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.

Objective:To investigate the current situation and organizational management policies of government procurement in public hospitals,and to improve the level of standardized management of government procurement.Methods:An electronic questionnaire survey was conducted to investigate the current status of organization and administration of government procurement in different types and levels of public hospitals across the country.The current situation of the organizational structure,management system,working mode,supervision and evaluation,budget establishment,bidding and procurement,contract signing,acceptance process,payment management,and other aspects of government procurement management in public hospitals were analyzed.Results:A total of 216 valid questionnaires were collected from 216 public hospitals in 28 provinces,municipalities and autonomous regions across the country,including 165 general hospitals,37 specialized hospitals and 13 traditional Chinese medicine hospitals,accounting for 76.39％,17.13％and 6.02％respectively;among the hospital levels,there were 202 tertiary hospitals(accounting for 93.52％).Among the surveyed government procurement management institutions of public hospitals,there were 112,103,110 and 112 organizations at the four levels of procurement management committee,procurement management office,procurement center and business and administrative logistics department,accounting for 51.85％,47.69％,50.93％and 51.85％respectively.The quota standards for public bidding for government procurement in all hospitals were in line with the requirements of national laws and regulations.The approval of funds payment must conditions of each hospital complied with relevant requirements.In terms of management effects of risk prevention and control,the hospitals with very good,good,average and inadequate were 48,125,34 and 9 respectively,accounting for 22.22％,57.87％,15.74％and 4.17％.Conclusion:The organizational framework and management system of government procurement in public hospitals are becoming increasingly standardized,and there are certain differences in the work mode and process of government procurement in different hospitals,and the supervision and evaluation are relatively weak,which is worthy of attention and strengthened administration.

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 test and evaluate the reliability and clinical effectiveness of osteoporotic thoracolumbar fracture (OTLF) scoring and classification system.Methods:A multicenter retrospective case series study was conducted to analyze the clinical data of 530 OTLF patients admitted to 8 hospitals including Honghui Hospital Affiliated to Xi'an Jiaotong University from January 2021 to June 2022. There were 212 males and 318 females, aged 55-90 years [(72.6±10.8)years]. There were 4 patients with grade C and 18 with grade D according to American Spinal Injury Association (ASIA) classification. According to the osteoporotic thoracolumbar injury classification and severity (OTLICS) score, all patients had an OTLICS score over 4 points and required surgical treatment. Among them, 410 patients had acute symptomatic OTLF (ASOTLF), including 24 patients with type I, 159 type IIA, 47 type IIB, 31 type IIC, 136 type IIIA, 8 type IIIB, 2 type IV (absence of neurological symptoms) and 3 type IV (presence of neurological symptoms), and 120 patients had chronic symptomatic OTLF (CSOTLF), including 62 patients with type I, 21 type II, 17 type III, 3 type IV (reducible under general anesthesia), 9 type IV (not reducible under general anesthesia), 1 type V (reducible under general anesthesia), 5 type V (presence of neurological symptoms), and 2 type V (not reducible under general anesthesia). Surgical procedures included percutaneous vertebroplasty (PVP), positional repositioning plus PVP, percutaneous kyphoplasty (PKP), posterior open reduction combined with bone graft fusion and bone cement augmented screw internal fixation, posterior open reduction combined with decompression, bone graft fusion and bone cement augmented screw internal fixation, and posterior open reduction combined with osteotomy and orthopedics, bone graft fusion and bone cement augmented screw internal fixation. A weighted Kappa was used to test the interobserver and intraobserver reliability of the OTLICS score, the ASOTLF classification, and the CSOTLF classification. The visual analog scale (VAS), Oswestry disability index (ODI), ASIA classification were compared before, at 1 month after surgery and at the last follow-up. Incidence of postoperative complications was observed.Results:The percentage of mean interobserver agreement for OTLICS staging was 93.4%, with a mean confidence Kappa value of 0.86, and the percentage of mean intraobserver agreement was 93.0%, with a mean confidence kappa value of 0.86. The percentage of mean interobserver agreement for ASOTLF staging was 94.2%, with a mean confidence Kappa value of 0.84, and the percentage of mean intraobserver agreement was 92.5%, with a mean confidence Kappa value of 0.83. The percentage of mean interobserver agreement for CSOTLF subtyping was 91.9%, with a mean confidence Kappa value of 0.80, and the percentage of mean intraobserver agreement was 91.3%, with a mean confidence Kappa value of 0.81. All the patients were followed up for 6-12 months [(9.0±2.1)months]. The VAS and ODI scores were significantly lower in patients with ASOTLF and CSOTLF classifications at 1 month after surgery and at the last follow-up than those before surgery (all P<0.05). The VAS scores in patients with ASOTLF types IIA, IIB, IIC, IIIA, and IV were significantly lower at the last follow-up than that at 1 month after surgery; the ODI scores in patients with ASOTLF types I, IIA, IIB, IIIA, IIIB and IV were significantly lower at the last follow-up than those at 1 month after surgery. The VAS scores in patients with CSOTLF types II, III, IV, and V were significantly lower at the last follow-up than those at 1 month after surgery, and the ODI scores in patients with all CSOTLF types were significantly lower at the last follow-up than those at 1 month after surgery (all P<0.05). Two patients with ASIA grade C recovered to grade D, and the rest recovered to grade E at the last follow-up ( P<0.01). No major vessel or nerve injury or internal fixation failure was found during follow-up. There were 18 patients with cement leakage, none of whom showed relevant clinical symptoms. There were 35 patients with new vertebral fractures, all of whom recovered well after symptomatic treatment. Conclusions:The OTLICS score, ASOTLF classification and CSOTLF classification have a high degree of reliability. Application of stepwise treatment for patients with different levels of injury according to the scoring and classification system can reduce pain, promote recovery of the spinal function, and reduce complications, which is of some significance in guiding the selection of clinical treatment.

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.