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潜在的益处是否超过风险?齐考诺肽在临床实践中的应用更新。

Do the potential benefits outweigh the risks? An update on the use of ziconotide in clinical practice.

机构信息

Pain and Rehabilitation Centre, Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.

出版信息

Eur J Pain. 2018 Aug;22(7):1193-1202. doi: 10.1002/ejp.1229. Epub 2018 Apr 25.

Abstract

Ziconotide is a selective and potent blocker of N-type voltage-gated calcium channels. It was approved by the Food and Drug Administration in 2004 and by the European Medicines Agency in 2005 for the treatment of severe chronic pain in patients needing intrathecal analgesia (ITA). The aim of this paper is to provide a practitioner-oriented, educational, narrative, up-to-date review on the use of ziconotide in clinical pain medicine. Of special concern regarding safety is the partial incongruity between dosing statements in the Summary of Product Characteristics and novel low-dosage, slow uptitration recommendations. Even though ziconotide has obvious advantages compared to opioids, pain practitioners pondering the use of ziconotide nonetheless have to balance its proved potential analgesic effect against its neurological side effects, with special consideration being given to dosing and neuropsychiatric dangers. Using a seesaw analogy, the paper discusses what factors pain physicians should weigh in when considering ziconotide as ITA drug, the non-opioid advantages of ziconotide being counterbalanced by its potential psychiatric side effects. Ziconotide is an important part of the armamentarium of modern interventional pain medicine. If ITA is deemed necessary, ziconotide is a rational alternative, at least in chronic (neuropathic) non-cancer pain. However, in many European countries, ziconotide treatment is only available in a few (if any) centres. The safety profile of ziconotide is not fundamentally more worrying than that of opioids or cannabinoids; it is just different. This paper provides a concise, up-to-date and clinically-oriented summary of the use of ziconotide in clinical practice, not least concerning safety and dosage issues.

摘要

唑尼沙胺是一种选择性和强效的 N 型电压门控钙通道阻滞剂。它于 2004 年被美国食品和药物管理局(FDA)批准,于 2005 年被欧洲药品管理局(EMA)批准,用于治疗需要鞘内镇痛(ITA)的严重慢性疼痛患者。本文的目的是为临床疼痛医学的从业者提供一份教育性、叙述性的、最新的关于唑尼沙胺使用的综述。特别需要关注的是,产品特性摘要中的剂量说明与新型低剂量、缓慢递增建议之间存在部分不一致。尽管唑尼沙胺与阿片类药物相比具有明显的优势,但考虑使用唑尼沙胺的疼痛治疗师仍必须权衡其已证实的潜在镇痛效果与其神经副作用,特别要考虑剂量和神经精神危险。本文采用跷跷板类比的方法,讨论了疼痛医师在考虑将唑尼沙胺作为 ITA 药物时应考虑的因素,唑尼沙胺的非阿片类药物优势与其潜在的精神副作用相平衡。唑尼沙胺是现代介入性疼痛医学武器库的重要组成部分。如果认为 ITA 是必要的,那么唑尼沙胺是一种合理的替代方案,至少在慢性(神经性)非癌性疼痛中是如此。然而,在许多欧洲国家,唑尼沙胺的治疗仅在少数(如果有的话)中心提供。唑尼沙胺的安全性概况并不比阿片类药物或大麻素更令人担忧;只是不同而已。本文提供了一份关于唑尼沙胺在临床实践中使用的简明、最新和以临床为导向的综述,尤其是关于安全性和剂量问题。

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