Institute for Quality Assurance in Pain Therapy and Palliative Care Medicine (Institut für Qualitätssicherung in Schmerztherapie und Palliativmedizin, IQUISP), Nürnberg, Germany.
Curr Med Res Opin. 2011 Jul;27(7):1385-94. doi: 10.1185/03007995.2011.583231. Epub 2011 May 11.
Breakthrough cancer pain (BTcP) affects more than half of patients with cancer pain and has severe detrimental impacts on quality of life (QoL). This study evaluated the efficacy, QoL impact and safety of sublingual fentanyl orally disintegrating tablet (sublingual fentanyl ODT), for the treatment of BTcP in a clinical setting.
This was a prospective, multi-center phase IV study. Opioid-tolerant adult patients with BTcP received sublingual fentanyl ODT in the course of routine clinical practice, and completed questionnaires over a 28-day observation period. Efficacy was assessed using measures of maximum BTcP intensity and the times to first effect and maximum effect of sublingual fentanyl ODT. Changes in QoL were evaluated using the modified pain disability index (mPDI) and the hospital anxiety and depression scale (HADS). Adverse events were recorded throughout.
Of 217 enrolled patients, 181 (83.4%) completed the observation period. During the study, 3163 episodes were treated with a mean dose of 401.4 μg per episode. The study recorded a significant improvement in maximum BTcP intensity with sublingual fentanyl ODT, compared with baseline (p < 0.0001). Patients reported experiencing the first effects of the study drug within 5 minutes of administration in 67.7% of episodes, and maximum effect within 30 minutes in 63.2% of episodes. mPDI and HADS scores significantly improved during the observation period (p < 0.0001). Sublingual fentanyl ODT was well-tolerated, with 12 patients (5.5%) experiencing ≥1 study drug-related adverse event. Study limitations include a modest size and duration, and the single-arm design.
Under the conditions of a phase IV study, sublingual fentanyl ODT was effective and well-tolerated for the treatment of BTcP in opioid-tolerant cancer patients. Study treatment was associated with significant improvements in BTcP intensity and QoL scores, and patients reported rapid onset of action in the majority of episodes.
突破性癌痛（BTcP）影响超过一半的癌痛患者，对生活质量（QoL）有严重的不利影响。本研究评估了舌下芬太尼口腔崩解片（sublingual fentanyl ODT）在临床环境下治疗 BTcP 的疗效、对 QoL 的影响和安全性。
这是一项前瞻性、多中心的 IV 期研究。阿片类药物耐受的 BTcP 成年患者在常规临床实践中接受舌下芬太尼 ODT，在 28 天观察期内完成问卷。使用舌下芬太尼 ODT 的最大 BTcP 强度和首次起效时间和最大效应的测量来评估疗效。使用改良疼痛残疾指数（mPDI）和医院焦虑抑郁量表（HADS）评估 QoL 的变化。整个过程中记录不良反应。
在 217 名入组患者中，181 名（83.4%）完成了观察期。在研究期间，3163 个发作用平均剂量 401.4μg 进行治疗。与基线相比，研究记录了舌下芬太尼 ODT 治疗 BTcP 最大强度的显著改善（p<0.0001）。在 67.7%的发作中，患者报告在给药后 5 分钟内首次感受到研究药物的作用，在 63.2%的发作中在 30 分钟内达到最大效应。在观察期间，mPDI 和 HADS 评分显著改善（p<0.0001）。舌下芬太尼 ODT 耐受性良好，12 名患者（5.5%）经历了≥1 次与研究药物相关的不良事件。研究局限性包括规模和持续时间较小，以及单臂设计。
在 IV 期研究条件下，舌下芬太尼 ODT 治疗阿片类药物耐受的癌症患者 BTcP 有效且耐受性良好。研究治疗与 BTcP 强度和 QoL 评分的显著改善相关，大多数发作中患者报告起效迅速。
