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对已批准用于慢性疼痛管理的鞘内注射镇痛药的安全性审查。

A safety review of approved intrathecal analgesics for chronic pain management.

作者信息

Chalil Alan, Staudt Michael D, Harland Tessa A, Leimer Elizabeth M, Bhullar Ravneet, Argoff Charles E

机构信息

Department of Clinical Neurological Sciences, London Health Sciences Centre, Western University, London, Ontario, Canada.

Department of Neurosurgery, Oakland University William Beaumont School of Medicine, Rochester, Michigan, USA.

出版信息

Expert Opin Drug Saf. 2021 Apr;20(4):439-451. doi: 10.1080/14740338.2021.1889513. Epub 2021 Mar 8.

DOI:10.1080/14740338.2021.1889513
PMID:33583318
Abstract

Intrathecal (IT) drug therapy is an effective treatment option for patients with chronic pain of malignant or nonmalignant origin, with an established safety profile and fewer adverse effects compared to oral or parenteral pain medications. Morphine (a μ-opioid receptor agonist) and ziconotide (a non-opioid calcium channel antagonist) are the only IT agents approved by the U.S. Food and Drug Administration for the treatment of chronic pain. Although both are considered first-line IT therapies, each drug has unique properties and considerations. This review will evaluate the pivotal trials that established the use of morphine and ziconotide as first-line IT therapy for patients with chronic pain, as well as safety and efficacy data generated from various retrospective and prospective studies. Morphine and ziconotide are effective IT therapies for patients with chronic malignant or nonmalignant pain that is refractory to other interventions. IT ziconotide is recommended as a first-line therapy due to its efficacy and avoidance of many adverse effects commonly associated with opioids. The use of IT morphine is also considered first-line; however, the risks of respiratory depression, withdrawal with drug discontinuation or pump malfunction, and the development of tolerance require careful patient selection and management.

摘要

鞘内(IT)药物治疗是恶性或非恶性来源慢性疼痛患者的一种有效治疗选择,与口服或胃肠外止痛药物相比,其安全性已确立且不良反应较少。吗啡(一种μ阿片受体激动剂)和齐考诺肽(一种非阿片类钙通道拮抗剂)是美国食品药品监督管理局批准用于治疗慢性疼痛的仅有的鞘内用药。虽然二者均被视为鞘内治疗的一线用药,但每种药物都有其独特的特性和注意事项。本综述将评估确立吗啡和齐考诺肽作为慢性疼痛患者一线鞘内治疗用药的关键试验,以及来自各种回顾性和前瞻性研究的安全性和疗效数据。吗啡和齐考诺肽是对其他干预措施无效的慢性恶性或非恶性疼痛患者的有效鞘内治疗方法。由于其疗效以及可避免许多与阿片类药物相关的不良反应,鞘内注射齐考诺肽被推荐作为一线治疗。鞘内注射吗啡的使用也被视为一线治疗;然而,呼吸抑制、停药或泵故障导致的戒断反应以及耐受性的产生等风险需要谨慎选择患者并进行管理。

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