1.Safety of teriflunomide in Chinese adult patients with relapsing multiple sclerosis: A phase IV, 24-week multicenter study.
Chao QUAN ; Hongyu ZHOU ; Huan YANG ; Zheng JIAO ; Meini ZHANG ; Baorong ZHANG ; Guojun TAN ; Bitao BU ; Tao JIN ; Chunyang LI ; Qun XUE ; Huiqing DONG ; Fudong SHI ; Xinyue QIN ; Xinghu ZHANG ; Feng GAO ; Hua ZHANG ; Jiawei WANG ; Xueqiang HU ; Yueting CHEN ; Jue LIU ; Wei QIU
Chinese Medical Journal 2025;138(4):452-458
BACKGROUND:
Disease-modifying therapies have been approved for the treatment of relapsing multiple sclerosis (RMS). The present study aims to examine the safety of teriflunomide in Chinese patients with RMS.
METHODS:
This non-randomized, multi-center, 24-week, prospective study enrolled RMS patients with variant (c.421C>A) or wild type ABCG2 who received once-daily oral teriflunomide 14 mg. The primary endpoint was the relationship between ABCG2 polymorphisms and teriflunomide exposure over 24 weeks. Safety was assessed over the 24-week treatment with teriflunomide.
RESULTS:
Eighty-two patients were assigned to variant ( n = 42) and wild type groups ( n = 40), respectively. Geometric mean and geometric standard deviation (SD) of pre-dose concentration (variant, 54.9 [38.0] μg/mL; wild type, 49.1 [32.0] μg/mL) and area under plasma concentration-time curve over a dosing interval (AUC tau ) (variant, 1731.3 [769.0] μg∙h/mL; wild type, 1564.5 [1053.0] μg∙h/mL) values at steady state were approximately similar between the two groups. Safety profile was similar and well tolerated across variant and wild type groups in terms of rates of treatment emergent adverse events (TEAE), treatment-related TEAE, grade ≥3 TEAE, and serious adverse events (AEs). No new specific safety concerns or deaths were reported in the study.
CONCLUSION:
ABCG2 polymorphisms did not affect the steady-state exposure of teriflunomide, suggesting a similar efficacy and safety profile between variant and wild type RMS patients.
REGISTRATION
NCT04410965, https://clinicaltrials.gov .
Humans
;
Crotonates/adverse effects*
;
Toluidines/adverse effects*
;
Nitriles
;
Hydroxybutyrates
;
Female
;
Male
;
Adult
;
ATP Binding Cassette Transporter, Subfamily G, Member 2/genetics*
;
Middle Aged
;
Multiple Sclerosis, Relapsing-Remitting/genetics*
;
Prospective Studies
;
Young Adult
;
Neoplasm Proteins/genetics*
;
East Asian People
2.Severe COVID-19 and inactivated vaccine in diabetic patients with SARS-CoV-2 infection.
Yaling YANG ; Feng WEI ; Duoduo QU ; Xinyue XU ; Chenwei WU ; Lihua ZHOU ; Jia LIU ; Qin ZHU ; Chunhong WANG ; Weili YAN ; Xiaolong ZHAO
Chinese Medical Journal 2025;138(10):1257-1259
3.Endoscopic and pathological features of 17 cases of colorectal cap polyposis
Xinyue GAO ; Zhenkai WANG ; Shuliang HUANG ; Dianmei HAN ; Yueyang LU ; Qin SHEN
Chinese Journal of Clinical and Experimental Pathology 2025;41(10):1314-1318
Purpose To explore the clinicopathological features and endoscopic manifestations of cap polyposis(CP).Methods Clinical,endoscopic,pathological,and follow-up data of 17 cases of CP were collected and ana-lyzed.Results There were 14 males and 3 females,aged 15-67 years,with a mean age of 36.5 years.The disease duration ranged from 2 weeks to 5 years,and most patients(64.7%,11/17)had symptoms for more than l year.The most common clinical manifestation was hematochezia(82.4%,14/17),while constipation was generally absent.En-doscopically,all lesions(100%,17/17)were located in the anal canal and lower rectum.The surface was invariably covered with a thick whitish exudate(100%,17/17),and annular growth was the most frequent pattern(76.5%,13/17).Pathologically,the mucosal layer was almost entirely replaced by granulation tissue,and the surface showed extensive inflammatory necrosis forming a cap-like structure.Conclusion CP predominantly occurrs in the anal canal and lower rectum of young men.The presence of abundant whitish exudate under endoscopy is differential diagnostic value.Complete endoscopic resection followed by pathological examination is required for definitive diagnosis.
4.Analysis of human bocavirus characteristics in children with acute respiratory infections in Bengbu City, Anhui province, 2024
Xinyue CHEN ; Yingli QU ; Jin CAO ; Wenyan TIAN ; Guangyu XUE ; Yuting HU ; Qin LUO ; Qinqin SONG ; Haijun DU ; Guoyong MEI ; Zhiqiang XIA ; Juan SONG ; Jun HAN ; Guoyu LU
Chinese Journal of Experimental and Clinical Virology 2025;39(2):214-218
Objective:To determine the epidemiological characteristics of human bocavirus (HBoV) in children with acute respiratory infections (ARI) in Bengbu City, Anhui Province, in 2024.Methods:Nasopharyngeal swab samples were collected from 269 children with ARI in Bengbu City, Anhui Province, in 2024. Seventeen respiratory pathogens were screened using quantitative fluorescence PCR. For HBoV-positive samples, the VP1/VP2 structural gene fragments of HBoV were amplified and sequenced for genetic evolutionary analysis.Results:Among the 269 nasopharyngeal swab samples from children with ARI, the overall detection rate of respiratory pathogens was 48.33% (103/269). The top three pathogens with the highest detection rates were: Influenza A virus (FluA): 10.04% (27/269), Respiratory syncytial virus (RSV): 8.18% (22/269), Human bocavirus (HBoV): 7.43% (20/269). The age distribution of HBoV-infected children showed that the detection rate was highest in the 0-2 years age group (50%, 10/20), followed by the 3-5 years age group (25%, 5/20) and the over 6 years age group (25%, 5/20). However, there was no statistically significant difference in viral detection rates among the age groups. Genetic evolutionary analysis based on VP1/VP2 revealed that all 13 HBoV strains were of the HBoV-1 genotype.Conclusions:HBoV is one of the major pathogens causing ARI in children in Bengbu City, Anhui Province, in 2024, with HBoV-1 being the predominant genotype. Additionally, infants aged 0-2 years are the most susceptible population to HBoV infection.
5.A study on user persona of bone transport patients in self-management during home rehabilitation
Huijie CHEN ; Huijuan SONG ; Ying REN ; Ping WANG ; Xinyue LUO ; Chenghe QIN ; Jinghua YANG
Chinese Journal of Orthopaedic Trauma 2025;27(8):726-731
Objective:To construct the user personas of the patients who practice self-management home rehabilitation after lower limb bone transport by exploring their self-management experiences and needs in rehabilitation at home so as to provide targeted countermeasures for related medical staff.Methods:A purposive sampling method was employed to select the 21 patients who had undergone home rehabilitation after lower limb bone transport at Department of Orthopedic Trauma, Nanfang Hospital from September to December 2024. The cohort included 12 males and 9 females, with an age of (39.8±15.1) years. The phenomenological research method was used to conduct semi-structured interviews with this cohort. After the data from interviews were explored by the Colaizzi 7-step analysis to extract the factual labels, role dimension models were built, covering 3 dimensions: description, characteristics (basic, cognitive, behavioral, social support, and psychological adjustment characteristics) and needs.Results:All patients were interviewed. Four user personas were constructed, including self-awareness growth type (5 cases), emotional dependency-driven type (4 cases), risk-aversion procrastination type (7 cases), and management motivation-impaired type (5 cases). The patients of self-awareness growth type were 21 to 36 years old and received high school or university education, characterized by high self-efficacy, active measures to improve and maintain their state of rehabilitation, good management of negative emotions, and a low sense of stigma. The patients of emotional low-driven type were 42 to 74 years old and received their education in a primary school or junior high school, characterized by lack of independence, dependence on others for rehabilitation management, common management of negative emotions, low self-efficacy, and a strong sense of stigma. The patients of risk-aversion procrastination type were 33 to 56 years old and received their education in a junior or senior high school, characterized by a willingness to cooperate but insufficient motivation for rehabilitation management, an awareness of rehabilitation which was vulnerable to external factors, common management of negative emotions, low self-efficacy, and a strong sense of stigma. The patients of management motivation-impaired type were 51 to 61 years old, received primary school education or lower, characterized by insufficient knowledge and poor self-management behavior, constant failure to follow the prescribed rehabilitation exercises, poor management of negative emotions, low self-efficacy, and a low sense of stigma.Conclusion:The user personas we have constructed for the patients who practice self-management home rehabilitation after lower limb bone transport can help healthcare professionals with specific targeted interventions to enhance self-management efficacy to facilitate the rehabilitation process for the patients.
6.Three-dimensional finite element analysis of digital wire loop space maintainers for missing deciduous teeth.
Lijuan MA ; Yonghui TENG ; Yong WANG ; Yijiao ZHAO ; Xinyue ZHANG ; Qingzhao QIN ; Dong YIN
Journal of Peking University(Health Sciences) 2025;57(2):376-383
OBJECTIVE:
To establish a three-dimensional finite element model of a digital wire loop space maintainer for the mandible and primary tooth loss, in order to investigate the stress, deformation, and shear force experienced by patients with the loss of the second primary molar when wearing the wire loop space maintainer.
METHODS:
Cone beam computed tomography (CBCT) scans were performed on the patients to create a digital model of the mandible with the absence of the second primary molar using Mimics 21.0 software. A digital model integrating the crown's retention and the wire loop structure of the full crown and ring wire loop space maintainer was constructed using pediatric space maintainer design software, utilizing three different materials: cobalt-chromium alloy, polyether ether ketone (PEEK), and titanium alloy. In ANSYS Work Beach 2023 R2 software, vertical loads of 70 N, tilted 45° along the long axis of the tooth loads of 70 N, and a 10 N load on the surface of the wire loop were applied to the occlusal surfaces of models 46 and 84, simulating centric and lateral occlusions during chewing with the wire loop space maintainer in place. The stress states of the wire loop space maintainer and supporting teeth were analyzed.
RESULTS:
Under various loading conditions, the maximum principal stress of the ring wire loop space maintainer was significantly lower than that of the full crown. Stress contour maps indicated that the peak of the maximum principal stress occurred at the junction of the wire loop and crown structure, indicating that this area was more susceptible to fracture. The ring wire loop space maintainer made from PEEK material exhibited the lowest maximum shear stress on the internal organizational surfaces, with equivalent stresses of 23.18 MPa and 36.35 MPa for models 46 and 84, respectively. Stress contour maps demonstrated that the maximum stress on tooth 46 was located at its mesial, while the maximum stress on tooth 84 was situated near the root area on its distal, in contact with the wire loop space maintainer.
CONCLUSION
In cases of second primary molar loss, wearing the digital ring wire loop space maintainer can effectively distribute stress, and the ring wire loop space maintainer made from PEEK material reduces the stress experienced by supporting teeth to some extent, demonstrating its superiority in clinical application.
Finite Element Analysis
;
Humans
;
Tooth, Deciduous
;
Cone-Beam Computed Tomography
;
Space Maintenance, Orthodontic/methods*
;
Imaging, Three-Dimensional
;
Orthodontic Wires
;
Dental Stress Analysis
;
Mandible
;
Stress, Mechanical
7.Exploration of the initial patterns of disease-modifying treatment in patients with multiple sclerosis:a real-world study
Xiaolin YANG ; Jinzhou FENG ; Xinyue QIN
Journal of Chongqing Medical University 2025;50(6):791-798
Objective:To explore the initiation patterns of disease-modifying treatment(DMT)in patients with multiple sclerosis(MS)in Chongqing,China.Methods:The clinical and imaging data of patients with relapsing-remitting MS(RRMS)who commenced DMT(teriflunomide,dimethyl fumarate,sphingosine-1-phosphate receptor modulators,or ofatumumab)for the first time at the Depart-ment of Neurology,The First Affiliated Hospital of Chongqing Medical University from November 2018 to January 2024 were obtained.The analysis focused on the distribution,persistence rate,and safety of initial DMT prescriptions,post-treatment disease activity,and risk factors affecting disease activity.Results:A total of 138 patients with RRMS were included.The distribution of initial DMT pre-scriptions was as follows:teriflunomide(46.4%),dimethyl fumarate(20.3%),sphingosine-1-phosphate receptor modulators(21.7%),and ofatumumab(11.6%).Throughout the follow-up period,72.5%of patients complied with their initial prescription,whereas 23.2%of patients altered their treatments,predominantly transitioning to ofatumumab.No drug-related death or hospitalization was docu-mented during the use of the four DMT prescriptions.However,sphingosine-1-phosphate receptor modulators exhibited the highest in-cidence of adverse events(43.3%).An analysis of post-treatment disease activity in 115 patients indicated that 47.0%of patients dis-played disease activity.Independent risk factors for disease activity comprised incomplete recovery after the initial onset of MS(odds ratio[OR]=3.645,95%CI=1.321-10.06,P=0.013)and smoking(OR=10.052,95%CI=1.025-98.556,P=0.048).Conclusion:In the last five years,the majority of initial DMT prescriptions for patients with RRMS in Chongqing,China,were low-to moderate-efficacy drugs.A considerable percentage of patients exhibited disease activity despite commencing DMT.Prompt commencement of high-efficacy DMT may be more effective in diminishing disease activity and postponing disability progression in patients with MS.
8.Endoscopic and pathological features of 17 cases of colorectal cap polyposis
Xinyue GAO ; Zhenkai WANG ; Shuliang HUANG ; Dianmei HAN ; Yueyang LU ; Qin SHEN
Chinese Journal of Clinical and Experimental Pathology 2025;41(10):1314-1318
Purpose To explore the clinicopathological features and endoscopic manifestations of cap polyposis(CP).Methods Clinical,endoscopic,pathological,and follow-up data of 17 cases of CP were collected and ana-lyzed.Results There were 14 males and 3 females,aged 15-67 years,with a mean age of 36.5 years.The disease duration ranged from 2 weeks to 5 years,and most patients(64.7%,11/17)had symptoms for more than l year.The most common clinical manifestation was hematochezia(82.4%,14/17),while constipation was generally absent.En-doscopically,all lesions(100%,17/17)were located in the anal canal and lower rectum.The surface was invariably covered with a thick whitish exudate(100%,17/17),and annular growth was the most frequent pattern(76.5%,13/17).Pathologically,the mucosal layer was almost entirely replaced by granulation tissue,and the surface showed extensive inflammatory necrosis forming a cap-like structure.Conclusion CP predominantly occurrs in the anal canal and lower rectum of young men.The presence of abundant whitish exudate under endoscopy is differential diagnostic value.Complete endoscopic resection followed by pathological examination is required for definitive diagnosis.
9.Analysis of human bocavirus characteristics in children with acute respiratory infections in Bengbu City, Anhui province, 2024
Xinyue CHEN ; Yingli QU ; Jin CAO ; Wenyan TIAN ; Guangyu XUE ; Yuting HU ; Qin LUO ; Qinqin SONG ; Haijun DU ; Guoyong MEI ; Zhiqiang XIA ; Juan SONG ; Jun HAN ; Guoyu LU
Chinese Journal of Experimental and Clinical Virology 2025;39(2):214-218
Objective:To determine the epidemiological characteristics of human bocavirus (HBoV) in children with acute respiratory infections (ARI) in Bengbu City, Anhui Province, in 2024.Methods:Nasopharyngeal swab samples were collected from 269 children with ARI in Bengbu City, Anhui Province, in 2024. Seventeen respiratory pathogens were screened using quantitative fluorescence PCR. For HBoV-positive samples, the VP1/VP2 structural gene fragments of HBoV were amplified and sequenced for genetic evolutionary analysis.Results:Among the 269 nasopharyngeal swab samples from children with ARI, the overall detection rate of respiratory pathogens was 48.33% (103/269). The top three pathogens with the highest detection rates were: Influenza A virus (FluA): 10.04% (27/269), Respiratory syncytial virus (RSV): 8.18% (22/269), Human bocavirus (HBoV): 7.43% (20/269). The age distribution of HBoV-infected children showed that the detection rate was highest in the 0-2 years age group (50%, 10/20), followed by the 3-5 years age group (25%, 5/20) and the over 6 years age group (25%, 5/20). However, there was no statistically significant difference in viral detection rates among the age groups. Genetic evolutionary analysis based on VP1/VP2 revealed that all 13 HBoV strains were of the HBoV-1 genotype.Conclusions:HBoV is one of the major pathogens causing ARI in children in Bengbu City, Anhui Province, in 2024, with HBoV-1 being the predominant genotype. Additionally, infants aged 0-2 years are the most susceptible population to HBoV infection.
10.A study on user persona of bone transport patients in self-management during home rehabilitation
Huijie CHEN ; Huijuan SONG ; Ying REN ; Ping WANG ; Xinyue LUO ; Chenghe QIN ; Jinghua YANG
Chinese Journal of Orthopaedic Trauma 2025;27(8):726-731
Objective:To construct the user personas of the patients who practice self-management home rehabilitation after lower limb bone transport by exploring their self-management experiences and needs in rehabilitation at home so as to provide targeted countermeasures for related medical staff.Methods:A purposive sampling method was employed to select the 21 patients who had undergone home rehabilitation after lower limb bone transport at Department of Orthopedic Trauma, Nanfang Hospital from September to December 2024. The cohort included 12 males and 9 females, with an age of (39.8±15.1) years. The phenomenological research method was used to conduct semi-structured interviews with this cohort. After the data from interviews were explored by the Colaizzi 7-step analysis to extract the factual labels, role dimension models were built, covering 3 dimensions: description, characteristics (basic, cognitive, behavioral, social support, and psychological adjustment characteristics) and needs.Results:All patients were interviewed. Four user personas were constructed, including self-awareness growth type (5 cases), emotional dependency-driven type (4 cases), risk-aversion procrastination type (7 cases), and management motivation-impaired type (5 cases). The patients of self-awareness growth type were 21 to 36 years old and received high school or university education, characterized by high self-efficacy, active measures to improve and maintain their state of rehabilitation, good management of negative emotions, and a low sense of stigma. The patients of emotional low-driven type were 42 to 74 years old and received their education in a primary school or junior high school, characterized by lack of independence, dependence on others for rehabilitation management, common management of negative emotions, low self-efficacy, and a strong sense of stigma. The patients of risk-aversion procrastination type were 33 to 56 years old and received their education in a junior or senior high school, characterized by a willingness to cooperate but insufficient motivation for rehabilitation management, an awareness of rehabilitation which was vulnerable to external factors, common management of negative emotions, low self-efficacy, and a strong sense of stigma. The patients of management motivation-impaired type were 51 to 61 years old, received primary school education or lower, characterized by insufficient knowledge and poor self-management behavior, constant failure to follow the prescribed rehabilitation exercises, poor management of negative emotions, low self-efficacy, and a low sense of stigma.Conclusion:The user personas we have constructed for the patients who practice self-management home rehabilitation after lower limb bone transport can help healthcare professionals with specific targeted interventions to enhance self-management efficacy to facilitate the rehabilitation process for the patients.

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