Division of Hematology and Oncology, Department of Internal Medicine, MacKay Memorial Hospital, Taipei, Taiwan.
Department of Medicine, MacKay Medical College, New Taipei City, Taiwan.
BMC Palliat Care. 2024 Jun 14;23(1):150. doi: 10.1186/s12904-024-01483-7.
Clinical evidence for the rapidity and effectiveness of fentanyl buccal soluble film (FBSF) in reducing pain intensity of breakthrough cancer pain (BTcP) remains inadequate. This study aimed to evaluate the efficacy of FBSF proportional to the around-the-clock (ATC) opioid regimens in rapidly relieving the intensity of BTcP episodes by determining the percentage of patients requiring further dose titration.
The study procedure included a dose-finding period followed by a 14-day observation period. Pain intensity was recorded with a Numeric Rating Scale (NRS) at onset and 5, 10, 15, and 30 min after FBSF self-administration. Meaningful pain relief was defined as the final NRS score ≤ 3. Satisfaction survey was conducted for each patient after treatment using the Global Satisfaction Scale.
A total of 63 BTcP episodes occurred in 30 cancer patients. Only one patient required rescue medication at first BTcP episode and then achieved meaningful pain relief after titrating FBSF by 200 µg. Most BTcP episodes relieved within 10 min. Of 63 BTcP episodes, 30 (47.6%), 46 (73.0%), and 53 (84.1%) relieved within 5, 10, and 15 min after FBSF administration. Only grade 1/2 adverse events were reported, including somnolence, malaise, and dizziness. Of the 63 BTcP episodes, 82.6% were rated as excellent/good satisfaction with FBSF.
FBSF can be administrated "on demand" by cancer patients at the onset of BTcP, providing rapid analgesia by achieving meaningful pain relief within 10 min.
This study was retrospectively registered 24 December, 2021 at Clinicaltrial.gov (NCT05209906): https://clinicaltrials.gov/study/NCT05209906 .
芬太尼颊膜（FBSF）在减轻爆发性癌痛（BTcP）疼痛强度方面的快速性和有效性的临床证据仍然不足。本研究旨在通过确定需要进一步剂量滴定的患者比例，评估 FBSF 与全天（ATC）阿片类药物方案的比例在快速缓解 BTcP 发作强度方面的疗效。
研究程序包括剂量探索期和 14 天观察期。疼痛强度用数字评分量表（NRS）记录，在 FBSF 自我给药后 5、10、15 和 30 分钟记录。有意义的疼痛缓解定义为最终 NRS 评分≤3。治疗后，每位患者使用全球满意度量表进行满意度调查。
30 例癌症患者共发生 63 例 BTcP 发作。只有 1 例患者在首次 BTcP 发作时需要抢救药物，然后通过滴定 FBSF 200μg 达到有意义的疼痛缓解。大多数 BTcP 发作在 10 分钟内缓解。在 63 例 BTcP 发作中，30 例（47.6%）、46 例（73.0%）和 53 例（84.1%）在 FBSF 给药后 5、10 和 15 分钟内缓解。仅报告了 1/2 级不良事件，包括嗜睡、不适和头晕。在 63 例 BTcP 发作中，82.6%的患者对 FBSF 非常满意/满意。
FBSF 可由癌症患者在 BTcP 发作时“按需”给药，在 10 分钟内达到有意义的疼痛缓解，从而提供快速镇痛。
本研究于 2021 年 12 月 24 日在 Clinicaltrial.gov 进行了回顾性注册（NCT05209906）：https://clinicaltrials.gov/study/NCT05209906。
