Risk MR Pharmacovigilance Services, Zaragoza, Spain.
N Engl J Med. 2010 Aug 5;363(6):542-51. doi: 10.1056/NEJMoa0909801.
A previous meta-analysis of data from clinical trials showed an association between antiepileptic drugs and suicidality (suicidal ideation, behavior, or both). We used observational data to examine the association between the use or nonuse of antiepileptic drugs and suicide-related events (attempted suicides and completed suicides) in patients with epilepsy, depression, or bipolar disorder.
We used data collected as part of the clinical care of patients who were representative of the general population in the United Kingdom to identify patients with epilepsy, depression, or bipolar disorder and to determine whether they received antiepileptic drugs. We estimated the incidence rate of suicide-related events and used logistic regression to compute odds ratios, controlling for confounding factors.
In a cohort of 5,130,795 patients, the incidence of suicide-related events per 100,000 person-years was 15.0 (95% confidence interval [CI], 14.6 to 15.5) among patients without epilepsy, depression, bipolar disorder, or antiepileptic-drug treatment, 38.2 (95% CI, 26.3 to 53.7) among patients with epilepsy who did not receive antiepileptic drugs, and 48.2 (95% CI, 39.4 to 58.5) among patients with epilepsy who received antiepileptic drugs. In adjusted analyses, the use of antiepileptic drugs was not associated with an increased risk of suicide-related events among patients with epilepsy (odds ratio, 0.59; 95% CI, 0.35 to 0.98) or bipolar disorder (1.13; 95% CI, 0.35 to 3.61) but was significantly associated with an increased risk among patients with depression (1.65; 95% CI, 1.24 to 2.19) and those who did not have epilepsy, depression, or bipolar disorder (2.57; 95% CI, 1.78 to 3.71).
The current use of antiepileptic drugs was not associated with an increased risk of suicide-related events among patients with epilepsy, but it was associated with an increased risk of such events among patients with depression and among those who did not have epilepsy, depression, or bipolar disorder.
先前对临床试验数据的荟萃分析表明抗癫痫药与自杀意念、行为或两者均相关。我们使用观察性数据，检查了癫痫、抑郁或双相情感障碍患者中使用或不使用抗癫痫药与自杀相关事件（自杀未遂和自杀死亡）之间的关联。
我们使用在英国作为一般人群临床护理一部分收集的数据，来识别癫痫、抑郁或双相情感障碍患者，并确定他们是否使用了抗癫痫药。我们估计了自杀相关事件的发生率，并使用逻辑回归计算了比值比，同时控制了混杂因素。
在一个 5130795 名患者的队列中，无癫痫、抑郁、双相情感障碍或抗癫痫药物治疗的患者中，每 100000 人年的自杀相关事件发生率为 15.0（95%置信区间[CI]，14.6 至 15.5），未使用抗癫痫药的癫痫患者为 38.2（95% CI，26.3 至 53.7），使用抗癫痫药的癫痫患者为 48.2（95% CI，39.4 至 58.5）。在调整分析中，癫痫患者使用抗癫痫药与自杀相关事件风险增加无关（比值比，0.59；95%CI，0.35 至 0.98）或双相情感障碍（1.13；95%CI，0.35 至 3.61），但与抑郁患者（1.65；95%CI，1.24 至 2.19）和无癫痫、抑郁或双相情感障碍的患者显著相关（2.57；95%CI，1.78 至 3.71）。
当前使用抗癫痫药与癫痫患者自杀相关事件风险增加无关，但与抑郁患者和无癫痫、抑郁或双相情感障碍患者的此类事件风险增加相关。
