摘要目的:探讨妊娠早期接种新型冠状病毒灭活疫苗后的急性不良事件及妊娠结局。方法:采用回顾-前瞻性队列研究方法。选取2021年5月至11月在社区医院建围产保健卡后、孕11～13周 +6于连云港市妇幼保健院产科门诊规范产前检查、符合纳入标准的孕妇作为研究对象。根据妊娠早期疫苗接种情况，将其分为接种组和未接种组，接种组进一步分为接种1剂组和接种2剂组。收集所有孕妇妊娠期相关筛查、妊娠期并发症、妊娠结局及急性不良事件的发生情况，采用独立样本 t检验或方差分析、Kruskal-Wallis H检验或Mann-Whitney U检验、 χ2检验或Fisher精确概率法进行统计分析。 结果:最终纳入接种1剂组孕妇105例，接种2剂组90例，未接种组194例。（1）3组孕妇急性不良事件的发生［接种1剂组：2.86%（3/105）；接种2剂组：6.67%（6/90）；未接种组：4.63%（9/194）； χ2=1.59。接种组为4.61%（9/195），与未接种组比较， χ2=0.00］、妊娠期相关筛查指标的异常情况、各项妊娠结局比较，差异均无统计学意义（ P值均>0.05）；接种组（接种1剂+接种2剂）与未接种组比较，差异亦均无统计学意义（ P值均>0.05）。各组发生的急性不良事件主要有发热、接种部位疼痛、乏力、局部硬结和皮疹。（2）3组孕妇妊娠期高血压疾病发生率比较差异有统计学意义［接种1剂组：10.5%（11/105）；接种2剂组：17.8%（16/90）；未接种组：7.7%（15/194）； χ2=6.46， P=0.040］，其中接种2剂组显著高于未接种组（Bonferroni校正， P<0.017）。（3）3组孕妇其他妊娠期并发症发生情况比较，差异均无统计学意义（ P值均>0.05）；接种组与未接种组比较，差异亦均无统计学意义（ P值均>0.05）。 结论:妊娠早期接种新型冠状病毒灭活疫苗后急性不良事件及妊娠结局与未接种者相似；孕妇接种2剂新型冠状病毒灭活疫苗后，建议孕期定期监测血压。

abstractsObjective:To investigate acute adverse events and pregnancy outcome after vaccination of inactivated COVID-19 vaccine in the first trimester of pregnancy.Methods:The retrospective-prospective cohort study was conducted among pregnant women of 11-13 +6 weeks of gestation who visited the obstetric clinics for prenatal check in Lianyungang Maternal and Child Health Hospital from May to November in 2021, after registration for perinatal health cards in the community. Those who met the inclusion criteria were recruited and were divided into vaccination group and non-vaccination group according to whether they received inactivated COVID-19 vaccine in the first trimester. Women in the vaccination group were further divided into 1-dose group and 2-dose group. Information, including pregnancy-related screening, pregnancy complications, pregnancy outcome and acute adverse events, were collected and compared with independent samples t-test or ANOVA, Kruskal- Wallis H test or Mann-Whitney U test, χ2 test or Fisher's exact probability method. Results:Totally, 105 pregnant women were analyzed in 1-dose group, 90 in 2-dose group, and 194 in non-vaccination group. (1) There were no statistically significant differences in the occurrence of acute adverse events [1-dose group: 2.86% (3/105); 2-dose group: 6.67% (6/90); non-vaccination group: 4.63% (9/194); χ2=1.59; vaccination group was 4.61% (9/195), when compared with non-vaccination group, χ2=0.00], abnormal pregnancy-related screening indicators and abnormal pregnancy outcome among the three groups (all P>0.05), neither between the vaccination and non-vaccination group (all P>0.05). The acute adverse events in these women included fever, pain at the inoculation site, fatigue, local induration and rash.(2) The differences in hypertensive disorders in pregnancy among the three groups were statistically significant [1-dose group: 10.5%(11/105); 2-dose group: 17.8%(16/90); non-vaccination group: 7.7%(15/194); χ2=6.46, P=0.040], and the incidence was higher in the 2-dose group than that in the non-vaccination group (adjusted by Bonferroni, P<0.017). (3) Regarding other pregnancy complications, no difference was found among the three groups (all P>0.05), neither between the vaccination and non-vaccination group (all P>0.05). Conclusion:The risk of acute adverse events and adverse pregnancy outcome is similar in pregnant women who received inactivated COVID-19 vaccine versus those who did not in the first trimester, and regular blood pressure monitoring is recommended for those who received two doses of inactivated COVID-19 vaccine.