Instituto de Neurociencias, Universidad de Granada, Granada, Spain.
Clin Exp Rheumatol. 2009 Sep-Oct;27(5 Suppl 56):S16-20.
To assess the potential efficacy and tolerability of levopromazine(methotrimeprazine) in the treatment of fibromyalgia.
Unicentre, open-label study conducted in thirty-five outpatients, aged 18 years or older, who met the ACR criteria for fibromyalgia and had not satisfactorily responded to previous fibromyalgia treatment. Levopromazine, flexibly dosed (12.5-100 mg/d), was added to the outpatients' original treatment regimens for 12 weeks. The primary outcome measure was the mean change from baseline to endpoint in the Fibromyalgia Impact Questionnaire (FIQ) total score in the intent-to-treat sample. Secondary outcomes included the Clinical Global Impression (CGI) of Severity scale, Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory, State-Trait Anxiety Inventory, 12-Item Short Form Health Survey, and individual items of the FIQ.
The mean FIQ total score did not decrease significantly at the study endpoint (63.37 SD 11.32 vs. 61.19 SD 9.32, p=0.73). Pain intensity, as evaluated by the Visual Analogue Scale, remained unchanged at study endpoint (8.5 SD 1.6 vs. 8.2 SD 1.2, p=0.49). A statistically significant reduction was observed in the PSQI score (15.65 SD 3.33 vs. 12.23 SD 3.79, p<0.001, effect size: 1.03) and the CGI-severity score (4.71 SD 0.64 vs. 4.03 SD 1.01, p<0.002, effect size: 1.06). No significant or relevant changes were seen in the remaining fibromyalgia symptoms, psychopathological scales or quality-of-life. The drug was well tolerated.
Despite its efficacy in improving sleep quality, levopromazine does not appear to be a useful alternative treatment for fibromyalgia.
评估左美丙嗪（甲硫苯嗪）治疗纤维肌痛的潜在疗效和耐受性。
这是一项在 35 名门诊患者中开展的单中心、开放性研究，患者年龄 18 岁及以上，符合 ACR 纤维肌痛标准，且对先前的纤维肌痛治疗反应不佳。左美丙嗪剂量灵活（12.5-100mg/d），加入患者原有治疗方案，治疗 12 周。主要疗效指标为意向治疗样本中纤维肌痛影响问卷（FIQ）总分从基线到终点的平均变化。次要结局指标包括临床总体印象（CGI）严重程度量表、匹兹堡睡眠质量指数（PSQI）、贝克抑郁量表、状态-特质焦虑量表、12 项简明健康调查和 FIQ 的个别项目。
研究终点时 FIQ 总分无显著下降（63.37±11.32 比 61.19±9.32，p=0.73）。视觉模拟评分法评估的疼痛强度在研究终点时保持不变（8.5±1.6 比 8.2±1.2，p=0.49）。PSQI 评分（15.65±3.33 比 12.23±3.79，p<0.001，效应量：1.03）和 CGI 严重程度评分（4.71±0.64 比 4.03±1.01，p<0.002，效应量：1.06）有统计学显著降低。其余纤维肌痛症状、精神病理学量表或生活质量未见明显或相关变化。药物耐受性良好。
尽管左美丙嗪可有效改善睡眠质量，但似乎不是治疗纤维肌痛的有效替代疗法。
