论文标题
氯氮平在三个大型精神病院的现实世界数据中的副作用概况
The side effect profile of Clozapine in real world data of three large mental hospitals
论文作者
论文摘要
目的:挖掘电子健康记录(EHR)中包含的数据可能会产生对现实世界中药物效应的更多了解,从而补充我们从随机控制试验(RCT)中知道的内容。我们提出了一种文本挖掘方法,以检测临床文本中的不良事件和药物发作,以增强我们对与氯氮平有关的不良影响的理解,氯氮平是治疗耐药性精神分裂症的最有效抗精神病药,但由于对其副作用的关注而造成的耐药性不足。材料和方法:我们使用了来自英国三个心理健康信托基金的DE鉴定的EHR的数据(> 5000万个文件,超过500,000名患者,其中2835例被处方为氯氮平)。我们探讨了按年龄,性别,种族,吸烟状况和入院型在患者开始氯氮平治疗前后的33例不良反应的患病率。我们将不良反应的流行率与副作用资源(SIDE)中报告的患病率进行了比较。结果:镇静,疲劳,搅动,头晕,超水平,体重增加,心动过速,头痛,便秘和混乱是在治疗开始后三个月中记录最高的氯氮平不良反应。在氯氮平治疗的第一个月发现,所有不良反应的百分比较高。使用(p <0.05)卡方检验的显着性水平表明,大多数ADR在吸烟状态和住院治疗中与性别和年龄段之间存在显着关联。此外,将数据从三个信托中组合在一起,并应用卡方检验以估算每个月间隔中ADR的平均效应。结论:对药物在现实世界中的工作方式的更好理解可以补充临床试验和精确医学。
Objective: Mining the data contained within Electronic Health Records (EHRs) can potentially generate a greater understanding of medication effects in the real world, complementing what we know from Randomised control trials (RCTs). We Propose a text mining approach to detect adverse events and medication episodes from the clinical text to enhance our understanding of adverse effects related to Clozapine, the most effective antipsychotic drug for the management of treatment-resistant schizophrenia, but underutilised due to concerns over its side effects. Material and Methods: We used data from de-identified EHRs of three mental health trusts in the UK (>50 million documents, over 500,000 patients, 2835 of which were prescribed Clozapine). We explored the prevalence of 33 adverse effects by age, gender, ethnicity, smoking status and admission type three months before and after the patients started Clozapine treatment. We compared the prevalence of adverse effects with those reported in the Side Effects Resource (SIDER) where possible. Results: Sedation, fatigue, agitation, dizziness, hypersalivation, weight gain, tachycardia, headache, constipation and confusion were amongst the highest recorded Clozapine adverse effect in the three months following the start of treatment. Higher percentages of all adverse effects were found in the first month of Clozapine therapy. Using a significance level of (p< 0.05) out chi-square tests show a significant association between most of the ADRs in smoking status and hospital admissions and some in gender and age groups. Further, the data was combined from three trusts, and chi-square tests were applied to estimate the average effect of ADRs in each monthly interval. Conclusion: A better understanding of how the drug works in the real world can complement clinical trials and precision medicine.