White William T, Patel Nileshkumar, Drass Michael, Nalamachu Srinivas
Southern Drug Research, Birmingham, Alabama 35205, USA.
Pain Med. 2003 Dec;4(4):321-30. doi: 10.1111/j.1526-4637.2003.03045.x.
To assess the effectiveness and safety of the lidocaine patch 5%, a targeted peripheral analgesic, in the treatment of postherpetic neuralgia, painful diabetic neuropathy, and low back pain patients with incomplete responses to their current analgesic treatment regimen containing gabapentin.
This was a 2-week, open-label, nonrandomized, multicenter pilot trial in the clinical setting. Patients with postherpetic neuralgia, painful diabetic neuropathy, or low back pain with partial responses (average daily pain intensity >4/10) to their current analgesic treatment regimen were included. Treatment consisted of daily application of up to four lidocaine patches to areas of maximal peripheral pain. Effectiveness was evaluated using the Brief Pain Inventory (BPI). Safety was assessed by adverse events, physical and neurologic examinations, vital signs, and clinical laboratory tests.
Significant improvements in BPI measures of pain intensity and pain relief were reported for all groups of patients after 2 weeks of lidocaine patch 5% treatment. Significant improvements in BPI measures of pain interference with general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life were noted. The lidocaine patch 5% was found to be safe and well tolerated.
Results of this study highlight the potential advantages achieved with rational polypharmacy using a targeted peripheral analgesic, the lidocaine patch 5%, with centrally acting agents such as the anticonvulsant gabapentin. Controlled trials are warranted to further define the impact of such combination therapy.
评估5%利多卡因贴剂(一种靶向性外周镇痛药)治疗带状疱疹后神经痛、糖尿病性疼痛性神经病变以及对当前含加巴喷丁的镇痛治疗方案反应不完全的下腰痛患者的有效性和安全性。
这是一项在临床环境中进行的为期2周的开放标签、非随机、多中心试验。纳入对当前镇痛治疗方案有部分反应(平均每日疼痛强度>4/10)的带状疱疹后神经痛、糖尿病性疼痛性神经病变或下腰痛患者。治疗方法为每日在最大外周疼痛区域最多贴敷4片利多卡因贴剂。使用简明疼痛量表(BPI)评估有效性。通过不良事件、体格和神经学检查、生命体征以及临床实验室检查评估安全性。
5%利多卡因贴剂治疗2周后,所有患者组在BPI疼痛强度和疼痛缓解测量方面均有显著改善。在BPI对一般活动、情绪、行走能力、正常工作、与他人关系、睡眠和生活乐趣的疼痛干扰测量方面也有显著改善。发现5%利多卡因贴剂安全且耐受性良好。
本研究结果突出了联合使用靶向性外周镇痛药5%利多卡因贴剂与抗惊厥药加巴喷丁等中枢作用药物进行合理多药联合治疗所取得的潜在优势。有必要进行对照试验以进一步明确这种联合治疗的影响。