Brisbane South Palliative Care Collaborative, Brisbane, Queensland, Australia.
J Pain Symptom Manage. 2010 Mar;39(3):548-54. doi: 10.1016/j.jpainsymman.2009.07.008. Epub 2010 Jan 18.
The adjunctive use of paracetamol (acetaminophen) with strong opioids has become entrenched practice in palliative care pain management, despite little evidence to support its use.
The study aim was to investigate potential analgesic benefits of 4 g of paracetamol daily for palliative cancer patients requiring high-dose opioids.
Thirty-one patients, using at least 200mg of oral morphine equivalent daily, were recruited to a prospective, double-blinded, randomized, crossover trial. Patients received usual medications plus 4 g of paracetamol or placebo for five days each in random order. Primary outcome, effect on pain, was assessed using daily diaries, including a numerical rating scale (NRS) from zero (no pain) to 10 (unbearable) and recording numbers of breakthrough analgesics. Secondary outcomes-nausea, vomiting, cognitive impairment, constipation, and overall well-being--were assessed using the NRS. Data from the last four days of each treatment were analyzed. Patients also indicated in which part of the study their pain was better controlled.
Twenty-two patients, requiring a median dose of 255 mg of oral morphine equivalent daily, completed the trial. There were no significant order or treatment-by-order interaction effects for any variable; paired t-tests were conducted to investigate change in mean levels on outcome variables with placebo vs. paracetamol. For none of the variables was there a statistically significant difference when assessed with placebo compared with paracetamol. No change approached clinically significant levels, with a mean difference in rated pain of 0.16, and mean difference of 0.42 for a number of breakthrough medications. Fifteen patients were undecided whether paracetamol improved pain.
These data do not support the common practice of adding regular paracetamol daily as an adjunct to high-dose opioids for pain control in cancer patients receiving palliative care.
尽管几乎没有证据支持其使用，但在姑息治疗疼痛管理中，将扑热息痛（对乙酰氨基酚）与强阿片类药物联合使用已成为一种既定做法。
本研究旨在调查每天给予 4 克扑热息痛对需要高剂量阿片类药物的姑息治疗癌症患者潜在的镇痛益处。
31 名患者每天至少使用 200mg 口服吗啡等效物，入组前瞻性、双盲、随机、交叉试验。患者随机顺序接受常规药物加 4 克扑热息痛或安慰剂，每种药物治疗 5 天。主要结局，即疼痛的影响，通过每日日记进行评估，包括从 0（无疼痛）到 10（无法忍受）的数字评分量表（NRS）和记录突破性镇痛药的数量。次要结局，包括恶心、呕吐、认知障碍、便秘和整体幸福感，使用 NRS 进行评估。分析每种治疗的最后四天的数据。患者还指出在研究的哪个部分他们的疼痛得到了更好的控制。
22 名患者完成了试验，每天需要 255mg 口服吗啡等效物的中位数剂量。任何变量均无明显的顺序或治疗顺序交互作用；进行配对 t 检验以调查安慰剂与扑热息痛相比，对结局变量的平均水平变化。在评估安慰剂与扑热息痛相比时，没有一个变量具有统计学意义上的差异。没有任何变化接近临床显著水平，疼痛评分的平均差异为 0.16，突破性药物的平均差异为 0.42。15 名患者不确定扑热息痛是否改善了疼痛。
这些数据不支持在姑息治疗中为控制癌症患者的疼痛而常规每日添加扑热息痛作为阿片类药物的辅助治疗的常见做法。
