Katz Jennifer, Pennella-Vaughan Janet, Hetzel Roderick D, Kanazi Ghassan E, Dworkin Robert H
Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York 14642, USA.
J Pain. 2005 Oct;6(10):656-61. doi: 10.1016/j.jpain.2005.05.002.
Clinical trials of the efficacy of antidepressant drugs in patients with chronic low back pain have had mixed results, possibly because of the different mechanisms of action of the drugs that have been studied. Because bupropion has a mechanism of action that differs from other antidepressants and has shown efficacy in neuropathic pain, a randomized, placebo-controlled, 2-period crossover trial was conducted to evaluate its efficacy in subjects with chronic low back pain. The primary efficacy variable was mean daily diary pain intensity ratings, and secondary pain intensity and relief outcomes included weekly pain intensity ratings, the McGill Pain Questionnaire (MPQ) Present Pain Intensity scale, pain relief ratings, and satisfaction with pain relief ratings. Adverse events were also assessed throughout the trial. Analyses were performed of an intention-to-treat sample of 44 patients, only 3 of whom met criteria for neuropathic low back pain. Daily and weekly pain intensity ratings, the MPQ Present Pain Intensity scale, and pain relief ratings were not significantly different following treatment with bupropion sustained release (SR) vs. placebo. These results suggest that bupropion SR was not significantly better than placebo in the treatment of patients with non-neuropathic chronic low back pain.
Antidepressant medications that have both noradrenergic and serotonergic effects appear to have greater efficacy in patients with chronic low back pain than those with only serotonergic activity. We studied bupropion because it inhibits the reuptake of both norepinephrine and dopamine, but found no evidence of efficacy in patients with non-neuropathic chronic low back pain.
抗抑郁药物治疗慢性下腰痛患者疗效的临床试验结果不一,这可能是由于所研究药物的作用机制不同。由于安非他酮的作用机制与其他抗抑郁药不同,且已显示出对神经性疼痛有效,因此进行了一项随机、安慰剂对照、两阶段交叉试验,以评估其对慢性下腰痛患者的疗效。主要疗效变量为每日日记疼痛强度评分,次要疼痛强度和缓解结果包括每周疼痛强度评分、麦吉尔疼痛问卷(MPQ)当前疼痛强度量表、疼痛缓解评分以及对疼痛缓解评分的满意度。在整个试验过程中还评估了不良事件。对44例患者的意向性治疗样本进行了分析,其中只有3例符合神经性下腰痛标准。与安慰剂相比,使用安非他酮缓释片(SR)治疗后,每日和每周疼痛强度评分、MPQ当前疼痛强度量表以及疼痛缓解评分无显著差异。这些结果表明,在治疗非神经性慢性下腰痛患者时,安非他酮SR并不比安慰剂显著更有效。
具有去甲肾上腺素能和5-羟色胺能双重作用的抗抑郁药物,在慢性下腰痛患者中似乎比仅具有5-羟色胺能活性的药物疗效更佳。我们研究了安非他酮,因为它能抑制去甲肾上腺素和多巴胺的再摄取,但未发现其对非神经性慢性下腰痛患者有效的证据。