Kraus M R, Schäfer A, Schöttker K, Keicher C, Weissbrich B, Hofbauer I, Scheurlen M
Medizinische Klinik und Poliklinik II, Department of Gastroenterology and Hepatology, Würzburg University, Klinikstr 6-8, 97070 Würzburg, Germany.
Gut. 2008 Apr;57(4):531-6. doi: 10.1136/gut.2007.131607. Epub 2007 Dec 13.
Interferon-induced depression represents a major complication in antiviral treatment of chronic hepatitis C virus (HCV) infection.
To evaluate in a placebo-controlled study the efficacy of a selective serotonin reuptake inhibitor (SSRI) in HCV patients on antiviral therapy with interferon-associated depression.
100 HCV outpatients were included in a randomised, double-blind, placebo-controlled study. During interferon therapy (peginterferon alpha-2b plus ribavirin), depression was monitored using the Hospital Anxiety and Depression Scale (HADS). Patients with clinically relevant interferon-induced depression (HADS >or=9) were randomly assigned to placebo or citalopram (SSRI, 20 mg/day).
In 28 patients (28%), HADS scores increased to >8 during interferon therapy. They were treated with placebo (n = 14) or SSRI (n = 14). HADS scores declined significantly in SSRI patients within four weeks of therapy (p<0.001) but not in placebo patients. This difference between subgroups was statistically significant (p = 0.032). Unblinding became necessary in five placebo patients as a result of intolerable depression. Rescue medication (20 mg citalopram) led to a significant decrease in HADS scores (p = 0.008). All citalopram patients were able to complete interferon therapy as planned. As an interim analysis showed a significant superiority of SSRI over placebo, the study was terminated prematurely. Three patients, who became depressed afterwards, were treated in an unblinded fashion with citalopram.
The findings demonstrate clearly that citalopram treatment is highly effective in HCV patients on interferon therapy, when initiated after the onset of clinically relevant depressive symptoms. This suggests that a general SSRI prophylaxis is not necessary in these patients.
干扰素诱导的抑郁是慢性丙型肝炎病毒（HCV）感染抗病毒治疗中的主要并发症。
在一项安慰剂对照研究中评估选择性5-羟色胺再摄取抑制剂（SSRI）对接受干扰素相关抑郁抗病毒治疗的HCV患者的疗效。
100例HCV门诊患者纳入一项随机、双盲、安慰剂对照研究。在干扰素治疗（聚乙二醇干扰素α-2b加利巴韦林）期间，使用医院焦虑抑郁量表（HADS）监测抑郁情况。具有临床相关干扰素诱导抑郁（HADS≥9）的患者被随机分配至安慰剂组或西酞普兰组（SSRI，20mg/天）。
28例患者（28%）在干扰素治疗期间HADS评分升至>8。他们接受了安慰剂治疗（n = 14）或SSRI治疗（n = 14）。SSRI组患者在治疗4周内HADS评分显著下降（p<0.001），而安慰剂组患者未下降。亚组间差异具有统计学意义（p = 0.032）。5例安慰剂组患者因难以忍受的抑郁而必须揭盲。补救用药（20mg西酞普兰）使HADS评分显著降低（p = 0.008）。所有西酞普兰组患者均能按计划完成干扰素治疗。由于中期分析显示SSRI优于安慰剂，该研究提前终止。3例随后出现抑郁的患者以非盲法接受西酞普兰治疗。
研究结果清楚地表明，在出现临床相关抑郁症状后开始使用西酞普兰治疗，对接受干扰素治疗的HCV患者非常有效。这表明这些患者无需常规预防性使用SSRI。
