Tollefson G D, Fawcett J, Winokur G, Beasley C M, Potvin J H, Faries D E, Rampey A H, Sayler M E
Psychopharmacology Division, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285.
Ann Clin Psychiatry. 1993 Dec;5(4):209-24. doi: 10.3109/10401239309148820.
Double-blind, controlled clinical trial data were evaluated to assess a hypothetical relationship between fluoxetine and suicidality (suicidal acts and ideation) in patients with mood (n = 5,655) and nonmood disorders (n = 4,959) (Mantel-Haenszel incidence difference method). In mood disorders, act rates (suicide attempts/completions) were low (treatment differences nonsignificant). Substantial suicidal ideation emerged less frequently with fluoxetine than placebo and was comparable with fluoxetine and tricyclic antidepressants. Improvement in ideation was greater with fluoxetine than placebo; it was comparable with fluoxetine and tricyclic antidepressants (United States trials) and greater with tricyclic antidepressants than fluoxetine (international trials). In nonmood disorders, no suicides occurred. Act and emergent ideation rates were low (treatment differences nonsignificant). Results do not suggest a causal relationship between pharmacotherapy and emergence of suicidality. Fluoxetine or tricyclic antidepressants reduce suicidal ideation and may protect against the emergence of substantial suicidal ideation.
对双盲对照临床试验数据进行评估,以通过Mantel-Haenszel发病率差异法评估氟西汀与患有情绪障碍(n = 5655)和非情绪障碍(n = 4959)患者的自杀行为(自杀行为和自杀观念)之间的假设关系。在情绪障碍中,行为发生率(自杀未遂/自杀完成)较低(治疗差异无统计学意义)。与安慰剂相比,氟西汀引发的严重自杀观念出现频率较低,且与氟西汀和三环类抗抑郁药相当。氟西汀对自杀观念的改善作用大于安慰剂;在美国的试验中,其与氟西汀和三环类抗抑郁药相当,而在国际试验中,三环类抗抑郁药对自杀观念的改善作用大于氟西汀。在非情绪障碍中,未发生自杀事件。行为和新发自杀观念发生率较低(治疗差异无统计学意义)。结果未提示药物治疗与自杀行为的出现之间存在因果关系。氟西汀或三环类抗抑郁药可减少自杀观念,并可能预防严重自杀观念的出现。