A randomized, double-blind, placebo-controlled trial of pramipexole, a dopamine agonist, in patients with fibromyalgia receiving concomitant medications
A randomized, double-blind, placebo-controlled trial of pramipexole, a dopamine agonist, in patients with fibromyalgia receiving concomitant medications
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DOI：
10.1002/art.21191
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发表时间：
2005-08-01
影响因子：
--
通讯作者：
Myers, RR
中科院分区：
文献类型：
--
作者：
Holman, AJ;Myers, RR
目标。评价多巴胺3受体激动剂普拉克索治疗纤维肌痛的疗效和安全性。在这项为期14周的单中心、双盲、安慰剂对照、平行组、剂量递增的试验中，60名纤维肌痛患者被随机分为2:1（普拉克索：安慰剂），每天晚上口服4.5 mg普拉克索或安慰剂。主要结局是疼痛评分（10 cm视觉模拟评分[VAS]）在14周时的改善。次要观察指标为纤维肌痛影响问卷（FIQ）、多维健康评估问卷（MDHAQ）、疼痛改善量表、压痛点评分、17题汉密尔顿抑郁量表（HAM-d）和贝克焦虑指数（BAI）。没有排除有合并症和残疾的患者。同时允许使用稳定剂量的药物，包括镇痛药。与安慰剂组相比，接受普拉克索治疗的患者在疼痛、疲劳、功能和整体状态方面的改善逐渐显著。14周时，普拉克索组VAS疼痛评分下降36%，安慰剂组下降9%（治疗差-1.77 cm）。42%接受普拉克索治疗的患者和14%接受安慰剂治疗的患者疼痛减轻了50%。普拉克索优于安慰剂的次要结果包括总FIQ评分（治疗差异-9.57）、功能改善百分比（22%对0%）、疲劳（29%对7%）和MDHAQ总体评分（38%对3%）。与基线相比，一些结果显示普拉克索治疗比安慰剂治疗有更好的趋势，但未达到统计学意义，包括压痛点评分的改善（51%对36%），MDHAQ精神病学评分的降低（37%对28%），BAI评分（39%对27%）和HAM-d评分（29%对9%）。没有终点显示安慰剂组有更好的趋势。与普拉克索相关的最常见不良事件是短暂性焦虑和体重减轻。没有患者因为与普拉克索相关的无效或不良事件而退出研究。在纤维肌痛患者的一个亚群中，大约50%的患者需要麻醉镇痛和/或残疾，用普拉克索治疗可以改善疼痛、疲劳、功能和整体状态的评估评分，并且安全且耐受性良好。
Objective. To assess the efficacy and safety of pramipexole, a dopamine 3 receptor agonist, in patients with fibromyalgia.Methods. In this 14-week, single-center, double-blind, placebo-controlled, parallel-group, escalating-dose trial, 60 patients with fibromyalgia were randomized 2:1 (pramipexole:placebo) to receive 4.5 mg of pramipexole or placebo orally every evening. The primary outcome was improvement in the pain score (10-cm visual analog scale [VAS]) at 14 weeks. Secondary outcome measures were the Fibromyalgia Impact Questionnaire (FIQ), the Multidimensional Health Assessment Questionnaire (MDHAQ), the pain improvement scale, the tender point score, the 17-question Hamilton Depression Inventory (HAM-d), and the Beck Anxiety Index (BAI). Patients with comorbidities and disability were not excluded. Stable dosages of concomitant medications, including analgesics, were allowed.Results. Compared with the placebo group, patients receiving pramipexole experienced gradual and more significant improvement in measures of pain, fatigue, function, and global status. At 14 weeks, the VAS pain score decreased 36% in the pramipexole arm and 9% in the placebo arm (treatment difference -1.77 cm). Forty-two percent of patients receiving pramipexole and 14% of those receiving placebo achieved >= 50% decrease in pain. Secondary outcomes favoring pramipexole over placebo included the total FIQ score (treatment difference -9.57) and the percentages of improvement in function (22% versus 0%), fatigue (29% versus 7%), and global (38% versus 3%) scores on the MDHAQ. Compared with baseline, some outcomes showed a better trend for pramipexole treatment than for placebo, but failed to reach statistical significance, including improvement in the tender point score (51% versus 36%) and decreases in the MDHAQ psychiatric score (37% versus 28%), the BAI score (39% versus 27%), and the HAM-d score (29% versus 9%). No end points showed a better trend for the placebo arm. The most common adverse events associated with pramipexole were transient anxiety and weight loss. No patient withdrew from the study because of inefficacy or an adverse event related to pramipexole.Conclusion. In a subset of patients with fibromyalgia, similar to 50% of whom required narcotic analgesia and/or were disabled, treatment with pramipexole improved scores on assessments of pain, fatigue, function, and global status, and was safe and well-tolerated.