1.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.
2.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.
3.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.
4.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.
5.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.
6.55 cases of perioperative mortality in oral maxillofacial head and neck cancer patients: a retrospective analysis
SUN Zhongyi ; CHEN Yiming ; WANG Yi ; JI Tong
Journal of Prevention and Treatment for Stomatological Diseases 2020;28(9):575-580
Objective:
To analyze the characteristics of perioperative mortality (POM) in oral maxillofacial head and neck cancer patients.
Methods:
A retrospective study was adapted for head and neck cancer patients who were treated and had POM in the department of oral maxillofacial & head and neck oncology in Shanghai Ninth People′s Hospital from Jan 1999 to Dec 2019. Demographic information, disease characteristic and clinical records were collected. The factors of POM were classified into surgical complication, medical complication, mixed complication (surgical and medical) and personal complication. SPSS 17.0 software was used to analyze the cause composition for POM under different condition.
Results :
55 patients were included: 39 were male, and 16 were female. A total of 12 patients had a smoking history. Furthermore, 28 patients had general comorbidities. 20 underwent preoperative radiotherapy and 9 received preoperative chemotherapy. Squamous cell carcinoma was the most frequent pathological diagnosis in 37 patients. A total of 9 patients had tumors in the maxilla and skull base. In addtition, 4 patients had POM preoperatively, 1 patient had POM within the operation, and 50 patients had POM postoperatively. The leading causes of death were as follows: rupture of the carotid artery was the most frequent (8), and the surgical complication of pulmonary infection was the main medical complication (6). Pulmonary infection and hemorrhage were regarded as the main mixed complication (4). Two patients had POM due to personal complications. The higher the American Society of Anesthesiologists (ASA) score, the higher the proportion of medical factors in POM (P=0.039).
Conclusion
The composition of POM in oral maxillofacial- head and neck cancer (OMHNC) patients was complicated. Carotid artery rupture was the most common and fatal surgical complication, especially for those who underwent preoperative radiotherapy. Pulmonary infection was the most frequent medical complication, and those who had a higher ASA grade tended to have more complication.
7.Study on Animal Models of Decompression Sickness.
Zhongyi JI ; Jinfu YUAN ; Chengxiang LEI ; Kaiyuan HU ; Qingrong WANG
Space Medicine & Medical Engineering 2006;0(02):-
Objective To study the profiles of decompression sickness(DCS) in various kinds of animals and to find out the target organ of decompression sickness by providing a basic experimental method for establishing animal models.Method Eleven kinds of animals were exposed to different pressures for different times at different compression/decompression rates.They were monitored at the precordial regions with Doppler flow meter for bubble sounds after decompression to normal pressure,to obtain a record about the developing course of the DCS.Pathological examinations of the bulbar conjunctiva were also made. Result Bubble sound of grade IV were recorded at the precordial regions after decompression.Among them,75%~100% incurred DCS with a diverse extent. Animals developed DCS showed vascular spasm,dysfunction and endothelial tumefaction.Conclusion Each of the 11 kinds of animals can serve as a model of DCS and the processes of development of DCS in various animals are similar.Blood vessels are the target organs of decompression sickness.
8.The early diagnosis and treatment of cervical vertebrae injury
Zhongyi JI ; Junqiang YE ; Mushun HE
Chinese Journal of Primary Medicine and Pharmacy 2006;0(03):-
Objective To study the early diagnosis and treatment of cervical vertebrae injury.Methods 86 cases with cervial vertebrae injury were retrospectively analyzed.8 cases were treated by head halter treaction,78 cases were treated by skull traction,15 cases treated in early-day operation,27 cases seclected-day operation.Results According to frankel grading.A degree was 36 cases,no betterment,one case died;B degree 18 cases,2 cases improved to C degree,3 cases improved to D degree,13 cases had no improverment;9 cases,all had one or two degree improvement.20 cases with the nerve root injury all had determinate improverment or were cured.Conclusion Quick and correct early diagnosis and treatment after cervical vertebrae injury are the key steps in decreasing the death rate and disability rate.
9.Determination of the Content of Main Components in Lipoic Acid Sustained-release Tablets by HPLC
Liang SUN ; Shouyao ZHANG ; Zhongyi ZHANG ; Aimin JI
China Pharmacy 2005;0(19):-
OBJECTIVE:To establish an HPLC method for the determination of lipoic acid in lipoic acid sustained-release tablets.METHODS:HPLC was conducted on a Hypersil ODS with acetonitrile-0.05 mol?mL-1 potassium dihydrogen phosphate(45∶55,adjust pH to 2.0)as mobile phase at a flow rate of 1.0 mL?min-1.The injection volume was 10 ?L;the detection wavelength was set at 219 nm and the column temperature was 25 ℃.RESULTS:The linear range of lipoic acid was 9.99~399.70 ?g?mL-1(r=0.999)with an average recovery rate of 99.17%(RSD=0.40%);the intra-day and inter-day RSD were all less than 2.6%.CONCLUSION:The method is simple and accurate,and suitable for the determination of the content of lipoic acid in lipoic acid sustained-release tablets.


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