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.Design, synthesis, and biological activity evaluation of photocaged cyclin-dependent kinase 2 inhibitors
Qingxiao WANG ; Xiaoyuan SUN ; Chunlei TANG ; Yan ZHANG
Journal of China Pharmaceutical University 2026;57(3):304-313
This study aimed to design and synthesize a series of novel photocaged compounds based on the precise binding mode of cyclin-dependent kinase 2 (CDK2) inhibitor AT7519 with its target, to achieve precise optical control over molecular activity. Using AT7519 as the structural foundation, different types of photoremovable protecting groups were introduced at its key interaction sites (the NH of the pyrazole ring and the NH of the piperidine ring), resulting in the synthesis of eight dual-photocaged compounds. Their structures were confirmed by NMR and mass spectrometry, and their photochemical properties—including photolysis wavelength, photolysis time, and photolysis efficiency—were systematically evaluated. The optically controlled inhibitory effects of the compounds on HCT116 cell proliferation were assessed using MTT assay. The photoresponsive characteristics of the photocaged compounds were significantly influenced by the type of photoremovable protecting group and its introduction site. Among them, compounds 1a, 1b, and 2d exhibited excellent photolysis efficiency, each achieving a rate exceeding 90%. Particularly, compounds 1b and 2d demonstrated excellent optically controlled activity: under dark conditions, their half maximal inhibitory concentration (IC50) values were both greater than 150 µmol/L, indicating negligible cell proliferation inhibitory activity; however, upon irradiation, their cell proliferation inhibitory activity significantly increased, with IC50 values comparable to those of the positive control AT7519. The obtained compounds 1b and 2d possess excellent optically controlled properties, and can be further investigated as potential candidates for optically controlled CDK2 inhibitors.
3.Research Progress on the Regulation of Growth Plate Endochondral Ossification by Mechanical Loading
Xiaoyuan GUO ; Yuxin SUN ; Yutong WANG ; Shi CHEN ; Hui PAN
Medical Journal of Peking Union Medical College Hospital 2026;17(4):1126-1134
The endochondral ossification of the growth plate is crucial for the longitudinal growth of long bones. Mechanical loading plays an important regulatory role in endochondral ossification. Absence or improper mechanical loading can inhibit growth plate development, while moderate mechanical stimuli promote chondrocyte proliferation and differentiation, thereby facilitating long bone growth. Mechanosensitive structures, such as primary cilia, mechanosensitive ion channels, integrins, and the cytoskeleton, play key roles in the regulation of mechanical loading. This review summarizes how mechanical loading influences growth plate endochondral ossification and discusses potential underlying mechanisms, offering theoretical insights for the management and research of bone development disorders in children and adolescents.
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.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.
6.Safety and efficacy of non-retrograde intubation combined with partially tubeless PCNL
Guangyuan YANG ; Xiaosong SUN ; Xiaoyuan QIAN ; Fuchao LIANG ; Linghui QIN
The Journal of Practical Medicine 2025;41(19):3072-3077
Objective To evaluate the safety and efficacy of non-retrograde intubation combined with selectively tubeless percutaneous nephrolithotomy(NR-ST-PCNL).Methods A retrospective analysis included 213 patients with upper urinary tract stones and hydronephrosis(renal pelvic separation>10 mm)undergoing PCNL at our hospital from October 2023 to June 2025.Patients were divided into Group A(non-retrograde intuba-tion,n=109)and Group B(retrograde intubation,n=104).Primary endpoint was postoperative complications and secondary endpoints included operative time,stone-free rate(SFR),visual analog scale(VAS)pain scores,postoperative hospital stay,and hospitalization costs.Results Group A demonstrated significantly lower rates of postoperative complications[7.3%(8/109)vs.18.2%(19/104),P=0.017],shorter operative time[51.00(37.00,65.00)min vs.71.50(55.00,90.75)min,P<0.001],lower postoperative VAS scores[1.00(0.00,1.00)vs.1.00(0.00,2.00),P=0.008],shorter hospital stay[3.00(2.00,3.00)days vs.4.00(4.00,4.00)days,P<0.001],and lower hospitalization costs[17 028.00(15 178.05,17 934.50)RMB vs.20 653.00(19 176.25,22 630.00)RMB,P<0.001]compared with Group B.There was no significant difference in SFR between groups(P>0.05).Conclusion For patients with upper urinary tract stones and renal pelvic separation>10 mm,NR-ST-PCNL performed by experienced surgeons achieves comparable stone clearance to conventional techniques while reducing complication risk,shortening operative and hospitalization times,and lowering costs.It represents a safe,efficient,and optimized clinical approach.
7.Performance evaluation of AI-enabled blood cell morphology system for peripheral blood smear and application in grading screening network of primary medical care system
Xiaobing SUN ; Gusheng TANG ; Kaiying YUAN ; Duanqin DIAO ; Jun HU ; Xiaoyuan SHI ; Hao YUAN ; Anmei WANG ; Yan FANG ; Liqin JIANG ; Xueliang QIN ; Chun XU ; Qi HOU ; Jiong WU
Chinese Journal of Clinical Laboratory Science 2025;43(4):246-252
Objective To evaluate the recognition capability of AI-enabled Cellsee CS-BM1 automatic cell morphology analyzer for pe-ripheral blood smears and its roles in assisting manual classification,and explore the application value of AI system in the diagnosis network of tiered primary medical units.Methods The blood samples which triggered the re-examination rules were collected from six primary medical units,including the Laboratory Department of Shanghai Jiahui International Hospital,and so on,from March to No-vember 2023.The smears of peripheral blood were prepared and AI analyzer was used for pre-classification to evaluate its recognition performance in identifying the samples with abnormal WBC and RBC.The sensitivity,specificity,and accuracy of WBC classification by six junior and intermediate technicians,both with and without AI assistance,were analyzed.Additionally,the roles of the AI system in tiered diagnosis of primary medical units were also evaluated.Results The sensitivity,specificity,and accuracy of AI system in recognizing malignant primitive cells were 92.86%,95.16%,and 95.10%,respectively.The sensitivities of AI system in recognizing immature granulocytes,reactive lymphocytes,and nucleated RBCs were all greater than 90%.The sensitivity of AI system in identif-ying abnormal morphology of RBCs reached 99.59%,along with rapid quantitative analysis for various anomalous types of RBCs.In AI-assisted mode,the sensitivity of recognition for all cell types was improved to varying degrees by junior and intermediate technicians,and the sensitivity for recognizing malignant primitive cells,reactive lymphocytes,and immature granulocytes increased to 58.24%,53.39%,and 62.37%for junior technicians,and to 92.06%,83.24%,and 83.12%for intermediate technicians,respectively.The improvements for junior technicians were particularly significant,with increases of 12.46%,10.61%,and 3.71%for each cell type,respectively.Both groups achieved higher specificity and accuracy.Through AI pre-classification and manual review,a variety of pe-ripheral blood cell-related diseases were accurately diagnosed in the tiered healthcare practice of primary medical units,including 339 cases(11.13%)of red blood cell diseases,5 cases(0.16%)of platelet diseases,2 343 cases(76.90%)of infection-related disea-ses,and 28 cases(0.92%)of malignant hematological diseases.In addition,332 cases(10.90%)which lacked an obvious related cause or required further examinations were identified as well.Conclusion AI pre-classification has demonstrated strong cell recogni-tion capabilities and may assist technicians in improving the sensitivity,specificity,and accuracy of blood cell classification.AI could en-hance the disease-screening capabilities in the tiered diagnosis network of primary medical units,presenting a broad application prospect.
8.Plasma-activated solutions alleviate DSS-induced colitis in mice and promote colonic epithelial cell repair through the eNOS pathway
Xueni WANG ; Kaijie REN ; Yuyi MA ; Tianhao MIN ; Xiaoyuan DENG ; Yuanchang PENG ; Yuanyuan LIU ; Wei WANG ; Tuanhe SUN ; Chengxue DANG ; Hao ZHANG
Journal of Xi'an Jiaotong University(Medical Sciences) 2025;46(1):28-34
Objective To explore the role and potential mechanisms of plasma-activated solution(PAS)in alleviating dextran sulfate sodium salt(DSS)-induced ulcerative colitis.Methods We constructed a DSS-induced ulcerative colitis mouse model and evaluated the effect of PAS in vivo by observing mouse weight,calculating disease activity indexes,detecting inflammatory factors and oxidative stress indicators through ELISA.We also evaluated the effect of PAS on colon cell proliferation and migration ability through clone formation experiments,scratch experiments,and used Western blotting to determine the expression levels of proliferation-related proteins.Results PAS significantly reversed DSS-induced weight loss and increased disease activity indexes in mice(P<0.05).The serum inflammatory cytokine levels(TNF-α,IL-6 and IL-1β)in PAS group were significantly reduced compared to those in DSS group(P<0.05).PAS treatment could improve the imbalance of colonic redox homeostasis including changes of malondialdehyde,catalase and superoxide dismutase caused by DSS(P<0.05).After the use of endothelial nitric oxide synthase inhibitors,changes in various indicators caused by in vivo PAS disappeared(P<0.001).The clone formation ability of colon cells was stronger in the group treated with PAS,and the expression of proliferation-related proteins increased.Cell scratch experiments suggested that intervention with PAS could reverse the decrease in cell migration ability caused by lipopolysaccharide(P<0.001).After the application of endothelial nitric oxide synthase inhibitors,the pro-proliferative and migratory effects of PAS disappeared(P<0.05).Conclusion PAS alleviate DSS-induced colitis in mice and promote colonic epithelial cell repair through the eNOS pathway.
9.Plasma-activated solutions promote tumor cells'anoikis and inhibit tumor peritoneal metastasis
Tuanhe SUN ; Yuyi MA ; Tianhao MIN ; Kaijie REN ; Xiaoyuan DENG ; Xueni WANG ; Yuanchang PENG ; Yuanyuan LIU ; Chengxue DANG ; Hao ZHANG ; Wei WANG
Journal of Xi'an Jiaotong University(Medical Sciences) 2025;46(1):35-42
Objective To explore the application of plasma-activated solution(PAS)in the treatment of peritoneal metastasis in mice.Methods A mice model of peritoneal tumor transplantation was established,and PAS was prepared for intervention in the mice.The growth of the peritoneally transplanted tumor was assessed using in vivo imaging technology,while the apoptosis level was evaluated through flow cytometry,immunofluorescence,and Western blotting.Results At the in vitro level,there was no significant impact on tumor cell apoptosis level under adherent conditions observed when utilizing PAS(P>0.05).Under non-adherent condition,PAS significantly augmented tumor cell apoptosis level(P<0.05),substantially increased the proportion of deceased cells(P<0.05),and markedly elevated intracellular total and mitochondrial reactive oxygen species levels(P<0.05).In vivo level,using PAS following peritoneal transplanted tumor formation exhibited no noteworthy influence on peritoneal transplanted tumor growth(P>0.05),while immediate utilization of PAS during model conducting effectively reduced abdominal tumor spread(P<0.05).Conclusion PAS inhibits tumor peritoneal dissemination in mice by promoting tumor cell anoikis.
10.Comparison of Ultrasound-guided Paravertebral Block and General Anesthesia in Percutaneous Nephrolithotomy
Jiangfeng DUAN ; Jiange WANG ; Xiaoyuan QIAN ; Jiahao SUN ; Xuejun ZHANG
Chinese Journal of Minimally Invasive Surgery 2025;25(1):8-13
Objective To compare the effectiveness between ultrasound-guided paravertebral block(PVB)and general anesthesia in percutaneous nephrolithotomy(PCNL).Methods Clinical data of 284 patients who underwent PCNL in our hospital from January 2023 to March 2024 were collected.These were 78 cases of PVB(PVB group)and 206 cases of general anesthesia(general anesthesia group).A total of 61 cases in each of the two groups were matched with propensity score,and the operative time,intraoperative fluid infusion volume,postoperative haemoglobin changes,postoperative visual analogue scale(VAS),hospital stay,hospital costs,and incidence of postoperative complications were compared.Results The operations were completed in both groups of patients successfully,with stable vital signs during the operation and no intraoperative anesthetic complications such as bradycardia,respiratory depression,or hypotension.There were significant differences between the two groups in heart rate(HR)before the start of surgery[(66.5±10.4)beats/min vs.(77.5±11.7)beats/min,t=-5.471,P=0.000],HR at the end of surgery[(60.5±8.4)beats/min vs.(71.0±12.3)beats/min,t=-5.472,P=0.000],mean arterial pressure(MAP)before the start of surgery[(97.2±11.9)mm Hg vs.(103.1±12.3)mm Hg,t=-2.694,P=0.008],MAP at the end of surgery[(85.2±8.8)mm Hg vs.(94.3±11.6)mm Hg,t=-4.892,P=0.000],pulse oxygen saturation(SpO2)before the start of surgery[(99.0±1.1)%vs.(99.6±0.6)%,t=-3.347,P=0.001]and SpO2 at the end of surgery[(99.2±1.1)%vs.(99.8±0.4)%,t=-4.122,P=0.000].The operative time was significantly shorter in the PVB group than that in the general anesthesia group[55.0(41.5,75.5)min vs.95.0(65.0,130.0)min,Z=-5.173,P=0.000].The postoperative haemoglobin changes[5(2,11)g/L vs.8(4,11)g/L,Z=-2.099,P=0.036],postoperative VAS score[1(1,1)points vs.1(1,2)points,Z=-3.342,P=0.001],postoperative hospital stay[3(2,3)dvs.4(3,6)d,Z=-6.016,P=0.000]and hospital costs[(14 499.4±2141.0)yuan vs.(19 634.2±3846.8)yuan,t=-9.109,P=0.000]were statistically lower in the PVB group than those in the general anesthesia group.Comparison of intraoperative fluid infusion volume[600(600,600)ml vs.600(600,1100)ml,Z=-1.800,P=0.072],postoperative venting time[1(1,1)d vs.1(1,1)d,Z=-1.045,P=0.296],and phase Ⅰ stone removal rate[88.5%(54/61)vs.82.0%(50/61),x2=1.043,P=0.307]showed no significant differences between the two groups.The incidence of postoperative complications in the PVB group was significantly lower than that in the general anesthesia group[6.6%(4/61)vs.19.7%(12/61),x2=4.604,P=0.032].Conclusion Ultrasound-guided PVB in PCNL maintains stable intraoperative vital signs,reduces operative time and bleeding,alleviates postoperative pain,reduces postoperative complications and postoperative hospital stay,and saves medical costs,having a good safety and efficacy.

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