1.Review and reflection on the practice of pre-ethical review for drug clinical trials
Min HOU ; Xiaoyuan SHI ; Rongguo SUN ; Fang LIU ; Lei CHEN ; Zejin ZUO
Chinese Medical Ethics 2026;39(5):594-600
ObjectiveTo sort out the pre-ethical review status of drug clinical trials in a tertiary A hospital, summarize practical experience, and provide references for pre-ethical review. MethodA retrospective analysis was conducted on the ethical review of pre-ethical projects in a tertiary A hospital from 2018 to 2023. ResultsFrom 2018 to 2023, a total of 285 pre-ethical projects were reviewed in this tertiary hospital, including 79 projects where it served as the leading unit. Among these, 279 clinical trials ultimately received approval of the ethical review committee, while 6 projects were not approved due to sponsors’ refusal to modify study protocols. In terms of trial phases, phase III clinical trials constituted the largest proportion, and the oncology center was the department with the highest number of projects. In 2023, the average time for pre-ethical review projects from submission to approval was 43 calendar days, 3 days longer than for other project types. In 2023, this hospital reviewed 75 pre-ethical review projects, including 58 where it served as a participating unit. Among these, 42 projects received approval later than the leading unit, while 9 projects were approved earlier than the leading unit’s ethical approval date. Among the pre-ethical review projects applied in 2023, 70 projects obtained drug clinical trial notifications from the National Medical Products Administration, while 5 projects had unknown notification status due to the lack of ethical approval or discontinuation. Of the projects receiving approval notifications, 16 were annotated with matters requiring enhanced attention during clinical trials, and 7 necessitated protocol improvements. ConclusionThis tertiary A hospital has implemented multiple measures to optimize the management of pre-ethical review. This ethical review model does not compromise the quality of ethical review and contributes to accelerating the initiation of clinical trials. Notably, it is crucial to construct a patient-centered drug development system. Clinical trials guided by this concept align with ethical values, laying the foundation for the smooth conduct of clinical trials, assisting in the drug development process, and safeguarding patients’ medication needs.
2.Effectiveness of "Internet plus" continuous intervention among patients with depression after hospital discharge
CHEN Chunmian ; JIN Tingting ; GAO Si ; CHEN Haoran ; LU Xiaoyuan ; ZHENG Lidan
Journal of Preventive Medicine 2025;37(10):1049-1053
Objective:
To evaluate the effectiveness of "Internet plus" continuous intervention on psychological status and nursing satisfaction of patients with depression after hospital discharge, so as to provide the reference for reducing the recurrence risk of patients with depression and improving the quality of life.
Methods:
From January to December 2024, patients with mild to moderate depression who were hospitalized in a tertiary grade-a mental health specialized hospital in Wenzhou City and met the discharge criteria were selected as the research objects. The patients were divided into the control group and the intervention group according to a ratio of 1∶1 by the random number table method. Hamilton Depression Scale, Hamilton Anxiety Scale, and Nursing Satisfaction Questionnaire were used to evaluate depressive symptoms, anxiety symptoms, and nursing satisfaction before and after intervention. Covariance analysis was used to compare the differences between the two groups before and after the intervention.
Results:
A total of 62 patients with mild to moderate depression were enrolled, with 31 patients in the intervention group and 31 patients in the control group. Before the intervention, there were no statistically significant differences in gender, age, course of disease, educational level, marital status, depression symptoms score, anxiety symptoms score, and nursing satisfaction score between the two groups (all P>0.05). After the intervention, the scores of depression and anxiety symptoms in the intervention group decreased by 8.87 and 5.01 points, respectively, compared with those before the intervention, and the scores of depression and anxiety symptoms in the control group decreased by 2.52 and 1.16 points, respectively (all P<0.05). After the intervention, the scores of depression and anxiety symptoms in the intervention group decreased more than those in the control group (both P<0.05). The nursing satisfaction score of the intervention group increased by 6.57 points on average compared with that before the intervention, and that of the control group increased by 4.23 points on average (both P<0.05). There was no statistically significant difference in the increase of nursing satisfaction scores between the two groups before and after intervention (P>0.05).
Conclusion
The "Internet plus" continuous intervention has a good effect on improving the depressive symptoms and anxiety symptoms of patients with depression after haspital discharge, which can consolidate the treatment effect and improve nursing satisfaction.
3.Impact of childhood trauma on internet addiction in medical students: the mediating role of perceived stress
Xiaohong PENG ; Xiaoyuan LIAO ; Dantong WU ; Yanyin ZHOU ; Yelu LIU ; Yuxiang WANG ; Luoya ZHANG ; Juan DENG ; Yanjie PENG ; Kezhi LIU ; Jing CHEN ; Wei LEI
Sichuan Mental Health 2025;38(3):267-272
BackgroundWith the rapid development of the networking technologies, internet addiction has increasingly become a serious mental health issue. Previous studies have revealed the link between childhood trauma and internet addiction, while the mediating role of perceived stress in this link is not yet clear. ObjectiveTo investigate the role of medical students' perceived stress in the relationship between childhood trauma and internet addiction, so as to provide references for the intervention of internet addiction. MethodsFrom February to March 2023, a random sampling technique was used to select 1 232 undergraduate students from the School of Clinical Medical Sciences of Southwest Medical University as research subjects. The Childhood Trauma Questionnaire-Short Form (CTQ-SF), Perceived Stress Scale (PSS), Internet Gaming Disorder Scale (IGDS), and Bergen Social Media Addiction Scale (BSMAS) were used for assessment. Pearson's correlation coefficients were calculated. The mediation effect of perceived stress in the relationship between childhood trauma and internet addiction was tested using Model 4 in the SPSS Process 4.1, and Bootstrapping procedure involving 5 000 replicates was employed to confirm the statistical significance. ResultsA total of 1 016 (82.47%) valid completed questionnaires were gathered. The CTQ-SF scores of medical students were positively correlated with PSS scores, IGD scores, and BSMAS scores (r=0.583, 0.474, 0.465, P<0.01). PSS scores were positively correlated with IGD scores and BSMAS scores (r=0.369, 0.479, P<0.01). Childhood trauma in medical students was found to positively predict perceived stress (β=0.191, P<0.01), social media addiction (β=0.160, P<0.01), and internet gaming disorder (β=0.106, P<0.01). Perceived stress played a significant mediating role in the relationship between childhood trauma and internet gaming disorder, indirect effect value was 0.018 (95% CI: 0.009~0.027), accounting for 16.98%. Perceived stress also exhibited a significant mediating role in the relationship between childhood trauma and social media addiction, indirect effect value was 0.063 (95% CI: 0.048~0.079), accounting for 39.38%. ConclusionChildhood trauma in medical students may affect internet gaming disorder and social media addiction through perceived stress. [Funded by 2022 Annual Research Project of Sichuan Applied Psychology Research Center,(number,CSXL-22102)]
4.Effect of Exercise on Blood Glucose Metabolism of Type 2 Diabetes Patients in East Asian Population: A Meta-Analysis
Yuxin SUN ; Bingtai HAN ; Xiaoyuan GUO ; Xueqing ZHENG ; Shi CHEN ; Hongbo YANG ; Hui PAN
Medical Journal of Peking Union Medical College Hospital 2025;16(2):492-505
To explore the effects of different exercise prescriptions on glycemic metabolism in East Asian patients with type 2 diabetes mellitus (T2DM) and to compare the differences in the impact of population characteristics and exercise components on glycemic metabolism. A systematic search was conducted in PubMed, Cochrane Library, EmBase, Web of Science, CNKI, and Wanfang Data Knowledge Service Platform to identify relevant studies published from database inception to June 15, 2024, on the effects of exercise on glycemic metabolism in East Asian patients with T2DM. The study type was limited to randomized controlled trials (RCTs), where the intervention group received exercise interventions and the control group did not. Two researchers independently screened the literature based on inclusion and exclusion criteria and extracted relevant data. Publication bias was assessed using Egger's test in Stata 17.0 and funnel plots in RevMan 5.3. Meta-analysis was performed using RevMan 5.3. A total of 21 RCTs involving 1289 participants (675 in the intervention group and 614 in the control group) were included. Publication bias assessment indicated overall good quality of the included studies. The random-effects model showed that exercise interventions significantly reduced fasting blood glucose (MD=-1.31 mg/L, 95% CI: -1.55 to -1.07, Exercise interventions can improve glycemic control and reduce insulin resistance in East Asian patients with T2DM. Aerobic exercise and combined exercise are more effective exercise prescriptions for glycemic management in this population.
5.Mechanisms by which microgravity causes osteoporosis
Dejian XIANG ; Xiaoyuan LIANG ; Shenghong WANG ; Changshun CHEN ; Cong TIAN ; Zhenxing YAN ; Bin GENG ; Yayi XIA
Chinese Journal of Tissue Engineering Research 2025;29(10):2132-2140
BACKGROUND:The imbalance between bone resorption and bone formation in microgravity environments leads to significant bone loss in astronauts.Current research indicates that bone loss under microgravity conditions is the result of the combined effects of various cells,tissues,and systems. OBJECTIVE:To review different biological effects of microgravity on various cells,tissues,or systems,and summarize the mechanisms by which microgravity leads to the development of osteoporosis. METHODS:Databases such as PubMed,Web of Science,and the Cochrane Database were searched for relevant literature from 2000 to 2023.The inclusion criteria were all articles related to tissue engineering studies and basic research on osteoporosis caused by microgravity.Ultimately,85 articles were included for review. RESULTS AND CONCLUSION:(1)In microgravity environment,bone marrow mesenchymal stem cells tend to differentiate more into adipocytes rather than osteoblasts,and hematopoietic stem cells in this environment are more inclined to differentiate into osteoclasts,reducing differentiation into the erythroid lineage.At the same time,microgravity inhibits the proliferation and differentiation of osteoblasts,promotes apoptosis of osteoblasts,alters cell morphology,and reduces the mineralization capacity of osteoblasts.Microgravity significantly increases the number and activity of osteoclasts.Microgravity also hinders the differentiation of osteoblasts into osteocytes and promotes the apoptosis of osteocytes.(2)In a microgravity environment,the body experiences changes such as skeletal muscle atrophy,microvascular remodeling,bone microcirculation disorders,and endocrine disruption.These changes lead to mechanical unloading in the bone microenvironment,insufficient blood perfusion,and calcium cycle disorders,which significantly impact the development of osteoporosis.(3)At present,the mechanism by which microgravity causes osteoporosis is relatively complex.A deeper study of these physiological mechanisms is crucial to ensuring the health of astronauts during long-term space missions,and provides a theoretical basis for the prevention and treatment of osteoporosis.
6.Association Between Vitamin D Status and Insulin Resistance in Adolescents: A Cross-sectional Observational Study
Xiaoyuan GUO ; Yutong WANG ; Zhibo ZHOU ; Shi CHEN ; Mei ZHANG ; Bo BAN ; Ping LI ; Xinran ZHANG ; Qiuping ZHANG ; Kai YANG ; Hongbo YANG ; Hanze DU ; Hui PAN
Medical Journal of Peking Union Medical College Hospital 2025;16(3):577-583
To investigate the correlation between vitamin D nutritional status and insulin resistance in pubertal adolescents. This cross-sectional observational study employed convenience sampling to recruit 2021-grade(8th grade) students from Jining No.7 Middle School in Shandong Province on June 5, 2023. Data collection included questionnaires, physical examinations, and imaging assessments to obtain general information, secondary sexual characteristics development, and bone age. Venous blood samples were collected to measure fasting blood glucose(FBG), fasting insulin(FINS), homeostasis model assessment of insulin resistance(HOMA-IR), and 25-hydroxyvitamin D[25(OH)D] levels. Spearman correlation analysis and multivariate linear regression models were used to examine the associations between serum vitamin D levels and FBG, FINS, and HOMA-IR. The study included 168 pubertal adolescents[69 females(41.1%), 99 males(58.9%); mean age(13.27±0.46) years]. All participants had entered puberty based on sexual development assessment. Vitamin D deficiency was observed in 41 participants(24.4%), insufficiency in 109(64.9%), and sufficiency in 18(10.7%). The median HOMA-IR was 3.49(2.57, 5.14).Significant differences were found across vitamin D status groups for HOMA-IR [4.45(2.54, 6.62) Vitamin D deficiency/insufficiency is prevalent among pubertal adolescents, and serum vitamin D levels show a significant inverse association with insulin resistance. These findings suggest the potential importance of vitamin D status in metabolic health during puberty.
7.The Mediating Effect of Vitamin D on the Association Between Exercise and Triglyceride in Adolescents: A Prospective Cross-sectional Study
Bochuan HUANG ; Xiaoyuan GUO ; Yutong WANG ; Jiaxuan LIU ; Hui PAN ; Shi CHEN
Medical Journal of Peking Union Medical College Hospital 2025;16(3):584-590
To investigate the mediating role of vitamin D in the association between exerciseand triglyceride among adolescents, as well as its potential molecular mechanisms. This prospective cross-sectional study utilized convenience sampling, enrolling 2021-grade students from Jining No. 7 Middle School on June 5, 2023. Moderate-intensity exercise frequency was assessed via standardized questionnaires, serum 25-hydroxyvitamin D levels were measured using chemiluminescence, and triglyceride levels were determined via fully automated biochemical analysis. Spearman's rank correlation analysis was employed to examine the relationships among moderate-intensity exercise, triglyceride, and vitamin D. A mediation model was constructed using the Baron & Kenny causal steps approach, adjusting for confounders including age, sex, body mass index (BMI), dairy intake, sweet food consumption, and fast-food intake. Subgroup analyses were performed based on BMI. The significance of the mediation effect was confirmed using both the Bootstrap and Sobel tests. A total of 354 adolescents meeting the inclusion criteria were enrolled, including 142 females (40.11%) and 212 males (59.89%), with a median age of 13.25(12.83, 13.83)years. Spearman's analysis revealed a significant negative correlation between moderate-intensity exercise and triglyceride levels ( Vitamin D serves as a key mediator in the triglyceride-lowering effect of exercise among adolescents, independent of age, sex, and dietary habits. This mediation effect is particularly pronounced in adolescents with BMI < 24 kg/m2. The underlying mechanism may involve vitamin D-regulated lipid metabolism-related gene expression and suppression of inflammatory pathways, suggesting that targeting vitamin D signaling could be a potential molecular strategy for early intervention in adolescent dyslipidemia.
8.Body Composition Profiles and Associated Factors in Adolescents UndergoingLong-term Regular Exercise
Yutong WANG ; Xiaoyuan GUO ; Hanze DU ; Hui PAN ; Wei WANG ; Mei ZHANG ; Bo BAN ; Ping LI ; Xinran ZHANG ; Qiuping ZHANG ; Hongshuang SUN ; Rong LI ; Shi CHEN
Medical Journal of Peking Union Medical College Hospital 2025;16(3):591-597
To investigate body composition and associated factors in adolescents undergoing long-term regular sports training. This prospective longitudinal cohort study employed convenience sampling to recruit adolescents receiving structured athletic training at Jining Sports Training Center in June 2023. Baseline measurements included height, weight, body mass index (BMI), blood pressure, heart rate, waist circumference, and hip circumference. Questionnaires assessed sleep duration, screen time, and household income. Follow-up measurements in June 2024 repeated these assessments while adding bioelectrical impedance analysis for body composition (lean mass, skeletal muscle mass, fat mass, and body fat percentage). Linear regression models examined associations between training type (direct-contact vs. non-contact sports) and follow-up body fat percentage, BMI, and waist circumference as dependent variables, adjusting for covariates. The study included 110 adolescents (39 female, 71 male) with median age 13.21 years (IQR: 12.46-14.33). Participants comprised 65 direct-contact and 45 non-contact athletes. Baseline prevalence rates were 27.27% for overweight/obesity, 24.55% for elevated waist circumference, and 16.36% for elevated blood pressure. At follow-up, corresponding rates were 24.55%, 26.36%, and 13.64% respectively. The elevated blood pressure subgroup showed significantly higher waist circumference ( Despite regular athletic training, substantial proportions of adolescents exhibited overweight/obesity, abdominal obesity, and elevated blood pressure, warranting clinical attention. Training modality appears to influence body composition changes, with direct-contact sports associated with more favorable adiposity-related outcomes.
9.Safety, dosimetry, and efficacy of an optimized long-acting somatostatin analog for peptide receptor radionuclide therapy in metastatic neuroendocrine tumors: From preclinical testing to first-in-human study.
Wei GUO ; Xuejun WEN ; Yuhang CHEN ; Tianzhi ZHAO ; Jia LIU ; Yucen TAO ; Hao FU ; Hongjian WANG ; Weizhi XU ; Yizhen PANG ; Liang ZHAO ; Jingxiong HUANG ; Pengfei XU ; Zhide GUO ; Weibing MIAO ; Jingjing ZHANG ; Xiaoyuan CHEN ; Haojun CHEN
Acta Pharmaceutica Sinica B 2025;15(2):707-721
Peptide receptor radionuclide therapy (PRRT) with radiolabeled SSTR2 agonists is a treatment option that is highly effective in controlling metastatic and progressive neuroendocrine tumors (NETs). Previous studies have shown that an SSTR2 agonist combined with albumin binding moiety Evans blue (denoted as 177Lu-EB-TATE) is characterized by a higher tumor uptake and residence time in preclinical models and in patients with metastatic NETs. This study aimed to enhance the in vivo stability, pharmacokinetics, and pharmacodynamics of 177Lu-EB-TATE by replacing the maleimide-thiol group with a polyethylene glycol chain, resulting in a novel EB conjugated SSTR2-targeting radiopharmaceutical, 177Lu-LNC1010, for PRRT. In preclinical studies, 177Lu-LNC1010 exhibited good stability and SSTR2-binding affinity in AR42J tumor cells and enhanced uptake and prolonged retention in AR42J tumor xenografts. Thereafter, we presented the first-in-human dose escalation study of 177Lu-LNC1010 in patients with advanced/metastatic NETs. 177Lu-LNC1010 was well-tolerated by all patients, with minor adverse effects, and exhibited significant uptake and prolonged retention in tumor lesions, with higher tumor radiation doses than those of 177Lu-EB-TATE. Preliminary PRRT efficacy results showed an 83% disease control rate and a 42% overall response rate after two 177Lu-LNC1010 treatment cycles. These encouraging findings warrant further investigations through multicenter, prospective, and randomized controlled trials.


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