This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, Observe changes in patients' biochemical and imaging indicators, liver stiffness values, fecal microbiota, and metabolites before and after the use of sulfasalazine.
Sign the informed consent form before the trial and be able to complete the study in accordance with the requirements of the trial protocol;
The age is 18~70 years old (including boundary value), the weight of male subjects is not less than 45 kg, and the weight of female subjects is not less than 40 kg. Body mass index (BMI) in the range of 18~32kg/m2 (including critical value);
Those who have a history of allergies in the past, or the investigator suspects that they are allergic to the active ingredients of the drug or their excipients under study;
Allergy to sulfasalazine and its metabolites, sulfonamides or salicylic acid;
Patients with intestinal obstruction or urinary tract obstruction;
Patients with porphyria, such as sulfonamides, have been reported to cause acute attacks.
Parallel
Sulfasalazine enteric-coated tablets
DrugSulfasalazine enteric-coated tablets Cohort A: PBC treatment group: (1) PBC patients with poor response to UDCA after treatment: 30 patients continued to take UDCA(13-15mg/kg), 30 patients took UDCA(13-15mg/kg)+SASP (0.5g orally three times a day), 30 patients took SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected. (2) Newly treated PBC patients: 30 patients took UDCA(13- 15mg/kg) and 30 patients took UDCA(13-15mg/kg)+SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.
Sulfasalazine enteric-coated tablets
DrugCohort B:60 cases with hepatitis B cirrhosis were collected from each group, 30 cases continued the current treatment, and 30 patients were taking SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.
Sulfasalazine enteric-coated tablets
DrugCohort C：Patients with HCV were treated with sulfasalazine Cohort C: 60 cases with hepatitis C cirrhosis were collected，30 cases continued the current treatment(people with hepatitis C cirrhosis continue to take antivirals), and30 patients were taking SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.
Sulfasalazine enteric-coated tablets
DrugCohort D：Patients with alcoholic liver fibrosis/cirrhosis were treated with sulfasalazine 60 cases with alcoholic cirrhosis were collected , 30 cases continued the current treatment and 30 patients were taking SASP (0.5g orally three times a day) for 12 months of follow-up observation. During 12 months of treatment, at the time of enrollment and the 1st/3rd/6th/9th/12th months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected.
Hepatic fibrosis
The changes of liver fibrosis
Serum alkaline phosphatase (ALP)
Serum alkaline phosphatase (ALP) level
Serum γ-glutamyl transpeptidase (GGT)
Serum γ-glutamyl transpeptidase (GGT) level
Serum bilirubin
Serum bilirubin level
The gut microbiota and metabolites.
The levels of changes in gut microbiota and metabolites.
Changes in immune cells
Th1 cells (CD3 + CD4 + IFN-γ +) , Th2 cells (CD3 + CD4 + IL-4 +) , Th17 cells (CD3 + CD4 + IL-17 +) , Treg cells (CD3 + CD4 + CD25 + CD127low) ,Tfh cells (CD3+CD4+CXCR5+CD127highCD25low), Tfh1 cells (CXCR3 + CCR6- on the basis of Tfh) , Tfh2 cells (CXCR3-CCR6- on the basis of Tfh) , Tfh17 cells (CXCR3-CCR6+ on the basis of Tfh) , Tfr cells (CD4+CXCR5+CD127lowCD25high)，activated CD8 + T cells (CD3 + CD8 + CD38 +) , B cells（CD3-CD19+），B regulatory cells（CD3-CD19 + CD24highCD38), Plasma cells(CD20lowCD27highCD38high based on B cells ).
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