Objective To summarize the current status of outcome indicators in randomized controlled trials of TCM intervention in pediatric myocarditis,to explore the existing problems,and to provide a reference for the construction of a core set of indicators for the treatment of pediatric myocarditis with TCM.Methods Randomized controlled trial literature on the treatment of pediatric myocarditis with TCM was retrieved from CNKI,Wanfang Data,VIP,SinoMed,PubMed,Embase,Cochrane Library and Web of Science from the establishment of the databases to 16th,Nov.2024.The basic characteristics,diagnostic criteria,TCM evidence,interventions and outcome indicators of the studies were extracted.The risk of bias was assessed for the selected studies using the Cochrane Collaboration's risk of bias tool(RoB 2.0),and the outcome indicators were statistically analyzed using Excel 2019.Results Finally,totally of 250 articles were included in the literature.The outcome indicators were counted to obtain 187 outcome indicators with a cumulative total of 1 540 occurrences,which were categorized into six indicator domains:symptoms and signs,physicochemical testing,TCM symptoms/signs,clinical efficacy evaluation,safety evaluation and quality of life evaluation;among them,the physicochemical testing indicators(112 types,926 times)had the highest frequency of occurrences,followed by the clinical efficacy evaluation(13 types.340 times),and safety evaluation(24 types,193 times).Conclusion The overall quality of randomized controlled trials of TCM treatment of pediatric myocarditis is low,and there are problems with primary and secondary differentiation of outcome indicators and lack of TCM characteristics.There is an urgent need to improve the core set of endpoint indicators that highlight the characteristics of TCM in order to improve the quality of clinical research.

Objective:To analyze the registration status of clinical trials of TCM treatment for functional dyspepsia (FD); To provide references for relevant clinical trial registration and implementation.Methods:The clinical registration trials of TCM for the treatment of FD were retrieved from ChiCTR and clinicaltrials.gov until January 1st, 2025. Excel 2019 was used to extract and analyze study characteristics, including basic information (registration time, country/region, institution, funding source), study features and quality (study type, trial design, phase, number of centers, sample size, interventions, outcome measures, methodological quality, reporting quality), as well as recruitment status and ethical review.Results:A total of 89 registered studies were included. Registration began in 2008 with 3 studies, peaking in 2021 with 14 studies. The studies involved 6 countries, with domestic trials covering 18 provincial-level regions in China and 52 clinical trial institutions. Primary funding sources were national funding and pharmaceutical company support. Most studies were interventional with randomized parallel-controlled designs, commonly using simple randomization. Post-marketing drug trials were the most frequent phase, and single-center trials predominated, involving a total sample size of 19 776 cases. Common interventions included acupuncture/massage and Chinese patent medicines. Frequently used outcome measures were effectiveness rate, symptom evaluation, and quality of life assessment, though issues existed with non-standardized reporting and lack of TCM-specific indicators. Methodological quality needed further improvement.Conclusions:Although the number of registered clinical trials of TCM treatment for FD has increased, the overall quantity remains insufficient. Researchers should emphasize optimization of registration details and study protocols to further enhance registration quality.

Objective To explore the distribution law of TCM syndromes in children with severe mycoplasma pneumoniae pneumonia(SMPP)based on factor analysis and clustering analysis;To provide references for accurately identifying this disease.Methods General data,symptoms,signs and tongue and pulse were retrospectively collected from 408 children with SMPP who were hospitalized in the Department of Traditional Chinese Medicine of Beijing Children's Hospital,Capital Medical University between September 2019 and November 2023.The relevant clinical information was extracted and entered into the Excel 2019 database,and SPSS 27.0 was used to perform factor analysis.The sample of 408 cases was subjected to K-means clustering analysis,and finally,the distribution of TCM syndromes was derived.Results Factor analysis screened five common factors with eigenvalue>1,and its cumulative contribution rate was 63.063%;clustering analysis co-classified four types of syndromes,among which phlegm-heat-closure lung syndrome,toxic-heat-closure lung syndrome,lung-spleen-qi deficiency syndrome and healthy qi deficiency and pathogens attachment syndrome accounted for 39.22%,32.35%,15.20%and 12.75%,respectively.Conclusion Pediatric SMPP is characterized by toxic heat,qi deficiency,phlegm-heat,damp-heat and yin deficiency,and the disease is located in lungs,spleen and heart;TCM syndromes are characterized by phlegm-heat-closure lung,toxic-heat-closure lung,healthy qi deficiency and pathogens attachment and lung-spleen-qi deficiency,with phlegm-heat-closure lung syndrome and toxic-heat-closure lung syndrome being the most common syndromes.

Objective To explore the distribution law of TCM syndromes in children with severe mycoplasma pneumoniae pneumonia(SMPP)based on factor analysis and clustering analysis;To provide references for accurately identifying this disease.Methods General data,symptoms,signs and tongue and pulse were retrospectively collected from 408 children with SMPP who were hospitalized in the Department of Traditional Chinese Medicine of Beijing Children's Hospital,Capital Medical University between September 2019 and November 2023.The relevant clinical information was extracted and entered into the Excel 2019 database,and SPSS 27.0 was used to perform factor analysis.The sample of 408 cases was subjected to K-means clustering analysis,and finally,the distribution of TCM syndromes was derived.Results Factor analysis screened five common factors with eigenvalue>1,and its cumulative contribution rate was 63.063%;clustering analysis co-classified four types of syndromes,among which phlegm-heat-closure lung syndrome,toxic-heat-closure lung syndrome,lung-spleen-qi deficiency syndrome and healthy qi deficiency and pathogens attachment syndrome accounted for 39.22%,32.35%,15.20%and 12.75%,respectively.Conclusion Pediatric SMPP is characterized by toxic heat,qi deficiency,phlegm-heat,damp-heat and yin deficiency,and the disease is located in lungs,spleen and heart;TCM syndromes are characterized by phlegm-heat-closure lung,toxic-heat-closure lung,healthy qi deficiency and pathogens attachment and lung-spleen-qi deficiency,with phlegm-heat-closure lung syndrome and toxic-heat-closure lung syndrome being the most common syndromes.

Objective To summarize the current status of outcome indicators in randomized controlled trials of TCM intervention in pediatric myocarditis,to explore the existing problems,and to provide a reference for the construction of a core set of indicators for the treatment of pediatric myocarditis with TCM.Methods Randomized controlled trial literature on the treatment of pediatric myocarditis with TCM was retrieved from CNKI,Wanfang Data,VIP,SinoMed,PubMed,Embase,Cochrane Library and Web of Science from the establishment of the databases to 16th,Nov.2024.The basic characteristics,diagnostic criteria,TCM evidence,interventions and outcome indicators of the studies were extracted.The risk of bias was assessed for the selected studies using the Cochrane Collaboration's risk of bias tool(RoB 2.0),and the outcome indicators were statistically analyzed using Excel 2019.Results Finally,totally of 250 articles were included in the literature.The outcome indicators were counted to obtain 187 outcome indicators with a cumulative total of 1 540 occurrences,which were categorized into six indicator domains:symptoms and signs,physicochemical testing,TCM symptoms/signs,clinical efficacy evaluation,safety evaluation and quality of life evaluation;among them,the physicochemical testing indicators(112 types,926 times)had the highest frequency of occurrences,followed by the clinical efficacy evaluation(13 types.340 times),and safety evaluation(24 types,193 times).Conclusion The overall quality of randomized controlled trials of TCM treatment of pediatric myocarditis is low,and there are problems with primary and secondary differentiation of outcome indicators and lack of TCM characteristics.There is an urgent need to improve the core set of endpoint indicators that highlight the characteristics of TCM in order to improve the quality of clinical research.