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咖啡因作为癌症疼痛阿片类药物辅助治疗的随机、双盲、安慰剂对照试验。

Caffeine as an adjuvant therapy to opioids in cancer pain: a randomized, double-blind, placebo-controlled trial.

机构信息

Department of Medicine, Dongguk University, Seoul, Korea; Department of Family Medicine, Dongguk University Ilsan Hospital, Goyang-si, Gyeonggi-do, Korea.

出版信息

J Pain Symptom Manage. 2013 Oct;46(4):474-82. doi: 10.1016/j.jpainsymman.2012.10.232. Epub 2013 Mar 13.

DOI:10.1016/j.jpainsymman.2012.10.232
PMID:23498965
Abstract

CONTEXT

Opioid therapy often shows insufficient efficacy and substantial adverse events in patients with advanced cancer.

OBJECTIVES

To assess the efficacy of caffeine infusion as an adjuvant analgesic to opioid therapy in patients with advanced cancer.

METHODS

A double-blind, randomized, placebo-controlled trial was conducted in the palliative care wards of two teaching hospitals in South Korea. A total of 20 of 41 participants were assigned to the caffeine group and 21 to the placebo group. The participants received caffeine (200mg) or normal saline intravenously once a day for two days. The primary outcome was pain, which was measured using a 10-point rating scale. Other outcomes included drowsiness, confusion, nausea, sleep disturbance, fatigue, and sadness.

RESULTS

Three participants (two in the caffeine group and one in the placebo group) dropped out after the first intervention because of insomnia; thus, 38 participants completed the trial. Pain score was significantly lower in the caffeine group than in the placebo group after the second trial (P=0.038). The mean reduction in pain intensity in the caffeine group was 0.833 (95% confidence interval [CI] 0.601-1.066), whereas that in the placebo group was 0.350 (95% CI 0.168-0.532). Considering an improvement higher than 30% from baseline as the threshold value, drowsiness improved significantly in the caffeine group after the first trial (P=0.041). Adverse event rate did not differ between the two groups.

CONCLUSION

Caffeine infusion significantly reduced pain and drowsiness, but the reduction did not reach clinical significance in patients with advanced cancer undergoing opioid therapy. Further investigations are warranted.

摘要

背景

阿片类药物疗法在晚期癌症患者中常常显示出疗效不足和大量不良反应。

目的

评估咖啡因输注作为阿片类药物治疗的辅助镇痛剂在晚期癌症患者中的疗效。

方法

在韩国的两家教学医院的姑息治疗病房进行了一项双盲、随机、安慰剂对照试验。共有 41 名参与者中的 20 名被分配到咖啡因组,21 名被分配到安慰剂组。参与者每天接受一次静脉注射咖啡因(200mg)或生理盐水,持续两天。主要结局是疼痛,使用 10 分制评分量表进行测量。其他结局包括嗜睡、意识混乱、恶心、睡眠障碍、疲劳和悲伤。

结果

三名参与者(两名在咖啡因组,一名在安慰剂组)在第一次干预后因失眠而退出;因此,38 名参与者完成了试验。第二次试验后,咖啡因组的疼痛评分明显低于安慰剂组(P=0.038)。咖啡因组疼痛强度的平均降低为 0.833(95%置信区间[CI]0.601-1.066),而安慰剂组为 0.350(95%CI0.168-0.532)。考虑到基线以上 30%的改善作为阈值,第一次试验后咖啡因组的嗜睡情况明显改善(P=0.041)。两组的不良事件发生率没有差异。

结论

咖啡因输注显著减轻了疼痛和嗜睡,但在接受阿片类药物治疗的晚期癌症患者中,减轻程度未达到临床意义。需要进一步的研究。

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