Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial.
Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial.
复制标题
DOI：
10.1016/j.psym.2011.02.005
复制
发表时间：
2011-07
期刊：
影响因子：
3.4
通讯作者：
Rabkin, Richard
中科院分区：
文献类型：
--
作者：
Rabkin, Judith G.;McElhiney, Martin C.;Rabkin, Richard
评价阿莫达非尼治疗HIV+患者疲劳的有效性和安全性，并评估疲劳缓解后对抑郁症状和行为的影响。在安慰剂对照随机双盲试验中，对具有临床显著疲劳的HIV+患者进行4周治疗。阿莫达非尼应答者和安慰剂无应答者或复发者接受了总共16周的阿莫达非尼开放治疗。疲劳和抑郁的主要结局指标是临床总体印象改善量表，辅以疲劳严重程度量表、汉密尔顿抑郁评定量表和贝克抑郁量表。采用CD 4细胞计数和HIV RNA病毒载量测定以及SAFTEE副作用评定量表评估安全性。阿莫达非尼的最大试验剂量为250 mg/天。70例患者入组。平均死亡率为9%。在意向治疗分析中，对阿莫达非尼的疲劳应答率为75%，安慰剂为26%。阿莫达非尼并没有减少抑郁症状，在没有改善的能量，但在那些轴I抑郁症患者在研究进入的能量改善，82%的情绪改善。免疫抑制标志物在治疗期间未发生变化。在6个月时，那些仍然服用阿莫达非尼的人比那些不再服用它的人有更多的精力和更少的抑郁症状。正如我们在我们的莫达非尼随机对照试验中发现的那样，阿莫达非尼在治疗HIV+患者的疲劳方面似乎是有效的，并且耐受性良好。副作用很小，大多数患者报告能量和情绪大幅改善。
To evaluate the efficacy and safety of armodafinil in the treatment of fatigue in HIV+ patients, and to assess effect on depressive symptoms and behavior once fatigue remitted. HIV+ patients with clinically significant fatigue were treated in a placebo controlled randomized double-blind trial for 4 weeks. Armodafinil responders and placebo non-responders or relapsers were treated openly for a total of 16 weeks of armodafinil. The primary outcome measure for fatigue and depression was the Clinical Global Impressions-Improvement Scale, supplemented by the Fatigue Severity Scale, Hamilton Depression Rating Scale and Beck Depression Inventory. Safety was assessed with assays of CD4 cell count and HIV RNA viral load and the SAFTEE side effects rating scale. Maximum trial dose of armodafinil was 250 mg/day. 70 patients were enrolled. Attrition was 9%. In Intention-to-treat analyses, fatigue response rate to armodafinil was 75% and to placebo, 26%. Armodafinil did not reduce depressive symptoms in the absence of improved energy, but of those patients with an Axis I depressive disorder at study entry whose energy improved, 82% experienced improved mood as well. Markers of immunologic suppression did not change during treatment. At 6 months, those still taking armodafinil had more energy and fewer depressive symptoms than those who were no longer taking it. As we found in our RCT of modafinil, armodafinil appears effective and well tolerated in treating fatigue in HIV+ patients. Side effects were minimal and most patients reported substantially improved energy and mood.
登录
查看更多内容
影响因子：
4.5
作者：
Darwish, Mona;Kirby, Mary;Hellriegel, Edward T.
通讯作者：
Hellriegel, Edward T.
影响因子：
1.7
作者：
Barroso, Julie;Carlson, John R;Meynell, Janet
通讯作者：
Meynell, Janet
影响因子：
5.3
作者：
Menza, MA;Kaufman, KR;Castellanos, A
通讯作者：
Castellanos, A
影响因子：
--
作者：
KRUPP, LB;LAROCCA, NG;STEINBERG, AD
通讯作者：
STEINBERG, AD
影响因子：
3.4
作者：
Paddison, Johanna;Fricchione, Gregory;Freudenreich, Oliver
通讯作者：
Freudenreich, Oliver