Italian registry on long-term intrathecal ziconotide treatment.

Italian registry on long-term intrathecal ziconotide treatment.
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意大利长期鞘内注射齐考诺肽治疗登记。

DOI：
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发表时间：
2011
期刊：
Pain Physician
影响因子：
3.7
通讯作者：
C. Bonezzi
C. Bonezzi
中科院分区：
医学2区
文献类型：
--
作者：
W. Raffaeli;D. Sarti;L. Demartini;Alberto Sotgiu;C. Bonezzi

文献摘要

被引文献

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背景 齐考诺肽常用于慢性疼痛的鞘内（IT）治疗，最近已被指定为一线IT药物。它也是非常有用的病人不耐受或难治性的常见IT药物（如吗啡）。文献，不包括注册研究，大多数包括小样本，并且仅提供了关于齐考诺肽长期风险和获益的不完整证据。 目的 在意大利疼痛中心收集长期齐考诺肽IT输注的安全性和有效性数据。 研究设计 意大利齐考诺肽使用的回顾性队列研究。该研究由ISAL基金会（藻类科学研究和培训所）设计和协调。来自几个疼痛治疗和神经外科单位的接受齐考诺肽治疗的患者被纳入本研究，从而创建了第一个意大利齐考诺肽登记处。 设置 17个意大利公立和私立疼痛和神经外科中心。 方法 患有癌症或非癌症顽固性慢性疼痛的患者，已接受齐考诺肽IT输注治疗至少1个月。考虑疼痛强度视觉模拟量表相对于基线观察值的变化，分析疗效。通过监测不良事件的数量和强度来评估安全性。 结果 目前，意大利齐考诺肽登记研究纳入了104例患者。齐考诺肽作为IT药物的首选给药55例患者。72名患者报告疼痛强度降低至少30%，平均剂量为4.36 ug/d。在一组45名患者中观察到齐考诺肽IT治疗的持续镇痛效果（P < 0.001），这些患者在研究中保持6个月以上，没有治疗中断，剂量相对稳定。66例患者报告了至少一种与齐考诺肽相关的副作用。然而，不良事件并不总是治疗中断的决定性因素。 限制 数据是从不同的疼痛中心回顾性收集的，这些中心使用不同的齐考诺肽治疗方法和临床形式进行数据收集;因此，缺乏标准化方法和安慰剂对照组，并且一些数据缺失。 结论 齐考诺肽IT疗法是17个意大利疼痛治疗和神经外科单位临床实践中常用的治疗选择。它可能会缓解难治性慢性疼痛患者，而且似乎有一个安全的轮廓。需要长期研究和对照试验。
BACKGROUND Ziconotide is commonly used for intrathecal (IT) therapy of chronic pain, and has been recently indicated as a first-line IT drug. It is also extremely useful for patients intolerant or refractory to the common IT drugs (such as morphine). The literature, excluding registration studies, mostly includes small samples, and gives only fragmentary evidence on the long-term risks and benefits of ziconotide. OBJECTIVE To collect data on safety and efficacy of long-term ziconotide IT infusion in Italian pain centers. STUDY DESIGN Retrospective cohort study on the use of ziconotide in Italy. The study was designed and coordinated by the Foundation ISAL (Algological Sciences Research and Training Institute). Patients treated with ziconotide from several pain therapy and neurosurgery units were included in the study, allowing the creation of the first Italian Registry of Ziconotide. SETTING Seventeen Italian public and private pain and neurosurgery centers. METHODS Patients suffering from cancer or non-cancer intractable chronic pain who had been treated with ziconotide IT infusion for at least one month. Efficacy was analyzed considering changes on the visual analog scale of pain intensity from baseline observation. Safety was assessed by monitoring the number and intensity of adverse events. RESULTS Currently, 104 patients are included in the Italian Registry of Ziconotide. Ziconotide was administered as the first IT drug choice to 55 patients. Seventy-two patients reported at least a 30% pain intensity reduction with a mean dose of 4.36 ug/d. The sustained analgesic effect (P < 0.001) of the ziconotide IT therapy was observed in a group of 45 patients who remained in the study over 6 months without treatment interruptions and with relatively stable doses. Sixty-six patients reported at least one side effect related to ziconotide. However, adverse events have not always been decisive for treatment interruptions. LIMITATIONS Data were collected retrospectively from different pain centers that used different methods for ziconotide treatment and clinical forms for its data collection; for this reason there is an absence of standardized methodologies and a placebo-controlled group, and some data were missing. CONCLUSIONS Ziconotide IT therapy is a treatment option commonly used for clinical practice in 17 Italian pain therapy and neurosurgery units. It might give relief to patients with refractory chronic pain, and it seems to have a safe profile. Long-term studies and controlled trials are required.