Efficacy of duloxetine in patients with fibromyalgia: pooled analysis of 4 placebo-controlled clinical trials.
Efficacy of duloxetine in patients with fibromyalgia: pooled analysis of 4 placebo-controlled clinical trials.
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DOI：
10.4088/pcc.08m00680
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发表时间：
2009-01-01
期刊：
影响因子：
--
通讯作者：
Chappell, Amy S
中科院分区：
文献类型：
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作者：
Arnold, Lesley M;Clauw, Daniel J;Chappell, Amy S
目的：通过对4项安慰剂对照、双盲、随机试验的汇总分析，探讨度洛沙汀在治疗纤维肌痛患者疼痛、改善功能障碍和生活质量方面的疗效。如果患者年龄至少为18岁，符合美国风湿病学会定义的纤维肌痛标准，并有指定的最低疼痛严重程度评分。在所有研究中，797例患者接受度洛昔单抗60 - 120 mg/d，535例患者接受安慰剂。采用简明疼痛量表（BPI）24小时平均疼痛严重程度评分评估疼痛;其他疗效测量包括临床总体印象-疾病严重程度量表（CGI-S）、患者总体印象-改善量表（PGI-I）、17项汉密尔顿抑郁评定量表（HDRS-17）、纤维肌痛影响问卷（FIQ）总评分、BPI疼痛干扰项目、希恩残疾量表（SDS）、和医学结局研究36项简表健康调查（SF-36）的精神和身体组成部分。从基线到终点的变化（末次观察值结转），为大多数上述疗效的措施进行了分析，使用协方差分析model.Results：治疗12周后，疼痛显着减少与度洛沙汀治疗的患者（P <0.001）与安慰剂相比。此外，度洛沙汀在改善CGI-S方面上级优于安慰剂PGI-I（P <.001）（P <.001）; FIQ总计（P <.001）; HDRS-17总数（P =.003）; SDS全球功能（P <0.001）、工作/学校（P = 0.018）和家庭生活（P <0.001）; SF-36精神（P <0.001）和身体（P = 0.026）成分;以及BPI疼痛干扰（P <0.001）评分。性别（P = 0.320）、年龄（P = 0.362）或种族（P = 0.180）与治疗亚组的相互作用不显著。结论：该汇总分析提供证据表明，度洛沙坦60 - 120 mg/d治疗12周可有效改善纤维肌痛症状，并可能提供疼痛缓解以外的益处。
OBJECTIVE: To investigate the efficacy of duloxetine in the treatment of pain and improvement in functional impairment and quality of life in patients with fibromyalgia from a pooled analysis of 4 placebo-controlled, double-blind, randomized trials.METHOD: Patients were eligible for inclusion in the studies if they were at least 18 years of age, met criteria for fibromyalgia as defined by the American College of Rheumatology, and had specified minimum pain severity scores. Across all studies, 797 patients received duloxetine 60-120 mg/d and 535 patients received placebo. Pain was assessed by the Brief Pain Inventory (BPI) 24-hour average pain severity score; other efficacy measures included the Clinical Global Impressions-Severity of Illness scale (CGI-S), Patient Global Impressions-Improvement scale (PGI-I), 17-item Hamilton Depression Rating Scale (HDRS-17), Fibromyalgia Impact Questionnaire (FIQ) total score, BPI pain interference items, Sheehan Disability Scale (SDS), and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) mental and physical components. Changes from baseline to endpoint (last observation carried forward) for most of the above efficacy measures were analyzed using an analysis-of-covariance model.RESULTS: After 12 weeks of treatment, pain was significantly reduced in patients treated with duloxetine (P < .001) compared with placebo. In addition, duloxetine was superior to placebo in improving CGI-S (P < .001); PGI-I (P < .001); FIQ total (P < .001); HDRS-17 total (P = .003); SDS global functioning (P < .001), work/school (P = .018), and family life (P < .001); SF-36 mental (P < .001) and physical (P = .026) component; and BPI pain interference (P < .001) scores. Treatment-by-subgroup interactions were not significant for sex (P = .320), age (P = .362), or race (P = .180).CONCLUSIONS: This pooled analysis provides evidence that 12 weeks of treatment with duloxetine 60-120 mg/d effectively improves fibromyalgia symptoms and may offer benefits beyond pain relief.