1.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
2.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
3.Equivalence of SYN008 versus omalizumab in patients with refractory chronic spontaneous urticaria: A multicenter, randomized, double-blind, parallel-group, active-controlled phase III study.
Jingyi LI ; Yunsheng LIANG ; Wenli FENG ; Liehua DENG ; Hong FANG ; Chao JI ; Youkun LIN ; Furen ZHANG ; Rushan XIA ; Chunlei ZHANG ; Shuping GUO ; Mao LIN ; Yanling LI ; Shoumin ZHANG ; Xiaojing KANG ; Liuqing CHEN ; Zhiqiang SONG ; Xu YAO ; Chengxin LI ; Xiuping HAN ; Guoxiang GUO ; Qing GUO ; Xinsuo DUAN ; Jie LI ; Juan SU ; Shanshan LI ; Qing SUN ; Juan TAO ; Yangfeng DING ; Danqi DENG ; Fuqiu LI ; Haiyun SUO ; Shunquan WU ; Jingbo QIU ; Hongmei LUO ; Linfeng LI ; Ruoyu LI
Chinese Medical Journal 2025;138(16):2040-2042
4.Color-component correlation and mechanism of component transformation of processed Citri Reticulatae Semen.
Kui-Lin ZHU ; Jin-Lian ZOU ; Xu-Li DENG ; Mao-Xin DENG ; Hai-Ming WANG ; Rui YIN ; Zhang-Xian CHEN ; Yun-Tao ZHANG ; Hong-Ping HE ; Fa-Wu DONG
China Journal of Chinese Materia Medica 2025;50(9):2382-2390
High-performance liquid chromatography(HPLC) was used to determine the content of three major components in Citri Reticulatae Semen(CRS), including limonin, nomilin, and obacunone. The chromaticity of the CRS sample during salt processing and stir-frying was measured using a color difference meter. Next, the relationship between the color and content of the salt-processed CRS sample was investigated through correlation analysis. By integrating the oil bath technique for processing simulation with HPLC, the changes in the relative content of nomilin and its transformation products were analyzed, with its structural transformation pattern during processing identified. Additionally, RAW264.7 cells were induced with lipopolysaccharides(LPSs) to establish an inflammatory model, and the anti-inflammatory activity of nomilin and its transformation product, namely obacunone was evaluated. The results indicated that as processing progressed, E~*ab and L~* values showed a downward trend; a~* values exhibited a slow increase over a certain period, followed by no significant changes, and b~* values remained stable with no significant changes over a certain period and then started to decrease. The limonin content remained barely unchanged; the nomilin content decreased, and the obacunone increased significantly. The changing trends in content and color parameters during salt-processing and stir-frying were basically consistent. The content of nomilin and obacunone was significantly correlated with the colorimetric values(L~*, a~*, b~*, and E~*ab), while limonin content showed no significant correlation with these values. By analyzing HPLC patterns of nomylin at different heating temperatures and time, it was found that under conditions of 200-250 ℃ for heating of 5-60 min, the content of nomilin significantly decreased, while the obacunone content increased pronouncedly. The in vitro anti-inflammatory activity results indicated that compared to the model group, the group with a high concentration of nomilin and the groups with varying concentrations of obacunone showed significantly reduced release of nitric oxide(NO)(P<0.01). When both were at the same concentration, obacunone showed better performance in inhibiting NO release. In this study, the obvious correlation between the color and content of major components during the processing of CRS samples was identified, and the dynamic patterns of quality change in CRS samples during processing were revealed. Additionally, the study revealed and confirmed the transformation of nomilin into obacunone during processing, with the in vitro anti-inflammatory activity of obacunone significantly greater than that of nomilin. These findings provided a scientific basis for CRS processing optimization, tablet quality control, and its clinical application.
Mice
;
Animals
;
Drugs, Chinese Herbal/pharmacology*
;
RAW 264.7 Cells
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Limonins/chemistry*
;
Chromatography, High Pressure Liquid
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Citrus/chemistry*
;
Color
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Benzoxepins/chemistry*
;
Anti-Inflammatory Agents/chemistry*
5.Mechanism and significance of cell senescence induced by viral infection.
Yunchuang CHANG ; Xinna WU ; Lingli DENG ; Sanying WANG ; Genxiang MAO
Journal of Zhejiang University. Medical sciences 2025;54(1):70-80
Virus-induced senescence (VIS) is a significant biological phenomenon, which is associated with declining immune function, accelerating aging process and causing aging-related diseases. A variety of common viruses, including RNA viruses (such as SARS-CoV-2), DNA viruses (such as herpesviruses and hepatitis B virus), and prions can cause VIS in host cells. The primary mechanisms include abnormal activation of the cGAS-STING signaling pathway, DNA damage response, and potential correlations with the integrated stress response due to intracellular phase separation. Viral infection and cellular senescence influence each other: cellular senescence serves as a defense to restrict viral replication and transmission, while some viruses exploit cellular senescence to enhance their infectivity and replication. Understanding the mechanisms of VIS is conducive to the development of therapeutic strategies for viral infections and promotion of healthy aging. However, there is lack of research on therapeutic targets and drug development in this field so far. Although senolytics may be effective for anti-senescent cells therapy, their efficacy for VIS needs evidence from further clinical trials. This article reviews the research progress on the connection between viral infection and cellular senescence, to provide insights for the prevention and treatment of aging related diseases.
Humans
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Cellular Senescence/physiology*
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Virus Diseases/physiopathology*
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Signal Transduction
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Nucleotidyltransferases/metabolism*
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DNA Damage
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Virus Replication
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COVID-19
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Membrane Proteins/metabolism*
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SARS-CoV-2
6.5 cases of occupational heat illness
Hongping DENG ; Hongying PAN ; Jianhua YAO ; Yuexin YANG ; Jie MAO
Chinese Journal of Industrial Hygiene and Occupational Diseases 2024;42(1):58-61
Objective:Through the analysis of five cases of occupational heat illness caused by high temperature, we expounded the pathogenesis and summarized the clinical characteristics of heat cramp and heat exhaustion of the newly revised diagnostic criteria for occupational heat illness (GBZ41-2019), in order to prevent the occurrence of occupational heat illness to put forward controllable countermeasures.Methods:According to the occupational history, clinical diagnosis and treatment and the other relevant data submitted by five patients, the diagnosis process was analyzed and summarized.Results:Five patients developed symptoms from July to August in summer, belonging to high-temperature operation. They improved by timely treatment. The symptoms, signs and laboratory tests of the five patients were different, but they were diagnosed as occupational heat illness.Conclusion:Employers should pay attention to the high temperature protection and cooling work, and strengthen the labor protection. If patients with heat cramp and heat exhaustion were timely treated, they could basically recover. Occupational disease diagnosticians should seriously study the new diagnostic criteria of occupational disease and constantly improve their diagnostic ability.
7.Development and validation of a prognostic scoring system for colorectal cancer patients with Hepato-bone metastasis:a retrospective study
Le QIN ; Yixin HENG ; Jiaxin XU ; Ning HUANG ; Shenghe DENG ; Junnan GU ; Fuwei MAO ; Yifan XUE ; Zhenxing JIANG ; Jun WANG ; Denglong CHENG ; Yinghao CAO ; Kailin CAI
Journal of Clinical Surgery 2024;32(9):947-954
Objective To establish a nomogram model for efficiently predicting overall survival(OS)and cancer-specific survival(CSS)in patients with CRCHBM.Method 2239 patients from 2010 to 2019 were retrospectively analyzed from the Surveillance,Epidemiology,and End Results Program(SEER)databases and Wuhan Union Hospital Cancer Center.SEER is randomly assigned to the training and internal validation cohorts,and the Wuhan database serves as the external validation.Cox regression analyses were used to determine the independent clinicopathological prognosis factors affecting OS and CSS,and a nomogram was constructed to predict OS and CSS.The clinical utility of columnar plots was assessed using calibration curves,area under the curve(AUC),and decision curve analysis(DCA).Result OS column line graphs were constructed based on nine independent predictors:age,tumor location,degree of differentiation,tumor size,TNM stage,chemotherapy,primary focus surgery,number of lymph nodes sampled,and serum carcinoembryonic antigen(CEA)level.The C-index of the nomogram to predict the 1-,3-,and 5-year OS were 0.764,0.790,and 0.805 in the training group,0.754,0.760,and 0.801 in the internal validation group,and 0.822,0.874,and 0.906 in the external validation group.CSS column line graphs were constructed based on 3 independent predictors of TNM staging,radiotherapy and chemotherapy.The 1-,3-,and 5-year CSS AUROC values of the training group were 0.791,0.757,and 0.782,respectively.0.682,0.709,0.625 in the internal validation group and 0.759,0.702,0.755 in the external validation group,respectively.The results of receiver operating characteristic curve(ROC),ROC and DCA showed that the use of our model was more effective in predicting OS and CSS than other single clinicopathological features.Conclusion In summary,the nomogram based on significant clinicopathological features can be conveniently used to predict OS and CSS individually in patients with CRCHBM.
8.Measuring and evaluating the level of high-quality development of higher education in China, 2001-2021
Meng ZHANG ; Yuqin TANG ; Haomin TANG ; Shuangyan MAO ; Dan DENG
Chinese Journal of Medical Education Research 2024;23(11):1472-1478
Objective:To conduct a multidimensional quantification and analysis of the development trajectory of both "quality" and "quantity" in China's higher education from 2001 to 2021, and lay a solid foundation for the construction of a high-quality education system.Methods:Based on macro statistical data on education in China from 2001 to 2021, a comprehensive indicator system for the development level of higher education was established. This system included six dimensions: educational conditions, financial support, institutional safeguards, scientific research, social services, and international collaboration. Methods such as entropy-weighted TOPSIS, general difference index, spatial autocorrelation, and hot spot analysis were used to evaluate the level of high-quality development of higher education and its spatial differentiation. Additionally, an obstacle degree analysis model was used to evaluate the factors hindering the high-quality development of higher education.Results:The high-quality development level of China's higher education has steadily improved, with a growth rate of 2.85%. The spatial distribution exhibited a clustering pattern, with stable hotspot regions established in the eastern region characterized by significant "spillover" effects. Concurrently, the western regions narrowed the development gap compared with other areas. Scientific research represents the primary challenge to achieving high-quality development in higher education, with an average obstacle degree of 18.46%. Books per student, fixed assets per student, foreign technology imported per institution, research & development project funds, research & development projects per institution, and personnel investment in research & development projects were important constraints on the development of higher education in China and the provinces.Conclusions:Resource sharing and linkage need to be guaranteed by policy and institutional support, and each subject of higher education should give full play to its own advantages to contribute to the high-quality development of higher education through interregional linkage development, mutual synergy, and common progress.
9.Impact of attachment anxiety on subjective well-being of warship officers and soldiers:the chain mediating effects of self-esteem and negative emotions
Jianguo ZHANG ; Wei DONG ; Tianya HOU ; Wenxi DENG ; Ziqiang LI ; Xiaofei MAO
Academic Journal of Naval Medical University 2024;45(9):1168-1173
Objective To explore the influence of attachment anxiety on subjective well-being of warship officers and soldiers,and reveal the mediating roles of self-esteem and negative emotions between them. Methods A total of 288 warship officers and soldiers were enrolled by convenience sampling method. Adult attachment scale,self-esteem scale,generalized anxiety disorder-7 items scale,patient health questionnaire-9 and Memorial University of Newfoundland scale of happiness were used for questionnaire survey. Pearson correlation analysis,multiple linear regression analysis and structural equation modeling were used to analyze the relationships between attachment anxiety,self-esteem,negative emotions and subjective well-being. Results Correlation analysis showed that attachment anxiety,self-esteem,anxiety,depression and subjective well-being were significantly correlated (all P<0.01). Multiple regression analysis showed that attachment anxiety,self-esteem,depression and anxiety could jointly predict 42.4% of subjective well-being. The analysis of chain mediating effect (x2/df=0.170,P=0.844,good fit index[GFI]=0.999,adjusted GFI=0.996,normative fit index[FI]=0.999,relative FI=0.997,comparative FI=1.000,root mean square error of approximation=0.000) showed that self-esteem and negative emotions played complete chain mediating roles between attachment anxiety and subjective well-being. Conclusion Attachment anxiety of warship officers and soldiers can affect their subjective well-being not only through the mediation of self-esteem and negative emotions,but also through the complete chain mediation of self-esteem and negative emotions.
10.Evaluation of clinical pharmacists participating in the perioperative nutritional management of pancreaticoduode-nectomy
Lina WANG ; Xiaojie BIAN ; Shaoyan JIANG ; Shaojie DENG ; Yudong QIU ; Liang MAO ; Weihong GE
China Pharmacy 2024;35(5):618-622
OBJECTIVE To explore the role of clinical pharmacists participating in the standardized perioperative nutritional management process for pancreaticoduodenectomy (PD) on improving postoperative recovery in patients. METHODS The clinical data of 100 patients undergoing PD in the Department of Biliary and Pancreatic Surgery, Drum Tower Hospital Affiliated to Nanjing University School of Medicine from November 2019 to February 2021 were analyzed retrospectively. According to the different perioperative nutrition management plans, they were divided into clinical pharmacist intervention group (n=51, clinical pharmacists intervened according to the standardized nutrition management process) and control group (n=49, clinical pharmacists only performed preoperative nutrition evaluation, and clinical physicians took nutrition support according to the patient’s condition). The differences in postoperative recovery index, economic evaluation index, hospitalization length, postoperative complications, and postoperative enteral nutrition support route were compared between 2 groups. RESULTS The time of postoperative diet, the first postoperative ventilation, the first postoperative defecation, and postoperative drainage time of abdominal drain were significantly earlier in the clinical pharmacist intervention group than in the control group (P<0.05); the hospitalization cost, medication cost, nutritional support cost, parenteral nutrition cost, albumin preparation cost, and the length of postoperative hospitalization were significantly lower/shorter in the clinical pharmacist intervention group than in the control group (P<0.05); there was no statistically significant difference in the incidence of postoperative complications between the two groups (P>0.05); there was statistically significant difference in the perioperative enteral nutrition support pathways between two groups (P<0.05). CONCLUSIONS Clinical pharmacists’ participation in perioperative nutritional management for PD can significantly reduce hospitalization costs and nutritional support costs, improve patients’ perioperative nutritional status, and shorten hospital stays. wanglina668@163.com

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