Mid-America Physiatrists, Overland Park, KS, USA.
Curr Med Res Opin. 2011 Apr;27(4):751-60. doi: 10.1185/03007995.2011.554808. Epub 2011 Feb 2.
To evaluate the long-term dosing, safety, and tolerability of fentanyl buccal tablet (FBT) in a large cohort of opioid-tolerant patients with chronic noncancer pain and breakthrough pain (BTP).
Combined analysis of three double-blind, placebo-controlled, and two open-label studies.
Of 1160 patients who received ≥1 dose of FBT, 83% achieved a successful dose, ranging from 100 to 800 μg, mostly at 600 or 800 μg. Not all of the patients included in this analysis were enrolled in long-term studies and 156 (13%) patients were still receiving ongoing treatment when their study site closed. Median treatment duration was 106.0 days. The mean FBT dose in the post-titration population (n = 946) increased from 2108 to 3132 μg/day, with ≥1 FBT dose increase in 27% of patients; most dose increases occurred during the first 6 months. The FBT daily dose as a proportion of the daily opioid dose remained fairly stable (59-65%) throughout the treatment period. Overall, 925 (80%) enrolled patients had ≥1 adverse event (AE). The most frequent AEs were nausea (21% of patients), vomiting (11%), dizziness (10%), and headache (10%). Common AEs generally occurred within 7 days of starting treatment and lasted for ≤2 days. Serious AEs occurred in 136 (12%) patients and included six deaths (none related to FBT) and 11 instances of opioid overdose (all with satisfactory resolution). AE-related discontinuations occurred in 163 (14%) patients and were similar to the common AEs.
Despite the limitations, including the controlled clinical setting, this pooled analysis of several clinical studies provides valuable information for the long-term management of BTP with FBT. Patients require regular evaluation and, when necessary, adjustment of opioid medications to maintain adequate pain control. FBT was generally safe and well tolerated in this setting.
评估芬太尼颊片剂（FBT）在大量慢性非癌痛和爆发痛（BTP）的阿片类药物耐受患者中的长期剂量、安全性和耐受性。
三项双盲、安慰剂对照和两项开放标签研究的联合分析。
在接受至少 1 剂 FBT 的 1160 名患者中，83%的患者达到了成功剂量，范围为 100 至 800μg，大多数为 600 或 800μg。并非所有纳入本分析的患者都参加了长期研究，当研究地点关闭时，仍有 156 名（13%）患者正在接受持续治疗。中位治疗持续时间为 106.0 天。在滴定后人群（n=946）中，FBT 的平均剂量从 2108μg/天增加到 3132μg/天，27%的患者至少增加了 1 次剂量；大多数剂量增加发生在最初 6 个月内。在整个治疗期间，FBT 日剂量作为阿片类药物日剂量的比例相对稳定（59-65%）。总体而言，80%（925 名）入组患者发生了≥1 次不良事件（AE）。最常见的 AE 是恶心（21%的患者）、呕吐（11%）、头晕（10%）和头痛（10%）。常见 AE 通常在开始治疗后 7 天内发生，持续时间不超过 2 天。136 名（12%）患者发生严重 AE，包括 6 例死亡（均与 FBT 无关）和 11 例阿片类药物过量（均有满意的解决办法）。因 AE 而停药的患者有 163 名（14%），与常见 AE 相似。
尽管存在局限性，包括对照临床环境，本研究对几项临床研究进行了汇总分析，为 FBT 治疗 BTP 的长期管理提供了有价值的信息。患者需要定期评估，并在必要时调整阿片类药物以维持充分的疼痛控制。在这种情况下，FBT 通常是安全且耐受良好的。
