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
;
Limonins/chemistry*
;
Chromatography, High Pressure Liquid
;
Citrus/chemistry*
;
Color
;
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
;
Cellular Senescence/physiology*
;
Virus Diseases/physiopathology*
;
Signal Transduction
;
Nucleotidyltransferases/metabolism*
;
DNA Damage
;
Virus Replication
;
COVID-19
;
Membrane Proteins/metabolism*
;
SARS-CoV-2
6.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
7.Multicenter study on the efficacy and safety of 3 kinds of Cephalosporin for injection from centralized procurement or non-centralized procurement
Lu LIU ; Cangsang SONG ; Xingde LI ; Yuqin DENG ; Panpan MAO ; Hanshu ZHANG ; Yanzhen DONG ; Yaoyao CHENG
China Pharmacy 2024;35(7):825-830
OBJECTIVE To compare the efficacy and safety of Cefazolin sodium for injection, Cefuroxime sodium for injection, and Ceftazidime for injection from nationally organized centralized drug procurement (hereinafter referred to as “centralized procurement”) and non-centralized procurement in patients with bacterial infection. METHODS The case data of hospitalized patients who had used 3 kinds of Cephalosporins for injection from centralized procurement or non-centralized procurement in the treatment of bacterial infections were retrospectively collected from 19 medical institutions in Kunming from January 2020 to September 2022. After balancing the baseline differences between the groups with the propensity score matching method, the effectiveness and safety differences of 3 kinds of Cephalosporins for injection from centralized procurement or non- centralized procurement were compared respectively. RESULTS After balancing the baseline differences among the groups, 394 cases in each group of Cefazolin sodium for injection from centralized procurement or non-centralized procurement, 472 cases in each group of Cefuroxime sodium for injection from centralized procurement or non-centralized procurement, 504 cases in group of Ceftazidime for injection from centralized procurement and 590 cases in group of non-centralized procurement were included in the analysis. In terms of effectiveness, there were no significant differences in clinical response rate, 72 h response rate, bacterial clearance rate, and the recovery rate of body temperature, white blood cell count, neutrophil count, neutrophil percentage, C-reactive protein, procalcitonin recovery between the centralized procurement group and non-centralized procurement group of Cefazolin sodium for injection and Cefuroxime sodium for injection (P>0.05). The proportion of patients in centralized procurement group of Ceftazidime for injection with C-reactive protein restored to normal reference range was significantly higher than that in non-centralized procurement group (46.9% vs. 27.9%, P<0.05), but there were no statistically significant differences in other effectiveness indicators among groups (P>0.05). In terms of safety, there was no statistical difference in the incidence of adverse drug reactions between centralized procurement group and non-centralized procurement group of 3 kinds of Cephalosporins for injection (P>0.05); the incidence of platelet count reduction in centralized procurement group of Cefazolin sodium for injection was significantly higher than non-centralized procurement group (20.7% vs. 7.1%, P<0.05), the incidence of eosinophilia elevation in centralized procurement group of Ceftazidime for injection was significantly higher than non-centralized procurement group (5.3% vs. 1.9%, P<0.05). In addition, there was no statistically significant difference in the abnormal rates of other laboratory indicators among the three types of injection Cephalosporins (P> 0.05). CONCLUSIONS The efficacy of 3 kinds of Cephalosporin for injection from centralized procurement is not inferior to non- centralized procurement varieties, and the safety is equivalent to that of non-centralized procurement varieties.
8.Consideration of countermeasures to promote family doctor contracting rate and first-return-visit rate in primary care institutions
Fei SHENG ; Ping LU ; Liqing ZHOU ; Bihua CHEN ; Chuntao YI ; Jiangen CHEN ; Fulai SHEN ; Tiantian DENG ; Dongjian XU ; Liling MAO
Chinese Journal of General Practitioners 2024;23(2):180-184
Based on the analysis of the existing problems and implementation dilemmas in family doctor contracting and first-return-visits faced by primary medical institutions in China, the authors propose countermeasures to provide reference for managers of primary health care institutions.
9.Practice and thinking of building active learning general practice team based on learning health system
Fei SHENG ; Tiantian DENG ; Dongjian XU ; Liling MAO ; Jing PU ; Yu LIU ; Ping YU ; Weifang LIU ; Fulai SHEN ; Puyang ZHENG
Chinese Journal of General Practitioners 2024;23(4):399-405
By sorting out the differences and connections between family doctor teams and specialized disease teams, role competency and mutual collaboration, and introducing the learning health system (LHS) mechanism, a comprehensive operating system for community general practice learning organizations based on LHS was constructed, focusing on five single disease types. The system includes a combination of general and specialized medicine that links three levels of medical institutions, thereby opening up the business cooperation process between professionals in different institutions, and establishing a sustainable collaboration mechanism. This allows medical institutions at three levels to continuously tap the potential of their disciplines, achieve their own ability growth and feel higher work value, and also bring better health solutions to residents, guided by the common goal of "health centered, patient centered".
10.Spatiotemporal distribution characteristics of polychlorinated dibenzo-p-dioxins and dibenzofurans in PM2.5 in Pudong of Shanghai and population health assessment
Wanlian MAO ; Lijuan JIA ; Xiaoyu SHEN ; Xiaoqian CHEN ; Yuxin ZHU ; Pinchuan YANG ; Yunyun DENG
Journal of Environmental and Occupational Medicine 2024;41(5):482-488
Background In the Global Burden of Disease research, it has been found that atmospheric fine particulate matter (PM2.5) pollution significantly harms human health. Currently, there is limited research on polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/Fs) that exhibit high toxicity effects in PM2.5 . Objective By studying the spatiotemporal distribution and variation characteristics of PCDD/Fs in PM2.5 in Pudong area of Shanghai, to assess the associated population health risk. Methods This study set up 28 sampling points in Pudong area. One sample of PM2.5 was collected during winter (February 2022) and summer (July 2022) at each site, with a sampling period lasting 24 h. The concentration of PM2.5 was measured by membrane filter method, and the content of 17 kinds of 2,3,7,8-substituted chlorinated PCDD/Fs in the samples was analyzed using isotope dilution. Seasonal variations (winter and summer) in the concentrations of PM2.5 and PCDD/Fs were evaluated, sources of PCDD/Fs pollution were tracing by principal component analysis, and health risks to the population from respiratory exposure to PCDD/Fs were estimated by VLIER-HUMAAN model. Results The PM2.5 concentrations in the 28 samples ranged from 10 to 126 μg·m−3, while the concentrations of PCDD/Fs in PM2.5 ranged from 58 to 2625 fg·m−3. The concentration of PM2.5 during winter (11-126 μg·m−3) was higher than that during summer (10-60 μg·m−3). The concentration range of PCDD/Fs in winter was from 58 to 2625 fg·m−3, which corresponded to a range of toxic equivalent quantity (WHO-TEQ) concentration from 2.99 to 40.97 fg·m−3 when taking World Health Organization's toxic equivalency factor (WHO-TEQ); the concentration range of PCDD/Fs in summer was from 72 to 446 fg·m−3, which corresponded to a range of WHO-TEQ concentration from 2.66 to 16.61 fg·m−3. This range in summer was significantly lower than that observed in winter. The results of principal component analysis revealed that waste incineration was the primary source of PCDD/Fs in winter PM2.5 in the area, whereas traffic emissions emerged as the main source in summer. The assessment of Pudong residents' respiratory exposure to PCDD/Fs in PM2.5 showed significantly higher exposure of children in summer and winter than that of adults, indicating higher susceptibility of children to air pollutants. Both the hazard ratios (HR) for children and adults were below 1, while the cancer risks (CR) ranged from 8.41×10−8 to 2.35×10−6. Notably, during winter, the CR at 4 locations slightly exceeds 1×10−6, indicating a potential carcinogenic risk. Conclusion The overall pollution level of PCDD/Fs in PM2.5 in Pudong area is relatively low, but it shows clear seasonal patterns. Waste incineration and traffic are the main sources of PCDD/Fs in PM2.5 in the area. Although the cancer risk of exposure to PCDD/Fs in PM2.5 for children or adults is relatively low, there is a certain risk at some locations in winter, necessitating additional monitoring and control.

Result Analysis
Print
Save
E-mail