1.Status of clinical trial registration for obesity among children and adolescents
LIANG Chenchen, ZHU Zhongyi, ZHANG Haoran, YANG Yan
Chinese Journal of School Health 2025;46(12):1760-1764
Objective:
To analyze the current status of clinical trial registration for childhood and adolescent obesity, so as to provide insights for the registration and implementation of related trials.
Methods:
ClinicalTrials.gov and the ChiCTR database were searched for obesity related clinical trial registrations up to 1 June 2025. Data included basic characteristics (registration region, date, funding source, status, sample size), trial design features, participant demographics, interventions, outcome measures, methodology, and reporting quality. Statistical and descriptive analyses were conducted.
Results:
A total of 1 450 registered studies were included, covering 59 regions globally. North America hosted the highest number of registrations (876, 60.41%), with the United States accounting for the largest share (771, 53.17%). The earliest registered study dated to 1985, while 2016 saw the highest annual registrations ( n =87). Funding sources predominantly originated from universities (834 studies, 57.52%). Currently, completed trials accounted for the majority (1 003 trials, 69.17%). Globally, the majority of studies employed sample sizes within the 11-50 range (331 studies, 22.83%). Interventional studies predominated in design type (1 186, 81.79%), predominantly employing randomized parallel group controlled trials. Main interventions included comprehensive lifestyle interventions, physical activity and exercise interventions, and diet and nutrition interventions. High frequency outcome indicators primarily involved body composition and anthropometric measurements, metabolic and biochemical indicators, etc. Methodology and reporting quality required improvement.
Conclusions
The registration of clinical trials related to childhood and adolescent obesity globally shows a positive development trend, but issues of regional imbalance and methodological limitations exist. It is necessary to strengthen clinical trial registration norms, optimize study designs, and focus on the innovation of interventions and the systematicity of outcome indicators.
2.Analysis on the current status of clinical trial registration of the TCM treatment for functional dyspepsia
Zhongyi ZHU ; Guowei PU ; Fengye JI ; Sujing LI ; Jing LI ; Yan YANG
International Journal of Traditional Chinese Medicine 2025;47(12):1752-1758
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.
3.Study on the Distribution of TCM Syndromes of Severe Mycoplasma Pneumoniae Pneumonia in Children Based on Factor Analysis and Clustering Analysis
Fengye JI ; Zhongyi ZHU ; Jin ZHANG ; Ling WANG ; Yan YANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(2):144-148
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.
4.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.
5.Study on the Distribution of TCM Syndromes of Severe Mycoplasma Pneumoniae Pneumonia in Children Based on Factor Analysis and Clustering Analysis
Fengye JI ; Zhongyi ZHU ; Jin ZHANG ; Ling WANG ; Yan YANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(2):144-148
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.
6.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.
7.Investigate the effect of Shenling Baizhu Powder on the spermatogenic function of the testes in hyperuricemic mice based on ferroptosis
Xiaocui JIANG ; Min XIAO ; Yinjuan LYU ; Chaoyang WANG ; Zhongyi ZHU ; Heng HAO ; Jigang CAO
Journal of Beijing University of Traditional Chinese Medicine 2024;47(8):1100-1110
Objective We aimed to investigate the effect of ferroptosis on Shenling Baizhu Powder,a compound prescription of Chinese herbal medicine,in improving testicular spermatogenic function in hyperuricemic mice with spermatogenic dysfunction. Methods Sixty BALB/c mice were randomly divided into normal group,model group,Shenling Baizhu Powder high-,medium-,and low-dose groups (20.14,10.07,5.04 g/kg,by gavage),and ferrostatin-1(Fer-1) group (0.8 mg/kg,by tail vein injection),with 10 mice each group. Except for the normal group,the other groups were intraperitoneally injected with potassium oxonate suspension[600mg/(kg·d)]for 7 days to establish the hyperuricemic model,and then the corresponding intervention was given for consecutive 14 days. Content of serum uric acid (UA),testicular Fe2+,reduced glutathione (GSH),malondialdehyde (MDA) and superoxide dismutase (SOD) activity were detected by biochemical method. Epididymal and testicular indices were measured. The spermatogenic function of testes was evaluated by eosin-hematoxylin staining. Sperm quality was detected by an automatic animal sperm analyzer. Prussian blue staining was used to detect iron deposition in testicular tissue. Immunohistochemistry was used to detect the related protein expressions of acyl-coenzyme A synthetase long-chain family member 4 (ACSL4) and glutathione peroxidase 4 (GPX4) in testicular tissue. Western blotting was used to detect the related protein expression levels of nuclear factor erythroid 2-related factor 2 (Nrf2)/heme oxygenase-1(HO-1)/GPX4 signaling pathway in testicular tissue. Results Compared with the normal group,the contents of serum UA,MDA,and Fe2+in the testis tissue of the model group were increased,the GSH content and SOD activity were decreased,the epididymal and testicular index,testicular spermatogenic function,sperm density and activity rate were decreased,and the iron deposition and ACSL4 protein expression in the testis tissue were increased. The expressions of kelch-like ECH-associated protein-1 (Keap1) and Nrf2 were increased. The expressions of nuclear Nrf2,HO-1,GPX4,and recombinant solute carrier family 7 member 11 (SLC7A11) protein were decreased (P<0.01). Compared with the model group,the above indexes in the Shenling Baizhu Powder groups and the Fer-1 group were improved to varying degrees (P<0.05,P<0.01). Conclusion Shenling Baizhu Powder can inhibit the ferroptosis of testicular cells through the Nrf2/HO-1/GPX4 signaling pathway,and improve the testicular spermatogenic function of mice with hyperuricemia spermatogenic dysfunction.
8.Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma (version 2024)
Zhu GUO ; Chao WANG ; Hongfei XIANG ; Zhongqiang CHEN ; Liang CHEN ; Tongwei CHU ; Shucai DENG ; Jian DONG ; Xinru DU ; Shiqing FENG ; Baorong HE ; Xijing HE ; Jianzhong HU ; Yong HAI ; Qingquan KONG ; Guiqing LIANG ; Qi LIAO ; Zhongjun LIU ; Shaoyu LIU ; Baoge LIU ; Xiaoguang LIU ; Weishi LI ; Li LI ; Fang LI ; Bin LIN ; Shibao LU ; Tao NIU ; Zhenli QIAO ; Dike RUAN ; Yueming SONG ; Haipeng SI ; Jun SHU ; Zhongyi SUN ; Qing WANG ; Zili WANG ; Huan WANG ; Hongli WANG ; Yan WANG ; Xiaolin WU ; Zhanyong WU ; Jinglong YAN ; Tengbo YU ; Qiang ZHANG ; Guoqing ZHANG ; Xuesong ZHANG ; Fengdong ZHAO ; Jie ZHAO ; Zhaomin ZHENG ; Qingsan ZHU ; Dingjun HAO ; Bohua CHEN
Chinese Journal of Trauma 2024;40(12):1057-1070
Spinal surgical site infection (SSI), especially deep SSI after internal fixation is difficult in treatment, with long course of disease and poor prognosis. At present, there are many controversies in the diagnosis and treatment of spinal SSI, with unsatisfactory overall efficacy of its diagnosis and treatment. Besides, no diagnosis and treatment guideline based on evidence-based medicine has been in existence. To this end, the Spinal Infection Group of the Orthopedic Branch of the Chinese Medical Doctor Association and the Spinal Infection Group of the Spinal Surgery Branch of the Chinese Rehabilitation Medicine Association jointly organized relevant experts to formulate Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma ( version 2024) based on an evidence-based approach. A total of 10 recommendations were proposed on the diagnosis and treatment of spinal SSI, so as to provide a clinical reference for the diagnosis and treatment of spinal SSI.
9.Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma (version 2024)
Zhu GUO ; Chao WANG ; Hongfei XIANG ; Zhongqiang CHEN ; Liang CHEN ; Tongwei CHU ; Shucai DENG ; Jian DONG ; Xinru DU ; Shiqing FENG ; Baorong HE ; Xijing HE ; Jianzhong HU ; Yong HAI ; Qingquan KONG ; Guiqing LIANG ; Qi LIAO ; Zhongjun LIU ; Shaoyu LIU ; Baoge LIU ; Xiaoguang LIU ; Weishi LI ; Li LI ; Fang LI ; Bin LIN ; Shibao LU ; Tao NIU ; Zhenli QIAO ; Dike RUAN ; Yueming SONG ; Haipeng SI ; Jun SHU ; Zhongyi SUN ; Qing WANG ; Zili WANG ; Huan WANG ; Hongli WANG ; Yan WANG ; Xiaolin WU ; Zhanyong WU ; Jinglong YAN ; Tengbo YU ; Qiang ZHANG ; Guoqing ZHANG ; Xuesong ZHANG ; Fengdong ZHAO ; Jie ZHAO ; Zhaomin ZHENG ; Qingsan ZHU ; Dingjun HAO ; Bohua CHEN
Chinese Journal of Trauma 2024;40(12):1057-1070
Spinal surgical site infection (SSI), especially deep SSI after internal fixation is difficult in treatment, with long course of disease and poor prognosis. At present, there are many controversies in the diagnosis and treatment of spinal SSI, with unsatisfactory overall efficacy of its diagnosis and treatment. Besides, no diagnosis and treatment guideline based on evidence-based medicine has been in existence. To this end, the Spinal Infection Group of the Orthopedic Branch of the Chinese Medical Doctor Association and the Spinal Infection Group of the Spinal Surgery Branch of the Chinese Rehabilitation Medicine Association jointly organized relevant experts to formulate Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma ( version 2024) based on an evidence-based approach. A total of 10 recommendations were proposed on the diagnosis and treatment of spinal SSI, so as to provide a clinical reference for the diagnosis and treatment of spinal SSI.
10.Robot-assisted laparoscopic enucleation in the treatment of leiomyosarcoma of urinary bladder: A case report.
Zhongyi ZENG ; Xiao WU ; Kai PENG ; Da REN ; Xuan ZHU ; Lei ZHANG
Journal of Central South University(Medical Sciences) 2023;48(5):782-788
Leiomyosarcoma of urinary bladder (LMS-UB) is a highly malignant mesenchymal tumor, accounting for less than 0.5% of all bladder malignancies, with a predominant clinical presentation of hematuria. Here we report a case of low-grade LMS-UB. A 44-year-old male patient was admitted to the hospital with urodynia for 2 weeks. The patient's pelvis CT showed a mass on the right part of the bladder. For this reason, he was initially diagnosed with bladder cancer. We performed a robot-assisted laparoscopic enucleation of the bladder tumor and low-grade LMS-UB was diagnosed with the histopathological examination. He underwent 5 cycles of adjuvant chemotherapy after surgery. At 19months postoperative follow-up, the patient had no symptoms, recurrence, or distant metastasis. There is no report on the treatment of LMS-UB with minimally invasive enucleation worldwide. This case provides a new comprehensive treatment method of enucleation combined with adjuvant chemotherapy for early low-grade LMS-UB to reduce complications and improve patients' quality of life after surgery.
Male
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Humans
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Adult
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Urinary Bladder/surgery*
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Leiomyosarcoma/secondary*
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Robotics
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Quality of Life
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Pelvis/pathology*
;
Urinary Bladder Neoplasms/pathology*
;
Laparoscopy/methods*


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