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.Haze weather health protection behavior and associated factors in adolescents
Chinese Journal of School Health 2022;43(3):367-371
Objective:
To investigate adolescent haze weather health protection behavior, and to provide scientific basis for behavioral intervention and health guidance for adolescents in haze weather.
Methods:
From June 2015 to April 2016, 1 025 adolescents were selected from 22 classes in two middle schools of Baoding City, Hebei Province, by stratified cluster sampling method. General information questionnaire and the Brief Haze Weather Health Protection Behavior Assessment Scale Adolescent Version (BHWHPBAS AV) were used. Multiple linear regressions were conducted to explore factors affecting adolescent haze weather health protection behavior. Different models were used to confirm associations between influencing factors and BHWHPBAS AV scores.
Results:
Adolescents had a low overall score of BHWHPBASAV (45.81±13.16). The score rate of self adjustment after haze weather was the highest (64.54%). The score rate of obtaining relevant knowledge before haze weather was the lowest (50.28%). Compared with adolescents in urban area, rural adolescents had a lower BHWHPBAS AV score ( β=-3.20, P <0.01). Compared with students (living with parents), those living without parents had a lower BHWHPBAS AV score ( β=-4.16, P =0.01). Compared with students never receive physical examination,those had received physical examination during the past years had a higher BHWHPBAS AV score ( β=4.44,5.66,9.04, P <0.01). Compared with students with no knowledge of respiratory system diseases, those with moderate to sufficient knowledge had a higher BHWHPBAS AV score ( β=9.34,12.19,P <0.01). These associations were stable and consistent.Multiple linear regression analysis showed that residence, residence with parents, physical examination and knowledge of respiratory diseases were the relevant factors of BHWHPBAS AV score ( P <0.05).
Conclusion
Adolescent haze weather health protection behavior level is low and is affected by many factors. Cooperation should be strengthened to conduct behavioral interventions and health guidance on haze health protection for adolescents, so as to promote healthy growth of adolescents.
3.Advances in the Development of Anti-Adhesive Biomaterials for Tendon Repair Treatment
Tissue Engineering and Regenerative Medicine 2021;18(1):1-14
BACKGROUND:
Peritendinous adhesion that simultaneous with tendon healing link the healing tendon to the surrounding tissue. It results in functional disability, and has a significant adverse impact on health as well as social and economic development.
METHODS:
Based on a search in the PubMed and Web of Science database, the research articles were screened by their time, main idea, impact factor index, while the ones with no credibility were excluded. Afterwards, we go through the analysis of the reliability and characteristics of the results were further screened from selected articles.
RESULTS:
A total of 17 biomaterials used to evaluate the adhesion mechanism and the properties of the material were found. All of these biomaterials contained randomized controlled studies and detailed descriptions of surgical treatment that support the reliability of their results which indicates that biomaterials act as barriers to prevent the formation of adhesion, and most of them exhibit satisfactory biocompatibility, biodegradability or selective permeability. Moreover, a few had certain mechanical strength, anti-inflammatory, or carrier capacities. However, there still existed some defects, such as time, technology, clinical trials, material targeting and different measurement standards which also lowered the reliability of their results.
CONCLUSION
In future, anti-adhesion biomaterials should focus on affordable raw materials with wide sources, and the production process should be simplified, in this way, the versatility and targeting of materials will be improved.
4.A nomogram for predicting the risk of multidrug-resistant tuberculosis
Qinglin CHENG ; Gang ZHAO ; Li XIE ; Le WANG ; Min LU ; Qingchun LI ; Yifei WU ; Yinyan HUANG ; Qingjun JIA ; Zijian FANG
Chinese Journal of Infectious Diseases 2021;39(7):415-423
Objective:To construct a simple, precise and personalized comprehensive nomogram for prediction the risk of multidrug-resistant tuberculosis (MDR-TB) and to evaluate its prediction value among individuals with previous tuberculosis history (PTBH).Methods:A matched case-control study (1∶2 ratios) was performed in 1 881 patients with PTBH treated in 12 designated tuberculosis hospitals in Hangzhou City between January 1, 2005 and December 31, 2019, and there were 1 719 patients in training set, and 162 in validation set. A multivariable Cox regression analysis was used to evaluate independent predictors for the incident of MDR-TB in individuals with PTBH. A comprehensive nomogram was developed based on the multivariable Cox model. The accuracy of the prediction was assessed using concordance index (C-index), calibration curve and area under the receiver operator characteristic (ROC) curve.Results:The nomogram constructed based on the multivariable Cox regression model incorporated 10 independent predictors of the risk of MDR-TB. A history of direct contact (grade 1, 0-100.0 points) ranked on the top of all risk factors, followed by duration of positive sputum culture (grade 2, 0-84.5 points), unfavorable treatment outcome (grade 3, 0-52.0 points), human immunodeficiency virus infection (grade 4, 0-48.5 points), retreated tuberculosis history (grade 5, 0-40.0 points), non-standardized treatment regimens of retreated tuberculosis (grade 6, 0-32.5 points), duration of pulmonary cavities (grade 7, 0-31.0 points), passive mode of tuberculosis case finding (grade 8, 0-25.0 points), age<60 years (grade 9, 0-17.5 points), and standard frequencies of chest X-ray examination (grade 10, 0-14.0 points). The C-indexes of this nomogram for the training and validation sets were 0.833 (95% confidence interval ( CI) 0.807-0.859) and 0.871 (95% CI 0.773-0.969), respectively, indicating that the nomogram had good fitting effect. The calibration curves for the risk of incident MDR-TB showed an optimal agreement between nomogram prediction and actual observation in the training and validation sets, respectively.The areas under ROC curve of the 1-year, 5-year, and 10-year MDR-TB risk probability of the training set were 0.904, 0.921, and 0.908, respectively, and those of the validation set were 0.954, 0.970, and 0.919, respectively. Conclusion:Through this nomogram model, clinicians could precisely predict the risk of incident MDR-TB among individuals with PTBH in the clinical practice.
5.Efficacy and safety of two prolonged therapeutic regimens in patients with plaque psoriasis after treatment with tazarotene/betamethasone dipropionate cream: a multicenter clinical observation
Hao CHEN ; Litao ZHANG ; Chengzhi LYU ; Xiumin YANG ; Fengming HU ; Xuefei LI ; Lijuan ZHANG ; Chunxia HE ; Qingchun DIAO ; Xiujuan XIA ; Tao LU ; Yuzhen LI ; Ruzhi ZHANG ; Jianfang SUN
Chinese Journal of Dermatology 2021;54(6):475-479
Objective:To explore the prolonged therapeutic regimen for patients with plaque psoriasis, who showed a positive response to 4-week treatment with tazarotene/betamethasone dipropionate cream, but were not completely cured.Methods:A multicenter, randomized, open-labelled, parallel-controlled clinical study was conducted. A total of 232 patients with plaque psoriasis were collected, who showed a positive response to previous 4-week treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream, but were not completely cured with the psoriasis area and severity index[PASI] improvement rate being 50%-90%. At week 5, they were randomly and equally divided into 2 groups: test group receiving treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream once a day, and control group receiving a sequential regimen of 0.05% tazarotene gel on weekdays once a day followed by 0.05%/0.05% tazarotene/betamethasone dipropionate cream on weekends once a day. After 2-and 4-week prolonged treatment, the efficacy and safety of the 2 therapeutic regimens were evaluated and compared. Measurement data were compared between 2 groups by using covariance analysis or t test, and enumeration data were compared by using chi-square test. Results:From the 5th to the 8th week, 200 out of the 232 patients completed the treatment. Data collected from 110 patients in the test group and 112 in the control group were enrolled into the full analysis set, and those from both 113 patients in the test group and control group were enrolled into safety analysis set. After consecutive 6-and 8-week treatment, the decline rates of the PASI score were 73.05% ± 16.69% and 78.46% ± 15.40% respectively in the test group, which were significantly higher than those in the control group (66.73% ± 21.77%, 67.02% ± 34.19%, respectively, both P < 0.05) . After 6-week treatment, the proportion of subjects who achieved PASI90 was significantly higher in the test group (14 cases, 12.7%) than in the control group (5 cases, 4.5%, χ2=4.842, P=0.028) ; After 8-week treatment, the proportions of subjects who achieved PASI75 and PASI90 (61.8%, 23.6%, respectively) were significantly higher in the test group than in the control group (48.2%, 12.5%, respectively, both P < 0.05) . During the consecutive 8-week treatment, there was no significant difference in the incidence rate of adverse reactions between the test group (15.0%) and control group (23.9%, χ2=2.822, P=0.093) . Conclusion:For patients who showed a positive response to 4-week treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream, but were not completely cured, the continuous use of 0.05%/0.05% tazarotene/betamethasone dipropionate cream for 4 weeks is a superior therapeutic regimen compared with the sequential regimen of 0.05% tazarotene gel followed by 0.05%/0.05% tazarotene/betamethasone dipropionate cream.
6.Advances in the Development of Anti-Adhesive Biomaterials for Tendon Repair Treatment
Tissue Engineering and Regenerative Medicine 2021;18(1):1-14
BACKGROUND:
Peritendinous adhesion that simultaneous with tendon healing link the healing tendon to the surrounding tissue. It results in functional disability, and has a significant adverse impact on health as well as social and economic development.
METHODS:
Based on a search in the PubMed and Web of Science database, the research articles were screened by their time, main idea, impact factor index, while the ones with no credibility were excluded. Afterwards, we go through the analysis of the reliability and characteristics of the results were further screened from selected articles.
RESULTS:
A total of 17 biomaterials used to evaluate the adhesion mechanism and the properties of the material were found. All of these biomaterials contained randomized controlled studies and detailed descriptions of surgical treatment that support the reliability of their results which indicates that biomaterials act as barriers to prevent the formation of adhesion, and most of them exhibit satisfactory biocompatibility, biodegradability or selective permeability. Moreover, a few had certain mechanical strength, anti-inflammatory, or carrier capacities. However, there still existed some defects, such as time, technology, clinical trials, material targeting and different measurement standards which also lowered the reliability of their results.
CONCLUSION
In future, anti-adhesion biomaterials should focus on affordable raw materials with wide sources, and the production process should be simplified, in this way, the versatility and targeting of materials will be improved.
7.Interpretation of Implementation Plan for Enrollment and Assessment of Clinical Pharmacist Teacher Training Project of Chinese Hospital Association (Trial)
Li YOU ; Jing BIAN ; Yangui XU ; Zhuo WANG ; Qingchun ZHAO ; Xin HUANG ; Jing LIU ; Jin LU ; Jiancun ZHEN
China Pharmacy 2021;32(21):2561-2566
OBJECTIVE:To interpret the new version of the Implementation Plan for Enrollment and Assessment of Clinical Pharmacist Teacher Training Project of Chinese Hospital Association (Trial)(hereinafter referred to as the “New Plan ”)officially announced by the Chinese Hospital Association in Sept. 2021,in order to provide guidance and reference for smoothly promoting the implementation of the New Plan and realizing the original intention of the reform. METHODS :The New Plan was interpreted from four aspects ,including the background of the formulation of the New Plan ,the main features presented ,the innovations and the issues that need to be paid attention to in the next implementation. RESULTS & CONCLUSIONS :The formulation and release of the New Plan marks the beginning of a new round of reform of the clinical pharmacist teacher training program of the Chinese Hospital Association. It is mainly based on the actual problems encountered in the operation of the current clinical pharmacist teacher training system ,the importance of clinical pharmacistteacher training itself ,and the opportunities and challenges that the development of the times has brought to our country ’s 163.com clinical pharmacy business. Research foundation , problem orientation and professional demonstration present important characteristics. Compared with the old plan ,the New Plan adds a substantive selection mechanism for majors ,which intends to achieve the necessary “strictness”in the enrollment process ;it reconstructs the overall training goal of the benchmarking project and the three-in-one assessment system ,which intends to achieve a reasonable “lax”of assessment link ;it removes restrictions on off-site training ,advocates wide-ranging professional docking,and improves the flexibility of the training system and process management. The implementation of the New Plan is a complex work involving multiple parties and is affected by many factors. It requires multiple teams to perform their duties and promote together. The teacher training base and expert team must understand the spirit of reform and achieve the stable implementation of the New Plan ;at the same time ,the communication between the project working group and the teaching base and experts should be strengthened ,and finally realize the original intention of the reform of cultivating more high-quality clinical pharmacy teachers.
8. Related influencing factors of gynecological diseases in grassroot level female medical staffs
Canjian LU ; Lian GAO ; Wenlan YU ; Haihong LI ; Qingchun ZHOU ; Cuilan TENG ; Meiqin DENG ; Zhuoxin HUANG ; He ZHONG
China Occupational Medicine 2019;46(05):595-598
OBJECTIVE: To investigate the prevalence and relevant influencing factors of gynecological diseases of grassroot level female medical staffs. METHODS: A total of 2 308 female medical workers from county, town and village in hengxian County of Guangxi Zhuang Autonomous Region were selected as study subjects by cluster sampling method. The basic information, occupational history, reproductive health and fertility of these subjects were investigated by Reproducetive Health Survey Questionnaine of Female Workers. RESULTS: The total prevalence of gynecological diseases in female medical staffs was 21.6%. Among them, the prevalence of genital tract infections was 15.6%, and gynecological tumors was 6.0%. The top three gynecologic diseases were vaginitis(9.2%), uterine fibroids(4.3%) and cervicitis(3.5%). Multivariate logistic regression analysis results indicated that the younger the patients, the higher the risk of reproductive tract infectious diseases(P<0.01), and the lower the risk of gynecological tumors(P<0.01). The risk of reproductive tract infectious diseases and gynecological tumors in married patients was higher than that in unmarried staffs(P<0.05). The higher the number of abortions, the higher the risk of reproductive tract infectious diseases and gynecological tumors(P<0.01). The risk of reproductive tract infectious diseases was higher and the risk of gynecological tumors was lower in female shift workers than that of non-shift workers(P<0.05). CONCLUSION: Vaginitis, uterine fibroids and cervicitis are the main gynecological diseases in grassroot level female medical staffs. The incidence of gynecological diseases is related to age, history of marriage, childbirth and abortion, and work-shifts.
9.Quercetin attenuates Ox-LDL-induced calcification in vascular smooth muscle cells by regulating ROS-TLR4 signaling pathway.
Qingchun LIANG ; Yanting CHEN ; Chuanxiang LI ; Lihe LU
Journal of Southern Medical University 2018;38(8):980-985
OBJECTIVETo determine whether quercetin inhibits oxidized low-density lipoprotein (Ox-LDL)-induced osteogenic differentiation and calcification of vascular smooth muscle cells (VSMCs) and understand the underlying mechanism.
METHODSThe calcification of human VSMCs following Ox-LDL treatment was assessed using alizarin red staining and by detecting ALP activity. The mRNA expressions of the bone-related genes including Msx2, BMP2 and Osterix, and the contractile proteins including SMA and SM22a were analyzed using qPCR. The effects of quercetin were investigated on OxLDL-induced VSMC calcification and changes in ALP activity, expressions of Msx2, BMP2, Osterix, SMA and SM22a, ROS levels and SOD activity. The effect of Toll like receptor 4 (TLR4) silencing mediated by siRNA transfection on cell calcification, ALP activity, gene expressions and ROS levels were investigated.
RESULTSOx-LDL treatment promoted VSMC calcification and up-regulated TLR4 expression. Quercetin treatment significantly attenuated Ox-LDL-induced VSMC calcification, reduced ALP activity, down-regulated the expression levels of Msx2, BMP2 and Osterix, and up-regulated the expressions of vascular smooth muscle contractile proteins SMA and SM22a. In addition, Quercetin treatment markedly increased SOD activity, reduced ROS levels and TLR4 expression in VSMCs. Silencing TLR4 expression using TLR4 siRNA also significantly decreased calcification of the VSMCs.
CONCLUSIONSQuercetin inhibits Ox-LDL-induced VSMC calcification in VSMCs possibly by targeting the ROS/TLR4 signaling pathway.
10.Influence of exercise rehabilitation combined diet guidance on patients after heart valve replacement
Qingchun ZHANG ; Haihui YIN ; Miaomiao CAO ; Zhong LU ; Fang WANG ; Yijun WU ; Zhongya YAN
Chinese Journal of cardiovascular Rehabilitation Medicine 2017;26(1):16-20
Objective:To observe influence of exercise rehabilitation combined diet guidance on cardiac function and quality of life (QOL) in patients after heart valve replacement .Methods:A total of 120 patients after heart valve replacement were selected and randomly divided into control group (n=60 ,received routine health education ) and experiment group (n=60 ,received diet guidance and exercise rehabilitation based on routine health education ) .After discharge ,patients re‐ceived outpatient follow‐up for six months ,body weight ,cardiac function and QOL on six months after surgery were fol‐lowed up and observed in two groups ,and the results were statistically compared .Results:Compared with control group six months after discharge ,there were significant rise in left ventricular ejection fraction [ (51.75 ± 9.30)% vs .(57.73 ± 6.13)% ] andoxygenmetabolicequivalent [(7.05±1.85)METsvs.(11.34±2.18)METs],andeachitemscoreofQOL and total score of QOL [ (4.98 ± 0.40) scores vs .(6.49 ± 0.53) scores] ,P<0.05 or <0.01;and significant reduction in body weight [(67.75 ± 10.67) kg vs .(61.25 ± 10.34) kg] in experiment group ,P<0.01. Conclusion:Exercise rehabili‐tation combined diet guidance can avoid rapid increase in body weight after surgery ,promote recovery of cardiac function and improve quality of life after surgery in patients with heart valvular diseases .


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