1.Revision of Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in Traditional Chinese Medicine-Edema-based on literature research and Delphi method
Xinxin MAO ; Bingxuan ZHANG ; Shuqing SHI ; Yumeng LI ; Qingqiao SONG
International Journal of Traditional Chinese Medicine 2025;47(7):886-891
Based on the Delphi method, this study conducted an expert questionnaire survey on the diagnostic criteria of edema in TCM by integrating preliminary literature research, aiming to further standardize the revision of Edema diagnosis in Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in Traditional Chinese Medicine (ZY/T001.1-94). Relevant literature on TCM edema was comprehensively retrieved from CNKI, Wanfang Data, VIP and CBM from 1994 to July 1, 2021. The content extracted from the literature was integrated with the diagnostic criteria outlined in the 1994 Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in Traditional Chinese Medicine to establish the questionnaire item pool; two rounds of Delphi expert surveys were conducted to identify content requiring revisions. Subsequently, the degree of concentration and coordination of the expert opinions were analyzed to determine items for inclusion in the revised draft. Ultimately, the finalized revised diagnostic criteria for edema were developed through expert panel discussions. Results showed expert participation rates of 84.21% and 78.13% in respective survey rounds. The progressive increase in Kendall's coefficient of concordance (Kendall's W=0.169 in Round 1 to Kendall's W=0.368 in Round 2) quantitatively validated enhanced expert consensus (both the degree of concentration and coordination) and systematic alignment of revision proposals for diagnostic items. The study findings demonstrated an urgent need for improving the diagnostic criteria section of the the 1994 Criteria of Diagnosis and Therapeutic Effect of Diseases and Syndromes in Traditional Chinese Medicine, and the proposed revisions would be expected to enhance the applicability and specificity of edema diagnostic standards in clinical practice.
2.Correlation Between Long-Term Prognosis and Traditional Chinese Medicine Syndrome Elements in Patients with Chronic Heart Failure:An Analysis of 546 Cases
Yuxin WANG ; Chunmei CHEN ; Qingqiao SONG
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(6):1306-1313
Objective To explore the characteristics of traditional Chinese medicine(TCM)syndrome elements in patients with chronic heart failure(CHF)and their correlation with long-term prognosis,thus to provide an objective basis for clinical treatment of CHF.Methods From January 2006 to July 2014,a retrospective analysis was carried out in 546 patients diagnosed as CHF in the Cardiology Department of Guang'anmen Hospital,China Academy of Chinese Medical Sciences.TCM syndrome elements of the patents were determined based on the data collected by four diagnostic methods.Patients were followed up for a maximum of 1 330 days,and long-term prognosis was recorded.With the patient's death as the endpoint event,and the patients were divided into a survival group(291 cases)and a death group(255 cases)according to the endpoint event.The distribution of TCM syndrome elements in the two groups was observed,and differences in the combination patterns of TCM syndrome elements were compared.After that,the correlation between long-term prognosis and TCM syndrome elements in CHF patients was analyzed.Results(1)The age of patients in the death group was greater and serum N-terminal pro-brain natriuretic peptide(NT-proBNP)level was higher than that in the survival group,the differences being statistically significant(P<0.01).In terms of New York Heart Association(NYHA)functional classification,the patients of death group had low proportion of heart function level Ⅲ while high proportion of heart function level Ⅳ in comparison with the patients of survival group,the differences being statistically significant(P<0.05 or P<0.01).Statistically significant differences were presented in the cardiac ultrasound indicators of left ventricular ejection fraction(LVEF),left ventricular end-diastolic diameter(LVEDD),and right ventricular end-diastolic diameter(RVEDD)between the two groups(P<0.05 or P<0.01),while left atrial diameter(LA)showed no significant difference between the two groups(P>0.05).In terms of underlying diseases,the proportion of coronary heart disease in the death group(87.45%)was higher than that in the survival group(80.76%),with a statistically significant difference(P<0.05).No significant differences were presented in other underlying diseases(P>0.05).(2)The death group had more cases of qi deficiency and yin deficiency syndrome elements while less cases of qi stagnation syndrome element than the survival group,and the differences were statistically significant(P<0.05 or P<0.01).The death group had higher proportions of syndrome element combinations such as qi deficiency and yin deficiency with blood stasis,yang deficiency and blood stasis with phlegm-heat,qi deficiency and yin deficiency with phlegm-heat,and yang deficiency and blood stasis with phlegm turbidity than the survival group,and the differences were statistically significant(P<0.05 or P<0.01).Conclusion CHF has the prognosis of developing into yin deficiency or yang deficiency.The death group has higher proportions of qi deficiency and yin deficiency with blood stasis syndrome,and yang deficiency and blood stasis with phlegm turbidity syndrome than the survival group,indicating that there is a poor prognosis,and more attention and early intervention should be done to avoid adverse events.
3.Correlation Between TCM Syndrome Types and Physicochemical Indicators as well as the Prognosis in Patients with Chronic Heart Failure Complicated with Chronic Kidney Disease
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(11):2629-2636
Objective To investigate the distribution patterns of traditional Chinese medicine(TCM)syndrome types in patients with chronic heart failure(CHF)complicated with chronic kidney disease(CKD),and to explore the correlation between TCM syndrome types and physicochemical indicators as well as the prognosis.Methods A total of 217 patients with CHF and CKD hospitalized in the Department of Cardiology,Guang'anmen Hospital,China Academy of Chinese Medical Sciences between January 2006 and March 2014 were included.Data from the four-examination methods of TCM were collected to determine TCM syndrome types.General information and physicochemical indicators of the patients were also recorded.SPSS 26.0 statistical software was used to analyze the distribution characteristics of TCM syndrome types and their relationships with general information,physicochemical indicators,and the prognosis.Results(1)Among the 217 patients,114 were male and 103 were female,with a male-to-female ratio of 1.11∶1,indicating similar incidence between genders.(2)The distribution of TCM syndrome types in descending order was as follows:yang deficiency with phlegm-stasis syndrome(23.04%),yin deficiency with phlegm-stasis syndrome(22.12%),blood stasis and phlegm turbidity syndrome(21.20%),qi and yin deficiency syndrome(17.51%),and qi deficiency with blood stasis syndrome(16.13%).(3)Regarding age,the blood stasis and phlegm turbidity syndrome group was the youngest,while the qi and yin deficiency syndrome group and the yin deficiency with phlegm-stasis syndrome group were relatively old.The differences between the blood stasis and phlegm turbidity syndrome group and the other two groups were statistically significant(P<0.05).In terms of disease duration,the blood stasis and phlegm turbidity syndrome group had a shorter course than the yang deficiency with phlegm-stasis syndrome group,with a statistically significant difference(P<0.01).Regarding mortality,the blood stasis and phlegm turbidity syndrome group had a lower mortality rate compared to the qi and yin deficiency syndrome,yin deficiency with phlegm-stasis syndrome,and yang deficiency with phlegm-stasis syndrome groups,with statistically significant differences(P<0.01).(4)The N-terminal pro-brain natriuretic peptide(NT-proBNP)level in the qi and yin deficiency syndrome group was higher than that in the blood stasis and phlegm turbidity syndrome group.The estimated glomerular filtration rate(eGFR-EPI)level in the yin deficiency with phlegm-stasis syndrome,yang deficiency with phlegm-stasis syndrome,and qi and yin deficiency syndrome groups was higher than that in the blood stasis and phlegm turbidity syndrome group.The very low-density lipoprotein(VLDL)level in the yin deficiency with phlegm-stasis syndrome and yang deficiency with phlegm-stasis syndrome groups was higher than that in the qi and yin deficiency syndrome group.The blood chloride(Cl-)level in the qi and yin deficiency syndrome group was lower than that in the yin deficiency with phlegm-stasis syndrome group.All these differences were statistically significant(P<0.05 or P<0.01).Additionally,no statistically significant differences were observed among different syndrome types in terms of gender,time of death,platelet count(PLT),white blood cell count(WBC),red blood cell count(RBC),hemoglobin(Hb),C-reactive protein(CRP),uric acid(UA),blood potassium(K+),blood sodium(Na+),triglycerides(TG),total cholesterol(TC),high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C),fasting plasma glucose(FPG),alanine aminotransferase(ALT),aspartate aminotransferase(AST),total bilirubin(TBIL),direct bilirubin(DBIL),indirect bilirubin(IBIL),ejection fraction(EF),fractional shortening(FS),serum creatinine(Scr),blood urea nitrogen(BUN),and New York Heart Association(NYHA)functional classification(P>0.05).Conclusion In clinical assessment of patients with CHF and CKD,it is essential to focus on the transition between deficiency and excess syndromes and to emphasize the intervention for the underlying deficiency.Efforts should be made to delay disease progression,prolong the timeline of transformation from excess to deficiency,and extend survival.Furthermore,the phlegm-stasis concretion is the core pathogenesis in these patients.Based on the TCM theory of the spleen being the source of phlegm production,interventions for mixed deficiency-excess syndromes should not only eliminate pathogenic factors but also reinforce spleen qi.Concurrently,attention should be paid to accompanying symptoms such as blood stasis and qi deficiency.By addressing the root cause and cutting off the source of internal phlegm formation while ensuring pathways for its elimination,targeted treatment can be achieved through clarifying the etiology and pathogenesis.
4.Revision of the curative effect evaluation part of Criteria for Diagnosis and Treatment of Diseases in Traditional Chinese Medicine - Edema based on delphi method
Xinxin MAO ; Qingqiao SONG ; Yumeng LI ; Huaqin WU ; Haoran ZHENG ; Bingxuan ZHANG
International Journal of Traditional Chinese Medicine 2024;46(10):1264-1270
Based on literature research and Delphi method, the curative effect evaluation criteria of Traditional Chinese Medicine (TCM) edema were revised, in order to promote the standardization construction of the curative effect evaluation of edema and strengthen the research on the revision technology of TCM standards. From January 1, 1994 to July 1, 2021, the China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (Chongqing VIP), Chinese Academic Periodical Database (Wanfang Data) and Chinese Biomedical Literature Service System (SinoMed) were searched, and 221 articles were included. Then the questionnaire item pool was constructed after extracting the contents of the articles. Delphi method was used to conduct two rounds of expert questionnaire survey. And then the concentration degree and coordination degree of expert opinions were counted and analyzed to screen out the content to be revised and the indicators to be included in the revised version, so as to form the revised version of curative effect evaluation criteria of edema. A total of 32 experts participated in this study, and the positive coefficient of experts in the first round was 84.21%, and the positive coefficient of experts in the second round was 78.13%. The mean value ( Xˉ), full score ratio, rank sum, coefficient of variation ( CV), Kendall's coefficient of concordace (Kendall's W) were used to select the questionnaire items. Kendall's W of the second round of expert questionnaire survey was 0.368, P=0.000, higher than that of the first round, and 11 items were finally included in the curative effect evaluation. The CV of the included items in the second round of the questionnaire is lower than that in the first round, and Kendall's W was higher than that in the first round, and the expert opinions tend to be unified. Consensus was reached after the expert discussion meeting, and the revised version of curative effect evaluation criteria of edema has been preliminarily formed.
5.Analysis on knowledge mapping of edema treated with TCM: a bibliometrics based quantitative study
Haoran ZHENG ; Bingxuan ZHANG ; Qingqiao SONG ; Shuqing SHI ; Huaqin WU ; Yumeng LI ; Xia XU ; Jiayu LYU ; Yajiao WANG ; Xinxin MAO
International Journal of Traditional Chinese Medicine 2023;45(7):884-891
Objective:Applying bibliometrics to analyze the research history, hotspots and trends of Traditional Chinese Medicine (TCM) interventions in edema-related diseases, and to provide reference for the revision of diagnostic and therapeutic criteria for edema in TCM.Methods:The literature about edema treated with TCM was retrieved from CNKI, Wanfang, VIP, CBM from 1 st. Jan 1995 to 25 th. May 2022. CiteSpace and VOSviewer softwares were used to draw the knowledge map, and analyze the co-occurrence relationship and clustering characteristics of the institution, author, keywords and mechanism hotspots. Results:Totally 3 198 articles were included. The annual number of documents issued generally shows a spiral rise trend. Liaoning University of Chinese Medicine published the most articles. Core authors published the most articles were Sun Wei (13 articles); the team with the highest cooperation intensity was Yang Hongtao's team; keywords formed 7 clusters. Hotspot mechanisms included metabolic disorders, immune balance, anti-inflammation, calcium and phosphorus metabolism. Keywords in the past 7 years were membranous nephropathy, chronic heart failure, diabetes, lymphedema etc.Conclusions:The attention paid to the intervention of TCM in the field of edema is generally on the rise, and has decreased in the past two years. The research categories focus on the experience of famous doctors, clinical trials, and mechanistic studies, and nephropathy-related edema has been the focus of research; diabetic nephropathy, chronic heart failure, metabolomics, and immunotherapy are expected to be the focus of attention in the next stage.
6.Study on the efficacy evaluation criteria of randomized controlled trials of TCM in the treatment for edema
Xinxin MAO ; Qingqiao SONG ; Huaqin WU ; Shuqing SHI ; Yumeng LI ; Xia XU ; Jiayu LYU ; Yajiao WANG ; Haoran ZHENG ; Bingxuan ZHANG
International Journal of Traditional Chinese Medicine 2023;45(9):1157-1161
Objective:To analyze the efficacy evaluation criteria of the existing TCM treatment for edema RCT research, and to provide reference for the construction of unified standards.Methods:The batabases CNKI, WanFang Data, VIP, CBM, Pubmed and Web of Science were retrieved. The randomized controlled trials for the treatment of edema of TCM research, from September 1, 1993 to July 31, 2022, were screened and included. The content of efficacy evaluation, performed statistics on evaluation standard, the curative effect evaluation indexes, as well as standard composition, usage were extracted. We analyzed the characteristics, application and problems of the existing efficacy evaluation criterion.Results:A total of 123 Chinese articles were included. The included literature involved nephrogenic edema, cardiogenic edema, idiopathic edema, apoplexy limb edema and other edema. In recent years, randomized controlled trials on the treatment of edema by TCM have mainly used four efficacy evaluation criteria. Of which the Guidelines for Clinical Research on New Chinese Medicines (Trial) in 2002 had the highest utilization rate of 29.27%. Secondly, the utilization rate of Standard for Diagnosis and Curative Effect of TCM Diseases and Syndromes was 21.14%. The rest of the criteria were used by less than 6%. While 39.02% of the literature did not use the standards or used self-designed standards. Among the composition of efficacy evaluation indices, the application rate of TCM syndrome or symptom efficacy index was the highest (91.87%), the utilization rate of the Minnesota Living with Heart Failure Questionnaire Indicators was only 4.88%; biochemical tests accounted for a large proportion of Western medical indicators, while the measurement of edema severity was rarely applied. Conclusions:At present, the evaluation criteria of edema curative effect are diversified and insufficiently popularized, which need to be further screened and improved. It is suggested to construct a TCM edema efficacy evaluation model based on the characteristics of edema syndrome, comprehensively evaluate the efficacy from multiple dimensions such as TCM syndromes, western medicine indicators, and quality of life, and improve the scientific indicators.
7.Preliminary application of three-dimensional visualization in interventional treatment of Budd-Chiari syndrome
Qiang ZHANG ; Juncheng SHA ; Wei SONG ; Huawei LI ; Zhongqiu FENG ; Hao XU ; Maoheng ZU ; Qingqiao ZHANG
Chinese Journal of Hepatobiliary Surgery 2019;25(5):340-343
Objective To analyze the application of three-dimensional visualization in interventional treatment of Budd-Chiari syndrome (BCS) with the hepatic vein occlusion type.Methods A retrospective study was conducted on 15 patients with BCS of the hepatic vein occlusion type who were admitted to the Affiliated Hospital of Xuzhou Medical University from January 2017 to June 2018.The study included 8 males and 7 females with a mean age of (36.7±14.4) years.All patients were examined with MRI enhanced scanning and the original MRI data of the DICOM format were extracted.The digital data were then extracted and reconstructed by the Mimics software to obtain a three-dimensional visualization model.The hepatic vein was recanalized under the guidance of the three-dimensional visualization model.Results The three-dimensional visualization model was successfully constructed.Of all the 15 three-dimensional visualization models,right hepatic vein ostial stenosis occurred in 4 patients and occlusion in 11 patients.The middle hepatic vein and the left hepatic vein formed a common trunk in 15 patients,and ostial stenosis and occlusion of the common trunk occurred in 3 and 12 patients,respectively.Communicating branches between the right and middle hepatic veins occurred in 6 patients.Accessory hepatic veins occurred in 3 of 15 patients,and the accessory hepatic vein ostium was stenosed in 3 patients.Communicating branches between the accessory hepatic vein and the right hepatic vein occurred in 2 patients,and communicating branches between the accessory hepatic vein and the middle hepatic vein occurred in 1 patient.All patients were treated successfully with interventional treatment without any complications.One,2,and 3 hepatic veins were recanalized in 7,5 and 3 patients,respectively.Conclusion The three-dimensional visualization was valuable in displaying the location,pattern and collateral vessels of the hepatic veins in BCS patients with the hepatic vein occlusion type.It was helpful for accurate preoperative assessment and to make individualized interventional treatment plans.
8.Efficacy of transjugular intrahepatic portosystemic shunt in treatment of sinusoidal obstruction syndrome caused by gynura segetum
Wei SONG ; Qingqiao ZHANG ; Hao XU ; Ning WEI ; Hongtao LIU ; Jinchang XIAO ; Wenliang WANG ; Zhikang GAO ; Duntao LYU ; Buqiang ZHUANG
Chinese Journal of Hepatobiliary Surgery 2019;25(6):418-421
Ohjective To evaluate the safety and efficacy of transjugular intrahepatic portosystemic shunt (TIPS) in the treatment of sinusoidal obstruction syndrome (SOS) caused by gynura segetum.Methods The clinical data of 9 patients with SOS caused by gynura segetum (5 males and 4 females) who underwent TIPS were retrospectively analyzed from February 2017 to June 2018.The Child-Pugh scores were (9.5 ± 1.3) and the MELD scores were (12.5 ± 5.0).The success rates,complications and follow-up results were evaluated.Results TIPS was performed successfully in all the 9 patients.The portal venous pressure gradient dropped from (22.4 ± 2.7) mmHg to (10.4 ± 3.2) mmHg (P < 0.05).There was no complication such as abdominal hemorrhage and biliary peritonitis.Nine patients were followed-up for 1 ~17months,mean 7.8 ± 6.0 months.One month after treatment,the Child-Pugh scores were (7.1 ± 1.8),compared with that of the preoperative scores,the difference was statistically significant (P < 0.05).The MELD scores were (5.3 ± 4.6),compared with that of the preoperative scores,the difference was also statistically significant (P < 0.05).At the end point of the follow-up,color Doppler ultrasound and portal CTA showed that the TIPS shunt was patent and hepatic congestion was relieved in all the 9 patients.All patients were alive.Conclusion TIPS was a safe and efficacious treatment for SOS caused by gynura segetum.

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