Amsterdam J D, Garcia-España F, Fawcett J, Quitkin F M, Reimherr F W, Rosenbaum J F, Schweizer E, Beasley C
University of Pennsylvania Medical Center, Philadelphia, USA.
J Clin Psychopharmacol. 1998 Dec;18(6):435-40. doi: 10.1097/00004714-199812000-00003.
As many as 45% of patients with major depressive episode also meet DSM-IV criteria for bipolar II (BP II) disorder. Although some clinicians advocate using a mood stabilizer in treating BP II depression, antidepressant monotherapy has been less well studied in this disorder. As part of a prospective, placebo-controlled, relapse-prevention study in 839 patients, the efficacy and safety of short- and long-term fluoxetine treatment in patients with BP II major depression compared with patients with unipolar (UP) major depression was retrospectively examined. Eighty-nine BP II patients (mean age, 41+/-11 years) were compared with 89 age- and gender-matched UP patients and with 661 unmatched UP patients (mean age, 39+/-11 years). All received short-term fluoxetine therapy at 20 mg daily for up to 12 weeks. Complete remission was defined as a final Hamilton Rating Scale for Depression score < or = 7 by week 9 that was then maintained for 3 additional weeks. Remitted patients were then randomly assigned to receive double-blind treatment with one of the following: (1) fluoxetine 20 mg daily for 52 weeks; (2) fluoxetine for 38 weeks, then placebo for 14 weeks; (3) fluoxetine for 14 weeks, then placebo for 38 weeks; or (4) placebo for 52 weeks. Antidepressant efficacy was similar in BP and UP patients during short-term therapy. Discontinuation for lack of efficacy was lower in BP II (5%) than in UP (12%) patients (p = not significant [NS]), whereas dropouts for adverse events were similar in BP II (11%) and UP (9%) patients. During long-term relapse-prevention therapy, relapse rates were similar in BP II and UP patients (p = NS). During short-term fluoxetine therapy, three BP II (3.8%) versus no matched UP (p = NS) and 0.3% unmatched UP (p = 0.01) patients had a "manic switch." During long-term fluoxetine therapy, one (2%) BP II and three (1%) unmatched UP patients (one taking placebo) had a manic switch (p = NS). In conclusion, fluoxetine may be a safe and effective antidepressant monotherapy for the short-term treatment of BP II depression with a relatively low manic switch rate. Fluoxetine may also be effective in relapse-prevention therapy in patients with BP II disorder.
在患有重度抑郁发作的患者中，多达45%也符合《精神疾病诊断与统计手册》第四版（DSM-IV）中双相II型（BP II）障碍的标准。尽管一些临床医生主张在治疗BP II型抑郁症时使用心境稳定剂，但抗抑郁药单药治疗在这种疾病中的研究较少。作为一项针对839名患者的前瞻性、安慰剂对照、预防复发研究的一部分，回顾性研究了短期和长期氟西汀治疗BP II型重度抑郁症患者与单相（UP）重度抑郁症患者相比的疗效和安全性。89名BP II型患者（平均年龄41±11岁）与89名年龄和性别匹配的UP患者以及661名不匹配的UP患者（平均年龄39±11岁）进行了比较。所有患者均接受每日20毫克的短期氟西汀治疗，最长持续12周。完全缓解定义为在第9周时汉密尔顿抑郁评定量表最终得分≤7分，并在接下来的3周内保持。缓解的患者随后被随机分配接受以下双盲治疗之一：（1）每日20毫克氟西汀治疗52周；（2）氟西汀治疗38周，然后安慰剂治疗14周；（3）氟西汀治疗14周，然后安慰剂治疗38周；或（4）安慰剂治疗52周。在短期治疗期间，BP患者和UP患者的抗抑郁疗效相似。因缺乏疗效而停药的比例在BP II型患者中（5%）低于UP患者（12%）（p=无显著性差异[NS]），而因不良事件退出的比例在BP II型患者（11%）和UP患者（9%）中相似。在长期预防复发治疗期间，BP II型患者和UP患者的复发率相似（p=NS）。在短期氟西汀治疗期间，3名BP II型患者（3.8%）出现“躁狂转换”，而匹配的UP患者中无此情况（p=NS），不匹配的UP患者中有0.3%出现（p=0.01）。在长期氟西汀治疗期间，1名（2%）BP II型患者和3名（1%）不匹配的UP患者（1名服用安慰剂）出现躁狂转换（p=NS）。总之，氟西汀可能是一种安全有效的抗抑郁药单药治疗方法，用于短期治疗BP II型抑郁症，躁狂转换率相对较低。氟西汀在BP II型障碍患者的预防复发治疗中也可能有效。
