A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain
A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain
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DOI：
10.1016/j.jpainsymman.2005.10.003
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发表时间：
2006-05-01
影响因子：
4.7
通讯作者：
Kartzinel, Ronald
中科院分区：
文献类型：
--
作者：
Rauck, Richard L.;Wallace, Mark S.;Kartzinel, Ronald
介绍了鞘内缓慢滴定(IT)治疗严重慢性疼痛的安全性和有效性数据。被随机分为齐康肽组(n=112)和安慰剂组(n=108)的患者开始以0.1MU/小时(2.4MU/小时)的速度输注IT，在3周内逐渐增加(0.05-0.1MU/小时递增)。终止时的平均剂量为0.29微克/小时(6.96微克/天)。患者基础疼痛强度视觉模拟评分(VASPI)为80.7(SD15)。VASPI平均改善百分比、至第3周的基线(齐康肽[14.7%]与安慰剂[7.2%；P=0.036])以及许多次要疗效结果指标均有统计学意义。报告的显著不良事件(AEs)有头晕、神志不清、共济失调、步态异常、蛙类记忆障碍。AEs和严重AEs的停药率在两组中是相当的。缓慢滴定非阿片类止痛剂齐康肽至低最大剂量可显著改善疼痛，且耐受性更好。在之前的两个对照试验中，使用了更快的滴定速度，达到了更高的平均剂量。(C)2006年美国癌症疼痛缓解委员会。爱思唯尔公司出版，版权所有。
Safety and efficacy data from a study of slow intrathecal (IT) ziconotide titration for the management of severe chronic pain are presented. Patients randomized to ziconotide (n = 112) or placebo (n = 108) started IT infusion at 0.1 mu g/hour (2.4 mu g/day), increasing gradually (0.05-0.1 mu g/hour increments) over 3 weeks. The ziconotide mean dose at termination was 0.29 mu g/hour (6.96 mu g/day). Patients' baseline Visual Analogue Scale of Pain Intensity (VASPI) score was 80.7 (SD 15). Statistical significance was noted for VASPI mean percentage improvement, baseline to Week 3 (ziconotide [14.7%] vs. placebo [7.2%;P = 0.036]) and, many of the secondary efficacy outcomes measures. Significant adverse events (AEs) reported in the ziconotide group were dizziness, confusion, ataxia,, abnormal gait,, toad memory impairment. Discontinuation-rates for AEs and serious AEs were comparable for both groups. Slow titration of ziconotide, a nonopioid analgesic, to a low maximum dose resulted in significant improvement in pain and was better tolerated titan. in, two previous controlled trials that used a faster titration, to a higher mean dose. (C) 2006 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.