Study: NCT06293378

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sulfasalazine enteric-coated tablets
Description: 1. 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, and 12 months of follow-up observation.~(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 and were followed up for 12 months.~2. Cohort B-D: 60 cases were collected from each group, 30 cases continued the current treatment(people with hepatitis B cirrhosis and hepatitis C cirrhosis continue to take antivirals), and 30 patients were taking sulfasalazine for 12 months of follow-up observation.~After 12 months of treatment, at the time of enrollment and the 1st/2nd/3rd/6th/9th/12 months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected。

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sulfasalazine enteric-coated tablets
Description: 1. 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, and 12 months of follow-up observation.~(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 and were followed up for 12 months.~2. Cohort B-D: 60 cases were collected from each group, 30 cases continued the current treatment(people with hepatitis B cirrhosis and hepatitis C cirrhosis continue to take antivirals), and 30 patients were taking sulfasalazine for 12 months of follow-up observation.~After 12 months of treatment, at the time of enrollment and the 1st/2nd/3rd/6th/9th/12 months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected。

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sulfasalazine enteric-coated tablets
Description: 1. 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, and 12 months of follow-up observation.~(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 and were followed up for 12 months.~2. Cohort B-D: 60 cases were collected from each group, 30 cases continued the current treatment(people with hepatitis B cirrhosis and hepatitis C cirrhosis continue to take antivirals), and 30 patients were taking sulfasalazine for 12 months of follow-up observation.~After 12 months of treatment, at the time of enrollment and the 1st/2nd/3rd/6th/9th/12 months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected。

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sulfasalazine enteric-coated tablets
Description: 1. 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, and 12 months of follow-up observation.~(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 and were followed up for 12 months.~2. Cohort B-D: 60 cases were collected from each group, 30 cases continued the current treatment(people with hepatitis B cirrhosis and hepatitis C cirrhosis continue to take antivirals), and 30 patients were taking sulfasalazine for 12 months of follow-up observation.~After 12 months of treatment, at the time of enrollment and the 1st/2nd/3rd/6th/9th/12 months, the liver function, fecal flora, liver fibrosis and immune related indexes were detected。