
Theme Issue:
New Exploration of the Clinical Efficacy Evaluation System for Chronic Liver Diseases Treated with Traditional Chinese Medicine
Executive Chief Editor: LI Xiuhui
Beijing YouAn Hospital,Capital Medical University
Traditional Chinese medicine (TCM) has unique advantages in the management of liver diseases; however, traditional TCM efficacy evaluation is highly subjective with a lack of standardized criteria, and the evaluation criteria for modern medicine are incompatible with the characteristics of TCM interventions, leading to a marked dissociation between diseases, symptoms, and syndromes. To address the above issues, this article proposes the core principle of disease-symptom-syndrome integration and establishes a four-dimensional efficacy evaluation system including TCM syndrome efficacy, patient-reported outcomes, overall disease prognosis, and changes in biological indicators. This article systematically elaborates on the core connotation, indicator selection criteria, and quantification methods of each dimension and clarifies the implementation principles and strategies, in order to provide methodological support for high-quality clinical research and the production of high-level evidence-based data in TCM treatment of liver diseases and promote the modernization and internationalization of TCM diagnosis and treatment.
Traditional Chinese medicine (TCM) is widely used in the clinical management of chronic hepatitis B in China and has exhibited certain advantages in alleviating symptoms, regulating overall physiological status, and assisting in the intervention against disease progression. However, there is still a lack of a comprehensive clinical efficacy evaluation system for TCM treatment of chronic hepatitis B, with inconsistencies in the selection of evaluation indicators and limited objectivity and standardization in the assessment of syndromes and symptoms, which have limited the systematic accumulation of evidence regarding TCM efficacy and the incorporation of TCM into clinical guidelines and expert consensus statements. This article systematically reviews the current status of research on the clinical efficacy evaluation of TCM for chronic hepatitis B and analyzes the achievements made in the field of TCM therapy and integrated traditional Chinese and Western medicine therapy for chronic liver diseases in China’s national major infectious disease research programs during the periods of the Eleventh to Thirteenth Five-Year Plans. It also points out related issues that remain to be addressed and proposes a conceptual framework and specific components for constructing a TCM clinical efficacy evaluation system from the perspectives of evaluation objectives, indicator composition, and application scenarios, in order to provide a reference for the development of related standards, clinical research, and the standardization of integrated traditional Chinese and Western medicine diagnosis and treatment.
Based on a review of clinical trial assessment indices for metabolic dysfunction-associated fatty liver disease (MAFLD) and the current status of traditional Chinese medicine (TCM) research, this article proposes a multi-dimensional, stratified, and operable clinical efficacy evaluation framework for TCM with reference to the features of MAFLD and the therapeutic effect of TCM. This system encompasses eight dimensions of liver histology, radiology, biochemical indicators, metabolic markers, anthropometry, TCM syndromes, patient-reported outcomes, and safety indicators, which are stratified according to research objectives and disease stages. This study further explores the implementation pathways for the standardization of syndrome evaluation, research design norms, and quality control, in order to provide methodological support for conducting high-quality TCM clinical research and promote the transition of TCM efficacy evaluation from “single indicators” to “multi-dimensional composite indicators”.
Traditional Chinese medicine (TCM) plays an important role in the full-cycle management of primary liver cancer; however, the current evidence-based evaluation system with the main assessment index of objective tumor remission is mainly centered on randomized controlled trials and systematic reviews/meta-analyses and cannot fully reflect the characteristics and advantages of TCM. Based on the current status of TCM efficacy evaluation in the prevention and treatment of liver cancer, this article proposes the construction of a multi-dimensional evaluation system that is oriented by stage-specific treatment goals and integrates outcome indicators with process indicators. Outcome indicators include modern medical endpoints such as overall survival and recurrence-free survival, and process indicators include short-term outcomes such as the improvement in TCM syndrome, patient-reported outcomes, the remission rate of adverse events, and the discontinuation rate of the core regimen. It is emphasized that the development of standardized TCM regimens should follow the order of theoretical connotation, accumulation of proven cases, observational evaluation, and interventional evaluation. Furthermore, it is recommended to incorporate artificial intelligence approaches into this evaluation system, so as to promote the intelligent and precise assessment of TCM efficacy.
Proteinuria is a common adverse reaction in patients with primary liver cancer undergoing molecular targeted therapy and falls in the categories of “turbid urine”, “edema”, and “consumptive disease”, among others, in traditional Chinese medicine. Currently, there is a lack of specific clinical treatments and monitoring and management strategies for proteinuria associated with targeted drugs for liver cancer, and integrated traditional Chinese and Western medicine therapy is an effective prevention and treatment method. Following the principles of evidence-based medicine and using the methods of literature review, grading of evidence, and multidisciplinary expert discussions, the work group established an expert consensus on integrated traditional Chinese and Western medicine diagnosis and treatment with unique advantages of traditional Chinese medicine and convenient clinical operation with reference to recent clinical practice experience and the latest guidelines and expert consensus statements in China and globally, in order to provide a reference for the clinical practice of integrated traditional Chinese and Western medicine therapy for proteinuria associated with targeted drugs for liver cancer.
In February 2026, the World Health Organization released the latest edition of Consolidated guidance on hepatitis B and C prevention, testing, treatment, service delivery and monitoring: An implementation handbook for a public health approach. This guidance integrates more than 80 evidence-based recommendations and good practice statements issued from 2015 to 2025, and it is the first handbook that combines all hepatitis B, C and D guidelines into a single reference document. The guideline centers around five core areas of prevention, testing and diagnosis, treatment and care, simplified services, and strategic information to simplify and expand access to interventions through public health approaches, so as to accelerate the achievement of the global goal of eliminating the public health threat of viral hepatitis by 2030. This article summarizes the core recommendations and implementation considerations in the handbook.
In December 2025, the American Association for the Study of Liver Diseases (AASLD) and the American Society of Transplantation (AST) jointly issued an updated guideline on the evaluation of adult liver transplant candidates. The guideline is organized into four domains, i.e., referral for liver transplantation, candidate evaluation, contraindications to liver transplantation, and special considerations (e.g., living donor liver transplantation), in order to provide a standardized framework for clinical assessment. This new guideline updates the 2013 edition based on the latest evidence-based medical evidence and incorporates discussions on emerging indications for liver transplantation, including intrahepatic cholangiocarcinoma and colorectal liver metastases. This guideline emphasizes that candidate assessment must be individualized, and the assessment process must be transparent and consistent. This article gives an excerpt of the key recommendations in this guideline for readers’ reference.
Drug-induced autoimmune-like hepatitis (DI-ALH) is one of the special phenotypes of drug-induced liver injury, and since it has similar autoimmune characteristics and liver histological manifestations as intrinsic autoimmune hepatitis, differential diagnosis of these two diseases may be difficult in some cases. This article reports a case diagnosed with DI-ALH after long-term follow-up and conducts a literature review to provide a reference for clinicians.
Cavernous transformation of the portal vein (CTPV) is a significant challenge in clinical practice. In recent years, transjugular intrahepatic portosystemic shunt has gradually been applied in the treatment of CTPV patients, but it had a technical success rate and a relatively high surgical risk. The scholars have adopted various modified techniques of portosystemic shunt to improve success rate and safety. However, for CTPV patients with extensive occlusion of the main portal vein, this surgery remains difficult, and individualized strategies for portosystemic shunt should be formulated. This article reports a case of CTPV treated by transjugular extrahepatic portosystemic shunt assisted by endoscopic ultrasound-guided portal vein localization, in order to explore a new pathway for the clinical management of patients with CTPV.
Metabolic dysfunction-associated fatty liver disease (MAFLD) has the core pathological feature of liver lipid accumulation, which is closely associated with the factors such as lipid metabolism disorders, insulin resistance, and inflammation, and abnormal lipid accumulation can exacerbate these factors and further intensify lipid accumulation, thereby forming a vicious circle. Huanglian Wendan decoction has shown unique advantages in alleviating lipid accumulation associated with MAFLD, but its mechanism of action is relatively complex. With reference to the latest literature evidence, this article systematically summarizes the mechanism of action of Huanglian Wendan decoction in improving lipid accumulation by regulating lipid metabolism, ameliorating insulin resistance, and exerting an anti-inflammatory effect, as well as the pharmacological actions of related active components, in order to provide a theoretical basis for the clinical application of Huanglian Wendan decoction in the management of MAFLD.
Short-chain fatty acids (SCFA) are the main metabolic products generated by the fermentation of dietary fiber by gut microbiota. Studies have shown that SCFA not only play a role in energy metabolism, but also act as important signaling molecules, exhibiting a significant potential in alleviating liver and pancreatic fibrosis. The core mechanism of SCFA mainly involves the regulation of various key signaling pathways by activating G protein-coupled receptors and inhibiting the activity of histone deacetylase, thereby suppressing the activation and proliferation of hepatic stellate cell (HSC) and pancreatic stellate cell (PSC), which is a key link in fibrosis formation. In addition, SCFA can effectively alleviate tissue inflammation response, improve intestinal barrier function, and regulate gut microbiota balance, thus indirectly preventing the process of fibrosis mediated by the “gut-liver/pancreas axis”. Compared with the research on SCFA in liver fibrosis, studies on their role in pancreatic fibrosis are limited. Given that HSC and PSC are highly homologous, the transcription factors and proteins that have been confirmed in liver fibrosis-related studies are also similarly expressed in PSC, suggesting that they may also influence the activation of PSC. This article systematically summarizes the recent advances in the research on SCFA in alleviating liver and pancreatic fibrosis, in order to provide new perspectives for exploring the mechanism of pancreatic fibrosis and developing related interventional strategies.
Hepatic sinusoidal capillarization is the first event in the process of fibrogenesis, and inhibiting hepatic sinusoidal capillarization can effectively improve the pathological process of liver fibrosis. Various studies have shown that traditional Chinese medicine can significantly inhibit hepatic sinusoidal capillarization. This article systematically reviews the effective constituents, monomers, and compound prescriptions of traditional Chinese medicine, summarizes their mechanism of action in inhibiting hepatic sinusoidal capillarization, and analyzes the theoretical core of traditional Chinese medicine in inhibiting hepatic sinusoidal capillarization from the perspective of traditional Chinese medicine, in order to provide ideas and literature support for the treatment of liver fibrosis.
Alcoholic liver fibrosis is a critical step in the progression of alcoholic liver disease toward liver cirrhosis, yet there is currently still a lack of effective and specific anti-fibrotic therapeutic strategies. Recent studies have shown that as an iron-dependent, lipid peroxidation-driven form of regulated cell death, ferroptosis plays an important role in alcohol-related hepatocellular injury and fibrogenesis. Reactive oxygen species generated during alcohol metabolism can damage hepatocytes, impair their antioxidant defense ability, and lead to disruption of iron homeostasis and accumulation of lipid peroxides, ultimately triggering ferroptosis. Hepatocyte ferroptosis can promote fibrosis by amplifying inflammatory responses and activating hepatic stellate cells, whereas selective induction of ferroptosis in activated hepatic stellate cells may attenuate fibrosis, highlighting the “double-edged sword” effect of ferroptosis. Current interventions against ferroptosis mainly focus on applying antioxidant approaches, reducing iron burden, or blocking the amplification of lipid peroxidation, which have shown preliminary efficacy and a potential clinical value, but there are still limitations such as single-target actions and insufficient cell selectivity. In the future, nanotechnology-based delivery and other targeting strategies may help to realize multi-pathway coordination and cell-specific modulation, thereby improving the anti-fibrotic efficacy of ferroptosis-oriented therapies.
Acute esophagogastric variceal bleeding (AEGVB) is one of the life-threatening complications of decompensated cirrhosis. Endoscopy is the main method for the diagnosis and treatment of AEGVB, and endoscopic treatment can effectively control acute bleeding and alleviate or eliminate varices. However, there is still a lack of consistent recommendations for the timing of endoscopic examination and intervention for AEGVB in related guidelines in China and globally. Existing studies in China and globally have low quality of evidence, with significant variations in the definition of “early endoscopy” and inconsistent conclusions. This article reviews the research advances in the timing of endoscopic treatment for AEGVB in liver cirrhosis, points out the controversies over the optimal timing of treatment, and discusses future research directions in this field.
Gastroesophageal varices (GOV) bleeding is a severe complication of portal hypertension with a high mortality rate. Animal models are indispensable tools for investigating its pathogenesis and developing novel therapeutic strategies. This article systematically reviews the methods for establishing various GOV models, with a particular focus on their efficacy in simulating the key pathological processes such as an increase in hepatic venous pressure gradient and the risk of bleeding, and it also proposes targeted strategies for model selection. Finally, this article discusses the application prospects of emerging techniques in the era of precision medicine, such as organoids and gene editing, in order to provide model selection and a theoretical reference for exploring the mechanism and clinical translation of GOV.
Sonodynamic therapy (SDT) applies low-frequency ultrasound to activate sonosensitizers that have accumulated in tumor location, which induces cavitation effects and leads to the in-situ generation of reactive oxygen species (ROS), thereby achieving precise and efficient tumor treatment. Owing to its advantages such as deep tissue penetration and controllable treatment range, SDT has attracted significant attention and has been widely used in the research on the treatment of various tumors. While conventional treatment modalities have achieved significant efficacy in the treatment of hepatocellular carcinoma (HCC), there are still certain limitations. In this context, nanomedicine-based SDT leverages the targeting capabilities of nano-agents to realize specific killing of HCC cells, and furthermore, it can synergize with photodynamic therapy, chemotherapy, and immunotherapy to provide new opportunities for developing novel treatment modalities for HCC. This article reviews the mechanism of action of SDT and the advances in the research and application of SDT in the treatment of HCC, analyzes the shortcomings of existing studies, and proposes the directions for future development, in order to provide a theoretical foundation and scientific guidance for related research on HCC.
Locoregional therapy (LRT), including transarterial chemoembolization, transarterial radioembolization, and various ablation techniques, is an important treatment method for hepatocellular carcinoma. Many studies in recent years have confirmed that LRT has a dual regulatory effect on tumor immune microenvironment. While LRT induces immunogenic cell death, activates dendritic cell-mediated and T cell-driven immunity, and triggers systemic antitumor responses, it concomitantly upregulates the adenosine signaling pathway, promotes the accumulation of TREM2+ macrophages, and enhances the expression of immunosuppressive factors, thereby forming an immunosuppressive microenvironment. At present, the combination of LRT and immune checkpoint inhibitors has shown a promising future and has promoted the exploration of novel targets within treatment-associated immunosuppressive pathways, such as adenosine, TREM2⁺ macrophages, and IL-6. This article summarizes the dual regulatory effect of LRT on immune microenvironment and highlights that multi-omics techniques and clinical trials should be used in the future to decipher its dynamic alterations, in order to optimize combination strategies, realize individualized precise treatment, and improve the prognosis of patients.
In recent years, mesenchymal stem cells (MSC) have been widely explored in the treatment of liver diseases due to their characteristics of multipotential differentiation and immunomodulatory capabilities. Current evidence has shown that MSC therapy can improve liver function, alleviate fibrosis, and promote hepatocyte regeneration in end-stage liver diseases such as liver cirrhosis and liver failure. However, safety concerns have emerged with the increasing clinical use of MSC. This article systematically reviews the acute adverse reactions and long-term safety of MSC-based therapies for liver diseases. It is shown that MSC therapy has a good overall safety profile, with common acute adverse reactions of fever, rash, and mild allergy, most of which are self-limiting or can be alleviated by symptomatic treatment. No clear evidence of tumorigenesis has been reported in long-term follow-up, but some studies have suggested a potential association between MSC and the development of hepatocellular carcinoma. In addition, the risks of embolism, immune rejection, and infection susceptibility should be monitored continuously. Overall, MSC therapy shows good prospects in short-term efficacy and safety in the treatment of liver diseases, but clinical studies with a large sample size and a long follow-up period are needed to further validate its long-term safety and efficacy.
As a key receptor for immune regulation, triggering receptor expressed on myeloid cells 2 (TREM2) plays an important role in the development and progression of liver diseases, but its specific mechanisms and regulatory strategies in different types and stages of liver diseases remain to be systematically elucidated. This article systematically reviews the molecular characteristics and signaling pathways of TREM2, elaborates on the multiple functions of TREM2+ macrophages in lipid metabolism, phagocytic function, inflammatory response, and fibrosis, and analyzes the dynamic and bidirectional roles of TREM2 in different liver diseases. Targeting the TREM2 signaling axis is expected to become a new strategy for regulating the hepatic immune microenvironment and intervening in disease progression.
Both chronic liver disease (CLD) and type 2 diabetes mellitus (T2DM) are major public health issues worldwide, and there is a significant difference in the prevalence rate of T2DM across patients with CLD of different etiologies. Chronic hepatitis C virus infection, dysregulation of fat metabolism, and excessive drinking not only lead to CLD, but also increase the prevalence rate of T2DM. It remains unclear whether chronic hepatitis B virus infection can cause an increase in the risk of T2DM, although the prevalence rate of T2DM significantly increases with disease progression in patients with chronic hepatitis B, and there is still a lack of large-sample evidence for the association between autoimmune liver disease and T2DM. In addition, T2DM may increase the risk of end-stage liver diseases such as cirrhosis and hepatocellular carcinoma. Therefore, early diagnosis and individualized management of T2DM are of great importance for improving the prognosis of patients with CLD.
Hepatic encephalopathy is a common and serious complication of end-stage liver diseases such as liver cirrhosis, and it is basically a neuropsychiatric syndrome resulting from metabolic disorders caused by severe acute or chronic liver dysfunction or portosystemic shunt. In clinical practice, the onset of hepatic encephalopathy does not completely correlate linearly with the level of blood ammonia and is often triggered by extrahepatic factors, suggesting the presence of complex multiorgan crosstalk in the pathogenesis of hepatic encephalopathy. Based on the four main pathogeneses of ammonia toxicity, inflammation, neurotransmitter imbalance, and oxidative/nitrosative stress, this article systematically elaborates on the mechanism of multiorgan crosstalk in hepatic encephalopathy and discusses the emerging risk factors such as sarcopenia and diabetes mellitus, in order to provide a novel theoretical framework for deepening the understanding of the pathophysiological mechanisms of hepatic encephalopathy and formulating clinical diagnosis and treatment strategies in the future.
Cholestatic liver injury (CLI) is a hepatic disorder characterized by the abnormal accumulation of bile acids in the body due to various etiologies, and without timely intervention, it can progress to liver fibrosis, liver cirrhosis, and liver failure and even lead to death. Studies have shown that modulating oxidative stress can alleviate lipid peroxidation and cellular damage, thereby suppressing inflammation and cell apoptosis. In recent years, remarkable progress has been made regarding the active components and compound prescriptions of traditional Chinese medicine in the treatment of CLI by regulating oxidative stress. This article systematically reviews the current status of research on the mechanism of action and clinical application of traditional Chinese medicine in the treatment of CLI by regulating oxidative stress.
Noninvasive preoperative assessment of microvascular invasion (MVI) of intrahepatic cholangiocarcinoma (ICC) is crucial for developing individualized treatment regimens and judging the prognosis of patients. This article comprehensively explores the application value of ultrasound in this field and elaborates on the performance of techniques such as gray-scale ultrasound, contrast-enhanced ultrasound, and ultrasound elastography in predicting MVI by analyzing lesion morphology, blood perfusion, and stiffness characteristics, and meanwhile, it also discusses the application prospects of emerging techniques such as radiomics, deep learning, and dynamic three-dimensional contrast-enhanced ultrasound. The comprehensive analysis shows that ultrasound has an important clinical value in assessing ICC MVI, and the integration of emerging techniques into the ultrasound evaluation system can help to achieve more objective and accurate preoperative prediction and thus has broad application prospects.
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- 1Current situation in the research of Gilbert’s syndrome
- 2Review of acute pancreatitis scoring systems
- 3Clinical value of 13C-methacetin breath test for assessing liver function in patients with cirrhosis
- 4Studies on relevant gactors of Child-Pugh grading in hepatic cirrhosis
- 5Meta-analysis of 111 patients with nonalcoholic steatohepatitis-associated hepatocellular carcinoma
- 6Relationship between Epstein-Barr virus infection and hepatic lesions in children
- 7Research state and prospect of hyponatremia in cirrhosis
- 8Congenital bile acid synthesis defect and cholestatic liver disease
- 9Interventional treatment for Budd-Chiari syndrome:reports of 883 cases
- 10
- 1The guideline of prevention and treatment for chronic hepatitis B: a 2015 update
- 2Chinese guidelines for the management of acute pancreatitis ( Shenyang , 2019 )
- 3The guideline of prevention and treatment for chronic hepatitis B(2010 version)
- 4Current situation in the research of Gilbert’s syndrome
- 5Comprehensive guidelines for the diagnosis and treatment of pancreatic cancer (2018 version)
- 6
- 7Consensus on the diagnosis and management of primary biliary cirrhosis (cholangitis)(2015)
- 8Diagnosis, management, and treatment of hepatocellular carcinoma (V2017)
- 9Consensus on the diagnosis and management of autoimmune hepatitis(2015)
- 10Guidelines for the prevention and treatment of chronic hepatitis B (version 2019)
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