1.Analysis on Current Status of Outcome Indicators in Randomized Controlled Trials of TCM Intervention in Pediatric Myocarditis
Fengye JI ; Zhongyi ZHU ; Ling WANG ; Sihui SU ; Zhaoxin ZHOU ; Xiaoxuan XIE ; Yan YANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(8):31-37
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.
2.Analysis on Registration Status of TCM Clinical Trials of Sepsis Based on WHO ICTRP and ChiCTR
Wenjing YIN ; Kai XIE ; Xinyu MIAO ; Xiaoxuan HE ; Haifeng WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(9):48-53
Objective To investigate the current status and characteristics of registered clinical trials on TCM interventions for sepsis;To provide references for relevant clinical trial registrations.Methods Clinical trials on TCM interventions for sepsis registered in the World Health Organization International Clinical Trials Registry Platform(WHO ICTRP)and the Chinese Clinical Trial Registry(ChiCTR)from inception to June 2024 were retrieved.Data on registration time,registry centers,regions,institutions,participating centers,funding sources,trial design,phase,sample size,randomization methods,blinding,interventions,disease types,and outcome measures were analyzed using Excel 16.0.Results A total of 118 TCM intervention trials for sepsis were included,registered regions involving Guangdong,Jiangsu,and Shanghai,with institutions including Guangdong Provincial Hospital of Chinese Medicine,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,and Jiangsu Provincial Hospital of Traditional Chinese Medicine.Most trials were single-center studies(94,79.66%),funded primarily by hospitals(38)and local governments(36).The majority were interventional studies(105,88.98%),with phases concentrated in pilot/exploratory studies and Phase Ⅳ trials(52).Sample sizes were mostly 60-99 cases(51).Randomized controlled trials predominantly used simple randomization(65)and double-blinding(22).Interventions mainly included empirical formulas,Chinese patent medicines,and classical prescriptions,targeting conditions such as gastrointestinal dysfunction and lung injury,with primary outcomes including SOFA,APACHE Ⅱ,and mortality rate.Conclusion The number of TCM registered clinical trials for sepsis has generally increased.There are some problems,such as uneven distribution of test areas,poor standardization and integrity of registration information,and the advantages and characteristics of TCM need to be further highlighted.
3.Mesenchymal stem cells from different sources in treatment of inflammatory bowel disease
Xiao YUAN ; Songlin LIANG ; Yanan XIE ; Dongmei GUAN ; Longyu FAN ; Xiaoxuan YIN
Chinese Journal of Tissue Engineering Research 2025;29(31):6811-6820
BACKGROUND:The incidence of inflammatory bowel disease has been steadily rising,accompanied by a lack of definitive therapeutic strategies.Recent research endeavors have illuminated the promising potential of mesenchymal stem cells in mitigating the symptoms of inflammatory bowel disease,offering a glimmer of hope for afflicted patients.OBJECTIVE:To review the mechanisms of action of mesenchymal stem cells derived from various sources in the management of inflammatory bowel disease,aiming to provide insights for future research endeavors.METHODS:Utilizing the keywords"mesenchymal stem cells,MSCs,exosomes,extracellular vesicles,EVs,inflammatory bowel disease,IBD,ulcerative colitis,UC,Crohn's disease,CD"in English and their Chinese equivalents in CNKI and PubMed databases,a total of 89 eligible articles were selected for this review.RESULTS AND CONCLUSION:Currently,six types of mesenchymal stem cells are being explored for inflammatory bowel disease therapy:bone marrow-derived mesenchymal stem cells,adipose tissue-derived mesenchymal stem cells,perinatal tissue-derived mesenchymal stem cells,induced pluripotent stem cell-derived mesenchymal stem cells,embryonic stem cell-derived mesenchymal stem cells,and gingival mesenchymal stem cells.Five administration routes have been adopted,with intravenous and intraperitoneal injections being the most prevalent,followed by local,mesenteric,and intra rectal injections.Their therapeutic mechanisms encompass differentiation,regeneration,anti-inflammatory effects,immune modulation,neuroprotection,antioxidant stress response,homing,modulation of gut microbiota,autophagy,ferroptosis,and endoplasmic reticulum stress.While sharing functional similarities,mesenchymal stem cells from different sources exhibit unique characteristics that confer them with distinct advantages and therapeutic potentials.Nevertheless,research into the specific properties of these mesenchymal stem cells remains limited,necessitating deeper exploration of their nuanced differences to optimize their therapeutic efficacy in inflammatory bowel disease.Additionally,the clinical safety of mesenchymal stem cells-based therapies warrants further observation and evaluation.
4.Level of vitamin D in children with cholestatic liver disease and its clinical features
Ziyun GUO ; Lina DU ; Xiaoxuan XIE ; Yan YANG
Journal of Clinical Hepatology 2025;41(1):99-103
ObjectiveTo investigate vitamin D level in children with cholestatic liver disease, and to provide a theoretical basis for vitamin D supplementation therapy in children with this disease. MethodsA total of 116 children with cholestatic liver disease who attended Department of Traditional Chinese Medicine, Beijing Children’s Hospital, Capital Medical University, for the first time from January 2022 to January 2024 were enrolled and divided into groups for comparison based on sex, age, vitamin D supplementation dose, course of the disease, and etiology. The data on the serum level of 25-hydroxyvitamin D (25-OH-D) and related biochemical parameters were collected to assess the correlation between vitamin D level and biochemical parameters. The chi-square test or the Fisher’s exact test was used for comparison of categorical data between groups, and the Spearman rank correlation test was used for correlation analysis. ResultsAmong the 116 children, 76 (65.5%) had vitamin D deficiency or insufficiency. The children with vitamin D deficiency or insufficiency accounted for 65.7% (46/70) among boys and 65.2% (30/46) among girls, with no significant difference between boys and girls (χ2=0.003, P=0.956). The children with vitamin D deficiency or insufficiency accounted for 83.3% (25/30) among the children who had never received vitamin D supplementation, 58.7% (27/46) among the children with a daily supplementation dose of 500 IU, 64.3% (18/28) among the children with a daily supplementation dose of 700 IU, and 50.0% (6/12) among the children with a daily supplementation dose of>700 IU, and there was no significant difference between these groups (χ2=6.460, P=0.091). Comparison between the groups with different etiologies showed that the children with vitamin D deficiency or insufficiency accounted for 57.7% (15/26) in the infectious disease group, 66.7% (10/15) in the inherited metabolic disease group, 66.7% (6/9) in the drug-induced liver injury group, 100.0% (8/8) in the group with abnormal structure of the biliary system, and 63.8% (37/58) in the group with unknown etiology, and there was no significant difference between these groups (χ2=5.304, P=0.252). Comparison between the groups with different courses of the disease showed that the children with vitamin D deficiency or insufficiency accounted for 78.4% (29/37) in the<1 month group, 54.3% (25/46) in the 1 — 3 months group, 53.3% (8/15) in the 3 — 6 months group, and 77.8% (14/18) in the>6 months group, with no significant difference between these groups (χ2=7.432, P=0.059). Comparison between different age groups showed that compared with the infant group, the children group had a significantly higher proportion of children with vitamin D deficiency or insufficiency (χ2=9.504, P=0.018). The correlation analysis showed that serum aspartate aminotransferase and alanine aminotransferase had no significant correlation with 25-OH-D (P>0.05); serum alkaline phosphatase (ALP) (r=-0.286, P=0.002), gamma-glutamyl transpeptidase (GGT) (r=-0.248, P=0.007), total bilirubin (TBil) (r=-0.353, P<0.001), direct bilirubin (DBil) (r=-0.299, P=0.001), and total bile acid (r=-0.236, P=0.011) were negatively correlated with 25-OH-D, while serum calcium (r=0.263, P=0.004) and phosphorus (r=0.385, P<0.001) were positively correlated with 25-OH-D. ConclusionMost children with cholestatic liver disease have vitamin D deficiency or insufficiency, and the increase in serum ALP, GGT, TBil, DBil or total bile acid and the reduction in calcium or phosphorus may suggest vitamin D deficiency or insufficiency.
5.Regularity of prescriptions for epidemic disease in Taiping Huimin Heji Ju Fang based on latent structure combined with association rules
Wenjing YIN ; Kai XIE ; Xinyu MIAO ; Xiaoxuan HE ; Haifeng WANG
Chinese Journal of Pharmacoepidemiology 2025;34(6):666-675
Objective To explore the regularity of prescriptions for epidemic disease in Taiping Huimin Heji Ju Fang based on the latent structure model and association rules analysis,and to provide references for modern epidemic treatment.Methods Prescriptions for epidemic diseases were extracted from Taiping Huimin Heji Ju Fang.A high-frequency herb matrix(frequency≥10)was constructed,and high-frequency herbs were analyzed using MicrosoftExcel 2016,Lantern 5.0,and IBM SPSS Modeler 18.0 for efficacy classification,property/flavor/channel tropism statistics,latent structure modeling,and association rule analysis.Results Among the 200 collected herbal prescriptions,46 high-frequency medicinal materials were identified,such as licorice,fresh ginger,dried ginger,poriae,and ginseng.The top 3 drugs efficacy were tonifying deficiency,relieving surface and warming inner.The medicinal properties were mainly warm,and the medicinal flavors were pungent,bitter,and sweet.The meridian tropisms mainly included the spleen meridian,lung meridian and stomach meridian.The analysis of latent structure model suggested that there were 8 types of common symptoms of epidemic disease,such as wind evil attack exterior,wind-cold-dampness,wind-heat,excess-heat in triple energizer,dampness inhibits qi stagnation,yang deficiency,blockage and spleen-qi deficiency.Theanalysis of association rules obtained licorice-ephedra and licorice-atractylodes,which with a core of licorice medicine,and the 16 association rules such as dried ginger-cinnamon,pericarpium citri reticulatae-mangnolia officinalis and poriae-ginseng-atractylodes macrocephala after eliminating ginger,jujube and licorice.Conclusion Most of the medicines used in the treatment of epidemic diseases in Taiping Huimin Heji Ju Fang are pungent,bitter and dispelling evil,the treatment should follow the principle of dispelling evil,warming yang to dissipate cold,dispelling dampness,clearing heat and expelling fire,inducing resuscitation,supporting the right and supplementing deficiency,which embodies the treatment principle of dispelling evil and supporting right,and provides reference and ideas for the treatment of clinical diseases based on syndrome differentiation.
6.Mesenchymal stem cells from different sources in treatment of inflammatory bowel disease
Xiao YUAN ; Songlin LIANG ; Yanan XIE ; Dongmei GUAN ; Longyu FAN ; Xiaoxuan YIN
Chinese Journal of Tissue Engineering Research 2025;29(31):6811-6820
BACKGROUND:The incidence of inflammatory bowel disease has been steadily rising,accompanied by a lack of definitive therapeutic strategies.Recent research endeavors have illuminated the promising potential of mesenchymal stem cells in mitigating the symptoms of inflammatory bowel disease,offering a glimmer of hope for afflicted patients.OBJECTIVE:To review the mechanisms of action of mesenchymal stem cells derived from various sources in the management of inflammatory bowel disease,aiming to provide insights for future research endeavors.METHODS:Utilizing the keywords"mesenchymal stem cells,MSCs,exosomes,extracellular vesicles,EVs,inflammatory bowel disease,IBD,ulcerative colitis,UC,Crohn's disease,CD"in English and their Chinese equivalents in CNKI and PubMed databases,a total of 89 eligible articles were selected for this review.RESULTS AND CONCLUSION:Currently,six types of mesenchymal stem cells are being explored for inflammatory bowel disease therapy:bone marrow-derived mesenchymal stem cells,adipose tissue-derived mesenchymal stem cells,perinatal tissue-derived mesenchymal stem cells,induced pluripotent stem cell-derived mesenchymal stem cells,embryonic stem cell-derived mesenchymal stem cells,and gingival mesenchymal stem cells.Five administration routes have been adopted,with intravenous and intraperitoneal injections being the most prevalent,followed by local,mesenteric,and intra rectal injections.Their therapeutic mechanisms encompass differentiation,regeneration,anti-inflammatory effects,immune modulation,neuroprotection,antioxidant stress response,homing,modulation of gut microbiota,autophagy,ferroptosis,and endoplasmic reticulum stress.While sharing functional similarities,mesenchymal stem cells from different sources exhibit unique characteristics that confer them with distinct advantages and therapeutic potentials.Nevertheless,research into the specific properties of these mesenchymal stem cells remains limited,necessitating deeper exploration of their nuanced differences to optimize their therapeutic efficacy in inflammatory bowel disease.Additionally,the clinical safety of mesenchymal stem cells-based therapies warrants further observation and evaluation.
7.Regularity of prescriptions for epidemic disease in Taiping Huimin Heji Ju Fang based on latent structure combined with association rules
Wenjing YIN ; Kai XIE ; Xinyu MIAO ; Xiaoxuan HE ; Haifeng WANG
Chinese Journal of Pharmacoepidemiology 2025;34(6):666-675
Objective To explore the regularity of prescriptions for epidemic disease in Taiping Huimin Heji Ju Fang based on the latent structure model and association rules analysis,and to provide references for modern epidemic treatment.Methods Prescriptions for epidemic diseases were extracted from Taiping Huimin Heji Ju Fang.A high-frequency herb matrix(frequency≥10)was constructed,and high-frequency herbs were analyzed using MicrosoftExcel 2016,Lantern 5.0,and IBM SPSS Modeler 18.0 for efficacy classification,property/flavor/channel tropism statistics,latent structure modeling,and association rule analysis.Results Among the 200 collected herbal prescriptions,46 high-frequency medicinal materials were identified,such as licorice,fresh ginger,dried ginger,poriae,and ginseng.The top 3 drugs efficacy were tonifying deficiency,relieving surface and warming inner.The medicinal properties were mainly warm,and the medicinal flavors were pungent,bitter,and sweet.The meridian tropisms mainly included the spleen meridian,lung meridian and stomach meridian.The analysis of latent structure model suggested that there were 8 types of common symptoms of epidemic disease,such as wind evil attack exterior,wind-cold-dampness,wind-heat,excess-heat in triple energizer,dampness inhibits qi stagnation,yang deficiency,blockage and spleen-qi deficiency.Theanalysis of association rules obtained licorice-ephedra and licorice-atractylodes,which with a core of licorice medicine,and the 16 association rules such as dried ginger-cinnamon,pericarpium citri reticulatae-mangnolia officinalis and poriae-ginseng-atractylodes macrocephala after eliminating ginger,jujube and licorice.Conclusion Most of the medicines used in the treatment of epidemic diseases in Taiping Huimin Heji Ju Fang are pungent,bitter and dispelling evil,the treatment should follow the principle of dispelling evil,warming yang to dissipate cold,dispelling dampness,clearing heat and expelling fire,inducing resuscitation,supporting the right and supplementing deficiency,which embodies the treatment principle of dispelling evil and supporting right,and provides reference and ideas for the treatment of clinical diseases based on syndrome differentiation.
8.Analysis on Current Status of Outcome Indicators in Randomized Controlled Trials of TCM Intervention in Pediatric Myocarditis
Fengye JI ; Zhongyi ZHU ; Ling WANG ; Sihui SU ; Zhaoxin ZHOU ; Xiaoxuan XIE ; Yan YANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(8):31-37
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.
9.Analysis on Registration Status of TCM Clinical Trials of Sepsis Based on WHO ICTRP and ChiCTR
Wenjing YIN ; Kai XIE ; Xinyu MIAO ; Xiaoxuan HE ; Haifeng WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(9):48-53
Objective To investigate the current status and characteristics of registered clinical trials on TCM interventions for sepsis;To provide references for relevant clinical trial registrations.Methods Clinical trials on TCM interventions for sepsis registered in the World Health Organization International Clinical Trials Registry Platform(WHO ICTRP)and the Chinese Clinical Trial Registry(ChiCTR)from inception to June 2024 were retrieved.Data on registration time,registry centers,regions,institutions,participating centers,funding sources,trial design,phase,sample size,randomization methods,blinding,interventions,disease types,and outcome measures were analyzed using Excel 16.0.Results A total of 118 TCM intervention trials for sepsis were included,registered regions involving Guangdong,Jiangsu,and Shanghai,with institutions including Guangdong Provincial Hospital of Chinese Medicine,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,and Jiangsu Provincial Hospital of Traditional Chinese Medicine.Most trials were single-center studies(94,79.66%),funded primarily by hospitals(38)and local governments(36).The majority were interventional studies(105,88.98%),with phases concentrated in pilot/exploratory studies and Phase Ⅳ trials(52).Sample sizes were mostly 60-99 cases(51).Randomized controlled trials predominantly used simple randomization(65)and double-blinding(22).Interventions mainly included empirical formulas,Chinese patent medicines,and classical prescriptions,targeting conditions such as gastrointestinal dysfunction and lung injury,with primary outcomes including SOFA,APACHE Ⅱ,and mortality rate.Conclusion The number of TCM registered clinical trials for sepsis has generally increased.There are some problems,such as uneven distribution of test areas,poor standardization and integrity of registration information,and the advantages and characteristics of TCM need to be further highlighted.
10.Role of apical sodium-dependent bile acid transporter in hepatobiliary diseases
Xiaoxuan XIE ; Lina DU ; Ziyun GUO ; Yan YANG
Journal of Clinical Hepatology 2024;40(1):199-203
Apical sodium-dependent bile acid transporter (ASBT) is a key transporter responsible for intestinal reabsorption of bile acid and plays an important role in maintaining bile acid and cholesterol homeostasis, and its expression is regulated by various factors including transcription factors, nuclear receptors, and intestinal microflora. The abnormal expression and function of ASBT can lead to disorders in the metabolism of bile acid and cholesterol, causing a variety of hepatobiliary diseases. At present, ASBT has attracted wide attention as a therapeutic target. This article elaborates on the biological characteristics and expression regulation mechanism of ASBT and reviews the role of ASBT in hepatobiliary diseases, in order to provide a new direction for the treatment of related diseases.

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