Anesthesia and Intensive Care Unit, La Maddalena Cancer Center, Palermo, Italy.
Curr Med Res Opin. 2012 Jun;28(6):963-8. doi: 10.1185/03007995.2012.683112. Epub 2012 May 22.
The aim of this study was to compare the efficacy and safety of doses of fentanyl buccal tablet (FBT) proportional to doses of opioids used for background analgesia versus dose titration starting with the minimal dose for the management of breakthrough cancer pain (BTcP).
A total of 82 cancer patients with BTcP who were receiving strong opioids in doses of at least 60 mg of oral morphine equivalents and having acceptable background analgesia, were selected for a multicenter unblinded study. Forty-one patients were randomized to receive FBT in doses proportional to the daily opioid doses for four consecutive episodes of BTcP (group P). Forty-one patients underwent dose titration of FBT, with an initial dose of 100 µg, for four consecutive episodes (group T). Pain intensity and symptoms associated with opioid therapy were measured before administering any dose of FBT (T0) and 15 minutes after (T15).
In all, 80 patients were considered for analysis (39 and 41 patients in group P and T, respectively). Patients were receiving a mean of 126 ± 100 mg of oral morphine equivalents (range 60-480 mg) for background analgesia. A total of 293 episodes of BTcP (144 and 149 in group P and T, respectively) were treated and considered for analysis. No differences were found in the decrease of pain intensity between the two groups. However, in patients receiving doses of oral morphine equivalents of >120 mg/day, a significant number of patients obtained a decrease in pain intensity >50% in group P in comparison with group T (p = 0.040). Also, the need for rescue medication was significantly more frequently reported in group T for the first episode of BTcP (p < 0.0005). No differences in the level of adverse effects were observed between the two groups. No differences in patients' satisfaction were reported.
According to the data obtained in this study, there is no evidence for the use of dose titration in the management of BTcP in opioid-tolerant patients. Indeed, doses proportional to basal opioid regimen for background pain seem to be effective and safe in the majority of patients. Further studies should confirm this data in patients receiving higher doses of opioids, with other rapid-onset opioids, and in other settings.
本研究旨在比较芬太尼颊片剂（FBT）剂量与用于背景镇痛的阿片类药物剂量成比例，与从管理突破性癌痛（BTcP）的最小剂量开始滴定剂量相比，其疗效和安全性。
共选择 82 例因 BTcP 而正在接受至少 60mg 口服吗啡等效物强阿片类药物且背景镇痛可接受的癌症患者进行多中心非盲研究。41 例患者被随机分为两组，连续 4 次 BTcP 发作时接受 FBT 剂量与每日阿片类药物剂量成比例（组 P）。41 例患者接受 FBT 剂量滴定，初始剂量为 100μg，连续 4 次（组 T）。在给予任何剂量 FBT 之前（T0）和 15 分钟后（T15）测量疼痛强度和与阿片类药物治疗相关的症状。
共有 80 例患者被纳入分析（组 P 和 T 分别为 39 例和 41 例）。患者接受背景镇痛的平均吗啡等效物剂量为 126±100mg（范围 60-480mg）。共治疗和分析了 293 次 BTcP（组 P 和 T 分别为 144 次和 149 次）。两组之间疼痛强度的降低无差异。然而，在接受>120mg/天吗啡等效物剂量的患者中，与组 T 相比，组 P 中有显著更多的患者疼痛强度降低>50%（p=0.040）。此外，对于 BTcP 的首次发作，组 T 报告需要急救药物的频率明显更高（p<0.0005）。两组之间未观察到不良反应水平的差异。两组患者的满意度无差异。
根据本研究获得的数据，在阿片类药物耐受患者中，BTcP 管理中没有证据支持剂量滴定。事实上，对于大多数患者而言，与背景疼痛的基础阿片类药物方案剂量成比例的剂量似乎是有效且安全的。应进一步研究在接受更高剂量阿片类药物的患者中、使用其他快速起效的阿片类药物和在其他情况下确认这些数据。
