Department of Psychiatry and Behavioral Neuroscience, Women's Health Research Program, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Clin J Pain. 2012 Nov-Dec;28(9):775-81. doi: 10.1097/AJP.0b013e3182510295.
To evaluate the efficacy and safety of duloxetine 30 mg/d in adults with fibromyalgia.
This 12-week, randomized, double-blind, placebo-controlled study was conducted in the United States, Mexico, Argentina, and Israel and enrolled patients meeting the criteria for primary fibromyalgia as defined by the American College of Rheumatology. The primary endpoint was the average pain severity item from the Brief Pain Inventory (BPI)-Modified Short Form, assessed by an analysis of covariance model using change from baseline to the modified baseline-observation-carried-forward endpoint. Secondary endpoints included the Patient Global Impression of Improvement (PGI-I) score and the Fibromyalgia Impact Questionnaire (FIQ) total score and those measuring pain, depression, anxiety, health outcomes, and safety.
Patients (mean age, 51 y; 95% female; 87% White; 22% with major depressive disorder) received duloxetine 30 mg/d (N=155) or placebo (N=153). Duloxetine-treated patients did not have a statistically significant BPI-Modified Short Form average pain severity reduction versus placebo-treated patients (-2.04 vs. -1.70; P=0.202). There was a significant difference between duloxetine-treated and placebo-treated patients (P<0.05) for the PGI-I endpoint score (2.97 vs. 3.35) and the changes in FIQ total score (-14.62 vs. -9.75) and the Short-Form Health Survey (SF)-36 mental component score. Discontinuations due to adverse events did not differ significantly between treatment groups; nausea and dry mouth were the only adverse events with a significantly higher incidence with duloxetine versus placebo.
Duloxetine 30 mg/d did not significantly reduce pain severity in patients with fibromyalgia. However, duloxetine-treated patients reported global improvement in symptoms and function. Safety findings were consistent with the known duloxetine safety profile.
评估度洛西汀 30mg/d 治疗纤维肌痛成人患者的疗效和安全性。
这是一项在美国、墨西哥、阿根廷和以色列进行的为期 12 周、随机、双盲、安慰剂对照研究，纳入了符合美国风湿病学会定义的原发性纤维肌痛标准的患者。主要终点是使用协方差分析模型从基线到改良基线观察延续终点评估的简明疼痛量表（BPI）改良短表的平均疼痛严重程度项目。次要终点包括患者总体印象改善（PGI-I）评分和纤维肌痛影响问卷（FIQ）总分以及测量疼痛、抑郁、焦虑、健康结果和安全性的指标。
患者（平均年龄 51 岁；95%为女性；87%为白人；22%患有重度抑郁症）接受度洛西汀 30mg/d（n=155）或安慰剂（n=153）治疗。与安慰剂组相比，度洛西汀组患者的 BPI 改良短表平均疼痛严重程度无统计学显著降低（-2.04 对-1.70；P=0.202）。与安慰剂组相比，度洛西汀组患者的 PGI-I 终点评分（2.97 对 3.35）、FIQ 总分变化（-14.62 对-9.75）和健康调查简表（SF）-36 心理成分评分有显著差异（P<0.05）。因不良事件停药的患者在两组间无显著差异；与安慰剂相比，度洛西汀组仅恶心和口干的发生率显著更高。
度洛西汀 30mg/d 不能显著减轻纤维肌痛患者的疼痛严重程度。然而，度洛西汀治疗的患者报告症状和功能有整体改善。安全性发现与已知的度洛西汀安全性特征一致。
