氢溴酸加兰他敏治疗慢性疲劳综合征的一项随机对照试验  

Effect of galantamine hydrobromide in chronic fatigue syndrome: A randomized controlled trial

作　　者：Blacker C.V.R. Greenwood D.T. Wesnes K.A. 黄卫东 

机构地区：[1]Dept. of Health and Social Sciences, Wonford House Hospit al, Dryden Road, Exeter, EX2 5AF, United Kingdom Dr.

出　　处：《世界核心医学期刊文摘（神经病学分册）》2005年第2期2-3,共2页Digest of the World Core Medical Journals:Clinical Neurology

摘　　要：Context: There is no established pharmacological treatment for the core sympto ms of chronic fatigue syndrome CORE JOURNALS IN CLINICAL NEUROLOGY CORE VIEW (CF S). Galantamine hydrobromide, an acetyl cholesterone inhibitor, has pharmacologi cal properties that might benefit patients with CFS. Objective: To compare the e fficacy and tolerability of galantamine hydrobromide in patients with CFS. Desig n, Setting, and Patients: Randomized, double blind trial conducted June 1997 th rough July 1999 at 35 outpatient centers in the United Kingdom(n=17), United Sta tes (n=14), the Netherlands (n=2), Sweden (n=1), and Belgium (n=1) involving 434 patients with a clinical diagnosis of CFS (modified US Centers for Disease Cont rol and Prevention criteria). Interventions: A total of 89 patients were randoml y assigned to receive 2.5 mg of galantamine hydrobromide; 86 patients, 5.0 mg; 9 1 patients, 7.5 mg; and,86 patients, 10 mg (these patients received medicine in the tablet form 3 times per day); a total of 82 patients received matching place bo tablets 3 times per day. Main Outcome Measures: The primary efficacy variable was the global change on the Clinician Global Impression Scale after 4, 8, 12, and 16 weeks of treatment. Secondary outcomes were changes in core symptoms of CFS on the Chalder Fatigue Rating Scale, the Fibromyalgia Impact Q uestionnaire, and the Pittsburgh Sleep Quality Index; changes in quality of life on the Nottingham Health Profile; and assessment of plasma free cortisol level s and cognitive performance on a computer based battery of tests. Results: Afte r 16 weeks, there were no statistically significant differences between any of t he galantamine or placebo groups in clinical condition on the Clinician Global I mpression Scale, or for any of the secondary end points. Exploratory regression analysis failed to detect any consistent prognostic factor that might have influ enced the primary or any secondary outcome measures. Conclusion: This trial did not demonstrate any benefit of galantamine over plaContext: There is no established pharmacological treatment for the core sympto ms of chronic fatigue syndrome CORE JOURNALS IN CLINICAL NEUROLOGY CORE VIEW (CF S). Galantamine hydrobromide, an acetyl cholesterone inhibitor, has pharmacologi cal properties that might benefit patients with CFS. Objective: To compare the e fficacy and tolerability of galantamine hydrobromide in patients with CFS. Desig n, Setting, and Patients: Randomized, double blind trial conducted June 1997 th rough July 1999 at 35 outpatient centers in the United Kingdom(n=17), United Sta tes (n=14), the Netherlands (n=2), Sweden (n=1), and Belgium (n=1) involving 434 patients with a clinical diagnosis of CFS (modified US Centers for Disease Cont rol and Prevention criteria). Interventions: A total of 89 patients were randoml y assigned to receive 2.5 mg of galantamine hydrobromide; 86 patients, 5.0 mg; 9 1 patients, 7.5 mg; and,86 patients, 10 mg (these patients received medicine in the tablet form 3 times per day); a total of 82 patients received matching place bo tablets 3 times per day. Main Outcome Measures: The primary efficacy variable was the global change on the Clinician Global Impression Scale after 4, 8, 12, and 16 weeks of treatment. Secondary outcomes were changes in core symptoms of CFS on the Chalder Fatigue Rating Scale, the Fibromyalgia Impact Q uestionnaire, and the Pittsburgh Sleep Quality Index; changes in quality of life on the Nottingham Health Profile; and assessment of plasma free cortisol level s and cognitive performance on a computer based battery of tests. Results: Afte r 16 weeks, there were no statistically significant differences between any of t he galantamine or placebo groups in clinical condition on the Clinician Global I mpression Scale, or for any of the secondary end points. Exploratory regression analysis failed to detect any consistent prognostic factor that might have influ enced the primary or any secondary outcome measures. Conclusion: This trial did not demonstrate any benefit of galantamine over pla

关 键 词：慢性疲劳综合征 随机对照试验 氢溴酸加兰他敏 随机双盲法 安慰剂 门诊医疗 无显著性差异 皮质醇浓度 主要疗效指标 Nottingham 

分 类 号：R96[医药卫生—药理学]