Effectiveness, tolerability, and impact on quality of life of the 5% lidocaine patch in diabetic polyneuropathy
Effectiveness, tolerability, and impact on quality of life of the 5% lidocaine patch in diabetic polyneuropathy
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DOI：
10.1001/archneur.61.6.914
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发表时间：
2004-06-01
影响因子：
--
通讯作者：
Dworkin, RH
中科院分区：
文献类型：
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作者：
Barbano, RL;Herrmann, DN;Dworkin, RH
背景：疼痛性糖尿病多发性神经病 (DPN) 的治疗往往不充分，并且经常受到药物全身不良反应的限制，因此需要对新疗法进行评估。目的：评估 5% 利多卡因贴剂治疗疼痛性糖尿病性多发性神经病的有效性、耐受性及其对生活质量的影响。设计：开放标签、灵活剂量、为期 3 周的研究，延长 5 周。地点：门诊诊所和临床研究中心患者：志愿者对 56 名临床定义的持续时间超过 3 个月的疼痛性糖尿病多发性神经病患者进行抽样。干预：5% 利多卡因贴片，每天最多 4 片，持续 18 小时。主要结果指标：平均每日疼痛日记评级从基线到第 3 周的变化。次要终点包括安全性、耐受性和生活质量的评估。结果：患有疼痛性糖尿病多发性神经病的患者在治疗期间显示出疼痛和生活质量结果指标的显着改善。 3周的治疗期。在接受额外 5 周治疗的亚组患者中，这些益处得以维持，在此期间允许逐渐减少伴随镇痛治疗。不良事件很少，并且没有发生利多卡因的全身蓄积。结论：对于疼痛性糖尿病多发性神经病患者来说，最多 4 个 5% 利多卡因贴剂持续 18 小时/天的耐受性良好，可显着改善疼痛和生活质量评级，并可能允许逐渐减少伴随的镇痛治疗。鉴于该试验的开放标签设计，有必要进行随机对照试验来证实这些结果。
Background: The treatment of painful diabetic polyneuropathy (DPN) is often inadequate and frequently limited by the systemic adverse effects of medications, necessitating the evaluation of novel treatments.Objective: To evaluate the effectiveness, tolerability, and impact on quality of life of the 5% lidocaine patch in painful diabetic polyneuropathy.Design: Open-label, flexible-dosing, 3-week study with a 5-week extension.Setting: Outpatient clinics and clinical research centersPatients: Volunteer sample of 56 patients with clinically defined painful diabetic polyneuropathy of longer than 3 months' duration.Intervention: The 5% lidocaine patch, with a maximum of 4 patches daily for 18 hours.Main Outcome Measures: Change in mean daily pain diary ratings from baseline to week 3. Secondary end points included assessments of safety, tolerability, and quality of life.Results: Patients with painful diabetic polyneuropathy showed significant improvements in pain and quality-of-life outcome measures during a 3-week treatment period. These benefits were maintained in a subgroup of patients treated for an additional 5 weeks, during which taper of concomitant analgesic therapy was permitted. Adverse events were minimal, and systemic accumulation of lidocaine did not occur.Conclusions: Up to four 5% lidocaine patches for up to 18 h/d are well tolerated in patients with painful diabetic polyneuropathy, significantly improve pain and quality-of-life ratings, and may allow tapering of concomitant analgesic therapy. Given the open-label design of this trial, a randomized controlled trial is necessary to confirm these results.