Comprehensive Pain Center (USC), University Hospital Carl Gustav Carus, Dresden, Germany.
Curr Med Res Opin. 2012 Aug;28(8):1337-46. doi: 10.1185/03007995.2012.707977. Epub 2012 Jul 18.
Prospective evaluation of the long-term efficacy and safety of the 5% lidocaine medicated plaster in patients with post-herpetic neuralgia (PHN).
Patients with persisting pain for ≥3 months after acute herpes zoster and a baseline pain intensity of at least 4 on an 11-point numerical rating scale (NRS 0-10) were treated with 5% lidocaine medicated plasters for up to 5 years and monitored in regular intervals. Efficacy parameters are presented for the first 4 years and include patients' recall of pain relief (6-point verbal rating scale (VRS), clinical global impression of change (CGIC), patients' global impression of change PGIC), and the global evaluations of study medication. Safety parameters (clinical examination, skin evaluation, laboratory) and adverse events (AEs) were assessed at regular visits.
KF10004/02.
A total of 102 patients continuing from a 1 year main study period were included in an extension phase of up to 3 years. Ten patients (9.8%) dropped out due to lack of efficacy and 9 patients (8.8%) due to treatment-related AEs; 56 patients (54.9%) left the study for non-treatment-related reasons. Twenty-seven patients (26.4%) were still under treatment after a total treatment period of 4 years. On average, a pain relief of at least 4.3 (between moderate and a lot) was achieved throughout the study. At all visits the CGIC and the PGIC were much or very much improved in about 80% of patients. At the final visit, study medication was rated at least to be good by 91% of physicians and 89% of patients. Drug-related adverse events (DRAEs) were reported in 19 of 102 patients, mainly mild to moderate localized skin reactions. There were no hints for a reduced analgesic effect or an increase of DRAEs with long-term treatment.
This study demonstrates that long-term treatment of ≥12 months with the 5% lidocaine medicated plaster is effective and well tolerated in PHN patients. These findings support the recommendations to use the 5% lidocaine medicated plaster as baseline therapy for localized neuropathic pain after herpes zoster infection (PHN).
前瞻性评估 5%利多卡因贴剂治疗带状疱疹后神经痛（PHN）患者的长期疗效和安全性。
对急性带状疱疹后持续疼痛≥3 个月且基线疼痛强度至少为 11 点数字评分量表（NRS 0-10）上 4 的患者，使用 5%利多卡因贴剂治疗，最长可达 5 年，并定期监测。在第 4 年呈现疗效参数，包括患者对疼痛缓解的回忆（6 点口头评分量表（VRS）、临床总体印象变化（CGIC）、患者总体印象变化（PGIC）），以及对研究药物的总体评价。定期就诊时评估安全性参数（临床检查、皮肤评估、实验室）和不良事件（AE）。
KF10004/02。
共有 102 名患者从 1 年的主要研究期继续进入 3 年的扩展期。10 名患者（9.8%）因疗效不佳和 9 名患者（8.8%）因治疗相关 AE 退出；56 名患者（54.9%）因非治疗相关原因退出研究。27 名患者（26.4%）在 4 年的总治疗期后仍在接受治疗。平均而言，整个研究期间至少有 4.3 的疼痛缓解（中度至重度）。在所有就诊时，CGIC 和 PGIC 约有 80%的患者得到了很大或非常大的改善。在最后一次就诊时，91%的医生和 89%的患者认为研究药物至少是好的。102 名患者中有 19 名报告了与药物相关的不良事件（DRAE），主要是轻度至中度局部皮肤反应。没有迹象表明长期治疗会降低镇痛效果或增加 DRAE。
这项研究表明，5%利多卡因贴剂治疗≥12 个月对 PHN 患者有效且耐受良好。这些发现支持将 5%利多卡因贴剂作为带状疱疹感染后局部神经性疼痛（PHN）的基础治疗的建议。
