Abbott, Abbott Park, IL, USA.
Ann Gen Psychiatry. 2011 Jan 18;10(1):1. doi: 10.1186/1744-859X-10-1.
Recent analyses of antiepileptic drugs have indicated an increase in the risk of suicidality. The objective of this report was to provide clinical information and an independent meta-analysis of divalproex sodium and suicidality events by analyzing data from 13 placebo-controlled studies and 1 low-dose controlled study.
Adverse events considered to be possibly suicide related were identified using the Columbia Classification Algorithm of Suicide Assessment (C-CASA) methodology. Indications included epilepsy, bipolar disorder, migraine prophylaxis, impulsive aggression, and dementia. Narratives were produced for every event, and suicidality event ratings were performed by a third party blinded to treatment assignment. Statistical analyses were conducted using methodology similar to that reported by the US Food and Drug Administration (FDA).
Suicidality events were identified in 5 of the 13 placebo-controlled studies. Of the 1,327 (0.83%) subjects taking divalproex sodium, 11 had suicidality events: 2 suicide attempts and 9 suicidal ideation. Of 992 (0.91%) subjects taking placebo, 9 had suicidality events: 1 preparatory act toward suicide, 2 suicide attempts, and 6 suicidal ideation. Across placebo-controlled studies, the overall estimated odds ratio (OR) of suicidal behavior or ideation was 0.72 (95% CI 0.29 to 1.84). The OR for suicidal behavior was 0.37 (95% CI 0.04 to 2.58), and the OR for suicidal ideation was 0.90 (95% CI 0.31 to 2.79).
In this meta-analysis, divalproex sodium does not appear to increase the risk of suicide-related adverse events relative to placebo in the populations studied. Clinicians should nonetheless remain vigilant in assessing suicidality, not only in patients treated for mental disorders with inherently high suicide risk, but also in patients taking antiepileptic medications.
最近对抗癫痫药物的分析表明，自杀风险增加。本报告的目的是通过分析 13 项安慰剂对照研究和 1 项低剂量对照研究的数据，提供有关丙戊酸钠和自杀事件的临床信息和独立的荟萃分析。
使用自杀评估的哥伦比亚分类算法（C-CASA）方法识别可能与自杀相关的不良事件。适应症包括癫痫、双相情感障碍、偏头痛预防、冲动攻击和痴呆。对每个事件都编写了叙述，并且由对治疗分配不知情的第三方进行自杀事件评分。使用与美国食品和药物管理局（FDA）报告的方法类似的方法进行统计分析。
在 13 项安慰剂对照研究中有 5 项确定了自杀事件。在服用丙戊酸钠的 1327 名（0.83%）受试者中，有 11 人发生自杀事件：2 人自杀未遂，9 人有自杀意念。在服用安慰剂的 992 名（0.91%）受试者中，有 9 人发生自杀事件：1 人有自杀预备行为，2 人自杀未遂，6 人有自杀意念。在安慰剂对照研究中，自杀行为或意念的总体估计比值比（OR）为 0.72（95%CI 0.29 至 1.84）。自杀行为的 OR 为 0.37（95%CI 0.04 至 2.58），自杀意念的 OR 为 0.90（95%CI 0.31 至 2.79）。
在这项荟萃分析中，与安慰剂相比，丙戊酸钠在研究人群中似乎不会增加与自杀相关的不良事件的风险。然而，临床医生仍应保持警惕，评估自杀风险，不仅要评估患有精神障碍且固有自杀风险高的患者，还要评估服用抗癫痫药物的患者。
