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Treatment of primary biliary cholangitis with ursodeoxycholic acid, prednisolone and immunosuppressants in patients not responding to ursodeoxycholic acid alone and the prognostic indicators - 22/11/20

Doi : 10.1016/j.clinre.2020.03.026 
Jian-Dan Qian a, 1 , Tian-Tian Yao a, 1 , Yan Wang a , Gui-Qiang Wang a, b, c,
a Department of Infectious Diseases and the Center for Liver Diseases, Peking University First Hospital, 100034 Beijing, China 
b The Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Zhejiang University, 310003 Hangzhou, Zhejiang Province, China 
c Peking University International Hospital, 102206 Beijing, China 

Corresponding author at: Department of Infectious Diseases, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, 100034 Beijing, China.Department of Infectious Diseases, Peking University First HospitalNo. 8 Xishiku Street, Xicheng DistrictBeijing100034China

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Highlights

Therapy combined with UDCA, prednisolone and immunosuppressants is more effectivity than UDCA monotherapy for PBC patients.
The improvements are mainly focus on liver biochemical parameters, immune indicators and noninvasive fibrosis indicators.
Anti-gp210 antibody positivity, AMA negativity, high ALP, TBIL and globulin levels and severe degree of fibrosis at baseline were associated with poor prognosis.
The triple therapy may be a rescue therapy for refractory PBC patients.

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Summary

Background and aim

We reviewed the medical records of primary biliary cholangitis patients who were diagnosed by liver biopsy and treated with the corresponding treatment. We evaluated the therapeutic effect and long-term prognostic indicators.

Methods

This observational cohort study enrolled 80 eligible patients diagnosed by liver biopsy between December 2013 and December 2018 in our department. UDCA monotherapy or UDCA added to prednisolone and immunosuppressant triple therapy was prescribed to patients. We analyzed and compared the demographic characteristics, biochemistry profiles, immune parameters, and noninvasive liver fibrosis assessments at baseline as well as the treatment efficacy, long-term outcomes and adverse effects at baseline and at each visit between the two groups. The indicators that could affect prognosis were assessed.

Results

Thirty-eight primary biliary cholangitis patients received UDCA monotherapy (group A), and another 42 patients received UDCA, prednisolone and immunosuppressant triple therapy (group B). After therapy, all patients showed significant improvements in liver biochemical parameters, immune indicators, and noninvasive fibrosis indicators (Fibrosis-4 (FIB-4), aspartate aminotransferase-to-platelet ratio index (APRI)), all P values<0.0001. The Mayo score also decreased significantly after treatment (P=0.022). Triple therapy was more effective, and there was a significant difference between the two groups. In addition, multivariate analysis showed that anti-gp210 antibody positivity; antimitochondrial antibody (AMA) negativity; high alkaline phosphatase (ALP), total bilirubin (TBIL) and globulin levels; and a severe degree of fibrosis at baseline were independent predictors of a poor prognosis.

Conclusions

Triple therapy was a treatment option for UDCA-refractory PBC patients. Anti-gp210 antibody positivity; AMA negativity; high ALP, TBIL and globulin levels; and a severe degree of fibrosis at baseline were associated with a poor prognosis.

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Keywords : Primary biliary cholangitis, Ursodeoxycholic acid, Prednisolone, Immunosuppressant, Prognostic value

Abbreviations : PBC, UDCA, AMA, ALP, TBIL, ULN, IgG, ANA, HCC, AZA, MMF, BMI, APRI, CT, MRI, ASMA, LKM-1, SLA/LP, GGT, TBA, ALT, AST, ALB


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Vol 44 - N° 6

P. 874-884 - Novembre 2020 Ritorno al numero
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