Service d'Oncologie Médicale Adulte et de Soins Palliatifs, CHU Timone, APHM, Université de la Méditerranée, Marseille, France.
J Palliat Med. 2012 Mar;15(3):287-93. doi: 10.1089/jpm.2011.0353. Epub 2012 Feb 15.
The literature has described the use of ketamine as an adjuvant treatment for opioid-refractory cancer pain. None of these studies have used the drug in a palliative care patient population.
The primary objective of the study was to assess the efficacy of continuous intravenous infusion of ketamine in patients suffering from cancer pain refractory to opiates who had been admitted to palliative care units. Secondary objectives were to assess patients' satisfaction with and tolerance of ketamine.
A randomized, double-blind, placebo-controlled study was designed, and the study setting included seven French adult palliative care units. Inclusion criteria were age ≥18 years, and cancer pain refractory to standard opiates. Evaluations were conducted at randomization (baseline), at ketamine or placebo introduction time (T0), and at 2 hours (T1), 24 hours (T2), and 48 hours (T3) after T0. The primary evaluation criterion was pain efficacy assessed using a patient self-rated Numeric Pain Intensity Scale (NPIS) at T1. The main secondary evaluation criteria were daily morphine dose, symptom evaluation (Edmonton Symptom Assessment Scale [ESAS]), and patient satisfaction (Pain Treatment Satisfaction Scale [PTSS]).
Twenty patients were analyzed (11 received ketamine and 9 received placebo). Self-reported pain did not differ between the two groups, as the symptoms continued to evolve during the study period. The tolerance for ketamine was satisfactory.
The present study did not confirm the efficacy of the ketamine-morphine combination in refractory cancer pain. The results suggest that specific populations could be "good responders" for this therapeutic approach. Further studies should be performed that take into account the difficulties of conducting clinical research in the palliative care context.
文献描述了氯胺酮作为治疗阿片类药物难治性癌痛的辅助治疗。这些研究均未在姑息治疗患者群体中使用该药物。
本研究的主要目的是评估氯胺酮持续静脉输注在接受姑息治疗的阿片类药物难治性癌痛患者中的疗效。次要目的是评估患者对氯胺酮的满意度和耐受性。
设计了一项随机、双盲、安慰剂对照研究，研究地点包括法国的七个成人姑息治疗病房。纳入标准为年龄≥18 岁，且癌症疼痛对标准阿片类药物难治。评估在随机分组时（基线）、氯胺酮或安慰剂引入时（T0）、T0 后 2 小时（T1）、24 小时（T2）和 48 小时（T3）进行。主要评估标准是 T1 时患者自评的数字疼痛强度量表（NPIS）评估的疼痛疗效。主要次要评估标准是每日吗啡剂量、症状评估（埃德蒙顿症状评估量表[ESAS]）和患者满意度（疼痛治疗满意度量表[PTSS]）。
分析了 20 名患者（11 名接受氯胺酮，9 名接受安慰剂）。两组患者的自我报告疼痛无差异，因为在研究期间症状仍在继续发展。对氯胺酮的耐受性良好。
本研究未证实氯胺酮-吗啡联合治疗在难治性癌痛中的疗效。结果表明，对于这种治疗方法，特定人群可能是“良好反应者”。应开展进一步的研究，考虑到在姑息治疗环境中进行临床研究的困难。
