Hans Guy, Sabatowski Rainer, Binder Andreas, Boesl Irmgard, Rogers Peter, Baron Ralf
Multidisciplinary Pain Center (PCT), Antwerp University Hospital (UZA), Edegem, Belgium.
Curr Med Res Opin. 2009 May;25(5):1295-305. doi: 10.1185/03007990902901368.
Evaluation of long-term efficacy and safety of the 5% lidocaine medicated plaster for neuropathic pain symptoms in patients with post-herpetic neuralgia (PHN).
Design - a 12-month, open-label, phase III study with an open-label extension conducted at 34 outpatient clinics in 12 European countries. Patients - aged >or=50 years, newly recruited (average pain intensity >or=4) or pre-treated with the 5% lidocaine medicated plaster in a previous study. Interventions - application of up to three 5% lidocaine medicated plasters dependent upon size of the painful area for up to 12 hours per day. Outcome measures - efficacy measures included patients' recall of pain relief and pain intensity in the previous week. Adverse events (AEs) were also reported.
249 patients participated in the 12-month study, 247 were analysed (full analysis set, FAS). Newly recruited patients had a mean average pain intensity (11-point numerical rating scale [NRS]) of 5.9 +/- 1.4 at baseline, which decreased to 3.9 +/- 1.6 at week 12 and remained stable at 3.9 +/- 2.3 until the end of the 12-month study. In pre-treated patients, pain intensity decreased further from baseline (3.9 +/- 1.9) to study end (3.4 +/- 2.0). Pain relief values were consistent with pain intensity reductions and were sustained in patients continuing treatment in the extension phase (mainly >or=24 months treatment in total). The most common AEs tended to be infections such as bronchitis and nasopharyngitis. Forty-eight drug-related adverse events (DRAEs), mainly mild to moderate localised skin reactions, occurred in 31 (12.4%) patients in the first 12 months. The profile of DRAEs was similar in the extension phase.
This study suggests that long-term treatment with the 5% lidocaine medicated plaster may provide substantial and maintained reductions in pain intensity, and that it is continuously well tolerated in patients suffering from peripheral neuropathic pain associated with previous herpes zoster infection. These findings support the use of the 5% lidocaine medicated plaster as one of the first-line therapies in this population.
评估5%利多卡因药用贴剂治疗带状疱疹后神经痛（PHN）患者神经性疼痛症状的长期疗效和安全性。
设计——一项为期12个月的开放标签III期研究，并在12个欧洲国家的34个门诊诊所进行了开放标签扩展研究。患者——年龄≥50岁，新招募患者（平均疼痛强度≥4）或在先前研究中接受过5%利多卡因药用贴剂预处理的患者。干预措施——根据疼痛区域大小，每天最多使用3片5%利多卡因药用贴剂，每次使用长达12小时。观察指标——疗效指标包括患者回忆前一周的疼痛缓解情况和疼痛强度。还报告了不良事件（AE）。
249例患者参与了为期12个月的研究，其中247例进行了分析（全分析集，FAS）。新招募患者在基线时的平均疼痛强度（11点数字评定量表[NRS]）为5.9±1.4，在第12周时降至3.9±1.6，并在12个月研究结束时保持稳定，为3.9±2.3。在预处理患者中，疼痛强度从基线（3.9±1.9）进一步降至研究结束时（3.4±2.0）。疼痛缓解值与疼痛强度降低情况一致，并且在延长阶段继续治疗的患者中得以维持（总共主要为治疗≥24个月）。最常见的不良事件往往是感染，如支气管炎和鼻咽炎。在最初的12个月中，31例（12.4%）患者发生了48例与药物相关的不良事件（DRAE），主要为轻度至中度局部皮肤反应。在延长阶段，DRAE的情况相似。
本研究表明，长期使用5%利多卡因药用贴剂可能会使疼痛强度大幅降低并维持，并且对于患有与先前带状疱疹感染相关的周围神经性疼痛的患者，其耐受性持续良好。这些发现支持将5%利多卡因药用贴剂用作该人群的一线治疗方法之一。
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