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随时间推移报告“严重”与“非严重”药物不良反应的趋势：法国药物警戒数据库中的一项研究。

Trends of reporting of 'serious'vs. 'non-serious' adverse drug reactions over time: a study in the French PharmacoVigilance Database.

机构信息

CHU Toulouse, Service de Pharmacologie Clinique, Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Toulouse, F-31059, France.

出版信息

Br J Clin Pharmacol. 2012 Jul;74(1):201-4. doi: 10.1111/j.1365-2125.2012.04185.x.

DOI:10.1111/j.1365-2125.2012.04185.x
PMID:22257367
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3394146/
Abstract

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT

• Several factors are known to influence spontaneous reporting of adverse drug reactions (ADRs). Among them, 'seriousness' of the reaction is one of the most important. • However, evolution in the reporting of 'serious'vs.'non-serious' ADRs over time for the same drug remains unknown.

WHAT THIS STUDY ADDS

• Spontaneous reports mainly involve 'non-serious' ADRs during the first years of marketing and 'serious' ADRs later, particularly for drugs with non-hospital use.

AIM

To investigate trends in spontaneous reporting to the French Pharmacovigilance system of 'serious' (SADRs) and 'non-serious' (NSADRs) adverse drug reactions over time.

METHODS

Annual SADR : NSADR ratios were calculated for each drug and their evolution tested with linear trend tests.

RESULTS

Among the 39 new active substances commercialized in France in 2000, 16 had sufficient data to perform linear trend tests. An increasing linear relation was found for five widely prescribed drugs, a non-significant increasing trend for eight others, i.e. drugs mostly used in hospitals.

CONCLUSION

ADR reports mainly concern NSADRs during first years of marketing. Reports of SADRs are proportionally more frequent later.

摘要

已知本主题的相关信息

  • 有几个因素已知会影响药物不良反应（ADR）的自发报告。其中，反应的“严重程度”是最重要的因素之一。

  • 然而，对于同一种药物，随着时间的推移，“严重”和“非严重”ADR 报告的演变情况仍不清楚。

本研究的新增内容

  • 自发报告主要涉及药物上市初期的“非严重”ADR，以及后期的“严重”ADR，特别是对于非医院使用的药物。

目的

调查法国药物警戒系统中“严重”（SADR）和“非严重”（NSADR）药物不良反应随时间的自发报告趋势。

方法

计算每种药物的年度 SADR：NSADR 比值，并通过线性趋势检验测试其演变。

结果

在 2000 年法国上市的 39 种新活性物质中，有 16 种有足够的数据进行线性趋势检验。五种广泛使用的药物呈明显的线性关系，另外八种药物呈非显著的上升趋势，即主要在医院使用的药物。

结论

ADR 报告主要在上市初期涉及非严重不良反应。随着时间的推移，严重不良反应的报告比例更高。