Christie J M, Simmonds M, Patt R, Coluzzi P, Busch M A, Nordbrock E, Portenoy R K
Hospice Institute of Florida Suncoast and University of South Florida, College of Medicine, Department of Anesthesiology, Tampa 33612-4799, USA.
J Clin Oncol. 1998 Oct;16(10):3238-45. doi: 10.1200/JCO.1998.16.10.3238.
Supplemental, "as-needed," administration of an opioid is a common approach to the problem of breakthrough pain in cancer patients. Oral transmucosal fentanyl citrate (OTFC) is undergoing investigation as a new treatment for breakthrough pain. The primary purpose of the study was to demonstrate that a single-unit dose of OTFC can safely and effectively treat breakthrough pain. A secondary goal was to determine appropriate dosing guidelines.
This was a multicenter, randomized, double-blind, dose-titration study in 62 adult cancer patients using transdermal fentanyl for persistent pain. Consenting patients provided 2 days of baseline data to evaluate the performance of their usual breakthrough pain medication. Patients then randomly received 200 microg or 400 microg OTFC in double-blind fashion. (Patients were always assigned, rather than randomized, to 200 microg if 400 microg represented > 20% of around-the-clock medication.) Pain intensity (PI), pain relief (PR), and global satisfaction scores were recorded. OTFC was then titrated until the patient received adequate PR for each episode using one OTFC unit. Orders to titrate up were ignored one third of the time to improve the blind. Two days of baseline data were compared with 2 days of OTFC data after titration identified an effective dose of OTFC.
Most patients (76%) found a safe and effective dose of OTFC. There was no meaningful relationship between the around-the-clock opioid regimen and the effective dose of OTFC. In open-label comparisons, OTFC produced a faster onset of relief and a greater degree of PR than patients' usual breakthrough medication. Somnolence, nausea, and dizziness were the most common side effects associated with OTFC.
Most patients find a single OTFC dosage that adequately treats breakthrough pain. The optimal dose is found by titration and is not predicted by around-the-clock dose of opioids.
补充使用阿片类药物“按需”给药是治疗癌症患者爆发性疼痛问题的常用方法。口服黏膜芬太尼枸橼酸盐（OTFC）作为一种治疗爆发性疼痛的新方法正在接受研究。该研究的主要目的是证明单剂量OTFC能够安全有效地治疗爆发性疼痛。次要目标是确定合适的给药指南。
这是一项针对62名使用透皮芬太尼治疗持续性疼痛的成年癌症患者的多中心、随机、双盲、剂量滴定研究。同意参与的患者提供2天的基线数据，以评估其常用爆发性疼痛药物的疗效。然后患者以双盲方式随机接受200微克或400微克OTFC。（如果400微克超过全天用药量的20%，则患者总是被分配而非随机接受200微克。）记录疼痛强度（PI）、疼痛缓解（PR）和总体满意度评分。然后滴定OTFC剂量，直到患者使用一个OTFC单位对每次发作获得足够的PR。为提高盲法质量，上调滴定的指令有三分之一的时间被忽略。在滴定确定OTFC有效剂量后，将2天的基线数据与2天的OTFC数据进行比较。
大多数患者（76%）找到了安全有效的OTFC剂量。全天阿片类药物治疗方案与OTFC有效剂量之间无显著关系。在开放标签比较中，OTFC比患者常用的爆发性疼痛药物起效更快，PR程度更高。嗜睡、恶心和头晕是与OTFC相关的最常见副作用。
大多数患者能找到充分治疗爆发性疼痛的单一OTFC剂量。最佳剂量通过滴定确定，而非由全天阿片类药物剂量预测。
Zotero 插件