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自杀倾向、抑郁症筛查与抗癫痫药物:对美国食品药品监督管理局警报的反应

Suicidality, depression screening, and antiepileptic drugs: reaction to the FDA alert.

作者信息

Shneker Bassel F, Cios Jacquelyne S, Elliott John O

机构信息

Department of Neurology, Ohio State University, Columbus, OH 43210, USA.

出版信息

Neurology. 2009 Mar 17;72(11):987-91. doi: 10.1212/01.wnl.0000344403.13815.8d.

DOI:10.1212/01.wnl.0000344403.13815.8d
PMID:19289738
Abstract

OBJECTIVE

To determine the reaction of neurology practitioners to the Food and Drug Administration (FDA) alert concerning suicidality (suicidal ideation or behavior) and antiepileptic drugs.

METHODS

We designed a 21-question survey asking about the participants' approach to suicidality and depression in patients with epilepsy (PWE), and their reaction to the FDA alert and its impact on their clinical practices. Participants (n = 780) were invited via e-mail to respond to a Zoomerang survey. Two reminders were sent to increase the response.

RESULTS

The survey was completed by 175 participants (22%). Most were epilepsy specialists practicing in academic settings. Almost 62% did not use any scale to routinely screen for depression in PWE. For those who used a scale, the Beck Depression Inventory was the most used one. About 42% did not feel comfortable initiating treatment for depression. Although 98% warn about behavioral side effects when starting antiepileptic drugs, only 44% warn specifically about suicidal ideations or behavior. More than half were not aware of patients who attempted to commit suicide or who had committed suicide. The mean scores for the FDA alert clarity, appropriateness, and impact on clinical practice (on a scale from 1 to 10) were low, at 5.3, 4.1, and 3.6. Almost 46% did not feel the alert is going to change their practice.

CONCLUSION

The Food and Drug Administration alert did not get a favorable score from the surveyed responders. Participants actively alert patients about behavioral side effects of antiepileptic drugs, but are not specific about suicide.

摘要

目的

确定神经科医生对美国食品药品监督管理局(FDA)关于自杀倾向(自杀意念或行为)与抗癫痫药物的警示的反应。

方法

我们设计了一项包含21个问题的调查问卷,询问参与者对癫痫患者(PWE)自杀倾向和抑郁的处理方法,以及他们对FDA警示的反应及其对临床实践的影响。通过电子邮件邀请780名参与者回答在线调查问卷。发送了两次提醒以提高回复率。

结果

175名参与者(22%)完成了调查。大多数是在学术机构执业的癫痫专科医生。近62%的人没有使用任何量表对PWE进行常规抑郁筛查。对于使用量表的人来说,贝克抑郁量表是使用最多的。约42%的人对开始治疗抑郁症感到不自在。虽然98%的人在开始使用抗癫痫药物时会警告行为副作用,但只有44%的人会特别警告自杀意念或行为。超过一半的人不知道有患者试图自杀或已经自杀。FDA警示的清晰度、适当性以及对临床实践的影响(评分从1到10)的平均得分较低,分别为5.3、4.1和3.6。近46%的人认为该警示不会改变他们的做法。

结论

FDA的警示在接受调查的受访者中得分不高。参与者会积极提醒患者抗癫痫药物的行为副作用,但对自杀方面并不具体。

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