Thompson James C, Dunbar Elmer, Laye Rashonda R
Pain Control Network, Louisville, KY 40205, USA.
Pain Physician. 2006 Apr;9(2):147-52.
The U.S. Food and Drug Administration (FDA) recently approved Ziconotide intrathecal infusion for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of, or refractory to, other methods of treatment, including intrathecal morphine. Ziconotide is approved as a monotherapy, but there are challenges associated with the decision to wean intrathecal opioids for Ziconotide alone. Maintaining adequate analgesia and managing opioid withdrawal symptoms may be difficult. Additionally, a variety of adverse physiological, cognitive and psychiatric events may be associated with this new drug. Patients with pretreatment psychiatric disorders may be at increased risk for treatment complications.
To present a report of a case series describing treatment challenges and complications associated with the decision to convert established pump patients from intrathecal opioid therapy to Ziconotide monotherapy.
Three established pump patients, refractory to intrathecal opioid therapy, were converted to Ziconotide monotherapy. All of these patients experienced significant emotional distress or psychological symptoms that threatened the success of the treatment. Achieving adequate analgesia, reducing Ziconotide to mitigate adverse physiological effects, managing opioid withdrawal symptoms, and supportive psychological consultation were combined to achieve successful outcomes in two of our three patients.
This report describes challenges associated with the decision to convert established pump patients from intrathecal opioid therapy to Ziconotide monotherapy. Inadequate analgesia, adverse medication effects, and opioid withdrawal symptoms can precipitate a stressful situation that may be perceived as dangerous or threatening by patients who are predisposed to anxiety. Screening patients for psychiatric disorders, anxiety-proneness and/or vulnerability to stress should be considered to reduce the risk of treatment complications. A multimodal approach is strongly advocated, including rapid responses of treating physicians and nurses along with strong psychological support.
美国食品药品监督管理局（FDA）最近批准鞘内注射齐考诺肽用于治疗严重慢性疼痛，适用于有鞘内治疗指征、对包括鞘内注射吗啡在内的其他治疗方法不耐受或难治的患者。齐考诺肽被批准为单一疗法，但仅用齐考诺肽撤减鞘内阿片类药物的决策存在挑战。维持足够的镇痛效果和处理阿片类药物戒断症状可能很困难。此外，这种新药可能会引发各种不良的生理、认知和精神事件。有预处理精神疾病的患者治疗并发症风险可能增加。
报告一组病例，描述将已植入泵的患者从鞘内阿片类药物治疗转换为齐考诺肽单一疗法时所面临的治疗挑战和并发症。
三名已植入泵且对鞘内阿片类药物治疗无效的患者被转换为齐考诺肽单一疗法。所有这些患者都经历了严重的情绪困扰或心理症状，这威胁到治疗的成功。在我们的三名患者中，有两名通过联合实现足够的镇痛效果、减少齐考诺肽以减轻不良生理效应、处理阿片类药物戒断症状以及进行支持性心理咨询而取得了成功的治疗结果。
本报告描述了将已植入泵的患者从鞘内阿片类药物治疗转换为齐考诺肽单一疗法时所面临的挑战。镇痛不足、药物不良反应和阿片类药物戒断症状可能会引发一种压力状况，对于易焦虑的患者而言，这种状况可能被视为危险或具有威胁性。应考虑对患者进行精神疾病、易焦虑倾向和/或应激易感性筛查，以降低治疗并发症的风险。强烈提倡采用多模式方法，包括治疗医生和护士的快速反应以及强有力的心理支持。
