1.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
2.The application value of quantitative parameters MRFDGmax and SUVmax in the stages of hepatitis,liver fibrosis and cirrhosis in rats by whole-body dynamic 18F-FDG PET/CT Patlak imaging
Huimin SHI ; Jinzhou ZHANG ; Xin WANG ; Gan ZHU ; Xuefeng ZHAO ; Hui WANG
Acta Universitatis Medicinalis Anhui 2024;59(2):230-235
Objective To investigate the application value of quantitative parameters MRFDGmax and SUVmax in the stages of hepatitis,liver fibrosis and cirrhosis in rats by whole-body dynamic 18 F-FDG PET/CT Patlak imaging.Methods Twenty-four SD rats were randomly divided into four groups of six rats each,which were the normal group,hepatitis group,liver fibrosis group and cirrhosis group.According to the experimental grouping,rats in each group were induced by the CC14 oil solution complex method.Whole-body dynamic 18 F-FDG PET/CT patlak imaging was performed on each group of rats separately at the completion of induction.After the imaging was com-pleted,the MRFDGmax,SUVmax and CT values of the livers of each group were analyzed;subsequently,the serum of rats in each group was extracted for the detection of liver function indexes(AST,ALT and ALP),and HE staining was performed on the livers of rats in the normal,hepatitis and cirrhosis groups,and Masson staining was performed on those in the liver fibrosis group;the α-SMA expression in the liver tissues of each group was analyzed by immu-nohistochemical method.The data were analyzed by one-way ANOVA,two independent samples t-test and Pearson correlation analysis.Results MRFDGmax,SUVmax values were statistically significant differences among normal,hep-atitis,liver fibrosis and cirrhosis groups(F=84.54,38.35,P<0.001).The difference in CT values between liver fibrosis and cirrhosis groups was not statistically significant(t=-0.407,P=0.693),and the difference was statistically significant when compared between the rest of the groups(F=112.25,P<0.001).Compared with the normal group,AST,ALT and ALP of the experimental group showed a staged increase,and the differences were statistically significant(F=93.32,64.63,145.03,P<0.001).HE staining showed that hepatocytes of the normal group were neatly arranged and structurally intact;a large number of inflammatory cells infiltrated the hepa-titis group with steatosis;pseudo lobe formation was observed in the cirrhosis group.Masson staining of the liver fi-brosis group showed collagen fiber proliferation and thickening of the peritoneum.Immunohistochemistry test results showed that α-SMA expression increased in hepatitis group,liver fibrosis group and cirrhosis group,with a staged increase,and the difference was statistically significant(F=80.57,P<0.001).Correlation analysis showed a positive correlation between SUVmax and MRFDGmax(r=0.967,P<0.01).α-SMA was positively correlated with AST,ALT and ALP in the hepatitis,liver fibrosis and cirrhosis groups,respectively(r=0.924,0.756,0.934,P<0.01).Conclusion Whole-body dynamic 18F-FDG PET/CT Patlak imaging has application value in monitoring hepatitis,liver fibrosis and cirrhosis stages through quantitative parameters MRFDGmax and SUVmax changes.
3.Influencing factors for rebleeding after endoscopic therapy in patients with liver cirrhosis receiving secondary prevention of gastroesophageal varices
Shuang ZHAO ; Yuxuan ZHU ; Yue LIU ; Jing WANG ; Qun LI ; Minghui WANG ; Qianqian DONG ; Feifei FAN ; Xiaofeng LIU
Journal of Clinical Hepatology 2024;40(12):2430-2440
ObjectiveTo investigate the influencing factors for rebleeding after endoscopic therapy and the effect of the number of sequential treatment sessions on postoperative rebleeding in patients with liver cirrhosis receiving secondary prevention of gastroesophageal varices (GOV). MethodsA total of 1 717 patients with liver cirrhosis who received secondary prevention of GOV and attended The 960th Hospital of the PLA Joint Logistice Support Force from January 2017 to December 2021 were enrolled, and according to the presence or absence of bleeding after endoscopic therapy, they were divided into non-bleeding group and rebleeding group. The influencing factors for rebleeding were analyzed, as well as the association between the number of endoscopic treatment sessions and rebleeding. The chi-square test was used for comparison of categorical data between groups; the independent-samples t test or the Mann-Whitney U test was used for comparison of continuous data between the two groups; the Kruskal-Wallis H test was used for comparison bertween multiple groups, and the Wilcoxon test was used for further comparison between two groups. The Cox regression model was used to investigate the influencing factors for rebleeding, and the Kaplan-Meier method was used to plot survival curves, while the Log-rank test was used for comparison between groups. ResultsOf all patients, 286 (16.7%) experienced rebleeding after endoscopic therapy, and 1 431 (83.3%) did not experience bleeding. There were significant differences between the two groups in history of smoking and drinking, etiology of liver cirrhosis, hemoglobin (Hb), prothrombin time (PT), prothrombin activity (PTA), international normalized ratio (INR), albumin (Alb), fasting blood glucose, blood urea nitrogen, Child-Pugh class, aspartate aminotransferase-to-platelet ratio index (APRI) score, albumin-bilirubin (ALBI) score, use of non-selective beta-blocker (NSBB) before surgery, treatment modality, type of varices, and maximal varicose vein diameter (all P<0.05). The univariate Cox regression analysis showed that in the patients with liver cirrhosis who received secondary prevention of GOV, rebleeding was associated with history of smoking and drinking, etiology of liver cirrhosis, use of NSBB before surgery, treatment modality, maximal varicose vein diameter, Hb, platelet count, PT, PTA, INR, Alb, total bilirubin (TBil), alkaline phosphatase (ALP), gamma-glutamyl transpeptidase, blood glucose, Child-Pugh class, and ALBI score (all P<0.05). The multivariate Cox regression analysis showed that Hb (hazard ratio [HR]=0.989, 95% confidence interval [CI]: 0.983 — 0.994, P<0.001), TBil (HR=1.020, 95%CI: 1.006 — 1.034, P=0.005), Alb (HR=0.868, 95%CI: 0.758 — 0.994, P=0.041), treatment modality (sclerosing agent: HR=2.158, 95%CI: 1.342 — 3.470, P=0.002; tissue adhesive: HR=2.709, 95%CI: 1.343 — 5.462, P=0.005; ligation+sclerosing agent: HR=3.181, 95%CI: 1.522 — 6.645, P=0.002; sclerosing agent+tissue adhesive: HR=1.851, 95%CI: 1.100 — 3.113, P=0.020), ALP (HR=1.003, 95%CI: 1.001 — 1.004, P=0.002), and maximal varicose vein diameter (HR=1.346, 95%CI: 1.119 — 1.618, P=0.002) were independent influencing factors for rebleeding after endoscopic therapy. Comparison of rebleeding rate after different numbers of sequential treatment sessions showed that the patients treated for three sessions had a significantly lower rebleeding rate than those treated for one or two sessions (χ2=8.643 and 5.277, P=0.003 and 0.022). The survival analysis showed that with the increase in the number of treatment sessions, there was a significantly longer interval between rebleeding (P=0.006) and a significantly lower mortality rate (P<0.001). ConclusionThe levels of TBil, ALP, Hb, and Alb on admission, endoscopic treatment modality, and maximal varicose vein diameter were the main predictive factors for rebleeding after endoscopic therapy for GOV in liver cirrhosis, and such predictive factors should be closely monitored in clinical practice. Regular endoscopic therapy can reduce the rebleeding and mortality rates of patients with liver cirrhosis and GOV and prolonmg the interval between rebleeding.
4.The use of whole-body dynamic 18 F-FDG PET/CT Patlak multiparametric imaging to monitor the synergistic effect and distant effect of PD-1 antibody combined with radiotherapy in the treatment of B16F10 melanoma in mice
Jinzhou ZHANG ; Huimin SHI ; Liya ZHANG ; Jingxuan MIAO ; Gan ZHU ; Xuefeng ZHAO ; Hui WANG
Acta Universitatis Medicinalis Anhui 2024;59(8):1385-1391
Objective To monitor and evaluate the synergistic antitumor effects of programmed death-1(PD-1)checkpoint inhibitor combined with radiation therapy through whole-body dynamic 18 F-Fluorodeoxy glucose positron emission computed tomography(18F-FDG PET/CT)and Patlak multi-parametric analysis.Methods B16F10 mel-anoma dual-tumor mouse model was established and randomly divided into control,PD-1 monoclonal antibody,ra-diation-only,and combination groups(n=6).Whole-body 18F-FDG PET/CT imaging was performed before and 24 hours post-treatment.The changes of maximum standardized uptake value(SUVmax)and metabolic rate of FDG(MRFDG)changes were analyzed and compared.Mice were then euthanized,tumors excised and underwent histo-pathology with HE,CD8,Ki-67 staining to assess immune infiltration and proliferation.Distal tumor volumes were monitored during treatment.Results At 24 hours post-treatment,in the primary tumors,SUVmax and MRFDG values increased compared to pre-treatment in the control group(P<0.000 1),while they decreased in the combination treatment group(P<0.000 1),with statistically significant differences.In the distal tumors,SUVmax and MRFDG values increased compared to pre-treatment in the control group,PD-1 monoclonal antibody group,and radiothera-py-alone group.The SUVmax differences were statistically significant in the control group before and after treatment(P<0.000 1).MRFDG values in the distal tumors showed statistically significant differences in all three groups(P<0.01 or P<0.000 1).In the combination treatment group,SUVmax and MRFDG values in the distal tumors de-creased significantly compared to pre-treatment(P<0.000 1).Post-treatment comparison of SUVmax and MRFDG values in the distal tumors showed that statistically significant differences in SUVmax and MRFDG values were observed among all groups except between the radiotherapy-alone and PD-1 monoclonal antibody groups(all P<0.05).Im-munohistochemistry results showed that the mean absorbance value of CD8 T lymphocytes in the distal tumor was significantly higher than that in the other three groups(P<0.001);the mean absorbance value of Ki-67 immuno-histochemistry in the distal tumor proliferation index was significantly lower than that in the other three groups(P<0.001).Conclusion The synergistic effects of combined treatment reduced distal tumor growth.Whole-body 18F-FDG PET/CT Patlak multi-parametric imaging can monitor the synergistic effects of PD-1 antibody and radiotherapy in B16F10 melanoma,providing reliable imaging parameters for optimizing combinatorial therapies.
5.Development of a few-shot learning based model for the classification of colorectal submucosal tumors and polyps on endoscopic images
Yahui WU ; Shiqi ZHU ; Yudong WU ; Rufa ZHANG ; Jinzhou ZHU
Chinese Journal of Medical Physics 2024;41(7):897-904
Objective To address the difficulty in collecting sufficient endoscopic images of colorectal submucosal tumors for traditional deep learning model training,a few-shot learning based model(FSL model)is proposed for classifying colorectal submucosal tumors and polyps on endoscopic images.Methods A total of 172 endoscopic images of colorectal submucosal tumors were collected from different centers,including 43 each of colorectal lipomas(CRLs),neuroendocrine tumors(NETs),serrated lesions and polyps(SLPs),and traditional adenomas.A support set and a query set were constructed using these endoscopic images.ResNet50 which was pre-trained on ImageNet and esophageal endoscopic images was used to extract image features.Subsequently,K-nearest neighbors algorithm was used for classification based on the calculated Euclidean distance.The classification performance of FSL model was evaluated through the comparison with the original model and endoscopists.Results FSL model had a 4-class classification accuracy of 0.831,Macro AUC of 0.925,Macro F1-score of 0.831;moreover,the proposed model achieved diagnostic accuracies of 0.925 and 0.906 for CRLs and NETs,with F1 score of 0.850 and 0.805.Additionally,the proposed model exhibited high classification consistency(Kappa=0.775)and interpretability.Conclusion The established FSL model performs well in distinguishing CRLs,NETs,SLPs and traditional adenomas on endoscopic images,indicating its potential utility in assisting the identification of colorectal submucosal tumors under endoscopy.
6. Effects of single nucleotide polymorphism of drug metabolizing enzyme cytochrome P450 on the efficacy of inhaled cortisol hormone in asthmatic children
Li ZHU ; Xiaoyu ZHENG ; Yajun LIU ; Bing WEI ; Shi'e LIAO ; Chao ZHANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2023;28(5):536-543
AIM: To elucidate the relationship between childhood asthma susceptibility and clinical efficacy of inhaled glucocorticoids (ICS) in children with different genotypes of asthma by exploring rs776746 and rs15524 single nucleotide polymorphisms (SNPs) of cytochrome P450 enzyme 3A5 (CYP3A5) gene in asthmatic children and healthy children. METHODS: The CYP3A5 gene rs776746 and rs15524 polymorphic sites were detected in 79 children (Case group) with asthma of Han nationality and 100 healthy children (Control group) who met the inclusion criteria admitted to the Northern Theater General Hospital in Northeast China from October 2016 to October 2020, and genotype, allele and linkage analysis were performed. The case group was given inhaled glucocorticoids by nebulised inhalation for 3 months, and lung function and exhaled breath nitric oxide (FeNO) were measured at entry and after treatment, and asthma control score C-ACT/ACT was done after treatment, so as to compare the prevalence of different genotypes and the differences in the above test index scores. RESULTS: There was complete linkage disequilibrium at rs776746 and rs15524 loci. There were three genotypes of T/T, T/C and C/C at rs776746 locus of CYP3A5 gene. There were significant differences in the frequency of different genotypes between the case group and the control group (χ
7.Quantitative susceptibility mapping of the substantia nigra subregions in relapsing-remitting multiple sclerosis patients
Feiyue YIN ; Yongmei LI ; Shuang DING ; Yayun XIANG ; Qiyuan ZHU ; Xiaohua WANG ; Zeyun TAN ; Jinzhou FENG ; Chun ZENG
Chinese Journal of Radiology 2023;57(6):632-639
Objective:To investigate the distribution of iron deposition in the substantia nigral (SN) subregions on quantitative susceptibility mapping (QSM) and the change of swallow tail sign (STS) in patients with relapsing-remitting multiple sclerosis (RRMS) of different disease stages.Methods:The clinical and imaging data of 53 patients with RRMS (case group) diagnosed at the First Hospital of Chongqing Medical University from November 2019 to December 2021 were retrospectively analyzed. The case group was divided into 0-5 years subgroup, 6-10 years subgroup, and >10 years subgroup according to the disease duration; another 37 age-and gender-matched healthy volunteers were recruited as the control group during the same period. All subjects underwent MRI and QSM reconstruction. First, the SN was divided into four subregions: rostral anterior-SN (aSNr), rostral posterior-SN (pSNr), caudal anterior-SN (aSNc), and caudal posterior-SN (pSNc) on the QSM, and the quantitative susceptibility value (QSV) of each subregion was measured, and then the STS of the SN was observed and scored on the susceptibility weighted imaging (SWI) generated by post-processing. ANOVA was used to compare the differences in the QSV of each subregion of SN among the groups, and the probability of abnormal STS was compared using the χ 2 test. Spearman′s test was used to analyze the correlation between the QSV of each subregion of SN and the STS score. Results:The differences in QSV of aSNr, pSNr, aSNc, and pSNc were statistically significant among the 0-5 years subgroup, 6-10 years subgroup,>10 years subgroup of RRMS patients and the control group ( P<0.05). The QSV of aSNr, pSNr, and aSNc in 0-5 years subgroup was higher than those in the control group ( P was 0.039, 0.008, 0.039, respectively). The QSV of aSNr, aSNc, and pSNc in the 6-10 years subgroup were higher than those in the 0-5 years subgroup ( P was <0.001, 0.020, 0.015, respectively). The QSV of the aSNc, pSNc in >10 years subgroup were lower than those in the 6-10 years subgroup ( P=0.037, 0.006). The QSV of aSNr, pSNr in >10 years subgroup were higher than those in the control group ( P was <0.001, 0.001). There were 7 cases of abnormal STS in the 0-5 years subgroup, 11 cases in the 6-10 years subgroup, 12 cases in >10 years subgroup, and 9 cases in the control subgroup, and there was a statistically significant difference in the probability of abnormal STS among the subgroups of the RRMS patients and the control subgroup (χ 2=16.20, P=0.011). Both the scores of STS in the 6-10 years subgroup and >10 years group were positively correlated with the QSV in pSNc ( r s=0.65, P=0.006; r s=0.48, P=0.045). Conclusions:In RRMS patients, SN iron deposition is concentrated on aSNr, pSNr, and aSNc in the 0-5 years subgroup and on aSNr, aSNc and pSNc in the 6-10 years subgroup. The QSVs of all SN subregions have a downward trend in >10 years subgroup compared with that in the 6-10 years subgroup. Both the QSVs of the pSNc in the 6-10 years group and >10 years group are positively related to STS scores. These help explore the potential progression pattern of SN iron deposition in RRMS patients and the cause of abnormal STS in RRMS patients.
8.Effect of different input functions of whole-body dynamic 18F-FDG PET/CT imaging reconstruction on quantitative parameters of lung cancer
Liya ZHANG ; Jinzhou ZHANG ; Gan ZHU ; Wenjing YU ; Huiqin XU ; Hui WANG
Chinese Journal of Radiological Medicine and Protection 2023;43(2):138-142
Objective:To investigate the effect of using two different input functions to reconstruct 18F-FDG PET/CT Patlak multi-parameter images on the quantitative parameters of lung cancer lesions. Methods:The original whole-body dynamic 18F-FDG PET/CT scan data of lung cancer patients in the Department of Nuclear Medicine, First Affiliated Hospital of Anhui Medical University were retrospectively analyzed. The total scan time was 75 min. Two input functions were used for Patlak multi-parameter reconstruction: ① Image-derived input function(IDIF)using the Time-activity curve(TAC)of descending aorta from 0 min to 75 min. ② Population-based input function (PBIF) developed by Yale University. Metabolic rate of FDG (MR FDG) and Distribution volume (DV) images were obtained by Patlak multi-parameter analysis software using the above input functions. The region of interest (ROI) method was used to delineate the lesions to obtain multi-parameter quantitative information, including the max, peak and mean value of MR FDG and DV. Paired t-test was used for statistical analysis. Results:The original data of 27 lung cancer patients who received whole-body dynamic 18F-FDG PET/CT imaging were reconstructed by Patlak with two different input functions. The max, peak and mean values of MR FDG-IDIF and MR FDG-PBIF in lung cancer lesions were as follows: (0.26 ± 0.15), (0.19 ± 0.12), (0.14 ± 0.08)μmol·min -1·ml -1 and (0.26 ± 0.15), ( 0.20 ± 0.13), (0.15 ± 0.09)μmol·min -1·ml -1, with no statistically significant difference between two functions( P > 0.05). The max, peak and mean values of DV IDIF and DV PBIF were (165.56 ± 99.89)%, (117.66 ± 72.24)%, (62.16 ± 33.65)% and(170.04 ± 103.93)%, (121.91 ± 73.71)%, (65.05 ± 37.17)%, with no statistically significant difference between two functions ( P > 0.05). Conclusions:The population-based input function may be an alternative for patients who could not lie supine for long time during whole-body dynamic 18F-FDG PET/CT Patlak multi-parameter imaging.
9.Research advances in machine learning models for acute pancreatitis
Minyue YIN ; Jinzhou ZHU ; Lu LIU ; Jingwen GAO ; Jiaxi LIN ; Chunfang XU
Journal of Clinical Hepatology 2023;39(12):2978-2984
Acute pancreatitis (AP) is a gastrointestinal disease that requires early intervention, and when it progresses to moderate-severe AP (MSAP) or severe AP (SAP), there will be a significant increase in the mortality rate of patients. Machine learning (ML) has achieved great success in the early prediction of AP using clinical data with the help of its powerful computational and learning capabilities. This article reviews the research advances in ML in predicting the severity, complications, and death of AP, so as to provide a theoretical basis and new insights for clinical diagnosis and treatment of AP through artificial intelligence.
10.Carnosic acid affects the proliferation, migration, and invasion of gastric cancer AGS cells by regulating CXCR7/CXCL12 axis
ZHANG Xina ; LI Dinuob ; TIAN Leia ; ZHU Jinpenga ; HAN Xiangdongb
Chinese Journal of Cancer Biotherapy 2023;30(8):695-700
[摘 要] 目的:探讨鼠尾草酸(CA)通过调节CXC基序趋化因子受体7(CXCR7)/CXC基序趋化因子配体(CXCL12)轴对胃癌AGS细胞增殖、迁移和侵袭的影响。方法:用不同浓度(0、5、10、20、40、80 µg/mL))的CA处理胃癌AGS细胞,采用CCK-8法筛选合适的CA浓度;将AGS细胞分为对照组(未经处理的AGS细胞)、CA组(20 µg/mL CA处理)、CA+siCXCR7组(转染siCXCR7+20 µg/mL CA处理)、CA+siNC组(转染siNC+20 µg/mL CA处理)、CA+vectorNC组(转染vectorNC+20 µg/mL CA处理)、CA+vectorCXCR7组(转染vectorCXCR7+20 µg/mL CA处理),采用CCK-8法检测AGS细胞增殖的变化,qPCR法检测细胞中CXCR7、CXCL12 mRNA表达水平的变化,Transwell实验检测细胞侵袭能力的变化,划痕实验检测细胞迁移能力的变化,WB法检测周期蛋白D1、Bcl-2、CXCR7、CXCL12、MMP-2蛋白表达的变化。结果:不同浓度CA均可抑制AGS细胞存活率,且浓度为20 µg/mL时,细胞存活率接近50%,故选择20 µg/mL CA用于后续研究。与对照组相比,CA组增殖率、侵袭数、迁移率、周期蛋白D1、MMP-2、Bcl-2、CXCR7、CXCL12 mRNA及蛋白表达显著降低(均P<0.05);与CA+siNC组相比,CA+siCXCR7组增殖率、侵袭数、迁移率、周期蛋白D1、MMP-2、Bcl-2、CXCR7、CXCL12 mRNA及蛋白表达显著降低(均P<0.05);与CA+vectorNC组相比,CA+vectorCXCR7组增殖率、侵袭数、迁移率、周期蛋白D1、MMP-2、Bcl-2、CXCR7、CXCL12 mRNA及蛋白表达显著增加(均P<0.05)。结论:CA可抑制AGS细胞增殖、迁移和侵袭,其机制可能与抑制CXCR7/CXCL12轴有关。


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