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Abstract：
BACKGROUND: In cancer-related pain refractory to systemic opioids, intrathecal (IT) administration of morphine can be a useful strategy. In clinical practice, IT morphine is usually combined with other drugs with different mechanisms of action, in order to obtain a synergistic analgesic effect. However, the discussion on efficacy and safety of IT combination therapy is still ongoing. The aim of this observational study was to report the effects of an IT combination of low doses of ziconotide, morphine, and levobupivacaine in end-stage cancer refractory pain.
METHODS: Sixty adult patients, 21 females and 39 males, were enrolled to an IT device implant. The mean visual analogue scale of pain intensity (VASPI) score was 88 ± 20 mm. All patients started with a triple combination therapy: the initial IT dose of morphine was calculated for each patient based on the equivalent daily dose of morphine; an oral/IT ratio of 400/1 was used. For ziconotide, a standard slow titration schedule was started at 1.2 μg/day and the initial dose of levobupivacaine was 3 mg/day.
RESULTS: The initial IT mean doses of morphine, ziconotide, and levobupivacaine were 0.8 ± 0.3 mg/day, 1.2 mcg/day and 3 mg/day, respectively. At day 2, a significant reduction in VASPI score was registered (49 ± 17, p < 0.001), and this significant reduction persisted at 56 days (mean VASPI score 44 ± 9, p < 0.001), with mean doses of morphine 2 ± 1 mg/day, ziconotide 2.8 ± 1 mcg/day, and levobupivacaine 3.8 ± 2 mg/day. Very few adverse effects (AEs) were observed. Patients\' satisfaction was very high during the entire study period.
CONCLUSIONS: Our results, within the limit of the study design, suggest that the IT combination of ziconotide, morphine, and levobupivacaine, at low doses, allows safe and rapid control of refractory cancer pain, with high levels of patient satisfaction.
METHODS: Sixty adult patients, 21 females and 39 males, were enrolled to an IT device implant. The mean visual analogue scale of pain intensity (VASPI) score was 88 ± 20 mm. All patients started with a triple combination therapy: the initial IT dose of morphine was calculated for each patient based on the equivalent daily dose of morphine; an oral/IT ratio of 400/1 was used. For ziconotide, a standard slow titration schedule was started at 1.2 μg/day and the initial dose of levobupivacaine was 3 mg/day.
RESULTS: The initial IT mean doses of morphine, ziconotide, and levobupivacaine were 0.8 ± 0.3 mg/day, 1.2 mcg/day and 3 mg/day, respectively. At day 2, a significant reduction in VASPI score was registered (49 ± 17, p < 0.001), and this significant reduction persisted at 56 days (mean VASPI score 44 ± 9, p < 0.001), with mean doses of morphine 2 ± 1 mg/day, ziconotide 2.8 ± 1 mcg/day, and levobupivacaine 3.8 ± 2 mg/day. Very few adverse effects (AEs) were observed. Patients\' satisfaction was very high during the entire study period.
CONCLUSIONS: Our results, within the limit of the study design, suggest that the IT combination of ziconotide, morphine, and levobupivacaine, at low doses, allows safe and rapid control of refractory cancer pain, with high levels of patient satisfaction.
摘要：
背景：在全身阿片类药物难治性癌症相关疼痛中，鞘内（IT）施用吗啡可以是一种有用的策略。在临床实践中,IT吗啡通常与其他具有不同作用机制的药物联合使用，以获得协同镇痛作用。然而,关于IT联合治疗的疗效和安全性的讨论仍在进行中.这项观察性研究的目的是报告低剂量齐科诺肽的IT组合的效果，吗啡,和左布比卡因在终末期癌症难治性疼痛中的应用。
方法：60名成年患者，21名女性和39名男性，参加了IT设备植入。平均疼痛强度视觉模拟评分（VASPI）评分为88±20mm。所有患者均从三联疗法开始：根据吗啡的等效日剂量为每位患者计算吗啡的初始IT剂量；使用400/1的口服/IT比率。对于ziconotide,开始采用标准的缓慢滴定方案,剂量为1.2μg/天,左旋布比卡因的初始剂量为3mg/天.
结果：吗啡的初始平均剂量，ziconotide,左布比卡因为0.8±0.3毫克/天，1.2微克/天和3毫克/天，分别。在第2天，VASPI评分显着降低（49±17，p<0.001），并且这种显着的降低持续到56天（平均VASPI评分44±9，p<0.001），吗啡的平均剂量为2±1毫克/天，ziconotide2.8±1mcg/天，和左布比卡因3.8±2毫克/天。观察到非常少的不良反应(AE)。在整个研究期间，患者的满意度非常高。
结论：我们的结果，在研究设计的范围内，建议齐科诺肽的IT组合，吗啡,和左旋布比卡因,在低剂量下，可以安全快速地控制难治性癌症疼痛，患者满意度高。
方法：60名成年患者，21名女性和39名男性，参加了IT设备植入。平均疼痛强度视觉模拟评分（VASPI）评分为88±20mm。所有患者均从三联疗法开始：根据吗啡的等效日剂量为每位患者计算吗啡的初始IT剂量；使用400/1的口服/IT比率。对于ziconotide,开始采用标准的缓慢滴定方案,剂量为1.2μg/天,左旋布比卡因的初始剂量为3mg/天.
结果：吗啡的初始平均剂量，ziconotide,左布比卡因为0.8±0.3毫克/天，1.2微克/天和3毫克/天，分别。在第2天，VASPI评分显着降低（49±17，p<0.001），并且这种显着的降低持续到56天（平均VASPI评分44±9，p<0.001），吗啡的平均剂量为2±1毫克/天，ziconotide2.8±1mcg/天，和左布比卡因3.8±2毫克/天。观察到非常少的不良反应(AE)。在整个研究期间，患者的满意度非常高。
结论：我们的结果，在研究设计的范围内，建议齐科诺肽的IT组合，吗啡,和左旋布比卡因,在低剂量下，可以安全快速地控制难治性癌症疼痛，患者满意度高。
