Abstract：
OBJECTIVE: There are few data regarding the safety and effectiveness of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with intractable hepatobiliary diseases. We conducted a multicenter, questionnaire-based, cross-sectional study to determine the safety and effectiveness of the SARS-CoV-2 vaccines in Japanese patients with intractable hepatobiliary disease.
METHODS: Patients aged ≥18 years with autoimmune hepatitis (AIH), primary biliary cholangitis, primary sclerosing cholangitis, Budd-Chiari syndrome, idiopathic portal hypertension, and extrahepatic portal vein obstruction at each center were consecutively invited to join the study. Participants were asked to complete a questionnaire regarding their characteristics, vaccination status, post-vaccination adverse effects, and SARS-CoV-2 infection. Additionally, liver disease status, treatment regimens, and liver function test values pre- and post-vaccination were collected.
RESULTS: The survey was conducted from September 2021 to May 2022, and 528 patients (220 AIH, 251 primary biliary cholangitis, 6 AIH- primary biliary cholangitis/primary sclerosing cholangitis overlap, 39 primary sclerosing cholangitis, 4 Budd-Chiari syndrome, 5 idiopathic portal hypertension, and 3 extrahepatic portal vein obstruction) participated in the study. Post-vaccination adverse effects were comparable to those observed in the general population. Post-vaccination liver injuries classified as grade 1 or higher were observed in 83 cases (16%), whereas grades 2 and 3 were observed in only six cases (1.1%); AIH-like liver injury requiring treatment was not observed. Overall, 12 patients (2.3%) were infected with SARS-CoV-2, and only one patient was infected 6 months after the second vaccination.
CONCLUSIONS: SARS-CoV-2 vaccines demonstrated satisfactory safety and effectiveness in Japanese patients with intractable hepatobiliary diseases.
METHODS: Patients aged ≥18 years with autoimmune hepatitis (AIH), primary biliary cholangitis, primary sclerosing cholangitis, Budd-Chiari syndrome, idiopathic portal hypertension, and extrahepatic portal vein obstruction at each center were consecutively invited to join the study. Participants were asked to complete a questionnaire regarding their characteristics, vaccination status, post-vaccination adverse effects, and SARS-CoV-2 infection. Additionally, liver disease status, treatment regimens, and liver function test values pre- and post-vaccination were collected.
RESULTS: The survey was conducted from September 2021 to May 2022, and 528 patients (220 AIH, 251 primary biliary cholangitis, 6 AIH- primary biliary cholangitis/primary sclerosing cholangitis overlap, 39 primary sclerosing cholangitis, 4 Budd-Chiari syndrome, 5 idiopathic portal hypertension, and 3 extrahepatic portal vein obstruction) participated in the study. Post-vaccination adverse effects were comparable to those observed in the general population. Post-vaccination liver injuries classified as grade 1 or higher were observed in 83 cases (16%), whereas grades 2 and 3 were observed in only six cases (1.1%); AIH-like liver injury requiring treatment was not observed. Overall, 12 patients (2.3%) were infected with SARS-CoV-2, and only one patient was infected 6 months after the second vaccination.
CONCLUSIONS: SARS-CoV-2 vaccines demonstrated satisfactory safety and effectiveness in Japanese patients with intractable hepatobiliary diseases.
摘要：
目的：关于严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗在难治性肝胆疾病患者中的安全性和有效性的数据很少。我们进行了一个多中心，以问卷调查为基础，横断面研究，以确定SARS-CoV-2疫苗在日本难治性肝胆疾病患者中的安全性和有效性。
方法：年龄≥18岁的自身免疫性肝炎（AIH）患者，原发性胆汁性胆管炎,原发性硬化性胆管炎,布加综合征,特发性门静脉高压症,连续邀请每个中心的肝外门静脉阻塞加入研究。参与者被要求填写一份关于他们特征的问卷，疫苗接种状况,疫苗接种后的不良反应，和SARS-CoV-2感染。此外,肝病状态，治疗方案,收集疫苗接种前后的肝功能检测值.
结果：调查于2021年9月至2022年5月进行，共528例患者（220AIH，251例原发性胆汁性胆管炎,6AIH-原发性胆汁性胆管炎/原发性硬化性胆管炎重叠，39原发性硬化性胆管炎，4布加综合征，5特发性门静脉高压症，和3例肝外门静脉阻塞）参加了研究。疫苗接种后的不良反应与一般人群中观察到的不良反应相当。在83例（16％）中观察到疫苗接种后肝损伤分类为1级或更高，而只有6例(1.1%)观察到2级和3级;未观察到需要治疗的AIH样肝损伤。总的来说,12例(2.3%)感染SARS-CoV-2,只有1例患者在第二次接种后6个月感染。
结论：SARS-CoV-2疫苗在日本难治性肝胆疾病患者中表现出令人满意的安全性和有效性。
方法：年龄≥18岁的自身免疫性肝炎（AIH）患者，原发性胆汁性胆管炎,原发性硬化性胆管炎,布加综合征,特发性门静脉高压症,连续邀请每个中心的肝外门静脉阻塞加入研究。参与者被要求填写一份关于他们特征的问卷，疫苗接种状况,疫苗接种后的不良反应，和SARS-CoV-2感染。此外,肝病状态，治疗方案,收集疫苗接种前后的肝功能检测值.
结果：调查于2021年9月至2022年5月进行，共528例患者（220AIH，251例原发性胆汁性胆管炎,6AIH-原发性胆汁性胆管炎/原发性硬化性胆管炎重叠，39原发性硬化性胆管炎，4布加综合征，5特发性门静脉高压症，和3例肝外门静脉阻塞）参加了研究。疫苗接种后的不良反应与一般人群中观察到的不良反应相当。在83例（16％）中观察到疫苗接种后肝损伤分类为1级或更高，而只有6例(1.1%)观察到2级和3级;未观察到需要治疗的AIH样肝损伤。总的来说,12例(2.3%)感染SARS-CoV-2,只有1例患者在第二次接种后6个月感染。
结论：SARS-CoV-2疫苗在日本难治性肝胆疾病患者中表现出令人满意的安全性和有效性。
