Randomized Double-Blind Trial of Pregabalin Versus Placebo in Conjunction With Palliative Radiotherapy for Cancer-Induced Bone Pain.
Randomized Double-Blind Trial of Pregabalin Versus Placebo in Conjunction With Palliative Radiotherapy for Cancer-Induced Bone Pain.
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DOI：
10.1200/jco.2015.63.8221
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发表时间：
2016-02-20
期刊：
影响因子：
--
通讯作者：
Laird BJ
中科院分区：
文献类型：
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作者：
Fallon M;Hoskin PJ;Colvin LA;Fleetwood-Walker SM;Adamson D;Byrne A;Murray GD;Laird BJ
癌症引起的骨痛 (CIBP) 影响三分之一的癌症患者。放射治疗仍然是金标准治疗方法；然而，实验室和临床工作表明普瑞巴林可能有助于治疗 CIBP。本研究的目的是检查接受放射治疗的 CIBP 患者中的普瑞巴林。进行了普瑞巴林与安慰剂的多中心、双盲随机试验。符合资格的患者年龄≥18岁，经放射学证实有骨转移，计划接受放射治疗，并且疼痛评分≥4分（满分10分）（按0到10的数字评分量表）。放疗前，完成基线评估，然后进行随机分配。普瑞巴林和安慰剂的剂量在 4 周内增加。主要终点是治疗反应，定义为与基线相比，第 4 周最严重疼痛减少 ≥ 2 分，同时阿片类药物剂量稳定或减少。次要终点评估平均疼痛、疼痛对活动的干扰、突发性疼痛、情绪、生活质量和不良事件。共有 233 名患者被随机分配：117 名接受安慰剂，116 名接受普瑞巴林。最常见的癌症是前列腺癌（n = 88；38%）、乳腺癌（n = 77；33%）和肺癌（n = 42；18%）。普瑞巴林组有 45 名患者 (38.8%) 达到主要终点，而安慰剂组有 47 名患者 (40.2%) 达到主要终点（调整后比值比，1.07；95% CI，0.63 至 1.81；P = 0.816）。双臂之间的平均疼痛、疼痛干扰或生活质量没有统计学上的显着差异。两组之间的情绪 (P = .031) 和爆发性疼痛持续时间 (P = .037) 存在差异。 4 周时比较结果。我们的研究结果不支持普瑞巴林在接受放疗的 CIBP 患者中的作用。普瑞巴林在具有临床神经性疼痛成分的 CIBP 中的作用尚不清楚。
Cancer-induced bone pain (CIBP) affects one third of patients with cancer. Radiotherapy remains the gold-standard treatment; however, laboratory and clinical work suggest that pregabalin may be useful in treating CIBP. The aim of this study was to examine pregabalin in patients with CIBP receiving radiotherapy. A multicenter, double-blind randomized trial of pregabalin versus placebo was conducted. Eligible patients were age ≥ 18 years, had radiologically proven bone metastases, were scheduled to receive radiotherapy, and had pain scores ≥ 4 of 10 (on 0-to-10 numeric rating scale). Before radiotherapy, baseline assessments were completed, followed by random assignment. Doses of pregabalin and placebo were increased over 4 weeks. The primary end point was treatment response, defined as a reduction of ≥ 2 points in worst pain by week 4, accompanied by a stable or reduced opioid dose, compared with baseline. Secondary end points assessed average pain, interference of pain with activity, breakthrough pain, mood, quality of life, and adverse events. A total of 233 patients were randomly assigned: 117 to placebo and 116 to pregabalin. The most common cancers were prostate (n = 88; 38%), breast (n = 77; 33%), and lung (n = 42; 18%). In the pregabalin arm, 45 patients (38.8%) achieved the primary end point, compared with 47 (40.2%) in the placebo arm (adjusted odds ratio, 1.07; 95% CI, 0.63 to 1.81; P = .816). There were no statistically significant differences in average pain, pain interference, or quality of life between arms. There were differences in mood (P = .031) and breakthrough pain duration (P = .037) between arms. Outcomes were compared at 4 weeks. Our findings do not support the role of pregabalin in patients with CIBP receiving radiotherapy. The role of pregabalin in CIBP with a clinical neuropathic pain component is unknown.