University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
Pain Physician. 2010 Jan-Feb;13(1):23-33.
Before long-term intrathecal analgesic therapy is initiated, patients often undergo a spinal analgesia trial. Ziconotide is a nonopioid intrathecal analgesic used to manage severe chronic pain, and a variety of methods have been used to trial ziconotide.
The purpose of this review is to compare and discuss the different methods of ziconotide trialing.
Various databases (i.e., PubMed, Excerpta Medica, Cumulative Index to Nursing and Allied Health Literature, Biological Abstracts, Cochrane Database of Systematic Reviews, EMBASE, International Pharmaceutical Abstracts, and Google Scholar) and association meeting abstracts were searched with the use of the terms ziconotide, Prialt, trial, and trialing. In addition, a search was conducted for abstracts/posters presented at a variety of association meetings.
Nine sources, including one expert opinion piece, were identified. Three methods of ziconotide trialing were discovered: continuous infusion, limited-duration infusion, and bolus injection. Results indicate that patients often achieve analgesia during trialing, regardless of the trialing method. Adverse events reported during ziconotide trialing studies were similar to those reported during ziconotide clinical trials. Preliminary evidence suggests that both effectiveness and safety may be dose-related. In 3 studies the value of ziconotide trialing in predicting long-term patient response to ziconotide therapy was investigated; however, the results were preliminary. The expert opinion piece from 2008 recommended trialing ziconotide via continuous infusion, using a starting dose of 1.2 mcg/d and dose increases of 1.2 mcg/d every 12 to 24 hours, for up to 3 days; the trial may be extended in some cases.
Given the small samples size and lack of controlled ziconotide trialing studies, it is currently not possible to determine the relative safety and effectiveness of different methods of ziconotide trialing, nor is it possible to determine if trialing is predictive of patient response to long-term ziconotide therapy.
All 3 methods of ziconotide trialing appear to be viable options, and no method can be considered superior on the basis of the evidence presented in this review. Controlled studies comparing ziconotide trialing methods may be warranted.
在开始长期鞘内镇痛治疗之前，患者通常要进行脊柱镇痛试验。地诺佐辛是一种非阿片类鞘内镇痛药，用于治疗严重的慢性疼痛，并且已经使用了各种方法来试验地诺佐辛。
本综述的目的是比较和讨论地诺佐辛试验的不同方法。
各种数据库（即 PubMed、Excerpta Medica、Cumulative Index to Nursing and Allied Health Literature、Biological Abstracts、Cochrane Database of Systematic Reviews、EMBASE、International Pharmaceutical Abstracts 和 Google Scholar）和协会会议摘要都使用了地诺佐辛、Prialt、试验和试验这几个术语进行了搜索。此外，还对各种协会会议上的摘要/海报进行了搜索。
确定了 9 个来源，包括 1 篇专家意见文章。发现了 3 种地诺佐辛试验方法：持续输注、有限时间输注和推注。结果表明，无论试验方法如何，患者在试验期间通常都能获得镇痛。地诺佐辛试验研究中报告的不良事件与地诺佐辛临床试验中报告的不良事件相似。初步证据表明，有效性和安全性可能与剂量有关。在 3 项研究中，调查了地诺佐辛试验在预测长期患者对地诺佐辛治疗反应中的价值；然而，结果是初步的。2008 年的专家意见文章建议通过持续输注来试验地诺佐辛，起始剂量为 1.2 mcg/d，每 12 至 24 小时增加 1.2 mcg/d，最多 3 天；在某些情况下，试验可以延长。
鉴于样本量小且缺乏对照的地诺佐辛试验研究，目前尚不可能确定不同地诺佐辛试验方法的相对安全性和有效性，也无法确定试验是否对地诺佐辛长期治疗的患者反应具有预测性。
所有 3 种地诺佐辛试验方法似乎都是可行的选择，根据本综述中的证据，无法认为任何一种方法具有优势。可能需要进行比较地诺佐辛试验方法的对照研究。
