Anaesthesia & Intensive Care Unit, and Pain Relief & Palliative Care Unit, La Maddalena Cancer Centre, Palermo, Italy.
Curr Med Res Opin. 2010 Dec;26(12):2765-8. doi: 10.1185/03007995.2010.532545. Epub 2010 Nov 1.
The aim of this study was to evaluate the effect and tolerability of low doses of transdermal (TD) fentanyl patches in opioid-naive patients with cancer pain.
This was a nonrandomized, open-label, uncontrolled study in fifty consecutive opioid-naive patients with advanced cancer and moderate pain. TD fentanyl was initiated at a dose of 12 µg/h. Doses were then adjusted according to the clinical response. Pain intensity, opioid-related adverse effects, TD fentanyl doses, and quality of life were monitored over 4 weeks. The time to dose stabilization and indexes of dose escalation were also calculated.
Thirty-one patients completed all 4 weeks of the study. Pain control was achieved within a mean of 1.7 days after the start of TS fentanyl therapy. Significant differences in TD fentanyl doses were observed during the study period (P = 0.03). Mean doses were doubled 4 weeks after starting the treatment. The level of adverse effects was acceptable in most patients and only a minority of patients discontinued the treatment (13.8%).
Low doses of TD fentanyl were well tolerated and effective. Observations from this study suggest that randomized, controlled, double-blind studies of TD fentanyl 12 µg/h in opioid-naive patients with cancer pain may be warranted.
本研究旨在评估低剂量经皮（TD）芬太尼贴剂在初用阿片类药物的癌症疼痛患者中的疗效和耐受性。
这是一项非随机、开放标签、非对照的研究，共纳入 50 例晚期癌症且中度疼痛的初用阿片类药物的患者。TD 芬太尼起始剂量为 12 µg/h。然后根据临床反应调整剂量。在 4 周内监测疼痛强度、与阿片类药物相关的不良反应、TD 芬太尼剂量和生活质量。还计算了剂量稳定所需的时间和剂量升级的指标。
31 例患者完成了所有 4 周的研究。在开始使用 TS 芬太尼治疗后平均 1.7 天内达到疼痛控制。在研究期间观察到 TD 芬太尼剂量有显著差异（P = 0.03）。治疗开始 4 周后平均剂量增加了一倍。大多数患者的不良反应程度可接受，只有少数患者（13.8%）停止治疗。
低剂量 TD 芬太尼具有良好的耐受性和疗效。本研究结果表明，对于初用阿片类药物的癌症疼痛患者，TD 芬太尼 12 µg/h 的随机、对照、双盲研究可能是合理的。
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