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EASL 立场文件:关于在慢性肝病、肝胆癌和肝移植受者中使用 COVID-19 疫苗的建议。

EASL position paper on the use of COVID-19 vaccines in patients with chronic liver diseases, hepatobiliary cancer and liver transplant recipients.

机构信息

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; Centre for Individualised Infection Medicine (CiiM), a joint venture of Helmholtz Centre for Infection Research and Hannover Medical School, Hannover, Germany; German Center for Infection Research (DZIF), Partner-Site Hannover-Braunschweig, Hannover, Germany.

Liver Unit. Hospital Universitario Valle Hebron and Ciber-ehd del Instituto Carlos III, Barcelona, Spain.

出版信息

J Hepatol. 2021 Apr;74(4):944-951. doi: 10.1016/j.jhep.2021.01.032. Epub 2021 Feb 6.

Abstract

According to a recent World Health Organization estimate, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, which originated in China in 2019, has spread globally, infecting nearly 100 million people worldwide by January 2021. Patients with chronic liver diseases (CLD), particularly cirrhosis, hepatobiliary malignancies, candidates for liver transplantation, and immunosuppressed individuals after liver transplantation appear to be at increased risk of infections in general, which in turn translates into increased mortality. This is also the case for SARS-CoV-2 infection, where patients with cirrhosis, in particular, are at high risk of a severe COVID-19 course. Therefore, vaccination against various pathogens including SARS-CoV-2, administered as early as possible in patients with CLD, is an important protective measure. However, due to impaired immune responses in these patients, the immediate and long-term protective response through immunisation may be incomplete. The current SARS-CoV-2 pandemic has led to the exceptionally fast development of several vaccine candidates. A small number of these SARS-CoV-2 vaccine candidates have already undergone phase III, placebo-controlled, clinical trials in healthy individuals with proof of short-term safety, immunogenicity and efficacy. However, although regulatory agencies in the US and Europe have already approved some of these vaccines for clinical use, information on immunogenicity, duration of protection and long-term safety in patients with CLD, cirrhosis, hepatobiliary cancer and liver transplant recipients has yet to be generated. This review summarises the data on vaccine safety, immunogenicity, and efficacy in this patient population in general and discusses the implications of this knowledge on the introduction of the new SARS-CoV-2 vaccines.

摘要

根据世界卫生组织最近的估计,2019 年起源于中国的严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)大流行已在全球范围内传播,到 2021 年 1 月,全球近 1 亿人感染。患有慢性肝病(CLD)的患者,特别是肝硬化、肝胆恶性肿瘤、肝移植候选者和肝移植后免疫抑制的个体,一般感染风险似乎增加,这反过来又导致死亡率增加。SARS-CoV-2 感染也是如此,特别是肝硬化患者,患严重 COVID-19 的风险很高。因此,对包括 SARS-CoV-2 在内的各种病原体进行疫苗接种,尽早在 CLD 患者中进行,是一项重要的保护措施。然而,由于这些患者的免疫反应受损,免疫接种可能无法立即和长期提供完全的保护作用。当前的 SARS-CoV-2 大流行导致了几种疫苗候选者的快速发展。其中少数 SARS-CoV-2 疫苗候选者已经在健康个体中进行了 III 期、安慰剂对照的临床试验,证明了短期安全性、免疫原性和疗效。然而,尽管美国和欧洲的监管机构已经批准了其中一些疫苗用于临床使用,但关于 CLD、肝硬化、肝胆癌和肝移植受者患者的免疫原性、保护持续时间和长期安全性的数据尚未产生。这篇综述总结了一般情况下该患者人群中疫苗安全性、免疫原性和疗效的数据,并讨论了这些知识对新 SARS-CoV-2 疫苗引入的影响。

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