Elliott A J, Uldall K K, Bergam K, Russo J, Claypoole K, Roy-Byrne P P
Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle 98104, USA.
Am J Psychiatry. 1998 Mar;155(3):367-72. doi: 10.1176/ajp.155.3.367.
This study examined whether a selective serotonin reuptake inhibitor (paroxetine) had comparable efficacy but greater tolerability than a tricyclic antidepressant (imipramine) in depressed patients with HIV infection.
Seventy-five HIV-positive patients (45% of whom had AIDS) were blindly and randomly assigned to receive paroxetine (N = 25), imipramine (N = 25), or placebo (N = 25) in a 12-week trial. The Hamilton Anxiety Rating Scale, the Hamilton Depression Rating Scale, the Clinical Global Impression scale, and the SAFETEE general inquiry (for safety and tolerability) were administered at weeks 2, 4, 6, 8, and 12.
Fifty-six (75%) of the 75 patients completed 6 weeks and 34 (45%) completed 12 weeks of the trial. The mean daily doses of both paroxetine (33.9 mg) and imipramine (162.5 mg) were significantly more effective than placebo; they were comparably effective at weeks 6, 8, and 12 according to the intent-to-treat analysis and at week 8 according to the analysis for the subjects who completed the trial (for them, only imipramine was superior to placebo at week 12). There were significantly more dropouts due to side effects from imipramine (48%) than from both paroxetine (20%) and placebo (24%).
Depressed patients with HIV infection responded to imipramine or paroxetine at a higher rate than to placebo irrespective of severity of immunosuppression. Because paroxetine was much better tolerated than imipramine, its overall effectiveness may be greater. However, because of the small study group and the high attrition rate, these findings cannot be generalized and may need replication in a larger study group.
本研究旨在探讨在感染人类免疫缺陷病毒（HIV）的抑郁症患者中，选择性5-羟色胺再摄取抑制剂（帕罗西汀）是否与三环类抗抑郁药（丙咪嗪）疗效相当，但耐受性更佳。
75例HIV阳性患者（其中45%患有获得性免疫缺陷综合征[艾滋病]）在一项为期12周的试验中被随机双盲分配，分别接受帕罗西汀（N = 25）、丙咪嗪（N = 25）或安慰剂（N = 25）治疗。在第2、4、6、8和12周时，使用汉密尔顿焦虑评定量表、汉密尔顿抑郁评定量表、临床总体印象量表以及SAFETEE综合询问表（用于评估安全性和耐受性）进行评估。
75例患者中有56例（75%）完成了6周的试验，34例（45%）完成了12周的试验。帕罗西汀（33.9毫克）和丙咪嗪（162.5毫克）的平均日剂量均显著优于安慰剂；根据意向性分析，在第6、8和12周时二者疗效相当，而根据对完成试验的受试者的分析，在第8周时二者疗效相当（对于这些受试者，仅丙咪嗪在第12周时优于安慰剂）。因丙咪嗪副作用导致的脱落患者（48%）显著多于帕罗西汀（20%）和安慰剂（24%）。
无论免疫抑制的严重程度如何，感染HIV的抑郁症患者对丙咪嗪或帕罗西汀的反应率均高于安慰剂。由于帕罗西汀的耐受性远优于丙咪嗪，其总体疗效可能更佳。然而，由于研究组规模较小且损耗率较高，这些发现无法推广，可能需要在更大的研究组中进行重复验证。
