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[普瑞巴林(Prialt®)的去向:关于齐考诺肽治疗慢性疼痛的观察性研究]

[What became of Prialt®? : Observational study on the use of ziconotide in the treatment of chronic pain].

作者信息

Löschner Denise, Dries Rebecca, Kalff Rolf, Walter Jan, Reichart Rupert

机构信息

Klinik und Poliklinik für Neurochirurgie, Universitätsklinikum Jena, Am Klinikum 1, 07747, Jena, Deutschland.

出版信息

Schmerz. 2021 Oct;35(5):343-348. doi: 10.1007/s00482-021-00531-y. Epub 2021 Jan 28.

Abstract

BACKGROUND

Prialt® was approved by the European Medicine Agency in February 2005. Besides morphine, it is the only analgesic approved for long-term intrathecal infusion in the treatment of chronic pain. As it does not bind to opioid receptors, its use in the treatment of chronic pain seemed to be safer and to lead to less adverse events compared with morphine. However, it is an orphan drug and studies of its long-term use are rare.

QUESTIONS

What role does Prialt® play in the treatment of chronic pain compared with other analgesics given intrathecally? What impact do the initial dose and the rate of infusion have on the analgesic effect and on the incidence of side effects?

MATERIAL AND METHODS

Medical reports were used to identify all patients receiving ziconotide monotherapy from February 2005 to the end of the analysis period in October 2018 in our department. Furthermore, a questionnaire was created and given to the patients to find out more about their experience with ziconotide.

RESULTS

The study included 12 patients, all of whom suffered from at least one adverse event. The most common adverse events were forgetfulness and paraesthesia, each affecting 25% of the patients. One third of the patients discontinued ziconotide therapy due to severe adverse events. The mean initial dose was 1.98 µg/day.

DISCUSSION

Ziconotide was used at the Jena University Hospital according to the latest guidelines. Nevertheless, morphine and other opioid analgesics are still more frequently used in the intrathecal management of chronic pain. There are various reasons for this, but the narrow therapeutic index, the high incidence of adverse events, and the difficulties in finding the right dose are among the most important.

摘要

背景

普瑞巴林(Prialt®)于2005年2月获得欧洲药品管理局批准。除吗啡外,它是唯一被批准用于长期鞘内输注治疗慢性疼痛的镇痛药。由于它不与阿片受体结合,与吗啡相比,其在慢性疼痛治疗中的使用似乎更安全,不良事件更少。然而,它是一种孤儿药,关于其长期使用的研究很少。

问题

与其他鞘内注射的镇痛药相比,普瑞巴林(Prialt®)在慢性疼痛治疗中起什么作用?初始剂量和输注速率对镇痛效果和副作用发生率有何影响?

材料与方法

利用医疗报告确定2005年2月至2018年10月分析期结束时在我们科室接受齐考诺肽单药治疗的所有患者。此外,还设计了一份问卷并分发给患者,以了解他们使用齐考诺肽的更多经历。

结果

该研究纳入了12名患者,所有患者都至少发生了一次不良事件。最常见的不良事件是健忘和感觉异常,各影响25%的患者。三分之一的患者因严重不良事件而停止齐考诺肽治疗。平均初始剂量为1.98微克/天。

讨论

耶拿大学医院按照最新指南使用齐考诺肽。然而,吗啡和其他阿片类镇痛药在慢性疼痛的鞘内治疗中仍更常用。原因有多种,但治疗指数窄、不良事件发生率高以及难以找到合适剂量是其中最重要的原因。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4468/8452570/02edc8ee2ea9/482_2021_531_Fig1_HTML.jpg

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