ObjectiveTo systematically evaluate the methodological quality and measurement properties of traditional Chinese medicine （TCM） syndrome efficacy evaluation scales， and to provide evidence-based references for selecting high-quality assessment tools in TCM clinical practice. MethodsChina National Knowledge Infrastructure （CNKI）， Wanfang Data， VIP Database， Chinese Biomedical Literature Database （CBM）， PubMed， the Cochrane Library， Embase， and Web of Science were searched from inception to April 2， 2025， for studies evaluating the measurement properties of TCM syndrome efficacy evaluation scales. Data were extracted， and the methodological quality and measurement properties of the included scales were assessed according to the consensus-based standards for the selection of health measurement instruments （COSMIN）. Recommendation levels were formulated based on the grading of evidence. ResultsA total of 46 studies were included， involving 22 generic syndrome efficacy evaluation scales and 24 disease-specific syndrome efficacy evaluation scales. None of the scales reported cross-cultural validity or measurement error. According to the recommendation grades， 2 scales met Grade A recommendations and are suggested for clinical use； 38 scales were classified as Grade B， indicating potential applicability but requiring further validation； and 6 scales were classified as Grade C， suggesting the need for further refinement. ConclusionExisting TCM syndrome efficacy evaluation scales exhibit substantial variability in methodological quality， incomplete reporting of measurement properties， and insufficient attention to scale revision. Future efforts should emphasize standardized design in the development of TCM syndrome scales， strengthen validation procedures for key measurement properties， and prioritize dynamic revision of scales， thereby providing high-quality tools to support the precise evaluation of syndrome efficacy.

By systematically reviewing the concept evolution of pre-chronic obstructive pulmonary disease （pre-COPD） and the research status of traditional Chinese medicine （TCM）， as well as considering the clinical practice， this paper puts forward the strategies for the prevention and treatment of pre-COPD with TCM. These strategies include identifying high-risk groups by combining TCM syndrome and constitution， advocating the principle of "treating disease before it arises" and promoting the combination of syndrome differentiation and constitution evaluation to achieve individualized intervention， promoting collaboration between TCM and western medicine， supported by digital and intelligent technologies， to establish a whole-process management mode of "hospital-community-family". The aim is to realize the early diagnosis， early intervention and whole-process management of pre-COPD， thereby helping reduce the incidence of COPD.

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.

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.

AIM:To investigate the effects of the Qingfei-Jiedu-Huatan formula(QJHF)on damage to the lung vascular endothelial barrier induced by Klebsiella pneumoniae in mice with severe pneumonia,as well as to elucidate its underlying mechanisms.METHODS:Fifty-one C57BL/6J mice were randomly divided into control group(n=6),model group(n=15),QJHF group(n=15),and ceftriaxone sodium(CRO)group(n=15).Severe pneumonia was in-duced in the mice by a single tracheal intubation with 50 μL of 1×1011 CFU/mL Klebsiella pneumoniae on day 0.Six hours after modeling,the mice in QJHF and CRO groups received their respective treatments,while those in control and model groups were administered an equal volume of saline.All mice were sacrificed on day 3 after the end of gavage.Lung histo-pathological changes were assessed using hematoxylin-eosin(HE)staining.Levels of tumor necrosis factor-α(TNF-α),interleukin-1β(IL-1β),and IL-6 in lung tissues were measured by enzyme-linked immunosorbent assay(ELISA).Flow cytometry was used to detect CD11b+Ly6g+cells in bronchoalveolar lavage fluid(BALF).Proteomics and network pharma-cology analyses were conducted to elucidate the mechanisms of drug action.Western blot was conducted to assess the ex-pression levels of vascular endothelial cadherin(VE-cadherin),zonula occludens-1(ZO-1),occludin,vascular endothe-lial growth factor(VEGF),P38 mitogen-activated protein kinase(P38),and phosphorylated P38(p-P38)in lung tis-sues.RESULTS:Treatment with QJHF significantly attenuated the symptoms such as mental status and respiratory dis-tress,reduced mortality,mitigated lung tissue lesions,and decreased levels of IL-6,TNF-α,IL-1β,as well as BALF to-tal protein concentration,total cell count and neutrophil content in a mouse model of severe pneumonia(P＜0.05 or P＜0.01).Additionally,QJHF increased the expression of VE-cadherin,ZO-1 and occludin proteins in lung tissues.Pro-teomic analysis demonstrated that QJHF modulated the expression of 129 proteins in the lung tissues of mice suffering from severe pneumonia.Network pharmacology identified 328 potential targets associated with 14 major bioactive components of QJHF and 1 665 genes related to severe pneumonia,with 125 overlapping genes between the two datasets.The construc-tion of a protein-protein interaction(PPI)network,along with Gene Ontology(GO)and Kyoto Encyclopedia of Genes and Genomes(KEGG)enrichment analyses of the regulated proteins and overlapping genes,indicated that QJHF primarily in-fluenced the PI3K-Akt,MAPK and Rap1 signaling pathways,as well as VEGFR.Western blot analysis showed that QJHF significantly inhibited the expression of VEGF and P38 in lung tissues(P＜0.05 or P＜0.01).CONCLUSION:Treatment with QJHF attenuates severe pneumonia in mice,potentially by inhibiting VEGF/P38 signaling to protect the vascular endothelial barrier.

Objective To provide methodological examples for related research,the influencing factors of the evolution of Qi deficiency syndrome in chronic obstructive pulmonary disease(COPD)based on a nonlinear mixed effects model was explored.Methods A research questionnaire on the influencing factors of the evolution of Qi deficiency syndrome in chronic obstructive pulmonary disease was developed,and clinical data of 650 COPD patients on the 1st and 14th day of acute exacerbation,the 1st and 28th day of risk window,the first day of stable period,and the 90th day were dynamically collected from 10 tertiary hospitals across the country.8 baseline data including gender and age were collected through the PROC NLMIXED process by SAS 9.4 software.Coronary heart disease,diabetes and hypertension accounted for the highest proportion.Nine concurrent syndromes including wind cold syndrome and phlegm heat syndrome were used as fixed effects,and individual level was used as random effects to gradually fit the model and screen the influencing factors of Qi deficiency syndrome in the entire process of disease occurrence and development.Results A total of 637 eligible cases were included,and clinical datas were dynamically collected on the 1st and 14th day of acute exacerbation,the 1st and 28th day of the risk window,the 1st and 90th day of the stable period.It was found that the number of acute exacerbations,alcohol consumption,concomitant hypertension,coronary heart disease,blood stasis syndrome,yin deficiency syndrome,yang deficiency syndrome,6-minute walking distance,and the modified Medical Research Council Dyspnea Questionnaire(mMRC)had an impact on the evolution of Qi deficiency syndrome in the previous year(P<0.05).Conclusion The use of a nonlinear mixed effects model revealed the relevant factors affecting the evolution of Qi deficiency syndrome from complex multi temporal dynamic data,providing methodological references for other related studies.

Objective To provide methodological examples for related research,the influencing factors of the evolution of Qi deficiency syndrome in chronic obstructive pulmonary disease(COPD)based on a nonlinear mixed effects model was explored.Methods A research questionnaire on the influencing factors of the evolution of Qi deficiency syndrome in chronic obstructive pulmonary disease was developed,and clinical data of 650 COPD patients on the 1st and 14th day of acute exacerbation,the 1st and 28th day of risk window,the first day of stable period,and the 90th day were dynamically collected from 10 tertiary hospitals across the country.8 baseline data including gender and age were collected through the PROC NLMIXED process by SAS 9.4 software.Coronary heart disease,diabetes and hypertension accounted for the highest proportion.Nine concurrent syndromes including wind cold syndrome and phlegm heat syndrome were used as fixed effects,and individual level was used as random effects to gradually fit the model and screen the influencing factors of Qi deficiency syndrome in the entire process of disease occurrence and development.Results A total of 637 eligible cases were included,and clinical datas were dynamically collected on the 1st and 14th day of acute exacerbation,the 1st and 28th day of the risk window,the 1st and 90th day of the stable period.It was found that the number of acute exacerbations,alcohol consumption,concomitant hypertension,coronary heart disease,blood stasis syndrome,yin deficiency syndrome,yang deficiency syndrome,6-minute walking distance,and the modified Medical Research Council Dyspnea Questionnaire(mMRC)had an impact on the evolution of Qi deficiency syndrome in the previous year(P<0.05).Conclusion The use of a nonlinear mixed effects model revealed the relevant factors affecting the evolution of Qi deficiency syndrome from complex multi temporal dynamic data,providing methodological references for other related studies.

Objective To explore the correlation between different syndromes of sepsis and laboratory parameters,SOFA score,and APACHE Ⅱ score,providing reference for improving the objectivity of traditional Chinese medicine syndrome differentiation.Methods Based on the cross-sectional survey,information of the four diagnostic methods of traditional Chinese medicine,laboratory parameters,and disease assessment scales were collected from sepsis patients admitted to ICUs in 8 hospitals across the country.ANOVA,non-parametric tests,and Logistic regression analysis were used to screen for sepsis syndrome related factors.Results A total of 905 sepsis patients were included,and the distributions of traditional Chinese medicine syndromes were as follows:163(18.01%)of phlegm heat obstructing the lungs syndrome,141(15.58%)of blood stasis and toxin obstruction(damage)syndrome,130(14.36%)of intense exuberant heat toxin syndrome,129(14.25%)of Yin exhaustion and Yang deficiency syndrome,124(13.70%)of Yangming fu-organ excess syndrome,96(10.61%)of lung Qi deficiency syndrome,68(7.51%)of Yin deficiency and internal heat syndrome,and 54(5.97%)of Qi and blood deficiency syndrome.The results of ANOVA and non-parametric tests showed that there were differences in 14 indicators,including body temperature,heart rate,WBC,NE%,PCT,CRP,PLT,D-D,APTT,Lac,HCT,Hb,SOFA score,APACHE Ⅱ score among 8 common syndromes(P<0.05);Using the 14 indicators mentioned above as independent variables,and syndrome as the dependent variable,Logistic regression analysis was conducted.The results showed that in the excess syndrome category:①Phlegm heat obstructing lung syndrome was positively correlated with heart rate and WBC,and negatively correlated with Lac and APACHE Ⅱ scores;②Intense exuberant heat toxin syndrome was positively correlated with body temperature,WBC,NE%,PCT,CRP,and negatively correlated with PLT and SOFA scores;③Yangming fu-organ excess syndrome was positively correlated with body temperature and negatively correlated with PCT;④Blood stasis and toxin obstruction(damage)syndrome was positively correlated with body temperature,NE%,PLT,CRP,and D-D,and negatively correlated with heart rate,WBC,PCT,and APTT.Deficiency syndrome category:①Lung Qi deficiency syndrome was positively correlated with Hb,and negatively correlated with body temperature,WBC,and HCT;②Yin deficiency and internal heat syndrome were negatively correlated with NE%and CRP;③Qi and blood deficiency syndrome was positively correlated with APACHE Ⅱ score,and negatively correlated with body temperature,Hb,PLT,D-D;④Yin exhaustion and Yang deficiency syndrome was positively correlated with heart rate,PCT,Lac,SOFA score,and APACHE Ⅱ score,and negatively correlated with body temperature.Conclusion Patients with sepsis with excess syndrome category have higher WBC,NE%,PCT,CRP scores,which suggests a drastic inflammatory response.Among them,Blood stasis and toxin obstruction(damage)syndrome have highest PLT,D-D,and lowest APTT,suggesting a more severe disorder of coagulation function.Deficiency syndrome category,especially patients with Yin exhaustion and Yang prostration syndrome has higher Lac and SOFA score and APACHE Ⅱ score than other patients with sepsis of other syndromes,suggesting a worse condition and poor prognosis.

Objective Cigarette smoke(CS)exposure combined with Klebsiella pneumoniae(KP)infection in mice was used to establish a model of chronic obstructive pulmonary disease(COPD)to investigate the mechanism of airway remodeling.Methods Male BALB/c mice were randomly divided into a Control group,CS group,KP group,and CS+KP group.The mice were exposed to CS,KP,and CS+KP from weeks 1 to 8,and were sacrificed in weeks 4,8,16,and 24.MV,Penh,MLI,MAN,and changes in lung pathological structure were detected.The expression levels of IL-1β and TNF-α in lung tissue were detected by ELISA.Collagen deposition was observed by Masson staining and immunohistochemistry.α-SMA and TGF-β1 expression in lung tissue was detected by immunofluorescence.Human bronchial epithelioid cells(16HBE)were also stimulated by CS and lipopolysaccharide(LPS)in vitro,and the expression levels of airway epithelial junction proteins,autophagy-related protein,and mTOR signaling proteins were detected.Results Compared with the Control group,the CS+KP group mice had significantly decreased MV from weeks 4 to 24(P＜0.05 or P＜0.01)and significantly increased Penh from weeks 8 to 24(P＜0.05 or P＜0.01);while the CS group had markedly decreased MV and markedly increased Penh from weeks 8 to 16(P＜0.05 or P＜0.01).Compared with the Control group,massive inflammatory cell infiltration,alveolar wall thickening,alveolar rupture and fusion,and airway wall thickening were observed by HE staining in CS+KP group from weeks 4 to 24.The CS+KP group mice had significantly decreased MAN and significantly increased MLI,IL-1β and TNF-α in their lung tissue from weeks 4 to 24(P＜0.05 or P＜0.01).The aforementioned inflammation and tissue damage were observed in the CS group and the KP group from week 8 to 16.Compared with the Control group,COL Ⅰ,COL Ⅲ,α-SMA,and TGF-β1 were significantly increased in lung tissue of mice in the CS+KP group from weeks 8 to 16(P＜0.01);COL Ⅰ was significantly increased in the CS group and KP group from weeks 8 to 16(P＜0.01).In addition,increased E-cad and decreased N-cad(P＜0.05);significantly decreased LC3B and Beclin-1(P＜0.05);and significantly increased p-mTORC1,p-P70-S6K,and p-4E-BP1 expression were observed in 16HBE cells exposed to CS and LPS(P＜0.05 or P＜0.01).Conclusion Pulmonary functional decline,pathological changes in lung tissue,and airway remodeling appeared to occur early and persist in COPD mice induced by CS and KP.The mechanisms may be related to the activation of mTORC1 signaling pathway and subsequent inhibition of autophagy.

Objective To explore the correlation between different syndromes of sepsis and laboratory parameters,SOFA score,and APACHE Ⅱ score,providing reference for improving the objectivity of traditional Chinese medicine syndrome differentiation.Methods Based on the cross-sectional survey,information of the four diagnostic methods of traditional Chinese medicine,laboratory parameters,and disease assessment scales were collected from sepsis patients admitted to ICUs in 8 hospitals across the country.ANOVA,non-parametric tests,and Logistic regression analysis were used to screen for sepsis syndrome related factors.Results A total of 905 sepsis patients were included,and the distributions of traditional Chinese medicine syndromes were as follows:163(18.01%)of phlegm heat obstructing the lungs syndrome,141(15.58%)of blood stasis and toxin obstruction(damage)syndrome,130(14.36%)of intense exuberant heat toxin syndrome,129(14.25%)of Yin exhaustion and Yang deficiency syndrome,124(13.70%)of Yangming fu-organ excess syndrome,96(10.61%)of lung Qi deficiency syndrome,68(7.51%)of Yin deficiency and internal heat syndrome,and 54(5.97%)of Qi and blood deficiency syndrome.The results of ANOVA and non-parametric tests showed that there were differences in 14 indicators,including body temperature,heart rate,WBC,NE%,PCT,CRP,PLT,D-D,APTT,Lac,HCT,Hb,SOFA score,APACHE Ⅱ score among 8 common syndromes(P<0.05);Using the 14 indicators mentioned above as independent variables,and syndrome as the dependent variable,Logistic regression analysis was conducted.The results showed that in the excess syndrome category:①Phlegm heat obstructing lung syndrome was positively correlated with heart rate and WBC,and negatively correlated with Lac and APACHE Ⅱ scores;②Intense exuberant heat toxin syndrome was positively correlated with body temperature,WBC,NE%,PCT,CRP,and negatively correlated with PLT and SOFA scores;③Yangming fu-organ excess syndrome was positively correlated with body temperature and negatively correlated with PCT;④Blood stasis and toxin obstruction(damage)syndrome was positively correlated with body temperature,NE%,PLT,CRP,and D-D,and negatively correlated with heart rate,WBC,PCT,and APTT.Deficiency syndrome category:①Lung Qi deficiency syndrome was positively correlated with Hb,and negatively correlated with body temperature,WBC,and HCT;②Yin deficiency and internal heat syndrome were negatively correlated with NE%and CRP;③Qi and blood deficiency syndrome was positively correlated with APACHE Ⅱ score,and negatively correlated with body temperature,Hb,PLT,D-D;④Yin exhaustion and Yang deficiency syndrome was positively correlated with heart rate,PCT,Lac,SOFA score,and APACHE Ⅱ score,and negatively correlated with body temperature.Conclusion Patients with sepsis with excess syndrome category have higher WBC,NE%,PCT,CRP scores,which suggests a drastic inflammatory response.Among them,Blood stasis and toxin obstruction(damage)syndrome have highest PLT,D-D,and lowest APTT,suggesting a more severe disorder of coagulation function.Deficiency syndrome category,especially patients with Yin exhaustion and Yang prostration syndrome has higher Lac and SOFA score and APACHE Ⅱ score than other patients with sepsis of other syndromes,suggesting a worse condition and poor prognosis.