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.Myelin oligodendrocyte glycoprotein antibody-associated disease combined with other neuroimmune antibodies
Xiaonan ZHONG ; Xia WANG ; Wei QIU ; Xueqiang HU ; Zhengqi LU
Chinese Journal of Neurology 2025;58(2):204-209
Although myelin oligodendrocyte glycoprotein (MOG)-IgG is a biological marker for diagnosing MOG antibody-associated disease (MOGAD), the specificity of MOG-IgG in disease diagnosis remains controversial. In clinical practice, there is significant heterogeneity in MOGAD patients with low titer of MOG-IgG and low titer MOG-IgG can even be detected in asymptomatic populations. At the same time, MOG-IgG-positive individuals often combine with the positivity of other multiple autoimmune antibodies in the nervous system. Therefore, the relationship between MOG-IgG and MOGAD is complex, and the pathogenesis of MOGAD may involve immune factors other than MOG-IgG. This article reviews the research progress of MOGAD combined with other neuroimmune antibodies, assisting in the early identification and treatment of such diseases by clinical physicians in the future.
3.Interpretation of the Chinese guidelines for diagnosis and treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (2025 edition)
Chinese Journal of Neurology 2025;58(7):669-672
Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) is a recently identified inflammatory demyelinating disease of the central nervous system, with strong heterogeneity in clinical manifestations and many challenges in diagnosis and treatment. At present, some international MOGAD diagnosis and treatment guidelines and consensus are mostly based on western population data, so Chinese neuroimmunology experts have been committed to customizing MOGAD diagnosis and treatment guidelines suitable for Chinese population. The Chinese guidelines for diagnosis and treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (2025 edition) has comprehensively revised the disease definition, diagnostic criteria, imaging features, treatment strategies, etc., based on the latest evidence-based research at home and abroad, as well as multi-center clinical research data in China. Some important revisions in the new guideline were interpreted in this article.
4.Myelin oligodendrocyte glycoprotein antibody-associated disease combined with other neuroimmune antibodies
Xiaonan ZHONG ; Xia WANG ; Wei QIU ; Xueqiang HU ; Zhengqi LU
Chinese Journal of Neurology 2025;58(2):204-209
Although myelin oligodendrocyte glycoprotein (MOG)-IgG is a biological marker for diagnosing MOG antibody-associated disease (MOGAD), the specificity of MOG-IgG in disease diagnosis remains controversial. In clinical practice, there is significant heterogeneity in MOGAD patients with low titer of MOG-IgG and low titer MOG-IgG can even be detected in asymptomatic populations. At the same time, MOG-IgG-positive individuals often combine with the positivity of other multiple autoimmune antibodies in the nervous system. Therefore, the relationship between MOG-IgG and MOGAD is complex, and the pathogenesis of MOGAD may involve immune factors other than MOG-IgG. This article reviews the research progress of MOGAD combined with other neuroimmune antibodies, assisting in the early identification and treatment of such diseases by clinical physicians in the future.
5.Interpretation of the Chinese guidelines for diagnosis and treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (2025 edition)
Chinese Journal of Neurology 2025;58(7):669-672
Myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) is a recently identified inflammatory demyelinating disease of the central nervous system, with strong heterogeneity in clinical manifestations and many challenges in diagnosis and treatment. At present, some international MOGAD diagnosis and treatment guidelines and consensus are mostly based on western population data, so Chinese neuroimmunology experts have been committed to customizing MOGAD diagnosis and treatment guidelines suitable for Chinese population. The Chinese guidelines for diagnosis and treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (2025 edition) has comprehensively revised the disease definition, diagnostic criteria, imaging features, treatment strategies, etc., based on the latest evidence-based research at home and abroad, as well as multi-center clinical research data in China. Some important revisions in the new guideline were interpreted in this article.
6.Status of HVPG clinical application in China in 2021
Wen ZHANG ; Fuquan LIU ; Linpeng ZHANG ; Huiguo DING ; Yuzheng ZHUGE ; Jitao WANG ; Lei LI ; Guangchuan WANG ; Hao WU ; Hui LI ; Guohong CAO ; Xuefeng LU ; Derun KONG ; Lin SUN ; Wei WU ; Junhui SUN ; Jiangtao LIU ; He ZHU ; Dongliang LI ; Wuhua GUO ; Hui XUE ; Yu WANG ; Jiancuo GENGZANG ; Tian ZHAO ; Min YUAN ; Shirong LIU ; Hui HUAN ; Meng NIU ; Xin LI ; Jun MA ; Qingliang ZHU ; Wenbo GUO ; Kunpeng ZHANG ; Xiaoliang ZHU ; Birun HUANG ; Jianan LI ; Weidong WANG ; Hongfeng YI ; Qi ZHANG ; Long GAO ; Guo ZHANG ; Zhongwei ZHAO ; Kai XIONG ; Zexin WANG ; Hong SHAN ; Mingsheng LI ; Xueqiang ZHANG ; Haibin SHI ; Xiaogang HU ; Kangshun ZHU ; Zhanguo ZHANG ; Hong JIANG ; Jianbo ZHAO ; Mingsheng HUANG ; Wenyong SHEN ; Lin ZHANG ; Feng XIE ; Zhiwei LI ; Changlong HOU ; Shengjuan HU ; Jianwei LU ; Xudong CUI ; Ting LU ; Shaoqi YANG ; Wei LIU ; Junping SHI ; Yanming LEI ; Jinlun BAO ; Tao WANG ; Weixin REN ; Xiaoli ZHU ; Yong WANG ; Lei YU ; Qiang YU ; Huiling XIANG ; Wenqiang LUO ; Xiaolong QI
Chinese Journal of Hepatology 2022;30(6):637-643
Objective:The investigation and research on the application status of Hepatic Venous Pressure Gradient (HVPG) is very important to understand the real situation and future development of this technology in China.Methods:This study comprehensively investigated the basic situation of HVPG technology in China, including hospital distribution, hospital level, annual number of cases, catheters used, average cost, indications and existing problems.Results:According to the survey, there were 70 hospitals in China carrying out HVPG technology in 2021, distributed in 28 provinces (autonomous regions and municipalities directly under the central Government). A total of 4 398 cases of HVPG were performed in all the surveyed hospitals in 2021, of which 2 291 cases (52.1%) were tested by HVPG alone. The average cost of HVPG detection was (5 617.2±2 079.4) yuan. 96.3% of the teams completed HVPG detection with balloon method, and most of the teams used thrombectomy balloon catheter (80.3%).Conclusion:Through this investigation, the status of domestic clinical application of HVPG has been clarified, and it has been confirmed that many domestic medical institutions have mastered this technology, but it still needs to continue to promote and popularize HVPG technology in the future.
7.Application of self-made multifunctional accessory stent in endoscopic mucosal dissection
Chunrong MO ; Xueqiang HE ; Shengai ZHONG ; Huajun LI ; Yu HU ; Lu QIN ; Shuihuan LU ; Lin WANG ; Hong XIONG ; Shuiying ZHOU
Chinese Journal of Practical Nursing 2022;38(1):45-49
Objective:To investigate the safety and efficacy of self-made multifunctional endoscopic instrument accessory stent in endoscopic mucosal dissection (ESD).Methods:A total of 80 patients who received ESD in 924th Hospital of Joint Logistic Support Force of Chinese People′s Liberation Army from May 2019 to February 2021 were selected as research object. Random number table method was used to divide patients into control group and experimental group, 40 cases in each group. The experimental group used self-made endoscopic instrument accessory stent, and the control group did not use self-made endoscopic instrument accessory stent. The length of operation, the number of instruments taken by mistake, the number of instruments polluted during operation and the infection of postoperative 3-7 days under the same operation position, operating doctors and nurses were analyzed and compared between the two groups.Results:The incidence of instruments taken by mistake, the incidence of instruments polluted during operation and the infection rate of postoperative 3-7 days were 0.9% (8/856), 1.4% (12/856) and 2.5% (1/40) in the experimental group, which in the control group were 10.8% (96/887), 11.8% (105/887) and 15.0% (6/40) respectively, there were significant differences between the two groups ( χ2=75.92, 75.76, 3.91, all P<0.05). The length of operation in the experimental group was (51.56 ± 2.32) min, and that in the control group was (79.02 ± 2.83) min, the difference was statistically significant ( t=-8.72, P<0.05). Conclusions:When the patients underwent ESD surgery, the self-made multifunctional accessory stent was used to place the required instrument accessory. The length of operation was shorter, the incidence of instruments taken by mistake, the incidence of instruments polluted during operation and the infection rate of postoperative 3-7 days were reduced, the quality of minimally invasive endoscopic surgery was improved.
8.Diagnosis and differential diagnosis of multiple sclerosis
Chinese Journal of Neurology 2022;55(9):1019-1024
Multiple sclerosis (MS) is an immune-mediated disease characterized by inflammatory demyelinating lesions of the central nervous system. It is one of the most common causes of neurological disability in young and middle-aged people. Clarifying the diagnosis and clinical classification of MS is very important for the early treatment and treatment strategy selection of MS patients. After fully collecting objective clinical evidence and excluding other differential diagnosis, clinicians can evaluate the dissemination in space and time of MS patients in reference to the current diagnostic criteria, and can make treatment strategy selection according to their clinical classification criteria. At present, more examination techniques and evaluation methods for MS diagnosis are being studied and discussed. It is believed that the sensitivity and specificity of MS diagnosis will be further improved in the future.
9.Application of optical coherence tomography in the diagnosis of congenital pseudarthrosis of tibia
Xueqiang NIU ; Yang LIU ; Fuyun LIU ; Weiming HU ; Yuran QU ; Long WEN
Chinese Journal of Applied Clinical Pediatrics 2021;36(7):529-532
Objective:To explore the feasibility of the application of optical coherence tomography (OCT) in the diagnosis of congenital pseudarthrosis of tibia (CPT) in children.Methods:Ten children with neurofibromatosis type Ⅰ (NF1) and CPT were treated in the Third Affiliated Hospital of Zhengzhou University from January 2016 to December 2019, and enrolled as the experimental group.The bone tissue samples were collected and subjected to OCT scanning after intraoperative observation and evaluation, and were contrasted with conventional histological examination.During the same period, the bone tissues of 5 non-NF1 and non-CPT induced-labor fetuses were collected as the control group for the above examination, and the bone tissue examination results of the experimental group and the control group were compared as well.Results:Compared with the bone tissues of the control group, that of the experimental group displayed thickening trabecular bone, part of trabecular bone fusion, disordered arrangement, proliferation and fatification of interstitial fibrous tissue.OCT scan can directly show the nerves and blood vessels in the bone tissue, scattered in adipose tissue.OCT scan showed that the bone tissues of the control group were neatly arranged, with dense and regular shadows.The bone tissues of the experimental group could be observed with strong refraction, loose arrangement, and disordered bone fractures, fibrous ossification, scattered nerves, blood vessels, and increased vacuolar fat cells.Conclusions:OCT can quickly and clearly scan the freshly isolated tissues and directly display the internal structure of the tissues.It is highly compatible with routine pathological examinations and can be an effective supplement to the pathological diagnosis of children with CPT and retain samples for subsequent genetic studies.
10.A preliminary study on the ultrasonic evaluation of deformity changes during the treatment of congenital clubfoot in infants
Bing XIA ; Yingmei DONG ; Panpan HE ; Chaohua WANG ; Hongqian WANG ; Junying YUAN ; Fuyun LIU ; Hezhou LI ; Weiming HU ; Feipeng WANG ; Guoming FENG ; Xueqiang NIU ; Yanzhao DONG
Chinese Journal of Ultrasonography 2021;30(11):993-997
Objective:To evaluate the deformity changes in the treatment of congenital clubfoot in infants by ultrasound, and to explore its clinical application value.Methods:Seventeen infants with congenital clubfoot treated in the Department of Pediatric Orthopaedics of the Third Affiliated Hospital of Zhengzhou University from March 2020 to June 2021 and 27 normal infants in the same period were selected. The distance between medial malleolus and scaphoids (MM-N distance) of all feet was measured by ultrasound. The distance from the tangent line of the lateral edge of calcaneus to the midpoint of the lateral edge of the chondroid bone (C-C distance), medial soft tissue thickness and tibial calcaneal angle were measured by ultrasound. The data before, after treatment and during follow-up were statistically analyzed.Results:A total of 88 feet of 44 infants were evaluated. The mean number of cast was 4.7±1.1, the follow-up time was (96.9±59.3)days. The MM-N distance, C-C distance and posterior tibial calcaneal angle in the clubfoot group were improved after treatment and at the last follow-up, and the differences were statistically significant (all P<0.01). During the treatment, 1 case had false correction, and 2 cases recurred in the last follow-up. Conclusions:Ultrasound can clearly display the medial, dorsal, lateral and posterior articular structures of normal and clubfoot, and can observe the deformity changes of clubfoot during the correction process, which can provide guidance for the clinical treatment of clubfoot.

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