Berliner Michael N, Giesecke Thorsten, Bornhövd Karin D
Department of Physical Medicine and Rehabilitation, HELIOS Klinikum Berlin-Buch, Teaching Hospital of the Humboldt University Berlin, Hobrechtsfelder Chaussee 100, 13125 Berlin, Germany.
Clin J Pain. 2007 Jul-Aug;23(6):530-4. doi: 10.1097/AJP.0b013e318074c9b1.
The purpose of the study was to investigate the effectiveness and tolerability of transdermal fentanyl in a treatment regimen in patients with rheumatoid arthritis (RA).
Two hundred twenty-six patients (mean age 66 y) with severe pain caused by RA who had not previously been treated with transdermal fentanyl were included in this prospective, open-label study. Pain intensity, functional impairment, and well-being were documented prospectively for 30 days after treatment with transdermal fentanyl had been initiated. Patients evaluated pain on an 11-point numerical rating scale. Quality of sleep, daily and social functioning, and treatment satisfaction were rated using 5-point categorical rating scales. General well-being was assessed by the Marburg questionnaire.
Adding transdermal fentanyl to the ongoing RA therapy reduced pain intensity significantly from 8.0 (7.82 to 8.18) to 4.0 (3.75 to 4.25). Mean functional impairment due to pain also decreased significantly from "severe" at the beginning to "mild to moderate." Treatment with transdermal fentanyl also led to a significant improvement by approximately 1.5 units for all items in the Marburg questionnaire on general well-being. At the end of the study, nearly all patients were satisfied with the pain treatment. Transdermal fentanyl was generally well tolerated. The most frequent side effects were nausea (9.7%) and vomiting (7.1%).
Patients with pain caused by RA improved in terms of pain intensity, sleep, function, and general well-being when transdermal fentanyl was added to the treatment regimen. Treatment satisfaction was high. Transdermal fentanyl also demonstrated good tolerability over a period of 30 days.
本研究旨在调查透皮芬太尼在类风湿关节炎（RA）患者治疗方案中的有效性和耐受性。
本前瞻性、开放标签研究纳入了226例（平均年龄66岁）此前未接受过透皮芬太尼治疗且因RA导致严重疼痛的患者。在开始使用透皮芬太尼治疗后的30天内，前瞻性记录疼痛强度、功能障碍和健康状况。患者使用11点数字评分量表评估疼痛。使用5点分类评分量表对睡眠质量、日常和社交功能以及治疗满意度进行评分。通过马尔堡问卷评估总体健康状况。
在现有的RA治疗方案中添加透皮芬太尼可使疼痛强度从8.0（7.82至8.18）显著降低至4.0（3.75至4.25）。因疼痛导致的平均功能障碍也从开始时的“严重”显著降至“轻度至中度”。透皮芬太尼治疗还使马尔堡问卷中所有关于总体健康状况的项目显著改善了约1.5个单位。在研究结束时，几乎所有患者对疼痛治疗都感到满意。透皮芬太尼总体耐受性良好。最常见的副作用是恶心（9.7%）和呕吐（7.1%）。
当在治疗方案中添加透皮芬太尼时，因RA引起疼痛的患者在疼痛强度、睡眠、功能和总体健康状况方面均有改善。治疗满意度较高。透皮芬太尼在30天内也表现出良好的耐受性。
