Wheadon D E, Rampey A H, Thompson V L, Potvin J H, Masica D N, Beasley C M
Division of Clinical Neurosciences, Eli Lilly and Company, Indianapolis, Ind 46285.
J Clin Psychiatry. 1992 Jul;53(7):235-41.
The coincidence of major depressive disorder in bulimia nervosa ranges from 35% to 80%. Because of this comorbidity and because suicidality (suicidal acts and ideation) is an inherent part of depression, assessment of the risk of suicide in patients with bulimia nervosa is of considerable interest.
Data from United States Investigational New Drug double-blind, placebo-controlled fluoxetine clinical trials in bulimia nervosa were analyzed comprehensively to assess the potential association between fluoxetine treatment and suicidality in 785 patients with DSM-III-R bulimia nervosa. Patients were predominantly women (98%), aged 17 to 63 years; of the randomly assigned patients, 16.9% exhibited 17-item Hamilton Rating Scale for Depression (HAM-D) total scores of 17 or greater at baseline (range, 0-31). Incidence of suicidality was analyzed by the incidence difference method.
No fatal suicidal acts occurred; 9 (1.15%) of 785 patients made nonfatal attempts; 24 (3.06%) experienced emergent (text-defined) suicidal ideation. No statistically significant increases in the incidence of suicidal acts or suicidal ideation were observed among fluoxetine-treated compared with placebo-treated patients. A smaller percentage of fluoxetine-treated (2.0%) than placebo-treated (3.8%) patients experienced emergence of substantial suicidal ideation (change in baseline HAM-D Item 3 [suicide item] score of 0 or 1 to 3 or 4 during therapy). A statistically significantly greater proportion of fluoxetine-treated than placebo-treated patients experienced improvement in suicidal ideation (decrease in HAM-D Item 3 score) from baseline to endpoint (p = .026).
Analyses of the incidence of suicidal acts and suicidal ideation did not indicate an increased risk of suicidality in patients with bulimia nervosa treated with fluoxetine compared with those treated with placebo.
神经性贪食症患者中重度抑郁症的并发率在35%至80%之间。鉴于这种共病情况，且自杀行为（自杀企图和自杀观念）是抑郁症的固有特征，对神经性贪食症患者的自杀风险进行评估具有重要意义。
对美国新药研究用双盲、安慰剂对照的氟西汀治疗神经性贪食症的临床试验数据进行全面分析，以评估785例符合DSM-III-R神经性贪食症诊断标准的患者中，氟西汀治疗与自杀行为之间的潜在关联。患者主要为女性（98%），年龄在17至63岁之间；在随机分组的患者中，16.9%在基线时汉密尔顿抑郁量表（HAM-D）17项总分达到或超过17分（范围为0至31分）。采用发病率差异法分析自杀行为的发生率。
未发生致命自杀行为；785例患者中有9例（1.15%）有非致命自杀企图；24例（3.06%）出现紧急（文本定义）自杀观念。与安慰剂治疗组相比，氟西汀治疗组患者的自杀行为或自杀观念发生率无统计学显著增加。与安慰剂治疗组（3.8%）相比，氟西汀治疗组（2.0%）出现严重自杀观念（治疗期间HAM-D第3项[自杀项目]基线评分从0或1分变为3或4分）的患者比例较小。从基线到终点，氟西汀治疗组患者自杀观念改善（HAM-D第3项评分降低）的比例在统计学上显著高于安慰剂治疗组（p = 0.026）。
对自杀行为和自杀观念发生率的分析表明，与安慰剂治疗组相比，氟西汀治疗的神经性贪食症患者自杀风险并未增加。
