Background::Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods::This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied.Results::At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs. placebo, 95% CI 31%–69%) and 45% (low vs. placebo, 95% CI 26%–64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator’s Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310. Conclusion::CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration::ClinicalTrials.gov, NCT04805411.

OBJECTIVE To optimize the processing technology of honey bran-fried Atractylodis Rhizoma， and to compare the anti-gastric ulcer effect before and after processing. METHODS Combing with entropy-weight and technique for order preference by similarity to ideal solution model， L（9 34） orthogonal experiment design was adopted to optimize the processing technology of honey bran-fried Atractylodis Rhizoma using the comprehensive score of the contents of atractylone， β-cineole， atractylenolide Ⅲ and atractylodine as evaluation index， using the ratio of excipients to medicine， frying temperature and frying time as factors. The validation tests were conducted. The gastric ulcer model of mice was induced by intragastrical administration of anhydrous ethanol； using Compound aluminum hydroxide tablet as positive control， anti-gastric ulcer effect of Atractylodis Rhizoma was compared with that of honey bran-fried Atractylodis Rhizoma using the contents of serum inflammatory factors [interleukin-2 （IL-2）， IL-6， tumor necrosis factor-α （TNF-α）]， ulcer index and inhibitory rate of gastric ulcer as evaluation indexes. RESULTS The optimal processing technology of honey bran-fried Atractylodis Rhizoma was as follows：ratio of adjuvant and medicinal materials of 3∶10 （g/g）， frying temperature at 140 ℃ and frying time of 4 min. Results of 3 validation tests showed that the contents of 4 components （including atractylone）， in honey bran-fried Atractylodis Rhizoma processed by the optimal technology kept stable （RSDs were 3.47%-5.80%， n＝3）； the comprehensive scores were 95.53%-95.89% （RSD＝0.21%， n＝3）. Atractylodis Rhizoma and honey bran-fried Atractylodis Rhizoma could increase the serum content of IL-2 in mice， but reduce serum contents of IL-6 and TNF-α to varying degrees； honey bran-fried Atractylodis Rhizoma could significantly decrease its ulcer indexes （P＜0.05 or P＜ 0.01）； the improvement effect of honey bran-fried Atractylodis Rhizoma on the above indicators was generally better than that of the same dosage of Atractylodis Rhizoma （P＜0.05 or P＜ 0.01）. The inhibitory rates of low-dose， medium-dose and high-dose Atractylodis Rhizoma and honey bran-fried Atractylodis Rhizoma to gastric ulcer in mice were 9.18%， 19.30%， 30.70%， and 50.32%， 61.39%， 53.16%， respectively. CONCLUSIONS The optimal processing technology of honey bran-fried Atractylodis Rhizoma is stable and feasible， and the anti-gastric ulcer effect of Atractylodis Rhizoma has been enhanced after being fried with honey bran.

Objective To explore the incidence of dysphagia and its potential risk factors.Methods From January 2014 to December 2015,a total of 187 patients who underwent single-level anterior cervical spine surgery were recruited in this retrospective analysis study.Specific perioperative data including age,gender,smoking,alcohol use,BMI,estimated blood loss,surgical segment,length of incision,and length of hospital stay were recorded respectively.The Bazaz grading system and the swallowing quality of life (SWAL-QOL) score were used to assess the presence and severity of dysphagia.According to the Bazaz grading system,the patients were divided into dysphagia group and non-dysphagia group 1 week after operation.One-factor x2 test and one-sample t test were used to univariate analyze the two groups of related factors,and select the potential variables for multivariate logistic regression analysis to identify the risk factors leading to dysphagia.Results The number of dysphagia patient was 99 (52.94％) at 1 week after surgery,and 16 (8.56％) at 1 year.The preoperative mean SWAL-QOL score was 65.62±4.41 points,which decreased to 58.72±7.54 points after surgery and rose up to 64.66±5.26 points at the 12-month follow-up.The SWAL-QOL score at 1 week after surgery was correlated with the operative time (r=-0.474;P ＜ 0.001).Multivariate analysis indicated that preoperative tracheal exercise (OR=0.302,95％CI:0.131,0.748),operation time ＜ 60 min (OR=0.407,95％CI:0.190,0.878),and arthroplasty (OR=0.211,95％CI:0.102,0.425) were the independent factors to reduce the incidence of postoperative dysphagia.Conclusion The incidence and severity of dysphagia symptoms after single-level anterior cervical spine surgery gradually decreased with the extension of follow-up time.Preoperative tracheal exercise,shortened operative time and manual artificial disc replacement may be helpful to reduce the postoperative occurrence of dysphagia.

BACKGROUNDCervical spondylotic myelopathy (CSM) is a common cause of disability in elderly patients. Previous studies have shown that spinal cord cell apoptosis due to spinal cord compression plays an important role in the pathology of myelopathy. Although changes in magnetic resonance imaging (MRI) T2 signal intensity ratio (SIR) are considered to be an indicator of CSM, little information is published supporting the correlation between changes in MRI signal and pathological changes. This study aims to testify the correlation between MRI T2 SIR changes and cell apoptosis using a CSM animal model.

METHODSForty-eight rabbits were randomly assigned to four groups: one control group and three experimental chronic compression groups, with each group containing 12 animals. Chronic compression of the cervical spinal cord was implemented in the experimental groups by implanting a screw in the C3 vertebra. The control group underwent sham surgery. Experimental groups were observed for 3, 6, or 9 months after surgery. MRI T2-weighted SIR Tarlov motor scores and cortical somatosensory-evoked potentials (CSEPs) were periodically monitored. At each time point, rabbits from one group were sacrificed to determine the level of apoptosis by histology (n = 6) and Western blotting (n = 6).

RESULTSTarlov motor scores in the compression groups were lower at all time points than the control group scores, with the lowest score at 9 months (P < 0.001). Electrophysiological testing showed a significantly prolonged latency in CSEP in the compression groups compared with the control group. All rabbits in the compression groups showed higher MRI T2 SIR in the injury epicenter compared with controls, and higher SIR was also found at 9 months compared with 3 or 6 months. Histological analysis showed significant apoptosis in the spinal cord tissue in the compression groups, but not in the control group. There were significant differences in apoptosis degree over time (P < 0.001), with the 9-month group displaying the most severe spinal cord apoptosis. Spearman's rank correlation test showed that there was close relation between MRI SIR and degree of caspase-3 expression in Western blotting (r = 0.824. P < 0.001).

CONCLUSIONSClear apoptosis of spinal cord tissue was observed during chronic focal spinal compression. Changes in MRI T2 SIR may be related to the severity of the apoptosis in cervical spinal cord.

Animals ; Apoptosis ; physiology ; Cervical Cord ; metabolism ; pathology ; Magnetic Resonance Imaging ; Male ; Rabbits ; Spinal Cord Compression ; metabolism ; pathology

Objective To analyze retrospectively clinical study efficacy and feasibility of one-stage posterior lumbar debridement,interbody fusion,and posterior instrumentation in treating lumbar spinal tuberculosis.Methods A total of 21 patients (14 males and 7 females) with lumbar tuberculosis collected from January 2009 to May 2012,underwent one-stage posterior lumbar debridement,interbody fusion,and posterior instrumentation.The age ranged 19 to 47 years (mean,34.8 years).All patients presented with presented with back pain,7 patients with constitutional symptoms including weakness,malaise,night sweats,fever and weight loss,2 with limbs numb and 1 with intermittence creep.Every patient underwent lumbar spine X -ray,CT scan and MRI examination of pathologic vertebra before surgery.All patients received at least a standard preoperative 2-4 week anti-tuberculosis treatment.Results All patients were confirmed by pathology or microbiology and were followed up for 12-48 months (mean,18 months).Average operation time was 3.1 h (range,2.5 to 4.3 h).Lumbar tuberculosis was completely cured and the grafted bones were fused 10 months after operation in all patients.There was no persistence or recurrence of infection and no nerve,blood vessel injury.After the treatment,the erythrocyte sedimentation rate (ESR) was decreased to normal level in 5.8 months.Conclusion With effective and standard anti-tuberculosis chemotherapy,the pedicle screw was placed due to pathologic vertebral body.One-stage posterior lumbar debridement,interbody fusion,and posterior instrumentation for lumbar tuberculosis could effectively relieve pain symptoms,and reconstruct the spinal stability.

Objective To ratiocinate the formula of relationship between opening size of laminoplasty and the increment of sagittal canal diameter following double-door cervical laminoplasty and to predict the increment of sagittal canal diameter and the cross sectional area of canal according to the opening size of laminoplasty.Methods Twenty patients (12 males and 8 females) with multilevel cervical spondylotic myelopathy had undergone double-door cervical laminoplasty (C3-C7 in 9 patients and C3-C6 in 11 patients,89 segments) in our institution between September 2010 and January 2013.The formula describing the relationship between the opening size of laminoplasty and the increment of sagittal diameter was deduced.The parameters of pre-and post-operative computed tomography scans of 20 patients who had undergone laminoplasty surgery were measured by picture archiving and communication system (PACS) software,and the increment of sagittal canal diameter and the cross sectional area of canal were predicted when the opening size of laminoplasty were 6 mm,8 mm,10 mm,12 mm,14 mm and 16 mm according to the formula.Results Increment of sagittal canal diameter and canal area respectively showed significant difference in the same segment laminoplasty.Increment of sagittal canal diameter between various groups in the same segment (C3-C6) showed significant difference.Increment of sagittal canal diameter between the opening size of 14 mm and 16 mm in C7 laminoplasty showed no significant difference.Increment of sagittal canal diameter was increased steadily following C3-C7 double-door laminoplasty with opening sizes of 6 mm,8 mm,10 mm,12 mm,14mm and 16mm,but the increasing trend in sagittal canal diameter diminished gradually.Conclusion Increment of sagittal canal diameter and canal area following C3-C7 laminoplasty can be accurately predicted according to the opening size of laminoplasty by this formula.The formula can help operator to perform double-door cervical laminoplasty based on accurate individual laminoplasty opening size,which prevents inadequate or excessive opening.

Objective To retrospectively analysis and compareabout Bryan artificial cervical disc arthroplasty with ante-rior cervical decompression and fusion (ACDF) on the clinical efficacy for“Skip”cervical spondylosis. Methods From February 2002 to May 2012, 49 cases were treated with Bryan artificial cervical disc arthroplasty (artificial cervical disc replacement surgery group, 18 cases) or anterior cervical decompression and fusion (ACDF group, 31 cases), 29 males and 20 females. Each case was evaluated at the moment of preoperatively, 3 months, 6 and 12 months and last follow-up after surgery by the Japanese Orthopedic Association (JOA), Neck Disability Index (NDI), Visual Analog Scale (VAS), Cervical sagittal curvature, the total cervical spine range of motion(ROM),middle segments of motion. MRI was also used to assess to adjacent segment disc degeneration, spinal cord compression and signal change situation. Results All patients were followed up for more than 24 months. The score of the JOA, NDI, VAS in the two groups of patients improved significantly after surgery than before surgery. In addition, the VAS score in last follow-up were significantly different between the two groups, but other index each time in the two groups showed no significant difference. In last follow-up, the result of artificial cervical disc arthroplasty group were better than ACDF group on the incidence of axial symptoms, the total cervical spine range of motion (ROM) and middle segments of motion. The incidence of axial symptoms in artificial cervical disc arthroplasty group were 11.1%,ACDF group were 45.2%. ROM in arti-ficial cervical disc arthroplasty group were 35.5°±5.9°,ACDF group were 24.5°±6.2°. Middle segments of motion in artificial cer-vical disc arthroplasty group were 7.3°±1.4°,ACDF group were 10.1°±1.6°. The above comparison of the datas were statistically different. There are two cases of adjacent segment degeneration in ACDF group without need to surgery. Conclusion Bryan artifi-cial cervical disc replacement surgery effectively retained the overall motion of the cervical spine, reduced the motion of middle segments, thus avoiding adjacent segment degeneration and the incidence of postoperative axial symptoms.

Objective To investigate the effect and prevention of complications of selective posterior enlarged decompression and lateral mass screw fixation for multisegmental cervical spondylotic myelopathy with kyphosis.Methods From January 2008 to January 2011,43 patients with multisegmental cervical spondylotic myelopathy combined with kyphosis,aged from 42 to 74 years (average,59.6 years),underwent selective posterior enlarged decompression and lateral mass screw fixation.The JOA (Japanese Orthopaedic Association) scoring system and Neck Disability Index (NDI) were applied to evaluate the neurological function and axial neck/shoulder pain before and after surgery,respectively.The Ishihara method was employed to measure the cervical curvature index (CI).The expanding and shifting of the spinal cord was calculated in MRI.Results The decompression range was 3 to 5 segments (average,3.91±0.86 segments).All patients were followed up for 20 to 60 months (average,38 months).There were significant differences between preand post-operative JOA score (8.16±1.11 vs.14.31±1.33),CI (7.36％±9.69％ vs.15.30％±3.18％),anteroposterior diameter of the dural sac at the level of maximum stenosis in MRI [(2.92±1.49) mm vs.(6.10±0.89)mm],and NDI score (19.36±8.61 vs.4.90±2.46).The mean spinal cord posterior shift was (4.59±1.20) mm (range,2.97 to 6.68 mm).The complete bone graft fusion was achieved in all patients 3 to 6 months after surgery.No C5 nerve root palsy or instrument failure occurred.Conclusion The selective posterior enlarged decompression and lateral mass screw fixation is effective in treating multisegmental cervical spondylotic myelopathy with kyphosis,which can improve neurological function,recover and maintain the normal cervical curvature,and decrease the incidences of axial symptoms and C5 nerve root palsy

Objective To analyze the effect of cervical.curvature and intervertebral height on the surgical outcome of posterior decompression in patients with multi-level cervical spondylotic myelopathy.Method A total of 50 patients with multi-segment cervical spondylotic myelopathy (≥ 3 segments),treated with posterior decompression from June 2006 to January 2009 were retrospectively analyzed.Twenty six patients underwent cervical omni-posterior decompression and lateral mass screw internal fixation (group A); 24patients underwent expansive open-door laminoplasty (group B).The effects of changing of cervical curvature and intervertebral height on JOA score and VAS score were analyzed.Results All patients were followed up for 8 months to 4 years (average,24 ±5.5 months).There were statistical differences of cervical curvature angles between preoperative and 3 days postoperatively in group A,while no statistical differences in group B.There were no statistical differences of cervical curvature angles between 3 days,6 months and 3 years postoperatively in group A,while there were differences in group B After further analysis of the loss of cervical curvature and intervertebral height,the result showed that JOA score and VAS score in the low-loss group were better than those in the high-loss group.Conclusion Lateral mass screw internal fixation after cervical omni-posterior decompression had many advantages such as reducing the change of cervical curvature,the loss of intervertebral height and incidence of cervical axial symptoms.

Objective To investigate prevention and treatment of cerebrospinal fluid leakage (CSFL)in anterior cervical spine surgery for severe ossification of posterior longitudinal ligament (OPLL).Methods A retrospective analysis of 47 patients with severe cervical OPLL (thickness of the ossified mass ＞ 5 mm,spinal stenosis ＞50％),who had undergone anterior cervical surgery between January 2008 and May 2011,was conducted.Fifteen cases of dural defect were found intraoperatively,including 11 males and 4 females,aged from 40 to 68 years (average,55.6 years).Preoperative CT scans were earefully analyzed.During the operation,the ossified mass was excised or floated and the arachnoid was reserved in order to reduce dural damage.Dural defects were repaired by suturing or covering with muscle.After surgery,patients were confined to bed rest to allow for drainage or puncture.Results All 15 patients were followed up for 12 to 18months (average,14.8 months).After operation,10 patients recovered fully without CSFL.Five patients developed CSFL,including 4 cases of spinal dural mater injury that healed within 4-6 days with bed rest and pressure dressing,and 1 case of cerebrospinal fluid pseudocyst that disappeared within 3 weeks with repeat puncture and aspiration treatment.No cases required secondary operations or shunt placement.All cases exhibited good neurological improvement.Conclusion During anterior surgical treatment for severe cervical OPLL,CSFL can be effectively prevented through eareful analysis of preoperative CT images,meticulous operative technique,reasonable handling of the ossified mass and positive repair of dural damage.Moreover,postoperative bed rest and drainage are effective to treat CSFL.