Kang Jung Hun, Oh Sung Yong, Song Seo-Young, Lee Hui-Young, Kim Jung Han, Lee Kyoung Eun, Lee Hye Ran, Hwang In Gyu, Park Se Hoon, Kim Won Seok, Park Young Suk, Park Keunchil
Department of Internal Medicine, Gyeongsang National University School of Medicine, Jinju, Korea.
Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
Korean J Intern Med. 2015 Jan;30(1):88-95. doi: 10.3904/kjim.2015.30.1.88. Epub 2014 Dec 30.
BACKGROUND/AIMS: Little is known about the efficacy of low-dose transdermal fentanyl (TDF) patches in opioid-naïve patients with moderate-to-severe cancer pain.
This study had an open-label, prospective design, and was conducted between April 2007 and February 2009 in seven tertiary cancer hospitals; 98 patients were enrolled. TDF was started using a low-dose formulation (12.5 µg/hr), and the dose was adjusted according to the clinical situation of individual patients. Pain intensity, the TDF doses used, and adverse events (AEs) were monitored over 4 weeks. Data were analyzed using the intent-to-treat and per-protocol principles.
Of the 98 patients enrolled, 64 (65%) completed the study. The median pain intensity decreased from 6.0 to 3.0 (p < 0.001) at the follow-up visit. The efficacy of low-dose TDF on pain relief was consistent across groups separated according to gender (p < 0.001), age (p < 0.001), metastasis (p < 0.001), previous treatment (p < 0.001), and baseline pain intensity (p < 0.001). The decrease in pain intensity was significantly greater in the severe group compared with the moderate group (mean ± SD, 5.10 ± 2.48 vs. 2.48 ± 1.56; p < 0.001). TDF dose (27.8 µg/hr vs. 24.8 µg/hr, p = 0.423) and the mean treatment time (7.5 days vs. 7.9 days, p = 0.740) required for pain control were not different between the two pain-intensity groups. Patients had AEs of only mild or moderate intensity; among these, nausea (38%) was the most common, followed by vomiting (22%) and somnolence (22%).
Low-dose TDF was an effective treatment for patients with cancer pain of moderate-to-severe intensity. Further randomized trials assessing the efficacy of TDF for severe pain and/or optimal starting doses are warranted.
背景/目的：对于阿片类药物初治的中重度癌痛患者，低剂量透皮芬太尼（TDF）贴剂的疗效鲜为人知。
本研究采用开放标签、前瞻性设计，于2007年4月至2009年2月在7家三级癌症医院进行；共纳入98例患者。TDF起始使用低剂量剂型（12.5μg/小时），并根据个体患者的临床情况调整剂量。在4周内监测疼痛强度、使用的TDF剂量和不良事件（AE）。采用意向性分析和符合方案原则对数据进行分析。
98例纳入患者中，64例（65%）完成了研究。随访时，中位疼痛强度从6.0降至3.0（p<0.001）。低剂量TDF缓解疼痛的疗效在按性别（p<0.001）、年龄（p<0.001）、转移情况（p<0.001）、既往治疗（p<0.001）和基线疼痛强度（p<0.001）分组的各组中均一致。重度组疼痛强度的下降显著大于中度组（均值±标准差，5.10±2.48对2.48±1.56；p<0.001）。两组疼痛强度组间控制疼痛所需的TDF剂量（27.8μg/小时对24.8μg/小时，p=0.423）和平均治疗时间（7.5天对7.9天，p=0.740）无差异。患者发生的AE仅为轻度或中度；其中，恶心（38%）最为常见，其次是呕吐（22%）和嗜睡（22%）。
低剂量TDF是中重度癌痛患者的有效治疗方法。有必要进行进一步的随机试验，以评估TDF对重度疼痛的疗效和/或最佳起始剂量。
