目的:我们假设在圣诞节期间,某些药物的安全性和毒性可能会加剧。因此,我们评估并表征了圣诞节期间药物安全性的变化。
方法:我们对2017年4月1日至2023年3月31日世界卫生组织(WHO)药物警戒数据库中报告的不良事件进行了回顾性纵向分析。
方法:我们提取了世卫组织药物警戒数据库中具有圣诞节传统的5个主要贡献者国家报告的病例:美国,法国,德国,意大利和英国。
方法:我们分析了来自美国的4,999,459例个体病例安全性报告(n=3,498,961),法国(n=419,018),德国(n=398,763),意大利(n=251,641)和英国(n=431,076),报告时间为2017年4月1日至2023年3月31日。
方法:分析每月不良事件报告。时间趋势,探索了季节性效应和圣诞节效应(12月至1月)。
结果:我们发现,在圣诞节期间,91起不良事件的报告频率明显更高,在控制冬季效应和总体趋势后独立进行。不良事件的主要类型是精神疾病,感染和皮肤和皮下疾病。圣诞节造成的病例最多的是药物依赖,情绪困扰,和药物戒断综合征。涉及最多的药物是羟考酮在精神疾病(n=47,527),多西他赛在皮肤病(n=9440)和社会环境(n=1940),奥美沙坦在胃肠道疾病中的应用(n=1263),芬太尼在心脏疾病中的应用(n=929),阿达木单抗在感染(n=11,316)和免疫系统疾病(n=3781),生殖系统疾病中的胶原酶和溶组织梭状芽胞杆菌(n=318)。
结论:我们的研究表明,与一年中的其他时期相比,圣诞节期间发生一系列药物不良事件的频率更高,特别是精神疾病,感染,和皮肤病。
OBJECTIVE: We hypothesized that during the Christmas season the safety profile and the toxicity of some drugs may be exacerbated. We therefore assessed and characterized changes in drug safety profiles over the Christmas period.
METHODS: We performed a retrospective longitudinal analysis of adverse events reported in the World Health Organization (WHO) pharmacovigilance database between April 1st 2017 to March 31th 2023.
METHODS: We extracted cases reported by the 5 main contributors\' countries of the WHO pharmacovigilance database with a Christmas tradition: USA, France, Germany, Italy and UK.
METHODS: We analyzed 4,999,459 individual case safety reports from USA (n=3,498,961), France (n=419,018), Germany (n=398,763), Italy (n=251,641) and UK (n=431,076), reported between April 1st 2017 to March 31th 2023.
METHODS: Monthly reports of adverse events were analyzed. Time trend, seasonal effect a Christmas effect (December-January) were explored.
RESULTS: We found 91 adverse events significantly more frequently reported during the Christmas period, independently after controlling for winter effect and general tendency. The main type of adverse events were psychiatric disorders, infections and skin and subcutaneous disorders. The highest numbers of attributable cases to Christmas were found for drug dependence, emotional distress, and drug withdrawal syndrome. The most involved drugs were oxycodone in psychiatric disorders (n=47,527), docetaxel in skin disorders (n=9440) and social circumstances (n=1940), olmesartan in gastrointestinal disorders (n=1263), fentanyl in cardiac disorders (n=929), adalimumab in infections (n=11,316) and immune system disorders (n=3781), and collagenase clostridium histolyticum in reproductive system disorders (n=318).
CONCLUSIONS: Our study shows that a range of drugs adverse events are more frequently reported at Christmas compared to other periods of the year, notably psychiatric disorders, infections, and skin disorders.