Analysis on clinical features of granulomatous hepatitis induced by intravesical instillation with Bacillus Calmette-Guérin vaccine
10.3760/cma.j.cn114015-20211217-01269
- VernacularTitle:卡介苗膀胱灌注相关肉芽肿性肝炎的临床特点分析
- Author:
Beibei NI
1
;
Jun ZHAO
1
;
Zhanqi CAO
1
;
Qie GUO
1
;
Wen XU
1
;
Ping LENG
1
Author Information
1. 青岛大学附属医院药学部，青岛 266071
- Publication Type:Journal Article
- Keywords:
Administration, intravesical;
BCG Vaccine;
Granulomatous disease, chronic;
Hepatitis
- From:
Adverse Drug Reactions Journal
2022;24(5):252-257
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To understand the clinical features of granulomatous hepatitis (GH) induced by intravesical instillation with Bacille Calmette-Guérin vaccine (BCG).Methods:Case reports of GH which was confirmed by liver biopsy and induced by intravesical BCG therapy were collected by searching PubMed and Elsevier databases as of December 2021. The following information of patients including general information, intravesical BCG situations (dose, times of instillation, traumatic catheterization occurrence), GH occurrence (onset time, clinical manifestations, laboratory tests and liver biopsy results), other adverse reactions, treatments, and outcomes were extracted and analyzed descriptively.Results:A total of 23 patients, who were all male, were entered in the analysis, aged from 34 to 80 years with a median age of 66 years. The primary diseases were bladder cancer in 22 patients and ureteral carcinoma in 1 patient. The times of instillation until GH occurred were recorded in 19 patients. Of them, 2 patients had instillation once and the time was 16 at most. Ten patients had traumatic catheterization during the last instillation, including hematuria in 7 patients, pain in 2 patients, and difficulty in urethral intubation in 1 patient. Time from the last instillation to the onset of GH was from 3 h to 440 days (≤7 days in 18 patients, 10, 14, 21, 180, and 440 days in 1 patient respectively) with a median time of 3 days. Among the 23 patients, 21 had fever, 12 had jaundice, 9 had hepatomegaly, 7 had fatigue, 5 had anorexia, 2 had weight loss, and 1 had night sweats; 12 manifested as GH alone and 11 had concomitant adverse reactions. Abnormal liver function appeared in 22 patients, mainly including elevated alkaline phosphatase and elevated aspartate aminotransferase (each in 17 patients). Mycobacterium bovis identification/culture results were recorded in 20 patients and 7 were positive. Liver biopsies showed noncaseating granuloma of epithelioid in 10 patients, noncaseating granuloma in 7 patients, epithelioid granuloma in 4 patients, and hepatic granuloma without details in 2 patients. After discontinuation of BCG instillations and treatments with anti-tuberculosis agents and/or corticosteroids, 22 patients were improved and 1 patient died of BCG sepsis and multiple organ failure.Conclusions:GH usually occurs within 1 week after intravesical instillation with BCG and mainly manifests as fever, jaundice, hepatomegaly, and abnormal liver function, which may be accompanied by other adverse reactions related to BCG instillation. Liver biopsy can help the diagnosis. The prognosis is good after combination therapy with anti-tuberculosis agents and corticosteroids, but death may occur in severe cases.
