Rabkin J G, Rabkin R, Harrison W, Wagner G
New York State Psychiatric Institute, NY 10032.
Am J Psychiatry. 1994 Apr;151(4):516-23. doi: 10.1176/ajp.151.4.516.
The authors' first objective was to ascertain whether imipramine is superior to placebo in treating axis I depressive disorders in the context of HIV illness. Supplementary questions were whether severity of immunodeficiency is associated with antidepressant response and whether patients with greater immunodeficiency can tolerate standard doses of imipramine. Second, the authors sought to determine whether imipramine treatment is associated with changes in immune status.
A double-blind, randomized placebo-controlled trial of imipramine was conducted in a university-affiliated research outpatient clinic. After 6 weeks of treatment, responders were maintained double-blind for another 6 weeks and nonresponders were removed from the study and treated openly. All patients were offered 26 weeks of treatment. Of the 97 patients who were randomly assigned to placebo or imipramine, 80 completed the 6-week phase. Main outcome measures included the Clinical Global Impression, the Hamilton Depression Rating Scale, the Brief Symptom Inventory, and CD4 cell count.
Among study completers, 31 (39%) had AIDS. The response rate to imipramine was 74% and the response rate to placebo was 26%. There was no difference in depression response between patients with more or less severe immunodeficiency, nor was there a difference in medication dose or side effects. Neither type nor duration of treatment influenced CD4 cell count during the course of treatment.
Depressed patients with HIV illness respond to imipramine at the same rate as medically healthy depressed patients. Severity of immunosuppression is not associated with imipramine treatment outcome. There is no evidence that imipramine has negative effects on enumerative measures of immune status.
作者的首要目标是确定在人类免疫缺陷病毒（HIV）疾病背景下，丙咪嗪治疗轴I型抑郁症是否优于安慰剂。补充问题包括免疫缺陷的严重程度是否与抗抑郁反应相关，以及免疫缺陷更严重的患者能否耐受丙咪嗪的标准剂量。其次，作者试图确定丙咪嗪治疗是否与免疫状态的变化有关。
在一家大学附属研究门诊进行了一项丙咪嗪的双盲、随机、安慰剂对照试验。治疗6周后，有反应者继续双盲治疗6周，无反应者退出研究并接受开放治疗。所有患者均接受26周的治疗。在97名随机分配接受安慰剂或丙咪嗪治疗的患者中，80名完成了6周阶段。主要结局指标包括临床总体印象、汉密尔顿抑郁量表、简明症状量表和CD4细胞计数。
在完成研究的患者中，31名（39%）患有获得性免疫缺陷综合征（AIDS）。丙咪嗪的有效率为74%，安慰剂的有效率为26%。免疫缺陷程度较轻或较重的患者在抑郁反应方面没有差异，药物剂量或副作用也没有差异。治疗类型和持续时间在治疗过程中均未影响CD4细胞计数。
患有HIV疾病的抑郁症患者对丙咪嗪的反应率与健康抑郁症患者相同。免疫抑制的严重程度与丙咪嗪的治疗结果无关。没有证据表明丙咪嗪对免疫状态的计数指标有负面影响。
