Collins J J, Dunkel I J, Gupta S K, Inturrisi C E, Lapin J, Palmer L N, Weinstein S M, Portenoy R K
Pain and Palliative Care Service and the Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
J Pediatr. 1999 Mar;134(3):319-23. doi: 10.1016/s0022-3476(99)70457-9.
(1) To assess the feasibility and tolerability of the therapeutic transdermal fentanyl system (TTS-fentanyl) by using a clinical protocol developed for children with cancer pain. (2) To estimate the pediatric pharmacokinetic parameters of TTS-fentanyl.
The drug was administered in open-label fashion; and measures of analgesia, side effects, and skin changes were obtained for a minimum of 2 doses (6 treatment days). Blood specimens were analyzed for plasma fentanyl concentrations. The pharmacokinetics of TTS-fentanyl were estimated by using a mixed effect modeling approach.
Treatment was well tolerated. Ten of the 11 patients who completed the 2 doses continued treatment with TTS-fentanyl. The duration of treatment ranged from 6 to 275 days. The time to reach peak plasma concentration ranged from 18 hours to >66 hours in patients receiving the 25 microg/h patch. Compared with published pharmacokinetic data from adults, the mean clearance and volume of distribution of transdermal fentanyl were the same, but the variability was less.
Treatment of children with TTS-fentanyl is feasible and well tolerated and yields fentanyl pharmacokinetic parameter estimates similar to those for adults. A larger study is required to confirm these findings and further test the clinical protocol.
（1）通过使用为癌症疼痛儿童制定的临床方案，评估治疗性透皮芬太尼系统（TTS - 芬太尼）的可行性和耐受性。（2）估算TTS - 芬太尼的儿科药代动力学参数。
以开放标签方式给药；至少获取2剂（6个治疗日）的镇痛、副作用和皮肤变化测量值。分析血样中的血浆芬太尼浓度。使用混合效应建模方法估算TTS - 芬太尼的药代动力学。
治疗耐受性良好。完成2剂治疗的11名患者中有10名继续使用TTS - 芬太尼治疗。治疗持续时间为6至275天。接受25微克/小时贴片的患者达到血浆峰浓度的时间为18小时至>66小时。与已发表的成人药代动力学数据相比，透皮芬太尼的平均清除率和分布容积相同，但变异性较小。
用TTS - 芬太尼治疗儿童是可行的且耐受性良好，并且产生的芬太尼药代动力学参数估算值与成人相似。需要进行更大规模的研究来证实这些发现并进一步测试该临床方案。
