1.Changes in the along the perivascular space index and its relationship with brain injury in patients with relapsing-remitting multiple sclerosis
Yuanjun SONG ; He ZHAO ; Shaoyu WANG ; Yang GAO
Chinese Journal of Radiology 2025;59(5):511-517
Objective:To explore changes in the along the perivascular space (ALPS) index in patients with relapsing-remitting multiple sclerosis (RRMS) and investigate its association with cerebral injury.Methods:The study was a cross-sectional investigation. A total of 32 patients diagnosed with RRMS (RRMS group) and 30 healthy controls (HC) were retrospectively collected from March 2023 to July 2024 at the Affiliated Hospital of Inner Mongolia Medical University. All participants underwent MRI scans, including high-resolution three-dimensional (3D) T 1-weighted magnetization-prepared rapid gradient echo sequence, 3D fluid-attenuated inversion recovery sequence, and diffusion spectrum imaging. Regions of interest (ROI) were manually placed on the axial plane of the lateral ventricular body based on fractional anisotropy (FA) maps to obtain diffusion rates along the x, y, and z axes for ALPS index calculation. Tract-based spatial statistics was used to extract diffusion values from the white matter skeleton of the participants, including FA, mean diffusivity (MD), axial diffusivity (AD), radial diffusivity (RD), and quantitative anisotropy (QA). Lesion growth algorithms were employed to extract white matter lesion volume (WMLV) and number (WMLN). After lesion filling on T 1 images, brain segmentation was performed, and normalized gray matter volume (nGMV), normalized white matter volume (nWMV), and normalized cerebrospinal fluid volume (nCSFV) were obtained by normalizing with total intracranial volume(TIV). Independent sample t-tests, Mann-Whitney U tests, and χ2 tests were used to assess differences in clinical and imaging indicators between the RRMS and HC groups. Spearman′s rank correlation analysis was performed to evaluate the relationship between the ALPS index and clinical and imaging indicators. Results:The ALPS index, FA, and nGMV values were lower in the RRMS group compared to the HC group ( t=2.42, P=0.019; Z=4.85, P<0.001; t=2.56, P=0.013), while the RD value was significantly higher in the RRMS group ( Z=-2.42, P=0.015). No significant difference was found in other clinical and imaging indicators between the two groups ( P>0.05). In the RRMS group, the ALPS index was negatively correlated with WMLV ( r=-0.43, P=0.018) and positively correlated with FA ( r=0.45, P=0.012). There was no correlation between ALPS index and MD values, AD values, RD values, QA values, WLMN values, nGMV values, nMWV values, nCSFV values, TIV values, and duration of the disease ( P>0.05). Conclusions:Patients with RRMS exhibit abnormal diffusion in the perivascular spaces at the lateral ventricular body, suggesting possible glymphatic system dysfunction. The ALPS index is associated with demyelination and neurodegeneration.
2.Construction of competency evaluation indicator system for special education teachers based on World Health Or-ganization rehabilitation competency framework
Jing CAO ; Jing LIU ; Xiaoyan ZHANG ; Shaoyu GAO
Chinese Journal of Rehabilitation Theory and Practice 2025;31(6):621-627
Objective To develop a scientific,systematic and operational competency evaluation index system for primary and sec-ondary school special education teachers based on World Health Organization rehabilitation competency frame-work(RCF),integrating the inclusive teacher frameworks of United Nations Educational,Scientific and Cultural Organization(UNESCO)and European Union(EU)as well as China's Professional Standards for Special Educa-tion Teachers(Trial).Methods A core competency framework and content for special education teachers in primary and secondary schools was constructed based on RCF,using a systematic analysis of UNESCO and EU policy documents and the Minis-try of Education's Professional Standards for Special Education Teachers(Trial).On this foundation,a corre-sponding competency evaluation index system was developed.Results The competency framework for primary and secondary school special education teachers comprised five compe-tency domains and two supporting dimensions,including 25 core competency modules and 59 evaluation points.The five competency domains were educational and teaching practice,professional ethics and values,profession-al learning and development,management and collaborative leadership,and educational research and innovation.The two supporting dimensions were professional beliefs and core values.Conclusion The competency evaluation index system for primary and secondary school special education teachers em-phasizes educational equity,inclusive principles,and values of care and justice.It can be used for competency di-agnosis and assessment of teachers at different developmental stages,as well as for designing continuing educa-tion courses and professional development plans.
3.Prediction of PD-1 monoclonal antibody human pharmacokinetic characteristics based on PK in cynomolgus monkeys
Yanjun XU ; Zijun HAN ; Liang WANG ; Fang YANG ; Beilei LOU ; Shaoyu YAN ; Jiman ZHU ; Lihui BAI ; Yong GAO
Chinese Journal of Pharmacology and Toxicology 2025;39(2):109-117
OBJECTIVE To establish a population pharmacokinetic(PopPK)model to predict the PK characteristics of GLS-010 in humans.METHODS Fifty-eight cynomolgus monkeys were used,18 of which were randomly divided into three groups and received a single intravenous infusion of GLS-010 at doses of 2,6,and 18 mg·kg-1,respectively.The rest were randomly assigned to four groups and received multiple intravenous infusions of GLS-010 at doses of 0,5,25,and 100 mg·kg-1,respectively,once a week(quaque week,qw)for five consecutive weeks.Blood samples were collected before and after administration.The concentrations of GLS-010 in the monkey serum were measured using a validated enzyme-linked immunosorbent assay,while those of anti-drug antibodies(ADA)in the cynomolgus monkey serum were determined by ultra-sensitive electrochemiluminescence immunoassay.The PK data on GLS-010 in cynomolgus monkeys was obtained,and the drug-time curves were plotted.A PopPK model was constructed using non-compartmental analysis and evaluated by goodness-of-fit plots and visual predictive checks.The constructed PopPK model was used to predict the PK characteristics in humans,which were finally compared with actual Phase Ⅰ clinical study results for validation.RESULTS The predictive results of the PopPK model were highly consistent with the actual Phase Ⅰ clinical study results.The model was able to predict the human PK characteristics under various dosing regimens,including 1 mg·kg-1 quaque 2 weeks(q2w),4 mg·kg-1(q2w),240 mg(q2w),240 mg(q3w),and 10 mg·kg-1(q2w).The predicted maximum plasma concentrations(Cmax)were 24.8,99.1,85.0,85.0,and 247.8 mg·L-1,respectively,and the AUC0-336h was 4 902.0,20 060.0,17 147.7,22 145.7(AUC0-504h),and 50 817.6 mg·h·L-1,respectively.The safety risks for the corresponding dosing regimens were 47.3,11.6,13.5,10.5,and 4.6,respectively.The predicted receptor occupancy at steady state(ROss)at Cmax,average plasma concentration(Cavg),and minimum plasma concentration(Cmin)were 38.8%,72.7%,69.4%,64.1%and 87.2%,29.1%,63.8%,60.0%,49.8%and 82.1%,21.9%,55.5%,51.3%,36.3%and 76.7%,respectively.CONCLUSION The PopPK model can effectively predict the human PK characteristics under different dosing regimens with high consistency with actual Phase Ⅰ clinical study results,which can serve as an important reference for selection of safe and effective doses for first-in-human research.
4.Construction of competency evaluation indicator system for special education teachers based on World Health Or-ganization rehabilitation competency framework
Jing CAO ; Jing LIU ; Xiaoyan ZHANG ; Shaoyu GAO
Chinese Journal of Rehabilitation Theory and Practice 2025;31(6):621-627
Objective To develop a scientific,systematic and operational competency evaluation index system for primary and sec-ondary school special education teachers based on World Health Organization rehabilitation competency frame-work(RCF),integrating the inclusive teacher frameworks of United Nations Educational,Scientific and Cultural Organization(UNESCO)and European Union(EU)as well as China's Professional Standards for Special Educa-tion Teachers(Trial).Methods A core competency framework and content for special education teachers in primary and secondary schools was constructed based on RCF,using a systematic analysis of UNESCO and EU policy documents and the Minis-try of Education's Professional Standards for Special Education Teachers(Trial).On this foundation,a corre-sponding competency evaluation index system was developed.Results The competency framework for primary and secondary school special education teachers comprised five compe-tency domains and two supporting dimensions,including 25 core competency modules and 59 evaluation points.The five competency domains were educational and teaching practice,professional ethics and values,profession-al learning and development,management and collaborative leadership,and educational research and innovation.The two supporting dimensions were professional beliefs and core values.Conclusion The competency evaluation index system for primary and secondary school special education teachers em-phasizes educational equity,inclusive principles,and values of care and justice.It can be used for competency di-agnosis and assessment of teachers at different developmental stages,as well as for designing continuing educa-tion courses and professional development plans.
5.Prediction of PD-1 monoclonal antibody human pharmacokinetic characteristics based on PK in cynomolgus monkeys
Yanjun XU ; Zijun HAN ; Liang WANG ; Fang YANG ; Beilei LOU ; Shaoyu YAN ; Jiman ZHU ; Lihui BAI ; Yong GAO
Chinese Journal of Pharmacology and Toxicology 2025;39(2):109-117
OBJECTIVE To establish a population pharmacokinetic(PopPK)model to predict the PK characteristics of GLS-010 in humans.METHODS Fifty-eight cynomolgus monkeys were used,18 of which were randomly divided into three groups and received a single intravenous infusion of GLS-010 at doses of 2,6,and 18 mg·kg-1,respectively.The rest were randomly assigned to four groups and received multiple intravenous infusions of GLS-010 at doses of 0,5,25,and 100 mg·kg-1,respectively,once a week(quaque week,qw)for five consecutive weeks.Blood samples were collected before and after administration.The concentrations of GLS-010 in the monkey serum were measured using a validated enzyme-linked immunosorbent assay,while those of anti-drug antibodies(ADA)in the cynomolgus monkey serum were determined by ultra-sensitive electrochemiluminescence immunoassay.The PK data on GLS-010 in cynomolgus monkeys was obtained,and the drug-time curves were plotted.A PopPK model was constructed using non-compartmental analysis and evaluated by goodness-of-fit plots and visual predictive checks.The constructed PopPK model was used to predict the PK characteristics in humans,which were finally compared with actual Phase Ⅰ clinical study results for validation.RESULTS The predictive results of the PopPK model were highly consistent with the actual Phase Ⅰ clinical study results.The model was able to predict the human PK characteristics under various dosing regimens,including 1 mg·kg-1 quaque 2 weeks(q2w),4 mg·kg-1(q2w),240 mg(q2w),240 mg(q3w),and 10 mg·kg-1(q2w).The predicted maximum plasma concentrations(Cmax)were 24.8,99.1,85.0,85.0,and 247.8 mg·L-1,respectively,and the AUC0-336h was 4 902.0,20 060.0,17 147.7,22 145.7(AUC0-504h),and 50 817.6 mg·h·L-1,respectively.The safety risks for the corresponding dosing regimens were 47.3,11.6,13.5,10.5,and 4.6,respectively.The predicted receptor occupancy at steady state(ROss)at Cmax,average plasma concentration(Cavg),and minimum plasma concentration(Cmin)were 38.8%,72.7%,69.4%,64.1%and 87.2%,29.1%,63.8%,60.0%,49.8%and 82.1%,21.9%,55.5%,51.3%,36.3%and 76.7%,respectively.CONCLUSION The PopPK model can effectively predict the human PK characteristics under different dosing regimens with high consistency with actual Phase Ⅰ clinical study results,which can serve as an important reference for selection of safe and effective doses for first-in-human research.
6.Changes in the along the perivascular space index and its relationship with brain injury in patients with relapsing-remitting multiple sclerosis
Yuanjun SONG ; He ZHAO ; Shaoyu WANG ; Yang GAO
Chinese Journal of Radiology 2025;59(5):511-517
Objective:To explore changes in the along the perivascular space (ALPS) index in patients with relapsing-remitting multiple sclerosis (RRMS) and investigate its association with cerebral injury.Methods:The study was a cross-sectional investigation. A total of 32 patients diagnosed with RRMS (RRMS group) and 30 healthy controls (HC) were retrospectively collected from March 2023 to July 2024 at the Affiliated Hospital of Inner Mongolia Medical University. All participants underwent MRI scans, including high-resolution three-dimensional (3D) T 1-weighted magnetization-prepared rapid gradient echo sequence, 3D fluid-attenuated inversion recovery sequence, and diffusion spectrum imaging. Regions of interest (ROI) were manually placed on the axial plane of the lateral ventricular body based on fractional anisotropy (FA) maps to obtain diffusion rates along the x, y, and z axes for ALPS index calculation. Tract-based spatial statistics was used to extract diffusion values from the white matter skeleton of the participants, including FA, mean diffusivity (MD), axial diffusivity (AD), radial diffusivity (RD), and quantitative anisotropy (QA). Lesion growth algorithms were employed to extract white matter lesion volume (WMLV) and number (WMLN). After lesion filling on T 1 images, brain segmentation was performed, and normalized gray matter volume (nGMV), normalized white matter volume (nWMV), and normalized cerebrospinal fluid volume (nCSFV) were obtained by normalizing with total intracranial volume(TIV). Independent sample t-tests, Mann-Whitney U tests, and χ2 tests were used to assess differences in clinical and imaging indicators between the RRMS and HC groups. Spearman′s rank correlation analysis was performed to evaluate the relationship between the ALPS index and clinical and imaging indicators. Results:The ALPS index, FA, and nGMV values were lower in the RRMS group compared to the HC group ( t=2.42, P=0.019; Z=4.85, P<0.001; t=2.56, P=0.013), while the RD value was significantly higher in the RRMS group ( Z=-2.42, P=0.015). No significant difference was found in other clinical and imaging indicators between the two groups ( P>0.05). In the RRMS group, the ALPS index was negatively correlated with WMLV ( r=-0.43, P=0.018) and positively correlated with FA ( r=0.45, P=0.012). There was no correlation between ALPS index and MD values, AD values, RD values, QA values, WLMN values, nGMV values, nMWV values, nCSFV values, TIV values, and duration of the disease ( P>0.05). Conclusions:Patients with RRMS exhibit abnormal diffusion in the perivascular spaces at the lateral ventricular body, suggesting possible glymphatic system dysfunction. The ALPS index is associated with demyelination and neurodegeneration.
7.Topological properties of resting-state functional brain networks in patient with trigeminal neuralgia
Xue BAI ; Qiong WU ; Yang GAO ; He ZHAO ; Shaoyu WANG ; Huapeng ZHANG
Journal of Practical Radiology 2024;40(11):1757-1761
Objective To explore the intrinsic connectivity alterations of brain-wide functional networks in patient with trigeminal neuralgia(TN)via combining resting-state functional magnetic resonance imaging(rs-fMRI)and graph theory methods.Methods A total of 41 patients with TN(TN group)and 41 healthy controls(HC)(HC group)were recruited,and differences in network topologyat-tributes and correlations with clinical variables were analyzed between the two groups.Results Both groups met the σ standard.The global efficiency(Eg)of TN group was lower than that of HC group(P<0.05),whereas the λ of TN group was higher than that of HC group(P<0.05).The node efficiency(Ne)of bilateral rectus gyrus and bilateral pallidum of TN group were significantly higher than those of HC group,while the Ne of left supraparietal gyrus,left angular gyrus,left post-central gyrus,bilateral marginal supraparietal gyrus,and left caudate nucleus of TN group were significantly lower than those of HC group(P<0.05).The local efficiency(Eloc)of the TN group was negatively correlated with the visual analogue scale(VAS)score(P<0.05),the clustering coefficient(Cp)of the TN group was negatively correlated with the short-form McGill pain questionnaire(SF-MPQ)sensory score(P<0.05),and the Ne of right rectus gyrus of the TN group was positively correlated with the disease duration(P<0.05).Conclusion The TN group retain σ,but the overall information transfer efficiency of the brain is reduced and functional integration is diminished.Several brain regions in the TN group has abnormal Ne,which provide an objective basis for altered brain functional networks in TN.
8.Research on content and psychometric properties of evaluations of functioning and adaptive behaviors in children with intellectual and developmental disabilities in educational settings using ICF
Qing ZHANG ; Jiangang SUN ; Hongrong YANG ; Shaoyu GAO ; Aihong WU ; Yongli WANG
Chinese Journal of Rehabilitation Theory and Practice 2024;30(3):249-256
Objective To explore the content and the psychometric properties of assessment tools used for evaluating functioning and adaptive behavior in school-age children with intellectual and developmental disabilities within educational settings. Methods The most used assessment tools included Vineland Adaptive Behavior Scales(VABS),Supports Intensity Scale for Children(SIS-C),Strengths and Difficulties Questionnaire(SDQ)and Repetitive Behavior Scale-Revised(RBS-R),for assessing functioning and adaptive behavior children with intellectual and developmental disabili-ties.Employing the framework and methods of the International Classification of Functioning,Disability,and Health(ICF),this research encoded and categorized the assessment dimensions and items of the four tools,and explored their psychometric properties. Results VABS's assessment content was solely focused on activities and participation,including speaking(d330),con-versation(d350),toileting(d530),eating(d550),drinking(d560),basic interpersonal interactions(d710),com-plex interpersonal interactions(d720),changing and maintaining body positions(d410-d429),carrying,moving and handing objects(d430-d449),and walking and moving(d450-d469).SIS-C assessed activities and participa-tion,and environmental factors,including washing oneself(d510),caring for body parts(d520),community life(d910),using transportation(d470),school education(d820),basic learning(d130-d159),looking after one's health(d570),basic interpersonal interactions(d710),and products and technology for education(e130).SDQ fo-cused on body functions,and activities and participation,including emotional functions(b152),global psychoso-cial functions(b122),attention functions(b140),and basic interpersonal interactions(d710).RBS-R focused on body functions,and activities and participation,including involuntary movement reaction functions(b755),invol-untary movement functions(b765),looking after one's health(d570),energy and drive functions(b130),under-taking a single task(d210),carrying out daily routine(d230),attention functions(b140),and handling stress and other psychological demands(d240).VABS was characterized by good specificity and excellent sensitivity.SIS-C demonstrated very good internal consistency,reliability and validity.SDQ was good in internal consistency,with excellent credibility and validity.RBS-R showed good internal consistency,reliability and validity. Conclusion SDQ and RBS-R cover both body functions,and activities and participation,SIS-C covers activity and par-ticipation,and environmental factors,while VABS solely assesses activities and participation.In terms of body functions,the assessment items primarily focus on mental functions(b130-b189)and movement functions(b750-b799).For activities and participation,the tools assess content across eight domains of functioning.Regarding en-vironmental factors,the assessment content mainly includes products and technology for education(e130),as well as design,construction and building products and technology of buildings for public use(e150).VABS,SIS-C,SDQ,and RBS-R are all norm-referenced measures,with moderate to excellent internal consistency,and good to excellent reliability and validity.
9.Effect of probiotics on the cognitive function of patients with schizophrenia
Caixia WANG ; Shaoyu ZHOU ; Wen ZHU ; Danqing GAO ; Longmei ZHOU ; Xiaoping SHI ; Zhenghui YI
Journal of Chinese Physician 2022;24(7):1032-1036
Objective:To explore the effect of probiotics on the cognitive function of patients with schizophrenia.Methods:100 schizophrenic patients admitted to Shanghai Jinshan District Mental Health Center from January 2019 to January 2021 were randomly divided into the conventional group (treated with atypical antipsychotics combined with placebo, 50 cases) and the intervention group (treated with atypical antipsychotics combined with probiotics, 50 cases). Before treatment and 3 months after treatment, the feces of the patients were taken for DNA detection to compare the composition of intestinal flora. The cognitive function of the patients was assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and the mental state of the patients was assessed by the Positive and Negative Symptom Scale(PANSS). The incidence of adverse drug reactions was compared between the two groups.Results:Before treatment, the relative abundance of Fusobacteria, Proteus and Actinobacteria in the two groups had no statistical significant difference (all P>0.05); After 3 months of treatment, the relative abundance of Fusobacteria, Proteus and Actinobacteria in the two groups decreased compared with that before treatment, and the decline was more significant in the intervention group (all P<0.05). Before treatment, there was no significant difference in immediate memory, visual span, speech function, attention function, delayed memory and RBANS between the two groups (all P>0.05); After 3 months of treatment, the scores of immediate memory, visual span, speech function, attention function, delayed memory and RBANS in the two groups were higher than those before treatment, and the increase was more significant in the intervention group (all P<0.05). Before treatment, there was no significant difference in PANSS scores between the two groups ( P>0.05); After 3 months of treatment, PANSS scores in both groups decreased compared with those before treatment, and the decrease degree in the intervention group was higher than that in the conventional group (all P<0.05). During the three months of treatment, there was no significant difference in the incidence of adverse drug reactions between the two groups ( P>0.05). Conclusions:Probiotics are used in adjuvant therapy for patients with schizophrenia, which can regulate the patients′ intestinal flora, improve patients′ cognitive function and mental disorders, and do not increase the incidence of adverse drug reactions. They have significant clinical efficacy and high treatment safety.
10.Synthesis of N-(2-18F-fluoropropionyl)-L-glutamine and its biodistribution study in mice
Caihua TANG ; Ganghua TANG ; Siyuan GAO ; Shaoyu LIU ; Fuhua WEN ; Dahong NIE
Chinese Journal of Nuclear Medicine and Molecular Imaging 2016;36(2):112-115
Objective To synthesize 18F labeled N-(2-18 F-fluoropropionyl)-L-glutamine (18 F-FPGLN) for tumor PET imaging,and to perform its biodistribution study on normal mice and PC-3 tumorbearing nude mice.Methods 4-nitrophenyl-2-18F-fluoropropionate (18F-NFP) was synthesized on the MF2V-IT-I synthesizer and was purified by semi-preparative HPLC.Anhydrous 18F-NFP was added to a solution of L-glutanine t-butyl ester to synthesize 18F-FPGLN t-butyl ester,which was hydrolyzed by HCl (3 mol/L) and neutralized with NaOH (2 mol/L) solution.18F-FPGLN product was collected for further study.Biodistribution study was performed on normal Kunming mice and PC-3 prostate cancer tumor-bearing nude mice,respectively.Results 18F-FPGLN was synthesized with 10%-15% (decay uncorrected) overall radiochemical yield after 130 min of radiosynthesis.The radiochemical purity was higher than 96%.Rapid and high uptake of radiotracer was observed within the kidneys,and was quickly excreted through the urinary bladder.The uptake in kidney reached (35.0±1.2) %ID/g at 5 min post-injection,and descended to (1.5±0.3) %ID/g at 120 min.The liver,lung,heart and small intestine showed relatively moderate uptake of radioactivity.The uptake in the pancreas,muscle,spleen,stomach and brain was low,and the lowest uptake of (1.5±0.3) %ID/g was found in the brain at 30 min post injection.High accumulation of 18F-FPGLN in PC-3 xenograft was observed,and the tumor/muscle ratio reached 2.07 at 60 min post injection.Conclusion A novel N-position 18F-labeled glutamine analogs 18F-FPGLN,with favorable pharmacokinetic characteristics,is synthesized successfully,which makes it possible to perform tumor PET imaging using 18F-FPGLN subsequently.

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