Ziconotide Trialing by Intrathecal Bolus Injections: An Open-Label Non-Randomized Clinical Trial in Postoperative/Posttraumatic Neuropathic Pain Patients Refractory to Conventional Treatment
Ziconotide Trialing by Intrathecal Bolus Injections: An Open-Label Non-Randomized Clinical Trial in Postoperative/Posttraumatic Neuropathic Pain Patients Refractory to Conventional Treatment
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DOI：
10.1111/ner.12293
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发表时间：
2015-07-01
期刊：
影响因子：
2.8
通讯作者：
Gerdle, Bjorn
中科院分区：
文献类型：
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作者：
Backryd, Emmanuel;Sorensen, Jan;Gerdle, Bjorn
目的：这个开放标签，非随机，临床试验的目的是评估的可行性，trialing ziconotide通过intrathecal bolus injections.Material and Methods：23例患者，谁有周围神经性疼痛难治性药物治疗和正在考虑脊髓电刺激，根据一个全面的算法，收到了三个ziconotide丸注射。首次注射2.5 g后，患者在算法中的进展取决于是否存在疼痛减轻和显著不良事件。一个病人被认为是一个“响应者”，如果经历疼痛减轻，并在两个连续场合在相同的dosage.Results：我们发现了一个低比例的响应者（13%）。然而，30%的患者在至少一次注射时经历了>= 30%的疼痛减轻，产生了类似于3例临床显著疼痛缓解所需的治疗数量。平均齐考诺肽剂量为2.75 μ g后，疼痛强度随时间（0- 6小时）发生显著变化（p = 0.047）。不良事件符合预期，未发生严重不良事件。我们没有发现脊髓刺激反应和ziconotide.Conclusions反应之间的任何统计学关联：Ziconotide推注试验似乎是可行的，但在本研究中的应答者的比例很低。不良事件符合预期，未发生严重不良事件。齐考诺肽推注试验的预测能力仍不清楚，齐考诺肽的药理学特征（由于高亲水性导致组织渗透缓慢）使推注试验的基本原理受到质疑。
Objectives: The aim of this open-label, non-randomized, clinical trial was to evaluate the feasibility of trialing ziconotide by intrathecal bolus injections.Material and Methods: Twenty-three patients, who had peripheral neuropathic pain refractory to pharmacological treatment and were under consideration for Spinal Cord Stimulation, received up to three ziconotide bolus injections according to a comprehensive algorithm. After a first injection of 2.5g, the patients progressed in the algorithm depending on the presence or absence of pain reduction and significant adverse events. A patient was considered a "responder" if experiencing pain reduction and no significant adverse event on two consecutive occasions at the same dosage.Results: We found a low proportion of responders (13%). However 30% of patients experienced >= 30% pain reduction on a least one injection, yielding a number needed to treat of similar to 3 for clinically significant pain relief. Pain intensity changed significantly over time (0-6h) (p = 0.047) after a mean ziconotide dose of 2.75 mu g. Adverse events were as expected, and no serious adverse event occurred. We did not find any statistical association between response to Spinal Cord Stimulation and response to ziconotide.Conclusions: Ziconotide bolus injection trialing seems feasible, but the proportion of responders in the present study was low. Adverse events were as expected, and no serious adverse event occurred. The predictive power of ziconotide bolus trialing remains unclear, and the pharmacological profile of ziconotide (slow tissue penetration due to high hydrophilicity) calls the rationale for bolus trialing into question.