Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS - A randomized controlled trial
Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS - A randomized controlled trial
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DOI：
10.1001/jama.291.1.63
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发表时间：
2004-01-07
影响因子：
120.7
通讯作者：
Ellis, D
中科院分区：
文献类型：
--
作者：
Staats, PS;Yearwood, T;Ellis, D
背景齐考诺肽（以前称为SNX-111）选择性阻断N型电压敏感性钙通道，并且可能对阿片类药物治疗难治性疼痛患者或具有不可耐受的阿片类药物相关不良反应的患者有效。1996年3月12日至1998年7月11日在美国、澳大利亚和荷兰的32个研究中心进行的随机试验。患者为111名年龄在24至85岁之间的癌症或AIDS患者，平均疼痛强度视觉模拟量表（VASPI）评分为50 mm或更高。患者以2：1的比例随机分配接受齐考诺肽或安慰剂治疗。干预鞘内齐考诺肽滴定5至6天，随后为5天的维持期，应答者和交叉无应答者到相反的治疗组。主要结果测量VASPI评分从基线到初始滴定期结束的平均百分比变化。结果在可评价人群中，67 68例齐考诺肽治疗患者中有98.5%（68/48）和40例安慰剂治疗患者中有38例（95%）在基线时服用阿片类药物（齐考诺肽组的吗啡等效剂量中位数为300 mg/d，安慰剂组为600 mg/d;基于平均值，P= 0.63），36例使用鞘内吗啡。齐考诺肽组的平均（SD）VASPI评分为73.6（1.8）mm，安慰剂组为77.9（2.3）mm（P= 0.18）。齐考诺肽组平均VASPI评分改善53.1%（95%可信区间[CI]，44.0%-62.2%），安慰剂组改善18.1%（95% CI，4.8%-31.4%）（P
Context Ziconotide (formerly SNX-111) selectively blocks N-type voltage-sensitive calcium channels and may be effective in patients with pain that is refractory to opioid therapy or those with intolerable opioid-related adverse effects.Objective To assess the safety and efficacy of intrathecal ziconotide in patients with pain that is refractory to conventional treatment.Design, Setting, and Patients Double-blind, placebo-controlled, randomized trial conducted from March 12, 1996, to July 11, 1998, at 32 study centers in the United States, Australia, and the Netherlands. Patients were 111 individuals ages 24 to 85 years with cancer or AIDS and a mean Visual Analog Scale of Pain Intensity (VASPI) score of 50 mm or greater. Patients were randomly assigned in a 2:1 ratio to receive ziconotide or placebo treatment.Interventions Intrathecal ziconotide was titrated over 5 to 6 days, followed by a 5-day maintenance phase for responders and crossover of nonresponders to the opposite treatment group.Main Outcome Measure Mean percentage change in VASPI score from baseline to the end of the initial titration period.Results Of the evaluable population, 67 (98.5%) of 68 patients receiving ziconotide and 38 (95%) of 40 patients receiving placebo were taking opioids at baseline (median morphine equivalent dosage of 300 mg/d for the ziconotide group and 600 mg/d for the placebo group; P=.63, based on mean values), and 36 had used intrathecal morphine. Mean (SD) VASPI scores were 73.6 (1.8) mm in the ziconotide group and 77.9 (2.3) mm in the placebo group (P=.18). Mean VASPI scores improved 53.1% (95% confidence interval [CI], 44.0%-62.2%) in the ziconotide group and 18.1% (95% CI, 4.8%31.4%) in the placebo group (P