Staltari Orietta, Cilurzo Felisa, Caroleo Benedetto, Greco Alexia, Corasaniti Francesco, Genovesi Maria Antonietta, Gallelli Luca
Centro Regionale di Informazione sul farmaco, AO Mater Domini, Catanzaro, and Department of Health Science, School of Medicine, University of Catanzaro, Italy.
Azienda Sanitaria Provinciale di Catanzaro, Italy.
J Pharmacol Pharmacother. 2013 Dec;4(Suppl 1):S61-5. doi: 10.4103/0976-500X.120951.
Vaccines are administered to large population of healthy individuals, particularly to millions of infants every year, through national immunization programs. Although vaccines represent a good defense against some infectious diseases, their administration may be related with the development of adverse vaccine events (AVEs); therefore their use is continually monitored to detect these side effects. In the presents work, we reported the suspected AVEs recorded in 2012 in Calabria, Italy. We performed a retrospective study on report forms of patients that developed AVEs in Calabria from January 1, 2012 to December 31, 2012. Naranjo score was used to evaluate the association between AVEs and vaccines and only suspected AVEs definable as certain, probable, or possible were included in this analysis. During the study period, we evaluated 461 records of adverse drug reactions (ADRs) and 18 (3.9%) were probably induced by vaccination. AVEs were common in females (almost 77.7%) and in children aged 0-3 years. The largest number of non-serious AVEs involved "skin and subcutaneous tissue disorders" and "general disorders and administration site conditions." In conclusion, we documented that in Calabria the total number of AVEs is very low and it may be useful to increase the pharmacovigilance culture in order to evaluate the safety of these products in large populations.
疫苗通过国家免疫规划被施用于大量健康个体，尤其是每年数百万的婴儿。尽管疫苗是抵御某些传染病的有效手段，但其接种可能与不良疫苗事件（AVE）的发生有关；因此，对其使用情况持续进行监测以检测这些副作用。在本研究中，我们报告了2012年意大利卡拉布里亚记录的疑似AVE。我们对2012年1月1日至2012年12月31日在卡拉布里亚发生AVE的患者报告表进行了回顾性研究。使用纳伦霍评分来评估AVE与疫苗之间的关联，本分析仅纳入可定义为肯定、很可能或可能的疑似AVE。在研究期间，我们评估了461份药物不良反应（ADR）记录，其中18例（3.9%）可能是由疫苗接种引起的。AVE在女性（近77.7%）和0至3岁儿童中较为常见。数量最多的非严重AVE涉及“皮肤和皮下组织疾病”以及“全身性疾病和接种部位情况”。总之，我们记录到在卡拉布里亚，AVE的总数非常低，提高药物警戒意识对于评估这些产品在大量人群中的安全性可能是有用的。
