Shackelford Steve, Rauck Richard, Quessy Steve, Blum David, Hodge Rachel, Philipson Richard
GlaxoSmithKline, Research Triangle Park, North Carolina 27709, USA.
J Pain. 2009 Jun;10(6):654-60. doi: 10.1016/j.jpain.2009.01.328. Epub 2009 May 5.
In this randomized, double-blind, placebo-controlled study, we evaluated the efficacy and safety of GW406381, an investigational selective cyclooxygenase (COX)-2 inhibitor with both peripheral and central actions, in 209 patients with postherpetic neuralgia (PHN). Patients were randomly assigned to GW406381 25 mg or 50 mg or placebo treatments for 3 weeks. The primary efficacy outcome measure was the change in average daily pain intensity score from baseline to the last week of treatment. Both doses of GW406381 produced greater reduction in pain score than placebo, but the treatment difference did not reach statistical significance. It was possible that the 3-week duration was too short, as there was a tendency for increasing separation from placebo over time that did not appear to reach maximum effect by the end of the study for either GW406381 treatment group. Overall, GW406381 was well tolerated in this elderly population.
To our knowledge, this is the first report of a randomized, controlled clinical trial of a selective or nonselective COX inhibitor in neuropathic pain. The results of this study were inconclusive regarding the clinical relevance of the role of COX-2 in modulation of the symptoms of PHN.
在这项随机、双盲、安慰剂对照研究中，我们评估了GW406381（一种具有外周和中枢作用的研究性选择性环氧化酶（COX）-2抑制剂）对209例带状疱疹后神经痛（PHN）患者的疗效和安全性。患者被随机分配接受GW406381 25毫克或50毫克或安慰剂治疗3周。主要疗效指标是从基线到治疗最后一周的平均每日疼痛强度评分的变化。GW406381的两种剂量均比安慰剂使疼痛评分降低得更多，但治疗差异未达到统计学显著性。3周的疗程可能太短，因为随着时间的推移，与安慰剂的差距有增大的趋势，在研究结束时，GW406381两个治疗组似乎都未达到最大效果。总体而言，GW406381在该老年人群中耐受性良好。
据我们所知，这是关于选择性或非选择性COX抑制剂治疗神经性疼痛的随机对照临床试验的首份报告。这项研究的结果对于COX-2在调节PHN症状中的作用的临床相关性尚无定论。
