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流感疫苗与慢性病药物之间无相互作用信号:疫苗不良事件报告系统和 vigibase 的逐个病例分析。

No signal of interactions between influenza vaccines and drugs used for chronic diseases: a case-by-case analysis of the vaccine adverse event reporting system and vigibase.

机构信息

a Unit of Clinical Pharmacology Department of Biomedical and Clinical Sciences L. Sacco , 'Luigi Sacco' University Hospital, Università di Milano , Milan , Italy.

b Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum , University of Bologna , Bologna , Italy.

出版信息

Expert Rev Vaccines. 2018 Apr;17(4):363-381. doi: 10.1080/14760584.2018.1442718. Epub 2018 Mar 9.

Abstract

BACKGROUND

An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated.

METHODS

From VAERS and VigiBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions.

RESULTS

116 AEFI reports submitted to VAERS and 83 from Vigibase were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days).

CONCLUSION

The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful.

摘要

背景

越来越多的报告表明,流感疫苗可能会通过药物代谢与特定药物发生相互作用。迄今为止,尚未研究在真实世界临床实践中观察到的疫苗-药物相互作用的实际影响。

方法

我们从 VAERS 和 VigiBase 中收集了接种流感疫苗的个体的不良事件报告,这些报告被记录为可疑病例,并选择了记录到口服抗凝剂、抗癫痫药和他汀类药物(即出血、用药过量和横纹肌溶解症)可预测毒性的病例。我们应用不良事件和药物相互作用可能性量表(DIPS)算法来评估药物-疫苗相互作用的因果关系。

结果

我们的分析纳入了 116 份向 VAERS 提交的不良事件报告和 83 份来自 Vigibase 的报告;根据不良事件和 DIPS,抗癫痫药和他汀类药物与最高数量的不确定/一致(93.7%;65.3%)和可能/可能(50%;57.7%)病例相关。大多数病例发生在疫苗接种后第一周内(5-7 天)。

结论

检测到的相互作用相对较少并不影响流感疫苗接种的益处,仍然强烈建议接种;这并不排除对同时接受慢性药物治疗和受易患因素影响的选定患者进行更密切监测可能是有用的。

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