摘要

InstanylA (R) (intranasal fentanyl spray) is a novel treatment for breakthrough pain (BTP) in cancer patients. It has shown a rapid onset of pain relief in clinical trials. This study examines the use of InstanylA (R) in real-life settings. A 3-month observational, prospective, cohort study of cancer patients with BTP receiving InstanylA (R) (50, 100, or 200 mu g) under routine clinical practice. Data were collected at three time points corresponding with routine clinic visits - baseline, Week 4, and Week 13. Primary outcomes: success of titration and maintenance dose after titration. Secondary outcomes: change in maintenance dose of InstanylA (R) and level of background pain medication; Brief Pain Inventory-Short Form (BPI-SF) and Patient Treatment Satisfaction Scale (PTSS) scores; adverse drug reactions (ADRs). Titration with InstanylA (R) was successful in 84.5 % of 309 patients; most patients were titrated at the lowest dose (50 mu g). The majority showed no change in maintenance dose, with little change in the level of background pain medication. BPI-SF and PTSS scores significantly improved from baseline to Week 4. The main reason for terminating InstanylA (R) was death, as expected due to the underlying disease; incidence of ADRs was low and no fatal ADRs were reported. In a real-life group of cancer patients with disease progression, InstanylA (R) was titrated successfully at doses < 200 mu g in the majority of patients, requiring only one dose, with no further change in maintenance dose. Pain severity, impact of pain on daily life, and treatment satisfaction significantly improved with InstanylA (R) treatment. No unexpected ADRs occurred.

  • 出版日期2014-6