1.Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 2b trial
Yan ZHAO ; Jianzhong ZHANG ; Bin YANG ; Jingyi LI ; Yangfeng DING ; Liming WU ; Litao ZHANG ; Jinyan WANG ; Xiaohong ZHU ; Furen ZHANG ; Xiaohua TAO ; Yumei LI ; Chunlei ZHANG ; Linfeng LI ; Jianyun LU ; Qingchun DIAO ; Qianjin LU ; Xiaoyong MAN ; Fuqiu LI ; Xiujuan XIA ; Hao CHENG ; Yingmin JIA ; Guoqing ZHAO ; Jinchun YAN ; Bo CHEN
Chinese Medical Journal 2024;137(2):200-208
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.
2.Efficacy of electrolysis of depigmented hair combined with hair follicle transplantation in the treatment of 25 cases of vitiligo-associated leukotrichia: a retrospective analysis
Tao WANG ; Yi WU ; Hong JIN ; Yeqin DAI ; Jianzhong PENG ; Ai′e XU ; Xiuzu SONG
Chinese Journal of Dermatology 2024;57(1):46-49
Objective:To analyze the clinical efficacy of electrolysis of depigmented hair using a trichiasis electrolyzer combined with hair follicle transplantation in the treatment of vitiligo-associated leukotrichia.Methods:Clinical data were retrospectively collected from 25 patients with stable vitiligo-associated leukotrichia in the Department of Dermatologic Surgery, Hangzhou Third People′s Hospital from January 2019 to January 2021. All the patients received electrolysis of depigmented hair using a trichiasis electrolyzer combined with hair follicle transplantation. Outpatient follow-up visits were conducted in the first week, as well as the first, third and sixth months after surgery. The texture and growth status of transplanted hair were observed, and the survival rate of transplanted hair follicles and the proportion of newborn white hair in white hair in the original lesions were recorded.Results:Among the 25 patients with stable vitiligo, there were 14 males and 11 females, and their disease duration ranged from 2 to 15 years, with the average duration being 5.8 years. A total of 30 white patches accompanied by leukotrichia were included, including 9 on the scalp, 7 on the eyebrows and 14 on the eyelashes. One week after surgery, the transplanted hair survived well in all patients, without obvious shedding or local infection. Six months after surgery, repigmentation was observed in most hair in the original lesion area, and only a small amount of white hair grew out, without obvious scarring; the survival rate of transplanted hair follicles was 76.5% ± 10.0%, and the proportion of newborn white hair in white hair in the original lesions was 16.7% ± 7.8%.Conclusion:Electrolysis of depigmented hair using a trichiasis electrolyzer combined with hair follicle transplantation was effective in the treatment of vitiligo-associated leukotrichia, with a simple treatment process and few postoperative complications, which provided a reliable choice for the clinical treatment of vitiligo-associated leukotrichia.
3.Current status and management strategies of occupational disease hazards in Shantou City from 2019 to 2022
Shaofang LIN ; Xiaohua WU ; Chaoxin LIN ; Shaorong LIANG ; Jianzhong CHEN
China Occupational Medicine 2024;51(5):570-574
Objective To analyze the status of occupational disease hazards in Shantou City for 2019 to 2022 and propose corresponding management measures. Methods Technical reports on various occupational-disease-specific activities in Shantou City from 2019 to 2022 were collected and the data were comprehensively analyzed. Results Among the 3 066 enterprises surveyed in the 2020 occupational disease hazard investigation in Shantou City, occupational hazards were reported in 2 982 enterprises (accounting for 97.3%), with 2 955 being small and micro enterprises, accounted for 99.1%(2 955/2 982). The exposure rate of occupational hazards was 58.7% (42 894/73 054) among workers in the surveyed enterprises, with dust and noise exposure rates of 59.7% and 77.8%, respectively. The reported rate of occupational disease hazard projects by employers, regular detection rate of workplace occupational hazards, detection rate of occupational medical examination among workers, and occupational health training rate of key responsible personnel and occupational health management staff were 8.4%, 1.4%, 2.4%, and 4.3%, respectively. The results of occupational hazards monitoring of workplace in key industries from 2019 to 2022 showed that noise had the highest rate of exceeding national standards workplace, followed by silica dust, accounting for 34.2% and 13.8%, with the on-site exceedance rate of 32.2% and 10.0%, respectively. From 2019 to 2022, 31 suspected occupational disease cases were identified in key occupational disease monitoring, including 27 suspected cases of occupational pneumoconiosis and four suspected cases of occupational noise-induced deafness. Conclusion The workers in Shantou City have a high exposure rate to occupational hazards, and the occupational health management level of employers remains low, with noise and silica dust being the most severe occupational hazards. It is essential to improve technical support and service system development for occupational disease prevention and treatment, strengthen supervision and management in key industries and positions, explore occupational health assistance mechanisms for small and micro enterprises, and enforce employers' responsibility in occupational disease prevention to protect workers' occupational health and safety.
4.Comparison of hamstring tendon graft, ligament advanced reinforcement system, and mixed ligament in reconstruction of posterior cruciate ligament
Lingxiao WU ; Zhi QIAO ; Yang YU ; Jun TAN ; Jianzhong XU
Chinese Journal of Orthopaedic Trauma 2024;26(6):512-518
Objective:To compare hamstring tendon graft (HTG), ligament advanced reinforcement system (LARS), and mixed HTG & LARS ligament in reconstruction of posterior cruciate ligament (PCL).Methods:A retrospective study was conducted to analyze the 59 patients with PCL rupture who had been admitted to Department of Orthopedics, The First Affiliated Hospital of Zhengzhou University for arthroscopic PCL reconstruction between January 2018 and August 2021. The patients were divided into 3 groups: in the HTG group of 21 cases [14 males and 7 females aged (37.8±12.6) years], PCL was reconstructed by HTG; in the LARS group of 20 cases [12 males and 8 females aged (34.3±9.1) years], PCL was reconstructed by LARS; in the mixed group of 18 cases [13 males and 5 females aged (33.2±8.3) years], PCL was reconstructed by the mixed HTG & LARS ligament. The 3 groups were compared in terms of Lysholm knee score, International Knee Documentation Committee (IKDC) score, and laxity disparity between bilateral knees at 1 and 2 years after surgery.Results:There was no statistically significant difference in the preoperative general data between the 3 groups, indicating comparability ( P>0.05). One year after surgery, the mixed group had a significantly higher IKDC score [(90.0±6.5) points] than the HTG group [(78.1±5.7) points] and the LARS group [(84.1±7.3) points], and a significantly higher Lysholm score [(88.9±5.5) points] and a significantly smaller laxity disparity between bilateral knees [(2.8±1.7) mm] than the HTG group [(81.8±4.6) points, (4.7±2.4) mm] ( P<0.05). Two years after surgery, the mixed group had a Lysholm score of (93.0±4.5) points, a IKDC score of (92.5±5.7) points, and a laxity disparity between bilateral knees of (2.3±1.8) mm, all significantly better than those in the HTG group [(88.5±5.5) points, (82.7±5.7) points, and (4.2±2.5) mm] and in the LARS group [(89.0±5.2) points, (86.5±7.3) points, and (3.8±2.2) mm] ( P<0.05). In all the 3 groups, the knee function scores and laxity disparities between bilateral knees at 1 and 2 years after surgery were significantly improved compared with the preoperative values ( P<0.05). Conclusions:Satisfactory clinical outcomes can be obtained after arthroscopic PCL reconstruction using HTG, LARS or the mixed HTG & LARS ligament. However, the mixed ligament as a graft can achieve better clinical efficacy than the other two grafts.
5.Risk factors analysis of neurogenic pain after adult high grade lumbar spondylolisthesis reduction surgery
Lang ZENG ; Yan YANG ; Liyuan JIANG ; Jianhuang WU ; Jianzhong HU ; Tianding WU
Chinese Journal of Orthopaedics 2024;44(13):866-873
Objective:To evaluate the significance of the lumbar bowstring ratio (LBR) and sagittal spine-pelvis parameters in predicting postoperative neurogenic pain in adult patients with high-grade lumbar isthmic spondylolisthesis following spinal fusion surgery.Methods:A retrospective analysis was conducted on the clinical and imaging data of 95 adult patients with high-grade lumbar isthmic spondylolisthesis treated by spinal surgery at Xiangya Hospital of Central South University from August 2012 to January 2023. Each patient was followed for a minimum of six months. Participants were categorized into pain and non-pain groups based on the presence of persistent radicular pain (≥8 weeks) and a visual analogue scale (VAS) score of ≥3 postoperatively. The pain group comprised 15 patients (5 males, 10 females; mean age 55.47±6.42 years, range 46-71 years), while the non-pain group included 80 patients (20 males, 60 females; mean age 60.98±11.50 years, range 40-85 years). Clinical outcomes were assessed using the Oswestry Disability Index (ODI) and VAS scores. LBR was defined as the ratio of the vertical distance from the anterior convexity of the L 1-L 5 anterior longitudinal ligament to a line connecting the posterior superior margin of the L1 vertebra and the posterior margin of the S1 vertebra, to the distance between these two points. Spinal-pelvic parameters measured included pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS), lumbar lordosis (LL), PT/SS ratio, and changes in LBR before and after surgery (ΔLBR). Statistical comparisons of demographic and imaging parameters were performed between the two groups, and variables showing significant differences were subjected to binary logistic regression analysis to identify independent risk factors for postoperative neurogenic pain. Results:All 95 patients achieved complete anatomical reduction of the dislocation without reported wound infections. Follow-up was completed at 7.68±2.98 months (range 6-12 months) postoperatively. Among the patients, 15 developed iatrogenic radicular pain. Postoperative complications included pulmonary infection (4 cases: 1 in the pain group, 3 in the non-pain group), cerebrospinal fluid leakage (8 cases: 2 in the pain group, 6 in the non-pain group), and delirium (5 cases: 2 in the pain group, 3 in the non-pain group). No significant differences were observed in demographic data between the groups ( P>0.05). Both groups demonstrated significant improvements in ODI (pain group Z=-3.413, P=0.001; non-pain group Z=-7.772, P<0.001) and VAS scores (pain group Z=-3.426, P=0.001; non-pain group Z=-7.838, P<0.001) at the 6-month follow-up compared to preoperative values. Significant differences were found between the pain and non-pain groups in PI ( t=3.315, P=0.004), PT ( t=5.087, P<0.001), SS ( t=7.431, P<0.001), LL ( t=3.764, P<0.001), PT/SS ( t=7.267, P<0.001), LBR ( t=6.455, P<0.001), and ΔLBR ( Z=5.362, P<0.001) before and after surgery. Binary logistic regression analysis identified smaller preoperative PT/SS [ OR=0.760, 95% CI(0.601, 0.961), P=0.022] and larger preoperative LBR [ OR=5.721, 95% CI (1.068, 30.634), P=0.042] as independent risk factors for postoperative neurogenic pain. Conclusion:High LBR and reduced PT/SS are significant risk factors for neurogenic pain following complete discectomy and fusion in adult patients with high-grade lumbar isthmic spondylolisthesis. For such patients, careful consideration is warranted regarding anatomical complete reduction during surgical intervention.
6.Endoscopic submucosal dissection for the treatment of gastric fundus adenocarcinoma(4 cases)
Yangqing WU ; Jianbo ZHOU ; Ying FANG ; Jianzhong SANG ; Qifeng SONG ; Jian HUANG
China Journal of Endoscopy 2024;30(8):80-84
Objective To summarize the endoscopic and clinical diagnosis and treatment of 4 cases of gastric fundus adenocarcinoma.Method A retrospective analysis was conducted on the clinical data of four cases of gastric fundus adenocarcinoma from July 2021 to December 2023.Result All the 4 cases of gastric fundus adenocarcinoma were completely removed by endoscopic submucosal dissection(ESD),with good postoperative recovery,no surgical complications,and no recurrence or metastasis during follow-up.Conclusion ESD treatment for gastric fundus adenocarcinoma is safe,reliable,and can completely remove the lesion.
7.Study on application of ultrasonic bone curette in anterior cervical spine surgery.
Chen XU ; Zhaodong WANG ; Yajun LIU ; Zhonglian ZHU ; Keyou DUAN ; Min WU ; Jianzhong GUAN
Chinese Journal of Reparative and Reconstructive Surgery 2023;37(8):996-1001
OBJECTIVE:
To investigate the effect of ultrasonic bone curette in anterior cervical spine surgery.
METHODS:
A clinical data of 63 patients with cervical spondylosis who were admitted between September 2019 and June 2021 and met the selection criteria was retrospectively analyzed. Among them, 32 cases were operated with conventional instruments (group A) and 31 cases with ultrasonic bone curette (group B). There was no significant difference between the two groups (P>0.05) in gender, age, surgical procedure, surgical segment and number of occupied cervical space, disease type and duration, comorbidities, and preoperative Japanese Orthopaedic Association (JOA) score, cervical dysfunction index (NDI), and pain visual analogue scale (VAS) score. The operation time, intraoperative bleeding, postoperative drainage, postoperative hospital stay, and the occurrence of postoperative complications were recorded in both groups. Before operation and at 1, 3, and 6 months after operation, the JOA score and NDI were used to evaluate the function and the postoperative JOA improvement rate was calculated, and VAS score was used to evaluate the pain improvement. The anteroposterior and lateral cervical X-ray films were taken at 1, 3, and 6 months after operation to observe whether there was any significant loosening and displacement of internal fixators.
RESULTS:
Compared with group A, group B had shorter operation time and postoperative hospital stay, less intraoperative bleeding and postoperative drainage, and the differences were significant (P<0.05). All incisions healed by first intention in the two groups, and postoperative complications occurred in 5 cases (15.6%) in group A and 2 cases (6.5%) in group B, showing no significant difference (P>0.05). All patients were followed up 6-12 months (mean, 7.9 months). The JOA score and improvement rate gradually increased in groups A and B after operation, while the VAS score and NDI gradually decreased. There was no significant difference in VAS score between 3 months and 1 month in group B (P>0.05), and there were significant differences between the other time points of each indicator in the two groups (P<0.05). At 1, 3, and 6 months after operation, the JOA score and improvement rate in group B were better than those in group A (P<0.05). X-ray films examination showed that there was no screw loosening or titanium plate displacement in the two groups after operation, and the intervertebral cage or titanium mesh significantly sank.
CONCLUSION
Compared with traditional instruments, the use of ultrasonic bone curette assisted osteotomy in anterior cervical spine surgery has the advantages of shorter operation time, less intraoperative bleeding, less postoperative drainage, and shorter hospital stay.
Humans
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Ultrasonics
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Retrospective Studies
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Titanium
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Postoperative Complications/epidemiology*
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Bone Plates
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Cervical Vertebrae/surgery*
8.Spondylodiscitis of lumbar complicated with spinal epidural abscess caused by Parvimonas micra:A case report and literature review
Yan YANG ; Jianhuang WU ; Jianzhong HU ; Tianding WU
Journal of Central South University(Medical Sciences) 2023;48(12):1929-1936
Spinal infection caused by Parvimonas micra(P.micra)is a rare infection.The characteristic imageology includes spondylodiscitis,spondylitis,paravertebral abscess,and epidural abscess.One case of spondylodiscitis of lumbar complicated with spinal epidural abscess caused by P.micra was admitted to the Department of Spinal Surgery,Xiangya Hospital,Central South University on February,2023.This case is a 60 years old man with lower back pain and left lower limb numbness.MRI showed spondylitis,spondylodiscitis,and epidural abscess.The patient underwent debridement,decompression and fusion surgery.The culture of surgical sample was negative.P.micra was detected by metagenomic next-generation sequencing(mNGS).The postoperative antibiotic treatment included intravenous infusion of linezolid and piperacillin for 1 week,then intravenous infusion of ceftazidime and oral metronidazole for 2 weeks,followed by oral metronidazole and nerofloxacin for 2 weeks.During the follow-up,the lower back pain and left lower limb numbness was complete remission.Spinal infection caused by P.micra is extremely rare,when the culture is negative,mNGS can help the final diagnosis.
9.Expert consensus for the clinical application of autologous bone marrow enrichment technique for bone repair (version 2023)
Junchao XING ; Long BI ; Li CHEN ; Shiwu DONG ; Liangbin GAO ; Tianyong HOU ; Zhiyong HOU ; Wei HUANG ; Huiyong JIN ; Yan LI ; Zhonghai LI ; Peng LIU ; Ximing LIU ; Fei LUO ; Feng MA ; Jie SHEN ; Jinlin SONG ; Peifu TANG ; Xinbao WU ; Baoshan XU ; Jianzhong XU ; Yongqing XU ; Bin YAN ; Peng YANG ; Qing YE ; Guoyong YIN ; Tengbo YU ; Jiancheng ZENG ; Changqing ZHANG ; Yingze ZHANG ; Zehua ZHANG ; Feng ZHAO ; Yue ZHOU ; Yun ZHU ; Jun ZOU
Chinese Journal of Trauma 2023;39(1):10-22
Bone defects caused by different causes such as trauma, severe bone infection and other factors are common in clinic and difficult to treat. Usually, bone substitutes are required for repair. Current bone grafting materials used clinically include autologous bones, allogeneic bones, xenografts, and synthetic materials, etc. Other than autologous bones, the major hurdles of rest bone grafts have various degrees of poor biological activity and lack of active ingredients to provide osteogenic impetus. Bone marrow contains various components such as stem cells and bioactive factors, which are contributive to osteogenesis. In response, the technique of bone marrow enrichment, based on the efficient utilization of components within bone marrow, has been risen, aiming to extract osteogenic cells and factors from bone marrow of patients and incorporate them into 3D scaffolds for fabricating bone grafts with high osteoinductivity. However, the scientific guidance and application specification are lacked with regard to the clinical scope, approach, safety and effectiveness. In this context, under the organization of Chinese Orthopedic Association, the Expert consensus for the clinical application of autologous bone marrow enrichment technique for bone repair ( version 2023) is formulated based on the evidence-based medicine. The consensus covers the topics of the characteristics, range of application, safety and application notes of the technique of autologous bone marrow enrichment and proposes corresponding recommendations, hoping to provide better guidance for clinical practice of the technique.
10.An evidence-based clinical guideline for the treatment of infectious bone defect with induced membrane technique (version 2023)
Jie SHEN ; Lin CHEN ; Shiwu DONG ; Jingshu FU ; Jianzhong GUAN ; Hongbo HE ; Chunli HOU ; Zhiyong HOU ; Gang LI ; Hang LI ; Fengxiang LIU ; Lei LIU ; Feng MA ; Tao NIE ; Chenghe QIN ; Jian SHI ; Hengsheng SHU ; Dong SUN ; Li SUN ; Guanglin WANG ; Xiaohua WANG ; Zhiqiang WANG ; Hongri WU ; Junchao XING ; Jianzhong XU ; Yongqing XU ; Dawei YANG ; Tengbo YU ; Zhi YUAN ; Wenming ZHANG ; Feng ZHAO ; Jiazhuang ZHENG ; Dapeng ZHOU ; Chen ZHU ; Yueliang ZHU ; Zhao XIE ; Xinbao WU ; Changqing ZHANG ; Peifu TANG ; Yingze ZHANG ; Fei LUO
Chinese Journal of Trauma 2023;39(2):107-120
Infectious bone defect is bone defect with infection or as a result of treatment of bone infection. It requires surgical intervention, and the treatment processes are complex and long, which include bone infection control,bone defect repair and even complex soft tissue reconstructions in some cases. Failure to achieve the goals in any step may lead to the failure of the overall treatment. Therefore, infectious bone defect has been a worldwide challenge in the field of orthopedics. Conventionally, sequestrectomy, bone grafting, bone transport, and systemic/local antibiotic treatment are standard therapies. Radical debridement remains one of the cornerstones for the management of bone infection. However, the scale of debridement and the timing and method of bone defect reconstruction remain controversial. With the clinical application of induced membrane technique, effective infection control and rapid bone reconstruction have been achieved in the management of infectious bone defect. The induced membrane technique has attracted more interests and attention, but the lack of understanding the basic principles of infection control and technical details may hamper the clinical outcomes of induced membrane technique and complications can possibly occur. Therefore, the Chinese Orthopedic Association organized domestic orthopedic experts to formulate An evidence-based clinical guideline for the treatment of infectious bone defect with induced membrane technique ( version 2023) according to the evidence-based method and put forward recommendations on infectious bone defect from the aspects of precise diagnosis, preoperative evaluation, operation procedure, postoperative management and rehabilitation, so as to provide useful references for the treatment of infectious bone defect with induced membrane technique.

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