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.Chain mediation of psychological resilience and coping styles between social support and psychological distress in elderly stroke patients
Xinying ZHANG ; Kunjuan JING ; Bei WANG ; Lijing BAI ; Yuejia ZHAO ; Qingchun ZHAO
Chinese Journal of Modern Nursing 2024;30(26):3579-3584
Objective:To investigate the chain mediating role of psychological resilience and coping styles between social support and psychological distress in elderly stroke patients.Methods:Using convenience sampling, 245 elderly stroke patients with their first episode, admitted to the Neurology Department of the Affiliated Hospital of Hebei University from June to July 2023, were recruited as study subjects. A questionnaire survey was conducted using a General Information Questionnaire, Distress Thermometer for Stroke Patients, Perceived Social Support Scale, Connor-Davidson Resilience Scale Short Form, and Medical Coping Modes Questionnaire. Pearson correlation analysis was used to examine the relationships between psychological distress, social support, psychological resilience, and coping styles in elderly stroke patients. Harman's single-factor test was employed to detect common method bias among variables. The PROCESS macro in SPSS software was utilized to test the chain mediation effects.Results:A total of 245 questionnaires were distributed, with 230 valid responses collected, yielding a response rate of 93.9%. Among the 230 elderly stroke patients, the incidence of psychological distress was 23.9% (55/230). Significant correlations were observed among psychological distress, social support, psychological resilience, and coping styles ( P<0.05). Social support influenced psychological distress through the mediation of psychological resilience and confrontational coping, with a total indirect effect of -0.098. The same relationship existed for social support through psychological resilience and avoidant coping, with a total indirect effect of -0.058. Additionally, social support influenced psychological distress through psychological resilience and submissive coping, with a total indirect effect of -0.113. Avoidant coping had a suppressing effect on the influence of social support on psychological distress. Conclusions:Elderly stroke patients experienced moderate to low levels of psychological distress. Psychological resilience and coping styles played a chain-mediating role between social support and psychological distress. Special attention should be given to elderly stroke patients with low levels of social support.
3.Preliminary Recommendations on the Timing of Lung Surgery after Novel Coronavirus Infection in Patients with Pulmonary Nodules and Lung Cancer.
Xin LI ; Ming DONG ; Song XU ; Honglin ZHAO ; Sen WEI ; Zuoqing SONG ; Minghui LIU ; Dian REN ; Fan REN ; Qingchun ZHAO ; Renwang LIU ; Chunqiu XIA ; Gang CHEN ; Jun CHEN
Chinese Journal of Lung Cancer 2023;26(2):148-150
In recent years, the corona virus disease 2019 (COVID-19) pandemic has had a huge impact on the global medical, political and economic fields. Since the beginning of the COVID-19 epidemic, our understanding of the impact of COVID-19 has grown exponentially. Recently, the COVID-19 epidemic has changed rapidly in China, and there has been controversy over how to carry out surgical operations for patients with lung neoplastic lesions. Some studies have shown that lung cancer patients undergoing surgery are more likely to experience respiratory failure and perioperative death after contracting COVID-19 than the general population, however, delays in cancer treatment are also associated with increased mortality among these patients. In particular, the novel coronavirus Omikron variant has a higher transmissibility and may escape the immunity obtained through the previous novel coronavirus infection and vaccination. In order to minimize the risk of novel coronavirus infection in surgical patients, it is necessary to develop new treatment guidelines, expert consensus and preventive measures. However, the current rapid change of the epidemic situation has led to insufficient time and evidence to develop guidelines and consensus. Therefore, thoracic surgeons need to evaluate specific patient populations at higher risk of severe complications before surgery and weigh the benefit of surgical treatment against the risk of novel coronavirus infection. We try to give some recommendations on lung surgery during the current domestic epidemic situation based on the guidelines and consensus of oncology and thoracic surgery organizations in different regions on lung surgery.
.
Humans
;
Lung Neoplasms/complications*
;
COVID-19
;
SARS-CoV-2
;
Multiple Pulmonary Nodules
;
Pandemics/prevention & control*
;
Lung
4.Analysis of the Incidence of Lower Limb Deep Venous Thrombosis and Its Related Risk Factors in the Postoperative Patients with Lung Cancer.
Hui DU ; Honglin ZHAO ; Qingchun ZHAO ; Jun CHEN
Chinese Journal of Lung Cancer 2023;26(5):386-391
BACKGROUND:
Lung cancer is the first leading cause of morbidity and mortality among the malignant tumors, which has become a hot issue in current research. Clinically, lung cancer is divided into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) according to the pathological types. NSCLC includes adenocarcinoma, squamous cell carcinoma and other types of lung cancer, accounting for about 80% of all lung cancer. Venous thromboembolism (VTE) includes deep venous thrombosis (DVT) and pulmonary embolism (PE), which is a recognized complication in lung cancer patients with higher morbidity and mortality. The aim of this study is to determine the incidence of DVT and reveal the risk factors for DVT in the postoperative patients with lung cancer.
METHODS:
We collected 83 postoperative patients with lung cancer admitted to the Department of Lung Cancer Surgery, Tianjin Medical University General Hospital from December 2021 to December 2022. All these patients were examined by color Doppler ultrasound of lower extremity vein upon admission and after operation to analyze the incidence of DVT. In order to explore the possible risk factors for DVT in these patients, we further analyzed the correlations between DVT and their clinical features. At the same time, the changes of coagulation function and platelet were monitored to investigate the value of blood coagulation in the patients with DVT.
RESULTS:
DVT occurred in 25 patients after lung cancer operation, and the incidence rate of DVT was 30.1%. Further analysis found that the incidences of postoperative lower limb DVT were higher in lung cancer patients of stage III+IV or over 60 years of age (P=0.031, P=0.028). D-Dimer level in patients with thrombosis was significantly higher than that in non-thrombus patients on the 1st, the 3rd, and the 5th day after operation (P<0.05), and there was no significant difference in platelets and fibrinogen (FIB) (P>0.05).
CONCLUSIONS
The overall incidence of DVT in our center after lung cancer patients operation was 30.1%. Late-stage and older postpatients were more likely to develop DVT, and these patients with higher D-Dimer values should be considered the possibility of VTE events.
Humans
;
Middle Aged
;
Aged
;
Lung Neoplasms/surgery*
;
Incidence
;
Carcinoma, Non-Small-Cell Lung
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Venous Thromboembolism
;
Venous Thrombosis/etiology*
5.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.
6.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.
7.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.
8.Effect of shortening of levator palpebrae complex on combined fascial sheath suspension in severe blepharoptosis
Xuan LI ; Qingchun XI ; Lingling ZHAO ; Mingsong FANG ; Lin CAO ; Pengfei SANG ; Chang LIU
Chinese Journal of Medical Aesthetics and Cosmetology 2021;27(4):289-292
Objective:To explore the treatment of levator complex in conjoint fascial sheath suspension correction on severe ptosis, and to seek a reliable and less complications operation.Methods:From October 2016 to February 2020, 40 eyes of 24 patients with severe ptosis (6 males and 18 females, aged from 10 to 73 years, with an average of 34.4 years) were divided into study group and control group. 20 eyes in study group were treated with combined fascia sheath suspension and levator palpebrae muscle complex tension-free shortening correction, while 20 eyes in control group were treated with combined fascia sheath suspension and levator palpebrae muscle complex tension-free shortening correction The effects and complications of the two groups were compared.Results:Follow-up studies were conducted at 1 week, 3 month and 6 months after operation. There was no significant difference between the two methods at different time points after operation, and the incidence of complications in the study group was less than that in the control group at 1 week after operation.Conclusions:Combined with fascial sheath suspension and levator palpebrae muscle complex tension-free shortening in the treatment of severe blepharoptosis has less complications and reliable curative effect in the early postoperative period, but it still needs to be improved to obtain more lasting curative effect.
9.Research Progress of Epigenetics in Pathogenesis and Treatment of Malignant Tumors.
Pan WANG ; Honglin ZHAO ; Fan REN ; Qingchun ZHAO ; Ruifeng SHI ; Xingyu LIU ; Jinghao LIU ; Yongwen LI ; Ying LI ; Hongyu LIU ; Jun CHEN
Chinese Journal of Lung Cancer 2020;23(2):91-100
Epigenetic modification is closely related to the occurrence and development of tumors. It mainly regulates gene function and expression level through DNA methylation, histone modification, regulation of non-coding RNA and chromatin structure reconstruction. At present, epigenetic drugs have been gradually applied to the treatment of malignant tumors. Common drug types include: DNA methyltransferase inhibitors and histone deacetylase inhibitors. However, these drugs still have many shortcomings and a wide range of clinical applications need further research. Encouragingly, the epigenetic drugs in combination with various anti-tumor drugs have shown great application potential. In this paper, we summarized the development mechanism of epigenetics in malignant tumors and the progress of related drugs.
10.The Role of Plasma CDO1 Methylation in the Early Diagnosis of Lung Cancer.
Pan WANG ; Honglin ZHAO ; Ruifeng SHI ; Xingyu LIU ; Jinghao LIU ; Fan REN ; Qingchun ZHAO ; Hongbing ZHANG ; Yongwen LI ; Hongyu LIU ; Jun CHEN
Chinese Journal of Lung Cancer 2020;23(5):314-320
BACKGROUND:
The incidence and mortality of lung cancer often rank first in all malignant tumors. DNA methylation, as one of epigenetics, often participates in the development and progression of tumors. CDO1 as a tumor suppressor gene always undergoes methylation changes early in tumor development. Therefore, this study aims to discuss the value of CDO1 methylation in the early diagnosis of lung cancer.
METHODS:
Peripheral blood samples were collected from tumor patients and healthy people. Detection of the methylation level of CDO1 in plasma by sulfite modification and quantitative real-time PCR.
RESULTS:
The level of gene methylation in peripheral blood of lung cancer patients was significantly higher than that of benign lung disease patients and healthy people. The methylation level of CDO1 was significantly different in the stratified comparison of gender, lymph node metastasis and tumor-node-metastasis (TNM) stage (P<0.05). The sensitivity and specificity of CDO1 were 52.2% and 78.6%, respectively. The overall accuracy of the diagnosis was significantly higher than that of the clinical tumor markers, and the sensitivity of CDO1 to stage I and II patients was the highest (40.8%, 47.1%). In addition, CDO1 could effectively increase the sensitivity of diagnosis in multiple joint examinations.
CONCLUSIONS
Detecting the methylation level of CDO1 has a potentially huge advantage for the early diagnosis of lung cancer.


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