Serpell Mick, Tripathi Shiva, Scherzinger Sabine, Rojas-Farreras Sònia, Oksche Alexander, Wilson Margaret
Gartnavel General Hospital, University of Glasgow, Glasgow, UK.
Royal Preston Hospital, Preston, UK.
Patient. 2016 Feb;9(1):35-46. doi: 10.1007/s40271-015-0151-y.
Opioids provide effective analgesia for moderate-to-severe, chronic pain. Transdermal buprenorphine (TDB) is available in the UK as weekly, lower-dose (5-20 μg/h) patches and twice-weekly, higher dose (35-70 μg/h) patches. This prospective, observational, multicenter study of patients with various chronic pain conditions assessed the safety, perceptions, and discontinuation of treatment with TDB in a real-world, non-interventional setting (ClinicalTrials.gov study ID: NCT01225861).
Patients aged ≥18 years who were already receiving or initiating treatment with TDB were recruited in the UK during routine clinical visits and were followed for 6 visits or 9 months (whichever came first). Self-reported treatment adherence, patient satisfaction, and safety data were collected at each study visit.
Of 465 patients, 272 were already receiving 7-day TDB at the study start (TDB experienced), 146 were TDB naïve, and 47 were prescribed twice-weekly TDB. Most patients were female (72.9 %) and overweight/obese (body mass index ≥25: 75.3 %). The median age was 67 years, and the mean duration of pain was 11.1 years. Arthritis/other musculoskeletal disorders (39.6 %) were the most common causes of pain. Mild adverse events were commonly reported. Skin irritations, which were most frequent in 7-day TDB-experienced patients (45.6 %), rarely resulted in treatment discontinuation (8.8 %). Nearly all patients used TDB in accordance with treatment recommendations. Most patients reported that TDB was 'effective'/'very effective' at relieving pain and were 'satisfied'/'very satisfied' with TDB therapy.
In everyday clinical practice, TDB was well tolerated and patients were satisfied with their therapy. Self-reported adherence to TDB was very high, and adverse events rarely resulted in treatment discontinuation. Opportunities were identified to limit common adverse events associated with TDB.
阿片类药物可为中重度慢性疼痛提供有效的镇痛作用。在英国,透皮丁丙诺啡(TDB)有每周一次、低剂量(5 - 20μg/小时)的贴片以及每周两次、高剂量(35 - 70μg/小时)的贴片。这项针对患有各种慢性疼痛病症患者的前瞻性、观察性、多中心研究,在真实世界、非干预性环境中评估了TDB治疗的安全性、患者感受及停药情况(ClinicalTrials.gov研究编号:NCT01225861)。
年龄≥18岁、已在接受或开始使用TDB治疗的患者,在英国常规临床就诊期间被招募,随访6次就诊或9个月(以先到者为准)。每次研究就诊时收集自我报告的治疗依从性、患者满意度及安全性数据。
465例患者中,272例在研究开始时已在接受7天一次的TDB治疗(有TDB使用经验),146例未曾使用过TDB,47例被处方每周两次的TDB。大多数患者为女性(72.9%)且超重/肥胖(体重指数≥25:75.3%)。中位年龄为67岁,平均疼痛持续时间为11.1年。关节炎/其他肌肉骨骼疾病(39.6%)是最常见的疼痛原因。轻度不良事件常见。皮肤刺激在有7天一次TDB使用经验的患者中最为频繁(45.6%),但很少导致停药(8.8%)。几乎所有患者都按照治疗建议使用TDB。大多数患者报告TDB在缓解疼痛方面“有效”/“非常有效”,并且对TDB治疗“满意”/“非常满意”。
在日常临床实践中,TDB耐受性良好,患者对其治疗满意。自我报告的TDB依从性非常高,不良事件很少导致停药。已确定有机会限制与TDB相关的常见不良事件。