1.Interpretation of the Syndrome Differentiation Capability Threshold of Artificial Intelligence-Based Traditional Chinese Medicine Diagnostic System and the Construction of Human-Machine Collaborative Paradigm:Based on the Dimension of Cognitive Subjectivity
Yingren ZHANG ; Nan NAN ; Wenzhi HAO ; Jiaxu CHEN
Journal of Traditional Chinese Medicine 2026;67(20):2155-2160
Traditional Chinese medicine (TCM) diagnosis is a cognitive process where practitioners rely on their subjective clinical experience and clinical perception abilities to comprehensively integrate the four examinations and flexibly differentiate syndromes, embodying a simple humanistic concern for the state of life. The essential characteristics of the subjectivity and experience of TCM diagnosis determine that there is a threshold in the syndrome differentiation capability of the artificial intelligence (AI)-based TCM diagnostic systems, which refers to a critical point of capability in the process of simulating the syndrome differentiation thinking, due to its inability to replicate the subjective cognition, clinical perception, and humanistic care of the practitioners. Furthermore, this threshold encompasses both a technical threshold and a theoretical threshold. Based on the above analysis, four human-machine collaborative practice paths are proposed to balance the application of AI technology and the subjectivity of TCM syndrome differentiation, including clarifying the auxiliary diagnosis and treatment positioning of AI, optimizing algorithms to achieve technical adaptation, strengthening the cultivation of the practitioner's subjectivity, and promoting interdisciplinary cross-collaboration, aiming to provide theoretical references for the development of AI-based TCM diagnostic systems towards human-machine collaborative clinical applications.
2.A phase Ⅲ clinical study to evaluate the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of adults with chronic hepatitis C
Lai WEI ; Jia SHANG ; Xuan AN ; Guoqiang ZHANG ; Yujuan GUAN ; Hongxin PIAO ; Jinglan JIN ; Lang BAI ; Xingxiang YANG ; Daokun YANG ; Xinhua LUO ; Shufang YUAN ; Yingren ZHAO ; Yingjie MA ; Guangming LI ; Feng LIN ; Xiaoping WU ; Jiawei GENG ; Guizhou ZOU ; Jiabao CHANG ; Zuojiong GONG ; Xiaorong MAO ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2025;33(6):560-569
Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA
3.A phase Ⅲ clinical study to evaluate the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of adults with chronic hepatitis C
Lai WEI ; Jia SHANG ; Xuan AN ; Guoqiang ZHANG ; Yujuan GUAN ; Hongxin PIAO ; Jinglan JIN ; Lang BAI ; Xingxiang YANG ; Daokun YANG ; Xinhua LUO ; Shufang YUAN ; Yingren ZHAO ; Yingjie MA ; Guangming LI ; Feng LIN ; Xiaoping WU ; Jiawei GENG ; Guizhou ZOU ; Jiabao CHANG ; Zuojiong GONG ; Xiaorong MAO ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2025;33(6):560-569
Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA
4.Chinese practice guideline for the prevention and treatment of mother-to-child transmission of hepatitis B virus(version 2024)
Infectious Diseases Physicians Branch,Chinese Medical Doctor Association ; Chinese Society of Infectious Diseases,Chinese Medical Association ; Yingren ZHAO ; Lanjuan LI ; Wenhong ZHANG
Journal of Clinical Hepatology 2024;40(8):1557-1566
The 2019 Chinese practice guideline for the prevention and treatment of mother-to-child transmission of hepatitis B virus developed by Chinese Society of Infectious Diseases,Chinese Medical Association,has shown a good guiding effect in standardizing the process for blocking the mother-to-child transmission of hepatitis B virus in China.Clinical practice guidelines and consensus statements require timely updates based on new research evidence,in order to better guide clinical practice and research.Chinese Physician Association for Infectious Diseases,Chinese Medical Doctor Association,and Chinese Society of Infectious Diseases,Chinese Medical Association,cooperated with multidisciplinary experts and performed updates and supplementations to the above guideline,in order to provide guidance and a reference for clinical physicians and medical staff engaged in maternal and child health care.
5.Mechanisms on radiation resistance induced by an estrogen receptor in breast cancer cells
Tianpeng YANG ; Shinan ZHANG ; Huilin JI ; Linhui ZHU ; Yujie ZHANG ; Jin HUANG ; Yingren WEN ; Shumei MA ; Xiaodong LIU
Chinese Journal of Radiological Medicine and Protection 2024;44(2):88-95
Objective:To explore the effects of estrogen receptor α (ERα) encoded by protein encoding gene ESR1 on the radiation resistance of breast cancer cells and their molecular mechanisms.Methods:The ESR1 overexpression plasmid was transfected into estrogen receptor (ER)-negative breast cancer cells. Then, the shRNA-ESR1 vector was introduced into ER-positive cell to establish models with different phenotype. The ATG5 mRNA level and protein expression levels of LC3B-I, LC3B-II, P62, FIP200, ATG5, ATG7, ATG12, Beclin1, ULK1 were detected using qPCR and Western blot techniques. Cell death was measured using flow cytometry. The radiation sensitivity was determined through the colony formation assay. The mortality of breast cancer cells under the autophagy gene knockdown and overexpression or treated with estrogen receptor inhibitor (TAM) combined with ionizing radiation were detected by trypan blue staining.Results:Under the condition of 8 Gy X-ray irradiation, the knockdown of ESR1 in ER-positive ZR75 breast cancer cells promoted cell death ( t = 3.49, 3.13, P < 0.05), while the overexpression of ESR1 in ER-negative MDA-MB-231 breast cancer cells inhibited cell death ( t = 4.16, 7.48, P < 0.05). Compared to the control group, the treatment with chloroquine increased the number of formed colonies of ESR1 knockdown ZR75 cells ( t = 8.49, P < 0.05), and inhibiting autophagy could reduce the death of ZR75 cells caused by ESR1 silencing. Under the treatment with ionizing radiation, the overexpression of ESR1 in MDA-MB-231 cells promoted protective autophagy, which, however, was reduced after ESR1 knockdown in ZR75 cells. Furthermore, it was observed that the knockdown of ATG5 in ZR75 cells was associated with reduced autophagy and an increase in cell death ( t = 4.19, 6.39, P < 0.05). In contrast, the overexpression of ATG5 in ZR75 cells reversed the increase in cell death caused by ESR1 knockdown ( t = 1.70, 4.65, P < 0.05). After the treatment of ER-positive ZR75 breast cancer cells with TAM, the expressions of ATG5 and ATG12 decreased, suggesting inhibited autophagy and an increase in cell death ( t = 18.70, P < 0.05). Furthermore, these processes were promoted by ionizing radiation ( t = 16.82, P < 0.05). Conclusions:The estrogen receptor encoded by ESR1 promotes protective autophagy of ER-positive breast cancer cells by increasing ATG5, further leading to radiation resistance in ER-positive breast cancer cells. Treatment with tamoxifen combined with ionizing radiation can increase the radiation sensitivity of ER-positive breast cancer cells.
6.Prognostic nutritional index application value for acute-on-chronic liver failure co-infection
Yamin WANG ; Yushan LIU ; Juan LI ; Qiao ZHANG ; Taotao YAN ; Danfeng REN ; Li ZHU ; Guoyu ZHANG ; Yuan YANG ; Jinfeng LIU ; Tianyan CHEN ; Yingren ZHAO ; Yingli HE
Chinese Journal of Hepatology 2024;32(3):235-241
Objective:To explore the predictive value of the prognostic nutritional index (PNI) in concurrently infected patients with acute-on-chronic liver failure (ACLF).Methods:220 cases with ACLF diagnosed and treated at the First Affiliated Hospital of Xi'an Jiaotong University from January 2011 to December 2016 were selected. Patients were divided into an infection and non-infection group according to whether they had co-infections during the course of the disease. Clinical data differences were compared between the two groups of patients. Binary logistic regression analysis was used to screen out influencing factors related to co-infection. The receiver operating characteristic curve was used to evaluate the predictive value of PNI for ACLF co-infection. The measurement data between groups were compared using the independent sample t-test and the Mann-Whitney U rank sum test. The enumeration data were analyzed using the Fisher exact probability test or the Pearson χ2 test. The Pearson method was performed for correlation analysis. The independent risk factors for liver failure associated with co-infection were analyzed by multivariate logistic analysis. Results:There were statistically significant differences in ascites, hepatorenal syndrome, PNI score, and albumin between the infection and the non-infection group ( P ?0.05). Among the 220 ACLF cases, 158 (71.82%) were infected with the hepatitis B virus (HBV). The incidence rate of infection during hospitalization was 69.09% (152/220). The common sites of infection were intraabdominal (57.07%) and pulmonary infection (29.29%). Pearson correlation analysis showed that PNI and MELD-Na were negatively correlated ( r ?=?-0.150, P ?0.05). Multivariate logistic analysis results showed that low PNI score ( OR=0.916, 95% CI: 0.865~0.970), ascites ( OR=4.243, 95% CI: 2.237~8.047), and hepatorenal syndrome ( OR=4.082, 95% CI : 1.106~15.067) were risk factors for ACLF co-infection ( P ?0.05). The ROC results showed that the PNI curve area (0.648) was higher than the MELD-Na score curve area (0.610, P ?0.05). The effectiveness of predicting infection risk when PNI was combined with ascites and hepatorenal syndrome complications was raised. Patients with co-infections had a good predictive effect when PNI ≤ 40.625. The sensitivity and specificity were 84.2% and 41.2%, respectively. Conclusion:Low PNI score and ACLF co-infection have a close correlation. Therefore, PNI has a certain appraisal value for ACLF co-infection.
7.Value of peripheral blood lymphocyte count in evaluating the short-term prognosis of patients with acute-on-chronic liver failure
Xiaohua LIU ; Shujuan YANG ; Yushan LIU ; Juan LI ; Qiao ZHANG ; Yamin WANG ; Taotao YAN ; Yuan YANG ; Yingren ZHAO ; Yingli HE
Journal of Clinical Hepatology 2023;39(10):2383-2389
ObjectiveTo investigate the influencing factors for the prognosis of patients with acute-on-chronic liver failure (ACLF), and to establish a short-term prognostic model. MethodsA retrospective analysis was performed for the baseline clinical data of 247 patients with ACLF who were hospitalized in Department of Infectious Diseases, The First Affiliated Hospital of Xi’an Jiaotong University, from January 2011 to December 2016, and the patients were divided into survival group and death group. The two groups were compared to identify the influencing factors for prognosis; a prognostic model was established, and the receiver operating characteristic (ROC) curve was used to assess its predictive efficacy and determine the optimal cut-off value. The independent-samples t test was used for comparison of normally distributed continuous data between groups, and the Mann-Whitney U rank sum test was used for comparison of non-normally distributed continuous data between groups; the Fisher’s exact test or the Pearson’s chi-square test was used for comparison of categorical data between groups. The univariate and multivariate logistic regression analyses were used to investigate the independent risk factors for 28- and 90-day prognosis, and the Kaplan-Meier method was used to plot the 28-day survival curves. ResultsA total of 220 patients with ACLF were included based on the inclusion and exclusion criteria; there were 148 patients in the 28-day survival group and 72 patients in the 28-day death group, with a 28-day transplantation-free survival rate of 67.27%; there were 115 patients in the 90-day survival group and 105 patients in the 90-day death group, with a 90-day transplantation-free survival rate of 52.27%. The logistic regression analysis showed that female sex (odds ratio [OR]=2.149, P=0.030), high Model for End-Stage Liver Disease (MELD) score (OR=1.120, P<0.001), and low lymphocyte count (OR=0.411, P=0.002) were independent risk factors for 28-day prognosis, and an LS-MELD model for 28-day prognosis was established as Logit (28-day prognosis)=-3.432+0.765×sex-0.890×lymphocyte count×10-9+0.113×MELD(1 for male sex and 2 for female sex). The ROC curve analysis showed that this model had an optimal cut-off value of 0.35, and then the patients were divided into low LS-MELD group (≤0.35) and high LS-MELD group (>0.35); the low LS-MELD group had a significantly higher 28-day survival rate than the high LS-MELD group (P<0.001). ConclusionPeripheral blood lymphocyte count combined with sex and MELD score has a certain value in predicting the short-term prognosis of ALCF patients.
8.Dynamic changes of lymphocytes and the disease progression in patients with coronavirus disease 2019 in Xi’an
Xi ZHANG ; Lei SHI ; Yonghao DU ; Feng YE ; Gang NIU ; Shumei LIN ; Yingren ZHAO ; Tianyan CHEN
Journal of Xi'an Jiaotong University(Medical Sciences) 2021;42(1):108-112
【Objective】 To analyze the clinical characteristics of patients with coronavirus disease 2019 (COVID-19) in Xi’an so as to investigate the relationship between the dynamic changes of lymphocytes and the disease progression. 【Methods】 We retrospectively analyzed the clinical data of 15 patients with COVID-19 in The First Affiliated Hospital of Xi’an Jiaotong University from January 22 to February 16, 2020. 【Results】 Among the 15 patients with COVID-19, 8 were males and 7 were females, aged from 22 to 89 years. There were 12 ordinary cases (80%), 1 severe case (6.67%), and 2 critical cases(13.33%). There were 6 groups of family clusters.Most of the patients (14/15, 93.3%) had fever of different degrees. The average time from illness onset to admission was 2.80±1.66 days, and the average time from illness onset to diagnosis was 2.83±2.29 days. The main accompanying symptoms were dry cough (8/15, 53.33%) and shortness of breath (4/15, 26.67%). Nine patients (60%) who had low lymphocyte counts at admission, including of all of the critically ill patients (1 severe case and 2 critical cases) and 6 (6/12, 50%) ordinary patients. Lymphocyte counts in the ordinary cases increased gradually, but fluctuated in the severely ill patients. They were always at low level, or even decreased overall in critical cases. 【Conclusion】 In Xi’an City, COVID-19 mostly occurred in family clusters. Lymphocyte counts were reduced in most patients, especially in critically ill (severe and critical) ones. The lymphocyte count at admission and its kinetics during therapy may be an important predictor for the severity and prognosis of the disease.
9.Clinical characteristics of patients with hemorrhagic fever with renal syndrome during pregnancy: a multicenter clinical study
Caini HE ; Hong DU ; Yinghua NIU ; Wenxuan ZHAO ; Ning GAO ; Shen LI ; Na HUANG ; Yunyu ZHAO ; Xiaofeng LI ; Yue ZHANG ; Mei LI ; Huan DENG ; Hailing LIU ; Yingren ZHAO ; Jianqi LIAN ; Fanpu JI
Chinese Journal of Infectious Diseases 2021;39(12):746-752
Objective:To analyze the clinical characteristics and prognosis of pregnant women with hemorrhagic fever with renal syndrome (HFRS).Methods:A total of 11 pregnant women with HFRS admitted to The Second Affiliated Hospital of Xi′an Jiaotong University (four cases), The Second Affiliated Hospital of Air Force Medical University (four cases), The First Affiliated Hospital of Xi′an Jiaotong University (one case) and Central Hospital of Xianyang City (two cases) between November 2009 and February 2019 were included as the study group, and 24 age-matched non-pregnant women with HFRS were selected as the control group. The age, complications, clinical classification and laboratory indexes of the two groups were analyzed retrospectively, and the clinical outcomes of pregnant women and their fetuses in the study group were followed up. The data between two groups were compared using Mann-Whitney U test or chi-square test. Results:Patients in the study and control groups were 29 (22, 33) and 32 (24, 37) years old, respectively. Seven of 11 patients in study group were severe and critical cases, which was significantly higher than that in the control group (16.7%(4/24), χ2=7.722, P=0.015). In the study group, 10 patients had hypervolemic syndrome, 10 patients had pulmonary edema and six patients had overlapping hypotension shock phase and oliguria phase, which were all higher than those in the control group ((2/24, 8.3%), (2/24, 8.3%) and (2/24, 8.3%), respectively; χ2=22.828, 22.828 and 9.135, respectively, all P<0.01). Compared with the control group, the pregnant patients in study group had a higher urea nitrogen maximum and serum creatinine maximum, and the differences were both statistically significant ( Z=-2.453 and -2.336, respectively, both P<0.05), while they had a lower serum albumin minimum, hemoglobin maximum and hemoglobin minimum, and the differences were all statistically significant ( Z=-3.742, -3.350 and -4.034, respectively, all P<0.01). All pregnant women with HFRS recovered. Nine pregnant women gave birth to nine healthy infants. All of them received breastfeeding and the feeding duration were more than six months. No abnormal growth and development were found during an average follow-up of three years. Conclusions:Pregnancy can aggravate the severity of HFRS, and pregnant women have higher risk of the multiple stages overlap and the complications such as hypervolemic syndrome and acute pulmonary edema. After recovery from HFRS, mother may carry to full-term pregnancy.
10. A phase II, single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of sofosbuvir combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection
Yinghui GAO ; Guangming LI ; Qinglong JIN ; Yingren ZHAO ; Zhansheng JIA ; Xiaorong MAO ; Yongfeng YANG ; Jia SHANG ; Gongchen WANG ; Wen XIE ; Shanming WU ; Mingxiang ZHANG ; Jinlin HOU ; Dongliang LI ; Yuemin NAN ; Yujuan GUAN ; Chunxia ZHU ; Yangzhou YUAN ; Lai WEI
Chinese Journal of Hepatology 2019;27(5):352-357
Objective:
To evaluate the efficacy and safety of sofosbuvir (Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.) combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection.
Methods:
Treatment-naïve or treatment experienced genotype 2 chronic hepatitis C patients from sixteen research centers of China were screened. All subjects received once-daily dose of sofosbuvir (400 mg) combined with ribavirin (body weight < 75 kg, 1 000 mg/day, 400 mg in the morning and 600 mg in the evening; body weight > 75 kg, 1 200 mg/d, 600 mg in the morning and 600 mg in the evening) for 12 weeks. Patients were followed-up for a period of 12 weeks after discontinuation of treatment. Continuous variables were expressed as mean ± standard deviation. The proportion of subjects with virologic response at different follow-up time points and 95% confidence intervals were estimated by maximum likelihood ratio and Clopper-Pearson interval.
Results:
132 cases with genotype 2 chronic hepatitis C virus infection from sixteen research centers of China were included, 12 cases of whom were associated with cirrhosis, and the remaining 120 cases were not associated with cirrhosis. One hundred and thirty-one cases completed the study, and one patient lost to follow-up at week 4 after the end of treatment. The sustained virological response rate was 96.2% (95% confidence interval: 92.37% - 99.16%) after 12 weeks of drug withdrawal. Virological relapse occurred in four cases. Of the 132 subjects enrolled in the study, 119 (90.2%) reported 617 adverse events during treatment, of which 359 (76.5%) were TEAE related to sofosbuvir and/or ribavirin. There were nine TEAEs of grade 3 and above, and six cases (4.5%) of them had six severe adverse events. Only one serious adverse event was associated with sofosbuvir and ribavirin (unstable angina pectoris). There were no adverse events leading to drug discontinuation or death.
Conclusion
Sofosbuvir combined with ribavirin has a high SVR rate in the treatment of genotype 2 chronic hepatitis C virus infection, and most of the adverse events occurred were mild with acceptable safety profile.

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