Narang Sanjeet, Gibson Daniel, Wasan Ajay D, Ross Edgar L, Michna Edward, Nedeljkovic Srdjan S, Jamison Robert N
Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
J Pain. 2008 Mar;9(3):254-64. doi: 10.1016/j.jpain.2007.10.018. Epub 2007 Dec 21.
We assessed the efficacy of dronabinol (Marinol capsules; Solvay Pharmaceuticals, Brussels, Belgium), a synthetic Delta(9)-THC (tetrahydrocannabinol), in 30 patients taking opioids for chronic pain to determine its potential analgesic effects as an adjuvant treatment. Phase I of this 2-phase study was a randomized, single-dose, double-blinded, placebo-controlled, crossover trial in which subjects were randomly administered either 10 mg or 20 mg of dronabinol or identical placebo capsules over the course of three, 8-hour visits. Baseline self-report measures, hourly ratings of pain intensity, pain relief, pain bothersomeness, treatment satisfaction, mood, side effects, and blood serum levels were obtained. Phase II was an extended open-label titrated trial of dronabinol as add-on medication to patients on stable doses of opioids. Results of the Phase I study showed that patients who received dronabinol experienced decreased pain intensity and increased satisfaction compared with placebo. No differences in benefit were found between the 20 mg and 10 mg doses. In the Phase II trial, titrated dronabinol contributed to significant relief of pain, reduced pain bothersomeness, and increased satisfaction compared with baseline. The incidence of side effects was dose-related. Overall, the use of dronabinol was found to result in additional analgesia among patients taking opioids for chronic noncancer pain.
This study examines the effect of adding a cannabinoid to the regimen of patients with chronic pain who report significant pain despite taking stable doses of opioids. The results of our preliminary study suggest that dronabinol, a synthetic THC, may have an additive effect on pain relief.
我们评估了屈大麻酚（商品名Marinol胶囊；索尔维制药公司，比利时布鲁塞尔），一种合成的Δ⁹-四氢大麻酚（THC），对30名因慢性疼痛服用阿片类药物的患者的疗效，以确定其作为辅助治疗的潜在镇痛效果。这项两阶段研究的第一阶段是一项随机、单剂量、双盲、安慰剂对照的交叉试验，在三个8小时的访视过程中，受试者被随机给予10毫克或20毫克屈大麻酚或相同的安慰剂胶囊。获取了基线自我报告测量值、每小时疼痛强度评分、疼痛缓解情况、疼痛困扰程度、治疗满意度、情绪、副作用以及血清水平。第二阶段是一项屈大麻酚作为稳定剂量阿片类药物患者附加用药的开放标签滴定扩展试验。第一阶段研究结果表明，与安慰剂相比，接受屈大麻酚治疗的患者疼痛强度降低，满意度提高。20毫克和10毫克剂量之间在疗效上未发现差异。在第二阶段试验中，与基线相比，滴定的屈大麻酚显著缓解了疼痛，减轻了疼痛困扰，提高了满意度。副作用发生率与剂量相关。总体而言，发现屈大麻酚的使用在因慢性非癌性疼痛服用阿片类药物的患者中产生了额外的镇痛效果。
本研究考察了在尽管服用稳定剂量阿片类药物仍报告有显著疼痛的慢性疼痛患者治疗方案中添加一种大麻素的效果。我们初步研究的结果表明，合成THC屈大麻酚可能对疼痛缓解有相加作用。
