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.LI Diangui's Experience in Treating Vitiligo from the Perspective of Turbid Toxins Latent in the Collaterals
Yuxin ZHANG ; Nan JIANG ; Qian YANG ; Wenzhao HAN ; Jiaqi LI ; Wenwen ZHOU ; Weiye LI ; Xiang LIU ;
Journal of Traditional Chinese Medicine 2026;67(21):2275-2279
This paper summarizes Professor LI Diangui's experience in treating vitiligo from the perspective of turbid toxins latent in the collaterals. Based on the theory of turbid-toxin, professor LI proposes that turbid toxins latent in the collaterals and qi-blood disharmony constitute the core pathogenesis of the onset and progression of the disease, and that resolving turbidity and removing toxins while harmonizing qi and blood should serve as the fundamental therapeutic principles. In clinical practice, treatment is tailored according to the evolution of the pathogenesis and syndrome differentiation. When stagnation of qi movement leads to the endogenous accumulation of turbid pathogens, treatment focuses on relieving constraint, dispersing turbidity, soothing the liver, and regulating qi, with a modified self-formulated Kaiyu Sanzhuo Decoction (开郁散浊汤). When turbid pathogens overflow to the superficial tissues and obstruct the cutaneous collaterals, treatment aims to resolve blood stasis, disperse turbidity, regulate qi, and unblock the collaterals, using a modified self-formulated Tongluo Huazhuo Decoction (通络化浊汤). When deficiency of healthy qi allows toxins to remain latent and the disease becomes prolonged, treatment emphasizes reinforcing healthy qi, eliminating turbidity, tonifying qi, and nourishing blood, with a modified self-formulated Fuzheng Quzhuo Decoction (扶正祛浊汤).
3.Quantitative evaluation of policies for the commercialization of traditional Chinese medicine preparations in medical institutions into new drugs in China
Qian GAO ; Ning CHEN ; Zhaonan HE ; Jie FAN ; Yuxin ZHANG ; Jingjia CHEN ; Wei LIU
China Pharmacy 2026;37(20):2647-2653
OBJECTIVE To quantitatively evaluate the policies for the commercialization of traditional Chinese medicine preparations in medical institutions into new drugs, and to provide a reference for improving and optimizing China’s policy system for the commercialization of such preparations into new drugs.METHODS Relevant policy documents were retrieved from the PKULaw database and official websites of relevant departments. After collection and screening, the policy texts were text-mined with ROST-CM 6.0 software. A policy modeling consistency (PMC) evaluation index system was constructed by combining the analysis of policy instruments with relevant literature. The PMC indices were calculated through binary assignment, and the evaluation grades were classified. MATLAB R2024a software was used to draw PMC surface maps, so as to reveal the structural characteristics and weak links of the policy system and put forward optimization suggestions. RESULTS &CONCLUSIONS A total of 44 policies related to the commercialization of traditional Chinese medicine preparations in medical institutions into new drugs were included, and a PMC index model containing 10 first-level variables and 44 second-level variables was constructed. The mean PMC index of the 44 policies was 6.07, and the overall evaluation grade was acceptable. Among the first-level variables, “policy nature”“policy approach”“policy evaluation” scored relatively high, whereas “policy instruments”“policy targets” scored relatively low. These findings were mainly reflected in insufficient support measures for funding, professionals and intellectual property rights transformation, limited coverage of policy targets, and relatively inadequate systematic support for commercialization. It is recommended that relevant departments strengthen financial, talent and intellectual property support, enhance local adaptability, expand the coverage of target entities, and formulate special support policies, so as to promote the commercialization of more traditional Chinese medicine preparations with high clinical value and distinctive advantages into new drugs.
4.Obstructive sleep apnea exacerbates cognitive impairment after stroke and the diagnostic value of serum BDNF and Tau protein
Dongmei ZHAO ; Feihu CAO ; Libo WANG ; Jun HUANG ; Yuxin DU ; Qian LIU
Basic & Clinical Medicine 2025;45(9):1195-1199
Objective To explore the impact of obstructive sleep apnea(OSA)on cognitive impairment in post-stroke patients,to explore its underlying mechanism and to evaluate potential diagnostic value by dynamically moni-toring the level of brain-derived neurotrophic factor(BDNF)and Tau protein in serum.Methods Totally 96 stroke patients admitted to Mianyang third People's Hospital from February 2022 to June 2024 were selected.They were divided into the groups complicated with OSA and control one without OSA following up of neuropsychological scales for 1 week,1 month,3 months,and 6 months after stroke for evaluating cognitive function.Enzyme-linked immunosorbent assay(ELISA)was applied to detect the level of BDNF and Tau protein in serum.The correlation of test results and the degree of cognitive impairment as well as their diagnostic value were analyzed.Results The AHI in the OSA group was significantly higher than that of control group,while LSaO2 and MSaO2 were significantly lower in the OSA group(P<0.05).One week and 1,3,6 month months after the onset of the disease,the MMSE and MoCA scores in the OSA group were significantly lower than those in the control group,BDNF level was signifi-cantly lower while Tau protein level was significantly higher as compare to those in control group(P<0.05).Pear-son correlation analysis showed that the serum BDNF level was positively correlated with both MMSE score(r=0.654,P<0.001)and MoCA score(r=0.689,P<0.001).However,the serum Tau protein level was nega-tively correlated with both MMSE score(r=-0.623,P<0.001)and MoCA score(r=-0.667,P<0.001).The ar-ea under the curve(AUC)of the combined detection of BDNF and Tau protein was greater than that of the individ-ual detection.The diagnostic value of the combined detection of BDNF and Tau protein for cognitive impairment in post-stroke patients was greater than that of the individual detection(P<0.05).Conclusions OSA significantly exacerbates patients'cognitive impairment after stroke.Elevated serum BDNF level and decreased Tau protein level may be the underlying mechanisms of cognitive impairment.Serum BDNF and Tau protein may function as potential biomarkers for diagnosis of cognitive impairment after stroke.
5.Influencing factors of overweight and obesity among primary and secondary school students in Pudong New Area of Shanghai
Mengyuan DING ; Ling HUANG ; Qian WU ; Chao LIANG ; Yuxin JIANG ; Chunhua GU
Journal of Public Health and Preventive Medicine 2025;36(6):142-146
Objective To investigate the status and influencing factors of overweight and obesity among primary and secondary school students in Pudong New Area of Shanghai, and to provide reference for formulating obesity-related intervention strategies for school-age children. Methods Stratified cluster random sampling method was used to conduct a questionnaire survey among primary and secondary school students in Pudong New Area. The overweight and obesity rate was calculated according to the Chinese health industry standard, and the risk factors of overweight and obesity in children and adolescents of different school age groups were analyzed by logistic regression. Results The overweight and obesity rate (25.3%) of primary and secondary school students in Pudong New Area exceeded the national average level. In primary school group, male, sleep time ≥ 8h per day, water intake ≥ 1200 mL per day, and the presence of mobile food stalls around the school were the risk factors for overweight and obesity. Daily extracurricular exercise time of 30 minutes to 2 hours was a protective factor. In junior high school group, male and electronic product use time of ≥ 2h per day were the risk factors for overweight and obesity. The daily extracurricular exercise time of 1 to 2 hours was a protective factor. In high school group, drinking water ≥1200mL per day was a risk factor for overweight and obesity. Eating breakfast every day for the past week was a protective factor. Conclusion Group intervention targeting overweight and obese school-age children, while changing corresponding unhealthy habits according to different school age groups, is crucial for weight loss in school-age children.
6.Regulation of autophagy on diabetic cataract under the interaction of glycation and oxidative stress
Rong WANG ; Pengfei LI ; Jiawei LIU ; Yuxin DAI ; Mengying ZHOU ; Xiaoxi QIAN ; Wei CHEN ; Min JI
International Eye Science 2025;25(12):1932-1937
Diabetic cataract, a prevalent ocular complication of diabetes mellitus, arises from a complex interplay of pathological mechanisms, with oxidative stress and glycation stress playing central roles. Autophagy, a critical cellular self-protection mechanism, sustains intracellular homeostasis by selectively degrading damaged organelles and misfolded proteins, thereby counteracting the detrimental effects of oxidative and glycation stress under hyperglycemic conditions. Emerging evidence indicates a synergistic interaction between glycation stress and oxidative stress, which may exacerbate autophagic dysfunction and accelerate the onset and progression of diabetic cataract. However, the precise molecular mechanisms underlying this relationship remain incompletely understood. This review systematically examines the regulatory role of autophagy inthe pathogenesis of diabetic cataract, with a particular focus on how autophagic impairment influences disease progression under the combined effects of glycation and oxidative stress. By elucidating these mechanisms, the paper aims to provide novel insights into molecular diagnostic approaches and targeted therapeutic strategies for diabetic cataract.
7.Aging and perioperative brain health: Mechanisms, management, and future.
Peilin CONG ; Qian CHEN ; Qianqian WU ; Jing WANG ; Xinwei HUANG ; Qian ZHANG ; Zheping CHEN ; Huanghui WU ; Yuxin ZHANG ; Mengfan HE ; Zhouxiang LI ; Li TIAN ; Lize XIONG
Chinese Medical Journal 2025;138(19):2381-2398
Globally, over 300 million surgeries are performed each year, and more than 50% of surgeries involve patients aged 65 and older. Aging poses significant challenges to perioperative brain health, as the deterioration of brain structure and function increases susceptibility to postoperative neurological complications. Protecting perioperative brain health remains a worldwide clinical challenge. With senescence, the brain undergoes a progressive decline in homeostasis across various molecular, cellular, and regional functions. Anesthetics and surgical stimuli may accelerate the disruption of brain homeostasis and exacerbate age-related neurodegeneration. This review provides a framework for understanding how anesthesia and surgery can affect brain health in the aging population and contribute to postoperative neurological complications, with a particular focus on perioperative neurocognitive disorder.
8.Study on the brain functional network and structural-functional coupling in children with drug-resistant epilepsy
Xuhong LI ; Jianhui XIAO ; Heng LIU ; Yulun HE ; Haifeng RAN ; Yuxin XIE ; Guiqin CHEN ; Qian′e YU ; Zhen ZENG ; Wenfu LI ; Tijiang ZHANG
Chinese Journal of Radiology 2025;59(2):184-191
Objective:To investigate the changes in brain functional network and structural-functional network coupling in children with drug-resistant epilepsy (DRE), and to analyze their correlation with cognitive function, disease duration, and age of onset.Methods:This study was a cross-sectional study. Clinical and imaging data of 19 children with DRE who received consultation and treatment at the Affiliated Hospital of Zunyi Medical University from August 2021 to August 2023 (DRE group) were prospectively included. Another 27 age-and sex-matched healthy children were collected as the healthy control group. All subjects had 3D-T 1WI, T 2 fluid-attenuated inversion recovery, diffusion tensor imaging (DTI), resting-state functional magnetic resonance imaging (rs-fMRI) scans and Wechsler Intelligence Scale assessments. Independent sample t-test and Mann-Whitney U test were used to analyze the global and local topological attributes, as well as the structural-functional coupling (SFC) values at the whole brain and modular levels in two groups. Correlations between abnormal resting state brain functional network indicators and the Wechsler Intelligence Scale score [verbal comprehension index (VCI), perceptual reasoning index (PRI), working memory index (WMI), processing speed index (PSI), full scale intelligence quotient (FSIQ)], disease duration and age of onset was evaluated using a Spearman or Pearson correlation analysis. Results:Compared to the healthy control group, DRE group exhibited decreased VCI, PRI, WMI, PSI, FSIQ and the differences were all statistically significant (all P<0.05). Both brain functional networks had small world attributes. There was a statistically significant difference in the area under the curve of sparsity of degree centrality (DC) in the left pallidum between the DRE group and healthy control group (2.998±0.942, 4.992±1.945, t=-4.07, FDR corrected P<0.05). Compared with the control group, the DRE group had decreased SFC within the limbic network (LN) ( P<0.05), increased SFC within the sensorimotor (SMN) ( P<0.05), decreased SFC between the default mode network-LN ( P<0.05), and increased SFC between the SMN-attentional network (AN) ( P<0.05). There was no statistically significant difference in SFC at the whole brain level between the two groups. Correlation analysis indicated that DC in left pallidum in DRE group negatively correlated with the PSI ( r=-0.537, P=0.018), and SFC between the SMN and AN demonstrated a negative correlation with age of onset ( r=-0.537, P=0.018). Conclusion:The altered DC in left pallidum may be related to cognitive impairment in children with DRE, providing biomarker information for the study of neural mechanisms in children with DRE.
9.Analysis and prediction of periodontal disease burden among the elderly in China from 1990 to 2021
Mingzhe XIN ; Lei ZHU ; Yuxin QIAN ; Zelong HU ; Lei JIN
Chinese Journal of Stomatology 2025;60(12):1386-1395
Objective:To assess the trends in the burden of periodontal disease among individuals aged 60 years and above in China from 1990 to 2021, thereby providing a scientific foundation for the development of targeted prevention and control strategies for periodontal disease in the elderly.Methods:Utilizing data from the Global Burden of Disease Study 2021 (GBD 2021), key indicators including incidence, prevalence, and disability-adjusted life years (DALY) rates were analyzed. Age-standardized rates were determined using the global standard population. Trends in the disease burden of periodontal disease among the elderly population in China from 1990 to 2021 were analyzed using Joinpoint regression analysis, and an autoregressive integrated moving average (ARIMA) model was applied to forecast the disease burden from 2022 to 2036.Results:The annual average percentage changes (AAPC) in the number of incident cases, prevalent cases, and DALYs due to periodontal disease among individuals aged 60 years and above in China from 1990 to 2021 were 3.215% (95% CI: 3.149%-3.281%, P<0.05), 3.161% (95% CI:3.037%-3.286%, P<0.05), and 3.091%(95% CI: 2.887%-3.296%, P<0.05), respectively. The results indicated that the average annual change trends of the number of incident cases, number of prevalent cases, and number of DALYs were real upward trends. Compared with other age groups, the number of incident cases, prevalent cases, and DALYs were the highest among the population aged 60-69 years. The AAPC for age-standardized incidence rate, prevalence, and DALY rates were -0.012% (95% CI:-0.031%-0.008%, P>0.05), 0.023% (95% CI:-0.070%-0.116%, P>0.05), and 0.013% (95% CI:-0.089%-0.115%, P>0.05), respectively. This indicated that the average annual change trends of the age-standardized incidence rate, age-standardized prevalence rate, and age-standardized DALY rate might be caused by random fluctuations. Males exhibited higher prevalence and DALY rates than females across all age groups ( P<0.05), whereas the incidence rates showed minimal differences between males and females across all age groups. The ARIMA forecast model indicated that the age-standardized incidence rate among males in the elderly population in China was relatively stable, while that among females showed a downward trend; the age-standardized prevalence and DALY rates followed a pattern of "decline-rise-decline". Conclusions:The disease burden of periodontal disease among Chinese adults aged 60 and above showed an overall upward trend from 1990 to 2021, with males and individuals aged 60-69 identified as high-risk groups. With the exacerbation of aging, the prevention and control situation remains severe, necessitating the implementation of gender-differentiated interventions to reduce the disease burden.
10.Application and optimization of HDEHP extraction chromatography in the determination of strontium-90 in seafood
Cen SHI ; Yuhan XIE ; Yuxin QIAN ; Yanqin JI
Chinese Journal of Radiological Health 2025;34(2):231-236
Objective To evaluate the environmental radioactive safety level in China, monitor the radioactivity of strontium-90 (90Sr) in seafood from selected marine regions of China, and optimize the di-(2-ethylhexyl)phosphoric acid (HDEHP) extraction chromatography method for determining Sr-90 in seafood. Methods In 2023, seafoods of fish, shrimp, shellfish, and seaweed were collected from the Shandong Province (Bohai Sea and Yellow Sea) and Hainan Province (South China Sea). The levels of Sr in the samples were determined by inductively coupled plasma atomic emission spectrometer (ICP-AES). The 90Sr separation were performed using HDEHP extraction chromatography, while the recovery of 90Sr were determined by the gravitmetry with the assistant of ICP-AES. Results The content of strontium in seafoods varies greatly, and excessive strontium and calcium in seafood may lead to overestimated recovery due to insufficient leaching during chromatographic separation by HDEHP extraction. Therefore, the yttrium content in the eluent should be analyzed by ICP . The radioactivity of 90Sr in seafood from the sea areas in Shandong Province was 0.22-1.85 Bq/kg (dry weight), and that of seafood from Hainan Province was 0.19-1.82 Bq/kg (dry weight). Conclusion For the analysis of shirmp and seaweed samples, the recovery rate of 90Sr should be analyzed using both gravimetry and ICP-AES. There is no significant linear correlation between total Sr and 90Sr in seafood. There is no significant difference in 90Sr radioactivity between the seafood samples collected from Shandong and Hainan. The 90Sr radioactivity levels of all 28 samples are below the limit specified in the Limited concentrations of radioactive materials in foods (GB 14882—1994) and are within the range of environmental background fluctuations.


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