强直性脊柱炎患者接种COVID-19灭活疫苗的调查

Investigation on Inoculation of Inactivated COVID-19 Vaccine in Patients with Ankylosing Spondylitis

摘要: 目的：调查强直性脊柱炎患者接种新型冠状病毒疫苗(新冠疫苗)安全性及接种后强直性脊柱炎活动度ASDAS评分变化，为AS患者接种新冠疫苗提供参考。方法：回顾性分析2022年1月1日至2022年6月1日期间就诊于青岛大学附属医院风湿免疫科，且明确诊断为AS患者共152人，全部接种2针北京生物或者科兴中维研发的灭活新冠疫苗，共计304人次。采用频数分析方法分析不良反应发生率；采用配对样本Wilcoxon符号秩检验比较ASDAS活动度评分差异有无统计学意义，P < 0.05为差异有统计学意义。结果：收集本次研究对象共152例，其中稳定期138例，活动期14例；稳定期患者接种信息共276人次，总不良反应的发生率为3.623% (10/276)；局部不良反应表现为接种部位疼痛，发生率为0.725% (1/276)；全身不良反应发生率为2.174% (6/276)，表现为带状疱疹、疲劳、恶心、腹泻。女性(9.09%)不良反应发生率高于男性(3.19%)。所有饮酒及进食辛辣刺激食物的研究对象均未发生接种后不良反应。接种疫苗前后停药、时间重合、间隔 < 3 d、间隔 > 3 d、已停药者接种后不良反应的发生率分别为37.5%、0.78%、8.82%、2.04%、12.5%。AS稳定期患者接种新冠疫苗前后ASDAS评分差异无统计学意义。随访到2022-06-06，所有研究对象无一例新冠病毒感染。活动期患者收集到接种信息共28人次，没有监测到接种前后饮酒、进食辛辣刺激性食物的患者，监测到接种后局部不良反应共计2条，全部表现为接种部位的疼痛，没有监测到全身不良反应发生。结论：稳定期：① 女性的不良反应发生率高于男性；② 接种新冠疫苗时间与用药时间重合不能增加不良反应发生率。③ 饮酒或进食刺激性食物均未出现不良反应。④ 没有理由怀疑接种新冠疫苗能引起AS活动性增加。活动期患者由于接种疫苗例数较少，仅监测到2条局部不良反应，局部不良反应发生率为7.143%。

Abstract: Objective: To investigate the safety of patients with ankylosing spondylitis vaccinated with novel coronavirus vaccine and the changes of ASDAS scores of activity of ankylosing spondylitis after vac-cination, and provide reference for patients with AS vaccinated with novel coronavirus vaccine. Methods: Retrospective analysis was performed on 152 patients who were admitted to the Rheu-matology and Immunology Department of the Affiliated Hospital of Qingdao University from January 1, 2022 to June 1, 2022, and were diagnosed as AS. All of them received 2 doses of inactivated COVID-19 vaccine developed by Beijing Biologic or Kexing Zhongwei, a total of 304 patients. Fre-quency analysis was used to analyze the incidence of adverse reactions; paired sample Wilcoxon symbolic rank test was used to compare the differences in ASDAS activity scores for statistical sig-nificance, and P< 0.05 was considered statistically significant. Results: A total of 152 cases were col-lected, including 138 cases in stable stage and 14 cases in active stage. A total of 276 patients were inoculated in stable stage, and the incidence of total adverse reactions was 3.623% (10/276). Local adverse reactions were pain at the site of inoculation, with an incidence of 0.725% (1/276). The in-cidence of systemic adverse reactions was 2.174% (6/276), which showed herpes zoster, fatigue, nausea and diarrhea. The incidence of adverse reactions was higher in women (9.09%) than in men (3.19%). There was no adverse reaction after inoculation in all subjects who drank alcohol and ate spicy stimulating food. The incidences of adverse reactions in patients who stopped the drug before and after vaccination, with the time overlapping, interval <3 d, interval >3 d, and had stopped the drug were 37.5%, 0.78%, 8.82%, 2.04%, 12.5%, respectively. There was no significant difference in ASDAS scores in patients with stable AS after vaccination. Follow-up until 2022-06-06, none of the subjects were infected with the novel coronavirus. A total of 28 patients in the active period re-ceived vaccination information, and no patients who drank alcohol or ate spicy and stimulating food before and after inoculation were detected. A total of 2 local adverse reactions were detected after inoculation, all of which were manifested as pain at the inoculation site, and no systemic adverse reactions were detected. Conclusions: Stability phase: ① The incidence of adverse reactions in sta-ble women was higher than that in men. ② The coincidence between the time of vaccination and the time of administration did not increase the incidence of adverse reactions. ③ There were no adverse reactions to drinking alcohol or eating irritating food. ④ There is no reason to doubt that vaccination causes an increase in AS activity. Due to the small number of vaccine cases in active pa-tients, only 2 local adverse reactions were detected, and the incidence of local adverse reactions was 7.143%.