Argoff Charles E, Clair Andrew, Emir Birol, Whalen Ed, Ortiz Marie, Pauer Lynne
*Albany Medical Center, Albany †Pfizer Inc, New York, NY ‡Pfizer Inc, Groton, CT.
Clin J Pain. 2016 Jul;32(7):555-61. doi: 10.1097/AJP.0000000000000232.
Fibromyalgia (FM) is a chronic pain disorder for which pregabalin is an approved treatment in the United States. Although opioids are not a recommended treatment option, they continue to be used by many FM patients. The impact of patients' prior opioid use on their subsequent response to pregabalin has not been assessed.
This was a pooled analysis of 4 clinical trials to assess the efficacy of pregabalin in FM patients both with and without prior opioid use. Patients were divided into those using opioids prior to the trial and those who were not. The change in least squares mean pain score (assessed by 0 to 10 numeric rating scale) with pregabalin compared with placebo was assessed together with FM symptoms, anxiety, and depression.
There were 2062 patients in the analysis set, including 371 patients with prior opioid use. Equal numbers of patients were treated with placebo, pregabalin 300 mg/d, and pregabalin 450 mg/d. Pregabalin significantly improved the least squares mean (95% confidence interval) difference in pain score compared with placebo in patients both with and without prior opioid use 0.87 (0.34-1.41) and 0.41 (0.17-0.65), respectively, at 300 mg/d and 0.91 (0.39-1.44) and 0.72 (0.48-0.96) at 450 mg/d (P≤0.001 for all). FM symptoms, anxiety, and depression were also improved with pregabalin compared with placebo, regardless of prior opioid use.
FM patients respond to treatment with pregabalin with significant improvements in pain scores irrespective of prior opioid use. These data could inform treatment decisions for FM patients with prior use of opioids.
纤维肌痛（FM）是一种慢性疼痛疾病，在美国普瑞巴林是其获批的治疗药物。尽管阿片类药物并非推荐的治疗选择，但仍有许多FM患者在使用。患者先前使用阿片类药物对其随后使用普瑞巴林的反应的影响尚未得到评估。
这是一项对4项临床试验的汇总分析，以评估普瑞巴林在有或无先前阿片类药物使用史的FM患者中的疗效。患者被分为试验前使用阿片类药物的患者和未使用的患者。将普瑞巴林与安慰剂相比，最小二乘均值疼痛评分（通过0至10数字评分量表评估）的变化与FM症状、焦虑和抑郁情况一起进行评估。
分析集中有2062例患者，包括371例有先前阿片类药物使用史的患者。接受安慰剂、300mg/d普瑞巴林和450mg/d普瑞巴林治疗的患者数量相等。在有和无先前阿片类药物使用史的患者中，普瑞巴林与安慰剂相比，均显著改善了疼痛评分的最小二乘均值（95%置信区间）差异，300mg/d时分别为0.87（0.34 - 1.41）和0.41（0.17 - 0.65），450mg/d时分别为0.91（0.39 - 1.44）和0.72（0.48 - 0.96）（所有P≤0.001）。与安慰剂相比，无论先前是否使用阿片类药物，普瑞巴林均改善了FM症状、焦虑和抑郁。
FM患者对普瑞巴林治疗有反应，无论先前是否使用阿片类药物，疼痛评分均有显著改善。这些数据可为先前使用过阿片类药物的FM患者的治疗决策提供参考。
