慢性乙型肝炎患者接种新型冠状病毒灭活疫苗的有效性和安全性

Efficacy and safety of inactivated novel coronavirus vaccine inoculation in patients with chronic hepatitis B

目的探讨慢性乙型肝炎(CHB)患者接种新型冠状病毒灭活疫苗(简称新冠疫苗)的安全性及中和抗体消长规律。方法采用回顾性和前瞻性流行病学研究方法,以2021年9月至2022年2月在山西医科大学第一医院感染病科就诊的153例CHB患者为研究对象,收集接种疫苗的不良反应信息,采用胶体金免疫层析法检测完成接种新冠疫苗3~6个月时体内的中和抗体。采用χ2检验或Fisher确切概率法,P<0.05为差异有统计学意义。结果153例CHB患者接种新冠疫苗3、4、5、6个月时新型冠状病毒中和抗体阳性率分别为45.50%、44.70%、40.00%、16.20%,中和抗体浓度分别为10.00(2.95,30.01)U/ml、6.08(3.41,24.50)U/ml、5.90(3.93,14.68)U/ml、1.25(0.92,3.75)U/ml;比较不同时间点HBV DNA阴性和阳性以及HBeAg阴性和阳性患者的中和抗体阳性率,差异均无统计学意义(P>0.05)。接种疫苗的不良反应总体发生率为18.30%,主要为接种部位疼痛、疲劳,未出现严重的不良反应。结论CHB患者接种新冠疫苗可产生中和抗体,3、4、5个月时中和抗体可维持一定的水平,但随着时间延长抗体水平逐渐下降,6个月时下降明显,故建议适时加强接种。研究结果提示在肝功能相对稳定的CHB患者中,乙型肝炎病毒复制状态对中和抗体的产生影响不大,新冠疫苗对CHB患者有良好的安全性。

Objective To explore the safety of inactivated novel coronavirus vaccine inoculation and the fluctuating neutralizing antibody in patients with chronic hepatitis B(CHB).Methods Retrospective and prospective epidemiological research methods were employed.153 CHB patients who visited the Department of Infectious Diseases at the First Hospital of Shanxi Medical University from September 2021 to February 2022 were selected as the research subjects.Information on vaccination-related adverse reactions was collected.Colloidal gold immunochromatography was used to identify neutralizing antibodies in the body after 3-6 months of vaccination.Statistical analysis was performed using theχ2-test or Fisher's exact test.Results The positive rates of neutralizing antibodies after inactivated novel coronavirus vaccine inoculation in 153 patients with CHB were 45.50%,44.70%,40.00%and 16.20%,respectively,at 3,4,5,and 6 months.The neutralizing antibody concentrations were 10.00(2.95,30.01)U/ml,6.08(3.41,24.50)U/ml,5.90(3.93,14.68)U/ml,and 1.25(0.92,3.75)U/ml,respectively.The difference was not statistically significant(P>0.05)when the neutralizing antibody positivity rates in hepatitis B virus(HBV)DNA-negative and positive patients and HBeAg-negative and positive patients at different time points were compared.The overall incidence of adverse reactions following vaccination was 18.30%.Pain at the site of inoculation and fatigue were the main presentations,and no serious adverse reactions occurred.Conclusion CHB patients,when inoculated with an inactivated novel coronavirus vaccine,can produce neutralizing antibodies,which can stay at certain levels for 3,4,and 5 months.However,the neutralizing antibody level gradually decreases over time,and the decrease is remarkable at 6 months.So,it is recommended to boost vaccinations at an appropriate time.Additionally,the results of the study suggest that HBV replication status has little effect on the production of neutralizing antibodies in CHB patients with relatively stable liver function,which means the inactivated novel coronavirus vaccine has a good safety profile.