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首页> 外文期刊>Current clinical pharmacology >Review of the Methods to Obtain Paediatric Drug Safety Information: Spontaneous Reporting and Healthcare Databases, Active Surveillance Programmes, Systematic Reviews and Meta-analyses
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Review of the Methods to Obtain Paediatric Drug Safety Information: Spontaneous Reporting and Healthcare Databases, Active Surveillance Programmes, Systematic Reviews and Meta-analyses

机译：审查获得儿科药物安全信息的方法：自发报告和医疗保健数据库，积极监督计划，系统评价和荟萃分析

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Background: Knowledge of drugs safety collected during the pre-marketing phase isinevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluatesafety. The small and selective groups of enrolled individuals and the limited duration of trials mayhamper the ability to characterize fully the safety profiles of drugs. Additionally, information aboutrare adverse drug reactions (ADRs) in special groups is often incomplete or not available for mostof the drugs commonly used in the daily clinical practice. In the paediatric setting several highimpactsafety issues have emerged.Hence, in recent years, there has been a call for improved post-marketing pharmacoepidemiologicalstudies, in which cohorts of patients are monitored for sufficient time in order to determine the preciserisk-benefit ratio.Objective: In this review, we discuss the current available strategies enhancing the post-marketingmonitoring activities of the drugs in the paediatric setting and define criteria whereby they can providevaluable information to improve the management of therapy in daily clinical practice includingboth safety and efficacy aspects.The strategies we cover include the signal detection using international pharmacovigilance and/orhealthcare databases, the promotion of active surveillance initiatives which can generate complete,informative data sets for the signal detection and systematic review/meta-analysis.Conclusion: Together, these methods provide a comprehensive picture of causality and risk improvingthe management of therapy in a paediatric setting and they should be considered as aunique tool to be integrated with post-marketing activities.
机译：背景：在营销前阶段患者中收集的药物安全性的知识，因为随​​机临床试验（RCT）很少被设计为评估缩短。小型和选择性的纳入个人群体和有限的试验持续时间可能会发现能够完全表征毒品的安全型材。此外，关于特殊群体的不良药物反应（ADRS）的信息往往不完全或不适用于日常临床实践中常用的药物。在儿科制定中出现了几个优秀的问题。近年来，近年来，呼吁改善营销后的药物病态学研究，其中监测患者的队列足够的时间，以确定预测效益比率。目的：在这篇综述中，我们讨论了当前可用的策略，提高儿科环境中药物的营销活动和定义标准，其中他们可以提供可估量的信息，以改善在包括禁止安全性和功效方面的日常临床实践中的治疗管理。我们封面包括使用国际药物知识和/孤立性数据库的信号检测，促进可以为信号检测和系统评论/元分析产生完整的，信息性数据集的主动监测举措。结论：在一起，这些方法提供了全面的图片因果关系和风险增长GRTHE在儿科环境中的治疗管理，它们应该被视为与营销后活动集成的AUNIQUE工具。

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