1.New insights and prospects of drug-induced liver injury in the context of chronic cholestatic liver diseases
Simiao YU ; Jiabo WANG ; Xiaohe XIAO ; Ruilin WANG
Journal of Clinical Hepatology 2025;41(2):365-369
Patients with chronic cholestatic liver diseases face numerous challenges in the detection, assessment, and management of suspected drug-induced liver injury (DILI), and in particular, it is difficult to distinguish cholestatic DILI from the progression of underlying cholestatic liver diseases clinically and histologically. Currently, there is a lack of related research and management guidelines for DILI with chronic cholestatic liver diseases. This article discusses the potential risks, causality, and classification criteria for chronic cholestatic liver diseases with DILI, in order to improve the understanding of such diseases among clinicians and provide a reference for prevention, treatment, and management strategies.
2.The Effect of Fuzheng Huaji Formula (扶正化积方) for Chronic Hepatitis B on Reduction of the Incidence of Liver Cirrhosis and Hepatocellular Carcinoma:A Retrospective Cohort Study
Simiao YU ; Jiahui LI ; Jing JING ; Tingting HE ; Yongqiang SUN ; Liping WANG ; Aozhe ZHANG ; Xiaohe XIAO ; Xia DING ; Ruilin WANG
Journal of Traditional Chinese Medicine 2025;66(3):268-274
ObjectiveTo evaluate the clinical efficacy of Fuzheng Huaji Formula (扶正化积方) for chronic hepatitis B to reduce the incidence of liver cirrhosis and hepatocellular carcinoma. MethodsA retrospective cohort study was conducted, collecting medical records of 118 patients with chronic hepatitis B and 234 patients with hepatitis B-related cirrhosis who visited the hospital between January 1, 2014, and December 31, 2018. The use of Fuzheng Huaji Formula was designated as the exposure factor. Patients receiving antiviral treatment for hepatitis B without concurrent Fuzheng Huaji Formula therapy were included in the western medicine group, while those receiving antiviral treatment combined with Fuzheng Huaji Formula for a cumulative treatment lasting longer than 3 months were included in the combined treatment group. The follow-up observation period was five years. Kaplan-Meier survival analysis was used to assess the cumulative incidence of cirrhosis in patients with chronic hepatitis B and the cumulative incidence of hepatocellular carcinoma in patients with hepatitis B-related cirrhosis. Univariate and multivariate Cox regression analyses were employed to examine the factors influencing the occurrence of cirrhosis and hepatocellular carcinoma. ResultsAmong patients with chronic hepatitis B, there were 55 cases in the combined treatment group and 63 cases in the western medicine group; among patients with hepatitis B-related cirrhosis, there were 110 cases in the combined treatment group and 124 cases in the western medicine group. Five-year follow-up outcomes for chronic hepatitis B patients showed that the cumulative incidence of cirrhosis was 5.45% (3/55) in the combined treatment group and 17.46% (11/63) in the western medicine group, with a statistically significant difference between groups (Z = 2.003, P = 0.045). Five-year follow-up outcomes for hepatitis B-related cirrhosis patients showed that the cumulative incidence of hepatocellular carcinoma was 8.18% (9/110) in the combined treatment group and 22.58% (28/124) in the western medicine group, also showing a statistically significant difference (Z = 3.007, P = 0.003). Univariate and multivariate Cox regression analyses indicated that treatment with Fuzheng Huaji Formula is an independent protective factor in preventing the progression of chronic hepatitis B to cirrhosis and the progression of hepatitis B-related cirrhosis to hepatocellular carcinoma (P<0.05). ConclusionCombining Fuzheng Huaji Formula with antiviral therapy for hepatitis B can effectively intervene in the disease progression of chronic hepatitis B, reducing the incidence of cirrhosis and hepatocellular carcinoma.
3.Establishment and stress analysis of a finite element model for adolescent cervical disc herniation
Yuxin ZHAO ; Liang LIANG ; Feng JIN ; Yangyang XU ; Zhijie KANG ; Yuan FANG ; Yujie HE ; Xing WANG ; Haiyan WANG ; Xiaohe LI
Chinese Journal of Tissue Engineering Research 2025;29(3):448-454
BACKGROUND:Cervical disc herniation can cause pain in the neck and shoulder area,as well as radiating pain in the upper limbs.The incidence rate is increasing year by year and tends to affect younger individuals.Fully understanding the biomechanical characteristics of the cervical spine in adolescents is of great significance for preventing and delaying the onset of cervical disc herniation in this age group. OBJECTIVE:To reconstruct cervical spine models for both healthy adolescents and adolescent patients with cervical disc herniation utilizing finite element analysis techniques,to analyze the motion range of the C1-T1 cervical vertebrae as well as the biomechanical characteristics of the annulus fibrosus,nucleus pulposus,endplates,and the cartilage of the small joints. METHODS:A normal adolescent's cervical spine and an adolescent patient with cervical disc herniation were selected in this study.The continuous scan cervical spine CT raw image data were imported into Mimics 21.0 in DICOM format.The C1-T1 vertebrae were reconstructed separately.Subsequently,the established models were imported into the 3-Matic software for disc reconstruction.The perfected models were then imported into Hypermesh software for meshing of the vertebrae,nucleus pulposus,annulus fibrosus,and ligaments,creating valid geometric models.After assigning material properties,the final models were imported into ABAQUS software to observe the joint motion range of the C1-C7 cervical vertebrae segments under different conditions,and to analyze the biomechanical characteristics of the annulus fibrosus,nucleus pulposus,endplates,and small joint cartilage of each cervical spine segment. RESULTS AND CONCLUSION:(1)In six different conditions,the joint motion range of the C1 vertebra in the cervical spine models of both normal adolescent and adolescent patient with cervical disc herniation was higher than that of the other vertebrae.Additionally,the joint motion range of each cervical spine segment in normal adolescent was greater than that in adolescent patient with cervical disc herniation.(2)In the cervical spine model of normal adolescent,the maximum stress values in the annulus fibrosus and nucleus pulposus were found on the left side during C2-3 flexion conditions(0.43 MPa and 0.17 MPa,respectively).In the cervical spine model of adolescent patient with cervical disc herniation,the maximum stress values were found on the left side during C7-T1 flexion conditions(0.54 MPa and 0.18 MPa,respectively).(3)In the cervical spine model of normal adolescent,the maximum stress value on the endplate was found on the left side of the upper endplate of C3 during flexion conditions(1.46 MPa).In the model of adolescent patient with cervical disc herniation,the maximum stress value on the endplate was found on the left side of the lower endplate of C7 during flexion conditions(1.32 MPa).(4)In the cervical spine model of normal adolescent,the maximum stress value in the small joint cartilage was found in the C2-3 left rotation conditions(0.98 MPa).In adolescent patient with cervical disc herniation,the stress in the small joint cartilage significantly increased under different conditions,especially in C1-2,with the maximum stress found during left flexion(3.50 MPa).(5)It is concluded that compared to normal adolescent,adolescent patient with cervical disc herniation exhibits altered cervical curvature and a decrease in overall joint motion range in the cervical spine.In adolescent with cervical disc herniation,there is a significant increase in stress on the annulus fibrosus,nucleus pulposus,and endplates in the C7-T1 segment.The stress on the left articular cartilage of the C1-2 is notable.Abnormal cervical curvature may be the primary factor causing these stress changes.
4.Effect of Tongxinluo Capsules on TCM Syndrome Elements in Patients with Chronic Coronary Syndrome of Qi Deficiency and Blood Stasis Type: A Multicenter and Prospective Cohort Study
Jia WANG ; Xilun TAN ; Xuesen WANG ; Xiaohe YANG ; Meili GAO ; Yiying LIU ; Chenhao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):170-177
ObjectiveTo investigate the effects of Tongxinluo capsules on traditional Chinese medicine (TCM) syndrome elements and major adverse cardiovascular events (MACEs) in patients with chronic coronary syndrome of Qi deficiency and blood stasis type. MethodsA multicenter and prospective cohort study was conducted. The intervention of Tongxinluo Capsules was used as the exposure factor, and the patients were divided into an exposure group (integrated traditional Chinese and western medicine treatment group) and a non-exposure group (western medicine treatment group). The patients were followed up for one year. The TCM syndrome element scores were assessed by using a syndrome element diagnosis scale on the day of enrollment and in the third, sixth, and twelfth months, and the incidence of MACE within one year was recorded. ResultsA total of 186 patients were included, with 128 patients in the exposure group and 58 patients in the non-exposure group. There was no significant difference in baseline data between the two groups. Compared with those in the pretreatment period for each group, the Qi deficiency and blood stasis syndrome scores in the treatment and follow-up period were significantly improved (P<0.05). Compared with the non-exposure group, the exposure group exhibited significantly decreased Qi deficiency syndrome scores in the treatment and follow-up period (P<0.01) and significantly reduced blood stasis syndrome scores in the sixth month (P<0.05). In the remaining follow-up period, there was no statistically significant difference between the two groups. Compared with that of the non-exposure group, during the treatment period (the third month), the difference in Qi deficiency and blood stasis syndrome scores of the exposure group was statistically significant (P<0.05, P<0.01). At the end of the follow-up period, patients in the non-exposure group had a MACE probability of 6.90% (4/58), higher than 3.13% in the exposure group (4/58). Compared with patients with angina pectoris who used conventional medicine, patients administered with Tongxinluo Capsules had a relative risk(RR) of 0.45 [95%confidence interval(95%CI) 0.12-1.75, P=0.26]. There was no significant difference in the incidence of MACE within one year between the two groups. ConclusionTongxinluo capsules can improve the degree of Qi deficiency in patients with chronic coronary syndrome in the short term, and the improvement effect of blood stasis syndrome appears in the medium and long term. They can better improve the Qi deficiency syndrome in the long term. Within one year, the incidence of MACE in the exposure group was lower than that in the non-exposure group.
5.Effect of Tongxinluo Capsules on TCM Syndrome Elements in Patients with Chronic Coronary Syndrome of Qi Deficiency and Blood Stasis Type: A Multicenter and Prospective Cohort Study
Jia WANG ; Xilun TAN ; Xuesen WANG ; Xiaohe YANG ; Meili GAO ; Yiying LIU ; Chenhao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):170-177
ObjectiveTo investigate the effects of Tongxinluo capsules on traditional Chinese medicine (TCM) syndrome elements and major adverse cardiovascular events (MACEs) in patients with chronic coronary syndrome of Qi deficiency and blood stasis type. MethodsA multicenter and prospective cohort study was conducted. The intervention of Tongxinluo Capsules was used as the exposure factor, and the patients were divided into an exposure group (integrated traditional Chinese and western medicine treatment group) and a non-exposure group (western medicine treatment group). The patients were followed up for one year. The TCM syndrome element scores were assessed by using a syndrome element diagnosis scale on the day of enrollment and in the third, sixth, and twelfth months, and the incidence of MACE within one year was recorded. ResultsA total of 186 patients were included, with 128 patients in the exposure group and 58 patients in the non-exposure group. There was no significant difference in baseline data between the two groups. Compared with those in the pretreatment period for each group, the Qi deficiency and blood stasis syndrome scores in the treatment and follow-up period were significantly improved (P<0.05). Compared with the non-exposure group, the exposure group exhibited significantly decreased Qi deficiency syndrome scores in the treatment and follow-up period (P<0.01) and significantly reduced blood stasis syndrome scores in the sixth month (P<0.05). In the remaining follow-up period, there was no statistically significant difference between the two groups. Compared with that of the non-exposure group, during the treatment period (the third month), the difference in Qi deficiency and blood stasis syndrome scores of the exposure group was statistically significant (P<0.05, P<0.01). At the end of the follow-up period, patients in the non-exposure group had a MACE probability of 6.90% (4/58), higher than 3.13% in the exposure group (4/58). Compared with patients with angina pectoris who used conventional medicine, patients administered with Tongxinluo Capsules had a relative risk(RR) of 0.45 [95%confidence interval(95%CI) 0.12-1.75, P=0.26]. There was no significant difference in the incidence of MACE within one year between the two groups. ConclusionTongxinluo capsules can improve the degree of Qi deficiency in patients with chronic coronary syndrome in the short term, and the improvement effect of blood stasis syndrome appears in the medium and long term. They can better improve the Qi deficiency syndrome in the long term. Within one year, the incidence of MACE in the exposure group was lower than that in the non-exposure group.
6.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.
7.Integrated evidence chain-based effectiveness evaluation of traditional Chinese medicines (Eff-iEC): A demonstration study.
Ye LUO ; Xu ZHAO ; Ruilin WANG ; Xiaoyan ZHAN ; Tianyi ZHANG ; Tingting HE ; Jing JING ; Jianyu LI ; Fengyi LI ; Ping ZHANG ; Junling CAO ; Jinfa TANG ; Zhijie MA ; Tingming SHEN ; Shuanglin QIN ; Ming YANG ; Jun ZHAO ; Zhaofang BAI ; Jiabo WANG ; Aiguo DAI ; Xiangmei CHEN ; Xiaohe XIAO
Acta Pharmaceutica Sinica B 2025;15(2):909-918
Addressing the enduring challenge of evaluating traditional Chinese medicines (TCMs), the integrated evidence chain-based effectiveness evaluation of TCMs (Eff-iEC) has emerged. This paper explored its capacity through a demonstration study that evaluated the effectiveness evidence of six commonly used anti-hepatic fibrosis Chinese patent medicines (CPMs), including Biejiajian Pill (BP), Dahuang Zhechong Pill (DZP), Biejia Ruangan Compound (BRC), Fuzheng Huayu Capsule (FHC), Anluo Huaxian Pill (AHP), and Heluo Shugan Capsule (HSC), using both Eff-iEC and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. The recognition of these CPMs within the TCM academic community was also assessed through their inclusion in relevant medical documents. Results showed that the evidence of BRC and FHC received higher assessments in both Eff-iEC and GRADE system, while the assessments for others varied. Analysis of community recognition revealed that Eff-iEC more accurately reflects the clinical value of these CPMs, exhibiting superior evaluative capabilities. By breaking through the conventional pattern of TCMs effectiveness evaluation, Eff-iEC offers a novel epistemology that better aligns with the clinical realities and reasoning of TCMs, providing a coherent methodology for clinical decision-making, new drug evaluations, and health policy formulation.
8.Clinical Characteristics and Potential Risk Factors Analysis of Liver Injury Related to Epimedii Folium Preparation
Yongkang ZHAO ; Yuyang LIU ; Wei SHI ; Han GAO ; Zheng LI ; Zhaofang BAI ; Haibo SONG ; Yuan GAO ; Jiabo WANG ; Xiaohe XIAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(6):205-210
ObjectiveThis paper aims to analyze the clinical characteristics and medication rationality of liver injury related to Epimedii Folium preparation (EP) and explore the possible risk factors of liver injury, so as to provide a reference for the safe clinical application of Epimedii Folium (EF). MethodA retrospective analysis was conducted on liver injury cases related to EP from 2012 to 2016. ResultThe number of reported liver injury cases and the proportion of severe cases related to the use of EP show an increasing trend, indicating the objective existence of liver injury caused by EP. There are more cases of liver injury related to EP in women than in men, with an onset age range of 15-91 years old and a median onset age of 60 years old (median onset ages for men and women are 59 and 60 years old, respectively). The time span from taking EP alone to the occurrence of liver injury is 1-386 days, with a median of 38 days. The time span from taking both EP and Western medicine to the occurrence of liver injury is 1-794 days, with a median of 34 days. EF-related liver injury preparations are mostly composed of traditional Chinese medicines that promote immunity and tonify the liver and kidney, indicating that immune stress in the body may be the mechanism of liver injury caused by the use of EP alone or in combination. There is no increasing trend of toxicity with time or dose in the liver injury caused by EP. By further exploring its risk factors, it is found that patients have unreasonable medication methods such as excessive dosage, repeated use, and multi-drug combination, which may also be one of the important risk factors for EF-related liver injury. ConclusionEP has a certain risk of liver injury and should be emphasized in clinical diagnosis and treatment. Immune stress may be the mechanism of liver injury caused by EP, and in clinical use, it is necessary to be vigilant about the risk of liver injury caused by unreasonable use and combined use with Western medicine.
9.The effect of job autonomy on job engagement in health care workers:the chain mediating role of in-terpersonal facilitation and occupational calling
Jin WU ; Handan WANG ; Yan WU ; Yongting YANG ; Xianhong HUANG ; Hao ZHANG ; Xiaohe WANG ; Liming ZHU
Modern Hospital 2024;24(6):887-890
Objective To explore the chain mediating effect of interpersonal promotion and calling on work autonomy and work engagement of medical staff.Methods From June to July 2023,a total of 310 medical staff from 5 tertiary public hos-pitals in Hangzhou were selected by convenience sampling.The questionnaire included work autonomy scale,interpersonal promo-tion scale,calling scale and work engagement scale for accurate and effective investigation,and data analysis was conducted using SPSS2 6.0 and AMOS 26.0.Results A total of 310 questionnaires were distributed and 257 were recovered with a recovery rate of 82.90%.There were statistically significant differences in work engagement among medical staff with different ages,marital status,working time,titles and positions(all P<0.05).Calling partially mediated the effect of work autonomy on work engage-ment(95%CI[0.090,0.291],P<0.001),and interpersonal promotion and calling played a partially chain mediating role be-tween work autonomy and work engagement(95%CI[0.016,0.103],P<0.001).Conclusion Interpersonal promotion and calling play a partially chain mediating role between work autonomy and work engagement of medical staff.Work autonomy of medical staff not only has an indirect effect on work engagement through the mediating role of calling,but also enhances calling through interpersonal promotion and ultimately affects work engagement.
10.A Study on the Relationship between Primary Indicators in Performance Assessment of Tertiary Public Hospitals
Feihu SHEN ; Xiaohe WANG ; Doudou YANG
Chinese Health Economics 2024;43(1):63-66
Objective:To explore the relationships among 4 primary indicators in the performance assessment and evaluation system of tertiary public hospitals.Methods:A questionnaire survey was employed to collect data on healthcare professionals'perceptions of the rationality of performance evaluation indicators.Structural equation modeling(SEM)and Amos 21.0 Statistical Software were utilized for data analysis,with the mediation effects tested using the Bootstrap method.Results:A total of 826 valid questionnaires were obtained.Medical quality,operational efficiency,and sustainable development had a positive impact on satisfaction.Operational efficiency and sustainable development played a chain-mediated role in the process of medical quality influencing satisfaction evaluation,namely"medical quality → operational efficiency → sustainable development → satisfaction".Conclusion:It helps to flexibly apply and deepen the integration of knowledge in the field of enterprise management into the field of hospital management,helps hospitals to scientifically formulate internal performance evaluation programs under the premise of limited resources,and provides new ideas for the country to optimize the performance appraisal index system of tertiary public hospitals.


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