Lidocaine patch 5% and its positive impact on pain qualities in osteoarthritis: results of a pilot 2-week, open-label study using the Neuropathic Pain Scale
Lidocaine patch 5% and its positive impact on pain qualities in osteoarthritis: results of a pilot 2-week, open-label study using the Neuropathic Pain Scale
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DOI：
10.1185/030079904x12951
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发表时间：
2004-01-01
影响因子：
2.3
通讯作者：
Argoff, CE
中科院分区：
文献类型：
--
作者：
Gammaitoni, AR;Galer, BS;Argoff, CE
目的：通过使用神经病理性疼痛评定量表(NIPS)来确定5%利多卡因贴片对与骨关节炎(OA)相关的不同疼痛质量的影响。NIPS是一种评估各种疼痛质量(如尖锐和迟钝)的评估工具。患者和方法：患者参加了一项前瞻性、开放、非随机、平行分组、为期2周的研究，涉及美国的8个临床试验地点。符合条件的患者在研究登记时有单膝或双膝骨关节炎的放射证据，并报告NIP有中到重度疼痛(尽管PRN或稳定剂量的止痛药)。在进入研究之前，服用PRN止痛药的患者停止所有止痛方案，并接受5%利多卡因贴片作为单一治疗。那些服用稳定剂量止痛药的患者继续接受其他止痛方案，除了5%的利多卡因贴片作为附加治疗外，不允许添加或改变剂量。将5%利多卡因贴片涂抹在疼痛最大的区域，每24小时更换贴片不超过4次，通过NPS-10、NPS-4、NPS-8和NPS-NPS-非痛觉4种综合测量方法从基线到第2周的变化来衡量疗效。安全性通过不良事件(AES)、涂抹部位皮肤评估(S)和皮肤感觉测试进行评估。结果：在联合患者群体中，5%利多卡因贴片治疗2周后，4项NIPS综合指标均有显著改善(p<；0.001)。按分组进行的单独分析显示，单一治疗组(n=12；p<；0.001)和附加治疗组(n=88；p<；0.001)的所有4项综合指标均有显著改善。单一治疗组没有报告与治疗相关的不良反应。在附加治疗组中，5名患者经历了轻至中度治疗相关的不良反应。结论：在膝关节模式重度骨性关节炎患者中，使用5%利多卡因贴片治疗2周可显著降低所有4项NIPS综合测量的疼痛强度。我们的结果与之前报道的相同患者群体中疼痛和身体功能的改善是一致的，这是由西安大略省和麦克马斯特大学的OA指数衡量的。测量疼痛的各种性质似乎是评估治疗骨性关节炎疼痛的临床结果的有效方法。像NIPS这样的疼痛测量方法可以捕捉患者疼痛体验的多维特性，并可能为临床医生提供识别止痛治疗对与OA相关的各种疼痛质量的不同影响的可能性。
Objective: To determine the impact of the lidocaine patch 5% on distinct pain qualities associated with osteoarthritis (OA) through use of the Neuropathic Pain Scale (NIPS), an assessment tool designed to assess intensity of various pain qualities (i.e. sharp, dull).Patients and methods: Patients were enrolled in a prospective, open-label, non-randomized, parallel-group, 2-week study involving 8 clinical trial sites in the United States. Eligible patients had radiographic evidence of OA involving one or both knees and reported moderate-to-severe pain (despite prn or stable doses of analgesics) on the NIPS at study enrollment. Patients on prn analgesics were discontinued from all analgesic regimens prior to study entry and received lidocaine patch 5% as monotherapy. Those on stable doses of analgesics were continued on their other analgesic regimens with no additions or dose alterations allowed other than the lidocaine patch 5% as add-on therapy. 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. Effectiveness was measured by change from baseline to Week 2 in 4 composite measures of the NIPS: 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 = 100), 2 weeks of treatment with lidocaine patch 5% significantly improved all 4 NIPS composite measures (p < 0.001). Separate analyses by subgroups revealed significant improvements in all 4 composite measures for both the monotherapy group (n = 12; p < 0.01) and add-on therapy group (n = 88; p < 0.001). No treatment-related AEs were reported for the monotherapy group. In the add-on therapy group, 5 patients experienced mild-to-moderate treatment-related AEs.Conclusions: In patients with mode rate-to-severe OA of the knee, 2 weeks of treatment with the lidocaine patch 5% significantly reduces the intensity of pain qualities as measured by all 4 NIPS composite measures. Our results coincide with previously reported improvements in pain and physical function in the same patient population, as measured by the Western Ontario and McMaster Universities OA Index. Measuring the various qualities of pain appears to be a valid approach for assessing clinical outcomes in the treatment of OA pain. Pain measures such as the NIPS can capture the multi-dimensional properties of a patient's pain experience and may offer clinicians the possibility to identify differential effects of analgesic treatments on various pain qualities associated with OA.