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

Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.

The incidence of osteoporotic thoracolumbar vertebral fracture (OTLVF) in the elderly is gradually increasing. The kyphotic deformity caused by various factors has become an important characteristic of OTLVF and has received increasing attention. Its clinical manifestations include pain, delayed nerve damage, sagittal imbalance, etc. Currently, the definition and diagnosis of OTLVF with kyphotic deformity in the elderly are still unclear. Although there are many treatment options, they are controversial. Existing guidelines or consensuses pay little attention to this type of fracture with kyphotic deformity. To this end, the Lumbar Education Working Group of the Spine Branch of the Chinese Medicine Education Association and Editorial Committee of Chinese Journal of Trauma organized the experts in the relevant fields to jointly develop Clinical guidelines for the diagnosis and treatment of osteoporotic thoracolumbar vertebral fractures with kyphotic deformity in the elderly ( version 2024), based on evidence-based medical advancements and the principles of scientificity, practicality, and advanced nature, which provided 18 recommendations to standardize the clinical diagnosis and treatment.

Female ; Humans ; Pregnancy ; Septate Uterus ; Uterus/surgery* ; Hysteroscopy/methods* ; Estrogens ; Tissue Adhesions/surgery* ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic

Objective To evaluate the radiation protection of “four-in-one” dental X-ray equipment and to investigate the safety interlock of the equipment by measuring the scattered radiation at the position of the patient during operation. Methods A cone-beam CT dental phantom was used to simulate the patient’s head. The intra-oral and extra-oral components of the “four-in-one” X-ray equipment were installed in a 5 m² room. The scattered radiation at patient position was measured using a γ/X-ray survey meter, and the effects of intra-oral and extra-oral components were compared. Results For a 5 m² room, when CBCT was exposed under typical conditions, the dose at the patient's position was 10.70 uSv/h when there was an intra-oral component and 10.60 uSv/h when there was no intraoral component. The intra-oral part did not affect the radiation dose at the patient's position. When the intra-oral component was exposed, the dose rate at the patient's position was 4.05-6.85 uSv/h, and the extra-oral part did not affect the scattered dose of the patient examined with intra-oral components. Conclusion The evaluation of radiation protection of new equipment must comprehensively consider radiation safety and equipment operation safety. The results of this study provide suggestions for clinical radiation protection supervision and evaluation of “four-in-one” dental X-ray equipment.

Objective:To evaluate the efficacy between pedicle screws combined with vertebroplasty (PSV) and pedicle screws combined with intermediate screws (PSIS) for the treatment of osteoporotic thoracolumbar fracture (OTLF).Methods:PubMed, Cochrane Library, Web of Science, CNKI, VIP and Wanfang database were searched for all randomized controlled trial (RCT) or case-control trial (CCT) studies that comparing PSV and PSIS for the treatment of OTLF. Two reviewers independently screened the studies in the light of the inclusion and exclusion criteria, extracted data and evaluated the quality of the included studies. The Meta-analysis was performed using the RevMan 5.4 software. The subjects were divided into PSV group and PSIS group according to different treatment methods. Operation time, intraoperative blood loss, postoperative incision infection rate, postoperative short-, mid- and long-term visual analogue scale (VAS) score, postoperative short- and mid-term Oswestry disability index (ODI), hospitalization time, postoperative short-, mid- and long-term Cobb angle, postoperative short-, mid- and long-term anterior vertebral height ratio (VBH) and implant failure rate were compared between the two groups.Results:A total of 12 studies were enrolled for review, involving 870 subjects (433 in PSV group and 437 in PSIS group). The results showed insignificant difference between the two groups in operation time ( WMD=7.07, 95% CI -4.00, 18.13, P>0.05), intraoperative blood loss ( WMD=0.62, 95% CI -7.19, 8.43, P>0.05), postoperative incision infection rate ( OR=0.65, 95% CI 0.10, 4.08, P>0.05), postoperative short-term Cobb angle ( WMD=-0.19, 95% CI -0.43, 0.05, P>0.05) and postoperative short-term VBH ( WMD=0.91, 95% CI -1.30, 3.13, P>0.05). However, there was significant difference between the two groups in postoperative short-term VAS score ( WMD=-0.59, 95% CI -1.02, -0.15, P<0.05), mid-term VAS score ( WMD=-0.41, 95% CI -0.65, -0.16, P<0.05), long-term VAS score ( WMD=-0.51, 95% CI -0.59, -0.43, P<0.05), postoperative short-term ODI ( WMD=-6.26, 95% CI -9.65, -2.87, P<0.05), postoperative mid-term ODI ( WMD=-2.44, 95% CI -3.43, -1.45, P<0.05), hospitalization time ( WMD=-2.65, 95% CI -4.61, -0.68, P<0.05), postoperative mid-term Cobb angle ( WMD=-1.40, 95% CI -2.41, -0.39, P<0.05), postoperative long-term Cobb angle ( WMD=-1.06, 95% CI -1.59, -0.52, P<0.05), postoperative mid-term VBH ( WMD=3.06, 95% CI 1.31, 4.81, P<0.05), postoperative long-term VBH ( WMD=4.11, 95% CI 2.44, 5.77, P<0.05) and implant failure rate ( OR=2.06, 95% CI 0.11, 0.59, P<0.05). Conclusion:Compared with PSIS, PSV can not reduce the operation time, intraoperative blood loss and incision infection in the treatment of OTLF, but it can significantly relieve pain, improve function, decrease reduce hospitalization time, help to maintain Cobb angle and anterior vertebral height after operation, and reduce implant failure rate.

Ankylosing spondylitis (AS) combined with spinal fractures with thoracic and lumbar fracture as the most common type shows characteristics of unstable fracture, high incidence of nerve injury, high mortality and high disability rate. The diagnosis may be missed because it is mostly caused by low-energy injury, when spinal rigidity and osteoporosis have a great impact on the accuracy of imaging examination. At the same time, the treatment choices are controversial, with no relevant specifications. Non-operative treatments can easily lead to bone nonunion, pseudoarthrosis and delayed nerve injury, while surgeries may be failed due to internal fixation failure. At present, there are no evidence-based guidelines for the diagnosis and treatment of AS combined with thoracic and lumbar fracture. In this context, the Spinal Trauma Academic Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate the Clinical guideline for the diagnosis and treatment of adult ankylosing spondylitis combined with thoracolumbar fracture ( version 2023) by following the principles of evidence-based medicine and systematically review related literatures. Ten recommendations on the diagnosis, imaging evaluation, classification and treatment of AS combined with thoracic and lumbar fracture were put forward, aiming to standardize the clinical diagnosis and treatment of such disorder.

The acute combination fractures of the atlas and axis in adults have a higher rate of neurological injury and early death compared with atlas or axial fractures alone. Currently, the diagnosis and treatment choices of acute combination fractures of the atlas and axis in adults are controversial because of the lack of standards for implementation. Non-operative treatments have a high incidence of bone nonunion and complications, while surgeries may easily lead to the injury of the vertebral artery, spinal cord and nerve root. At present, there are no evidence-based Chinese guidelines for the diagnosis and treatment of acute combination fractures of the atlas and axis in adults. To provide orthopedic surgeons with the most up-to-date and effective information in treating acute combination fractures of the atlas and axis in adults, the Spinal Trauma Group of Orthopedic Branch of Chinese Medical Doctor Association organized experts in the field of spinal trauma to develop the Evidence-based guideline for clinical diagnosis and treatment of acute combination fractures of the atlas and axis in adults ( version 2023) by referring to the "Management of acute combination fractures of the atlas and axis in adults" published by American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) in 2013 and the relevant Chinese and English literatures. Ten recommendations were made concerning the radiological diagnosis, stability judgment, treatment rules, treatment options and complications based on medical evidence, aiming to provide a reference for the diagnosis and treatment of acute combination fractures of the atlas and axis in adults.

Objective:To compare the efficacy of percutaneous vertebroplasty (PVP) in the treatment of osteoporotic lumbar compression fracture (OLCF) via the approach through midpoint transverse process-transition zone of articular process and the unilateral transpedicular approach.Methods:A prospective cohort study was conducted to analyze the clinical data of 794 patients with OLCF treated in Honghui Hospital affiliated to Xi′an Jiaotong University School of Medicine from January 2017 to December 2019. The patients were divided into transitional-zone puncture group (400 patients, 400 vertebrae) and pedicle puncture group (394 patients, 394 vertebrae) according to the envelope method. The transitional-zone puncture group was treated with PVP via the approach through midpoint transverse process-transition zone of articular process, and the pedicle puncture group was treated with PVP via the unilateral transpedicular approach. The operation time and radiation dose were documented. The visual analogue score (VAS) and Oswestry dysfunction index (ODI) were evaluated before operation and at 1 day, 3 months, 1 year after operation. The cement distribution and the incidence of complications such as cement leakage, re-fracture of the injured vertebra, spinal cord nerve injury and facet joint injury were detected.Results:The patients were composed of 270 males and 524 females, at the age of 68.9-78.5 years [(73.7±4.8)years]. All patients were followed up for 12-14 months [(13.4±0.8)months]. The operation time and radiation dose in transitional-zone puncture group were reduced compared with pedicle puncture group ( P<0.01). There was no significant difference in VAS and ODI between the two groups before operation (all P>0.05). The VAS between transitional-zone puncture group [(2.1±0.9)points, (2.3±1.1)points, (2.7±1.3)points] and pedicle puncture group [(2.3±0.7)points, (2.5±0.9)points, (2.9±1.1)points] was obviously reduced from that before operation (all P<0.01), significantly different at 1 day, 3 months, 1 year after operation ( P<0.05 or 0.01). The ODI between transitional-zone puncture group (14.3±1.8, 13.6±3.4, 11.3±4.4) and pedicle puncture group (25.5±5.7, 20.7±6.3, 20.6±6.9) was significantly different at 1 day, 3 months, 1 year after operation (all P<0.01), and all were obviously reduced from that before operation (all P<0.01). With regard to the cement distribution, the number of bilaterally cemented vertebrae in transitional-zone puncture group (324) was more than that in pedicle puncture group (94) ( P<0.01). The incidence of cement leakage, re-fracture of the injured vertebra and facet joint injury was 8.25%(22/400), 0.00%(0/400) and 3.25%(13/400) in transitional-zone puncture group, significantly different from 20.81%(82/394), 2.03%(8/394) and 9.90%(39/394) in pedicle puncture group ( P<0.05 or 0.01). There was no significant difference in spinal cord nerve injury between the two groups ( P>0.05). Conclusion:For OLCF, PVP via the approach through the midpoint transverse process-transition zone of articular process and the unilateral transpedicular approach are both effective, but the former has advantages of shorter operation time, smaller radiation dose, greater dispersion of bone cement and lower incidence of cement leakage, re-fracture of the injured vertebra and facet joint injury.