Portenoy Russell K, Raffaeli William, Torres Luis M, Sitte Thomas, Deka Akhil Chandra, Herrera Ileana Gonzalez, Wallace Mark S
Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, New York, New York, USA.
J Opioid Manag. 2010 Sep-Oct;6(5):319-28. doi: 10.5055/jom.2010.0029.
to assess the long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray (FPNS) in patients with breakthrough cancer pain (BTCP).
a multicenter, open-label study.
patients with chronic cancer pain treated with > or = 60 mg/d oral morphine or equivalent experiencing 1-4 episodes per day of BTCP.
all patients entered into a 16-week treatment phase after undergoing a dose-titration phase with FPNS.
safety and tolerability were assessed by adverse events (AEs) and by nasal tolerability assessments. Consistency of effect was monitored through additional rescue medication use and FPNS dose change.
four hundred three patients were included in the safety analyses. Of these, 356 patients entered the treatment phase and 110 patients completed the study. FPNS was self-administered for 42,227 episodes. During the treatment phase, 99 patients (24.6 percent) reported treatment-related AEs; most were mild or moderate and typical of opioids. Serious AEs were reported by 61 patients (15.1 percent), but only five were considered related to study drug. Of the 80 deaths that occurred during this study, one was assessed as possibly related to study drug. Nasal assessments revealed no significant local effects. No additional rescue medication was required after 94 percent of FPNS-treated episodes. More than 90 percent of patients required no increase in their initial dose of FPNS.
FPNS use for BTCP was associated with AEs, typical of opioids, with no evidence of nasal toxicity. A large proportion of BTCP episodes were treated with a single dose, and doses remained stable over the 4-month period.
评估芬太尼果胶鼻喷雾剂（FPNS）在癌痛突发（BTCP）患者中的长期安全性、耐受性及疗效一致性。
一项多中心、开放标签研究。
接受≥60mg/d口服吗啡或等效药物治疗的慢性癌痛患者，每天经历1 - 4次BTCP发作。
所有患者在经历FPNS剂量滴定阶段后进入为期16周的治疗阶段。
通过不良事件（AE）和鼻耐受性评估来评估安全性和耐受性。通过额外急救药物的使用和FPNS剂量变化来监测疗效一致性。
403例患者纳入安全性分析。其中，356例患者进入治疗阶段，110例患者完成研究。FPNS自行给药共42227次。在治疗阶段，99例患者（24.6%）报告了与治疗相关的AE；大多数为轻度或中度，是阿片类药物的典型反应。61例患者（15.1%）报告了严重AE，但只有5例被认为与研究药物有关。在本研究期间发生的80例死亡中，1例被评估为可能与研究药物有关。鼻评估未发现明显局部效应。94%的FPNS治疗发作后无需额外急救药物。超过90%的患者初始FPNS剂量无需增加。
FPNS用于BTCP与阿片类药物典型的AE相关，无鼻毒性证据。很大一部分BTCP发作单次给药即可治疗，且剂量在4个月期间保持稳定。
