Pharmacokinetics, pharmacodynamics and safety of 15 mg-tolvaptan administered orally for 7 consecutive days to Chinese patients with child-Pugh B cirrhosis.

Tolvaptan, a selective vasopressin V-receptor antagonist, can elicit a diuretic effect without significant electrolyte loss. The aims were to evaluate multiple-dose pharmacokinetics, pharmacodynamics and safety of daily administration of 15 mg tolvaptan in Chinese adult patients with confirmed Child-Pugh Class B cirrhosis accompanied by ascites. This was an open-label, single-center, single- and multiple-dose study.

Exploring the efficacy and safety of polyene phosphatidylcholine for treatment of drug-induced liver injury using the Roussel Uclaf causality assessment method: a propensity score matching comparison.

In China, polyene phosphatidylcholine (PPC) is widely used to treat alanine aminotransferase (ALT) elevation associated with various liver diseases. Here, we assessed the efficacy and safety of PPC in treating drug-induced liver injury (DILI). Data from a multicenter retrospective cohort study (DILI-R) were analyzed to compare PPC and magnesium isoglycyrrhizinate (MgIG) for treatment of DILI.

Tolvaptan therapy of Chinese cirrhotic patients with ascites after insufficient diuretic routine medication responses: a phase III clinical trial.

Background: To determine the safety and efficacy of different doses of tolvaptan for treating Chinese cirrhotic patients with or without hyponatraemia who still had ascites after routine therapy with diuretics.

Methods: In the present placebo-controlled, randomized, double-blinded, multicentre clinical trial, patients with cirrhotic ascites who failed to adequately respond to a combination of an aldosterone antagonist plus an orally administered loop diuretic were randomly placed at a 4:2:1 ratio into 3 groups [the 15 mg/day tolvaptan group (N = 301), 7.5 mg/day tolvaptan group (N = 153) and placebo group (N = 76)] for 7 days of treatment.

Efficacy and safety of magnesium isoglycyrrhizinate injection in patients with acute drug-induced liver injury: A phase II trial.

Background: Drug-induced liver injury (DILI) is the most common reason for a drug to be withdrawn from the market. Apart from stopping the offending drug, no regimens are available for treating idiosyncratic DILI in clinical practice.

Methods: We carried out a randomized, double-blind, multidoses, active drug controlled, multicentre phase II trial to assess the safety and efficacy of the study drug, magnesium isoglycyrrhizinate (MgIG), as compared to tiopronin, a standard therapy for DILI in China.

CSH guidelines for the diagnosis and treatment of drug-induced liver injury.

Drug-induced liver injury (DILI) is an important clinical problem, which has received more attention in recent decades. It can be induced by small chemical molecules, biological agents, traditional Chinese medicines (TCM), natural medicines (NM), health products (HP), and dietary supplements (DS). Idiosyncratic DILI is far more common than intrinsic DILI clinically and can be classified into hepatocellular injury, cholestatic injury, hepatocellular-cholestatic mixed injury, and vascular injury based on the types of injured target cells.

Gene-metabolite network analysis in different nonalcoholic fatty liver disease phenotypes.

We sought to identify common key regulators and build a gene-metabolite network in different nonalcoholic fatty liver disease (NAFLD) phenotypes. We used a high-fat diet (HFD), a methionine-choline-deficient diet (MCDD) and streptozocin (STZ) to establish nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH) and NAFL+type 2 diabetes mellitus (T2DM) in rat models, respectively. Transcriptomics and metabolomics analyses were performed in rat livers and serum.

A multicenter, randomized, double-blind trial comparing the efficacy and safety of TUDCA and UDCA in Chinese patients with primary biliary cholangitis.

Aim: Tauroursodeoxycholic acid (TUDCA) is a taurine conjugated form of ursodeoxycholic acid (UDCA) with higher hydrophility. To further evaluate the efficacy and safety of TUDCA for primary biliary cholangitis (PBC), we performed this study on Chinese patients.

Methods: 199 PBC patients were randomly assigned to either 250 mg TUDCA plus UDCA placebo or 250 mg UDCA plus TUDCA placebo, 3 times per day for 24 weeks.

Validation of Ten Noninvasive Diagnostic Models for Prediction of Liver Fibrosis in Patients with Chronic Hepatitis B.

Background And Aims: Noninvasive models have been developed for fibrosis assessment in patients with chronic hepatitis B. However, the sensitivity, specificity and diagnostic accuracy in evaluating liver fibrosis of these methods have not been validated and compared in the same group of patients. The aim of this study was to verify the diagnostic performance and reproducibility of ten reported noninvasive models in a large cohort of Asian CHB patients.

S100A9: A Potential Biomarker for the Progression of Non-Alcoholic Fatty Liver Disease and the Diagnosis of Non-Alcoholic Steatohepatitis.

Unlabelled: Non-alcoholic fatty liver (NAFL) has the potential to progress to non-alcoholic steatohepatitis (NASH) or to promote type 2 diabetes mellitus (T2DM). However, NASH and T2DM do not always develop coordinately. Additionally, there are no definite noninvasive methods for NASH diagnosis currently.

The aggravation of mitochondrial dysfunction in nonalcoholic fatty liver disease accompanied with type 2 diabetes mellitus.

Objective: Nonalcoholic fatty liver disease (NAFLD) is a mitochondrial disease associated with the metabolic syndrome, but few data are available on the mitochondrial dysfunction of NAFLD after the development of type 2 diabetes mellitus (T2DM). We aimed to identify the changes of mitochondrial function in rat livers when T2DM develops after NAFLD.

Material And Methods: Rat models of nonalcoholic fatty liver (NAFL) and T2DM were established using high-fat diet and streptozocin.

Transient elastography compared to serum markers to predict liver fibrosis in a cohort of Chinese patients with chronic hepatitis B.

Background And Aim: Liver stiffness measurement (LSM) using transient elastography (FibroScan) is a useful tool to assess fibrosis in various chronic liver diseases. However, studies were mainly performed in Western countries and largely focused on chronic hepatitis C (CHC). We therefore carried out a multicenter study to validate the accuracy of LSM in the assessment of liver fibrosis in a large cohort of Chinese patients with chronic hepatitis B (CHB).

[Validation of transient elastography (Fibroscan) in assessment of hepatic fibrosis in autoimmune hepatitis].

Objective: To validate transient elastography (Fibroscan) in assessment of hepatic fibrosis in autoimmune hepatitis (AIH).

Methods: Liver stiffness was assessed using Fibroscan in totally 30 patients with AIH. We compared the results of Fibroscan with the Scheuer fibrosis stage in liver biopsy in each patient.

Five years of treatment with adefovir dipivoxil in Chinese patients with HBeAg-positive chronic hepatitis B.

Background: Adefovir dipivoxil (ADV) is a nucleotide analogue with proven efficacy in chronic hepatitis B (CHB).

Aims: This study investigated long-term ADV treatment in HBeAg-positive patients.

Methods: A total of 480 Chinese subjects with HBeAg-positive CHB who participated in a 1-year, double-blind, placebo-controlled study of ADV 10 mg daily were offered open-label continuation for a further 208 weeks.

[General characteristics and clinical practices of Chinese patients with non-alcoholic fatty liver disease].

Objective: To assess the characteristics and daily treatment compliance of non-alcoholic fatty liver disease (NAFLD) patients in China.

Methods: NAFLD adult patients from 21 clinics of 12 cities in China were enrolled in this registry. Physical examination such as demographic characteristics (height, weight, waist circumference measurement), blood pressure and clinical laboratory and ultrasonographic examination of liver were undertaken.

Simpler score of routine laboratory tests predicts liver fibrosis in patients with chronic hepatitis B.

Background And Aim: In recent years, a great interest has been dedicated to the development of noninvasive predictive models to substitute liver biopsy for fibrosis assessment and follow-up. Our aim was to provide a simpler model consisting of routine laboratory markers for predicting liver fibrosis in patients chronically infected with hepatitis B virus (HBV) in order to optimize their clinical management.

Methods: Liver fibrosis was staged in 386 chronic HBV carriers who underwent liver biopsy and routine laboratory testing.

[Magnesium isoglycyrrhizinate in the treatment of chronic liver diseases: a randomized, double-blind, multi-doses, active drug controlled, multi-center study].

Objective: To evaluate the efficacy and safety of Magnesium isoglycyrrhizinate in treatment of chronic liver diseases.

Methods: It is a randomized, double-blind, multi-doses, active drug controlled, multi-center study. 480 proper patients were randomly divided into group A (180 patients), group B (180 patients) or group C (120 patients).

[Capsule metadoxine in the treatment of alcoholic liver disease: a randomized, double-blind, placebo-controlled, multicenter study].

Objective: To evaluate the efficacy and safety of Capsule metadoxine in the treatment of alcoholic liver disease.

Methods: A randomized double blind multicenter placebo-controlled clinical study was performed to evaluate the therapeutic effectiveness and safety of capsule metadoxine. Patients in metadoxine group received capsule metadoxine 500mg tid po.

[Assessment of the health-related quality of life of patients with minimal hepatic encephalopathy].

Objective: The Medical Outcome Study of 36-item Short-Form Health Survey (SF-36) is a well-validated generic questionnaire widely used to assess health-related quality of life (HRQOL), and the Chronic Liver Disease Questionnaire (CLDQ) is a specific HRQOL assessment designed for patients with liver diseases. The aim of our study is to evaluate the HRQOL based on SF-36 and CLDQ (Chinese version) in patients with chronic hepatitis B and liver cirrhosis, especially in the status of minimal hepatic encephalopathy (MHE).

Methods: The SF-36 and CLDQ were answered by 160 healthy volunteers, 20 patients with chronic hepatitis B and 106 patients with cirrhosis.

Assessment of health-related quality of life in Chinese patients with minimal hepatic encephalopathy.

Aim: To evaluate the health-related quality of life (HRQOL) based on the Chinese version of SF-36 and Chronic Liver Disease Questionnaire (CLDQ) in subjects with chronic hepatitis B, liver cirrhosis, including patients with minimal hepatic encephalopathy (MHE).

Methods: The SF-36 and CLDQ were administered to 160 healthy volunteers, 20 subjects with chronic hepatitis B and 106 patients with cirrhosis (33 cases exhibited MHE). HRQOL scores were compared among the different study groups.

Phase I safety and pharmacokinetic study of magnesium isoglycyrrhizinate after single and multiple intravenous doses in chinese healthy volunteers.

The safety and pharmacokinetics of magnesium isoglycyrrhizinate were assessed in healthy Chinese volunteers. In the single-dose format of this pharmacokinetic study, 100-, 200-, and 300-mg doses of magnesium isoglycyrrhizinate were given by intravenous infusion. The results indicated that the plasma levels were directly proportional to the administered dose, with the mean C(max) and AUC(0-72) ranging from approximately 28.

[The effect of ligand of peroxisome proliferators-activated receptor gamma 15d-PGJ2 on the proliferation and activation of hepatic stellate cells].

Objective: To observe the effect of ligand of peroxisome proliferators-activated receptor gamma (PPAR gamma) 15d-PGJ2 on the proliferation and activation of hepatic stellate cells (HSC) and to study the role played by PPAR gamma during the process of HSC activation.

Methods: By using RT-PCR and cell culture, we investigated the effects of 5 micro mol/L and 10 micro mol/L 15d-PGJ2 on culture-activated HSC and on PDGF-induced HSC proliferation, production of extracellular matrix and expression of chemokines.

Results: The expression of alpha-SMA was significantly suppressed by 5mumol/L 15d-PGJ2, and the expression of PPAR gamma was significantly higher in the 15d-PGJ2 treated group than in the untreated group (0.

A double-blind randomized trial of adefovir dipivoxil in Chinese subjects with HBeAg-positive chronic hepatitis B.

Four hundred and eighty Chinese subjects with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) were enrolled in a multicenter, double-blind, randomized, placebo-controlled study of adefovir dipivoxil (ADV) 10 mg once daily. There was a significant difference in reduction of serum hepatitis B virus (HBV) DNA after 12 weeks between subjects who received ADV and those who received the placebo (3.4 and 0.