NGX-4010，一种 8%辣椒素贴剂，用于治疗与 HIV 相关的远端感觉性多发性神经病疼痛：两项 III 期、随机、对照临床试验的综合分析。
NGX-4010, a capsaicin 8% patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: integrated analysis of two phase III, randomized, controlled trials.
机构信息
AIDS Research Alliance, Los Angeles, CA, USA.
出版信息
AIDS Res Ther. 2013 Jan 28;10(1):5. doi: 10.1186/1742-6405-10-5.
BACKGROUND
HIV-associated distal sensory polyneuropathy (HIV-DSP) is the most frequently reported neurologic complication associated with HIV infection. NGX-4010 is a capsaicin 8% dermal patch with demonstrated efficacy in the treatment of HIV-DSP. Data from two phase III, double-blind studies were integrated to further analyze the efficacy and safety of NGX-4010 and explore the effect of demographic and baseline factors on NGX-4010 treatment in HIV-DSP.
METHODS
Data from two similarly designed studies in which patients with HIV-DSP received NGX-4010 or a low-concentration control patch (capsaicin 0.04% w/w) for 30 or 60 minutes were integrated. Efficacy assessments included the mean percent change from baseline in Numeric Pain Rating Scale (NPRS) scores to Weeks 2-12. Safety and tolerability assessments included adverse events (AEs) and pain during and after treatment.
RESULTS
Patients (n = 239) treated with NGX-4010 for 30 minutes demonstrated significantly (p = 0.0026) greater pain relief compared with controls (n = 100); the mean percent change in NPRS scores from baseline to Weeks 2-12 was -27.0% versus -15.7%, respectively. Patients who received a 60-minute application of NGX-4010 (n = 243) showed comparable pain reductions (-27.5%) to patients treated for 30 minutes, but this was not statistically superior to controls (n = 115). NGX-4010 was effective regardless of gender, baseline pain score, duration of HIV-DSP, or use of concomitant neuropathic pain medication, although NGX-4010 efficacy was greater in patients not receiving concomitant neuropathic pain medications. NGX-4010 was well tolerated; the most common AEs were application-site pain and erythema, and most AEs were mild to moderate. The transient increase in pain associated with NGX-4010 treatment decreased the day after treatment and returned to baseline by Day 2.
CONCLUSIONS
A single 30-minute application of NGX-4010 provides significant pain relief for at least 12 weeks in patients with HIV-DSP and is well tolerated.
TRIAL REGISTRATION
C107 = NCT00064623; C119 = NCT00321672.
背景
HIV 相关远端感觉性多发性神经病（HIV-DSP）是 HIV 感染相关的最常见神经系统并发症。NGX-4010 是一种 8%辣椒素贴剂，已被证实对 HIV-DSP 的治疗有效。对两项 III 期、双盲研究的数据进行整合，进一步分析了 NGX-4010 的疗效和安全性，并探讨了人口统计学和基线因素对 HIV-DSP 中 NGX-4010 治疗的影响。
方法
整合了两项设计相似的研究的数据，其中 HIV-DSP 患者接受 NGX-4010 或低浓度对照贴剂（辣椒素 0.04%w/w）治疗 30 或 60 分钟。疗效评估包括从基线到第 2-12 周的数字疼痛评分量表（NPRS）评分的平均百分比变化。安全性和耐受性评估包括不良事件（AE）和治疗期间及治疗后的疼痛。
结果
接受 NGX-4010 治疗 30 分钟的患者（n=239）与对照组（n=100）相比，疼痛缓解程度显著（p=0.0026）；从基线到第 2-12 周的 NPRS 评分平均百分比变化分别为-27.0%和-15.7%。接受 NGX-4010 60 分钟应用的患者（n=243）与接受 30 分钟治疗的患者疼痛减轻程度相当（-27.5%），但与对照组（n=115）相比，这并没有统计学上的优势。无论性别、基线疼痛评分、HIV-DSP 持续时间或是否使用伴随神经病理性疼痛药物，NGX-4010 均有效，尽管在未使用伴随神经病理性疼痛药物的患者中，NGX-4010 的疗效更大。NGX-4010 耐受性良好；最常见的 AE 是贴剂部位疼痛和红斑，大多数 AE 为轻度至中度。与 NGX-4010 治疗相关的疼痛短暂增加，在治疗后第 1 天减轻，第 2 天恢复到基线。
结论
单次 30 分钟应用 NGX-4010 可显著缓解 HIV-DSP 患者至少 12 周的疼痛，且耐受性良好。
试验注册
C107=NCT00064623；C119=NCT00321672。
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