NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study
NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study
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DOI：
10.1016/s1474-4422(08)70228-x
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发表时间：
2008-12-01
期刊：
影响因子：
48
通讯作者：
Tobias, Jeffrey
中科院分区：
文献类型：
--
作者：
Backonja, Miroslav;Wallace, Mark S.;Tobias, Jeffrey
背景目前带状疱疹后神经痛（PHN）治疗方法的局限性促使人们研究局部、非全身性的替代方案。NGX-4010是一种高浓度（8%）辣椒素皮肤贴剂，用于治疗神经性疼痛患者。我们报告了一项随机、双盲、为期12周的NGX-4010应用于PHN患者的疗效和安全性研究的结果。402名患者被随机分配到一个60分钟的NGX-4010应用（640 μ g/cm（2）[8%辣椒素]）或低浓度辣椒素对照贴剂（3-2 μ g/cm（2）[0.04%辣椒素]）。患者年龄在18-90岁之间，患有带状疱疹后神经痛至少6个月，平均基线疼痛数字评定量表（NPRS）评分为3 - 9。主要疗效终点是NPRS评分从基线到第2 - 8周的百分比变化。该试验注册于ClinicalTrials.gov，编号NCT 00115310。结果随机分配至NGX-4010组的患者（n=206）在第2至8周期间的疼痛减轻程度显著高于对照贴剂组（n=196）。NPRS评分的平均变化为-29.6% vs -19.9%（差异-9.7%，95%CI-15.47至-3.95; p=0.001）。87名（42%）接受NGX-4010的患者和63名（32%）对照具有平均NPRS评分的30%或更多降低（比值比[OR] 1.56，95%CI 1.03至2.37; p=0.03）。服用NGX-4010的患者在第2至12周期间疼痛有显著改善（NPRS评分的平均变化为-29.9%对-20.4%，差异为-9.5，-15.39至-3.61; p=0.002）。在治疗当天记录与疼痛水平变化相关的一过性血压变化，给药部位的短暂红斑和疼痛是常见的自限性，在NGX-4010组中通常为轻度至中度，而在对照组中不太频繁和严重。4010为带状疱疹后神经痛患者提供了快速和持续的疼痛缓解。除了局部反应和与治疗相关的疼痛外，没有与治疗相关的不良事件。
Background The limitations of current treatments for postherpetic neuralgia (PHN) have led to the investigation of localised, non-systemic alternatives. NGX-4010, a high-concentration (8%) capsaicin dermal patch, was developed to treat patients with neuropathic pain. We report the results of a randomised, double blind, 12-week study of the efficacy and safety of one application of NGX-4010 in patients with PHN.Methods In this multicentre, double-blind, parallel-group trial, 402 patients were randomly assigned to one 60-min application of NGX-4010 (640 mu g/cm(2) [8% capsaicin]) or a low-concentration capsaicin control patch (3-2 mu g/cm(2) [0.04% capsaicin]). Patients were aged 18-90 years, had had postherpetic neuralgia for at least 6 months, and had an average baseline numeric pain rating scale (NPRS) score of 3 to 9. The primary efficacy endpoint was percentage change in NPRS score from baseline to weeks two to eight. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00115310.Findings Patients who were randomly assigned to NGX-4010 (n=206) had a significantly greater reduction in pain during weeks two to eight than did patients who had the control patch (n=196). The mean changes in NPRS score were -29.6% vs -19.9% (difference -9.7%, 95% CI -15.47 to -3.95; p=0.001). 87 (42%) patients who received NGX-4010 and 63 (32%) controls had a 30% or greater reduction in mean NPRS score (odds ratio [OR] 1.56, 95% CI 1.03 to 2.37; p=0.03). The patients who had NGX-4010 had significant improvements in pain during weeks two to 12 (mean change in NPRS score -29.9% vs -20.4%, difference -9.5, -15.39 to -3.61; p=0.002). Transient blood pressure changes associated with changes in pain level were recorded on the day of treatment, and short-lasting erythema and pain at the site of application were common, self-limited, and generally mild to moderate in the NGX-4010 group and less frequent and severe in the controls.Interpretation One 60-min application of NGX-4010 provided rapid and sustained pain relief in patients with postherpetic neuralgia. No adverse events were associated with treatment except for local reactions at the site of application and those related to treatment-associated pain.Funding NeurogesX.