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在欧洲,用于慢性疼痛管理和姑息/支持性治疗的基于大麻的药物的可及性和批准情况:对欧洲疼痛联合会各章节现状的调查。

Availability and approval of cannabis-based medicines for chronic pain management and palliative/supportive care in Europe: A survey of the status in the chapters of the European Pain Federation.

机构信息

Department of Anesthesiology, Intensive Care and Pain Treatment, University Medical Center Maribor, Slovenia.

Faculty of Medicine of University Maribor, Institute for Palliative Medicine and Care, Slovenia.

出版信息

Eur J Pain. 2018 Mar;22(3):440-454. doi: 10.1002/ejp.1147. Epub 2017 Nov 13.

DOI:10.1002/ejp.1147
PMID:29134767
Abstract

BACKGROUND

There is considerable public and political interest in the use of cannabis products for medical purposes.

METHODS

The task force of the European Pain Federation (EFIC) conducted a survey with its national chapters representatives on the status of approval of all types of cannabis-based medicines, the covering of costs and the availability of a position paper of a national medical association on the use of medical cannabis for chronic pain and for symptom control in palliative/supportive care.

RESULTS

Thirty-one out of 37 contacted councillors responded. Plant-derived tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray is approved for spasticity in multiple sclerosis refractory to conventional treatment in 21 EFIC chapters. Plant-derived THC (dronabinol) is approved for some palliative care conditions in four EFIC chapters. Synthetic THC analogue (nabilone) is approved for chemotherapy-associated nausea and vomiting refractory to conventional treatment in four EFIC chapters'. Eight EFIC chapters' countries have an exceptional and six chapters an expanded access programme for medical cannabis. German and Israeli pain societies recommend the use of cannabis-based medicines as third-line drug therapies for chronic pain within a multicomponent approach. Conversely, the German medical association and a team of finish experts and officials do not recommend the prescription of medical cannabis due to the lack of high-quality evidence of efficacy and the potential harms.

CONCLUSIONS

There are marked differences between the countries represented in EFIC in the approval and availability of cannabis-based products for medical use. EFIC countries are encouraged to collaborate with the European Medicines Agency to publish a common document on cannabis-based medicines.

SIGNIFICANCE

There are striking differences between European countries in the availability of plant-derived and synthetic cannabinoids and of medical cannabis for pain management and for symptom control in palliative care and in the covering of costs by health insurance companies or state social security systems.

摘要

背景

公众和政治对将大麻产品用于医疗目的有着浓厚的兴趣。

方法

欧洲疼痛联合会(EFIC)的特别工作组对其国家分会代表进行了一项调查,内容涉及各种基于大麻的药物的批准情况、费用覆盖情况以及国家医学协会关于使用医用大麻治疗慢性疼痛和姑息/支持性护理症状控制的立场文件的可用性。

结果

37 个联系到的委员中有 31 个做出了回应。植物源性四氢大麻酚/大麻二酚(THC/CBD)口腔喷雾剂已在 21 个 EFIC 分会批准用于多发性硬化症的痉挛,这些痉挛对常规治疗无反应。植物源性大麻酚(屈大麻酚)已在 4 个 EFIC 分会批准用于某些姑息治疗条件。合成大麻素类似物(纳布隆)已在 4 个 EFIC 分会批准用于化疗相关的恶心和呕吐,这些恶心和呕吐对常规治疗无反应。EFIC 8 个分会的国家有特殊和 6 个分会有扩大准入方案,用于医疗大麻。德国和以色列疼痛学会建议在多组分方法中,将大麻类药物作为慢性疼痛的三线药物治疗。相反,德国医学协会和一个芬兰专家和官员小组不建议开医用大麻处方,因为缺乏高质量的疗效证据和潜在危害。

结论

EFIC 代表的国家在批准和提供医用大麻类产品方面存在显著差异。鼓励 EFIC 国家与欧洲药品管理局合作,发表一份关于大麻类药物的共同文件。

意义

在植物源性和合成大麻素以及医用大麻的可用性方面,欧洲国家之间存在显著差异,这些差异涉及疼痛管理和姑息治疗中的症状控制以及医疗保险公司或国家社会保障系统的费用覆盖。

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