新型冠状病毒灭活疫苗对广东省奥密克戎变异株感染者临床结局影响的研究

Effect of inactivated SARS-CoV-2 vaccine on the clinical outcomes of patients infected with the Omicron variant in Guangdong Province

目的:了解新型冠状病毒(SARS-CoV-2)灭活疫苗对奥密克戎变异株感染者临床结局的影响。方法:以2022年1月1日至5月31日广东省20家定点医院收治的1403例奥密克戎变异株感染者为对象,基于中国疾病预防控制信息系统和广东省远程医疗平台收集对象人口学资料、基础疾病资料、疫苗接种情况、末次暴露日期、感染毒株基因测序和临床结局等资料,采用病例对照研究设计,将肺炎(普通型、重型和危重型)作为病例组,非肺炎(无症状感染者和轻型)作为对照组,分析SARS-CoV-2灭活疫苗对奥密克戎变异株感染者临床结局影响。结果:1403例对象年龄的M(Q1,Q3)为36(27~47)岁,男性占52.25%(733例)。感染结局以非肺炎为主,占92.09%(1292例),病程的M(Q1,Q3)为18(14~22)d。无免疫史或部分免疫、基础免疫90 d内、基础免疫90 d以上、完成加强免疫90 d内和完成加强免疫90 d以上者分别为134(9.55%)、39(2.78%)、403(28.72%)、437(31.15%)和390(27.80%)例。多因素logistic回归分析显示:调整性别、年龄、基础病和报告地等因素后,与无免疫史或部分免疫者比较,基础免疫90 d以上、加强免疫90 d内、加强免疫90 d以上者发展为肺炎风险较低[OR(95%CI)值分别为0.52(0.28~0.98)、0.39(0.21~0.73)和0.40(0.21~0.77)]。Cox比例风险回归模型分析显示:调整性别、年龄、基础疾病和报告地等因素后,与无免疫史或部分免疫者相比,加强免疫90 d以上者病程较短[HR(95%CI):1.26(1.03~1.55)]。结论:新冠病毒灭活疫苗接种史影响奥密克戎变异株感染者临床结局。

Objective To evaluate the effect of inactivated SARS-CoV-2 vaccine on the clinical outcomes of patients infected with the Omicron variant.Methods A total of 1403 Omicron-infected patients admitted to 20 designated hospitals in Guangdong Province from January 1 to May 31,2022,were selected as subjects in this study.A case-control study was conducted to collect the demographic data,underlying disease,vaccination status,last exposure date,gene sequencing of infected strains and clinical outcomes from the China Disease Prevention and Control Information System and Guangdong telemedicine platform.Pneumonia(common,severe and critical)and non-pneumonia(asymptomatic and mild)were selected as the case group and control group.The effect of inactivated SARS-CoV-2 vaccine on the clinical outcomes of patients infected with the Omicron variant was analyzed.Results The median age[M(Q1,Q3)]of the subjects was 36(27-47)years old,with males accounting for 52.25%(733 cases).The main outcome of the infection was non-pneumonia,accounting for 92.09%(1292 cases),and the duration[M(Q1,Q3)]of the disease was 18(14-22)days.There were 134(9.55%),39(2.78%),403(28.72%),437(31.15%)and 390(27.80%)cases with no or partial vaccination,within 90 days of primary vaccination,over 90 days of primary vaccination,within 90 days of booster vaccination and over 90 days of booster vaccination,respectively.Multivariate logistic regression analysis showed that after adjusting for gender,age,underlying disease,and location of the report,compared with those with no or partial vaccination,the risk of developing pneumonia was lower in those with over 90 days of primary vaccination,within 90 days of booster vaccination and over 90 days of booster vaccination[OR(95%CI)values were 0.52(0.28-0.98),0.39(0.21-0.73)and 0.40(0.21-0.77),respectively].Cox proportional hazard regression model analysis showed that after adjusting for gender,age,underlying disease and location of the report,the duration of the disease was shorter in those who received booster vaccinated for more than 90 days compared with that in those who had no or partial vaccination[HR(95%CI):1.26(1.03-1.55)].Conclusion The inactivated SARS-CoV-2 vaccine affects the clinical outcomes of patients infected with the Omicron variant.