1.Efficacy and safety of tegoprazan (LXI-15028) vs. esomeprazole in patients with erosive esophagitis: A multicenter, randomized, doubleblind, non-inferiority phase Ⅲ trial
Huiyun ZHU ; Qian XUE ; Yingxiao SONG ; Zhenyu ZHANG ; Xing LI ; Shengxiang LYU ; Qiang ZHAN ; Fei LIU ; Lungen LU ; Liang ZHONG ; Weixing CHEN ; Dong SHAO ; Yanbing DING ; Deliang LIU ; Xiaozhong YANG ; Zhiming HUANG ; Zhaoshen LI ; Yiqi DU
Chinese Medical Journal 2025;138(19):2464-2471
Background::An evidence gap still exists regarding the efficacy and safety of tegoprazan in patients with erosive esophagitis (EE) in China. This study aimed to verify the efficacy and safety of tegoprazan vs. esomeprazole in patients with EE in China. Methods::This study was a multicenter, randomized, double-blind, parallel, active-controlled, non-inferiority phase III trial of patients with EE randomized 1:1 to tegoprazan 50 mg/day vs. esomeprazole 40 mg/day. This study was conducted in 32 sites between October 24, 2018 and October 18, 2019. The primary endpoint was the cumulative endoscopic healing rate at week 8. The secondary endpoint included endoscopic healing rate at week 4, changes in the reflux disease questionnaire (RDQ) and gastroesophageal reflux disease health-related quality of life (GERD-HRQL) scores, and symptom improvement. Results::A total of 261 patients were randomized: 132 to the tegoprazan group and 129 to the esomeprazole group. The cumulative endoscopic healing rate at 8 weeks in the tegoprazan group was non-inferior to that of the esomeprazole group (91.1% vs. 92.8%, difference: -1.7%, 95% confidence interval [CI]: -8.5%, 5.0%, P = 0.008). There were no statistically significant differences in the changes in RDQ (total, severity, and frequency) and GERD-HRQL scores between the two groups (all P >0.05). The percentages of days without symptoms, including daytime and nighttime symptoms based on patients' diaries, were similar between the two groups (all P >0.05). In the tegoprazan and esomeprazole groups, 71.5% (93/130) and 61.7% (79/128) of the participants reported adverse events (AEs), 2.3% and 0 experienced serious AEs, while 70.0% and 60.2% had treatment-emergent AEs, respectively. Conclusion::Tegoprazan 50 mg/day demonstrated non-inferior efficacy in healing EE, symptom improvement, and quality of life, and it has similar tolerability compared with esomeprazole 40 mg/day.
2.Clinical characteristics, diagnosis, and treatment strategies for drug-induced autoimmune hepatitis
Fei LI ; Qidi ZHANG ; Lungen LU
Chinese Journal of Hepatology 2025;33(7):633-636
Drug-induced liver injury (DILI) is an important adverse drug reaction with diverse clinical manifestations. Drug-induced autoimmune-like hepatitis (DI-ALH) is a special type of DILI possessing clinical, serological, and histological features similar to autoimmune hepatitis (AIH). However, there are significant differences between DI-ALH and AIH in terms of treatment plan, course of disease, and prognosis; therefore, differential diagnosis between DI-ALH and AIH is crucial. This article summarizes the epidemiology, pathogenesis, clinical characteristics, diagnosis and differential diagnosis, treatment, and prognosis of DI-ALH and analyzes the existing problems in order to provide guidance for the diagnosis, treatment, and future research direction.
3.Clinical treatment controversies and progress in liver cirrhosis: an evidence-based medicine perspective from managing portal hypertension to preventing complications
Yufei YANG ; Junjun WANG ; Guangwen CHEN ; Qichao GE ; Lungen LU
Chinese Journal of Hepatology 2025;33(8):734-737
Liver cirrhosis as the terminal stage of chronic liver disease has seen many new insights and advances in its treatment strategies and perspectives in recent years. However, there are still many controversies about cirrhotic portal hypertension management, prevention, therapy, and complications. This article summarizes the main key controversial points in the current treatment of liver cirrhosis from an evidence-based medicine perspective, including the use of non-selective β-blockers during decompensated stages, exploration of precise strategies for albumin, re-evaluation of the risks of statins, weighing the pros and cons of proton pump inhibitors, new understandings of anticoagulation therapy, breakthroughs in targeting gut microbiota, and nutritional support management. In addition, it combines the latest research data and guideline recommendations to explore future development directions so as to provide clinical practice reference.
4.Advances and challenges in new technologies for imaging evaluation of liver fibrosis
Chinese Journal of Hepatology 2025;33(10):923-927
Liver fibrosis is a common pathological process in various chronic liver diseases. Early-stage and accurate diagnosis, as well as assessment of the degree of liver fibrosis, is crucial for the management of chronic liver diseases. Conventional imaging techniques for liver fibrosis (elastography and magnetic resonance elastography) still have the drawback of low sensitivity in detecting early-stage fibrosis. In recent years, emerging imaging omics based on ultrasound and magnetic resonance have improved the diagnostic accuracy and visualization stage of liver fibrosis. The emergence of artificial intelligence technology has also provided more options for the technological advancement of liver fibrosis imaging. This article aims to review the emerging liver fibrosis imaging technologies in recent years and compare their diagnostic performance with ultrasound elastography, shear wave elastography, and magnetic resonance elastography recommended by the current domestic and international guidelines and to pinpoint simultaneously the limitations and challenges that still exist in liver fibrosis imaging while reflecting the technological advances.
5.A case of portal hypertensive cholangiopathy
Ruling ZHANG ; Congying CHEN ; Li HUANG ; Min XU ; Lungen LU ; Xiaobo CAI
Chinese Journal of Hepatology 2025;33(11):1104-1106
Portal hypertensive biliopathy is a secondary condition of intrahepatic and extrahepatic bile duct abnormalities caused by portal hypertension, especially in extrahepatic portal venous obstruction. Most patients may remain asymptomatic for a long time, while a few may present with symptomatic portal hypertensive biliopathy, such as obstructive jaundice, cholelithiasis with or without cholangitis, gastrointestinal bleeding, and others. Such disease is rare in clinical practice and is prone to misdiagnosis and missed diagnosis. Improper treatment can lead to serious adverse consequences. We report a case of unexpected discovery of bile duct dilation due to abdominal pain, which was ultimately diagnosed as portal hypertensive biliopathy based on the medical history, manifestations of portal hypertension, and imaging examinations, especially intraductal ultrasonography.
6.A multidisciplinary management pathway for patients with metabolic associated fatty liver disease
Chinese Journal of Hepatology 2025;33(9):822-825
Metabolic associated fatty liver disease (MAFLD) has replaced non-alcoholic fatty liver disease (NAFLD), emphasizing the core role of metabolic dysfunctions and necessitating a multidisciplinary (MDT) approach for diagnosis and treatment to concurrently manage liver disease and metabolic disorders.Downplaying the non-alcohol label while focusing more on metabolic driving factors allows it to coexist with other liver diseases. The gastroenterology and hepatology department is the initial assessment department, and MDT, which includes endocrinology, nutrition, sports medicine, surgery, and psychology, develops individualized treatment plans. With the aim of halting the progression of the disease (steatosis → fibrosis → cirrhosis) and eventually improving patient prognosis, MAFLD management must be based on metabolic intervention and accomplish "liver disease metabolic co-treatment" through multidisciplinary integration.
7.Advances in the mechanism of aging-driven metabolic associated fatty liver disease and related targeted therapeutic strategies
Journal of Clinical Hepatology 2025;41(6):1174-1180
Metabolic associated fatty liver disease (MAFLD) is a liver disease associated with metabolic disorders, and it is characterized by excessive fat deposition in hepatocytes and is closely associated with insulin resistance and genetic susceptibility. Aging is an important factor in the progression of MAFLD and is positively correlated with the mortality rate of patients with MAFLD. The pathophysiological mechanisms of MAFLD involve lipid metabolism disorders, insulin resistance, inflammation, and oxidative stress, and aging exacerbates the pathological process of MAFLD by further affecting these key mechanisms. Cell senescence is an important factor in organismal aging, and therapeutic strategies targeting senescent cells can reduce the number of senescent cells or inhibit the inflammatory factors secreted by such cells, thereby helping to slow down the progression of MAFLD. In addition, the screening of novel regulatory factors provides new targets for the development of new drugs for MAFLD treatment. Although several anti-aging therapies have entered clinical trials, further studies are needed to validate the specificity and potential liver damage of these therapies due to the complex mechanisms of aging on the liver. Transforming multisystem metabolic dysfunction therapies for MAFLD into specialized therapies for aging may provide new ideas for MAFLD drug development.
8.Clinical management of cholestatic liver disease
Yuecheng GUO ; Xiaobo CAI ; Lungen LU
Journal of Clinical Hepatology 2025;41(7):1246-1250
Cholestatic liver disease(CLD)is a group of hepatobiliary disorders caused by impaired bile production,secretion,or excretion.With the application of liquid biopsy,multi-parameter radiological examination,and genomics technology,significant progress has been made in the diagnosis and prognostic evaluation of CLD.At present,the therapeutic principles for CLD mainly focus on addressing the underlying causes and managing cholestasis,and commonly used drugs include ursodeoxycholic acid,S-adenosylmethionine,cholestyramine,fibrates,and obeticholic acid.Based on the latest clinical consensus statements and research advances in CLD,this article systematically elaborates on the clinical management strategies for CLD from the aspects of diagnosis,treatment,and prognostic evaluation.
9.Clinical management of cholestatic liver disease
Yuecheng GUO ; Xiaobo CAI ; Lungen LU
Journal of Clinical Hepatology 2025;41(7):1246-1250
Cholestatic liver disease(CLD)is a group of hepatobiliary disorders caused by impaired bile production,secretion,or excretion.With the application of liquid biopsy,multi-parameter radiological examination,and genomics technology,significant progress has been made in the diagnosis and prognostic evaluation of CLD.At present,the therapeutic principles for CLD mainly focus on addressing the underlying causes and managing cholestasis,and commonly used drugs include ursodeoxycholic acid,S-adenosylmethionine,cholestyramine,fibrates,and obeticholic acid.Based on the latest clinical consensus statements and research advances in CLD,this article systematically elaborates on the clinical management strategies for CLD from the aspects of diagnosis,treatment,and prognostic evaluation.
10.Clinical characteristics, diagnosis, and treatment strategies for drug-induced autoimmune hepatitis
Fei LI ; Qidi ZHANG ; Lungen LU
Chinese Journal of Hepatology 2025;33(7):633-636
Drug-induced liver injury (DILI) is an important adverse drug reaction with diverse clinical manifestations. Drug-induced autoimmune-like hepatitis (DI-ALH) is a special type of DILI possessing clinical, serological, and histological features similar to autoimmune hepatitis (AIH). However, there are significant differences between DI-ALH and AIH in terms of treatment plan, course of disease, and prognosis; therefore, differential diagnosis between DI-ALH and AIH is crucial. This article summarizes the epidemiology, pathogenesis, clinical characteristics, diagnosis and differential diagnosis, treatment, and prognosis of DI-ALH and analyzes the existing problems in order to provide guidance for the diagnosis, treatment, and future research direction.

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