1.Methodological Consideration on Combination Model of TCM Clinical Practice Guidelines and Real-world Study
Guozhen ZHAO ; Huizhen LI ; Ning LIANG ; Haili ZHANG ; Bin LIU ; Qianzi CHE ; Feng ZHOU ; He LI ; Xiaowen CHEN ; Long YE ; Jiahao LIN ; Xingyu ZONG ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):87-93
The clinical practice guidelines of traditional Chinese medicine (TCM) have problems such as limited clinical application and unclear implementation effects, which may be related to the lack of clinical practice evidence. To provide reliable and precise evidence for clinical practice, this article proposes a model of combining TCM guidelines with real-world study, which includes 4 steps. Firstly, during the implementation process of the guidelines, a high-quality research database is established. Secondly, the recommendations in the guidelines are evaluated based on the established database in multiple dimensions, including applicability, effectiveness, safety, and cost-effectiveness, and thus their effectiveness in practical applications can be determined. Thirdly, based on the established database, core prescriptions are identified, and the targeted populations and medication plans are determined. That is, the best treatment regimen is established based on the analysis of abundant clinical data regarding the effects of different medication frequencies, dosages, and duration on efficacy. Fourthly, the guidelines are updated according to the real-world evidence. The research based on this model can provide real-world evidence for ancient and empirical prescriptions, improving their application in clinical practice. Moreover, this model can reduce research costs and improve research efficiency. When applying this model, researchers need to pay attention to the quality of real-world evidence, ensuring that it can truly reflect the situation in clinical practice. In addition, importance should be attached to the clinical application of guideline recommendations, ensuring that doctors can conduct standardized diagnosis and treatment according to the guidelines. Finally, full-process participation of multidisciplinary experts is encouraged to ensure the comprehensiveness and scientificity of the study. In conclusion, the application of this model will contribute to the development of TCM guidelines responsive to the needs of clinical practice and achieve the goal of promoting the homogenization of TCM clinical diagnosis and treatment.
2.Thinking and Practice of Clinical Evidence-based Evaluation in TCM with Disease-syndrome Diagnostic System
Tengwen LIU ; Yifan SHI ; Tianyuan WANG ; Qian LIU ; Zhishuo FAN ; Guozhen ZHAO ; Jing HU ; Dong WANG ; Bo LI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):127-136
In recent years, there have been both achievements and criticisms in using the methods of evidence-based medicine to evaluate the efficacy of traditional Chinese medicine (TCM), which is mainly due to the differences between TCM and Western medicine. To facilitate the clinical evidence-based evaluation in TCM, this paper analyzes the challenges faced in TCM clinical evaluation, particularly in the diagnosis, clinical intervention, and efficacy assessment methods. Considering the current state of TCM clinical evaluation and our clinical research experience, we believe that establishing and refining the TCM disease-syndrome diagnostic system is a prerequisite for the practice of clinical evidence-based evaluation in TCM. Furthermore, this paper discusses the specific connotation, development, and challenges of the disease-syndrome diagnostic system, especially the choice of TCM disease name or modern medical disease name in this system. Then, the clinical application scenarios are expounded from ''TCM disease name + syndrome differentiation'' and ''Western medicine disease name + syndrome differentiation''. Moreover, this paper proposed solutions for practical issues such as the standardization of disease and syndrome diagnosis, selection of clinical evaluation methods, and application of evidence-based approaches in clinical evaluation. Establishing the criteria for the disease-syndrome diagnostic system is crucial for the determination of clinical intervention regimen, the selection of clinical research methods, and the establishment of evaluation indicators, which are essential for generating high-quality clinical evidence. To sum up, this paper reviews the development and current situation of the disease-syndrome diagnostic system and proposes an exploratory approach for the standardization and application of this system in clinical evidence-based evaluation. This approach aims to facilitate the integration of TCM with modern clinical practice, thereby achieving standardized evaluation of TCM efficacy and deepening the integration of TCM with evidence-based medicine.
3.Role of risk perception between social media use and human papilloma virus vaccination willingness of college students
GUO Xiuyang,WANG Chenghao,ZHANG Guozhen
Chinese Journal of School Health 2024;45(6):817-821
Objective:
To understand the impact of social media usage on the human papilloma virus(HPV) vaccination willingness among college students in Xinjiang, so as to provide a theoretical basis for early prevention of HPVrelated diseases and preventive education.
Methods:
From March to April 2022, a total of 834 college students were selected from three universities including Xinjiang Agricultural University, Xinjiang Normal University and Xinjiang Medical University by stratified cluster random sampling method for online and offline surveys. The demographic characteristics, social media usage, risk perception, HPV vaccination willingness were obtained through questionnaires, and the Logistic regression analysis method was used to explore the role of HPV vaccine risk perception between social media use and HPV vaccination willingness of college students.
Results:
Associations were found between social media use (contact intensity, satisfaction, trust), risk perception (risk perception disorder, risk perception benefit) and HPV vaccination willingness among college students (r=0.37, 0.34, 0.35; 0.25, 0.31, P<0.05). Risk perception benefit had an intermediary effect between social media contact intensity, social media satisfaction, social media trust and HPV vaccination willingness, and the intermediary effects were 0.03 (95%CI=0. 01-0.06), 0.04(95%CI=0.02-0.07), 0.04(95%CI=0.01-0.06),and the proportions of intermediary effect were 18.00%, 26.35%, 23.00%, respectively.Risk perception disorder had an intermediary effect between social media satisfaction and HPV vaccination willingness [0.02 (95%CI=0.00-0.04)], and the intermediary effect accounts for 11.36%.
Conclusions
Risk perception benefit is the most important related factors of HPV vaccine willingness, which plays an intermediary effect between social media usage and the willingness to HPV vaccination. HPV publicity and education should be strengthened on social media platforms to promote HPVrelated knowledge and awareness of active prevention of HPV infection among college students.
4.Optimization of Menin inhibitors based on artificial intelligence-driven molecular factory technology
Hao ZENG ; Guozhen WU ; Wuxin ZOU ; Zhe WANG ; Jianfei SONG ; Hui SHI ; Xiaojian WANG ; Tingjun HOU ; Yafeng DENG
Journal of China Pharmaceutical University 2024;55(3):326-334
The new generation of artificial intelligence technology,represented by deep learning,has emerged as a crucial driving force in the advancement of new drug research and development.This article creatively proposes a workflow named"Molecular Factory"for the design and optimization of drug molecules based on artificial intelligence technology.This workflow integrates intelligent molecular generation models,high-performance molecular docking algorithms,and accurate protein-ligand binding affinity prediction methods.It has been integrated as a core module into DrugFlow,a one-stop drug design software platform,providing a comprehensive set of mature solutions for the discovery and optimization of lead compounds.Utilizing the"Molecular Factory"module,we conducted the research of second-generation inhibitors against Menin that can combat drug resistance.Through the integration of computational and experimental approaches,we rapidly identified multiple promising compounds.Among them,compound RG-10 exhibited the IC50 values of 9.681 nmol/L,233.2 nmol/L,and 40.09 nmol/L against the wild-type Menin,M327I mutant,and T349M mutant,respectively.Compared to the positive reference molecule SNDX-5613,which has entered Phase Ⅱ clinical trials,RG-10 demonstrated significantly enhanced inhibitory activity against the M327I and T349M mutants.These findings fully demonstrate the unique advantages of the"Molecular Factory"technology in practical drug design and development scenarios.It can rapidly and efficiently generate high-quality active molecules targeting specific protein structures,holding significant value and profound implications for advancing new drug discovery.
5.Reference values of carotid intima-media thickness and arterial stiffness in Chinese adults based on ultrasound radio frequency signal: A nationwide, multicenter study
Changyang XING ; Xiujing XIE ; Yu WU ; Lei XU ; Xiangping GUAN ; Fan LI ; Xiaojun ZHAN ; Hengli YANG ; Jinsong LI ; Qi ZHOU ; Yuming MU ; Qing ZHOU ; Yunchuan DING ; Yingli WANG ; Xiangzhu WANG ; Yu ZHENG ; Xiaofeng SUN ; Hua LI ; Chaoxue ZHANG ; Cheng ZHAO ; Shaodong QIU ; Guozhen YAN ; Hong YANG ; Yinjuan MAO ; Weiwei ZHAN ; Chunyan MA ; Ying GU ; Wu CHEN ; Mingxing XIE ; Tianan JIANG ; Lijun YUAN
Chinese Medical Journal 2024;137(15):1802-1810
Background::Carotid intima-media thickness (IMT) and diameter, stiffness, and wave reflections, are independent and important clinical biomarkers and risk predictors for cardiovascular diseases. The purpose of the present study was to establish nationwide reference values of carotid properties for healthy Chinese adults and to explore potential clinical determinants.Methods::A total of 3053 healthy Han Chinese adults (1922 women) aged 18-79 years were enrolled at 28 collaborating tertiary centers throughout China between April 2021 and July 2022. The real-time tracking of common carotid artery walls was achieved by the radio frequency (RF) ultrasound system. The IMT, diameter, compliance coefficient, β stiffness, local pulse wave velocity (PWV), local systolic blood pressure, augmented pressure (AP), and augmentation index (AIx) were then automatically measured and reported. Data were stratified by age groups and sex. The relationships between age and carotid property parameters were analyzed by Jonckheere-Terpstra test and simple linear regressions. The major clinical determinants of carotid properties were identified by Pearson’s correlation, multiple linear regression, and analyses of covariance.Results::All the parameters of carotid properties demonstrated significantly age-related trajectories. Women showed thinner IMT, smaller carotid diameter, larger AP, and AIx than men. The β stiffness and PWV were significantly higher in men than women before forties, but the differences reversed after that. The increase rate of carotid IMT (5.5 μm/year in women and 5.8 μm/year in men) and diameter (0.03 mm/year in both men and women) were similar between men and women. For the stiffness and wave reflections, women showed significantly larger age-related variations than men as demonstrated by steeper regression slopes (all P for age by sex interaction <0.05). The blood pressures, body mass index (BMI), and triglyceride levels were identified as major clinical determinants of carotid properties with adjustment of age and sex. Conclusions::The age- and sex-specific reference values of carotid properties measured by RF ultrasound for healthy Chinese adults were established. The blood pressures, BMI, and triglyceride levels should be considered for clinical application of corresponding reference values.
6.Epidemiological characteristics of hemorrhoids in a healthy physical examination population in China
Chenghua GUO ; Xiaoyu CHE ; Zhi LIN ; Shan CAI ; Guozhen LIU ; Lang PAN ; Jun LV ; Liming LI ; Sailimai MAN ; Bo WANG ; Canqing YU
Journal of Peking University(Health Sciences) 2024;56(5):815-819
Objective:To describe the epidemiological distribution of hemorrhoids in a physical exami-nation population in China,which could provide evidence for precision prevention and early intervention of hemorrhoids.Methods:Chinese subjects over 18 years of age who underwent a physical examination in a nationwide chain of physical examination centers in 2018 were studied in a cross-sectional design,which collected information by a questionnaire and physical examination results from each subject.The epidemiological distribution of hemorrhoids was described using Logistic models.The gender-,age-,and region-detection rates of hemorrhoids were standardized to the Sixth National Population Census of the People's Republic of China(2010).Results:A total of 2 940 295 adult subjects were included in the study,of whom the average age was(41.7±14.0)years,and 52.6%were females.The standardized detection rate of hemorrhoids was higher for females(43.7%)than that for males(17.7%;P<0.001)in this study.In the females,the age distribution of hemorrhoids was inverted U-shaped,with the highest standardized detection rate of hemorrhoids in the age group of 30-39 years(63.5%).In the males,the standardized detection rate of hemorrhoids increased along with age,with the highest percentage of 17.2%in the age group of 50-59 years,and the standardized detection rate of hemorrhoids in the age group of 60 and above decreased slightly(P<0.001 for trend test).The participants with hypertension had a higher standardized detection rate of hemorrhoids than those with normal blood pressure in both males and females(P<0.001).The standardized detection rate of hemorrhoids showed a positive corre-lation with body mass index(P<0.001 for trend test in males).Conclusion:The detection rate of hemorrhoids varied to gender,age,obesity,and hypertension status,which could help to identify the risk factors and the high-risk sub-groups,and hence to strengthen health education and early detection accordingly,which could eventually reduce the incidence of hemorrhoids and improve the quality of life and health in the Chinese population.This study was conducted in a physical examination population,and the conclusions of this study should be extrapolated with caution.
7.Role of macrophages in pulmonary blood-air barrier impairment induced by PM2.5 exposure
Mengfei YAO ; Guozhen WANG ; Xiaonan HOU ; Duo TANG ; Zijia LIU ; Chao SHENG ; Yuchen ZHENG ; Qi ZONG ; Wenke LI ; Zhixiang ZHOU
Journal of Army Medical University 2024;46(8):849-858
Objective To investigate the role of macrophages in the process of fine particulate matter (PM2.5)exposure induced damage to pulmonary blood-air barrier.Methods Eighteen male BALB/C mice (aged of 10 weeks,weighing 24~27 g)were randomly divided into control group and low-and high-dose PM2.5 exposure groups (receiving 1 .8 and 16.2 mg/kg,respectively),with 6 mice in each group.The control group received tracheal instillations of normal saline on days 1,4,and 7,whereas the exposure groups were administered corresponding dose of PM2.5 exposure at the same time points.In 24 h after last exposure,pathological changes in the lung tissues were observed,and the contents of total protein (TP ),lactate dehydrogenase (LDH ),and alkaline phosphatase (AKP ) in bronchoalveolar lavage fluid (BALF ),and F4/80 protein level in lung tissue were measured to evaluate the blood-air barrier damage and macrophage infiltration within the lung tissues.Additionally,an in vitro model of the blood-air barrier was established using A549 alveolar epithelial cells and EA.hy926 vascular endothelial cells.In combination with a THP-1 macrophage model,the supernatant PM2.5 supernatant,macrophage supernatant,and PM2.5-macrophage supernatant were incubated with the barrier model for 24 h,respectively.Transmembrane electrical resistance (TEER),sodium fluorescein permeability of the barrier model,and LDH release from the barrier cells were measured to ascertain the extent of macrophage-mediated enhancement in barrier damage induced by PM2.5 exposure.Furthermore,the expression of inflammatory cytokines,such as TNF-α,IL-1β,IL-6,and IL-8 in the macrophages after PM2.5 exposure was analyzed with quantitative real-time PCR (qPCR)and enzyme-linked immunosorbent assay (ELISA).Results PM2.5 exposure induced lung tissue damage in mice in a dose-dependent manner,significantly elevated the contents of TP,LDH and AKP in the BALF and caused marked infiltration of macrophages into the lung tissue,especially the high-dose exposure when compared with the mice from the control group (P<0.01 ).In vitro barrier model exposure experiments showed that in comparison with the treatment of 150 and 300 μg/mL PM2.5 and macrophage supernatant,the same doses of PM2.5-macrophage supernatant resulted in notably decreased TEER and significantly enhanced permeability in the barrier model (P<0.01 ),and markedly increased LDH release from epithelial and endothelial barrier cells (P<0.01 ).Additionally,the exposure of 150 and 300μg/mL PM2.5 led to a significant up-regulation of TNF-α,IL-1β,IL-6,and IL-8 in the macrophages (P<0.01 ).Conclusion Macrophages deteriorate PM2.5-induced functional impairment of the pulmonary blood-air barrier.
8.Development of the Fecal Microbiota Transplantation Knowledge, Attitude, and Practice Scale for Patients with Inflammatory Bowel Disease and its reliability and validity
Qianyi WANG ; Weidong SHEN ; Lihua ZHAO ; Min WANG ; Yuee QIN ; Yuanyuan PENG ; Rongrong LI ; Guozhen SUN ; Jufen PU
Chinese Journal of Modern Nursing 2024;30(4):461-468
Objective:To develop the Fecal Microbiota Transplantation Knowledge, Attitude, and Practice Scale for Patients with Inflammatory Bowel Disease (IBD), and test its reliability and validity.Methods:Guided by the theory of knowledge, attitude, and practice, a preliminary draft of the scale was formed through literature review, Delphi expert consultation, and pre-survey. From May to August 2022, convenience sampling was used to select 200 IBD patients who visited the Gastroenterology Clinic of three ClassⅢ Grade A comprehensive hospitals in Jiangsu Province as the research subject for a questionnaire survey. The critical ratio method, correlation analysis method, internal consistency method, commonality and factor loadings were used for item analysis of the scale. Exploratory factor analysis, content validity index, and internal consistency reliability were applied to test the reliability and validity of the scale.Results:A total of 200 questionnaires were distributed, and 181 valid questionnaires were collected, with an effective response rate of 90.50% (181/200). The Fecal Microbiota Transplantation Knowledge, Attitude, and Practice Scale for Patients with IBD included three dimensions of knowledge, attitude and practice, with a total of 21 items. The content validity index at the scale level was 0.917, and the content validity index at the item level ranged from 0.833 to 1.000. Exploratory factor analysis extracted three common factors, with a cumulative variance contribution rate of 74.197%. The Cronbach's α coefficient of the total scale was 0.951, and the coefficients of each dimension were 0.914 to 0.942. The test-retest reliability coefficient of the total scale was 0.918, and the test-retest reliability coefficients of each dimension ranged from 0.737 to 0.833.Conclusions:The Fecal Microbiota Transplantation Knowledge, Attitude, and Practice Scale for Patients with IBD has good reliability and validity, which can help medical and nursing staff evaluate patients' understanding and acceptance of microbial transplantation, so as to provide a basis for personalized communication in shared decision making between doctors and patients.
9.Barriers and facilitators for exercise rehabilitation in patients with atrial fibrillation after radiofrequency ablation: a mixed study
Wei YAN ; Tianxi YU ; Min GAO ; Jie WANG ; Guozhen SUN
Chinese Journal of Modern Nursing 2024;30(7):906-912
Objective:To explore the barriers and facilitators of exercise rehabilitation in patients with atrial fibrillation (AF) after radiofrequency ablation.Methods:From March to August 2022, 285 patients with atrial fibrillation who underwent radiofrequency ablation within three months were recruited from the "Cloud Ward" of the Department of Cardiovascular of the First Affiliated Hospital with Nanjing Medical University by convenience sampling. The Cardiac Rehabilitation Barriers Scale (CRBS) and the Self-efficacy for Exercise Scale (SEE) were used to evaluate the barriers and self-efficacy of patients participating in exercise rehabilitation, respectively. Among them, 22 patients were subjected to semi-structured interviews to extract themes.Results:Among 285 patients with atrial fibrillation, 202 (70.88%) participated in exercise rehabilitation programs. Work/time conflicts, lack of cardiac rehabilitation knowledge, and health/physical function limitations affected the participation of patients in exercise rehabilitation ( P<0.05). Qualitative research extracted three themes that affected the patient's exercise rehabilitation, including capability, opportunity, and motivation. Conclusions:The participation of atrial fibrillation patients in exercise rehabilitation is influenced by multiple factors such as family responsibility, capability, motivation, and opportunity. Medical and nursing staff should comprehensively consider the above factors, develop targeted interventions from all aspects and multiple angles, so as to effectively improve the participation of patients in exercise rehabilitation.
10.Scoping review of outcome indicators in randomized controlled trials on exercise rehabilitation in patients with atrial fibrillation
Zhanhong YOU ; Zhijie TANG ; Jie WANG ; Yunxia LI ; Qin WANG ; Guozhen SUN
Chinese Journal of Modern Nursing 2024;30(27):3768-3776
Objective:To analyze the selection of outcome indicators for randomized controlled trials (RCT) on exercise rehabilitation in patients with atrial fibrillation (AF), promote the construction of the core outcome set and provide reference for the research design of subsequent RCT.Methods:The RCT literature related to exercise rehabilitation of patients with atrial fibrillation was systematically searched from CNKI, Wanfang, VIP, PubMed, Web of Science, Embase and Cochrane Library databases, and the search period was from establishment of the databases until July 31, 2023. After literature screening, Cochrane Risk of Bias Assessment Tool was used for quality evaluation, information extraction, classification of outcome indicators, frequency of use statistics, analysis and extraction of current shortcomings in the selection of outcome indicators, and corresponding suggestions were proposed.Results:A total of 32 articles were included, and 19 RCT were evaluated twice for outcome measures. The number of outcome measures ranged from 2 to 17, with 10 RCT setting outcome measures according to primary and secondary criteria and 6 RCT setting safety outcome measures. A total of 96 outcome indicators were extracted in this study, total 266 frequency, which could be divided into 4 categories, such as safety evaluation (18 times), clinical response (75 times), patient-reported outcomes (68 times) and laboratory and other examination (105 times) .Conclusions:Existing RCT outcome indicators of exercise rehabilitation in patients with atrial fibrillation emphasize the changes in subjective feelings and objective indicators of individuals, covering four aspects such as the physical condition, exercise ability, quality of life and psychological status of individuals. However, there is a lack of uniform standards and the safety evaluation indicators are fewer. The categories of exercise rehabilitation indicators for atrial fibrillation patients extracted in this paper can provide a reference for the design of future RCT studies and promote the generation of higher quality evidence-based medical evidence.


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