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一项评估静脉注射利多卡因用于癌症患者阿片类药物难治性疼痛的II期试点研究。

A phase II pilot study to evaluate use of intravenous lidocaine for opioid-refractory pain in cancer patients.

作者信息

Sharma Shekhar, Rajagopal M R, Palat Gayatri, Singh Charu, Haji Altaf G, Jain Dimpel

机构信息

Amrita Institute of Medical Sciences, Cochin, Kerala, India.

出版信息

J Pain Symptom Manage. 2009 Jan;37(1):85-93. doi: 10.1016/j.jpainsymman.2007.12.023. Epub 2008 Jul 2.

DOI:10.1016/j.jpainsymman.2007.12.023
PMID:18599258
Abstract

Opioid-refractory pain is distressing because it is notoriously difficult to treat. Relief from adjuvant therapies often occurs after a lag time. Retrospective evidence points to a role for intravenous (IV) lidocaine in this setting for pain relief. This study was planned as a randomized, double-blind, placebo-controlled, crossover study in which eligible patients received both lidocaine and placebo infusions separated by two weeks. Primary endpoints were magnitude and duration of pain relief. Fifty patients were included in the study. Pain relief was significantly better (P<0.001) and more patients reported a decrease in analgesic requirements (P=0.0012) after lidocaine infusion than after placebo. Onset of analgesia was noted at a mean of 40+/-16.28 minutes after initiation of infusion of IV lidocaine. Mean duration of this analgesia, 9.34+/-2.58 days after the single infusion, was significantly longer than that for placebo (P<0.01). Side effects observed were tinnitus, perioral numbness, sedation, light-headedness, and headache. All side effects were self-limited and did not require any intervention except termination of lidocaine infusion in one case. These data demonstrate that a single IV infusion of lidocaine provided a significantly greater magnitude and duration of pain relief than placebo infusion in opioid-refractory patients with cancer pain. Side effects were tolerable. It is thus a promising modality worth investigating further to establish guidelines for its use in cancer patients with opioid-refractory pain.

摘要

阿片类药物难治性疼痛令人痛苦,因为其治疗难度众所周知。辅助治疗的缓解通常会有一段延迟时间。回顾性证据表明静脉注射利多卡因在这种情况下对缓解疼痛有作用。本研究设计为一项随机、双盲、安慰剂对照的交叉研究,符合条件的患者接受利多卡因和安慰剂输注,间隔两周。主要终点是疼痛缓解的程度和持续时间。50名患者纳入研究。与安慰剂输注后相比,利多卡因输注后疼痛缓解明显更好(P<0.001),更多患者报告镇痛需求减少(P=0.0012)。静脉注射利多卡因开始输注后平均40±16.28分钟出现镇痛效果。单次输注后这种镇痛的平均持续时间为9.34±2.58天,明显长于安慰剂(P<0.01)。观察到的副作用有耳鸣、口周麻木、镇静、头晕和头痛。所有副作用均为自限性,除1例终止利多卡因输注外,无需任何干预。这些数据表明,对于患有癌症疼痛的阿片类药物难治性患者,单次静脉输注利多卡因比安慰剂输注能提供明显更大程度和更长时间的疼痛缓解。副作用是可耐受的。因此,这是一种有前景的治疗方式,值得进一步研究以制定其在患有阿片类药物难治性疼痛的癌症患者中的使用指南。

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