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Intrathecal combination of ziconotide and morphine for refractory cancer pain: A rapidly acting and effective choice

机译:鞘内注射齐考诺肽和吗啡治疗难治性癌症疼痛:快速有效的选择

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Ziconotide is a nonopioid intrathecal analgesic drug used to manage moderate to severe chronic pain. The aim of this work is to assess the safety and efficacy of intrathecal (IT) combination of ziconotide and morphine in malignant pain refractory to high doses of oral opioids. Patients with malignant pain refractory to high oral opioids doses with a mean visual analogue scale of pain intensity (VASPI) score of ≥70 mm were enrolled. An IT combination therapy was administered: Ziconotide was started at a dose of 2.4 μg/day, followed by increases of 1.2 μg/day at intervals of at least 7 days, and an initial IT daily dose of morphine was calculated based on its oral daily dose. Percentage change in VASPI scores from baseline was calculated at 2 days, at 7 days, and weekly until the first 28 days. The mean percentage change of VASPI score from baseline was used for efficacy assessment. Safety was monitored based on adverse events and routine laboratory values. Twenty patients were enrolled, with a mean daily VASPI score at rest of 90 ± 7. All had a disseminated cancer with bone metastases involving the spine. The percentage changes in VASPI mean scores from baseline to 2 days, 7 days, and 28 days were 39 ± 13% (95% confidence interval [CI] = 13.61-64.49, P <.001), 51 ± 12% (95% CI = 27.56-74.56, P <.001), and 62 ± 13% (95% CI = 36.03-87.89%, P <.001), respectively. Four patients experienced mild adverse events related to the study drugs. In conclusion, an IT combination of low doses of ziconotide and morphine allows safe and rapid control of oral opioid-refractory malignant pain.
机译:Ziconotide是一种非阿片类鞘内镇痛药,用于治疗中度至重度慢性疼痛。这项工作的目的是评估ziconotide和吗啡鞘内(IT)组合在高剂量口服阿片类药物难以治疗的恶性疼痛中的安全性和有效性。入选了高剂量口服阿片类药物难以治疗的恶性疼痛且平均视觉模拟疼痛强度评分(VASPI)≥70 mm的患者。进行了IT联合疗法:Ziconotide以2.4μg/天的剂量开始,然后以至少7天的间隔增加1.2μg/天的剂量,并根据口服的吗啡每日IT初始剂量进行计算剂量。在第2天,第7天和每周至第28天,计算VASPI分数相对于基线的百分比变化。 VASPI评分相对于基线的平均百分比变化用于疗效评估。根据不良事件和常规实验室值监控安全性。入组20例患者,其余时间每日平均VASPI评分为90±7。所有患者均患有弥漫性癌症,并伴有脊柱骨转移。从基线到2天,7天和28天VASPI平均得分的变化百分比为39±13%(95%置信区间[CI] = 13.61-64.49,P <.001),51±12%(95%) CI = 27.56-74.56,P <.001)和62±13%(95%CI = 36.03-87.89%,P <.001)。四名患者经历了与研究药物有关的轻度不良事件。总之,低剂量齐考诺肽和吗啡的IT结合可以安全,快速地控制口服阿片类药物难治性恶性疼痛。

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