1.Outcome indicators in randomized controlled trials of traditional Chinese medicine treatment of post-stroke depression.
Jin HAN ; Yue YUAN ; Fang-Biao XU ; Yan-Bo SONG ; Yong-Kang SUN ; Xin-Zhi WANG
China Journal of Chinese Materia Medica 2025;50(2):542-559
This study systematically reviewed the randomized controlled trial(RCT) of traditional Chinese medicine(TCM) treatment of post-stroke depression(PSD) and analyzed the clinical study characteristics and outcome indicators, aiming to optimize the design and establish the core outcome set in the future clinical trials of the TCM treatment of PSD. PubMed, Web of Science, Cochrane Library, EMbase, CNKI, VIP, Wanfang, and SinoMed were searched for the relevant RCT published in recent 3 years. The basic characteristics, intervention measures, and outcome indicators of the included RCT were extracted, and the descriptive analysis was carried out. A total of 76 RCTs were eventually included, with the sample size concentrated in 80-100 cases. The most frequent TCM syndromes were liver depression and Qi stagnation(15 times, 31.91%) and phlegm combined with stasis(5 times, 10.63%). The frequency of intervention methods followed a descending trend of TCM decoction(35 times, 46.05%) and TCM decoction + acupuncture(4 times, 5.26%), Chinese patent medicine(3 times, 3.94%), and the intervention mainly lasted for 1 to 3 months(43 times, 60.56%). The adverse reactions of patients were mainly digestive system reaction(150 patients, 39.37%) and nervous system reaction(112 patients, 29.39%). Most of the included studies had unclear risk of bias, involving 84 outcome indicators, which belonged to 8 indicator domains. The RCTs of TCM treatment of PSD showed a variety of problems, such as non-standard TCM syndrome differentiation, inconsistent names of TCM syndrome scores and measurement tools, low quality, unclear risk of bias, neglect of endpoint indicators, unreasonable selection of substitute indicators, lack of differentiation between primary and secondary outcome indicators, non-standard reporting of safety indicators, insufficient attention to economic indicators, and lack of long-term prognosis evaluation. It is suggested that the future research should improve the quality of methodology and build a standardized core outcome set to promote the development of high-quality clinical research in this field.
Humans
;
Randomized Controlled Trials as Topic
;
Drugs, Chinese Herbal/administration & dosage*
;
Stroke/psychology*
;
Depression/etiology*
;
Treatment Outcome
;
Medicine, Chinese Traditional
2.Network Meta-analysis of efficacy of different Chinese medicine injections in treating transient ischemic attack.
Jin HAN ; Yong-Kang SUN ; Yue YUAN ; Fang-Biao XU ; Yan-Bo SONG ; Wei-Jie WANG ; Xin-Zhi WANG
China Journal of Chinese Materia Medica 2025;50(8):2282-2297
This study aims to evaluate the efficacy of Chinese medicine injections in treating transient ischemic attack(TIA) based on network Meta-analysis. Randomized controlled trial(RCT) about Chinese medicine injections in treating TIA were retrieved from PubMed, Web of Science, Cochrane Library, EMbase, CNKI, VIP, Wanfang, and SinoMed with the time interval from inception to March 1, 2024. The methodological quality of the included articles was assessed by ROB 2.0, and the GRADE system was employed to evaluate the quality of evidence. The gemtc package of R 4.1.2 was used to perform the network Meta-analysis. Finally, 63 RCTs with a total sample size of 5 750 cases were included, involving 11 Chinese medicine injections(Shuxuetong Injection, Danhong Injection, Shuxuening Injection, Ginkgo Damo Injection, Shenxiong Glucose Injection, Ligustrazine Injection, Salviae Miltiorrhizae and Ligustrazine Hydrochloride Injection, Salvianolic Acids for Injection, Dengzhan Xixin Injection, Guhong Injection, and Xueshuantong Injection). All patients received conventional western medicine treatment, and the experimental group was additionally treated with Chinese medicine injection. Network Meta-analysis yielded the following results.(1) In terms of improving the clinical total response rate, 11 Chinese medicine injections combined with conventional western medicine outperformed conventional western medicine alone, and Dengzhan Xixin Injection + conventional western medicine had the best effect.(2) In terms of reducing plasma viscosity, 7 Chinese medicine injections combined with conventional western medicine outperformed conventional western medicine alone, and Shenxiong Glucose Injection + conventional western medicine had the best effect.(3) In terms of reducing whole blood high shear viscosity, 6 Chinese medicine injections combined with conventional western medicine outperformed conventional western medicine alone, and Guhong Injection + conventional western medicine had the best effect.(4) In terms of reducing whole blood low shear viscosity, 6 Chinese medicine injections combined with conventional western medicine outperformed conventional western medicine alone, and Shuxuening Injection + conventional western medicine had the best effect.(5) In terms of reducing fibrinogen, 9 Chinese medicine injections combined with conventional western medicine outperformed conventional western medicine alone, and Ginkgo Damo Injection + conventional western medicine had the best effect.(6) In terms of increasing the average blood flow velocity, 3 Chinese medicine injections combined with conventional western medicine outperformed conventional western medicine alone, and Shuxuening Injection + conventional western medicine had the best effect. In summary, compared with conventional western medicine alone, Chinese medicine injections combined with conventional western medicine were effective in improving the clinical total response rate and the average blood flow velocity, as well as reducing plasma viscosity, whole blood high shear viscosity, whole blood low shear viscosity, and fibrinogen. However, due to the limited quality and quantity of the included articles, the above conclusions need to be verified by more high-quality, multi-center, and large-sample RCT.
Humans
;
Drugs, Chinese Herbal/administration & dosage*
;
Injections
;
Ischemic Attack, Transient/drug therapy*
;
Randomized Controlled Trials as Topic
;
Treatment Outcome
3.Percutaneous endoscopic discectomy with lateral approach and dual-channel method for the treatment of highly free lumbar disc herniation.
Qi-Ming CHEN ; Chun-Hua YU ; Gang CHEN ; Han-Rong XU ; Yi-Biao JING ; Yin-Jiang LU ; Shan-Chun TAO ; Jian-Bo WU
China Journal of Orthopaedics and Traumatology 2025;38(9):924-929
OBJECTIVE:
To explore clinical efficacy of percutaneous endoscopic discectomy with a lateral approach and dual-channel method in treating highly free lumbar disc herniation(LDH).
METHODS:
A retrospective analysis was conducted on 54 patients with highly free LDH who were treated with spinal endoscopic techniques from January 2021 to December 2022. Twenty-seven patients were treated with lateral approach dual-channel(lateral approach dual-channel group), including 16 males and 11 females, with an average age of (54.6±10.5) years old. Twenty-seven patients were treated with unilateral biportal endoscopic (UBE group), including 17 males and 10 females, with an average age of (52.9±12.3) years old. The number of intraoperative fluoroscopy, operation time and hospital stay, as well as visual analogue scale (VAS) and Oswestry diability index (ODI) of low back and leg pain between two patients before operation, 1 day, 1, 3, and 12 months after operation, and the efficacy was evaluated by the modified MacNab criteria at 12 mohths after operation.
RESULTS:
All patients were successfully completed surgical and were followed up, the time raged from 12 to 22 months with an average of (13.57±4.12) months. There was no statistically significant difference in operation time between two groups (P>0.05). The hospital stay of lateral approach dual-channel group was (3.9±1.1) days, which was shorter than that of UBE group (6.5±1.4) days, the number of intraoperative fluoroscopy in lateral approach dual-channel group was (12.7±2.1) times, which was more than that in UBE group (6.6±1.3) times, the differences were statistically significant (t=5.197, -7.532;P<0.05). VAS and ODI for low back pain at 1 day and 1 month after operation, and VAS for leg pain at 1 day after operation of lateral approach dual-channel group were superior to those of UBE group, and the differences were statistically significant (P<0.05). However, there were no statistically significant differences in VAS and ODI for low back and leg pain between two groups before operation and 3 and 12 months after operation (P>0.05). VAS and ODI of low back and leg pain were significantly improved at each time point before and after operation in both groups, and the difference were statistically significant (P<0.05). At 12 months after operation, according to the modified MacNab criteria, the excellent and good rates of therapeutic effects between lateral approach dual-channel group and UBE group were 92.6% (25/27) and 88.9% (24/27), respectively, and the difference was not statistically significant (χ2=0.22, P>0.05).
CONCLUSION
For patients with highly free lumbar intervertebral disc protrusion, both of lateral approach dual-channel method and UBE endoscopic surgery are safe and effective. Endoscopic surgery with lateral approach and dual-channel method could be performed under local anesthesia, allowing for the removal of the nucleus pulposus under direct vision. It is simpler, more efficient.
Humans
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Male
;
Female
;
Intervertebral Disc Displacement/surgery*
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Middle Aged
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Diskectomy, Percutaneous/methods*
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Lumbar Vertebrae/surgery*
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Endoscopy/methods*
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Adult
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Retrospective Studies
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Aged
4.WW domain-containing ubiquitin E3 ligase 1 regulates immune infiltration in tumor microenvironment of ovarian cancer.
Xiaojuan GUO ; Ruijuan DU ; Liping CHEN ; Kelei GUO ; Biao ZHOU ; Hua BIAN ; Li HAN
Journal of Southern Medical University 2025;45(5):1063-1073
OBJECTIVES:
To explore the association of the expression of WW domain-containing ubiquitin E3 ligase 1 (WWP1) with immune infiltration in tumor microenvironment (TME) of ovarian cancer.
METHODS:
Ovarian cancer patient data from The Cancer Genome Atlas (TCGA) were used to analyze the association of WWP1 expression with patient prognosis. TISCH2 was utilized to analyze the changes in immune cell subtypes in TME of metastatic tumor and after chemotherapy. The impact of WWP1 on immune cell infiltration, somatic copy number alterations of WWP1 and evolution of immune cell subtypes was evaluated using TIMER and TIGER pseudo-time analysis. A deep learning model was used to analyze TCGA pathological images to investigate the effect of WWP1 on TME of ovarian cancer. RNA-seq analysis was conducted to identify the differentially expressed genes in WWP1-overexpressing SKOV3 cells and validate immune infiltration. Multicolor immunofluorescence assay was used to analyze the immune markers in SKOV3 and SKOV3/DDP cell xenografts in nude mice.
RESULTS:
The patients with high WWP1 expression levels had significantly lower overall survival rate (P=0.0012). High WWP1 expression levels and Stage IV disease were both associated with a poor prognosis (P<0.05). In metastatic ovarian cancer or after chemotherapy, the percentages of malignant tumor cells and tumor-associated fibroblasts increased in the TME, accompanied by elevated WWP1 levels. WWP1 expression level was positively correlated with pro-tumorigenic immunosuppressive cells (r=0.1323-0.3955, P<0.05) and negatively with tumor-inhibiting immune cells (r=-0.1949- -0.1333, P<0.05). Specific copy number alterations of WWP1 also influenced CD8+ T cell percentage and neutrophil infiltration levels in the TME. RNA-seq analysis of WWP1-overexpressing SKOV3 cells and immunofluorescence assay of the tumor-bearing mice yielded findings consistent with those of bioinformatics analysis.
CONCLUSIONS
WWP1 may serve as a prognostic biomarker and a potential target for immune regulation in the TME of ovarian cancer.
Female
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Ovarian Neoplasms/genetics*
;
Humans
;
Ubiquitin-Protein Ligases/metabolism*
;
Tumor Microenvironment/immunology*
;
Animals
;
Mice
;
Cell Line, Tumor
;
Mice, Nude
;
Prognosis
;
Gene Expression Regulation, Neoplastic
5.Longitudinal Associations between Vitamin D Status and Systemic Inflammation Markers among Early Adolescents.
Ting TANG ; Xin Hui WANG ; Xue WEN ; Min LI ; Meng Yuan YUAN ; Yong Han LI ; Xiao Qin ZHONG ; Fang Biao TAO ; Pu Yu SU ; Xi Hua YU ; Geng Fu WANG
Biomedical and Environmental Sciences 2025;38(1):94-99
6.Preparation and efficacy of a circRNA vaccine with herpes simplex virus type Ⅱ gD as immunogen.
Suixin ZHANG ; Xiaodi ZHENG ; Peng NI ; Zhong WANG ; Biao LIU ; Yang WANG ; Han HU ; Binlei LIU
Chinese Journal of Biotechnology 2025;41(4):1354-1371
This study investigated the specific immune response of BALB/c mice that was induced by a circular RNA (circRNA) vaccine expressing the herpes simplex virus type II (HSV-2) glycoprotein D (gD). The aim was to evaluate the immunological potential of this vaccine and lay a foundation for developing an mRNA vaccine against HSV-2. PCR and homologous recombination were employed to integrate the gD gene obtained from the pT7AMP-gD ectodomain plasmid into pUC57 to generate the recombinant plasmid pUC57-circ-gD, which was then sequenced and characterized. In vitro transcription and cyclization were performed on the template DNA to generate pUC57-circ-gD mRNA. To validate the formation of circular RNA, we cleaved the pUC57-circ-gD mRNA with RNase R and employed RT-PCR to validate the cyclization. The pUC57-circ-gD mRNA was then transfected into 293T cells. After 72 h, the cell supernatant was collected, and Western blotting was employed to measure the protein level of gD. Subsequently, the mRNA was encapsulated in lipid nanoparticles (LNPs) by microfluidic encapsulation. BALB/c mice were administrated with the encapsulated mRNA, and blood was collected from the fundus venous plexus after 21 and 35 days, and from the enucleated eyeballs after 49 days. Enzyme-linked immunosorbent assay was employed to measure the titers of antibodies, including virus-neutralizing antibodies. After 49 days, spleens were harvested and assessed for secretion of interferon-gamma (IFN-γ) by solid-phase enzyme-linked immunospot. The results showed successful construction and sequencing of the recombinant plasmid. RNase R digestion confirmed the presence of circular RNAs. Western blotting of the 293T cells transfected with the mRNA showed clear specific bands. The quality of the vaccine was tested by size exclusion chromatography-high performance liquid chromatography, which showed that the purity of the vaccine was about 90%. The mRNA-LNP showcased the particle size of 82.76 nm and an encapsulation rate of approximately 98%. Following three-dose vaccination, all immunized mice exhibited steady weight gain with 100% survival rate throughout the 28-day observation period, indicating no significant acute toxicity associated with the vaccine formulation. The immunized mice showed dose-dependent increases in serum IgG antibody titer and IFN-γ secretion by splenocytes and they were resistant to virus attacks. These findings indicate good immunogenicity and persistence of the pUC57-circ-gD mRNA vaccine, providing a reference for further studies on circRNA vaccines.
Animals
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Mice, Inbred BALB C
;
RNA, Circular
;
Mice
;
Humans
;
Herpesvirus 2, Human/genetics*
;
Viral Envelope Proteins/genetics*
;
Antibodies, Viral/blood*
;
HEK293 Cells
;
Female
;
Nanoparticles
;
Plasmids
7.Development, reliability evaluation and validity of a health sevice experience assessment tool for patients with pulmonary tuberculosis
Jiajia YAO ; Yutong HAN ; Beibei CHE ; Danni LI ; Biao XU ; Qi ZHAO
Shanghai Journal of Preventive Medicine 2025;37(10):871-877
ObjectiveTo develop a scientifically rigorous and contextually appropriate instrument for evaluating the health service experience of pulmonary tuberculosis patients in China, to enable systematic assessment of core medical care dimensions, and to provide quantitative evidence for service improvement. MethodsGrounded in the theoretical framework of healthcare accessibility and the clinical care pathway for tuberculosis patients, the tool was developed through a systematic literature review and the Delphi expert consultation method. A multi-stage cluster sampling strategy was employed to survey pulmonary tuberculosis patients who had been receiving treatment for more than two months, aimed to explore the scale’s applicability in real-world settings. Reliability was assessed using Cronbach’s α and split-half reliability coefficients. Validity was evaluated through content validity, structural validity, convergent validity, and discriminant validity. ResultsThe tool was composed of 21 items across four dimensions: awareness, accessibility, affordability, and acceptability of tuberculosis medical care. It demonstrated a Cronbach’s α coefficient of 0.838 and a split-half reliability coefficient of 0.859. Exploratory factor analyses extracted six factors: satisfaction with healthcare services, supportive role of nurses, affordability of treatment costs, doctor-patient communication, waiting time for medical appointments, and transportation cost. The goodness-of-fit index (GFI) and other indices met the recommended standards, with the loading matrix indicating robust structural validity of the tool. The constructed factor model exhibited satisfactory content validity and discriminant validity. ConclusionThe scale for assessing patients’ experiences with tuberculosis-related medical care developed in this study demonstrates good reliability and validity and serves as a practical tool for evaluating patient experiences of tuberculosis medical care in China.
8.Dosimetric study of intensity-modulated radiotherapy and volumetric intensity modulated arc therapy based on the inner edge tangent field for radiotherapy after breast-conserving surgery of left-sided breast cancer
Biao ZHAO ; Qin PU ; Meifang YUAN ; Lishuang MA ; Han LI ; Yi YANG ; Chaoxi SUN
Journal of International Oncology 2024;51(7):441-447
Objective:To explore the dosimetry difference between intensity-modulated radiotherapy (IMRT) and volumetric intensity modulated arc therapy (VMAT) based on the inner edge tangent field (IETF) after left-sided breast conserving surgery.Methods:The localization CT and target organ at risk (OAR) data of 35 patients with left-sided breast cancer treated with IMRT after breast conserving surgery at Department of Radiotherapy in Yunnan Cancer Hospital from June 2022 to June 2023 were selected. The IETF-IMRT and the IETF-VMAT plans were designed for the same patient based on IETF, the dosimetry differences of target areas and OAR, as well as the planned execution time were compared between the two groups.Results:Dosimetry of target areas: for IETF-IMRT and IETF-VMAT, the D 98% of the planning target volume were (47.92±0.51) and (48.21±0.33) Gy, respectively, while the D 50% were (52.04±0.22) and (51.91±0.26) Gy, respectively, and the D 2% were (53.93±0.36) and (53.62±0.41) Gy, respectively, the conformity index were 0.84±0.03 and 0.87±0.02, respectively, while the homogeneity index were 0.12±0.01 and 0.10±0.01, respectively, with statistically significant differences ( t=-3.87, P<0.001; t=3.53, P=0.001; t=5.30, P<0.001; t=-13.60, P<0.001; t=6.24, P<0.001). Dosimetry of OAR: for IETF-IMRT and IETF-VMAT, the left lung V 5 were (31.91±6.28) % and (33.99±6.31) %, respectively, and the V 20 were (11.71±2.06) % and (9.73±2.12) %, respectively, with statistically significant differences ( t=-4.18, P<0.001; t=12.40, P<0.001). The right lung V 5 were (0.11±0.08) % and (7.13±3.12) %, respectively, and the D mean were (1.05±0.12) and (2.71±0.27) Gy, respectively, with statistically significant differences ( t=-33.62, P<0.001; t=-13.30, P<0.001). The spinal cord D 2% were (1.08±0.11) and (4.83±1.40) Gy, respectively, with a statistically significant difference ( t=-15.99, P<0.001). The left lung D mean were (7.45±1.08) and (7.37±1.03) Gy, the heart D mean were (4.21±0.96) and (4.41±0.48) Gy, and the right-sided breast D mean were (3.74±1.52) and (3.48±1.11) Gy, respectively, with no statistically significant difference ( t=1.16, P=0.253; t=-1.76, P=0.088; t=1.41, P=0.169). Planned execution time: the execution time of IETF-IMRT and IETF-VMAT was (10.73±1.21) and (2.18±0.17) min, respectively, with a statistically significant difference ( t=44.71, P<0.001) . Conclusion:Both IETF-IMRT and IETF-VMAT can meet clinical requirements, however the two techniques have their own characteristics. IETF-VMAT has better conformity and homogeneity of target region. The planned OAR dosimetry in both plans are significantly lower than the dose limit of postoperative radiotherapy for breast cancer, among which the left lung V 5, the right lung V 5, D mean and spinal cord D 2% of IETF-IMRT are slightly lower, the left lung V 20 of IETF-VMAT is slightly lower. IETF-VMAT significantly reduces the planned execution time compared with IETF-IMRT, thus can greatly reduce the dose deviation caused by patient position change, and significantly improve patients experience and comfort of radiotherapy. Taken together, IETF-VMAT has advantages over IETF-IMRT in radiotherapy after breast conserving surgery of left-sided breast cancer.
9.Prevalence of fatigue in patients with multiple system atrophy and its relationship with depression
Jing PAN ; Jia KANG ; Xin WANG ; Rihan HAI ; Xiaoyu HAN ; Biao CHEN
Chinese Journal of Geriatrics 2024;43(5):581-585
Objective:Fatigue is one of the common disabling non-motor symptoms of multiple system atrophy(MSA).This study aimed to investigate the prevalence of fatigue in MSA patients and its relationship with anxiety and depression.Methods:In this cross-sectional study, 44 MSA inpatients from Xuanwu Hospital of Capital Medical University were enrolled.Fatigue was defined as a Fatigue Severity Scale(FSS)score ≥4.The motor symptoms of the patients were evaluated using the Unified Parkinson's Disease Rating Scale(MDS-UPDRS)and Unified Multi-System Atrophy Rating Scale(UMSARS).The Hamilton Rating Scale for Depression(HAMD), Geriatric Depression Scale(GDS)and Hamilton Anxiety Scale(HAMA)were used to assess anxiety and depression.Results:The mean age of the MSA patients was 60.1±6.4 years, and the score of FSS was 4.3±2.4, with 28 patients(63.6%)having fatigue.Compared with the non-fatigue group, the fatigue group showed clear anxiety(HAMA: 16.5±8.9 vs.9.4±5.0, t=-2.292, P=0.010)and depression(HAMD: 14.4±7.0 vs.8.4±3.4, t=6.192, P=0.017; GDS: 18.2±7.4 vs.10.7±5.2, t=-3.560, P=0.044).The severity of fatigue in MSA patients was positively correlated with anxiety( r=0.516, P<0.001), depression(HAMD: r=0.551, P<0.001; GDS: r=0.636, P=0.000)and the score of activities of daily living( r=0.320, P=0.034), but not correlated with motor symptoms or disease severity. Conclusions:Nearly two-thirds of MSA patients have symptoms of fatigue, and fatigue is significantly associated with levels of anxiety and depression, affecting patients' mood and activities of daily living.
10.A cross-sectional study on the relationship between 24-hour activities and depressive symptoms in vocational school students
Biao-Qian TANG ; Bo-Hao CHEN ; Yi-Yang LI ; Han-Qing LIU ; Shu-Qing XU ; Shu-Mei WANG
Fudan University Journal of Medical Sciences 2024;51(2):159-165
Objective An isotemporal substitution model was used to explore the associations between activities including 10 minutes per day of physical activity(PA),sedentary behavior(SB),and sleep(SLP),and depressive symptoms among vocational school students with and without depressive symptoms.Methods Questionnaire survey was conducted on grade one to grade three students attending vocational schools in Shanghai and Jiangsu Province from Dec 2021 to Jan 2022.Fourteen schools were selected using the convenience cluster sampling method.The selected students were categorized into depressive symptoms group and non-depressive symptoms group according to the Centre for Epidemiologic Studies Depression Scale(CES-D)scores.Results A total of 40 339 questionnaires were collected,of which 10 086 were able to clearly remember the time of physical activity in the past week,and 8 149 were valid after data cleaning.According to the valid questionnaires,5 496 students(67.44%)were in the non-depressive symptoms group and 2 653(32.56%)were in the depressive symptoms group.The mean age of the students were(16.70±1.19)years.In the non-depressive symptoms group,substituting moderate physical activity(MPA)for all the other behaviors was negatively associated with CES-D scores,while substituting vigorous physical activity(VPA)for MPA and SB was positively associated with CES-D scores.In the depressive symptoms group,substituting walking,SB,and SLP with MPA was negatively associated with CES-D scores,respectively.The associations of MPA substituted for walking,SB,and SLP with CES-D scores were much stronger in the depressive symptoms group than in the non-depressive symptoms group.Conclusion The detection rate of depressive symptoms was high among vocational students.Substituting MPA for walking,SB,and SLP were negatively associated with CES-D scores,with a stronger association observed in the depressive symptoms group than in the non-depressive symptoms group.

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