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药用大麻对慢性疼痛患者疼痛及生活质量的影响:一项前瞻性开放标签研究。

The Effect of Medicinal Cannabis on Pain and Quality-of-Life Outcomes in Chronic Pain: A Prospective Open-label Study.

作者信息

Haroutounian Simon, Ratz Yael, Ginosar Yehuda, Furmanov Karina, Saifi Fayez, Meidan Ronit, Davidson Elyad

机构信息

*Pain Relief Unit ‡Department of Anesthesia and Critical Care Medicine, Hadassah-Hebrew University Medical Center §Hadassah School of Dental Medicine, Hebrew University, Jerusalem, Israel †Department of Anesthesiology, Division of Clinical and Translational Research, Washington University School of Medicine, Saint Louis, MO.

出版信息

Clin J Pain. 2016 Dec;32(12):1036-1043. doi: 10.1097/AJP.0000000000000364.

Abstract

OBJECTIVES

The objective of this prospective, open-label study was to determine the long-term effect of medicinal cannabis treatment on pain and functional outcomes in participants with treatment-resistant chronic pain.

PATIENTS AND METHODS

The primary outcome was the change in the pain symptom score on the S-TOPS (Treatment Outcomes in Pain Survey-Short Form) questionnaire at the 6-month follow-up in an intent-to-treat population. Secondary outcomes included the change in S-TOPS physical, social, and emotional disability scales, the pain severity, and pain interference on the Brief Pain Inventory, sleep problems, and the change in opioid consumption.

RESULTS

A total of 274 participants were approved for treatment; complete baseline data were available for 206 (intent-to-treat), and complete follow-up data for 176 participants. At follow-up, the pain symptom score improved from median 83.3 (95% confidence interval [CI], 79.2-87.5) to 75.0 (95% CI, 70.8-79.2) (P<0.001). The pain severity score (7.50 [95% CI, 6.75-7.75] to 6.25 [95% CI, 5.75-6.75]) and the pain interference score (8.14 [95% CI, 7.28-8.43] to 6.71 [95% CI, 6.14-7.14]) improved (both P<0.001), together with most social and emotional disability scores. Opioid consumption at follow-up decreased by 44% (P<0.001). Serious adverse effects led to treatment discontinuation in 2 participants.

DISCUSSION

The treatment of chronic pain with medicinal cannabis in this open-label, prospective cohort resulted in improved pain and functional outcomes, and a significant reduction in opioid use. Results suggest long-term benefit of cannabis treatment in this group of patients, but the study's noncontrolled nature should be considered when extrapolating the results.

摘要

目的

这项前瞻性、开放标签研究的目的是确定药用大麻治疗对难治性慢性疼痛参与者的疼痛及功能结局的长期影响。

患者与方法

主要结局是在意向性治疗人群中,6个月随访时疼痛症状评分在S-TOPS(疼痛调查治疗结局-简表)问卷上的变化。次要结局包括S-TOPS身体、社会和情感残疾量表的变化、疼痛严重程度、简明疼痛量表上的疼痛干扰、睡眠问题以及阿片类药物消耗量的变化。

结果

共有274名参与者被批准接受治疗;206名(意向性治疗)有完整的基线数据,176名参与者有完整的随访数据。随访时,疼痛症状评分从中位数83.3(95%置信区间[CI],79.2 - 87.5)改善至75.0(95%CI,70.8 - 79.2)(P< <0.001)。疼痛严重程度评分(从7.50[95%CI,6.75 - 7.75]降至6.25[95%CI,5.75 - 6.75])和疼痛干扰评分(从8.14[95%CI,7.28 - 8.43]降至6.71[95%CI,6.14 - 7.14])均有所改善(均P< <0.001),大多数社会和情感残疾评分也有所改善。随访时阿片类药物消耗量减少了44%(P < <0.001)。严重不良反应导致2名参与者停止治疗。

讨论

在这项开放标签的前瞻性队列研究中,药用大麻治疗慢性疼痛使疼痛及功能结局得到改善,阿片类药物使用显著减少。结果表明大麻治疗对该组患者有长期益处,但在推断结果时应考虑该研究非对照的性质。

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