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.

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.

Objective:To compare the efficacy of robot-assisted and conventional fluoroscopy-guided percutaneous vertebroplasty (PVP) combined with pediculoplasty in treating symptomatic chronic thoracolumbar osteoporotic vertebral fracture (SCOVF) without neurological symptoms.Methods:A retrospective cohort study was used to analyze the clinical data of 120 patients with thoracolumbar SCOVF without neurological symptoms, who were admitted to Honghui Hospital Affiliated to Xi′an Jiaotong University from January 2015 to January 2020. The patients included 34 males and 86 females, aged 63-85 years [(72.9±5.7)years]. All patients were treated with PVP combined with pediculoplasty. A total of 87 patients were treated with robot-assisted and C-arm X-ray machine guided puncture (robot group) and 33 patients with C-arm X-ray machine fluoroscopic-guided puncture (conventional group). The operation time, amount of bone cement injection and puncture accuracy were compared between the two groups. The results of vertebral body index, Cobb angle, visual analogue scale (VAS), and Oswestry disability index (ODI) were also compared before operation, at 1 day and 1 year after operation and at the final follow-up. Complications such as bone cement leakage and displacement were observed.Results:All patients were followed up for 24-36 months [(29.4±3.4)months]. The operation time was (85.2±10.5)minutes in the robot group, significantly longer than (37.2±3.7)minutes in the conventional group ( P<0.01). The amount of bone cement injection was (5.0±0.7)ml in the robot group, significantly less than (5.3±0.8)ml in the conventional group ( P<0.05). The puncture accuracy in the robot group was 95.4% (83/87), significantly higher than 81.8% (27/33) in the conventional group ( P<0.01). There were no significant differences in vertebral body index, Cobb angle, VAS or ODI between the two groups before operation (all P>0.05). The values of vertebral body index were 87.1±4.5, 86.9±4.3, 86.8±4.3 in the robot group at 1 day after operation, 1 year after operation and the final follow up, respectively, which were significantly higher than 83.6±4.4, 84.1±3.8, 84.4±3.9 in the conventional group (all P<0.01). There were no significant differences in Cobb angle or ODI between the two groups at 1 day after operation, 1 year after operation or the final follow-up (all P>0.05). The values of VAS were (2.9±1.0)points, (1.8±0.7)points, (1.8±0.7)points in the robot group at 1 day after operation, 1 year after operation and the final follow-up, respectively, which were significantly lower than (4.4±1.1)points, (3.1±0.8)points, (3.0±0.9)points in the conventional group (all P<0.01). The bone cement leakage occurred in 7 patients in the robot group [8.0%(7/87)] and in 10 in the conventional group [30.3%(10/33)] ( P<0.01). No delayed bone cement displacement [0.0%(0/87)] occurred in the robot group from 1 day after operation to the final follow-up, but 3 patients [9.1%(3/33)] were noted in the conventional group ( P<0.05). Conclusion:Both robot-assisted and conventional fluoroscopy-guided PVP combined with pediculoplasty have satisfactory effect for SCOVF patients without neurological impairment, but the robot-assisted one has the advantages of higher puncture accuracy, more satisfactory vertebral height recovery, more rapid pain relief, lower incidence of bone cement leakage and effective avoidance of cement displacement.

Objective:To compare the clinical efficacies of O-arm combined with CT three-dimensional navigation system assisted screw placement versus manual screw placement in treating lower cervical fracture and dislocation.Methods:A retrospective cohort study was used to analyze the clinical data of 41 patients with lower cervical fracture and dislocation, who were treated in Honghui Hospital, Xi′an Jiaotong University from May 2021 to February 2022. The patients included 26 males and 15 females, aged 31.5-48.6 years [(41.5±15.0)years]. The injured segments were C 3 in 3 patients, C 4 in 12, C 5 in 13, C 6 in 10 and C 7 in 3. Nineteen patients were treated with cervical pedicle screws by O-shaped arm combined with CT three-dimensional navigation system (navigation group, 76 screws) and 22 by bare hands (traditional group, 88 screws). The total operation time, effective operation time, single nail placement time, single screw correction times, screw distance from anterior cortex, intraoperative blood loss, intraoperative fluoroscopic radiation dose, incision length and length of hospital stay were compared between the two groups, and the height of intervertebral space, Cobb angle, interbody slip distance and American Spinal injury Association (ASIA) grade were compared before operation and at 3 days after operation. Visual analogue score (VAS), Japanese Orthopedic Association (JOA) score, and neck dysfunction index (NDI) were evaluated before operation, at 3 days, 3 months after operation and at the last follow-up. Accuracy of screw placement and incidence of complications (adjacent facet joint invasion, infection, screw loosening) were detected as well. Results:All the patients were followed up for 11.1-13.9 months [(12.5±1.4)months]. The total operation time, intraoperative blood loss, intraoperative fluoroscopic radiation dose and incision length in the navigation group were more or longer than those in the traditional group (all P<0.05). The effective operation time, single nail placement time, single nail correction times and screw distance from anterior cortex in the navigation group were markedly less or smaller than those in the traditional group (all P<0.05). There was no significant difference in the length of hospital stay between the two groups ( P>0.05). There were significant improvements in the height of intervertebral space, Cobb angle and interbody slip distance between the two groups at 3 days after operation (all P<0.05). There was no significant difference in the height of intervertebral space, Cobb angle, interbody slip distance or ASIA grade between the two groups before operation or at 3 days after operation (all P>0.05). Compared with pre-operation, the VAS, JOA score and NDI were significantly improved in both groups at 3 days, 3 months after operation and at the last follow-up (all P<0.05), with further improvement with time. There was no significant difference in VAS between the two groups before operation or at 3 months after operation (all P>0.05), but it was markedly lower in the navigation group compared with the traditional group at 3 days after operation and at the last follow-up (all P<0.05). There were no significant differences in JOA score or NDI between the two groups before operation or at 3 days and 3 months after operation (all P>0.05), but both were lower in the navigation group compared with the traditional group at the last follow-up (all P<0.05). The accuracies of placement of grade 0 and grade 0+1 screws were 92.0% (70/76) and 96.6% (73/76) in the navigation group, respectively, which were markedly higher than 88.7% (78/88) and 93.5% (82/88) in the traditional group (all P<0.05). The rates of adjacent facet joint invasion of A, B, and C degrees were 71.2% (54/76), 28.8% (22/76) and 0% (0/76) in the navigation group, respectively, while the invasion rates were 60.5% (53/88), 32.3% (28/88) and 7.3% (7/88) in the traditional group ( P<0.05). No screw loosening was noted in the navigation group, but the screw loosening rate was 9.1% (8/88) in the traditional group ( P<0.01). Conclusion:Compared with manual screw placement, O-arm combined with CT three-dimensional navigation system assisted screw placement for lower cervical fracture and dislocation has the advantages of shorter effective operation time, quicker screw placement, stronger screw holding force, better cervical stability, slighter postoperative pain, higher screw placement accuracy, and lower facet joint invasion and screw loosening rates.

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.

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