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首页> 外文期刊>Current therapeutic research, clinical and experimental. >Analgesic Effects of Ketamine Infusion Therapy in Korean Patients With Neuropathic Pain: A 2-Week, Open-Label, Uncontrolled Study
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Analgesic Effects of Ketamine Infusion Therapy in Korean Patients With Neuropathic Pain: A 2-Week, Open-Label, Uncontrolled Study

机译：氯胺酮输注疗法在韩国神经性疼痛患者中的镇痛作用：一项为期2周，未公开标签的非对照研究

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BACKGROUND: The overexcitation of the N-methyl-D-aspartate receptor complex appears to play a critical role in the development of neuropathic pain, and ketamine acts as an antagonist to that receptor. Some publications have reported on the prominent relief of neuropathic pain with intravenous or subcutaneous ketamine infusions or a single-dose intravenous ketamine injection, despite adverse effects.OBJECTIVES: The primary objective of this study was to determine the analgesic effect of intravenous ketamine infusion therapy for neuropathic pain refractory to conventional treatments. Secondary objectives included identifying the variables related to the analgesic effect and the pain descriptors susceptible to ketamine infusion.METHODS: This 2-week, open-label, uncontrolled study was conducted in Korean patients with neuropathic pain recruited from the Samsung Seoul Hospital (Seoul, Republic of Korea) outpatient pain management unit. Patients were required to have a pain severity score >5 (visual analog scale [VAS}, where 0 = no pain and 10 = worst pain imaginable) over a period of >1 month while on standard treatment. The patients were required to have shown no benefit from standard treatment and no pain relief lasting over 1 month. The ketamine infusion therapy was composed of 3 sessions performed consecutively every other day. Midazolam was administered concomitantly to reduce the occurrence of central nervous system-related adverse events (AEs) secondary to ketamine. Each session was as follows: ketamine 0.2 mg/kg and midazolam 0.1 mg/kg were administered intravenously for 5 minutes as a loading dose, followed by a continuous infusion of ketamine 0.5 mg/kg/h and midazolam 0.025 mg/kg/h for 2 hours. AEs were assessed in the following ways: close monitoring of ECG, blood pressure, oxygen saturation, and evaluating the need for treatment of AEs during infu-sion and until discharge by an attending anesthesiologist; an open question about discomfort at the end of each session; spontaneous reports about AEs during each session; and the patients' and caregivers' checklist of AEs occurring at home for 2 weeks after discharge. All the descriptors of pain expressed by the patients in Korean were recorded and translated into appropriate English terminology on the basis of the literature on Korean verbal descriptors of pain. Each of the translated pain descriptors was then classified into 1 of 18 sensory items.RESULTS: The overall VAS score for pain decreased from a baseline mean (SD) of 7.20 (1.77) to 5.46 (2.29) (P < 0.001) 2 weeks after treatment in 103 patients (53 males and 50 females; mean age, 52.56 [17.33] years) who completed the study. Variables such as age, sex, and the duration and diagnosis of pain were not found to be associated with analgesic effect. Seven of the 18 pain descriptors were found to have a significant response to ketamine infusion treatment between baseline and 2 weeks follow-up: burning pain (P = 0.008); dull, aching pain (P < 0.001); overly sensitive to touch (P = 0.002); stabbing pain (P = 0.008); electric pain (P = 0.031); tingling pain (P < 0.001); and squeezing pain (P < 0.001). A total of 52 patients reported AEs: 33 during infusion and 44 during recovery and up to 2 weeks follow up. The most commonly reported AEs were snoring (15 [15%]) during infusion and dizziness (43 [42%]) during recovery.CONCLUSIONS: Ketamine infusion therapy was associated with reduced severity of neuropathic pain and generally well tolerated for up to 2 weeks in these patients with neuropathic pain refractory to standard treatment. Variables such as sex, age, and the diagnosis and duration of pain had no association with the analgesic effect of this treatment. Randomized controlled trials are needed to evaluate the efficacy and tolerability of treatment with ketamine infusion.
机译：背景：N-甲基-D-天冬氨酸受体复合物的过度兴奋似乎在神经性疼痛的发展中起关键作用，氯胺酮充当该受体的拮抗剂。一些出版物报道了尽管有不良反应，但静脉或皮下注射氯胺酮输注或单剂量静脉注射氯胺酮可以显着缓解神经性疼痛。目的：这项研究的主要目的是确定静脉注射氯胺酮输注疗法的镇痛作用传统疗法难治的神经性疼痛。次要目标包括确定与镇痛作用有关的变量和氯胺酮输注敏感的疼痛指标。方法：这项为期2周的开放标签，非对照研究是从三星首尔医院招募的韩国神经性疼痛患者中进行的（首尔，大韩民国）门诊疼痛管理部门。在标准治疗期间，要求患者在> 1个月内的疼痛严重度评分> 5（视觉模拟评分[VAS}，其中0 =无疼痛，而10 =可想象的最严重疼痛）。要求患者在1个月内没有表现出对标准治疗的任何好处，也没有缓解疼痛的方法。氯胺酮输注疗法由每隔一天连续进行的3次疗程组成。咪达唑仑应同时服用，以减少氯胺酮引起的中枢神经系统相关不良事件（AE）的发生。每次会议如下：以负荷剂量静脉内注射氯胺酮0.2 mg / kg和咪达唑仑0.1 mg / kg 5分钟，然后连续输注氯胺酮0.5 mg / kg / h和咪达唑仑0.025 mg / kg / h 2小时。通过以下方式评估AE：密切监测心电图，血压，血氧饱和度，并评估输注期间直至主治麻醉师出院前需要治疗AE的情况;每节课结束时有一个关于不适的公开问题;在每次会议期间自发报告不良事件;以及出院后2周内在家中发生的AE的患者和护理人员清单。记录韩语患者的所有疼痛描述符，并根据有关韩语疼痛描述符的文献将其翻译成适当的英语术语。然后，将每个翻译的疼痛描述词归为18个感官项目中的1个。结果：疼痛的总体VAS评分从基线平均（SD）的7.20（1.77）降至5.46（2.29）（P <0.001）研究完成的103例患者（男53例，女50例;平均年龄52.56 [17.33]岁）接受了治疗。未发现诸如年龄，性别，疼痛持续时间和疼痛诊断等变量与镇痛作用相关。在基线至2周随访之间，发现18种疼痛描述中的7种对氯胺酮输注治疗有显着反应：灼痛（P = 0.008）;钝痛，疼痛（P <0.001）;对触摸过于敏感（P = 0.002）;刺痛（P = 0.008）;电痛（P = 0.031）;刺痛（P <0.001）;和挤压疼痛（P <0.001）。共有52例患者报告了AE：输注期间33例，恢复期间44例，长达2周的随访。输注过程中最常见的不良事件为打nor（15 [15％]），恢复期出现头晕（43 [42％]）。结论：氯胺酮输注治疗可减轻神经性疼痛的严重程度，并且一般可耐受2周这些患者的神经性疼痛难于标准治疗。诸如性别，年龄，疼痛的诊断和持续时间等变量与该疗法的镇痛作用无关。需要评估氯胺酮输注的疗效和耐受性的随机对照试验。

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