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.Changes in hepatic bile acid profile in a mouse model of metabolic-associated steatohepatitis induced by a high-fat, high-sugar, and high-cholesterol diet combined with carbon tetrachloride
Jingjing WANG ; Jinghua PENG ; Yu LIU ; Feipeng XU ; Wei LIU ; Hailin YANG ; Ping LIU
Journal of Clinical Hepatology 2025;41(4):661-669
ObjectiveTo compare the hepatic bile acid profile between a mouse model of metabolic-associated steatohepatitis (MASH) induced by a high-fat, high-sugar, and high-cholesterol diet combined with intraperitoneal injection of 10% carbon tetrachloride (CCl4) and MASH cases in clinical practice, and to investigate the feasibility of this model in studying drug interventions on bile acid profile in MASH. MethodsA total of 30 male C57BL/6J mice were randomly divided into control group and model group, with 15 mice in each group. The mice in the control group were given normal diet and drinking water and weekly injections of olive oil, and those in the model group were given a high-fat, high-sugar, and high-cholesterol diet, high-sugar drinking water, and weekly injections of CCl4+olive oil. At the end of weeks 8, 12, and 16, 5 mice were selected from each group to collect samples. Behavioral assessments were performed, and body weight and liver wet weight were measured; liver pathology and lipid deposition were evaluated by HE staining, SAF scoring, oil Red O staining, the semi-quantitative analysis of stained area, the serum levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and liver triglyceride (TG) content; Sirius Red staining was performed for liver tissue to assess liver fibrosis; ultra-performance liquid chromatography-tandem mass spectrometry and targeted metabolomics were used to measure the hepatic bile acid profile, including cholic acid (CA), glycocholic acid (GCA), chenodeoxycholic acid (CDCA), glycochenodeoxycholic acid (GCDCA), ursodeoxycholic acid (UDCA), tauroursodeoxycholic acid (TUDCA), hyodeoxycholic acid (HDCA), and glycodeoxycholic acid (GDCA). The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Wilcoxon rank-sum test was used for comparison of non-normally distributed continuous data between two groups. ResultsCompared with the control group at the same time point, the model group had disheveled and dull fur, reduced activity, and relatively slow reactions at weeks 8, 12, and 16, as well as significant increases in liver wet weight (P<0.05), the serum level of ALT (P<0.05), the content of TG in the liver (P<0.05), and SAF score (P<0.05). As for the differentially expressed bile acids in liver tissue, compared with the control group at week 8, the model group had significantly higher levels of CA and CDCA and significantly lower levels of UDCA, TUDCA, HDCA, and GDCA (all P<0.05); compared with the control group at week 12, the model group had significantly higher levels of CA, GCA, CDCA, and GCDCA and significantly lower levels of UDCA and HDCA (all P<0.05); compared with the control group at week 16, the model group had significantly higher levels of CA, GCA, CDCA, GCDCA, and TUDCA and significantly lower levels of UDCA, HDCA, and GDCA (all P<0.05). As for the differentially expressed bile acids in the bile acid pool of liver tissue, compared with the control group at week 8, the model group had significantly higher levels of CA and CDCA and significantly lower levels of UDCA, TUDCA, GDCA, and HDCA (all P<0.05); compared with the control group at weeks 12 and 16, the model group had significantly higher levels of GCA and GCDCA and significantly lower levels of UDCA, GDCA, and HDCA (all P<0.05). ConclusionThere are significant changes in the hepatic bile acid profile in a mouse model of MASH induced by a high-fat, high-sugar, and high-cholesterol diet combined with CCl4, which are similar to the changes in bile acids in MASH cases in clinical practice, suggesting that this model can be used to explore the interventional effect of drugs on the bile acid profile in MASH.
4.Measurement and application of radiation field distribution in Halcyon linear accelerator treatment room
Yatao LIU ; Yanling YI ; Wentao ZHAO ; Haikuan LIU ; Xiangyu E ; Jingping YU ; Hongwei ZENG
Chinese Journal of Radiological Health 2025;34(5):740-745
Objective To measure radiation filed distribution in the treatment room of the Varian Halcyon medical linear accelerator, and to provide a basis for shielding design and potential exposure analysis of treatment rooms for this type of accelerator. Methods Under the 6 MV X-ray (FFF) mode at a maximum dose rate of 800 MU/min and a maximum irradiation field of 28.00 cm × 28.00 cm, a total of 540 MU was delivered during gantry rotation. Radiation field distribution was measured using thermoluminescence dosimeters located at multiple points in the room. The measured data were then applied to shielding calculations, and the results were compared with those obtained using empirical formulas. Results The overall radiation levels in the treatment room were in the range of 12.2 µGy/540 MU to 5.520 Gy/540 MU, with the highest dose (5.520 Gy/540 MU) observed at the isocenter, and the lowest dose (12.2 µGy/540 MU) recorded at approximately 6.5 m from the gantry head. The radiation levels at most points were within the range of 100-
5.Immunological mechanism of drug-induced liver injury
Yu WANG ; Shuang LI ; Chenghai LIU
Journal of Clinical Hepatology 2024;40(12):2538-2542
Drug-induced liver injury (DILI) has a complex mechanism involving various pathways with a synergistic effect on each other and a causal relationship with each other, among which immune response plays an important role in the pathogenesis of DILI. In the context of genetic background, drug active metabolites, drug-molecule complexes, and danger signal molecules may be used as the trigger factors for immune response in DILI, activating the mechanism of drug antigenic hypersensitivity, P-i hypothesis, and danger signal mechanism in innate immunity. The cascade reaction of innate immunity and adaptive immunity leads to the imbalance of the innate immune tolerance of the liver and thus causes immunoinflammatory injury of liver tissue. This article mainly elaborates on the immunological mechanism of DILI, in order to provide new ideas for the research and development of therapeutic targets for DILI and the methods for avoiding adverse drug reactions.
6.Analysis of image features of fundus blood vessel in healthy human eye based on deep learning techniques
Mengyu HUI ; Jinglin SHI ; Xiaohan YU ; Jian LI ; Yan ZHANG ; Zhengli TANG ; Shanghai YU ; Yue GAO ; Ping LIU ; Hua ZHANG
International Eye Science 2024;24(10):1542-1550
AIM:To explore the fundus vascular characteristics of healthy individuals based on deep learning techniques, with a view to discovering the range of normal values of the fundus arteries and veins, as well as the relationship between physiological factors, such as gender, age, body mass index(BMI), blood pressure, and fundus vasculature characteristics.METHODS:Fundus images of healthy people were taken from a professional fundus camera, and the subject's blood pressure and laboratory test was collected. Additionally, the fundus arteries and veins were segmented by the improved U-Net model, and the color, morphology and Haralick texture features of the vessels were extracted from computer vision technology.RESULTS:A total of 4 487 cases fundus images were taken and 326 cases with healthy and clear fundus images were screened, including 200 males and 126 females. There were differences in the morphology, color, and textural characteristics of the left and right eyes, as well as of the fundus arterioles and veins, with a mean vessel width(width)of 1.146 in the arteries and 1.430 in the veins, and an arteriovenous ratio about 4:5. Fundus artery and vein characteristics in healthy individuals of different ages(21-30, 31-40, 41-50): compared with the healthy population aged 21-30 and 31-40 years, arterial and venous inverse difference moment(idm), f12 and venous angular second moment(asm)values increased, and arterial and venous contrast(con), entropy(ent), difference entropy(den), and venous sum entropy(sen)values decreased in 41-50 years. Compared with the 21-30 years age group, arterial f12 values increased and venous con values decreased in 31-40 years(all P<0.05). Fundus vascular characteristics of healthy individuals of different sexes: compared with male, fundus arterial and venous sum average(sav), sum variance(sva)values, arterial curved values, and venous b mean, bsd, variance(var), sen, ent values increased in female, while venous area value of female decreased(all P<0.05). There were no statistically significant differences in fundus arteriosus and venous features in healthy subjects with different levels of BMI(all P>0.05). Fundus characteristics of healthy people with different degrees of blood pressure: there were statistically significant differences in fundus arteriosus area, width, and venous con, idm, dva, and den values between the normal blood pressure and high blood pressure groups(all P<0.05).CONCLUSION: The characteristics of the left and right eyes as well as the fundus arteries and veins differ in healthy individuals and correlate with physiological factors such as gender, age and blood pressure, which have the value of a potential microcirculation marker.
7.Variation of 137Cs activity concentration in aerosol in Beijing
Huan WANG ; Qinghua MENG ; Yun LOU ; Bin BAI ; Weijie ZHU ; Hongfang WANG ; Yuxia KONG ; Zechen FENG ; Shuguang ZHAI ; Jun YU ; Yaru SUN ; Yongzhong MA
Journal of Environmental and Occupational Medicine 2024;41(9):1038-1042
Background 137Cs in atmospheric aerosol is the product of past nuclear weapon tests and nuclear accidents. When 137Cs is released into the atmosphere, it will deposit in dry land and marine environment, causing pollution of soil surface, water, agricultural products, and animal byproducts, and affecting public health. Objective To identify the variation pattern of 137Cs activity concentration in aerosol and its correlation with dust concentration in Beijing area from 2017 to 2020. Methods A total of 958 aerosol samples were collected from November 1, 2017 to June 30, 2020 in Beijing with a high volume air sampler at a sampling flow rate about 600 m3·h−1 and a collection time for each sample about 24 h. The activity concentration of 137Cs in the aerosol samples was determined with a low-background high-purity germanium γ spectrometer. The dust concentration was calculated using the difference in the mass of the aerosol filter before and after sampling. The detection rate of 137Cs and dust concentration in different seasons were compared. Spearman rank correlation test was used to analyze the correlation between 137Cs activity concentration and dust concentration. Results From 2017 to 2020, the 137Cs activity concentrations of 33 from 958 aerosol samples in Beijing were above the minimum detectable activityconcentration, the overall detection rate of 137Cs was 3.4%, and the activity concentration ranged from 1.86 to 45.53 μBq·m−3, with a median value of 4.85 μBq·m−3. The detection rate of 137Cs was highest in spring, followed by autumn, and lowest in winter and summer (8.4%, 3.0%, 1.1%, and 0.5%, respectively). The dust concentration ranged from 0.03 to 1.55 mg·m−3, with an average value of 0.18 mg·m−3. There was a statistically significant difference in the dust concentrations in spring, summer, autumn, and winter (F=45.51, P<0.05), and the highest value was 0.24 mg·m−3 in spring (P<0.05). The 137Cs activity concentration was positively correlated with the dust concentration (P<0.05). Conclusion The 137Cs activity concentration in aerosol in Beijing from 2017 to 2020 fluctuates within the range of background level, and its activity concentration is highest in spring, followed autumn, and lowest in summer and winter.
8.Evaluation of analgesic effect of nalbuphine in patients with non-mechanical ventilation in intensive care unit: a multi-center randomized controlled trail
Yi ZHOU ; Shaohua LIU ; Song QIN ; Guoxiu ZHANG ; Yibin LU ; Xiaoguang DUAN ; Haixu WANG ; Ruifang ZHANG ; Shuguang ZHANG ; Yonggang LUO ; Yu FANG ; Xiaoyun FU ; Tao CHEN ; Lening REN ; Tongwen SUN
Chinese Journal of Emergency Medicine 2024;33(1):59-64
Objective:To analyze the efficacy and safety of nalbuphine for analgesia in patients with non-mechanical ventilation in intensive care unit (ICU).Methods:From December 2018 to August 2021, a multicenter randomized controlled clinical study was conducted to select non-mechanical ventilation patients with analgesic needs admitted to ICU of four hospitals in Henan Province and Guizhou Province. Patients were randomly assigned to nalbuphine group and fentanyl group. The nalbuphine group was given continuous infusion of nalbuphine [0.05~0.20 mg/(kg·h)], and the fentanyl group was given continuous infusion of fentanyl [0.5~2.0 μg/(kg·h)]. The analgesic target was critical-care pain observation tool (CPOT) score<2. The observation time was 48 hours. The primary endpoint was CPOT score, the secondary endpoints were Richmond agitation-sedation score (RASS), ICU length of stay, adverse events, and proportion of mechanical ventilation. The quantitative data of the two groups were compared by t test or Mann-Whitney U test. The enumeration data were compared by chi square test or Fisher exact probability method. The data at different time points between groups were compared by repeated measures analysis of variance. Results:A total of 210 patients were enrolled, including 105 patients in the nalbuphine group and 105 patients in the fentanyl group. There was no significant difference in baseline data between the two groups (all P>0.05). There was no significant difference in CPOT score between nalbuphine group and fentanyl group at each time point after medication ( P>0.05), the CPOT score of both groups at each time point after medication was significantly lower than that before medication, and the analgesic target could be achieved and maintained 2 hours after medication. There was no significant difference in RASS between the two groups at each time point after medication ( P>0.05), which was significantly lower than that before medication, and the target sedative effect was achieved 2 hours after medication. There was no significant difference in ICU length of stay between nalbuphine group and fentanyl group [5.0(4.0,7.5) d vs. 5.0(4.0,8.0) d, P=0.504]. The incidence of delirium, nausea and vomiting, abdominal distension, pruritus, vertigo and other adverse events in the nalbuphine group was lower than that in the fentanyl group (all P<0.05). There was no significant difference in the incidence of other adverse events such as deep sedation, hypotension and bradycardia between the two groups (all P>0.05). The incidence of respiratory depression in nalbuphine group was not significantly different from that in fentanyl group ( P>0.05), but the proportion of mechanical ventilation was significantly lower than that in the fentanyl group [1.9% (2/105) vs. 8.6%(9/105), P=0.030]. Conclusions:Nalbuphine could be used for analgesia in ICU patients with non-mechanical ventilation. The target analgesic effect could be achieved within 2 hours, and it had a certain sedative effect with a low incidence of adverse reactions.
9.Discussion on the Difference of Acupuncture Points Efficacy in Improving Ulcerative Colitis by"Zusanli"or"Neiguan"Based on Transcriptomics Data
Longcong DONG ; Ruibin ZHANG ; Yuan SHEN ; Hongying LI ; Qin HUANG ; Shuguang YU ; Qiaofeng WU
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(1):119-128
Objective To observe the intervention effect of acupuncture at"Zusanli"(ST36)or"Neiguan"(PC6)on the ulcerative colitis(UC)model mice.And to analyze the similarities and differences of gene transcription expression between the diseased colon and the non-diseased heart after acupuncture intervention by using transcriptomics,to explore whether there are efficacy differences between the two acupoints.Methods The UC mouse model was established by inducing dextran sulfate sodium salt(DSS).After successful modeling,the mice were randomly divided into model group,Zusanli group,and Neiguan group,with 9 mice in each group.Zusanli group and Neiguan group intervened with acupuncture at"Zusanli"and"Neiguan",respectively,30 min each time,once a day,for 5 consecutive days.The control and model groups were only bound without acupuncture.Observe the general situation of mice in each group,calculate the disease activity index(DAI),observe the morphological changes of colon tissue by HE staining.Use transcriptome sequencing technology to sequence and biologically analyze the colon tissue of mice in each group,and compare and study whether the two acupoints have differences in acupoint efficacy from the perspective of diseased tissue.At the same time,take the heart tissues of each group for comparative analysis,and discuss whether the effects of the two acupoints are different from the perspective of non-diseased tissue.Results Compared with control group,the DAI score of the model group increased significantly(P<0.001),and HE staining results showed significant pathological damage;after acupuncture at Zusanli or Neiguan,the DAI scores of UC mice were reduced considerably(P<0.05),and the pathological damage was significantly improved.The results of transcriptome sequencing and bioinformatics analysis showed that the effects of acupuncture at Zusanli or Neiguan on the colon of diseased tissue involved multiple genes,and 825 differential genes with similar changes(co-DEGs)were mainly enriched in white blood cells and chemokine pathways;there were 168 differentially expressed genes(ST36 only-DEGs)affected only by Zusanli,which were enriched to gastric acid secretion and other pathways;there were 325 differentially expressed genes(PC6 only-DEGs)only affected by Neiguan,which were enriched in cytokine-cytokine receptor interaction and other pathways.There were 95 co-DEGs in the heart of non-diseased tissue,which were mainly enriched in positive regulation of defense response and response to interleukin-1;there were 28 ST36 only-DEGs;there were114 PC6 only-DEGs,which were enriched in cardiovascular diseases and other pathways.Conclusion Acupuncture of"Zusanli"and"Neiguan"could improve UC mice's symptoms and pathological colon changes.However,through transcriptomic analysis,it was found that the two acupoints had differences in gene transcription effects on the colon of diseased tissue and the heart of non-diseased tissue,suggesting that acupoints with different distribution positions had some similarities in macro efficacy.Still,there were some differences at a micro level.
10.Research progress on experimental models of idiopathic pulmonary fibrosis
Zhihui LI ; Xueqing YU ; Shuguang YANG ; Ningxia YU ; Danyang ZANG
Acta Laboratorium Animalis Scientia Sinica 2024;32(1):118-127
Idiopathic pulmonary fibrosis(IPF)is a chronic,progressive interstitial lung disease.IPF incidence is increasing yearly with high mortality and poor prognoses.At present,IPF pathogenesis remains unclear,and its treatments are limited.The experimental model is important to further study IPF pathogenesis and explore effective preventive and therapeutic measures.In recent years,its modeling method have been continuously developed and optimized.This study summarizes the establishment method and research progress of IPF experimental models in recent years to provide ideas and references for preclinical research to select appropriate experimental models.

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