Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial.
Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial.
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吸食药用大麻治疗艾滋病毒神经性疼痛：一项随机、交叉临床试验。
DOI：
10.1038/npp.2008.120
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发表时间：
2009-02
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影响因子：
--
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尽管使用阿片类药物和其他疼痛缓解疗法进行管理，但神经性疼痛继续降低艾滋病毒感染者的生活质量和日常功能。中枢和外周神经系统中的大麻素受体已被证明可以调节痛觉。我们进行了一项临床试验，以评估吸烟大麻对艾滋病毒神经病理性疼痛的影响。这是一项II期双盲、安慰剂对照、交叉试验，用于HIV相关的远端感觉神经显性多发性神经病(DSPN)患者的止痛。符合条件的受试者有神经病理性疼痛，对至少两个先前的止痛类药物无效；他们在整个试验过程中继续进行研究前的止痛方案。监管方面的考虑要求受试者在医院环境中直接观察吸烟。治疗为安慰剂和活性大麻，效力在1%至8%的Δ-9-四氢大麻酚之间，在2周的治疗期间，每天4次，连续5天，间隔2周。主要结果是从治疗前基线到每周治疗结束时疼痛强度的变化，由描述符差异量表(DDS)衡量。次要测量包括对情绪和日常功能的评估。在127名接受筛选的志愿者中，34名符合条件的受试者入选，28名完成了大麻和安慰剂治疗。在服用大麻的患者中，服用大麻的疼痛缓解效果优于安慰剂(DDS疼痛强度变化的中位数差异为3.3点，效应大小=0.6；p=0.016)。与安慰剂相比，服用大麻至少缓解30%疼痛的受试者比例分别为0.46(95%可信区间0.28，0.65)和0.18(0.03，0.32)。在两个治疗期间，情绪和日常功能都有类似程度的改善。虽然大多数副作用是轻微的和自限的，但有两名受试者经历了治疗限制的毒性。吸食大麻一般耐受性良好，在与HIV DSPN引起的内科顽固性疼痛患者的同时止痛治疗中添加大麻也是有效的。
Despite management with opioids and other pain modifying therapies, neuropathic pain continues to reduce the quality of life and daily functioning in HIV-infected individuals. Cannabinoid receptors in the central and peripheral nervous systems have been shown to modulate pain perception. We conducted a clinical trial to assess the impact of smoked cannabis on neuropathic pain in HIV. This was a phase II, double-blind, placebo-controlled, crossover trial of analgesia with smoked cannabis in HIV-associated distal sensory predominant polyneuropathy (DSPN). Eligible subjects had neuropathic pain refractory to at least two previous analgesic classes; they continued on their prestudy analgesic regimens throughout the trial. Regulatory considerations dictated that subjects smoke under direct observation in a hospital setting. Treatments were placebo and active cannabis ranging in potency between 1 and 8% Δ-9-tetrahydrocannabinol, four times daily for 5 consecutive days during each of 2 treatment weeks, separated by a 2-week washout. The primary outcome was change in pain intensity as measured by the Descriptor Differential Scale (DDS) from a pretreatment baseline to the end of each treatment week. Secondary measures included assessments of mood and daily functioning. Of 127 volunteers screened, 34 eligible subjects enrolled and 28 completed both cannabis and placebo treatments. Among the completers, pain relief was greater with cannabis than placebo (median difference in DDS pain intensity change, 3.3 points, effect size = 0.60; p = 0.016). The proportions of subjects achieving at least 30% pain relief with cannabis versus placebo were 0.46 (95%CI 0.28, 0.65) and 0.18 (0.03, 0.32). Mood and daily functioning improved to a similar extent during both treatment periods. Although most side effects were mild and self-limited, two subjects experienced treatment-limiting toxicities. Smoked cannabis was generally well tolerated and effective when added to concomitant analgesic therapy in patients with medically refractory pain due to HIV DSPN.
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