Mercadante Sebastiano, Adile Claudio, Cuomo Arturo, Aielli Federica, Marinangeli Franco, Casuccio Alessandra
Pain relief and Palliative/supportive care unit, La Maddalena Cancer Center, Palermo, Italy.
Pain Therapy, National Cancer Institute "Pascale", Naples, Italy.
Support Care Cancer. 2017 Feb;25(2):645-649. doi: 10.1007/s00520-016-3457-y. Epub 2016 Oct 15.
The aim of this study was to prospectively assess the efficacy and safety of low doses of sublingual fentanyl (SLF) for the treatment of breakthrough pain (BTP) in cancer patients in patients who were receiving low opioid doses for background analgesia.
A sample of cancer patients presenting BTP episodes and receiving stable low doses of opioids for background pain (less than 60 mg of oral morphine equivalents) was selected to assess the efficacy and safety of low doses of SLF (67 μg). For each patient, data from four consecutive episodes were collected. For each episode, changes in pain intensity and adverse effects when pain got severe (T0), and 5, 10, and 15 min after SLF administration (T5-T30) were recorded. The occurrence of serious effects occurring within 2 h of SLF administration were also considered.
Fifty-one patients were recruited for the study. The mean age was 66.8 (SD 12.9). A mean of 3.3 episodes/patient were recorded. Four patients did not have episodes of BTP. 147 episodes were evaluated. Six episodes (4.1 %) required a rescue medication at T30. Pain intensity significantly decreased at T5, T10, T15 and T30 (p < 0.0005 in all cases). A high percentage of patients had a pain reduction of more than 33 and 50 % at T5, T10, T15 and T30. Adverse effects were mild and generally already present, due to basal opioid treatment or disease. No serious adverse effects were observed for the subsequent 2 h.
This study suggests that SLF given in low doses in patients receiving lower doses of opioids for background analgesia is safe and effective in clinical practice.
本研究旨在前瞻性评估低剂量舌下含服芬太尼（SLF）对接受低剂量阿片类药物进行背景镇痛的癌症患者爆发性疼痛（BTP）的治疗效果及安全性。
选取出现BTP发作且接受稳定低剂量阿片类药物治疗背景疼痛（口服吗啡当量小于60mg）的癌症患者样本，评估低剂量SLF（67μg）的疗效和安全性。为每位患者收集连续4次发作的数据。每次发作时，记录疼痛严重时（T0）、SLF给药后5、10和15分钟（T5 - T30）的疼痛强度变化及不良反应。还考虑了SLF给药后2小时内发生的严重不良反应。
51名患者被纳入研究。平均年龄为66.8岁（标准差12.9）。每位患者平均记录到3.3次发作。4名患者未出现BTP发作。共评估了147次发作。6次发作（4.1%）在T30时需要使用解救药物。在T5、T10、T15和T30时疼痛强度显著降低（所有情况p < 0.0005）。在T5、T10、T15和T30时，高比例患者疼痛减轻超过33%和50%。不良反应轻微，通常因基础阿片类药物治疗或疾病已存在。随后2小时未观察到严重不良反应。
本研究表明，对于接受较低剂量阿片类药物进行背景镇痛的患者，低剂量舌下含服芬太尼在临床实践中是安全有效的。
