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从经皮给药转换用药:一项关于芬太尼和丁丙诺啡的观察性“单病例”研究。

Switching from transdermal drugs: an observational "N of 1" study of fentanyl and buprenorphine.

作者信息

Mercadante Sebastiano, Porzio Giampiero, Fulfaro Fabio, Aielli Federica, Verna Lucilla, Ficorella Corrado, Casuccio Alessandra, Riina Salvatore, Intravaia Giuseppe, Mangione Salvatore

机构信息

Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy.

出版信息

J Pain Symptom Manage. 2007 Nov;34(5):532-8. doi: 10.1016/j.jpainsymman.2007.01.006. Epub 2007 Jul 16.

DOI:10.1016/j.jpainsymman.2007.01.006
PMID:17629666
Abstract

The aim of this study was to confirm that the concomitant presence of transdermal fentanyl (TTS FE) and buprenorphine (TTS BU) may be feasible without important consequences, using doses presumed to be equianalgesic. A prospective "N of 1" study was carried out in a sample of volunteers with cancer pain receiving stable doses of TTS FE or TTS BU, with adequate pain and symptom control. In the study design, each patient provided data before and after a switch from one opioid to the other and then back to the previous one. Sixteen patients receiving daily stable doses of 0.6 or 1.2mg of TTS FE were switched to TTS BU using an FE-BU ratio of 0.6-0.8. After three days, the TTS BU patch was removed and TTS FE patch was placed for another three days. Six patients receiving TTS BU were switched to TTS FE and then rotated back to TTS BU with the same dosing considerations. No statistical differences in changes in pain and symptom intensity during switching and between the two different sequences were observed. No significant changes in rescue doses of oral morphine were reported at the same intervals. Cancer patients receiving stable doses of TTS FE or TTS BU can be safely switched to the alternative transdermal opioid. Further studies should be performed to gather data about the use of TTS BU with other opioids, at different doses, and in different clinical conditions.

摘要

本研究的目的是使用假定为等效镇痛剂量,证实同时使用透皮芬太尼(TTS FE)和丁丙诺啡(TTS BU)可能是可行的,且不会产生重大后果。在一组接受稳定剂量TTS FE或TTS BU且疼痛和症状得到充分控制的癌症疼痛志愿者样本中,开展了一项前瞻性“单病例”研究。在研究设计中,每位患者在从一种阿片类药物转换为另一种阿片类药物,然后再换回之前使用的药物之前和之后均提供数据。16名每天接受0.6或1.2mg稳定剂量TTS FE的患者,按照FE - BU比例为0.6 - 0.8转换为TTS BU。三天后,移除TTS BU贴片,并放置TTS FE贴片,持续三天。6名接受TTS BU的患者转换为TTS FE,然后按照相同的给药考虑因素再换回TTS BU。在转换期间以及两种不同顺序之间,未观察到疼痛和症状强度变化的统计学差异。在相同时间段内,口服吗啡的解救剂量也未报告有显著变化。接受稳定剂量TTS FE或TTS BU的癌症患者可以安全地转换为另一种透皮阿片类药物。应开展进一步研究,以收集关于在不同剂量以及不同临床情况下,TTS BU与其他阿片类药物联合使用的数据。

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