Randomized Clinical Trial to Evaluate the Efficacy and Safety of Valganciclovir in a Subset of Patients With Chronic Fatigue Syndrome
Randomized Clinical Trial to Evaluate the Efficacy and Safety of Valganciclovir in a Subset of Patients With Chronic Fatigue Syndrome
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DOI：
10.1002/jmv.23713
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发表时间：
2013-12-01
影响因子：
12.7
通讯作者：
Desai, Manisha
中科院分区：
文献类型：
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作者：
Montoya, Jose G.;Kogelnik, Andreas M.;Desai, Manisha
慢性疲劳综合征（CFS）没有已知的治疗方法。其发病机制知之甚少。人类疱疹病毒6型（HHV-6）和EB病毒（EBV）已被提出作为感染性触发因素。在一项双盲、安慰剂对照试验中，30例抗HHV-6和EBV IgG抗体滴度升高的CFS患者以2：1随机接受缬更昔洛韦（VGCV）或安慰剂治疗6个月。旨在测量身体和精神疲劳的临床终点包括多维疲劳量表（MFI-20）和疲劳严重程度量表（FSS）评分、自我报告的认知功能和医生确定的应答者状态。生物学终点包括单核细胞和中性粒细胞计数以及细胞因子水平。与安慰剂组患者相比，VGCV组患者在9个月时MFI-20较基线的改善更大，但该差异无统计学显著性。然而，在MFI-20精神疲劳分项评分（P=0.039）、FSS评分（P=0.006）和认知功能（P=0.025）中观察到组间轨迹的统计学显著差异。VGCV患者在前3个月内经历了这些改善，并在剩余的9个月内保持了这种益处。VGCV组的患者被归类为应答者的可能性高7.4倍（P=0.029）。在VGCV组，单核细胞计数降低（P
There is no known treatment for chronic fatigue syndrome (CFS). Little is known about its pathogenesis. Human herpesvirus 6 (HHV-6) and Epstein-Barr virus (EBV) have been proposed as infectious triggers. Thirty CFS patients with elevated IgG antibody titers against HHV-6 and EBV were randomized 2:1 to receive valganciclovir (VGCV) or placebo for 6 months in a double-blind, placebo-controlled trial. Clinical endpoints aimed at measuring physical and mental fatigue included the Multidimensional Fatigue Inventory (MFI-20) and Fatigue Severity Scale (FSS) scores, self-reported cognitive function, and physician-determined responder status. Biological endpoints included monocyte and neutrophil counts and cytokine levels. VGCV patients experienced a greater improvement by MFI-20 at 9 months from baseline compared to placebo patients but this difference was not statistically significant. However, statistically significant differences in trajectories between groups were observed in MFI-20 mental fatigue subscore (P=0.039), FSS score (P=0.006), and cognitive function (P=0.025). VGCV patients experienced these improvements within the first 3 months and maintained that benefit over the remaining 9 months. Patients in the VGCV arm were 7.4 times more likely to be classified as responders (P=0.029). In the VGCV arm, monocyte counts decreased (P