortical layer during embryogenesis,characterized by significant heterogeneity and diversity,which may lead to adverse clinical outcomes such as epilepsy and intellectual disabilities.The progresses in prenatal evaluation on fetal MCD were reviewed in this article.
7.Determination of 9 synthetic cannabinoids in e-cigarette oil by liquid chromatography-high resolution mass spectrometry
Chunyan XIN ; Yu FANG ; Shaohua FANG ; Ziyuan YANG ; Qianqian GUO ; Sicui JIANG
Chinese Journal of Forensic Medicine 2025;40(2):207-212
Objective This study established a qualitative and quantitative detection method for 9 new synthetic cannabinoids in e-cigarette oil using liquid chromatography-high resolution mass spectrometry.Methods E-cigarette oil was extracted with methanol,concentrated by nitrogen blowing under a water bath at 60℃,and separated using an Acquity UPLC? HSS T3(100 mm×2.1 mm,1.8 μm)column.Gradient elution was performed with ammonium acetate buffer solution(20 mmol/L)containing 0.1%formic acid and acetonitrile as the mobile phase.Detection was carried out in the positive ion mode of the HESI ion source using DDA(FullScan+dd-MS2)mode.Quantification was performed using the external standard method based on precise precursor ion peak areas,while qualitative analysis relied on retention times and characteristic fragment ions.Results The results showed that the standard curves of all 9 synthetic cannabinoids in blank e-cigarette oil matrix exhibited good linearity with R2 values>0.999.The limits of detection ranged from 0.0001 to 0.01 μg/g,and the limits of quantification ranged from 0.0003 to 0.03 μg/g.Recovery rates at low,medium,and high spiking levels in blank e-cigarette oil matrix ranged from 75.7%to 115%,with relative deviations<8.5%.Conclusion This method features a short instrument detection time of only 10 min,relatively simple operation,low detection limits,high accuracy,and good precision,making it applicable for rapid screening and quantitative analysis of synthetic cannabinoids in e-cigarette oil.
8.Nursing care for 3 patients with severe hypercapnia in AECOPD treated with extracorporeal carbon dioxide removal
Yu ZHANG ; Yu JIN ; Shuqin WANG ; Na WAN ; Chunyan ZHANG
Chinese Journal of Nursing 2025;60(5):539-544
To summarize the nursing experience of 3 patients with severe hypercapnia during the acute exacer-bation of chronic obstructive pulmonary disease(COPD)undergoing extracorporeal carbon dioxide removal(ECCO2R),as well as adjustment of oxygen therapy support strategy and implementation of non-pharmacological airway clearance techniques.Additionally,the nursing focus includes all process nursing of ECCO2R,which covers the key aspects such as catheter selection and placement management,pre-flush setting and bubble handling,dual connection with initial parameter setting for patients,heparin pathway management and bleeding monitoring,observation of thrombosis formation and pressure monitoring during operation and self-examination,evaluation of carbon dioxide removal effi-ciency and implementation of decommissioning tests.After careful treatment and nursing,2 patients recovered and were discharged,and a patient's condition improved and was transferred to the respiratory ward for further treat-ment,and was discharged after 5 days.
9.Changes in the intestinal microbiota structure of patients with colorectal adenoma
Meng SIJIA ; Li JIQIU ; Wang DAN ; Liu CHEN ; Li CHUNYAN ; Zhao JING ; Wang YU ; Du MEIZHI ; Wang YUAN ; Lu WENLI ; Zhu YUN ; Zhang KEMING
Chinese Journal of Clinical Oncology 2025;52(4):177-182
Objective:To investigate gut microbiota differences between individuals with and without colorectal adenoma(CRA)and to identify gut microbes associated with CRA.Methods:This cross-sectional study analyzed the gut microbiota of 100 patients with CRA and 68 individuals without CRA(aged 40-75 years)who underwent colonoscopies between March 2021 and March 2022 at Tianjin Nankai Hospital.Fecal samples were sequenced for the V3-V4 region of the bacterial 16S rRNA gene using the Illumina NovaSeq platform.Results:Compared to the non-CRA group,the CRA group exhibited reduced relative abundances of identified and unidentified Lachnospiraceae,with increased Faecalibacterium and Streptococcus.In the non-CRA group,the relative abundances of Coprococcus,unidentified Clostridiaceae,and Clostridium were higher.LEfSe analysis revealed significant enrichment of Gammaproteobacteria,Proteobacteria,Enterobacteriales,and Faecalibacterium in the CRA group,while the non-CRA group was enriched for Moraxellaceae,Acinetobacter,and Anaerostipes.Conclusions:These findings suggest a discernible disparity in the gut microbiota structure between CRA patients and individuals without adenoma.The enrichment of potential pathogenic taxa,such as Faecalibacterium and Streptococcus,in the CRA group suggests a possible association with adenoma development.
10.The Impact of Three Different Types of Twin-Block on Stress Distribution and Displacement of Anterior Teeth
Xingyu LI ; Chunyan ZHANG ; Xibei LI ; Wenli HUANG ; Shaoyang YU ; Wenke YANG ; Yingyue ZHANG ; Jun GUO ; Xiao YAN ; Qiang ZHANG ; Xiao YUAN
Journal of Medical Biomechanics 2025;40(4):844-850
Objective To investigate the effects of three types of twin-block(TB)appliances on the stress and displacement of anterior teeth,periodontal ligaments,and alveolar bone.Methods A three-dimensional(3D)finite element model was constructed,including maxillofacial bones,articular discs,teeth,and periodontal ligaments.Three types of twin-block appliances were designed:classic twin-block(classic-TB),twin-block with acrylic capping(capping-TB),and clear twin-block aligner(CTBA).All appliances had an inclination angle of 70°,and a masticatory force of 200 N was applied to their inclined planes.The finite element method was used to analyze the stress distribution and displacement differences of anterior teeth.Results All three types of TB appliances induced lingual tilting of maxillary anterior teeth and labial tilting of mandibular anterior teeth.The CTBA group showed the greatest lingual displacement and stress of maxillary anterior teeth,with a maximum stress of 30.6 MPa,while the mandibular anterior teeth in this group exhibited the smallest labial displacement(approximately 0.02 mm)and stress.Additionally,the CTBA group had the lowest compressive stress in mandibular anterior teeth,periodontal ligaments,and alveolar bone,whereas the classic-TB group had the highest.Conclusions In the treatment of Angle Class Ⅱ malocclusion,classic-TB(with or without acrylic capping)causes labial inclination of mandibular anterior teeth.Compared with classic-TB,CTBA effectively reduces the compressive stress and displacement of mandibular anterior teeth,potentially minimizing adverse periodontal risks.However,attention should be paid to the lingual displacement of maxillary anterior teeth.

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