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.Application of single-layer with full thickness of duct-to-mucosa pancreaticojejunostomy in laparoscopic pancreaticoduodenectomy
Chengxu DU ; Dongrui LI ; Weihong ZHAO ; Wei HE ; Minghao SU ; Xueqiang YA ; Wenbin WANG
Chinese Journal of Pancreatology 2023;23(4):258-264
Objective:To explore the clinical efficacy and safety of single-layer with full thickness of duct-to-mucosa pancreaticojejunostomy in laparoscopic pancreaticoduodenectomy.Methods:The clinical data of 45 patients who underwent laparoscopic pancreaticoduodenectomy with the procedures of single-layer with full thickness in Second Hospital of Hebei Medical University from Jan 2020 to Jan 2022 were retrospectively collected and compared with 45 matched patients with traditional two-layer pancreaticojejunostomy.Results:The laparoscopic pancreaticoduodenectomy procedures were successfully performed in all the 90 cases. The mean operation time (285.6±92.4 minutes) and the media pancreaticojejunostomy time 20(15, 35) minutes) of the single-layer with full thickness pancreaticojejunostomy group were shorter than those of the two-layer pancreaticojejunostomy group [the mean operation time: 317.0±85.5 minutes, the media pancreaticojejunostomy time: 46(30, 58) minutes] with significantly statistical differences (all P value<0.05). There were no significantly statistical differences on intraoperative blood loss, the postoperative complications or hospital stay between the two groups. Conclusions:Compared with traditional pancreaticojejunostomy, the single-layer with full thickness of duct-to-mucosa pancreaticojejunostomy is simple and safe, which has the advantage of easy manipulation and less time-consuming and can be recommended for laparoscopic procedures.
7.Free flap of second dorsal metacarpal artery: anatomical study and clinical application
Xueqiang WU ; Huiren LIU ; Yan WANG ; Zhanyong YU ; Jiayin LIU ; Rutao SUN ; Zongzhe WU ; Zheng XU ; Jianhua LIU ; Haonan WANG ; Haoyu QIN
Chinese Journal of Microsurgery 2023;46(4):442-446
Objective:To observe the path and anatomic distribution of cutaneous branch of second dorsal metacarpal artery(SDMA) from the back of hand to the web of the fingers, and to explore the feasibility and clinical effect on the transfer of free flap of SDMA.Methods:Between June 2018 and September 2018, with perfusion of red latex, 22 hand specimens were dissected to explore the course, vessel calibre and distribution of cutaneous branches of SDMA, and to discover the existence of an innervation of cutaneous nerve in Department of Hand Surgery of Tangshan Second Hospital. Later on, from February 2019 to July 2020, 2 thumb pulp defects of 2 patients were reconstructed with the free flaps of SDMA. One defect was in the left thumb and the other in the right, both were male and compression injuries. Size of thumb pulp and a skin defect was at 3.5 cm×2.0 cm in 1 patient, and 2.0 cm×2.5 cm in the other. There was no neurovascular injury, but 1 patient had a distal phalangeal fracture and a nail bed laceration. The sizes of the flaps were 3.8 cm×2.3 cm and 2.8 cm×2.5 cm. Functional exercises started from 3 weeks after surgery. Patients attended postoperation follow up regularly by outpatient visit, telephone or internet interviews. Follow-up observations included the appearance, texture, sensory recovery of the flaps and thumb functions.Results:Multiple perforating branches (4-9 branches) were found from SDMA, which distributed in the distal 1/3 of SDMA in the anatomic study. It was found that the outer diameter of SDMA was 0.76 mm±0.25 mm at the intersection of extensor tendon of index finger and that of the digital web artery was 0.71 mm±0.12 mm. The length of digital web artery was 11.00 mm±1.27 mm. The 2 surgically transferred flaps were all survived. One patient showed the function of thumb in excellent with two-point discrimination (TPD) at 7.0 mm, at 18 months of follow-up. The other patient showed good thumb movement, soft and elastic skin of the flap and with a 7.5 mm in TPD, at 15 months of follow-up. According to the Evaluation Standard of Upper Limb Partial Functional of Hand Surgery of Chinese Medical Association, the results of the 2 flaps were all excellent.Conclusion:The flap of SDMA has a constant cutaneous nerve and a long vascular pedicle with an ideal vessel size. It is suitable for free transfer and can be used to reconstruct soft tissue defects of thumb.
8.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.
9.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.
10.A study comparing PTCD with ENBD on jaundiced patients before laparoscopic pancreaticoduodenectomy
Chengxu DU ; Jiaxuan LI ; Dongrui LI ; Minghao SU ; Xueqiang YA ; Wenbin WANG ; Jianhua LIU
Chinese Journal of Hepatobiliary Surgery 2022;28(2):113-116
Objective:To compare and analyze the perioperative outcomes of jaundiced patients undergoing laparoscopic pancreaticoduodenectomy (LPD) using preoperative percutaneous transhepatic cholangial drainage (PTCD) versus endoscopic nasobiliary drainage (ENBD).Methods:The perioperative data of 173 patients who underwent LPD at the Second Hospital of Hebei Medical University from January 2016 to December 2020 and were treated preoperatively with either PTCD versus ENBD to alleviate jaundiced were retrospectively analyzed. There were 100 males and 73 females, with age of (60.4±10.8) years old. These patients were divided into the PTCD group ( n=126) and the ENBD group ( n=47). Clinical data including operation time, blood loss, transfusion volume, R 0 resection, and postoperative complications were compared. Results:There was no convension to open surgery. There were no significant differences in operation time, blood loss, transfusion volume, R 0 resection rate, pathological results and hospital stay between the two groups ( P>0.05). For the PTCD group, the pancreatic fistula rate was 10.3% (13/126) and the post-operative hemorrhage rate was 8.7% (11/126). They were both significantly lower than those of the ENBD group [25.5% (12/47) and 25.5% (12/47) respectively, P<0.05]. There were also significant differences in the postoperative complications according to the Clavien-Dindo classification system between the two groups ( P=0.008). Conclusion:Compared with ENBD, PTCD had the advantages of lower post-operative pancreatic fistula and post-operative hemorrhage rates, resulting in a better postoperative recovery.

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