A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia
A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia
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DOI：
10.1016/s0002-9343(01)01089-0
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发表时间：
2002-02-15
影响因子：
5.9
通讯作者：
Keck, PE
中科院分区：
文献类型：
--
作者：
Arnold, LM;Hess, EV;Keck, PE
目的：评价氟西汀治疗纤维肌痛的疗效。对象和方法：在一项双盲、平行组、灵活剂量研究中，60例纤维肌痛门诊患者（均为女性，年龄21-71岁）随机分配接受氟西汀（10- 80mg /d）或安慰剂治疗12周。主要结局指标为纤维肌痛影响问卷总分（评分范围0[无影响]至80）和疼痛评分（评分范围0-10）。次要测量包括麦吉尔疼痛问卷，压痛点数量的变化和总肌痛评分。结果：在意向治疗分析中，与接受安慰剂的女性相比，接受氟西汀（平均[+/- SD]剂量，45 - 25 mg/d）的女性在纤维肌痛影响问卷总分方面有显著改善（P = 0.005），差异为-12（95%可信区间[Cl]: 19至- 4）。与接受安慰剂的受试者相比，他们在纤维肌痛影响问卷疼痛评分（差异为-2.2 [95% CI: -3.6至-0.91）以及纤维肌痛影响问卷疲劳（P = 0.05）和抑郁（P = 0.01）评分和McGill疼痛问卷（P = 0.01）方面也有显著改善（P = 0.002）。虽然与安慰剂组相比，氟西汀组的压痛点数和总肌痛评分改善更多，但这些差异没有统计学意义。结论：在一项为期12周、灵活剂量、安慰剂对照的试验中，氟西汀在大多数结局指标上都是有效的，并且在纤维肌痛女性患者中普遍耐受良好。(C)2002年由摘录医学公司。
PURPOSE: To assess the efficacy of fluoxetine in the treatment of patients with fibromyalgia.SUBJECTS AND METHODS: Sixty outpatients (all women, aged 21-71 years) with fibromyalgia were randomly assigned to receive fluoxetine (10-80 mg/d) or placebo for 12 weeks in a double-blind, parallel-group, flexible-dose study. The primary outcome measures were the Fibromyalgia Impact Questionnaire total score (score range, 0 [no impact] to 80) and pain score (score range, 0-10). Secondary measures included the McGill Pain Questionnaire, change in the number of tender points, and total myalgic score.RESULTS: In the intent-to-treat analysis, women who received fluoxetine (mean[+/- SD] dose, 45 25 mg/d) had significant (P = 0.005) improvement in the Fibromyalgia Impact Questionnaire total score compared with those who received placebo, with a difference of -12 (95% confidence interval [Cl]: -19 to - 4). They also had significant (P = 0.002) improvement in the Fibromyalgia Impact Questionnaire pain score (difference, -2.2 [95% CI: -3.6 to -0.91), as well as in the Fibromyalgia Impact Questionnaire fatigue (P = 0.05) and depression (P = 0.01) scores and the McGill Pain Questionnaire (P = 0.01), when compared with subjects who received placebo. Although counts for the number of tender points and total myalgic scores improved more in the fluoxetine group than in the placebo group, these differences were not statistically significant.CONCLUSION: In a 12-week, flexible-dose, placebo-controlled trial, fluoxetine was found to be effective on most outcome measures and generally well tolerated in women with fibromyalgia. (C)2002 by Excerpta Medica, Inc.