1.Methodological Issues in the Design,Evaluation,and Reporting of Randomized Controlled Trials with "Pattern Dominating Disease"
Lu WANG ; Jiajia WANG ; Yingying ZHANG ; Xufei LUO ; Yaolong CHEN ; Jiansheng LI
Journal of Traditional Chinese Medicine 2026;67(14):1497-1502
This study explores methodological issues in the design, evaluation, and reporting of randomized controlled trials (RCTs) under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design, the screening of research participants, the standardization of syndrome differentiation, the balance between intervention individualization and standardization, the integration of multi-dimensional outcome measures, and the limitations of existing evaluation and reporting tools when applied to this type of research, along with corresponding recommendations and future perspectives. Regarding research design, it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs, in order to innovate the design format of RCTs. Meanwhile, criteria for participant screening, TCM syndrome differentiation, and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization, and a multidimensional assessment system encompassing TCM syndromes, disease-specific outcomes, and patient-reported outcomes should be established. For risk of bias assessment and research reporting, it is recommended,to develop specialized assessment and reporting tools based on existing instruments, in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design, risk-of-bias assessment, and reporting quality assessment of RCTs based on the "syndrome dominating disease" model, with a particular focus on methodological optimization, data integration, and enhancement of research quality.
2.Methodological Issues in the Design,Evaluation,and Reporting of Randomized Controlled Trials with "Pattern Dominating Disease"
Lu WANG ; Jiajia WANG ; Yingying ZHANG ; Xufei LUO ; Yaolong CHEN ; Jiansheng LI
Journal of Traditional Chinese Medicine 2026;67(14):1497-1502
This study explores methodological issues in the design, evaluation, and reporting of randomized controlled trials (RCTs) under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design, the screening of research participants, the standardization of syndrome differentiation, the balance between intervention individualization and standardization, the integration of multi-dimensional outcome measures, and the limitations of existing evaluation and reporting tools when applied to this type of research, along with corresponding recommendations and future perspectives. Regarding research design, it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs, in order to innovate the design format of RCTs. Meanwhile, criteria for participant screening, TCM syndrome differentiation, and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization, and a multidimensional assessment system encompassing TCM syndromes, disease-specific outcomes, and patient-reported outcomes should be established. For risk of bias assessment and research reporting, it is recommended,to develop specialized assessment and reporting tools based on existing instruments, in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design, risk-of-bias assessment, and reporting quality assessment of RCTs based on the "syndrome dominating disease" model, with a particular focus on methodological optimization, data integration, and enhancement of research quality.
3.Time-series study on the impact of atmospheric fine particulate matter PM2.5 on short-term pulmonary function in elderly patients with chronic obstructive pulmonary disease in Taiyuan City
Yingying SHAO ; Chen WANG ; Anfeng CUI ; Haodong WANG ; Tian-e LUO
Journal of Public Health and Preventive Medicine 2025;36(1):18-22
Objective To explore the effect of fine particulate matter (PM2.5) in Taiyuan City on short-term pulmonary function in elderly patients with chronic obstructive pulmonary disease (COPD). Methods Among the 1 015 elderly COPD patients admitted to the respiratory departments of five general hospitals in Taiyuan City from December 2021 to December 2023 were retrospectively selected for research; medical records, air pollutant data and meteorological data were analyzed; the relationship between PM2.5 and lung function indicators and air pollutants was analyzed; the impact of PM2.5 on lung function and its lag effect were analyzed; the cumulative effect of PM2.5 concentration on the risk of pulmonary ventilation dysfunction was analyzed; The influence of gender and age on the relationship between PM2.5 and patients ' short-term pulmonary function was analyzed. Results PM2.5, respirable particulate matter (PM10), sulfur dioxide (SO2), carbon monoxide (CO) were negatively correlated with average temperature and average humidity (P<0.05) ; Nitrogen dioxide (NO2), ozone (O3) were negatively correlated with average temperature (P<0.05) ; There was a positive correlation among PM2.5, PM10, SO2, CO, NO2, and O3 (P<0.05) ; Elevated PM2.5 is an independent risk factor for decreased lung function and increased air pollutants (P<0.05) ; At lag0 and lag1, PM2.5 concentration was negatively correlated with lung function in a dose-response manner (P<0.05); daily average PM2.5 concentration at lag0 was a dangerous effect (P<0.05). Conclusion The impact of PM2.5 concentration on lung function has a certain time lag. An increase in PM2.5 concentrations can lead to a decline in lung function.
4.Low-energy CO2 fractional laser treatment for post-burn scars via activating Wnt/β-catenin pathway in scar epithelial cells in rats
Haoyu GU ; Yingying LIU ; Lu YANG ; Shichu XIAO ; Pengfei LUO ; Zhaofan XIA
Academic Journal of Naval Medical University 2025;46(1):53-64
Objective To investigate the role of scar epithelial cells and its potential molecular mechanisms in the efficacy of low-energy CO2 fractional laser treating post-burn scars.Methods The model of post-major burn scars on the back of rat was established.Three rats with post-major burn scars received 30 mJ low-energy CO2 fractional laser treatment to detect the activation of scar epidermal cells.Epidermal tissue of scars was isolated for RNA sequencing to screen activated pathways.Subsequently,18 rats with post-major burn scars were randomly divided into 3 groups(n=6):the control group without laser treatment,the laser group receiving 30 mJ CO2 fractional laser treatment,and the laser+inhibitor group receiving laser treatment and intra-scar injection of IWR-1(a Wnt/β-catenin pathway inhibitor),to verify the activation status and effects of the selected pathways.Hematoxylin-eosin staining,Masson staining,and Western blotting were used to detect the proliferation of epithelial cells and fibroblasts,the activation of Wnt/β-catenin pathway,as well as the improvement of scar profiles.Results After low-energy laser treatment,there was a significant increase in the number of Ki67-positive,proliferating cell nuclear antigen(PCNA)-positive,cytokeratin 19(CK19)-positive,and p63-positive cells in the scar epithelial tissue.RNA sequencing coupled with literature analysis identified Wnt/β-catenin pathway as a potential candidate pathway.In the confirmatory experiment,compared to the control group,the Wnt/β-catenin pathway was activated in scar epithelial cells in the laser group 5 d post-laser intervention.After 30 d laser intervention,dermal collagen exhibited a more loosened arrangement,with reduced dermal thickness and significantly less α-smooth muscle actin(α-SMA)-positive fibroblasts compared to the control group.CollagenⅠ,collagen Ⅲ,and the relative ratio of collagen Ⅰ to Ⅲ in the laser group were at a lower level than those in the control group.Administration of the Wnt/β-catenin pathway inhibitor blocked the activation of the Wnt/β-catenin pathway induced by low-energy laser,the proliferation of scar epithelial cells and the improvement of scar profiles.Conclusion Low-energy CO2 fractional laser treatment can activate the Wnt/β-catenin pathway of scar epithelial cells,thereby activating epithelial cells and yielding significant scar improvements.
5.Tirzepatide in chronic weight management: From mechanism to clinical application
Yingying LUO ; Ziwei LIN ; Linong JI
Chinese Journal of Endocrinology and Metabolism 2025;41(7):596-600
Obesity is a common chronic disease associated with an increased risk of multiple comorbidities and premature mortality. Tirzepatide, a glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide 1 (GLP-1) receptor agonist, has demonstrated significant efficacy in multiple studies in reducing body weight and fat mass, improving body composition and metabolic parameters, lowering the risk of obesity-related complications and improving health and quality of life. This review summarizes the underlying mechanisms of tirzepatide and recent advances in its clinical research, providing a reference for clinical practice.
6.Design and considerations of cardiovascular outcomes trials in type 2 diabetes
Yingying LUO ; Rui WANG ; Linong JI
Chinese Journal of Endocrinology and Metabolism 2025;41(9):793-798
Recent large cardiovascular outcomes trials(CVOT) in patients with type 2 diabetes mellitus have demonstrated that several glucose-lowering agents provide cardiovascular benefits, advancing treatment concepts while also posing new ethical and clinical challenges for the design and conduct of future trials if traditional placebo-controlled designs are continued. In this context, conducting active-controlled CVOTs with optimized design strategies should be considered as a future research trend. This article reviews the design and clinical implications of CVOTs for glucose-lowering agents and explores potential directions for improvement, aiming to provide insights into optimized design strategies for future trials.
7.Construction of a Modern TCM Epidemic Diagnosis and Treatment System
Yingying YANG ; Jinli LUO ; Qingwei LI ; Chuanxi TIAN ; Qiang WANG ; Han WANG ; Linhua ZHAO ; Xiaolin TONG
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(11):1407-1413
Traditional Chinese medicine(TCM)has rich experience in the diagnosis and treatment of epidemics,but the basic con-cepts and diagnosis and treatment strategies of TCM for epidemics have not yet formed a common understanding.This paper preliminar-ily constructs a diagnosis and treatment system of TCM epidemics from the perspective of"type differentiation-stage differentiation-syndrome differentiation"by combing the basic concepts of the etiology,pathogenesis,and identification of epidemics,taking state-target differentiation and treatment as the general principle.First,the epidemics are divided into five types:cold epidemics,warm epi-demics,cold-damp epidemics,damp epidemics,and miscellaneous epidemics;then,according to the overall course of the epidemics,they are divided into four stages:"initial stage-peak stage-extreme stage-relapse stage",the initial stage is the stage of exterior syn-dromes,the peak stage is the stage of heat peak,the extreme stage is the stage of internal closure and external loss,and the relapse stage is the stage of recovery of the healthy qi and retreat of the evil qi;finally,on the basis of staging,combined with the syndrome char-acteristics of various epidemics(five types of background diseases)at different stages,the syndromes are divided demonstratively.Through the construction of a modern diagnosis and treatment system of TCM epidemics,the basic theoretical concepts and basic diag-nosis and treatment strategies of epidemics can be clarified,various new and emerging infectious diseases can be actively responded to,and a diagnosis and treatment plan for a new and emerging infectious disease can be quickly constructed.
8.18 F-PSMA-1007 PET/MRI for diagnosing seminal vesicle invasion of prostatic cancer
Yingying LUO ; Yihong YANG ; Zhiwen YOU ; Xing CHEN ; Zirong ZHOU ; Zengbei YUAN ; Haifeng WANG ; Jun ZHAO ; Haiyan WANG
Chinese Journal of Medical Imaging Technology 2025;41(2):310-315
Objective To observe the value of 18F-prostate specific membrane antigen(PSMA)-1007 PET/MRI for diagnosing seminal vesicle invasion(SVI)of prostatic cancer(PCa).Methods Totally 92 male patients with PCa who underwent radical prostatectomy were retrospectively enrolled and divided into positive group(n=26)and negative group(n=66)based on postoperative pathology showed SVI or not.PET/MRI parameters,including maximum standard uptake value(SUVmax),minimum apparent diffusion coefficient(ADCmin),mean apparent diffusion coefficient(ADCmean),SUVmax/ADCmin,SUVmax/ADCmean,PSMA tumor volume(PSMA-TV)and total lesion PSMA(TL-PSMA)were compared between groups.The receiver operating characteristic curve was drawn,and the efficacy of each parameter for diagnosing SVI was analyzed.Results Among 92 cases of PCa,18F-PSMA-1007 PET/MRI showed 30 cases with SVI and 62 cases without SVI,with accuracy of 73.91%,sensitivity of 61.54%,specificity of 78.79%,positive predictive value of 53.33%and negative predictive value of 83.87%.Significant differences of ADCmin,PSMA-TV and TL-PSMA were found between groups(all P<0.05).The area under the curve(AUC)of SUVmax,ADCmin,ADCmean,SUVmax/ADCmin,SUVmax/ADCmean,PSMA-TV and TL-PSMA for diagnosing SVI of PCa was 0.554,0.341,0.396,0.603,0.581,0.755 and 0.705,respectively.The AUC of PSMA-TV was higher than other parameters except for TL-PSMA,with sensitivity of 84.60%and specificity of 56.10%.Conclusion 18 F-PSMA-1007 PET/MRI was helpful for diagnosing SVI of PCa.
9.Rustic Opinion on"Reverse Spread to the Pericardium"
Jinli LUO ; Yayun WANG ; Yingying YANG ; Qingwei LI ; Ling ZHOU ; Ye MIN ; Linhua ZHAO ; Xiaolin TONG
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(4):421-424
"When warm evil is received,it first attacks the lungs and then spread to the pericardium reversely"is the general rule of warm diseases.Doctors of different dynasties have different views on the phrase"reverse spread to the pericardium",especially the word"reverse".Professor Tong Xiaolin proposed that the heart governs the mind,the pericardium and the heart are connected in qi,and when the heart is affected by evil,the pericardium instead suffers from the evil.The"reverse spread to the pericardium"proposed by Ye Tianshi is actually the spread of warm evil to the brain.Taking meningococcal meningitis as the basic disease,it can be matched one by one with the typical stages of the transmission of Wei-Qi-Ying-Xue.Combined with the theory of Dingjiao,it is believed that the function of"the heart governing the mind"focuses more on the brain in the modern anatomical sense.Combining traditional Chinese medicine's ideas on diagnosis and treatment of warm diseases with modern medicine,revealing the essence of the disease,grasping the core of the pathogenesis,analyzing the word"reverse"from a new perspective,and exploring its true meaning,is of great significance for clarifying its connotation,exploring the development laws of warm diseases,and guiding the diagnosis and treatment of warm disea-ses.
10.Rustic Opinion on"Reverse Spread to the Pericardium"
Jinli LUO ; Yayun WANG ; Yingying YANG ; Qingwei LI ; Ling ZHOU ; Ye MIN ; Linhua ZHAO ; Xiaolin TONG
Journal of Nanjing University of Traditional Chinese Medicine 2025;41(4):421-424
"When warm evil is received,it first attacks the lungs and then spread to the pericardium reversely"is the general rule of warm diseases.Doctors of different dynasties have different views on the phrase"reverse spread to the pericardium",especially the word"reverse".Professor Tong Xiaolin proposed that the heart governs the mind,the pericardium and the heart are connected in qi,and when the heart is affected by evil,the pericardium instead suffers from the evil.The"reverse spread to the pericardium"proposed by Ye Tianshi is actually the spread of warm evil to the brain.Taking meningococcal meningitis as the basic disease,it can be matched one by one with the typical stages of the transmission of Wei-Qi-Ying-Xue.Combined with the theory of Dingjiao,it is believed that the function of"the heart governing the mind"focuses more on the brain in the modern anatomical sense.Combining traditional Chinese medicine's ideas on diagnosis and treatment of warm diseases with modern medicine,revealing the essence of the disease,grasping the core of the pathogenesis,analyzing the word"reverse"from a new perspective,and exploring its true meaning,is of great significance for clarifying its connotation,exploring the development laws of warm diseases,and guiding the diagnosis and treatment of warm disea-ses.


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