DEXTROMETHORPHAN FOR THE TREATMENT OF NEUROPATHIC PAIN - A DOUBLE-BLIND RANDOMIZED CONTROLLED CROSSOVER TRIAL WITH INTEGRAL N-OF-1 DESIGN
DEXTROMETHORPHAN FOR THE TREATMENT OF NEUROPATHIC PAIN - A DOUBLE-BLIND RANDOMIZED CONTROLLED CROSSOVER TRIAL WITH INTEGRAL N-OF-1 DESIGN
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DOI：
10.1016/0304-3959(94)90056-6
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发表时间：
1994-10-01
期刊：
影响因子：
7.4
通讯作者：
WIFFEN, PJ
中科院分区：
文献类型：
--
作者：
MCQUAY, HJ;CARROLL, D;WIFFEN, PJ
目的是比较口服右美沙芬（DM）与安慰剂对神经性疼痛患者的镇痛效果和不良反应发生率。第一个 10 天治疗期是每天 3 次 13.5 mg DM (t.d.s.) 与安慰剂 t.d.s. 的多剂量双盲随机对照交叉比较：5 个治疗对，每对 1 天 DM 和 1 天安慰剂。第二个 10 天治疗期使用 27 mg DM t.d.s。与安慰剂相比，具有相同的设计。该研究对 2 个剂量的 DM 中的每一个都采用了 5 对 n-of-1 设计。除了任何预先存在的镇痛方案外，患者还服用研究药物。研究后报告获益的患者可以继续接受糖尿病治疗。对 19 名患有慢性神经性疼痛的患者进行了两个为期 10 天的治疗期的研究。结果指标包括疼痛强度、疼痛缓解、不良反应、情绪、睡眠和治疗的总体评级。这些都是通过每日患者日记以及每个治疗期前后的临床评估来记录的。 DM 和安慰剂在任何临床评估结果指标上均无显着差异。两名患者在患者内部测试的一项以上结果测量中镇痛效果明显更好。 DM 镇痛效果更好。另一人使用安慰剂镇痛效果更好。 10 名患者对任一剂量的 DM 均未产生不良影响。两名患者在第一个治疗期间因不良反应（包括疼痛强度增加）退出，5 名患者在第二个治疗期间退出。研究后 1-3 个月，5 名患者继续患有 DM。对于那些继续接受开放性糖尿病的人来说，没有明显的长期临床获益。每日 40.5 或 81 毫克右美沙芬并不能缓解神经性疼痛。
The aim was to compare the analgesic effectiveness and adverse effect incidence of oral dextromethorphan (DM) with placebo in patients with neuropathic pain. The first 10-day treatment period was a multiple-dose double-blind randomised controlled cross-over comparison of 13.5 mg of DM 3 times a day (t.d.s.) with placebo t.d.s.: 5 treatment pairs, each pair 1 day DM and 1 day placebo. The second 10-day treatment period used 27 mg of DM t.d.s. vs, placebo, with the same design. The study incorporated a 5 pair n-of-1 design for each of the 2 doses of DM. Patients took the study medication in addition to any pre-existing analgesic regime. Patients who reported benefit could continue with DM after the study. Nineteen patients with chronic neuropathic pain were studied over two 10-day treatment periods. Outcome measures were pain intensity, pain relief, adverse effects, mood, sleep and global rating of treatment. These were recorded by daily patient diaries and by clinic assessments before and after each treatment period. There were no significant differences between DM and placebo on any of the clinic assessment outcome measures. Two patients had significantly better analgesia on more than one outcome measure on within-patient testing. One had better analgesia with DM. The other had better analgesia with placebo. Ten patients had no adverse effects on either dose of DM. Two patients withdrew during the first treatment period because of adverse effects (which included increased pain intensity), and 5 during the second period. Five patients continued with DM after the study for 1-3 months. No long-term clinical benefit was apparent in those who continued with open DM. Dextromethorphan at either 40.5 or 81 mg daily did not relieve neuropathic pain.