Department of Psychiatry, Weill Cornell Medical College, New York, NY, USA.
Stat Med. 2012 Nov 30;31(27):3255-60. doi: 10.1002/sim.5339. Epub 2012 Aug 3.
The US Food and Drug Administration issued separate warnings for suicidality with antidepressants and antiepileptic drugs in the past 5 years. This study describes methods for examining the association of these agents with suicide attempts and suicide deaths in more broadly generalizable samples than examined by the US Food and Drug Administration. An observational study of mood disorders was examined that includes three decades of prospective assessments. Because of sample size differences, two distinct longitudinal implementations of the propensity adjustment are used in separate analyses of antidepressants and antiepileptic drugs. Propensity score quintile-stratified safety analyses were used with the large antidepressant data set; whereas, propensity score matched safety analyses were used with the smaller antiepileptic drug data because stratification was not feasible. In each case, mixed-effects survival models compared the safety of participants when receiving the respective class of medication to periods when they did not receive that medication. When participants were more severely ill, they were significantly more likely to receive either class of psychotropics. Propensity quintile-stratified safety analyses found that risk of suicide attempts or suicides was significantly reduced when participants received antidepressants. In contrast, propensity score matched safety analyses found neither significant risk nor protection from suicidality among participants receiving antiepileptics.
美国食品和药物管理局在过去 5 年中分别就抗抑郁药和抗癫痫药的自杀倾向发出了警告。本研究描述了在比美国食品和药物管理局检查更广泛的可推广样本中,检查这些药物与自杀企图和自杀死亡之间关联的方法。这项研究对心境障碍进行了观察性研究,其中包括了三十年的前瞻性评估。由于样本量的差异,在对抗抑郁药和抗癫痫药的单独分析中使用了两种不同的倾向调整纵向实施。在较大的抗抑郁药数据集上使用了倾向评分五分位数分层安全性分析;而在较小的抗癫痫药数据集上使用了倾向评分匹配的安全性分析,因为分层不可行。在每种情况下,混合效应生存模型将接受各自类别的药物治疗的参与者的安全性与他们未接受该药物治疗的时期进行了比较。当参与者病情更严重时,他们更有可能接受这两类精神药物中的任何一种。倾向五分位数分层安全性分析发现,参与者服用抗抑郁药时,自杀企图或自杀的风险显著降低。相比之下,倾向评分匹配的安全性分析发现,接受抗癫痫药治疗的参与者既没有明显的自杀风险,也没有受到自杀的保护。