Gibbons Robert D, Hur Kwan, Brown C Hendricks, Mann J John
Center for Health Statistics, University of Illinois at Chicago, Chicago, IL 60614, USA.
Arch Gen Psychiatry. 2009 Dec;66(12):1354-60. doi: 10.1001/archgenpsychiatry.2009.159.
On January 31, 2008, the Food and Drug Administration issued an alert regarding increased risk of suicidal thoughts and behavior related to use of antiepileptic drugs (AEDs). On July 10, 2008, a Food and Drug Administration scientific advisory committee voted that, yes, there was a significant positive association between AEDs and suicidality but voted against placing a black box warning on AEDs for suicidality.
To determine if AEDs increase the risk of suicide attempt in patients with bipolar disorder.
A pharmacoepidemiologic study in which suicide attempt rates were compared before and after treatment and with a medication-free control group. Analyses were restricted to AED and lithium monotherapy.
We used the PharMetrics medical claims database to study the relationship between the 11 AEDs identified in the FDA alert, and lithium, to suicide attempts.
Suicide attempts. Patients A cohort of 47 918 patients with bipolar disorder with a minimum 1-year window of information before and after the index date of their illness.
Overall, there was no significant difference in suicide attempt rates for patients treated with an AED (13 per 1000 person-years [PY]) vs patients not treated with an AED or lithium (13 per 1000 PY). In AED-treated subjects, the rate of suicide attempts was significantly higher before treatment (72 per 1000 PY) than after (13 per 1000 PY). In patients receiving no concomitant treatment with an antidepressant, other AED, or antipsychotic, AEDs were significantly protective relative to no pharmacologic treatment (3 per 1000 vs 15 per 1000 PY).
Despite Food and Drug Administration reports regarding increased risk of suicidality associated with AED treatment, the current study reveals that, as a class, AEDs do not increase risk of suicide attempts in patients with bipolar disorder relative to patients not treated with an AED or lithium. Use of AEDs reduces suicide attempt rates both relative to patients not receiving any psychotropic medication and relative to their pretreatment levels.
2008年1月31日,美国食品药品监督管理局发布一项警示,指出使用抗癫痫药物(AEDs)会增加自杀念头和行为的风险。2008年7月10日,美国食品药品监督管理局的一个科学咨询委员会投票表决,认为AEDs与自杀倾向之间确实存在显著的正相关,但投票反对在AEDs上标注关于自杀倾向的黑框警告。
确定AEDs是否会增加双相情感障碍患者自杀未遂的风险。
一项药物流行病学研究,比较治疗前后以及与无药物治疗对照组的自杀未遂率。分析仅限于AED和锂盐单一疗法。
我们使用PharMetrics医疗理赔数据库来研究美国食品药品监督管理局警示中确定的11种AEDs以及锂盐与自杀未遂之间的关系。
自杀未遂情况。对47918例双相情感障碍患者进行队列研究,在其疾病索引日期前后至少有1年的信息记录。
总体而言,接受AED治疗的患者(每1000人年中有13例)与未接受AED或锂盐治疗的患者(每1000人年中有13例)的自杀未遂率无显著差异。在接受AED治疗的受试者中,治疗前的自杀未遂率(每1000人年中有72例)显著高于治疗后(每1000人年中有13例)。在未同时接受抗抑郁药、其他AED或抗精神病药治疗的患者中,相对于无药物治疗,AEDs具有显著的保护作用(每1000人年中有3例 vs 每1000人年中有15例)。
尽管美国食品药品监督管理局报告称AED治疗与自杀倾向风险增加有关,但当前研究表明,作为一类药物总体而言,相对于未接受AED或锂盐治疗的患者,AEDs不会增加双相情感障碍患者自杀未遂的风险。与未接受任何精神药物治疗的患者相比以及与治疗前水平相比,使用AEDs均可降低自杀未遂率。