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首页> 外文期刊>Clinical drug investigation >Absorption of Fentanyl from Fentanyl Buccal Tablet in Cancer Patients With or Without Oral Mucositis A Pilot Study
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Absorption of Fentanyl from Fentanyl Buccal Tablet in Cancer Patients With or Without Oral Mucositis A Pilot Study

机译：芬太尼颊片中芬太尼对有或没有口腔粘膜炎的癌症患者的吸收性初步研究

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Background and objectives: Patients witlrcancer, particularly those undergoing chemotherapy or radiotherapy, may develop oral mucositis. This is the first study to investigate the absorption profile of fentanyl buccal tablet (FBT) - an efferves-cent formulation of fentanyl indicated for the management of breakthrough pain in opioid-tolerant cancer patients - in patients with or without oral mucositis. Methods:In this open-label study, patients with or without oral mucositis self-administered a single 200mug dose of FBT by placing the tablet between the upper gum and cheek above a molar tooth. Venous blood samples for measurement of plasma fentanyl concentrations were collected at regular intervals up to 8 hours following FBT administration. Parameters of interest included maximum plasma concentration (C_max), time to reach Cmax (t_max), area under the plasma concentra-tion-time curve from time zero to 8 hours (AUC8), and AUC from time zero to the median tmax (AUC_tmax')- Adverse events were monitored throughout the study. Oral mucosal examinations and measurements of vital signs were performed at intervals up to 8 hours following FBT administration.Results: Sixteen patients, 8 with and 8 without oral mucositis, received FBT and completed the study. The severity of oral mucositis was mild in the patients exhibiting this condition. Median Cmax values were comparable: 1.14 ng/mL (range 0.26-2.69 ng/mL) in patients with mucositis, and 1.21 ng/mL (range 0.21-2.34 ng/mL) in patients without mucositis. The tmax was not significantly different in the two groups: median tmax was 25.0 min (range 15-45 min) in patients with mucositis and 22.5 min (range 10-121 min) in patients without mucositis. Median AUCtmax' values were 0.17ng h/mL (range 0.04-0.52 ng h/ mL) in patients with mucositis, and 0.20 ng h/mL (range 0.00-0.65 ng h/mL) in patients without mucositis. The corresponding AUC8 values were 2.05 ng h/ mL (range 1.16-3.83 ng h/mL) and 1.55 ng.h/mL (range 0.74-3.07 ng.h/ mL), respectively. FBT was generally well tolerated in this small group. No application site adverse events or changes in oral mucosal assessments were reported.Conclusion: The absorption profile of a single dose of FBT 200mug was similar in patients with or without mild oral mucositis. The compound was generally well tolerated.
机译：背景与目的：监护人，尤其是接受化学疗法或放射疗法的患者，可能会发生口腔粘膜炎。这是第一个研究芬太尼口腔片剂（FBT）（一种芬太尼的泡腾剂制剂，用于治疗阿片类药物耐受的癌症患者的突破性疼痛的治疗方法）在有或没有口腔粘膜炎的患者中的吸收特性。方法：在这项开放标签研究中，患有或未患有口腔粘膜炎的患者通过将片剂放置在上牙龈和磨牙上方的脸颊之间，自行服用200杯单剂量的FBT。 FBT给药后最多8个小时定期采集静脉血样品，以测定血浆中的芬太尼浓度。感兴趣的参数包括最大血浆浓度（C_max），达到Cmax的时间（t_max），从时间零到8小时的血浆浓度-时间曲线下的面积（AUC8）和从时间零到中值tmax的AUC（AUC_tmax） '）-在整个研究过程中监测不良事件。 FBT给药后最多8个小时进行一次口腔粘膜检查和生命体征测量。结果：16例患者（其中8例患有口腔粘膜炎，8例没有口腔粘膜炎）接受了FBT并完成了研究。患有这种情况的患者口腔粘膜炎的严重程度较轻。 Cmax值中位数可比：粘膜炎患者为1.14 ng / mL（范围0.26-2.69 ng / mL），非粘膜炎患者为1.21 ng / mL（范围0.21-2.34 ng / mL）。两组的tmax没有显着差异：粘膜炎患者的中值tmax为25.0分钟（15-45分钟），而无粘膜炎患者的中值tmax为22.5分钟（10-121分钟）。黏膜炎患者的AUCtmax中位数为0.17ng h / mL（范围为0.04-0.52 ng h / mL），非黏膜炎患者的AUCtmax'中值为0.20 ng h / mL（范围为0.00-0.65 ng h / mL）。相应的AUC8值分别为2.05 ng h / mL（范围1.16-3.83 ng h / mL）和1.55 ng.h / mL（范围0.74-3.07 ng.h / mL）。在这个小组中，FBT的耐受性通常很好。没有应用部位不良事件或口腔粘膜评估改变的报道。结论：单剂量FBT 200mug的吸收曲线在有或没有轻度口腔粘膜炎的患者中相似。该化合物通常具有良好的耐受性。

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