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首页> 外文期刊>Open Pharmaceutical Sciences Journal >Signal Detection and their Assessment in Pharmacovigilance
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Signal Detection and their Assessment in Pharmacovigilance

机译：信号检测及其在药物警戒中的评估

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摘要

Signal detection and its assessment is the most important aspect in pharmacovigilance which plays a key role inensuring that patients receive safe drugs. For detection of adverse drug reactions, clinical trials usually provide limited informationas they are conducted under strictly controlled conditions. Some of the adverse drug reactions can be detectedonly after long term use in larger population and in specific patient groups due to specific concomitant medications or disease.The detection of unknown and unexpected safety signals as early as possible from post marketing data is one of themajor challenge of pharmacovigilance. The current method of detecting a signal is predominantly based on spontaneousreporting, which is mainly helpful in detecting type B adverse effects and unusual type A adverse effects. Other sources ofsignals detection are prescription event monitoring, case control surveillance and follow up studies. Signal assessment ismainly performed by using Upsala Monitoring scale & Naranjo scale of probability to analyze the cause and effect analysis.Signal detection and their assessment is very vital and complex process. Thus, the main objective of this review is toprovide a summary of the most common methods of signal detection and their assessment used in pharmacovigilance toconfirm the safety of a drug. Recent developments, challenges, & future needs have also been discussed.
机译：信号检测及其评估是药物警戒中最重要的方面，在确保患者接受安全药物方面起着关键作用。为了检测药物不良反应，临床试验通常会在严格控制的条件下提供有限的信息。由于特定的伴随用药或疾病，只有在较大的人群和特定的患者群体中长期使用后，才能发现一些药物不良反应。从上市后数据中尽早检测未知和意外的安全信号是主要挑战之一药物警戒。当前的检测信号的方法主要基于自发报告，这主要有助于检测B型不良反应和异常的A型不良反应。信号检测的其他来源包括处方事件监视，病例控制监视和后续研究。信号评估主要是通过Upsala监测量表和Naranjo概率量表对因果分析进行分析。信号检测及其评估是非常重要和复杂的过程。因此，本综述的主要目的是提供最常见的信号检测方法及其在药物警戒中的评估方法的总结，以确认药物的安全性。还讨论了最近的发展，挑战和未来需求。

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