Sabatowski Rainer, Bösl Irmgard, König Simone, Buchheister Bettina, Meier Torsten, Baron Ralf
a Comprehensive Pain Center, University Hospital Carl Gustav Carus Dresden , Dresden , Germany.
b Grünenthal Global Innovations/Clinical Development , Aachen , Germany.
Curr Med Res Opin. 2017 Mar;33(3):595-603. doi: 10.1080/03007995.2016.1277990. Epub 2017 Jan 12.
To investigate short- and long-term effectiveness and safety of the 5% lidocaine medicated plaster in the treatment of postherpetic neuralgia (PHN) in elderly patients (≥70 years of age).
Data from three European clinical trials was compared after stratification according to age (<70 years and ≥70 years). Length of study phase investigated was 4 weeks for study 1, 8 weeks for study 2, and up to 12 months for study 3. Effectiveness outcome measures were pain intensity, pain relief, allodynia severity, Clinical Global Impression of Change, and Patient Global Impression of Change. Safety was assessed by adverse event documentation.
Mean average pain intensity improved in the elderly by -2.1 (SD 2.1) vs. -2.5 (SD 2.0) for <70 year old patients after 4 weeks, by -1.4 (SD 1.8) vs. -1.7 (SD 1.3) after 8 weeks, and by -1.5 (SD 1.9) vs. -2.7 (SD 2.2) after 12 months. Most patients presented with allodynia (>85% of elderly, >78% of younger patients) which was described by >51% as painful or extremely painful. Allodynia severity was markedly reduced in both groups during all three trials. Drug-related adverse events occurred in <20% of elderly and <15% of <70 year old patients and were mainly skin related.
The 5% lidocaine medicated plaster provided pain relief and marked reductions in allodynia severity in elderly PHN patients with an excellent safety profile under short- and long-term treatment supporting the addition of the plaster to the treatment armamentarium for this age group.
All analyzed study phases were open-label and lacking a placebo control group.
探讨5%利多卡因药用贴剂治疗老年患者（≥70岁）带状疱疹后神经痛（PHN）的短期和长期有效性及安全性。
根据年龄（<70岁和≥70岁）分层后，比较三项欧洲临床试验的数据。研究1的研究阶段时长为4周，研究2为8周，研究3最长为12个月。有效性指标包括疼痛强度、疼痛缓解情况、痛觉过敏严重程度、临床总体印象变化和患者总体印象变化。通过不良事件记录评估安全性。
4周后，老年患者平均疼痛强度改善值为-2.1（标准差2.1），<70岁患者为-2.5（标准差2.0）；8周后，分别为-1.4（标准差1.8）和-1.7（标准差1.3）；12个月后，分别为-1.5（标准差1.9）和-2.7（标准差2.2）。大多数患者存在痛觉过敏（老年患者>85%，年轻患者>78%），其中>51%的患者称疼痛或极其疼痛。在所有三项试验中，两组的痛觉过敏严重程度均显著降低。老年患者中<20%、<70岁患者中<15%发生与药物相关的不良事件，且主要与皮肤有关。
5%利多卡因药用贴剂可缓解老年PHN患者的疼痛，并显著降低痛觉过敏严重程度，在短期和长期治疗中安全性良好，支持将该贴剂纳入该年龄组的治疗手段。
所有分析的研究阶段均为开放标签，且缺乏安慰剂对照组。
