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医用大麻和大麻类药物既有潜在疗效,也有潜在危害:丹麦医用大麻试点项目中基于自我评估和访谈评估结果的与对照组的横断面比较。

Medical cannabis and cannabis-based medicine show both potential efficacy and potential harms: Cross-sectional comparison with controls on self-rated and interviewer-rated outcomes within the Danish pilot program on medical cannabis.

机构信息

Copenhagen Research Center for Mental Health - CORE, Mental Health Center Copenhagen, Copenhagen University Hospital, Denmark; University of Copenhagen, Department of Psychology, Center for Phenomenological Psychology and Aesthetics, Denmark.

Copenhagen Research Center for Mental Health - CORE, Mental Health Center Copenhagen, Copenhagen University Hospital, Denmark.

出版信息

Complement Ther Clin Pract. 2021 Nov;45:101476. doi: 10.1016/j.ctcp.2021.101476. Epub 2021 Aug 20.

DOI:10.1016/j.ctcp.2021.101476
PMID:34425501
Abstract

BACKGROUND AND PURPOSE

Denmark launched a pilot program of medical cannabis in January 2018. The aim was to establish whether medical cannabis and cannabis-based medicine (MC/CBM) were superior and safe compared to conventional treatment, regardless of the indications for which people received such medication.

MATERIALS AND METHODS

People (cases) were identified who had redeemed at least one prescription of MC/CBM according to the nationwide, unselected Danish registers. These were propensity-score matched to controls with the same indications who had not used MC/CBM. Potential participants were contacted electronically, and if willing to participate filled in various survey instruments online. Participants were also interviewed in person in order to investigate symptoms of depression, anxiety, and to assess cognitive levels. Different sets of analyses were conducted, handling potential confounders in different ways.

RESULTS

In the primary analyses, cases were more satisfied with their treatment than were controls (mean (SD) 29.2 (4.8) versus 26.5 (4.5) on the CSQ, p = 0.006), and scored lower on depression (3.3 (3.0) versus 4.6 (2.9), p = 0.03). Cases reported higher levels of pain than controls when measured on the SF-36 bodily-pain subdomain (36.3 (23.0) versus 48.7 (30.1), p = 0.01). There were indications of worse symptoms of multiple sclerosis in cases compared to controls. Reported side-effects were generally mild.

CONCLUSION

Both potential effects and harms of MC/CBM were observed. Randomized trials are required to establish if these are true effects and harms, or due to confounding by indication.

摘要

背景与目的

丹麦于 2018 年 1 月启动了医用大麻试点计划。目的是确定医用大麻和大麻类药物(MC/CBM)是否优于常规治疗,并且无论人们接受这些药物的适应症如何,都应确保其安全。

材料与方法

根据全国范围内的非选择性丹麦登记册,确定了至少有一张 MC/CBM 处方的人(病例)。这些病例与未使用 MC/CBM 的具有相同适应症的对照组进行了倾向评分匹配。通过电子邮件联系潜在参与者,如果愿意参加,则在线填写各种调查问卷。还对参与者进行了面对面访谈,以调查抑郁和焦虑症状,并评估认知水平。通过不同的方式处理潜在的混杂因素,进行了不同的分析。

结果

在主要分析中,与对照组相比,病例对治疗的满意度更高(CSQ 的平均(SD)得分分别为 29.2(4.8)和 26.5(4.5),p=0.006),并且抑郁评分更低(分别为 3.3(3.0)和 4.6(2.9),p=0.03)。当使用 SF-36 身体疼痛子量表对病例进行测量时,他们报告的疼痛水平高于对照组(分别为 36.3(23.0)和 48.7(30.1),p=0.01)。与对照组相比,病例报告多发性硬化症的症状更为严重。报告的副作用通常是轻度的。

结论

观察到了 MC/CBM 的潜在作用和危害。需要进行随机试验以确定这些是否是真实的作用和危害,或者是否是由于适应症的混杂引起的。

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