Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study
Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study
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DOI：
10.1111/bcp.13923
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发表时间：
2019-07-01
影响因子：
3.4
通讯作者：
van Puijenbroek, Eugene P.
中科院分区：
文献类型：
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作者：
de Vries, Sieta T.;Denig, Petra;van Puijenbroek, Eugene P.
AimsWe的目的是评估和描述性别差异的药物不良反应（ADR）报告的国家药物警戒中心在荷兰，同时考虑药物use. MethodsADR的差异自发报告的医疗保健专业人员和患者的荷兰药物警戒中心Lareb。包括2003-2016年期间至少10次报告的药物-ADR组合，该期间有10，000人使用药物。关于吸毒者人数的数据来自国家保健研究所。排除了性别特异性ADR，如妇科问题。在特定的药物-ADR组合的性别差异进行了测试，使用双变量Logistic回归分析，其中每个性别的吸毒者的数量被考虑到。ResultsIn总数，2483药物-ADR组合进行了分析。在363种组合（15%）中显示了可能相关的性别差异。大多数药物-ADR组合在女性中更常见（322种组合）。在女性中更常报告的ADR数量最多的药物包括甲状腺激素（32种组合）和抗抑郁药（中枢作用拟交感神经药16种组合;其他抗抑郁药14种组合）。一些药物不良反应，主要是在一系列的药物，如头痛和头晕，而其他的药物不良反应，如肌腱断裂和侵略，更经常报告的男性.ConclusionsIdentified性别差异，报告的药物不良反应往往是指妇女。这些差异可能有各种原因，包括药理学和行为原因，需要进一步评估。结果可能最终导致性别特异性处方或监测建议。
AimsWe aimed to assess and characterize sex differences in adverse drug reactions (ADRs) reported to the national pharmacovigilance centre in the Netherlands while considering differences in drug use.MethodsADRs spontaneously reported by healthcare professionals and patients to the Netherlands pharmacovigilance centre Lareb were used. Drug-ADR combinations reported at least 10 times between 2003-2016 for drugs used by 10,000 persons in that period were included. Data about the number of drug users was obtained from the National Health Care Institute. Sex-specific ADRs, like gynaecological problems, were excluded. Sex differences in specific drug-ADR combinations were tested using bivariate logistic regression analyses in which the number of drug users per sex was taken into account.ResultsIn total, 2483 drug-ADR combinations were analysed. Possibly relevant sex differences were shown in 363 combinations (15%). Most of these drug-ADR combinations were reported more often for women (322 combinations). Drugs with the highest number of ADRs that were more often reported for women included thyroid hormones (32 combinations) and antidepressants (16 combinations for the centrally acting sympathomimetics; 14 combinations for other antidepressants). Some ADRs were predominantly reported for women across a range of drugs such as headache and dizziness whereas other ADRs such as tendon ruptures and aggression were reported more often for men.ConclusionsIdentified sex differences in reported ADRs often referred to women. These differences may have various causes, including pharmacological and behavioural causes, which need to be further assessed. The results may ultimately lead to sex-specific prescribing or monitoring recommendations.