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慢性神经性疼痛患者吸食大麻:一项随机对照试验。

Smoked cannabis for chronic neuropathic pain: a randomized controlled trial.

机构信息

Department of Anesthesia, McGill University, Montréal, Que.

出版信息

CMAJ. 2010 Oct 5;182(14):E694-701. doi: 10.1503/cmaj.091414. Epub 2010 Aug 30.

Abstract

BACKGROUND

Chronic neuropathic pain affects 1%-2% of the adult population and is often refractory to standard pharmacologic treatment. Patients with chronic pain have reported using smoked cannabis to relieve pain, improve sleep and improve mood.

METHODS

Adults with post-traumatic or postsurgical neuropathic pain were randomly assigned to receive cannabis at four potencies (0%, 2.5%, 6% and 9.4% tetrahydrocannabinol) over four 14-day periods in a crossover trial. Participants inhaled a single 25-mg dose through a pipe three times daily for the first five days in each cycle, followed by a nine-day washout period. Daily average pain intensity was measured using an 11-point numeric rating scale. We recorded effects on mood, sleep and quality of life, as well as adverse events.

RESULTS

We recruited 23 participants (mean age 45.4 [standard deviation 12.3] years, 12 women [52%]), of whom 21 completed the trial. The average daily pain intensity, measured on the 11-point numeric rating scale, was lower on the prespecified primary contrast of 9.4% v. 0% tetrahydrocannabinol (5.4 v. 6.1, respectively; difference = 0.7, 95% confidence interval [CI] 0.02-1.4). Preparations with intermediate potency yielded intermediate but nonsignificant degrees of relief. Participants receiving 9.4% tetrahydrocannabinol reported improved ability to fall asleep (easier, p = 0.001; faster, p < 0.001; more drowsy, p = 0.003) and improved quality of sleep (less wakefulness, p = 0.01) relative to 0% tetrahydrocannabinol. We found no differences in mood or quality of life. The most common drug-related adverse events during the period when participants received 9.4% tetrahydrocannabinol were headache, dry eyes, burning sensation in areas of neuropathic pain, dizziness, numbness and cough.

CONCLUSION

A single inhalation of 25 mg of 9.4% tetrahydrocannabinol herbal cannabis three times daily for five days reduced the intensity of pain, improved sleep and was well tolerated. Further long-term safety and efficacy studies are indicated. (International Standard Randomised Controlled Trial Register no. ISRCTN68314063).

摘要

背景

慢性神经性疼痛影响 1%-2%的成年人口,且常对标准药物治疗产生抗药性。患有慢性疼痛的患者报告称,使用吸食大麻来缓解疼痛、改善睡眠和改善情绪。

方法

在一项交叉试验中,患有创伤后或手术后神经性疼痛的成年人被随机分配在四个 14 天的周期内接受四种效力的大麻(0%、2.5%、6%和 9.4%四氢大麻酚)。参与者在每个周期的前五天内每天通过烟斗吸入三次 25 毫克的剂量,每次间隔 11 点数字评分量表来测量每日平均疼痛强度。我们记录了对情绪、睡眠和生活质量的影响,以及不良事件。

结果

我们招募了 23 名参与者(平均年龄 45.4[标准差 12.3]岁,12 名女性[52%]),其中 21 名完成了试验。在预设的主要对比中,9.4%四氢大麻酚的平均每日疼痛强度(分别为 5.4 和 6.1;差值为 0.7,95%置信区间 [CI] 0.02-1.4)低于 0%四氢大麻酚。效力中等的制剂产生了中等但无显著差异的缓解程度。接受 9.4%四氢大麻酚的参与者报告说入睡能力提高(更容易入睡,p=0.001;入睡更快,p<0.001;更昏昏欲睡,p=0.003)和睡眠质量提高(醒来的次数更少,p=0.01)与 0%四氢大麻酚相比。我们发现情绪或生活质量没有差异。参与者接受 9.4%四氢大麻酚期间最常见的药物相关不良事件是头痛、眼睛干涩、神经性疼痛区域烧灼感、头晕、麻木和咳嗽。

结论

每天三次吸入 25 毫克 9.4%四氢大麻酚草药大麻,连续五天,可减轻疼痛强度,改善睡眠,且耐受性良好。需要进一步进行长期的安全性和疗效研究。(国际标准随机对照试验注册编号 ISRCTN68314063)。

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