文章摘要
慢性HBV感染者接种新型冠状病毒疫苗的安全性及有效性研究
Study on the safety and efficacy of SARS-CoV-2 vaccination in patients with chronic HBV infection
  
DOI:10.3969/j.issn.1007-8134.2023.03.01
中文关键词: 慢性乙型肝炎  新型冠状病毒肺炎  新型冠状病毒  疫苗  安全性  有效性  HBV感染  抗体
英文关键词: chronic hepatitis B virus  COVID-19  SARS-CoV-2  vaccination  safety  efficacy hepatitis B virus infection  antibody
基金项目:广州实验室应急攻关项目(EKPG21-30-4);蚌埠医学院研究生科研创新课题(Byycx21043)
作者单位
毛玉锋 蚌埠医学院研究生院2020级 
乔?菲 解放军总医院第五医学中心感染病医学部 国家感染性疾病临床研究中心 
刘诗洋 解放军总医院第五医学中心感染病医学部 国家感染性疾病临床研究中心 
张仁杰 解放军总医院第五医学中心感染病医学部 国家感染性疾病临床研究中心 
李元元 解放军总医院第五医学中心感染病医学部 国家感染性疾病临床研究中心 
王福生 解放军总医院第五医学中心感染病医学部 国家感染性疾病临床研究中心 
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中文摘要:
      目的?分析慢性HBV感染者全程接种3剂新型冠状病毒(severe acute respiratory syndrome coronavirus 2, SARS-CoV-2)疫苗的安全性及有效性。方法?纳入2021年10月—2022年8月在解放军总医院第五医学中心就诊并自愿接种SARS-CoV-2疫苗的慢性HBV感染者107例,在第0(基线)、1、2、4、7、8月时进行访视并定期检测血常规、血生化及凝血四项等实验室指标。通过记录慢性HBV感染者接种每剂SARS-CoV-2疫苗后28 d内的不良反应及实验室指标的动态变化特点以评估其安全性。在随访时留取血浆样本检测中和抗体滴度以评估其有效性,同时分析抗体滴度可能的影响因素。结果?慢性HBV感染者接种3剂SARS-CoV-2疫苗后不良反应发生率依次为22.43%(24/107)、19.79%(19/96)和16.67%(12/72),最常见的局部不良反应为接种部位疼痛,最常见的全身性的不良反应为疲劳、乏力;接种疫苗后生化学及病毒学指标未出现恶化;接种每剂SARS-CoV-2疫苗后中和抗体滴度均显著上升(P均<0.05),而后随着时间逐渐下降;抗体阳性组受试者年龄低于阴性组受试者[(42.27±9.40)岁 vs. 48.00(43.00,53.50)岁,P = 0.040]。结论?慢性HBV感染者接种SARS-CoV-2疫苗后具有良好的安全性及有效性,不良反应发生率低且未发生疫苗相关严重不良事件;接种第3剂加强针后产生的中和抗体反应最为强烈;而年龄则会影响慢性HBV感染者接种疫苗后的抗体滴度。
英文摘要:
      Objective To analyze the safety and efficacy of 3 doses of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in patients with chronic hepatitis B virus (HBV) infection. Methods?A total of 107 patients with chronic HBV infection who attended the Fifth Medical Center of PLA General Hospital from October 2021 to August 2022 and voluntarily received SARS-CoV-2 vaccine were followed up at the 0 (baseline), 1, 2, 4, 7 and 8 months, and their blood routine, blood biochemistry and coagulation were tested regularly. The safety of the vaccine was evaluated by recording the adverse events within 28 days and the dynamic changes of laboratory indexes after each dose of SARS-CoV-2 vaccine of patients with chronic HBV infection. During the follow-up, plasma samples were taken to detect the neutralizing antibody titers to evaluate its effectiveness, and the possible influencing factors of antibody titer were analyzed. Results?After three doses of SARS-CoV-2 vaccine, the incidence of adverse events in patients with chronic HBV infection was 22.43% (24/107), 19.79% (19/96) and 16.67% (12/72) respectively, and the most common adverse event was pain at the injection site. After vaccination, the chemical and virological indexes did not deteriorate. After each dose of SARS-CoV-2 vaccine, the titer of neutralizing antibody increased significantly (P<0.05), and then decreased gradually with time. The age of the subjects in antibody positive group was lower than that in negative group [(42.27±9.40)vs. 48.00 (43.00, 53.50), P=0.040]. Conclusions?SARS-CoV-2 vaccine is safe and effective for patients with chronic HBV infection.There was a low incidence of adverse reactions and no vaccine-related serious adverse events. Patients with chronic HBV infection have the highest neutralizing antibody titers after receiving a booster dose. Age affects antibody titers after vaccination in people with chronic HBV infection.
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