Watson C P, Babul N
Department of Medicine, University of Toronto, Ontario, Canada.
Neurology. 1998 Jun;50(6):1837-41. doi: 10.1212/wnl.50.6.1837.
Although opioid analgesics are used in the management of neuropathic pain syndromes, evidence of their efficacy remains to be established. We evaluated the clinical efficacy and safety of oxycodone in neuropathic pain using postherpetic neuralgia as a model.
Patients with postherpetic neuralgia of at least moderate intensity were randomized to controlled-release oxycodone 10 mg or placebo every 12 hours, each for 4 weeks, using a double-blind, crossover design. The dose was increased weekly up to a possible maximum of 30 mg every 12 hours. Pain intensity and pain relief were assessed daily, and steady (ongoing) pain, brief (paroxysmal) pain, skin pain (allodynia), and pain relief were recorded at weekly visits. Clinical effectiveness, disability, and treatment preference were also assessed.
Fifty patients were enrolled and 38 completed the study (16 men, 22 women, age 70+/-11 years, onset of postherpetic neuralgia 31+/-29 months, duration of pain 18+/-5 hours per day). The oxycodone dose during the final week was 45+/-17 mg per day. Compared with placebo, oxycodone resulted in pain relief (2.9+/-1.2 versus 1.8+/-1.1, p=0.0001) and reductions in steady pain (34+/-26 versus 55+/-27 mm, p=0.0001), allodynia (32+/-26 versus 50+/-30 mm, p=0.0004), and paroxysmal spontaneous pain (22+/-24 versus 42+/-32 mm, p=0.0001). Global effectiveness, disability, and masked patient preference all showed superior scores with oxycodone relative to placebo (1.8+/-1.1 versus 0.7+/-1.0, p=0.0001; 0.3+/-0.8 versus 0.7+/-1.0, p=0.041; 67% versus 11%, p=0.001, respectively).
Controlled-release oxycodone is an effective analgesic for the management of steady pain, paroxysmal spontaneous pain, and allodynia, which frequently characterize postherpetic neuralgia.
尽管阿片类镇痛药用于治疗神经性疼痛综合征，但其疗效仍有待证实。我们以带状疱疹后神经痛为模型，评估了羟考酮治疗神经性疼痛的临床疗效和安全性。
采用双盲、交叉设计，将至少中度疼痛的带状疱疹后神经痛患者随机分为两组，分别每12小时服用10mg控释羟考酮或安慰剂，各治疗4周。剂量每周增加，最大剂量可达每12小时30mg。每天评估疼痛强度和疼痛缓解情况，每周就诊时记录持续性（持续）疼痛、短暂性（阵发性）疼痛、皮肤疼痛（痛觉过敏）及疼痛缓解情况。还评估了临床疗效、功能障碍及治疗偏好。
共纳入50例患者，38例完成研究（男性16例，女性22例，年龄70±11岁，带状疱疹后神经痛发病时间31±29个月，每日疼痛持续时间18±5小时）。最后一周羟考酮剂量为每日45±17mg。与安慰剂相比，羟考酮可缓解疼痛（2.9±1.2对1.8±1.1，p = 0.0001），并减轻持续性疼痛（34±26对55±27mm，p = 0.0001）、痛觉过敏（32±26对50±30mm，p = 0.0004）及阵发性自发疼痛（22±24对42±32mm，p = 0.0001）。总体疗效、功能障碍及患者偏好评分显示，羟考酮相对于安慰剂均有显著优势（1.8±1.1对0.7±1.0，p = 0.0001；0.3±0.8对0.7±1.0，p = 0.041；分别为67%对11%，p = 0.001）。
控释羟考酮是治疗持续性疼痛、阵发性自发疼痛及痛觉过敏的有效镇痛药，这些症状常为带状疱疹后神经痛的特征。
