International Clinical Research Institute, Overland Park, KS, USA.
Curr Med Res Opin. 2011 Mar;27(3):519-30. doi: 10.1185/03007995.2010.545380. Epub 2011 Jan 6.
Breakthrough cancer pain (BTcP) is a transient exacerbation of cancer pain in patients with otherwise stable, persistent background pain. This study evaluated the long-term effectiveness and tolerability of sublingual fentanyl orally disintegrating tablet (sublingual fentanyl ODT), for the treatment of BTcP in opioid-tolerant patients with cancer.
This was a non-randomized, open-label, multi-center, Phase III study conducted in opioid-tolerant patients (aged ≥17 years) with BTcP. The study comprised a 2-week titration phase, followed by a maintenance phase of up to 12 months. Patients self-administered sublingual fentanyl ODT for episodes of BTcP. Effectiveness was assessed using patients' global evaluation of medication (PGEM), the brief pain inventory (BPI) and the depression, anxiety and positive outlook scale (DAPOS). Adverse events were recorded throughout.
NCT00263575 (http://www.clinicaltrials.gov/).
Of 139 recruited patients, 69% identified an effective dose of sublingual fentanyl ODT (a dosage that successfully treated all episodes of BTcP over two consecutive days) and entered the maintenance phase, during which they were treated for a median of 149.0 days (mean dose 507.5 µg). The study recorded a significant increase in reported satisfaction with pain medication at the 6-month and end-of-study visits, compared to screening (p ≤ 0.01). Evaluation of quality of life using BPI and DAPOS identified no deterioration in scores and significant improvements in certain parameters (p < 0.05). Sublingual fentanyl ODT was well tolerated, with no study drug-related deaths, and 49 patients (35.3%) experiencing ≥1 study drug-related adverse event. The most common of these included nausea (8.6%), constipation (5.8%) and somnolence (5.8%). There was no evidence of sublingual mucosal irritation due to the study medication. The pattern of adverse events was similar to that previously observed with transmucosal fentanyl.
Sublingual fentanyl ODT was effective and well tolerated for the long-term treatment of BTcP in opioid-tolerant cancer patients. There was an increase in satisfaction with pain medication during the study, and sublingual fentanyl ODT showed an acceptable safety profile over 12 months of treatment.
突破性癌痛（BTcP）是指在原本稳定、持续存在背景性疼痛的癌症患者中，疼痛出现一过性恶化。本研究评估了舌下芬太尼口腔崩解片（舌下芬太尼 ODT）治疗阿片类药物耐受的癌症患者 BTcP 的长期疗效和耐受性。
这是一项非随机、开放标签、多中心、III 期研究，纳入了 BTcP 阿片类药物耐受的患者（年龄≥17 岁）。该研究包括为期 2 周的滴定阶段，随后是长达 12 个月的维持阶段。患者自行使用舌下芬太尼 ODT 治疗 BTcP 发作。采用患者对药物的总体评价（PGEM）、简明疼痛量表（BPI）和抑郁、焦虑和积极展望量表（DAPOS）评估疗效。整个研究过程中均记录不良反应。
NCT00263575（http://www.clinicaltrials.gov/）。
在 139 例入选的患者中，69%的患者确定了舌下芬太尼 ODT 的有效剂量（连续两天成功治疗所有 BTcP 发作的剂量），并进入维持阶段，在此期间他们接受了中位数为 149.0 天（平均剂量 507.5μg）的治疗。与筛选时相比，6 个月和研究结束时的调查显示，患者对疼痛药物的满意度显著提高（p≤0.01）。使用 BPI 和 DAPOS 评估生活质量，发现评分无恶化，某些参数显著改善（p<0.05）。舌下芬太尼 ODT 耐受性良好，无研究药物相关死亡，49 例（35.3%）患者发生≥1 例研究药物相关不良事件。其中最常见的是恶心（8.6%）、便秘（5.8%）和嗜睡（5.8%）。无研究药物导致的舌下黏膜刺激的证据。不良事件的模式与先前观察到的经黏膜芬太尼相似。
在阿片类药物耐受的癌症患者中，舌下芬太尼 ODT 是治疗 BTcP 的有效且耐受良好的长期治疗方法。研究期间患者对疼痛药物的满意度增加，并且舌下芬太尼 ODT 在 12 个月的治疗期间具有可接受的安全性。
