Scheifele David W, Duval Bernard, Russell Margaret L, Warrington Richard, DeSerres Gaston, Skowronski Danuta M, Dionne Marc, Kellner James, Davies Dele, MacDonald Judy
Canadian Association for Immunization Research and Evaluation of Vancouver, British Columbia, Canada.
Clin Infect Dis. 2003 Apr 1;36(7):850-7. doi: 10.1086/368189. Epub 2003 Mar 18.
In 2000, an influenza vaccine was associated with unusual ocular and respiratory symptoms (known as "oculorespiratory syndrome" [ORS]) that possibly were due to numerous microaggregates of unsplit viruses present in the product. We assessed the potential for an improved vaccine formulation (for use in 2001-2002) to cause ORS and other symptoms in adults, using a double-blind, randomized, crossover study design. Symptoms were ascertained 24 h after 622 doses of vaccine and 626 doses of saline placebo were injected. The risk of ORS was 6.3% after vaccine injection and 3.4% after placebo injection, which yielded a significant vaccine-attributable risk of 2.9% (95% confidence interval, 0.6-5.2). ORS symptoms were mild. Significant differences in risk after injection of vaccine versus placebo existed for ocular soreness and/or itching (2.4%), coughing (1.6%), and hoarseness (1.2%). Vaccine-attributable general symptoms were infrequent. We conclude that certain mild oculorespiratory symptoms were triggered by an influenza vaccine that was otherwise minimally reactogenic and, hence, that such symptoms might be associated with influenza vaccines in general.
2000年，一种流感疫苗与异常的眼部和呼吸道症状（称为“眼呼吸综合征”[ORS]）相关，这些症状可能归因于该产品中存在的大量未裂解病毒微聚体。我们采用双盲、随机、交叉研究设计，评估了一种改进的疫苗制剂（用于2001 - 2002年）在成人中引发ORS和其他症状的可能性。在注射622剂疫苗和626剂生理盐水安慰剂后24小时确定症状。注射疫苗后ORS风险为6.3%，注射安慰剂后为3.4%，疫苗归因风险显著为2.9%（95%置信区间，0.6 - 5.2）。ORS症状较轻。注射疫苗与安慰剂后，眼部酸痛和/或瘙痒（2.4%）、咳嗽（1.6%）和声音嘶哑（1.2%）的风险存在显著差异。疫苗归因的一般症状并不常见。我们得出结论，某种流感疫苗引发了某些轻度眼呼吸症状，而该疫苗在其他方面反应原性极小，因此，此类症状可能总体上与流感疫苗相关。
