Rabkin J G, Wagner G J, Rabkin R
New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York 10032, USA.
Am J Psychiatry. 1999 Jan;156(1):101-7. doi: 10.1176/ajp.156.1.101.
The goals of this study were to determine whether fluoxetine is superior to placebo in treating HIV-seropositive patients with major depression or dysthymia or both, whether severity of immunosuppression is associated with treatment response, and whether fluoxetine treatment is associated with change in immune status as measured by CD4 cell count.
A double-blind, randomized, placebo-controlled 8-week trial of fluoxetine was conducted in a university-affiliated research outpatient clinic. The fluoxetine-placebo randomization was 2:1. All patients were offered 4 months of additional open treatment. Main outcome measures included the Clinical Global Impression, Hamilton Depression Rating Scale, and CD4 cell count.
Of 120 patients randomly assigned to fluoxetine or placebo, 87 completed 8 weeks of treatment. In the total group, 51% had AIDS. All but three were men, 35% were nonwhite, and 6% had intravenous drug use as a risk factor. In an intention-to-treat analysis, 57% of fluoxetine patients and 41% of placebo patients were responders. Among patients who completed the study, 74% responded to fluoxetine and 47% to placebo; this difference was statistically significant. Severity of immunosuppression was not related to antidepressant response, attrition, or side effects, and fluoxetine treatment was not associated with change in CD4 cell count.
Fluoxetine is an effective antidepressant in the context of HIV illness. However, both placebo response and attrition were substantial, suggesting both that nonspecific factors may be more salient and that yet another medication (i.e., an antidepressant) may be less acceptable among patients with serious medical illness already requiring multiple concomitant medications.
本研究的目的是确定氟西汀在治疗合并重度抑郁或心境恶劣或两者皆有的HIV血清反应阳性患者方面是否优于安慰剂，免疫抑制的严重程度是否与治疗反应相关，以及氟西汀治疗是否与通过CD4细胞计数测量的免疫状态变化相关。
在一家大学附属研究门诊对氟西汀进行了一项为期8周的双盲、随机、安慰剂对照试验。氟西汀与安慰剂的随机分组比例为2:1。所有患者均接受4个月的额外开放治疗。主要结局指标包括临床总体印象量表、汉密尔顿抑郁量表和CD4细胞计数。
在120名随机分配接受氟西汀或安慰剂治疗的患者中，87名完成了8周的治疗。在整个研究组中，51%的患者患有艾滋病。除3名患者外均为男性，35%为非白人，6%有静脉吸毒作为危险因素。在意向性分析中，57%的氟西汀治疗患者和41%的安慰剂治疗患者有反应。在完成研究的患者中，74%的患者对氟西汀有反应，47%的患者对安慰剂有反应；这一差异具有统计学意义。免疫抑制的严重程度与抗抑郁药反应、脱落或副作用无关，氟西汀治疗与CD4细胞计数的变化无关。
在HIV疾病背景下，氟西汀是一种有效的抗抑郁药。然而，安慰剂反应和脱落率都很高，这表明非特异性因素可能更突出，而且在已经需要多种合并用药的重症患者中，另一种药物（即抗抑郁药）可能不太容易被接受。
