1.Analysis of the evaluation mechanism and methodology of clinical comprehensive evaluation cases of drugs in China
Yuan QIAO ; Fangyi MA ; Yubei HAN ; Mingyue ZHAO ; Minghuan JIANG ; Yu FANG
China Pharmacy 2025;36(2):146-153
OBJECTIVE To sort out the evaluation mechanism and methodology of published cases of comprehensive clinical evaluation of drugs in China, and provide a reference for promoting standardized comprehensive clinical evaluation of drugs and strengthening policy transformation in China. METHODS Clinical comprehensive evaluation cases of drugs published in China from CNKI, Wanfang Data, PubMed and Web of Science were systematically searched, and the retrieval time was from the inception to December 31st, 2023. The summary and analysis were performed from the aspects of theme selection, indicator system construction, evaluation methods, comprehensive decision-making, quality control, etc. RESULTS A total of 143 pieces of literature were ultimately included from 2014 to 2023. The number of publications has shown a rapid upward trend since 2019. The subjects of the evaluation cases were mainly pediatric drugs, Chinese patent medicines, cardiovascular drugs and anti-tumor drugs. The evaluation dimensions were between 3-8, all involving safety and effectiveness dimensions. Most cases adopted rapid evaluation methods based on literature review and expert interviews/questionnaire surveys with less emphasis on real-world research. Most cases did not involve comprehensive decision-making, quality control, or policy transformation. CONCLUSIONS The clinical comprehensive evaluation of drugs in China has made rapid progress under the guidance of national policies. However, there are still issues and challenges such as incomplete evaluation methods and standards, few cases of evaluation results being converted into decision-making, and a lack of quality control mechanisms. It is suggested that standardized evaluation paths and quality control mechanisms should be explored; when the evidence-based basis is insufficient, real-world research should be conducted as much as possible, so as to accelerate the policy transformation of evaluation results.
2.Analysis of the evaluation mechanism and methodology of clinical comprehensive evaluation cases of drugs in China
Yuan QIAO ; Fangyi MA ; Yubei HAN ; Mingyue ZHAO ; Minghuan JIANG ; Yu FANG
China Pharmacy 2025;36(2):146-153
OBJECTIVE To sort out the evaluation mechanism and methodology of published cases of comprehensive clinical evaluation of drugs in China, and provide a reference for promoting standardized comprehensive clinical evaluation of drugs and strengthening policy transformation in China. METHODS Clinical comprehensive evaluation cases of drugs published in China from CNKI, Wanfang Data, PubMed and Web of Science were systematically searched, and the retrieval time was from the inception to December 31st, 2023. The summary and analysis were performed from the aspects of theme selection, indicator system construction, evaluation methods, comprehensive decision-making, quality control, etc. RESULTS A total of 143 pieces of literature were ultimately included from 2014 to 2023. The number of publications has shown a rapid upward trend since 2019. The subjects of the evaluation cases were mainly pediatric drugs, Chinese patent medicines, cardiovascular drugs and anti-tumor drugs. The evaluation dimensions were between 3-8, all involving safety and effectiveness dimensions. Most cases adopted rapid evaluation methods based on literature review and expert interviews/questionnaire surveys with less emphasis on real-world research. Most cases did not involve comprehensive decision-making, quality control, or policy transformation. CONCLUSIONS The clinical comprehensive evaluation of drugs in China has made rapid progress under the guidance of national policies. However, there are still issues and challenges such as incomplete evaluation methods and standards, few cases of evaluation results being converted into decision-making, and a lack of quality control mechanisms. It is suggested that standardized evaluation paths and quality control mechanisms should be explored; when the evidence-based basis is insufficient, real-world research should be conducted as much as possible, so as to accelerate the policy transformation of evaluation results.
3.Epidemiological trends and disease burden of lower gastrointestinal bleeding in children within 10 years
Guoying TANG ; Qing LIU ; Mingyue ZHU ; Yongping ZHAO ; Pingying JIANG ; Linyun YANG
Journal of Public Health and Preventive Medicine 2024;35(1):100-103
Objective To retrospectively analyze the epidemiological trend of children with lower gastrointestinal bleeding in recent 10 years,and investigate the change of their disease burden,so as to provide a theoretical basis for the accurate prevention and control of children's lower gastrointestinal bleeding. Methods A total of 671 children with "lower gastrointestinal bleeding" who were diagnosed in our hospital from 2012 to 2021 were collected as research subjects. To analyze the microscopic examination rate and common etiology of lower gastrointestinal bleeding in children in the past 10 years,as well as the epidemiological characteristics of different age groups, different regions and different basic diseases; Calculate and compare the rate of disability life lost (YLD), early death life lost (YLL) and disability adjusted life year (DALY) of children with lower gastrointestinal bleeding within 10 years, and calculate the annual change percentage (AAPC) to analyze the change trend of disease burden. Results The microscopic examination rate of children with lower gastrointestinal bleeding showed a trend of increasing in the past 10 years (P<0.001). Among them, the most common causes are Crohn's disease, ulcerative colitis and chronic colitis. The proportion of children with lower gastrointestinal bleeding was higher in boys, >18 years old, hypertension and gastroenteritis. The DALY rate, YLL rate and YLD rate caused by lower gastrointestinal bleeding in the past 10 years showed an upward trend (P<0.05). Conclusion The microscopic examination rate of lower gastrointestinal bleeding in children was graduallyincreasing,and the prevalence rate of basic diseases such as boys,hypertension and gastroenteritis was increasing;in addition,the disease burden caused by children's lower gastrointestinal bleeding was also increasing year by year and should be protected.
4.Anemoside B4 inhibits SARS-CoV-2 replication in vitro and in vivo.
Mingyue XIAO ; Ronghua LUO ; Qinghua LIANG ; Honglv JIANG ; Yanli LIU ; Guoqiang XU ; Hongwei GAO ; Yongtang ZHENG ; Qiongming XU ; Shilin YANG
Chinese Herbal Medicines 2024;16(1):106-112
OBJECTIVE:
Anemoside B4 (AB4), the most abundant triterpenoidal saponin isolated from Pulsatilla chinensis, inhibited influenza virus FM1 or Klebsiella pneumoniae-induced pneumonia. However, the anti-SARS-CoV-2 effect of AB4 has not been unraveled. Therefore, this study aimed to determine the antiviral activity and potential mechanism of AB4 in inhibiting human coronavirus SARS-CoV-2 in vivo and in vitro.
METHODS:
The cytotoxicity of AB4 was evaluated using the Cell Counting Kit-8 (CCK8) assay. SARS-CoV-2 infected HEK293T, HPAEpiC, and Vero E6 cells were used for in vitro assays. The antiviral effect of AB4 in vivo was evaluated by SARS-CoV-2-infected hACE2-IRES-luc transgenic mouse model. Furthermore, label-free quantitative proteomics and bioinformatic analysis were performed to explore the potential antiviral mechanism of action of AB4. Type I IFN signaling-associated proteins were assessed using Western blotting or immumohistochemical staining.
RESULTS:
The data showed that AB4 reduced the propagation of SARS-CoV-2 along with the decreased Nucleocapsid protein (N), Spike protein (S), and 3C-like protease (3CLpro) in HEK293T cells. In vivo antiviral activity data revealed that AB4 inhibited viral replication and relieved pneumonia in a SARS-CoV-2 infected mouse model. We further disclosed that the antiviral activity of AB4 was associated with the enhanced interferon (IFN)-β response via the activation of retinoic acid-inducible gene I (RIG-1) like receptor (RLP) pathways. Additionally, label-free quantitative proteomic analyses discovered that 17 proteins were significantly altered by AB4 in the SARS-CoV-2 coronavirus infections cells. These proteins mainly clustered in RNA metabolism.
CONCLUSION
Our results indicated that AB4 inhibited SARS-CoV-2 replication through the RLR pathways and moderated the RNA metabolism, suggesting that it would be a potential lead compound for the development of anti-SARS-CoV-2 drugs.
5.Progress of research on brain breaks in cultural classrooms to promote students physical activity levels
JIANG Jiajun, YIN Mingyue, LIU Haohui, SONG Jian, NIU Xiao, YIN Zhihua
Chinese Journal of School Health 2024;45(4):595-598
Abstract
Brain Breaks is a physical activity program that combines cultural classroom based physical activity with modern technology while providing children with multi level guidance. As an intervention for intermittent sedentary activities, Brain Breaks can improve students physical activity level, thereby improving their physical fitness and positively affecting their motivation to participate in physical activities and positive learning behaviors. The paper understands this intervention from the connotation, implementation basis, and application effect of Brain Breaks, and then proposes practical application suggestions and future research directions.When Brain Breaks in the cultural classroom is promoted and practiced in China in the future, attention should be paid to the means of implementation by the teachers, the selection of representative target groups, and the precise implementation plan.At the research level, the effects of motor skills, special group interventions, gender differences, environmental changes, and physiological mechanisms of the Brain Breaks are to be explored.
6.Relationship between practice efficacy and professional identity in public health master's graduates: A study on the mediating role of anxiety
Rui ZHU ; Mingyue WEN ; Jinzhong JIA ; Huangtao LIN ; Quanrong ZHU ; Peiyao SHI ; Wei JIANG ; Jingrui LI ; Mengquan LIU
Chinese Journal of Medical Education Research 2024;23(9):1191-1196
Objective:To investigate the current status of and relationship between practice efficacy, professional identity, and anxiety among public health master's graduates.Methods:From a national survey on the satisfaction with education of fresh medical master's graduates conducted from June to July, 2022, we selected 461 master's graduates of public health with internship experience from 49 institutions. With the use of SPSS 21.0, we compared the scores of practice efficacy, professional identity, and self-rated anxiety by personal characteristics through t-tests and analysis of variance; and explored the mediating role of anxiety in the relationship between practice efficacy and professional identity through stratified regression analysis. Results:The public health master's graduates scored (3.47±1.23) points for anxiety, (3.92±0.88) points for practice efficacy, and (4.33±0.77) points for professional identity. The score of anxiety differed significantly by sex, the degree of being affected by public health emergencies/major outbreaks, and internship initiative (all P<0.05). The score of practice efficacy was significantly different by sex, the type of institution, the degree of being affected by public health emergencies/major outbreaks, and internship initiative (all P<0.05). The score of professional identity differed significantly by sex, the type of institution, major transfer, the degree of being affected by public health emergencies/major outbreaks, internship initiative, and internship duration (all P<0.05). Professional identity was positively correlated with practice efficacy ( r=0.652, P<0.01) and negatively correlated with anxiety ( r=-0.213, P<0.05). The stratified regression results showed that practice efficacy positively influenced professional identity ( β=0.782, P<0.001), and anxiety partially mediated the relationship between the two ( β=-0.104, P<0.05). Conclusions:Anxiety plays a mediating role in the relationship between practice efficacy and professional identity, suggesting that reducing anxiety can help enhance practice efficacy to promote the professional identity of public health master's graduates.
7.Development of a health behavior guidance program for stroke rehabilitation patients based on the adaptive leadership framework
Mingyue WANG ; Caiqin WU ; Jieting JIANG ; Jie SUN ; Binhai SUN ; Kunpeng LI
Chinese Journal of Modern Nursing 2024;30(27):3678-3684
Objective:To develop a health behavior guidance program for stroke rehabilitation patients based on the adaptive leadership framework (ALF) .Methods:Relevant stroke health behavior guidelines were systematically retrieved, screened, included, and recommendations extracted from domestic and international websites. The initial draft of the health behavior guidance program for stroke rehabilitation patients was developed in light of the ALF. From January to March 2022, the draft was refined through two rounds of Delphi expert consultation, resulting in the finalized health behavior guidance program.Results:A total of 10 guidelines were included, and 73 guideline recommendations were extracted. These recommendations were categorized into six dimensions and 25 specific items. In both rounds of expert consultation, 15 questionnaires were distributed and all were returned, yielding an effective recovery rate of 100.00%, with an expert authority coefficient greater than 0.8. Based on expert feedback and group discussions, the final program included eight dimensions and 31 items, adding sleep management and regular health consultations to the original six dimensions.Conclusions:The health behavior guidance program for stroke rehabilitation patients, based on the ALF, introduces a new perspective on nursing by reasonably dividing adaptive and technical problems. This approach aligns with clinical practice in China, providing scientific and practical value for promoting health behaviors and offering a new perspective for health education in stroke patients.
8.Research progress of non-invasive brain stimulation in treatment of patients with post-stroke cognitive impairment
Xinlin JIANG ; Mingyue ZHU ; Lei FAN ; Wenxin ZHU ; Yuwei XIU ; Yuanbiao LIU
Journal of Clinical Medicine in Practice 2024;28(13):144-148
Post-stroke cognitive impairment (PSCI) is a common complication after stroke, which has high disability rate and mortality rate, and can affect the patient′s daily living ability and quality of life. Non-invasive brain stimulation (NIBS) has the advantages of non-invasiveness, safety, and ease of operation, and is easily accepted by patients. NIBS has a good application prospect in the treatment of PSCI, especially the representative treatment repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) such as have good clinical application effects. At present, there is no standardized treatment plan for NIBS, and there are large individual differences in therapeutic effects. This study reviewed the mechanism and clinical application of NIBS in the treatment of PSCI, and discussed the future application direction of NIBS.
9.High-throughput screening of SARS-CoV-2 main and papain-like protease inhibitors.
Yi ZANG ; Mingbo SU ; Qingxing WANG ; Xi CHENG ; Wenru ZHANG ; Yao ZHAO ; Tong CHEN ; Yingyan JIANG ; Qiang SHEN ; Juan DU ; Qiuxiang TAN ; Peipei WANG ; Lixin GAO ; Zhenming JIN ; Mengmeng ZHANG ; Cong LI ; Ya ZHU ; Bo FENG ; Bixi TANG ; Han XIE ; Ming-Wei WANG ; Mingyue ZHENG ; Xiaoyan PAN ; Haitao YANG ; Yechun XU ; Beili WU ; Leike ZHANG ; Zihe RAO ; Xiuna YANG ; Hualiang JIANG ; Gengfu XIAO ; Qiang ZHAO ; Jia LI
Protein & Cell 2023;14(1):17-27
The global COVID-19 coronavirus pandemic has infected over 109 million people, leading to over 2 million deaths up to date and still lacking of effective drugs for patient treatment. Here, we screened about 1.8 million small molecules against the main protease (Mpro) and papain like protease (PLpro), two major proteases in severe acute respiratory syndrome-coronavirus 2 genome, and identified 1851Mpro inhibitors and 205 PLpro inhibitors with low nmol/l activity of the best hits. Among these inhibitors, eight small molecules showed dual inhibition effects on both Mpro and PLpro, exhibiting potential as better candidates for COVID-19 treatment. The best inhibitors of each protease were tested in antiviral assay, with over 40% of Mpro inhibitors and over 20% of PLpro inhibitors showing high potency in viral inhibition with low cytotoxicity. The X-ray crystal structure of SARS-CoV-2 Mpro in complex with its potent inhibitor 4a was determined at 1.8 Å resolution. Together with docking assays, our results provide a comprehensive resource for future research on anti-SARS-CoV-2 drug development.
Humans
;
Antiviral Agents/chemistry*
;
COVID-19
;
COVID-19 Drug Treatment
;
High-Throughput Screening Assays
;
Molecular Docking Simulation
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Protease Inhibitors/chemistry*
;
SARS-CoV-2/enzymology*
;
Viral Nonstructural Proteins
10.Study on the clinical comprehensive evaluation of blood lipid-regulating drugs in five provinces and regions in Northwest China
Yuan QIAO ; Hang ZHAO ; Jiaxi DU ; Jingyi MAN ; Sen XU ; Fangyi MA ; Shuchen HU ; Jin PENG ; Minghuan JIANG ; Mingyue ZHAO ; Yu FANG
China Pharmacy 2023;34(10):1165-1171
OBJECTIVE To explore standardized evaluation process for clinical comprehensive evaluation of blood lipid- regulating drugs and perform rapid assessment of clinical comprehensive evaluation of blood lipid-regulating drugs with different mechanisms so as to provide reference for the drug catalogue selection and rational drug use of medical institutions. METHODS Referring to guidelines and consensus such as the guideline for the management of comprehensive clinical evaluation of drugs, the methods such as literature research, expert interviews, and Delphi expert consultation were used to establish a multi-dimensional and multi-criteria clinical comprehensive evaluation index system and quantitative scoring table for blood lipid-regulating drugs around the two main lines of technical evaluation and policy evaluation. Then 13 blood lipid-regulating drugs with different mechanisms in 21 third-grade class-A medical institutions from five provinces and regions of Northwest China were scored from both technical and policy dimensions to form a comprehensive evaluation result. RESULTS The clinical comprehensive evaluation index system and corresponding rapid evaluation quantitative scoring table were constructed for blood lipid-regulating drugs in the five northwest provinces and regions. The technicalevaluation section included 6 primary indicators, 13 secondary indicators, and 34 tertiary indicators, totaling 110 points. The policy evaluation section included 4 primary indicators and 6 secondary indicators, with a total score of 40 points (30 points for some drugs) and a total score of 150 points (or 140 points). The scoring results showed that the highest score was atorvastatin, followed by rosuvastatin and simvastatin. CONCLUSIONS Statins are still the cornerstone of drug therapy for patients with dyslipidemia; the rapid evaluation quantitative scoring table constructed in this study is comprehensive, systematic and operable. The evaluation process in this study can provide empirical references for other groups to exploring the standardized path and quality control mechanism of clinical comprehensive evaluation of drugs.


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