1.Equivalence of SYN008 versus omalizumab in patients with refractory chronic spontaneous urticaria: A multicenter, randomized, double-blind, parallel-group, active-controlled phase III study.
Jingyi LI ; Yunsheng LIANG ; Wenli FENG ; Liehua DENG ; Hong FANG ; Chao JI ; Youkun LIN ; Furen ZHANG ; Rushan XIA ; Chunlei ZHANG ; Shuping GUO ; Mao LIN ; Yanling LI ; Shoumin ZHANG ; Xiaojing KANG ; Liuqing CHEN ; Zhiqiang SONG ; Xu YAO ; Chengxin LI ; Xiuping HAN ; Guoxiang GUO ; Qing GUO ; Xinsuo DUAN ; Jie LI ; Juan SU ; Shanshan LI ; Qing SUN ; Juan TAO ; Yangfeng DING ; Danqi DENG ; Fuqiu LI ; Haiyun SUO ; Shunquan WU ; Jingbo QIU ; Hongmei LUO ; Linfeng LI ; Ruoyu LI
Chinese Medical Journal 2025;138(16):2040-2042
2.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.
3.Relationship between ruminative thinking, life events and learning value doubt among junior high school students
XU Jing, FAN Chunlei, WANG Ligang, TAO Ting, GAO Wenbin
Chinese Journal of School Health 2024;45(3):384-387
Objective:
To explore the mediating effect of rumination between life events and learning value doubt among junior high school students, so as to provide reference for the psychological health education of junior high school students.
Methods:
From March to July 2023, a total of 930 junior high school students from Guangdong, Jiangsu and Hebei were selected by a combination of convenient sampling methods. Participants completed the Scales of Value of Learning (SVL), Ruminative Response scale (RRS) and Adolescent Self rating Life Events Checklist (ASLEC). The t test and ANOVA were used for inter group comparisons and Pearson correlation analysis was used for correlation analysis and bootstrap method was used for mediating effect test.
Results:
The life events of junior middle school students were positively correlated with learning value doubt ( r =0.18), rumination ( r = 0.65 ) and its three dimensions (brooding, reflective pondering, and symptom focused rumination) ( r =0.60, 0.59, 0.66). Learning value doubt was positively correlated with rumination ( r =0.15) and its three dimensions ( r =0.07, 0.13, 0.19) ( P <0.05).The symptom focused rumination (effect size=0.09, 95% CI =0.06-0.11) and brooding (effect size=-0.07, 95% CI =-0.09--0.04) dimensions partially mediated the relationship between life events and learning value doubt. In the two influential pathways, symptom focused rumination exerts a stronger impact, and the difference was statistically significant (effect size=0.15, 95% CI =0.11- 0.20 , excluding 0) ( P <0.05).
Conclusions
Life events experienced by junior high school students can positively predict learning value doubt through symptom focused rumination, and negatively predict learning value doubt through brooding. Active attention should be paid to the mental health status of junior high school students, intervene promptly when they experience life events, reduce symptom based rumination, and improve their learning enthusiasm.
4.Relationship between parental mediation and adolescents'tendency of online game addiction
Li WANG ; Ting TAO ; Ligang WANG ; Wenbin GAO ; Chunlei FAN
Chinese Mental Health Journal 2024;38(11):984-989
Objective:To explore the relationship between parental mediation and adolescents'tendency of online game addiction,and the effect of self-control in it.Methods:Totally 553 senior high school students were tested with the Chinese version of Parental Mediation of Online Activities Questionnaire,Internet Gaming Disorder Scale-Short-form(IGDS9-SF)and Dual-mode of Self-control Scale for Adolescents(DMSC-S).Parental active me-diation,restrictive mediation,Internet game addictive tendency,adolescent self-control impulsive system,control system were evaluated respectively.SPSS macro program PROCESS was used to test the mediating role.Results:The scores of restrictive mediation of parents were negatively associated with the scores of adolescents'tendency of online game addiction(β=-0.14,P<0.001).Self-control scores played an independent mediating role between parental active mediation scores and online game addiction tendency scores(indirect effect=-0.09,95%CI=-0.09--0.01)and a partial mediating role between parental restrictive mediation scores and online game addiction tendency scores(indirect effect=-0.04,95%CI=0.00-0.07).Conclusion:Parental active and restrictive medi-ation are related to adolescents'tendency of online game addiction.Self-control plays a partial mediating role.
5.Application of Photoplethysmography Combined with Deep Learning in Postoperative Monitoring of Flaps
Jing YANG ; Xinlei YANG ; Yuwei GAO ; Chunlei ZHANG ; Di WANG ; Tao SONG
Chinese Journal of Medical Instrumentation 2024;48(4):419-425
Objective Photoelectric volumetric tracing(PPG)exhibits high sensitivity and specificity in flap monitoring.Deep learning(DL)is capable of automatically and robustly extracting features from raw data.In this study,we propose combining PPG with 1D convolutional neural networks(1D-CNN)to preliminarily explore the method's ability to distinguish the degree of embolism and to localize the embolic site in skin flap arteries.Methods Data were collected under normal conditions and various embolic scenarios by creating vascular emboli in a dermatome artery model and a rabbit dermatome model.These datasets were then trained,validated,and tested using 1D-CNN.Results As the degree of arterial embolization increased,the PPG amplitude upstream of the embolization site progressively increased,while the downstream amplitude progressively decreased,and the gap between the upstream and downstream amplitudes at the embolization site progressively widened.1D-CNN was evaluated in the skin flap arterial model and rabbit skin flap model,achieving average accuracies of 98.36%and 95.90%,respectively.Conclusion The combined monitoring approach of DL and PPG can effectively identify the degree of embolism and locate the embolic site within the skin flap artery.
6.Research progress on the application of external diaphragm pacemaker combined with respiratory training in lung rehabilitation
Liang LIU ; Yuanhong LIU ; Chunlei SHAN ; Yan LI ; Tao ZHANG
Chinese Journal of General Practitioners 2024;23(9):991-997
External diaphragm pacing and respiratory training have been applied in clinical practice for many years, in recent years, researchers combine two techniques for pulmonary function rehabilitation and achieved some accomplishments. This article reviews the progress of the application of external diaphragm pacemakers with respiratory training in the field of lung rehabilitation, in order to provide reference for clinical practice and further studies.
7.Mechanisms of self-control on health behavior change
Baofang LIU ; Ligang WANG ; Ying XU ; Wenbin GAO ; Ting TAO ; Chunlei FAN
Chinese Journal of Behavioral Medicine and Brain Science 2023;32(4):379-384
Self-control brings important effects on the process and maintenance of health behavior change in individuals, but its mechanism is unclear.Healthy behavior change could be divided into goal-oriented behavior initiation stage, combating habit rejection stage, and habit acquisition and maintenance stage.Established theories of health behavior change mainly focus on the conflict between the goal-directed behavior initiation phase and habitual behavior.It is also indicated that disgust is the key mechanism to restrain the implementation of goal-oriented behavior, but ignore the mechanisms in the action implementation and new behavior acquisition phases.In fact, goal-directed and habitual behaviors work together to ensure that individuals adapt efficiently to their environment.However, when goal-oriented behavior becomes habitual, old habit and new goal-oriented behavior begin to compete, causing conflicts and aversion.The core phase of self-control functioning is just in the confrontation with habit rejection phase.On the one hand, self-control directly assists individual goal-directed behavior habituation through conflict sense adaptation.On the other hand, intensive management and stimulus control indirectly assist goal-directed behavior habituation through the relief of conflict sense.Further exploration of the theory and clinical practice of self-control affecting healthy behavior change is needed in the future.
9.βE2 activates Nrf2 pathway to resist light-induced retinal dysfunction in rats
Fangying DU ; Chunhui ZHU ; Chunlei DENG ; Tao CHEN ; Yecheng XIONG ; Chenghu HU ; Xiaorui YU
Journal of Xi'an Jiaotong University(Medical Sciences) 2021;42(2):251-256
【Objective】 To investigate whether 17β-estradiol (βE2) can activate the NF-E2-related factor 2(Nrf2) pathway to resist the downregulation of retinal function induced by light damage. 【Methods】 Two weeks after female SD rats were castrated, they were divided into the following six groups: control group (control), light-damage group (LD), saline group, saline light-damage group (saline-LD), βE2 group, and βE2 light-damage group (βE2-LD). Rats in the light-damage were exposed to 8000-lux fluorescence for 12 h after 18 h of dark adaptation. Then electroretinogram (ERG), immunofluorescence, Real-time PCR and immunohistochemical detection were performed after one day of dark recovery. 【Results】 The results of ERG showed that ERG was lower in LD group than in control group (P<0.05). After light damage, ROS was increased and the mRNA expressions of antioxidant genes, such as Sod1, Sod2, Cat, Glrx1, Glrx2, Txn1, and Txn2 were decreased (all P<0.05). After βE2 administration, compared with those in saline-LD, ROS level was decreased, the levels of Nrf2 protein and antioxidant genes were increased, and ERG was recovered to a certain extent in βE2-LD (P<0.05). 【Conclusion】 βE2 can restore the function of rat retina, and its mechanism might be related to the upregulation of Nrf2 and antioxidant genes.
10.The evaluation of health-related quality of life for prostate cancer patients receiving androgen deprivation therapy
Yaojun DUN ; Chunlei LIU ; Lili CHEN ; Xiaowei ZHANG ; Luping YU ; Qing LI ; Yiqing DU ; Zhengzuo SHENG ; Huaqi YIN ; Tao XU
Chinese Journal of Urology 2017;38(1):33-37
Objective To evaluate the health-related quality of life (HRQOL) for prostate cancer patients receiving androgen deprivation therapy (ADT).Methods We studied 200 patients with prostate cancer who were treated with primary ADT in Peking University People's Hospital from June 2014 to June 2015.The patients'average age was 73.9 years.The mean PSA level was 21.57 ng/ml when they were diagnosed with prostate cancer.Of these 200 patients,79% (158/200) were localized and seclected ADT therapy due to age,body condition,basic diseases or individual will.21% (42/200) were locally advanced or metastasic,which accord with the indication of ADT therapy.The scales,including the MOS item short from health survey (SF-36),Functional Assessment of Cancer Therapy-General module (FACT-G),Functional Assessment of Cancer Therapy-Prostate instrument (FACT-P),Self-Rating Depression Scale (SDS) and Self-Rating Anxiety Scale (SAS) were used to evaluate their HRQOL.Results According to results of SF36,the physical health component score and mental health component score was 67.41 ± 16.39 and 64.81 ± 17.51,respectively.They indicated that the overall quality of life of these patients was at an acceptable level.And the average score of all domains exceeded 60 except general health domain,which the score was only 40.03 ± 21.89.When it comes to FACT-P,the sum score,emotional well-being score and prostate cancer component score were 8.15 ± 3.72,12.30 ± 4.04 and 77.41 ± 9.95,respectively,which were less than half of their respective top score.However the physical well-being score was 20.41 ±4.29,which was a relatively satisfactory value.In addition,61% (121/200) patient selected not at all in item I am able to have and keep an erection.The score of SDS and SAS was 46.76 ± 8.29 and 43.25 ±9.69,respectively.And there were 23.0% (46/200) and 21.5% (43/200) patiens exhibited depression and anxiety,respectively.Conclusion In the present study,the prostate cancer patients receiving ADT showed acceptable HRQOL,but some patients sufferd from depression,anxiety and erectile dysfunction.


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