【摘要】 目的 评价安徽省两市≥18岁人群大规模接种新型冠状病毒灭活疫苗(简称新冠灭活疫苗)在真实世界中的安全性。方法 采用开放性研究，在知情同意的前提下，2021年6月―2022年6月在安徽省阜阳市太和县、亳州市谯城区招募≥18岁人群大规模接种新冠灭活疫苗，将研究对象分为健康组和慢性基础疾病(简称基础疾病)组，评价两组接种每剂次疫苗后的不良反应发生率及其严重程度。结果 (1)本研究共纳入研究对象12 257人，其中健康组9 984人，基础疾病组2 273人；完成新冠灭活疫苗两剂次接种的研究对象共11 874人，全程接种率为96.88%,基础疾病患病率占比居于前3位的分别为高血压(68.28%)、糖尿病(18.43%)、脑梗死(8.32%);(2)总体不良反应发生率为0.42%(51/12 257),所有不良反应均发生于28 d内，基础疾病组和健康组的不良反应发生率分别为0.40%和0.42%,差异无统计学意义(χ~2=0.028,P=0.868);(3)除硬结/肿胀外，其余不良反应健康组与基础疾病组差异均无统计学意义(均P>0.05);严重程度以1级为主(45例),1级不良反应发生率为0.37%,两组的1级、2级不良反应发生率差异均无统计学意义(均P>0.05);(4)健康组、基础疾病组第1剂次与第2剂次不良反应均以1级为主，2剂次间不良反应等级差异均无统计学意义(均P>0.05)。结论 不同年龄、不同健康状况的成年人在接种不同剂次新冠灭活疫苗时均具有较好的安全性。更多还原

【Abstract】 Objective To evaluate the real-world safety of large-scale vaccination of inactivated novel coronavirus vaccine(inactivated vaccine) for adults aged among ≥18-year-old adults in two cities in Anhui Province. Methods An open-label study was conducted, with informed consent obtained. From June 2021 to June 2022, we recruited individuals aged ≥18 years from Taihe County, Fuyang City, and Qiaocheng District, Bozhou City, Anhui Province, for large-scale inactivated vaccine administration. The subjects were divided into healthy group and chronic underlying disease(referred to as underlying disease) group, and the incidence and severity of adverse reactions after each dose of vaccine were evaluated in the two groups. Results(1) A total of 12 257 subjects over 18 years old were included in this study, including 9 984 healthy subjects and 2 273 subjects with underlying diseases, and 11 874 subjects completed two doses of inactivated vaccine, with a full vaccination rate of 96.88%, and the top three underlying diseases were hypertension(68.28%), diabetes mellitus(18.43%), and cerebral infarction(8.32%).(2) The overall incidence of adverse reaction was 0.42%(51/12 257), all adverse reaction occurred within 28 days, the incidence of adverse reaction in the underlying disease group and the healthy group were 0.40% and 0.42%, respectively, with no statistically significant difference was observed(χ~2=0.028, P=0.868).(3) Except for induration/swelling, there was no significant difference in adverse reaction between the healthy group and the underlying disease group(all P>0.05). The severity was mainly grade 1(45 cases), and the incidence of grade 1 adverse reaction was 0.37%, there was no significant difference in the incidence of grade 1 and grade 2 adverse reaction between the two groups(all P>0.05).(4) The adverse reaction of the first dose and the second dose in the healthy group and the underlying disease group were mainly grade 1, and there was no significant difference in the grade of adverse reaction between the two doses(all P>0.05). Conclusions Adults over the age of 18 who receive the inactivated vaccine against the novel coronavirus have a good safety profile for different ages, different health conditions, and different doses.更多还原