1.Application of artificial intelligence in clinical trials of liver diseases: A methodological perspective
Lichen SHI ; Ruishi FENG ; Jidong JIA ; Hong YOU ; Yuanyuan KONG
Journal of Clinical Hepatology 2025;41(11):2227-2234
In recent years, the exploration and development of artificial intelligence (AI) technology in clinical trials for liver diseases have promoted the continuous innovation of research methods and processes in this field. AI has gradually become an important technical tool for various links of clinical trial including patient selection, risk stratification, endpoint evaluation, and result interpretation. Nevertheless, the standardized integration of AI into clinical trials still faces the methodological challenges such as data quality control, model interpretability, and causal inference. From the perspective of methodology, this article systematically reviews the principal application scenarios of AI as an object under investigation (validation trials) and as a research tool (supportive trials) in clinical trials for liver diseases, as well as the major methodological challenges of AI-related clinical trials along and the corresponding solution strategies, in order to provide methodological guidance for promoting the scientific and standardized implementation of AI technologies.
2.An excerpt of management of acute variceal bleeding: updated APASL guidelines (2025 edition)
Lijuan FENG ; Min WANG ; Guanhua ZHANG ; Yuhong SUO ; You DENG ; Fuliang HE ; Yu WANG ; Jidong JIA
Journal of Clinical Hepatology 2025;41(11):2252-2257
On August 31, 2025, the Asian Pacific Association for the Study of the Liver (APASL) updated and released management of acute variceal bleeding: updated APASL guidelines (2025 edition), which systematically elaborates on the definition, diagnosis, assessment, and treatment of acute variceal bleeding. This article gives an excerpt of the recommendations in this guideline.
3.Clinical features and prognosis of patients with primary sclerosing cholangitis:An analysis of 107 cases
Tongtong MENG ; Weijia DUAN ; Xinyu LI ; Junqi NIU ; Huiguo DING ; Ying HAN ; Wen XIE ; Lu ZHOU ; Bangmao WANG ; Liping GUO ; Jie LI ; Bei JIA ; Lingyi ZHANG ; Liang WANG ; Xiaoqian XU ; Yu WANG ; Xiaojuan OU ; Xinyan ZHAO ; Hong YOU ; Jidong JIA ; Yuanyuan KONG
Journal of Clinical Hepatology 2025;41(7):1337-1343
Objective To describe the clinical features of patients with primary sclerosing cholangitis(PSC)in China based on a nationwide multicenter patient cohort,and to investigate the risk factors for prognosis.Methods A retrospective cohort study was conducted among the patients with a confirmed diagnosis of PSC based on the electronic medical record system of seven grade A tertiary hospitals across the country,and related data were extracted.The Mann-Whitney U test was used for comparison of continuous data between groups,and the chi-square test was used for comparison of categorical data between groups.The Kaplan-Meier method was used to estimate liver transplant-free survival,and the log-rank test was used for comparison of survival rate between PSC patients with different features.The Cox regression model was used to identify independent risk factors for the prognosis of PSC patients and the interactions between key factors.Results A total of 107 patients were enrolled,among whom 55.6%(55/99)had large-duct PSC and 29.0%(31/107)had comorbidity with inflammatory bowel disease(IBD).The positivity rate of anti-neutrophil cytoplasmic antibody(ANCA)was 32.9%(24/73),and 50.0%(40/80)of the patients had an increase in IgG/IgM.The median symptom-to-diagnosis interval was 1 year(<1-4.0),and 38.3%(41/107)of the patients had progressed to decompensated cirrhosis at the time of diagnosis.The median liver transplant-free survival time was 114 months(95%confidence interval[CI]:62-166),with a 5-year survival rate of 65.7%.The multivariate analysis showed that an increase in total bile acid(TBA)(hazard ratio[HR]=1.006,95%CI:1.002-1.010,P=0.001)and a prolonged symptom-to-diagnosis interval(HR=1.252,95%CI:1.059-1.480,P=0.009)were independent risk factors for prognosis.The interaction analysis showed that compared with the female patients with TBA<50 μmol/L,both male and female patients with TBA≥50 μmol/L had a significant increase in the risk of liver transplantation or death(male:HR=16.563,95%CI:2.103-130.449,P<0.001;female:HR=17.009,95%CI:2.113-136.934,P<0.001),and compared with the patients with an age of<45 years and a TBA level of<50 μmol/L,the patients with an age of≥45 years and a TBA level of≥50 μmol/L had a significant increase in the risk of liver transplantation or death(HR=10.729,95%CI:1.325-86.859,P=0.026).Compared with the female patients with an symptom-to-diagnosis interval of≤2 years,the male patients with a symptom-to-diagnosis interval of>2 years had an increased risk of liver transplantation or death(HR=4.825,95%CI:1.725-13.644,P=0.003),and compared with the patients with an age of<45 years and a symptom-to-diagnosis interval of≤2 years,the patients with an age of<45 years and a symptom-to-diagnosis interval of>2 years had an increased risk of liver transplantation or death(HR=4.983,95%CI:1.366-18.173,P=0.015).Conclusion Compared with the reports from Western countries,large-duct PSC is also the main type of PSC in China,but with a relatively low proportion,and there is also a relatively low proportion of patients with IBD or positive ANCA.An increase in TBA and a prolonged symptom-to-diagnosis interval are independent risk factors for prognosis,with significant interactions with age and sex.This suggests that early screening and intervention should be enhanced to improve prognosis.
4.Rheumatic diseases and portal hypertension
Li SHEN ; Weijia DUAN ; Tingting LYU ; Jidong JIA
Journal of Clinical Hepatology 2025;41(5):812-816
Rheumatic diseases are a group of chronic disorders characterized by abnormalities in the immune system, while portal hypertension occurs due to increased blood flow or heightened resistance in the portal venous system or obstruction of hepatic venous outflow. Both rheumatic diseases and their medications can lead to noncirrhotic portal hypertension. The hypercoagulable state associated with rheumatic diseases can result in thrombosis within the portal and hepatic venous systems, and damage to the intrahepatic portal system and hepatic sinusoidal endothelial system can lead to porto-sinusoidal vascular disease and hepatic sinusoidal obstruction syndrome. Moreover, drugs used for the treatment of rheumatic diseases may cause liver parenchymal injury, which further leads to liver fibrosis and cirrhosis, or they may damage the hepatic vascular endothelium and thus cause noncirrhotic portal hypertension. This article elaborates on the mechanisms and characteristics by which common rheumatic diseases and their therapeutic agents lead to portal hypertension, in order to provide insights and assistance for clinical diagnosis, treatment, and follow-up monitoring.
5.Global and Chinese burden of non-alcoholic fatty liver disease in chronic liver disease: Findings from the Global Burden of Disease Study 2021.
Xinyu ZHAO ; Dong XU ; Wei JI ; Zhengzhao LU ; Cheng HUANG ; Jingjie ZHAO ; Tingting XIAO ; Dongxu WANG ; Yuanyuan KONG ; Jidong JIA ; Hong YOU
Chinese Medical Journal 2025;138(14):1741-1751
BACKGROUND:
Chronic liver disease (CLD), mainly non-alcoholic fatty liver disease (NAFLD), is a significant public health concern worldwide. This study aims to quantify the burden of NAFLD in CLD globally and within China, using data from the Global Burden of Disease (GBD) Study 2021, providing crucial insights for global and local health policies.
METHODS:
The study used comprehensive data from the GBD study 2021. It included estimates of prevalence, incidence, mortality, and disability-adjusted life years (DALYs). Age-standardized rates and average annual percent change (AAPC) from 2011 to 2021 were reported. A meticulous decomposition analysis was conducted.
RESULTS:
In 2021, there were 1582.5 million prevalent cases, 47.6 million incident cases, 1.4 million deaths, and 44.4 million DALYs attributable to CLD, globally. Among these, NAFLD has emerged as the predominant cause, accounting for 78.0% of all prevalent CLD cases (1234.7 million) and 87.2% of incident cases (41.5 million). Correspondingly, NAFLD had the highest age-standardized prevalence (15,017.5 per 100,000 population) and incidence (876.5 per 100,000 population) rates among CLDs. In addition, China's CLD age-standardized prevalence rate was 21,659.5 per 100,000 population, and the age-standardized incidence rate was 752.6 per 100,000 population, higher than the global average. From 2011 to 2021, the global prevalence rate of CLD increased slowly (AAPC = 0.17), consistent with the trend in China (AAPC = 0.23). Furthermore, the prevalence rate of NAFLD rose significantly in China (AAPC = 1.30) compared with the global average (AAPC = 0.91). Decomposition analysis also showed the worldwide increase in deaths and DALYs for NAFLD, which were primarily attributable to population growth and aging.
CONCLUSIONS
The burden of CLD and NAFLD remains substantial globally and within China in terms of high prevalence and incidence. As such, this underscores the need for targeted prevention and treatment strategies. These findings emphasize the importance of continued surveillance and research to mitigate the growing impact of liver diseases on global and Chinese health systems.
Humans
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Non-alcoholic Fatty Liver Disease/mortality*
;
Global Burden of Disease
;
China/epidemiology*
;
Prevalence
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Male
;
Disability-Adjusted Life Years
;
Female
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Incidence
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Middle Aged
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Chronic Disease
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Adult
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Quality-Adjusted Life Years
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Liver Diseases/epidemiology*
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Aged
6.Rheumatic diseases and portal hypertension
Li SHEN ; Weijia DUAN ; Tingting LYU ; Jidong JIA
Journal of Clinical Hepatology 2025;42(5):812-816
Rheumatic diseases are a group of chronic disorders characterized by abnormalities in the immune system,while portal hypertension occurs due to increased blood flow or heightened resistance in the portal venous system or obstruction of hepatic venous outflow.Both rheumatic diseases and their medications can lead to noncirrhotic portal hypertension.The hypercoagulable state associated with rheumatic diseases can result in thrombosis within the portal and hepatic venous systems,and damage to the intrahepatic portal system and hepatic sinusoidal endothelial system can lead to porto-sinusoidal vascular disease and hepatic sinusoidal obstruction syndrome.Moreover,drugs used for the treatment of rheumatic diseases may cause liver parenchymal injury,which further leads to liver fibrosis and cirrhosis,or they may damage the hepatic vascular endothelium and thus cause noncirrhotic portal hypertension.This article elaborates on the mechanisms and characteristics by which common rheumatic diseases and their therapeutic agents lead to portal hypertension,in order to provide insights and assistance for clinical diagnosis,treatment,and follow-up monitoring.
7.Advances and challenges in the treatment of chronic hepatitis B in China
Journal of Clinical Hepatology 2025;41(2):205-209
Since 1992, China has adopted a comprehensive strategy centered on universal infant hepatitis B vaccination. This approach has led to a significant reduction in the prevalence of hepatitis B surface antigen, particularly among younger age groups. Antiviral therapy not only improves the liver histology but also reduces the incidences of complications of cirrhosis and portal hypertension, as well as the risk of hepatocellular carcinoma. Clinical guidelines for the prevention and treatment of chronic hepatitis B have been periodically updated, and the prices of antiviral drugs have been substantially lowered, enhancing treatment accessibility and affordability. However, the HBV-related disease burden remains high in China due to its large population, the considerable number of individuals already chronically infected with HBV, and the low rates of diagnosis and treatment. To meet the global goal of eliminating viral hepatitis as a public health threat by 2030, large-scale testing and treatment of those already infected with HBV are critical.
8.Research advances in the disease burden of viral hepatitis in China
Jian LI ; Fuzhen WANG ; Zhongdan CHEN ; Jinlei QI ; Ailing WANG ; Fanghui ZHAO ; Yuanyuan KONG ; Jing SUN ; Jiaqi KANG ; Zundong YIN ; Zhongfu LIU ; Jidong JIA ; Yu WANG
Journal of Clinical Hepatology 2025;41(2):221-227
Over the past three decades, China has made significant progress in the prevention and control of viral hepatitis, and the incidence rates of new-onset pediatric hepatitis B virus infections and acute viral hepatitis in the population have reduced to a relatively low level; however, there is still a heavy disease burden of chronic viral hepatitis in China, which severely affects the health status of the population. This study systematically summarizes the achievements of viral hepatitis prevention and control in China, analyzes existing problems and challenges, and proposes comprehensive prevention and control strategies and measures to eliminate viral hepatitis as a public health threat based on the national conditions of China, in order to provide a reference for related departments in China on how to achieve the action targets for eliminating viral hepatitis as a public health threat by 2030.
9.Driving innovation and fostering collaboration to advance the development and clinical research of next-generation human serum albumin
Journal of Clinical Hepatology 2025;41(3):401-403
Albumin is the most abundant protein in human plasma, and in addition to the function of maintaining plasma colloid osmotic pressure, it also has the functions of material transport, detoxification, maintaining vascular integrity, antioxidation, anti-inflammation, and immune modulation. In the field of liver disease, albumin is mainly used to prevent circulatory dysfunction after large-volume paracentesis and treat cirrhotic hypoalbuminemia and ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome. The development of recombinant human serum albumin helps to reduce the potential biosafety risks of human serum albumin products and the disadvantages of relying heavily on import. Due to the lack of reference to the results of pivotal clinical trials of marketed human albumin products, there are still various challenges in the design, implementation, and evaluation of clinical trials of human albumin. Therefore, experts in pharmaceutical enterprises, clinical medicine, methodology, and evaluation/supervision are needed to be pragmatic, innovative and collaborative.
10.Statistical considerations in the design of albumin clinical trials
Yuanyuan KONG ; Chen YAO ; Jidong JIA
Journal of Clinical Hepatology 2025;41(3):420-423
Albumin is widely used in clinical practice, and the rationality of trial design directly affects the reliability of research findings and clinical application value. This article reviews the key statistical considerations in the design of albumin clinical trials, including the selection of primary endpoints, the establishment of statistical hypotheses and non-inferiority margins, clinical evaluation criteria for ascites improvement, sample size, and interim analyses, in order to provide methodological guidance for clinical researchers to optimize clinical trial design and enhance its scientific rigor and feasibility.

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