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

Objective To investigate the effect of self decoction wet compress on puncture venous sclerosis.Methods 180 patients received intravenous therapy,they were randomly divided into group A,group B and group C,60 cases in each group.Group A was given with Traditional Chinese medicine decoction(rhubarb 20g,Xuan Ming powder 20g,Cortex Phellodendri 15g,20g purslane fried together) for in the direction of blood vessel along the direction of the blood vessel after operation of conventional intravenous infusion,8 layer 10cm×5cm sterile gauze soaked wet,then covered with plastic wrap plastic to the end of infusion 30 min after removal.Group B was given with Traditional Chinese medicine decoction at the end of intravenous infusion at the puncture point along the direction of the blood vessels,8 layer 10cm×5cm sterile gauze soaked wet and then with plastic wrap plastic cover 6h after removing.Group C was given with routine intravenous infusion operation without wet compress intervention.In 3d,5d,vein elasticity of each group was assessed,the normal was effective,mild,moderate and severe hardening was invalid.Results After 3d,5d treatment,the effective rates of group A were 100.0%,91.7% respectively,which in group B were 100.0%,81.7%,respectively,the effective rate at 5d had statistically significant difference between group A and group B (x2=5.17,P<0.05);after 3d,5d treatment,the effective rates of group C were 71.7%,60.0%,and the effective rate at 5 d had statistically significant difference compared with group B and group A (x2=21.07,6.82,all P<0.01).Conclusion The effect of intravenous infusion process to local decoction wet compress on the prevention of venous puncture hardening is significant,and the method is simple,has non-toxic side effects,it is worthy of clinical application.

Objective To investigate effect of single anterior decompression and fusion for pinching cervical spondylosis myelopathy.Methods 82 patients with pinching cervical spondylosis myelopathy,treated with single anterior decompression and fusion,were analyzed,including 43 males and 39 females,with an average age of 54.4 years (range,33-79 years).Occupying rate,anterior occupying rate and posterior occupying rate were measured on pre- and post-operative midsagittal MRIs.Multiple regression analysis was performed between preoperative occupying rate,intervertebral space height,postoperative imaging changes and neural function recovery.Results All patients were followed up for an average of 25.8 months (range,9-72 months).Significant differences were found between pre- and postoperative Japanese Orthopaedic Association (JOA) scores,anterior occupying rate,posterior occupying rate,and intervertebral space height,respectively.Pre- and post-operative posterior occupying rate was averagely 29.0％±10.5％ and 19.9％+11.6％,respectively,and improvement rate of posterior occupying rate was 9.0％±6.1％.Regression analysis found that preoperative intervertebral space height did not relate to posterior occupying rate,while preoperative posterior occupying rate related to improvement rate of posterior occupying rate.JOA scores improved significantly after operation in patients with preoperative posterior occupying rate between 20％ and 40％.However,the decompression results were poor in patients with preoperative posterior occupying rate ≥40％.Conclusion Anterior decompression and fusion can achieve satisfactory results in patients with pinching cervical spondylotic myelopathy.For patients with preoperative posterior occupying rate between 20％ and 40％,the decompression results are better.

Objective To assess the value of using MRI to evaluate the histopathological characteristic of limb soft-tissue aggressive fibromatosis (AF). Methods The MBI findings and histopathological data of 20 patients with AF were obtained and analyzed. The difference between the different signal regions in AF were compared of signal intensity in T1-weighted images, T2-weighted images and degree of enhancement. The data were processed with paired t test. The histopathology of different signal regions was observed in 6 cases on HE stain and Masson trichromic stain of AF specimen. Results (1) AF predominantly originated from the skeletal muscles (19/20), presenting as Iobulated mass with infiltrative growth(20/20) ;(2) A few claw-shaped neo-arteries(7/7) were delineated in the periphery of the mass in the 3D DCEMRA images as well as the mild tumor staining(7/7) ; (3) Based on the MRI findings, the porenchyma of 20 AF was divided into two distinct regions of structure: region Ⅰ and region Ⅱ. Region Ⅰ presented as hypointensity on both T1-weighted and T2-weighted images and no enhancement after i. v. administration of contrast. Region Ⅱ presented as mild hyperintensity on T2-weighted images and iso- or hypointensity on T1-weighted images and marked enhancement; (4) The signal intensity in T1-weighted images, T2-weighted images and degree of enhancement was 0. 10 ± 0. 02,0. 24 ± 0. 03, and ( 5.22 ± 0.42)% in region Ⅰ , respectively; and 0.79±0.04,3.05±0.08 and(151.5±8.61)% in region Ⅱ, respectively. The differences between region Ⅰ and region Ⅱ were statistically significant of signal intensity in T1-weighted images( t = 67. 37 ), and signal intensity in T2-weighted images( t = 196. 56) and degree of enhancement(t =76. 62) (P <0. 01 ) ; (5) Histologically, AF was composed of fibroblasts, fibrecytes and bundles of collagen fiber. On Massen triehromie stain, region Ⅰ was stained blue, being proven the mature collagen fibers. Region Ⅱ was predominantly composed of fibroblasts, fibrecytes and was not stained. Conclusion The region Ⅰ and region Ⅱ are the characteristic MRI manifestations of AF, and MBI precisely reflects the histopathological and biological feature of the tumor.