Centro de Dor, Departamento de Neurologia, Faculdade de Medicina da Universidade de São Paulo, São Paulo/SP, Brazil.
Clinics (Sao Paulo). 2013 Jul;68(7):1057-60. doi: 10.6061/clinics/2013(07)25.
This research was designed as a pilot proof-of-concept study to evaluate the use of low-dose methadone in post-herpetic neuralgia patients who remained refractory after first and second line post-herpetic neuralgia treatments and had indications for adding an opioid agent to their current drug regimens.
This cross-over study was double blind and placebo controlled. Ten opioid naïve post-herpetic neuralgia patients received either methadone (5 mg bid) or placebo for three weeks, followed by a 15-day washout period and a second three-week treatment with either methadone or placebo, accordingly. Clinical evaluations were performed four times (before and after each three-week treatment period). The evaluations included the visual analogue scale, verbal category scale, daily activities scale, McGill pain questionnaire, adverse events profile, and evoked pain assessment. All patients provided written informed consent before being included in the study. ClinicalTrials.gov: NCT01752699 RESULTS: Methadone, when compared to placebo, did not significantly affect the intensity of spontaneous pain, as measured by the visual analogue scale. The intensity of spontaneous pain was significantly decreased after the methadone treatment compared to placebo on the category verbal scale (50% improved after the methadone treatment, none after the placebo, p=0.031). Evoked pain was reduced under methadone compared to placebo (50% improved after the methadone treatment, none after the placebo, p=0.031). Allodynia reduction correlated with sleep improvement (r=0.67, p=0.030) during the methadone treatment. The side effects profile was similar between both treatments.
Methadone seems to be safe and efficacious in post-herpetic neuralgia. It should be tried as an adjunctive treatment for post-herpetic neuralgia in larger prospective studies.
本研究旨在设计一项初步概念验证研究,以评估在一线和二线带状疱疹后神经痛治疗后仍未缓解且需要在现有药物治疗方案中添加阿片类药物的带状疱疹后神经痛患者中使用低剂量美沙酮的效果。
这是一项交叉双盲安慰剂对照研究。10 名阿片类药物初治的带状疱疹后神经痛患者分别接受美沙酮(5mg,每日两次)或安慰剂治疗 3 周,随后进行 15 天洗脱期,再分别接受美沙酮或安慰剂治疗 3 周。临床评估在 4 次(每次 3 周治疗前后)进行。评估包括视觉模拟评分、言语类别评分、日常活动评分、麦吉尔疼痛问卷、不良事件概况和诱发疼痛评估。所有患者在参与研究前均签署了书面知情同意书。ClinicalTrials.gov:NCT01752699
与安慰剂相比,美沙酮对视觉模拟评分测量的自发性疼痛强度没有显著影响。与安慰剂相比,美沙酮治疗后言语类别评分的自发性疼痛强度显著降低(美沙酮治疗后 50%改善,安慰剂治疗后无改善,p=0.031)。与安慰剂相比,美沙酮治疗后诱发疼痛减轻(美沙酮治疗后 50%改善,安慰剂治疗后无改善,p=0.031)。在美沙酮治疗期间,触诱发痛减轻与睡眠改善相关(r=0.67,p=0.030)。两种治疗的副作用谱相似。
美沙酮治疗带状疱疹后神经痛似乎安全有效。在更大的前瞻性研究中,应尝试将其作为带状疱疹后神经痛的辅助治疗方法。