This is a two-way (retrospective+prospective) cohort study of patients with primarybiliary cholangitis (PBC) and autoimmune hepatitis (AIH) infected with COVID-19. EnrolledPBC and AIH patients in clinical diagnosis and treatment at Beijing Ditan Hospitalaffiliated with Capital Medical University from January 2021 to December 2023. Afterenrollment, collect the demography data of patients, the treatment information of PBC andAIH patients, the use of ursodeoxycholic acid (UDCA) and immunosuppressants, COVID-19vaccination, COVID-19 infection and incidence, clinical symptoms, clinical biochemistry,liver imaging, lung imaging, COVID-19 nucleic acid, COVID-19 antibody, and the incidenceand treatment information of COVID-19 from January 2022 to pre enrollment. Afterenrollment, the corresponding treatment and clinical observation of PBC and AIH werecontinued, and the occurrence and incidence of COVID-19 infection were observed. Forpatients with COVID-19 infection during the prospective observation period, COVID-19infection, onset and treatment were observed, including clinical symptoms, signs, heart,lung imaging, COVID-19, clinical biochemistry, disease degree, virus negative, hospitalstay and prognosis. To compare the difference of COVID-19 infection rate, diseaseseverity, clinical biochemical indicators, hospital stay and prognosis between UDCAtreated and non UDCA treated patients, and to study the impact of UDCA on the occurrence,incidence and prognosis of COVID-19 infection.
This is a two-way (retrospective+prospective) cohort study of patients with primary
biliary cholangitis (PBC) and autoimmune hepatitis (AIH) infected with COVID-19. Enrolled
PBC and AIH patients in clinical diagnosis and treatment at Beijing Ditan Hospital,
Capital Medical University from January 2021 to December 2023. After enrollment, the
demography data of patients, the treatment information of PBC and AIH patients, the use
of ursodeoxycholic acid (UDCA) and immunosuppressants, COVID-19 vaccination, COVID-19
infection and incidence, clinical symptoms, clinical biochemistry, liver imaging, lung
imaging, COVID-19 nucleic acid, COVID-19 antibody, and the incidence and treatment
information of COVID-19 from January 2022 to pre enrollment were collected. Meanwhile,
the corresponding treatment and clinical observation of PBC and AIH were continued, and
the occurrence and incidence of COVID-19 infection were observed. For patients with
COVID-19 infection during the prospective observation period, COVID-19 infection, onset
and treatment were observed, including clinical symptoms, signs, heart, lung imaging,
COVID-19, clinical biochemistry, disease degree, virus negative, hospital stay and
prognosis. This study is aim to compare the difference of COVID-19 infection rate,
disease severity, clinical biochemical indicators, hospital stay and prognosis between
UDCA treated and non UDCA treated patients, and to study the impact of UDCA on the
occurrence, incidence and prognosis of COVID-19 infection.
Drug: ursodeoxycholic acid
To study the incidence of COVID-19 infection and COVID-19 pneumonia in patients with
autoimmune liver disease treated by UDCA, and to explore the impact of UDCA on COVID-19
infection, disease occurrence and clinical outcome.
Other Name: UDCA
Inclusion Criteria:
- Autoimmune liver disease patients who have been treated with UDCA for six months or
more and those who have not been treated with UDCAExclusion.
Exclusion Criteria:
- Patients with decompensated liver cirrhosis or previous history of decompensated
liver cirrhosis;
- At the same time, it is associated with other viral infections, such as hepatitis A
virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV, etc;
- Accompanied with other serious physical and mental diseases, including uncontrolled
primary kidney, heart, lung, vascular, nervous, digestive, severe metabolic diseases
(such as uncontrolled hyperthyroidism, diabetes, serious complications, adrenal
diseases, etc.), immunodeficiency disease, and accompanied with serious infection;
History of active or suspected malignant tumors or malignant tumors.
Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, Beijing, China
Investigator: Yao Xie, Doctor
Contact: 8610-84322200
xieyao00120184@sina.com
Yao Xie, Doctor
8610-84322200 - 2489
xieyao00120184@sina.com
Rui Song, Doctor
13126595640
songruii@hotmail.com
Rui Song, Doctor, Principal Investigator
Beijing Ditan Hospital