FALSE-POSITIVES IN SPONTANEOUS REPORTING - SHOULD WE WORRY ABOUT THEM
FALSE-POSITIVES IN SPONTANEOUS REPORTING - SHOULD WE WORRY ABOUT THEM
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DOI：
10.1111/j.1365-2125.1994.tb04373.x
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发表时间：
1994-11-01
影响因子：
3.4
通讯作者：
HARAMBURU, F
中科院分区：
文献类型：
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作者：
BEGAUD, B;MORIDE, Y;HARAMBURU, F
1自发报告仍然是最常用的，毫无疑问，也是最具成本效益的药物不良反应（ADR）识别方法。这种方法的大部分局限性都得到了很好的认识，但接收巧合药物事件关联的假阳性报告的可能性却很少受到关注。2在本文中，我们提出了一种基于泊松分布的方法，用于计算预期巧合报告的ADR报告的最大数量。需要三个参数：（i）参考人群中事件的背景风险，（ii）接受所考虑药物治疗的患者总数，（iii）已报告给药物警戒系统的病例比例。3对于上市后监测环境中发生的大多数经验情况，预期的数量仍然很低，最多只有1 - 3例病例可以被认为是可能的巧合。4对于罕见的不良事件，如粒细胞缺乏症或中毒性表皮坏死松解症，巧合相关性的可能性非常小，因此超过3份的报告构成强烈警告，需要进一步调查。5这些结果表明，对于罕见事件，巧合药物事件相关性的报告不太可能被视为自发报告的重要限制。
1 Spontaneous reporting remains the most used and, undoubtedly, the most cost-effective approach for the identification of adverse drug reactions (ADRs). Most of the limitations of this method are well recognised but the possibility of receiving false-positive reports of coincidental drug-event associations has received little attention.2 In this paper we propose a method based on the Poisson distribution for computing the maximum number of reports of an ADR that could be expected to be reported coincidentally. Three parameters are required: (i) the background risk of the event in the reference population, (ii) the total number of patients treated with the drug considered and, (iii) the proportion of cases that have been reported to the pharmacovigilance system.3 For most empirical situations occurring in the post-marketing surveillance setting, the expected number remains low and only a maximum of one to three cases could be accepted as possibly coincidental.4 For rare adverse events such as agranulocytosis or toxic epidermal necrolysis, coincidental associations are so unlikely that a number of reports greater than three constitutes a strong warning and requires further investigation.5 These findings suggest that for rare events, reports of coincidental drug-event associations are too unlikely to be considered as an important limitation of spontaneous reporting.