ter Borg Pieter C J, van Os Erik, van den Broek Walter W, Hansen Bettina E, van Buuren Henk R
Department of Gastroenterology and Hepatology, Erasmus MC, Dr, Molewaterplein 40, Rotterdam, The Netherlands.
BMC Gastroenterol. 2004 Jul 13;4:13. doi: 10.1186/1471-230X-4-13.
Fatigue is a major clinical problem in many patients with primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC). An effective treatment has not been defined. Recently, a large proportion of patients with these diseases was found to have symptoms of depression. Because fatigue is a frequent symptom of depression and there is some evidence that treatment with an antidepressant improves fatigue in patients with fibromyalgia, we hypothesised that the antidepressant fluvoxamine might improve fatigue related to PBC and PSC.
Fatigued patients were randomised to receive fluvoxamine (75 mg BID) or placebo for a six-week period. Fatigue and quality of life were quantified using a visual analogue scale, the Fisk Fatigue Severity Scale, the Multidimensional Fatigue Inventory and the SF-36.
Seventeen and 16 patients were allocated to fluvoxamine and placebo, respectively. There was no statistically significant beneficial effect of fluvoxamine on fatigue or quality of life. The median VAS scores in the fluvoxamine and placebo groups were 7.40 and 7.45 at day 0, 6.9 and 7.15 at day 14, 7.45 and 7.65 at day 42 and 7.8 and 8.0 four weeks after treatment discontinuation.
We found no evidence for a beneficial effect of fluvoxamine on fatigue in these patients with cholestatic liver disease and severe chronic fatigue.
疲劳是许多原发性胆汁性肝硬化（PBC）和原发性硬化性胆管炎（PSC）患者的主要临床问题。尚未确定有效的治疗方法。最近，发现这些疾病的很大一部分患者有抑郁症状。由于疲劳是抑郁症的常见症状，并且有证据表明用抗抑郁药治疗可改善纤维肌痛患者的疲劳，我们推测抗抑郁药氟伏沙明可能改善与PBC和PSC相关的疲劳。
将疲劳患者随机分为接受氟伏沙明（75毫克，每日两次）或安慰剂治疗六周。使用视觉模拟量表、菲斯克疲劳严重程度量表、多维疲劳量表和SF - 36对疲劳和生活质量进行量化。
分别有17例和16例患者被分配到氟伏沙明组和安慰剂组。氟伏沙明对疲劳或生活质量没有统计学上的显著有益影响。氟伏沙明组和安慰剂组在第0天的视觉模拟量表中位数得分分别为7.40和7.45，第14天为6.9和7.15，第42天为7.45和7.65，治疗停止四周后为7.8和8.0。
我们没有发现氟伏沙明对这些胆汁淤积性肝病和严重慢性疲劳患者的疲劳有有益影响的证据。
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