Longitudinal medical records as a complement to routine drug safety signal analysis.
Longitudinal medical records as a complement to routine drug safety signal analysis.
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DOI：
10.1002/pds.3739
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发表时间：
2015-05
影响因子：
2.6
通讯作者：
Edwards IR
中科院分区：
文献类型：
--
作者：
Star K;Watson S;Sandberg L;Johansson J;Edwards IR
探讨纵向医疗记录是否以及如何可以用作全球药物警戒数据库中新型药物不良反应 (ADR) 信号检测和分析早期阶段的参考来源。 2011 年 VigiBase® 常规信号检测过程中的药物和 ADR 组合与健康改善网络 (THIN) 中的组合进行了匹配。对数据集中的药物和 ADR 的数量和类型进行了调查。对于未标记的组合，检查了 THIN 中纵向事件模式（计时码表）的图形显示，以确定该模式是否支持 VigiBase 组合。在 VigiBase 数据集中的 458 个组合中，有 190 个与 THIN 中的相应组合相匹配（排除 THIN 中少于 100 个处方的药物后）。 18% 的 VigiBase 和 9% 的匹配 THIN 组合提到了报告有严重反应的新药。在与 THIN 匹配的 112 个未标记组合中，有 52 个计时码表没有结论，主要是因为缺乏数据； 34 在处方期间没有任何明显的模式； 24人在处方前期间事件增多，因此削弱了药物关系的怀疑；其中两人的事件模式仅在处方后期间升高，但在审查个别患者病史后，不支持这种关联。纵向医疗记录有助于了解药物和可疑 ADR 组合的临床背景以及因果关系的可能性。一个缺点是缺乏新上市药物发生严重反应的数据。 © 2015 作者。药物流行病学和药物安全由 John Wiley & Sons, Ltd 出版。
To explore whether and how longitudinal medical records could be used as a source of reference in the early phases of signal detection and analysis of novel adverse drug reactions (ADRs) in a global pharmacovigilance database. Drug and ADR combinations from the routine signal detection process of VigiBase® in 2011 were matched to combinations in The Health Improvement Network (THIN). The number and type of drugs and ADRs from the data sets were investigated. For unlabelled combinations, graphical display of longitudinal event patterns (chronographs) in THIN was inspected to determine if the pattern supported the VigiBase combination. Of 458 combinations in the VigiBase data set, 190 matched to corresponding combinations in THIN (after excluding drugs with less than 100 prescriptions in THIN). Eighteen percent of the VigiBase and 9% of the matched THIN combinations referred to new drugs reported with serious reactions. Of the 112 unlabelled combinations matched to THIN, 52 chronographs were inconclusive mainly because of lack of data; 34 lacked any outstanding pattern around the time of prescription; 24 had an elevation of events in the pre‐prescription period, hence weakened the suspicion of a drug relationship; two had an elevated pattern of events exclusively in the post‐prescription period that, after review of individual patient histories, did not support an association. Longitudinal medical records were useful in understanding the clinical context around a drug and suspected ADR combination and the probability of a causal relationship. A drawback was the paucity of data for newly marketed drugs with serious reactions. © 2015 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
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影响因子：
2.6
作者：
Coloma, Preciosa M.;Trifiro, Gianluca;Sturkenboom, Miriam
通讯作者：
Sturkenboom, Miriam
影响因子：
4.2
作者：
Caster, Ola;Juhlin, Kristina;Watson, Sarah;Noren, G. Niklas
通讯作者：
Noren, G. Niklas
影响因子：
39.2
作者：
Stang, Paul E.;Ryan, Patrick B.;Woodcock, Janet
通讯作者：
Woodcock, Janet
影响因子：
4.2
作者：
Meyboom, RHB;Egberts, ACG;Gribnau, FWJ
通讯作者：
Gribnau, FWJ
影响因子：
2.9
作者：
Bate, A;Lindquist, M;De Freitas, RM
通讯作者：
De Freitas, RM