Argoff Charles E, Galer Bradley S, Jensen Mark P, Oleka Napoleon, Gammaitoni Arnold R
Cohn Pain Management Center, North Shore University Hospital/NYU School of Medicine, Bethpage, NY 11714, USA.
Curr Med Res Opin. 2004;20 Suppl 2:S21-8. doi: 10.1185/030079904X12960.
OBJECTIVE: To determine the impact of the lidocaine patch 5% on pain qualities associated with chronic pain from postherpetic neuralgia (PHN), painful diabetic neuropathy (DN), and low-back pain (LBP), using the Neuropathic Pain Scale (NPS). PATIENTS AND METHODS: Patients with PHN, painful DN, and LBP were enrolled if they had partial response to gabapentin-containing analgesic regimens and if they reported moderate-to-severe pain on the NPS at study enrollment. Eligible patients were included in an open-label, non-randomized, prospective, 2-week study across 7 clinical trial sites in the United States. The lidocaine patch 5% was applied to the area of maximal pain, using no more than a total of 4 patches changed every 24 h. Patients were maintained on their other analgesic regimens with no dose adjustment or additions allowed. Treatment effect was measured by change from baseline to Week 2 in 4 composite measures of the NPS: NPS-10, NPS-4, NPS-8, and NPS-non-allodynia. Safety was assessed by adverse events (AEs), dermal assessment of application site(s), and skin sensory testing. RESULTS: In the combined patient population (n = 77), 2 weeks of treatment with the lidocaine patch 5% significantly improved all 4 composite measures (p < 0.01). In the subgroup analyses, the lidocaine patch 5% demonstrated numerical advantage for all 4 NPS composite measures for the PHN patients (n = 8), and significantly improved all 4 composite measures for the painful DN patients (n = 41; p < 0.001) and LBP patients (n = 28; p < or = 0.005). Overall, 8 patients (10%) experienced mild-to-moderate treatment-related AEs. CONCLUSIONS: The lidocaine patch 5% effectively reduces the intensity of all common pain qualities in patients with moderate-to-severe chronic pain resulting from PHN, painful DN, or LBP. Treatment is well tolerated in combination with other analgesic regimens, with no reports of serious AEs or adverse drug interactions. Assessment scales such as the NPS may offer the possibility to differentiate between various pain states and to assess treatment outcomes for various pain qualities associated with a given pain state.
目的：使用神经病理性疼痛量表（NPS）确定5%利多卡因贴剂对带状疱疹后神经痛（PHN）、痛性糖尿病神经病变（DN）和腰痛（LBP）所致慢性疼痛相关疼痛性质的影响。 患者与方法：患有PHN、痛性DN和LBP的患者，若对含加巴喷丁的镇痛方案有部分反应，且在研究入组时NPS评分显示为中重度疼痛，则纳入研究。符合条件的患者参加在美国7个临床试验地点开展的一项开放标签、非随机、前瞻性、为期2周的研究。将5%利多卡因贴剂贴于疼痛最严重的部位，每24小时更换不超过4片。患者继续使用其他镇痛方案，不允许调整剂量或增加药物。治疗效果通过NPS的4项综合指标从基线到第2周的变化来衡量：NPS-10、NPS-4、NPS-8和NPS-非异常性疼痛。通过不良事件（AE）、贴剂应用部位的皮肤评估和皮肤感觉测试评估安全性。 结果：在合并患者群体（n = 77）中，5%利多卡因贴剂治疗2周显著改善了所有4项综合指标（p < 0.01）。在亚组分析中，5%利多卡因贴剂在PHN患者（n = 8）的所有4项NPS综合指标上显示出数值优势，在痛性DN患者（n = 41；p < 0.001）和LBP患者（n = 28；p ≤ 0.005）中显著改善了所有4项综合指标。总体而言，8例患者（10%）经历了轻度至中度的治疗相关AE。 结论：5%利多卡因贴剂可有效降低PHN、痛性DN或LBP所致中重度慢性疼痛患者的所有常见疼痛性质的强度。与其他镇痛方案联合使用时耐受性良好，未报告严重AE或药物不良相互作用。像NPS这样的评估量表可能有助于区分不同的疼痛状态，并评估与特定疼痛状态相关的各种疼痛性质的治疗结果。
Curr Med Res Opin. 2004
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