Baron Ralf, Mayoral Victor, Leijon Göran, Binder Andreas, Steigerwald Ilona, Serpell Michael
Division of Neurological Pain Research and Therapy, Department of Neurology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Curr Med Res Opin. 2009 Jul;25(7):1677-87. doi: 10.1185/03007990903048078.
Neuropathic pain is often difficult to treat due to a complex pathophysiology. This study evaluated the efficacy, tolerability and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin for neuropathic pain in patients with post-herpetic neuralgia (PHN) or painful diabetic polyneuropathy (DPN).
Patients completing 4-week monotherapy with 5% lidocaine medicated plaster or pregabalin were enrolled in an 8-week combination phase. Patients with adequate response to monotherapy (recalled average pain intensity of 4 or less on 11-point numeric rating scale in the previous 3 days [NRS-3 score]) continued their previous therapy, whereas those with insufficient response received combination therapy. Efficacy endpoints included change in NRS-3 from combination phase baseline, Patient and Clinical Global Impression of Change (PGIC/CGIC), and patient's satisfaction with treatment. Safety evaluation included adverse events (AEs), drug-related AEs (DRAEs), and withdrawal due to AEs.
EudraCT No. 2006-003132-29.
Of 229 patients in the per-protocol set (PPS: 68 PHN and 161 DPN), 71 received 5% lidocaine medicated plaster monotherapy, 57 had pregabalin added to 5% lidocaine medicated plaster, 57 pregabalin monotherapy and 44 received 5% lidocaine medicated plaster in addition to continued pregabalin treatment. There were no meaningful differences in demographic data between the treatment groups. Patients continuing on monotherapy demonstrated additional decreases in NRS-3 scores. Patients receiving combination therapy achieved clinically relevant reduction in NRS-3 values in addition to improvement achieved during the 4 weeks of monotherapy. Improvement was similar between the two combination therapy groups. Considerable improvements in patients' treatment satisfaction were reported. Incidences of AEs were in line with previous reports for the two treatments and combination therapy was generally well tolerated.
In patients with PHN and painful DPN failing to respond to monotherapy, combination therapy with 5% lidocaine medicated plaster and pregabalin provides additional clinically relevant pain relief and is safe and well-tolerated.
由于病理生理过程复杂，神经性疼痛往往难以治疗。本研究评估了5%利多卡因药用贴剂与普瑞巴林联合治疗带状疱疹后神经痛（PHN）或疼痛性糖尿病周围神经病变（DPN）患者神经性疼痛的疗效、耐受性和安全性。
完成4周5%利多卡因药用贴剂或普瑞巴林单药治疗的患者进入为期8周的联合治疗阶段。对单药治疗有充分反应的患者（在前3天11点数字评定量表上回忆的平均疼痛强度为4或更低 [NRS-3评分]）继续之前的治疗，而反应不足的患者接受联合治疗。疗效终点包括联合治疗阶段基线时NRS-3的变化、患者和临床总体变化印象（PGIC/CGIC）以及患者对治疗的满意度。安全性评估包括不良事件（AE）、药物相关不良事件（DRAE）以及因AE导致的停药。
EudraCT No. 2006-003132-29。
在意向性分析集（PPS：68例PHN和161例DPN）的229例患者中，71例接受5%利多卡因药用贴剂单药治疗，57例在5%利多卡因药用贴剂基础上加用普瑞巴林，57例接受普瑞巴林单药治疗，44例在继续普瑞巴林治疗的基础上再加用5%利多卡因药用贴剂。各治疗组之间的人口统计学数据无显著差异。继续接受单药治疗的患者NRS-3评分进一步降低。接受联合治疗的患者除了在单药治疗的4周内有所改善外，NRS-3值在临床上也有显著降低。两个联合治疗组的改善情况相似。据报告患者的治疗满意度有显著提高。AE的发生率与这两种治疗方法先前的报告一致，联合治疗总体耐受性良好。
对于单药治疗无效的PHN和疼痛性DPN患者，5%利多卡因药用贴剂与普瑞巴林联合治疗可提供额外的临床相关疼痛缓解，且安全、耐受性良好。
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