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.Expert recommendations on vision friendly built environments for myopia prevention and control in children and adolescents
Chinese Journal of School Health 2026;47(1):1-5
Abstract
The prevention and control of myopia in Chinese children and adolescents has become a major public health issue. While maintaining increased outdoor activity as a cornerstone intervention, there is an urgent need to explore new complementary approaches that can be effectively implemented in both indoor and outdoor settings. In recent years, environmental spatial frequency has gained increasing attention as one of the key environmental factors influencing the development and progression of myopia. Both animal studies and human research have confirmed that indoor environments lacking mid to high spatial frequency components, often characterized as "visually impoverished", can promote axial elongation and myopia through mechanisms such as disruption of retinal neural signaling, impaired accommodative function, and altered expression of related molecules. Based on the scientific consensus, it is recommended that "enriching of environmental spatial frequency" should be integrated into the myopia prevention and control framework. Following the principles of schoolled organization, family cooperation, community involvement, and student participation, specific measures are put forward in three areas:optimizing school visual settings, improving home spatial environments, and promoting healthy visual behavior. The aim is to create "visually friendly" indoor environments as an important supplement to outdoor activity, thereby providing a novel perspective and strategy for comprehensively advancing myopia prevention and control among children and adolescents.
3.Improving microclimate standards in primary and secondary school classrooms to promote student health
ZHANG Fengyun, WU Ming, LIU Mingfa, YANG Dongling, LUO Chunyan
Chinese Journal of School Health 2026;47(2):153-157
Abstract
The study examines the development and application of microclimate standards for primary and secondary school classrooms, so as to ensure and promote the healthy growth of primary and secondary school students. The paper systematically reviews relevant domestic and international standards, analyzes the problems and shortcomings arising from their practical application and proposes effective countermeasures, in order to provide robust references aimed at optimizing the classroom environment in primary and secondary schools for student health, as well as offering practical support to advance the construction of a healthy China.
4.Indoor environment management and CO 2 volume concentration of primary and secondary school classrooms in winter across three provinces and municipalities of China
Chinese Journal of School Health 2026;47(2):163-167
Objective:
To evaluate the classroom environmental management and CO 2 volume concentration in primary and secondary schools from Liaoning, Tianjin, and Shanghai, thereby providing a scientific basis for developing targeted strategies to improve classroom air quality.
Methods:
From December 16 to 26, 2024, by using stratified random cluster sampling method, the questionnaire survey was conducted in 72 primary and secondary schools (24 each of primary, junior high, and regular high schools) across Liaoning, Tianjin and Shanghai. Information on heating, ventilation and other classroom environmental management was collected. Additionally, 108 classrooms were selected for on site microclimate measurements, including temperature, humidity, wind speed and CO 2 volume concentration. Univariate analysis and multiple linear regression models were employed to explore related factors of classroom CO 2 volume concentration.
Results:
Among the three provinces/municipalities, 20.8% of schools regularly monitored the microclimate. The overall compliance rate for classroom CO 2 volume concentration was 17.6%. Multiple linear regression analysis showed that CO 2 volume concentration in regular and junior high school classrooms were higher than in primary school classrooms ( β=0.067, 0.046, 95%CI =0.036-0.099, 0.013-0.080); classrooms ventilated regularly in the morning and afternoon had higher CO 2 volume concentration than those ventilated during every break between classes ( β=0.043, 95%CI = 0.007- 0.080); both temperature ( β=0.010, 95%CI =0.004-0.016) and humidity ( β=0.003, 95%CI =0.002-0.004) were positively correlated with CO 2 volume concentration (all P <0.05).
Conclusions
Excessive CO 2 volume concentration in primary and secondary school classrooms is a prominent issue, and ventilation frequency is a key intervenable factor for controlling CO 2 levels. It is recommended to promote ventilation during every break between classes as a core management measure and to emphasize air quality supervision in regular high school classrooms.
5.Influenza surveillance results in Ordos City in 2017 - 2023
Xiaomin ZHANG ; Hongtao XIAO ; Sheng WANG ; Rong SUN ; Shangwu JIN ; Di ZHANG ; Jiming HAO ; Jialin LYU ; Chunyan YANG
Journal of Public Health and Preventive Medicine 2026;37(2):54-58
Objective To analyze the influenza-like illness (ILI) data in Ordos City from 2017 to 2023 and conduct nucleic acid detection of the virus to understand the local influenza epidemic situation, and to provide a reliable basis for influenza prevention and control in the city. Methods Real-time quantitative polymerase chain reaction (qPCR) was used to identify virus subtypes in ILI throat swab samples. Comparisons of positive rates were conducted using the chi-square test, with a significance level of α=0.05. Results From 2017 to 2023, a total of 3,283,434 outpatient and emergency visits were recorded at the Ordos City Central Hospital, including 74,159 ILI cases, with an ILI proportion of 2.26%. The majority of ILI cases (74.43%) occurred in children aged 0~14 years old. The overall positive rate of influenza virus nucleic acid detection was 10.87%, with the highest proportion being subtype A (seasonal H3) at 43.03%. The highest detection rate was observed in the 5~14 years age group, with statistically significant differences in positive rates across age groups (χ2=155.638, P<0.001). Influenza peaks occurred mainly from November to March of the following year. From January to April, three types of influenza were prevalent alternately or mixed, while from October to December, subtype A (seasonal H3) predominated. Positive rates varied significantly across months (χ2=250.923, P<0.001). The temporal trends of ILI proportions and PCR-positive rates were consistent. Conclusion Influenza in Ordos City exhibits distinct seasonal and age distribution characteristics, with alternating or mixed circulation of three virus types. Continued efforts are needed to strengthen influenza surveillance, especially the prevention and control of influenza in infants and adolescents.
6.Effects of shared decision-making oriented vocational training on the social function of patients with schizophrenia
Chunyan JIANG ; Jiuhong SHUAI ; Hongyuan DENG ; Junhua ZHENG ; Chunfeng GOU ; Xiaoli YANG ; Deying TONG ; Hao FENG ; Xia HUANG ; Ru GAO
Sichuan Mental Health 2025;38(3):229-234
BackgroundAs a high prevalence disorder, schizophrenia has caused significant burden to family and society due to the impairment of occupational and social function. Currently, the dominant vocational training model in China follows a paternalistic, clinician-led decision-making approach. Although it improves patients' social function to some extent, it undermines their autonomy and treatment adherence. Therefore, it is urgently necessary to explore a new intervention method to enhance treatment compliance and social function in patients. ObjectiveTo explore the impact of shared decision-making oriented vocational training on social function in hospitalized schizophrenia patients, so as to provide references for rehabilitation interventions. MethodsA total of 68 patients diagnosed with schizophrenia according to the International Classification of Diseases, tenth edition (ICD-10) criteria were consecutively enrolled from January to June 2024 at The Third People's Hospital of Wenjiang Distric, Chengdu. Participants were randomly allocated into the research group (n=34) and the control group (n=34) using a random number table method. Both groups received routine rehabilitation training, while the research group received shared decision-making oriented vocational training for 12 weeks, 2 times a week for 2 hours each time. Before and at the 4th and 12th week of intervention, two groups were evaluated by General Self-Efficacy Scale (GSES), Stigma Scale for Mental Illness (SSMI), Scale of Social function of Psychosis Inpatients (SSFPI) and Inpatient Psychiatric Rehabilitation Outcome Scale (IPROS). ResultsA total of 63 participants completed the study, with 30 cases in the research group and 33 cases in the control group. Repeated measures ANOVA revealed statistically significant time effects and interaction effects in both groups for GSES, SSMI, SSFPI and IPROS scores (F=20.451, 16.022; 26.193, 12.944; 23.957, 5.023; 11.776, 3.985, P<0.05 or 0.01), while no significant group effects were observed (F=0.188, 0.742, 1.878, 0.474, P>0.05). At the 12th week of intervention, there were statistically significant differences in GSES, SSMI, SSFPI and IPROS scores between the two groups. ConclusionShared decision-making oriented vocational training may help to improve social function in patients with schizophrenia. [Funded by 2023 Chengdu Medical Research Project (number, 2023468)]
7.Synthesis and anti-inflammatory activity of three series of coumarin-based derivatives
Xiujuan ZHAO ; Hengli YANG ; Jinye WU ; Xiaoqi ZHENG ; Yaoping ZHANG ; Yuping LIN ; Chunyan HU
Journal of China Pharmaceutical University 2025;56(1):40-48
In this work, starting from 4-hydroxycoumarin, three series of 22 coumarin derivatives, among which 8 have not been reported in the literature, were synthesized and their in vitro anti-inflammatory activities and mechanisms of action were preliminarily investigated using mouse macrophage model. The results showed that most of the derivatives could significantly inhibit the production of pro-inflammatory factor NO, with compounds 2e, 2f, 2g, 2h, 2i, 2j, 4e, and 4f showing better anti-inflammatory activity than the positive control drug dexamethasone. Further experiments showed that compounds 2h and 4f significantly inhibited the production of pro-inflammatory factors IL-6, TNF-α and IL-1β in RAW264.7 macrophages, and could, therefore, be used as lead compounds for further studies.
8.Influence of antiviral treatment adjustment on the prognosis of chronic hepatitis B patients with low-level viremia
Mengwen HE ; Wucai YANG ; Chunyan WANG ; Yiming FU ; Chang GUO ; Jianjun WANG ; Dong JI
Journal of Clinical Hepatology 2025;41(6):1056-1061
ObjectiveTo investigate the incidence rate of primary liver cancer (PLC) and the progression of liver fibrosis in chronic hepatitis B (CHB) patients with low-level viremia (LLV) (HBV DNA<2 000 IU/mL but ≥20 IU/mL) after treatment adjustment, and to provide more robust evidence for clinical practice. MethodsA retrospective analysis was performed for the clinical data of LLV patients who initially received nucleos(t)ide analogue (NAs) for at least 48 weeks at the Fifth Medical Center of PLA General Hospital from August 2007 to April 2017 and subsequently underwent NAs adjustment due to LLV, and according to the virologic response after 48 weeks of treatment adjustment, the patients were divided into LLV group and complete virological response (CVR) group (HBV DNA<20 IU/mL). The patients were followed up once every 3 — 6 months till the primary endpoint event of PLC or October 2024. The incidence rate of PLC and the progression of liver fibrosis were observed, and the progression of liver fibrosis was defined as an increase of ≥1 grade in fibrosis-4 (FIB-4) index. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of continuous data with skewed distribution between two groups; the chi-square test was used for comparison of categorical data between groups. The Kaplan-Meier method was used to calculate the cumulative incidence rate of PLC, and the Log-rank test was used for comparison between groups; the Cox regression analysis was used to investigate the risk factors for PLC, and the Logistic regression analysis was used to investigate the influencing factors for the progression of liver fibrosis. ResultsA total of 307 patients were enrolled, with a mean age of 50.0 years, and the male patients accounted for 80.5%. After 48 weeks of treatment with the adjusted NAs regimen, 254 patients (82.7%) achieved CVR, and 53 patients (17.3%) still had LLV. For the LLV group, the incidence rate of PLC was 30.2% and the rate of liver fibrosis progression was 22.6%, while for the CVR group, the incidence rate of PLC was only 13.4%, and the rate of liver fibrosis progression was 7.5%. The multivariate regression analyses showed that LLV was an independent risk factor for the onset of PLC (hazard ratio=2.623, 95% confidence interval [CI]: 1.315 — 5.234, P=0.006) and the progression of liver fibrosis (odds ratio=3.213, 95%CI: 1.385 — 7.455, P=0.007). ConclusionActive adjustment of treatment is needed immediately after the diagnosis of LLV to improve CVR, and if LLV persists after treatment adjustment, it is necessary to enhance the monitoring of liver fibrosis progression and PLC, so as to facilitate early diagnosis and treatment.
9.Relationship between home reading-writing illuminance and screening myopia among children and adolescents
ZHANG Jingji, LUO Chunyan, YANG Huijuan, YANG Dongling, HUANG Shenglei, ZHENG Keyang, QU Shuangxiao
Chinese Journal of School Health 2025;46(8):1190-1193
Objective:
To understand the home reading-writing levels among children and adolescents in Shanghai after school, and to explore its association with screening myopia, so as to provide a scientific basis for the prevention and control of myopia.
Methods:
From April to December 2024, 641 primary and middle school students were recruited from 2 urban schools and 1 rural school in Shanghai to participate in the survey. An illuminance meter was used to measure the illuminance of home reading-writing activities after school. Screening myopia was determined through visual acuity examination and refractive detection under non ciliary muscle paralysis conditions among children and adolescents. A binary Logistic regression model was used to analyze the association between home reading-writing illuminance and screening myopia.
Results:
The detection rate of screening myopia among children and adolescents in Shanghai was 59.9%. The median home reading-writing illuminance after school was 340.9(112.2, 753.5) lx, and 45.4% was found of less than 300 lx. The family illuminance in the primary school stage [432.0 (136.9, 837.0) lx] was higher than that in the junior high school stage [113.1(53.7, 375.1) lx], and main urban area group [503.9 (212.6, 969.5) lx] was higher than that in the rural group [141.6 (53.7, 416.9) lx], the differences were statistically significant (Z=-7.56, -9.95,both P<0.05). The results of Logistic regression analysis showed that compared with the family illuminance of 150-500 lx, children and adolescents with family illuminance<150 and >500 lx had increased risks of screening myopia detection[OR(95%CI)=1.56(1.01-2.42), 1.74(1.15-2.62),both P<0.05].
Conclusions
The home reading-writing illuminance after school is suboptimal. Both excessively low and high home reading-writing illuminance levels are associated with screen-detected myopia. It is necessary for children and adolescents to improve lighting conditions during evening reading-writing activities, and strengthen health education according to different regions and school stages.
10.Influence of chronic psychological stress during pregnancy on intestinal flora and eczema incidence of offspring rats
Chunyan WANG ; Ying GAO ; Deguang YANG ; Rui WANG ; Hongyu LI ; Ye LI ; Can LIU ; Suzhen GUAN
Journal of Environmental and Occupational Medicine 2025;42(8):962-970
Background Prenatal chronic psychological stress may increase the risk of allergic diseases in children, and eczema is the most common allergic disease in children, the pathogenesis of which is not yet fully understood. Objective To preliminarily clarify the changes in offspring intestinal flora after chronic stress exposure during pregnancy in rats that increases offspring immune imbalance and eczema susceptibility. Methods Thirty SPF-grade adult female SD rats were selected and randomly divided into a model group and a control group (n=15). Sixteen male rats were randomly divided into a model mating group and a control mating group (n=8). A 28-day chronic unpredictable mild stress (CUMS) model during pregnancy was established. On the 7th day of stress, male and female rats were caged in a ratio of 3:1. Blood samples were collected from female rats in each group via angular vein on the 1st day before stress, and on the 7th, 14th, 21st, and 28th days after stress. The content of plasma corticosterone during pregnancy was determined by enzyme-linked immunosorbent assay (ELISA). For the offspring rats, an eczema model was constructed using 2,4-dinitrochlorobenzene (DNCB). The number of scratching times of the offspring rats within 5 min was recorded. The offspring rats were divided into 4 groups: DNCB-CUMS group (MM), DNCB-control group (MC), solvent control-CUMS group (CM), and blank control group (CC), with 8 rats in each group. The eczema was induced once every 3 days, and the induction period was 12 d. The expression level of immunoglobulin E (IgE) in the serum of offspring rats after the eczema induction experiment were determined by ELISA. The concentrations of tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ), interleukin-2 (IL-2), interleukin-4 (IL-4), and interleukin-13 (IL-13) in the serum were quantified by multi-parameter flow cytometry. The composition and abundance of intestinal microbiota in the feces of offspring rats were detected by 16S rRNA high-throughput sequencing technology. Results The plasma corticosterone concentrations in the model group were higher than those in the control group on the 7th and 21st days of stress (P<0.05). On the 14th and 21st days of stress, the 1% sucrose preference percentages of female rats in the model group were lower than that in the control group. On the 7th, 14th, and 21st days of stress, the horizontal movement scores of female rats in the model group and the vertical movement scores on the 7th and 14th days were lower than those in the control group (P<0.05). After 6, 9, and 12 d of model building, the scratching frequencies in the MC group and MM group were significantly higher than those in the CC group and CM group (P<0.05). Moreover, there were differences in the contents of cytokines including IFN-γ, IL-2, TNF-α, IL-4, IL-13, and IgE among the offspring rat groups (P<0.05). The CM group and MM group led to an increase in the contents of TNF-α, IL-4, IL-13, and IgE cytokines (P<0.05), while the MM group caused a decrease in the contents of IFN-γ and IL-2 (P<0.05). After the eczema induction experiment, the α-diversity analysis showed that the Simpson index and Shannon index in the CM were higher than those in the CC (P<0.05), indicating that CUMS during the pregnancy of female rats could increase the species abundance of their offspring. The abundances of Prevotella and Lactobacillus in the CM group decreased (P<0.05). Conclusion Intestinal dysbiosis in offspring due to chronic prenatal psychological stress, which may be one of the mechanisms linking maternal stress to immune imbalance and increased susceptibility to eczema in offspring.


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