1.Effect of Erchen Decoction (二陈汤) on Serum Leptin and Expression of LepR,POMC,and NPY in Hypothalamus of Metabolic Syndrome Model Mice with Phlegm Syndrome
Menghan YANG ; Yuanyuan LI ; Xiujuan ZHENG ; Wenhui XIONG ; Xirui HUANG ; Bizhen GAO
Journal of Traditional Chinese Medicine 2025;66(9):948-954
ObjectiveTo explore the potential mechanism of Erchen Decoction (二陈汤, ECD) in improving metabolic syndrome (MS) with phlegm syndrome. MethodsForty mice were randomly divided into a blank group of 10 mice and a modeling group of 30 mice. The MS model with phlegm syndrome was induced in the modeling group by high-fat diet. Thirty successfully modeled mice were randomly divided into a model group, a ECD group, and a metformin group, with 10 mice in each group. The ECD group was given 0.4 g/(kg·d) of ECD, while the metformin group was intervened with 11.1 g/(kg·d) of metformin solution, and the blank group and the model group were given 0.02 ml/(g·d) of sterilized drinking water, all by gavage, once daily for 4 weeks. Body weight, abdominal circumfe-rence, body length, Lee's index and food intake were recorded. Blood glucose and blood lipid levels including fasting blood glucose, triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) were measured. ELISA was used to detect serum leptin levels, while HE staining was used to observe liver pathological changes. Western Blot and q-PCR were used to detect protein and mRNA expression of hypothalamic leptin receptor (LepR), pro melanocortin (POMC), and neuropeptide Y (NPY) in the hypothalamus. Immunofluorescence was used to detect fluorescence expression of POMC and NPY in the hypothalamic arcuate nucleus region. ResultsPathological results showed that the mice in the model group had numerous fat vacuoles in hepatocytes and significant liver fat deposition, while the ECD and metformin groups showed reduced fat vacuoles and less liver fat deposition. Compared to those in the blank group, the mice in the model group mice showed liver fat deposition, increased body weight, abdominal circumference, Lee's index and food intake; fasting blood glucose, TG, TC, LDL-C, and serum leptin levels were elevated, while HDL-C was decreased; the expression of LepR, POMC protein levels and their mRNA expression decreased, while the protein level and mRNA expression of NPY increased; the fluorescence expression of POMC in the arcuate nucleus was reduced, while NPY fluorescence expression increased (P<0.05 or P<0.01). Compared to the model group, the ECD group and metformin group showed significant improvements in the above indicators (P<0.05 or P<0.01). Compared to the ECD group, the metformin group showed a reduction in body weight and NPY fluorescence expression, and an increase in HDL-C levels (P<0.05 or P<0.01). ConclusionECD can downregulate serum leptin levels and improve glucose and lipid metabolism in the MS of phlegm syndrome. Its mechanism of action may be to reduce liver fat deposition and thereafter affect the expression of neuropeptides related to feeding activity in the hypothalamus.
2.Analysis of classroom environment hygiene in primary and secondary schools in Guizhou Province from 2022 to 2024
HUANG Xiaoli, ZHANG Xiaoqin, LI Xin, PENG Xiying, WANG Zhuan, LU Xiujuan
Chinese Journal of School Health 2025;46(7):1032-1036
Objective:
To understand classroom environmental conditions and their association with spinal curvature abnormalities among students of primary and secondary schools in Guizhou Province, so as to provide a basis for formulating school health policies and scientific prevention and control measures for abnormal spinal curvature in students.
Methods:
Using a stratified random sampling method, 471 schools (2 811 classrooms) were selected annually across the province from 2022 to 2024 in order to monitor and evaluate classroom environment according to national standards. Spinal examinations were conducted for 196 606 (2022), 194 876 (2023), and 195 048 (2024) students, and χ 2 test was used to analyze the correlation of desk and chair compliance with student spinal curvature abnormalities.
Results:
The qualified rates of classroom blackboard illuminance uniformity ( 85.41 %) and the blackboard size (82.24%) were the highest in primary and secondary schools in Guizhou Province, while the average blackboard surface illumination qualified rate (20.10%) was the lowest. The average desk illumination (50.11%-58.63%), desk illumination uniformity (61.92%-72.27%) and qualified noise rate (50.04%-51.94%) increased significantly in 3 years; in addition, the compliance rate of desks and chairs decreased from 25.00% to 13.52%, and the differences were all statistically significant ( χ 2=42.48, 80.93, 46.09, 129.72, all P <0.05). Middle school classrooms outperformed primary schools in terms of per capita area, average blackboard illuminance, blackboard illuminance uniformity, average desktop illuminance, desktop illuminance uniformity, and noise compliance ( χ 2=311.55, 12.41, 20.64, 40.76, 10.25, 52.47), but had lower compliance for blackboard size and reflectance ( χ 2=537.29, 7.59) (all P <0.01). Urban schools had higher compliance than suburban schools for per capita area, average blackboard illuminance, average desktop illuminance, and desktop illuminance uniformity ( χ 2=73.71, 17.68, 29.30 , 36.03), but lower compliance for desk-chair suitability, blackboard size, and blackboard reflectance ( χ 2=4.72, 26.02, 5.43 ) (all P <0.05). The spinal curvature abnormality detection rate was 0.83%. A significant association was found between abnormality detection and desk-chair non compliance ( χ 2=223.85, P <0.01).
Conclusions
Classroom environment hygiene in Guizhou schools is suboptimal. Strengthening school environmental hygiene infrastructure and greater attention to its impact on student s health are essential.
3.Epidemiological characteristics of spinal curvature abnormalities in children and adolescents
LU Xiujuan, LI Xin, PENG Xiying, WANG Zhuan, HUANG Xiaoli, ZHANG Xiaoqin
Chinese Journal of School Health 2025;46(7):1046-1050
Objective:
To understand the epidemiological characteristics of abnormalities spinal curvature among children and adolescents in Karst landform in Guizhou Province, so as to provide a scientific basis for targeted comprehensive intervention.
Methods:
From September to December 2023, 194 875 children and adolescents aged 6-18 were selected from all countieldistricts of 9 cities (prefectures) in Guizhou Province by stratified random cluster sampling method according to the proportion of Karst landform area in Guizhou Province for carrying out spinal curvature abnormality screening, and a questionnaire survey was conducted on 139 449 students in the fourth grade and above of primary school. Binary Logistic regression was used for multivariate analysis.
Results:
The detection rate of abnormal spinal curvature among children and adolescents aged 6-18 in Guizhou Province was 1.13%. The detection rates of abnormal spinal curvature in areas with a high proportion of Karst landform, areas with a low proportion of Karst landform, intercalation areas, and nonKarst landform areas were 1.10%, 2.00%, 0.90%, and 0.60%, respectively. Among them, the detection rates of abnormal spinal curvature in female students (2.40%, 1.60%, 0.90%) in areas with a low proportion of Karst landform, intercalation areas and nonKarst landform were higher than those in male students (1.60%, 0.10%, 0.30) (χ2=12.66, 112.69, 30.22, all P<0.05). The detection rates of abnormal spinal curvature among senior high school students (2.00%, 4.30%, 1.40%, 1.30%) in different Karst landform distributions were successively higher than those among junior high school students (1.40%, 3.20%, 1.00%, 0.60%) and primary school students (0.70%, 0.80%, 0.60%, 0.30%) (χ2=306.11, 175.80, 14.24, 39.57, all P<0.05). The results of multivariate Logistic regression analysis showed that the detection rates of abnormal spinal curvature in both highproportion and lowproportion Karst landform areas were higher than those in nonKarst landform areas [OR(95%CI)=1.84(1.05-2.25), 1.60(1.23-2.09), both P<0.05].
Conclusion
The detection rate of abnormal spinal curvature in children and adolescents aged 6-18 in Guizhou Province is related to the distribution of Karst landform, so it is necessary to strengthen screening and appropriate comprehensive interventions.
4.Effects of Ferroptosis Inhibitor KIF20A on Biological Behavior and Ferroptosis of Esophageal Carcinoma Cells
Maimaitizunong REZEYE ; Xiujuan LI ; Ling LIU ; Hui LI
Journal of Kunming Medical University 2024;45(2):49-56
Objective To investigate the expression of KIF20A in ESCC and its effect on Eca109 cell biological behavior and ferroptosis.Methods The expression of KIF20A in ESCC was predicted by bioinformatics analysis.KIF20A knockdown/overexpression Eca109 cell line was constructed,Experimental groups:control group,KIF20A knockdown group,KIF20A overexpression group,and the effects of KIF20A on the proliferation,invasion,and migration of Eca109 cells were detected by CCK-8,Transwell invasion assay and cell scratch assay.On this basis,the ferroptosis model induced by RSL3 was established,and GSH and MDA contents were detected.Results Compared with the control group,the cell proliferation activity of the KIF20A knockdown group was significantly decreased(P<0.05),and that of the KIF20A overexpression group was significantly increased(P<0.05).Compared with the control group,the invasion and migration ability of the KIF20A knockdown group was decreased(P<0.05),and the invasion and migration ability of the KIF20A overexpression group was increased(P<0.05).After RSL3 induction,the GSH content in the cell lysate of the KIF20A knockdown group was lower than that of the control group(P<0.05),and the MDA content was higher than that of the control group(P<0.05).Conclusion KIF20A is highly expressed in ESCC and plays a role in promoting proliferation,invasion,migration and inhibiting ferroptosis in Eca109 cells.
5.Correlation between the Expression of Serum Elabela,LRG1 Levels and Disease Activity Index in Patients with Ulcerative Colitis
Yan WANG ; Xiujuan HU ; Li ZHANG ; Zhujie LÜ ; Long WANG ; Gaocheng TONG
Journal of Modern Laboratory Medicine 2024;39(1):100-105
Objective To investigate the expression of serum Elabela and leucine-rich-alpha-2-glycoprotein-1(LRG1)in ulcerative colitis(UC)patients and their correlation with disease activity index(DAI).Methods A total of 98 patients with UC admitted to Yuncheng Central Hospital from January to December 2022 were selected as the UC group,including 62 patients in active stage and 36 patients in remission stage.According to the severity of the disease,these patients were divided into mild group(n=26),moderate group(n=43)and severe group(n=29).In addition,these patients were grouped into gradeⅠ group(n=25),grade Ⅱ group(n=40)and grade Ⅲ group(n=33)based on the endoscopic activity index(EAI).According to the mucosal healing condition under endoscopy,these patients were divided into the healed group(n=65)and the unhealed group(n=33).Another 51 patients with colonic polyps were selected as control group 1,and 50 healthy individuals were selected as control group 2.Serum Elabela and LRG1 levels were detected by enzyme-linked immunosorbent assay(ELISA).Pearson method was used to analyze the correlation between serum Elabela,LRG1 levels and DAI in UC patients.Receiver operating characteristic(ROC)curve was applied to analyze the predictive value of serum Elabela and LRG1 for endoscopic mucosal healing.Results The levels of Elabela(4.77±1.36 ng/ml)and LRG1(352.12±39.45 ng/ml)in UC group were higher than those in control group 1(2.51±0.53 ng/ml,121.02±21.06 ng/ml)and control group 2(2.35±0.42 ng/ml,120.35±23.49 ng/ml),and the differences were statistically significant(t= 11.410~39.000,all P<0.05).The levels of Elabela(5.26±0.54 ng/ml)and LRG1(370.42±12.49 ng/ml)in the active group were higher than those in the remission group(3.93±0.42 ng/ml,320.60±8.47 ng/ml),and the differences were statistically significant(t=12.705,21.242,all P<0.05).The levels of Elabela(5.89±0.20 ng/ml)and LRG1(369.92±16.59 ng/ml)in the severe group were higher than those in the moderate groups(4.51±0.67 ng/ml,356.12±18.75 ng/ml)and mild groups(3.95±0.21 ng/ml,325.65±10.14 ng/ml),and the differences were statistically significant(t=3.205~35.077,all P<0.05).The levels of Elabela(5.80±0.18 ng/ml)and LRG1(369.16±13.47 ng/ml)in grade Ⅲ group were higher than those in grade Ⅱ group(4.49±0.35 ng/ml,355.46±16.34 ng/ml)and grade Ⅰgroup(3.86±0.16 ng/ml,324.15±8.71 ng/ml),and the differences were statistically significant(t= 3.854~48.725,all P<0.05).The levels of Elabela(5.12±0.42 ng/ml)and LRG1(367.12±14.27 ng/ml)in unhealed group were higher than those in healed group(4.08±0.37 ng/ml,322.57±10.35 ng/ml),and the differences were statistically significant(t=12.043,15.917,all P<0.05).The serum levels of Elabela and LRG1 in UC patients were positively correlated with EAI and ESR(r=0.602,0.298;0.576,0.302,all P<0.05),but negatively correlated with hemoglobin level(r=-0.351,-0.334,all P<0.05).The area under the curve predicted by the combination of serum Elabela and LRG1 for endoscopic mucosal healing was 0.926(95%CI:0.880~0.958),was higher than the 0.803(95%CI:0.741~0.856)and 0.783(95%CI:0.720~0.838)predicted by Elabela and LRG1 alone,and the difference was statistically significant(Z=4.101,4.228,all P<0.05).Conclusion The serum levels of Elabela and LRG1 in UC patients increased,and they were related to the increase of DAI and worsening of the condition.Testing serum Elabela and LRG1 can provide a reference for evaluating mucosal healing under UC endoscopy.
6.Expression of lncRNA SNHG8 in placenta accreta and its effect on trophoblast invasion and migration
Li'na GAO ; Xiaohui LIU ; Yufang ZHANG ; Xiaoling LIU ; Xiaochun HE ; Jing GAO ; Li ZHANG ; Jun SUN ; Xiujuan WANG ; Yan DONG
The Journal of Practical Medicine 2024;40(5):646-652
Objective To investigate the expression of lncRNA SNHG8 in placenta accrete(PA)and its effect on trophoblast invasion and migration.Methods qRT-PCR was used to detect the expression of lncRNA SNHG8 in placenta tissue of 30 cases in PA group and 30 cases in control group,and the correlation between lncRNA SNHG8 expression and prenatal ultrasound score of 30 cases in PA group was analyzed.Transwell and scratch assay were used to detect the effect of lncRNA SNHG8 interference on the invasion and migration of human chorionic trophoblast cells(HTR8/SVneo cells),and western blot was used to detect the expression of MMP-2 and MMP-9.The downstream targets of lncRNA SNHG8 were predicted by StarBase software,and the expression of lncRNA SNHG8 was detected in placental tissues of the two groups.Dual luciferase reporter assay was used to detect the targeting relationship between lncRNA SNHG8 and miR-542-3p.Results Compared with that of the control group,the expression of lncRNA SNHG8 was up-regulated in the placenta tissue of the PA group(P<0.05),and it was positively correlated with prenatal ultrasound score.Interference with lncRNA SNHG8 inhibited the invasion and migration of trophoblast cells(P<0.05);the protein expression of MMP-9 and MMP-2 also decreased signifi-cantly(P<0.05).Biological prediction indicates that miR-542-3p had a binding site with lncRNA SNHG8,and miR-542-3p expression was down-regulated in PA placental tissue(P<0.05).Dual luciferase reporter assay confirmed that lncRNA SNHG8 could target miR-542-3p.Compared with si-SNHG8+inhibitor-NC,co-transfection of si-SNHG8 and miR-542-3p inhibitor enhanced the invasion and migration ability of trophoblast cells(P<0.05).Conclusion lncRNA SNHG8 is highly expressed in PA and is related to the severity of PA.LncRNA SNHG8 promotes the invasion and migration of trophoblast by regulating the level of miR-542-3p.The study suggests that lncRNA SNHG8 plays an important role in the invasion and migration of PA trophoblast cells,which is expected to be a clinical diagnostic biomarker and therapeutic target.
7.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine:Fibromyalgia Syndrome
Juan JIAO ; Jinyang TANG ; Xiujuan HOU ; Mengtao LI ; Dongfeng LIANG ; Yuhua WANG ; Weixia JING ; Guangtao LI ; Qin ZHANG ; Yongfeng ZHANG ; Guangyu LI ; Qian WANG ; Yang YANG ; Jin HUO ; Mei MO ; Jihua GUO ; Xiaoxiao ZHANG ; Quan JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(1):216-222
Fibromyalgia syndrome (FMS) is a refractory, chronic non-articular rheumatic disease characterized by widespread pain throughout the body, for which there are no satisfactory therapeutic drugs or options. There are rich Chinese medical therapies, and some non-drug therapies, such as acupuncture, Tai Chi, and Ba-Duan-Jin, have shown satisfactory efficacy and safety and definite advantages of simultaneously adjusting mind and body. FMS is taken as a disease responding specifically to traditional Chinese medicine (TCM) by the National Administration of Traditional Chinese Medicine in 2018. In order to clarify the research progress in FMS and the clinical advantages of TCM/integrated Chinese and Western medicine, the China Academy of Chinese Medicine organized a seminar for nearly 20 experts in Chinese and Western medicine, including rheumatology, psychology, acupuncture and moxibustion, and encephalopathy, with the topic of difficulties in clinical diagnosis and treatment of FMS and advantages of TCM and Western medicine. The recommendations were reached on the difficulties in early diagnosis and solutions of FMS, mitigation of common non-specific symptoms, preferential analgesic therapy, TCM pathogenesis and treatment advantages, and direction of treatment with integrated Chinese and Western medicine. FMS is currently facing the triple dilemma of low early correct diagnosis, poor patient participation, and unsatisfactory benefit from pure Western medicine treatment. To solve the above problems, this paper suggests that rheumatologists should serve as the main diagnostic force of this disease, and they should improve patient participation in treatment decision-making, implement exercise therapy, and fully utilize the holistic and multidimensional features of TCM, which is effective in alleviating pain, improving mood, and decreasing adverse events. In addition, it is suggested that FMS treatment should rely on both TCM and Western medicine and adopt multidisciplinary joint treatment, which is expected to improve the standard of diagnosis and treatment of FMS in China.
8.Relation between neuroticism and tendency of mobile phone addiction among nursing undergraduates: the mediating role of perceived stress and self-control
Maoning LI ; Meifang WANG ; Xiujuan FENG ; Xue BAI ; Jiao FANG ; Wenkai ZHENG
Sichuan Mental Health 2024;37(1):70-76
BackgroundNegative effects of mobile phone addiction on undergraduate students have led to several health problems including depression, anxiety, attention deficit disorder, cognitive impairment and sleep disturbance. The undergraduate nursing students serve as an important reserve force of the clinical nursing work, and their poor psychological health would have a non-ignorable impact on the quality of the nursing work and the nurse-patient relationship in the future. ObjectiveTo investigate the relation between neuroticism and tendency of mobile phone addiction among undergraduate nursing students, and to examine the pathways through which perceived stress and self-control play a role in the relation by constructing a chain-mediated model. MethodsFrom February to March 2023, a total of 900 undergraduate nursing students across 10 universities in Xi'an, Shaanxi Province were selected through convenient sampling method. Several scales were adopted to assess undergraduate nursing students respectively, including the neuroticism subscale of Eysenck Personality Questionnaire-Revised Short Scale for Chines (EPQ-RSC), Perceived Stress Scale (PSS), Self-Control Scale (SCS) and Mobile Phone Addiction Tendency Scale (MPATS). The assessment were conducted on multiple aspects of these students including neurotic personality, subjective stress, self-control and mobile phone addiction tendency. Model 6 in the SPSS Macro Process 4.1 was used to examine the mediating effect of perceived stress and self-control between neuroticism and mobile phone addiction tendency among undergraduate nursing students. Results① Among the 900 students, 314 cases (34.89%) were found to be addicted to mobile phones. ② The score of neuroticism subscale in EPQ-RSC of nursing undergraduates was positively correlated with the total scores of PSS and MPATS (r=0.400, 0.287, P<0.01), and negatively correlated with score of SCS (r=-0.364, P<0.01). The total score of MPATS was positively correlated with the total score of PSS (r=0.362, P<0.01), and negatively correlated with the total score of SCS (r=-0.468, P<0.01). The total score of SCS was negatively correlated with the total score of PSS (r=-0.515, P<0.01). ③ Perceived stress and self-control performed partial mediation between neuroticism personality and mobile phone addiction tendency (with indirect effect values of 0.056 and 0.065, respectively, accounting for 19.72% and 22.89% of the total effect). Perceived stress and self-control played a chain mediating role between neuroticism personality and mobile phone addiction tendency (with an indirect effect value of 0.064, accounting for 22.54% of the total effect). ConclusionNeuroticism personality, perceived stress and self-control are confirmed to play important roles in mobile phone addiction tendency among undergraduate nursing students. Neuroticism personality not only directly affects the tendency of mobile phone addiction, but also affects their mobile phone addiction tendency through the chain mediating effect of perceived stress and self-control.[Funded by The 2020 Annual Project of the 13th Five-Year Plan of Education Science in Shaanxi Province (number, SGH20Y1386)]
9.Study on influencing factors of neurobehavioral development in young children suspected of developmental delays
Xiaoman LI ; Lijuan HUANG ; Xiao WANG ; Zumin LIU ; Runmin GUO ; Xueyan NONG ; Xiujuan HUANG ; Jinyuan ZHU ; Yanting CHEN ; Jinlin DU
Acta Universitatis Medicinalis Anhui 2024;59(7):1244-1250
Objective To investigate the neurobehavioral development of young children aged 24 to 60 months in Shunde and explore the factors influencing the development of young children and provide reference for the interven-tion of neurobehavioral development delays in young children.Methods A retrospective cohort study was used to enroll the young children who were initially screened by the Pediatric Neuropsychological Developmental Scale(Pe-diatric Heart Scale)with a score of ≤85 was included in the study.With a score of ≤85,the young children might be at risk of developmental delays,and needed to be further diagnosed by the GESELL Developmental Diagnostic Scale,the basic information of the young children and their mothers at the time of birth were investigated,as well as basic information about the young children at the time of completing the GESELL Developmental Diagnostic Scale was collected.Results A total of 271 young children were included,196 males and 75 females.Young children had the lowest developmental quotient(DQ)in the language domain among the five domains(P<0.001).Multiple lin-ear regression models showed:compared with girls,the language domain DQ of boys decreased by 5.321 points(P=0.049,95%CI:-10.620--0.021),and the personal-social domain DQ decreased by 4.474 points(P=0.023,95%CI:-8.316--0.631).Compared with young children via natural vaginal delivery(NVD),the gross motor domain DQ of young children via caesarean section(CS)decreased by 4.890 points(P=0.008,95%CI:-8.499--1.281),the fine motor domain DQ decreased by 3.373 points(P=0.037,95%CI:-6.532--0.213),the language domain DQ decreased by 7.621 points(P=0.004,95%CI:-12.826--2.416),per-sonal-social domain DQ decreased by 6.232 points(P=0.001,95%CI:-10.006--2.457).The results of bi-nary logistic regression models showed,compared with young children via NVD,the risk of gross motor domain retar-dation in young children increased(OR=1.763,95%CI:1.003-3.100),the risk of fine motor domain retardation increased(OR=2.217,95%CI:1.235-3.980),the risk of language domain retardation increased(OR=3.306,95%CI:1.080-10.124).Conclusion Young children with suspected neurobehavioral delays were more likely to have delayed development in language domain than in other domains,boys had lower DQ in language domain and personal-social domain than girls,and the development of young children via CS was slower than that via NVD.Fo-cus should be on the language development of young children especially on the language and personal-social devel-opment of boys.Carefully chose delivery way.Focus should be placed on assessment of young children's comprehen-sive neurobehavioral development in early time.
10.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.


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