Spring House Surgery, Bolton, Lancashire, United Kingdom.
J Pain Symptom Manage. 2010 Aug;40(2):266-78. doi: 10.1016/j.jpainsymman.2010.01.013. Epub 2010 Jun 11.
Osteoarthritis (OA) is a common cause of chronic pain, particularly in the older population. Modern approaches to the management of OA pain recommend tailoring treatment to the individual. This study examines treatment options for OA pain in the form of low-dose transdermal and sublingual opioid analgesia.
The aims of this trial were to compare the efficacy and tolerability of seven-day, low-dose transdermal buprenorphine patches (BuTrans, Napp Pharmaceuticals Limited UK) with sublingual buprenorphine (Temgesic, Schering-Plough Limited UK) in patients with moderate to severe pain caused by OA of the hip(s) and/or knee(s), and to establish analgesic equivalence of the two products.
Two hundred forty-six patients with OA pain in the hip(s) and/or knee(s) were enrolled in this randomized, double-blind, parallel-group study; 110 completed the study. Patients were randomized to receive transdermal buprenorphine patches (5, 10, and 20 microg/hour) or sublingual buprenorphine (200 and 400 microg tablets). Their medication was titrated to pain control and they were treated for up to seven weeks. The main outcome measures were pain intensity (primary outcome), sleep disturbance, quality of life, and safety assessments.
Patients' Box Scale-11 pain scores decreased between entry and assessment in both treatment groups. During the 28-day assessment period, the estimated mean treatment differences (95% confidence intervals) were 0.00 (-0.68,0.69), -0.11 (-0.85,0.63), and -0.13 (-0.95,0.68), for the morning, midday, and evening scores, respectively. All the confidence intervals were within the prespecified limits for equivalence (-1.5, 1.5). Use of escape medication was low. In both treatment groups, sleep disturbance caused by pain decreased between entry and assessment. Patients' quality of life improved during the study. Significantly fewer patients receiving the transdermal buprenorphine patches reported nausea (P=0.035), dizziness (P=0.026), and vomiting (P=0.039).
In conclusion, seven-day, low-dose transdermal buprenorphine patches are as effective as sublingual buprenorphine, with a better tolerability profile.
骨关节炎（OA）是慢性疼痛的常见原因，尤其是在老年人群中。OA 疼痛管理的现代方法建议根据个体情况定制治疗方案。本研究探讨了低剂量透皮和舌下阿片类镇痛药治疗 OA 疼痛的选择。
本试验的目的是比较七天低剂量透皮丁丙诺啡贴片（BuTrans，Napp 制药有限公司英国）与舌下丁丙诺啡（Temgesic，先灵葆雅有限公司英国）在髋部和/或膝部 OA 引起的中度至重度疼痛患者中的疗效和耐受性，并确定两种产品的镇痛等效性。
246 名髋部和/或膝部 OA 疼痛患者参加了这项随机、双盲、平行组研究；110 名患者完成了研究。患者被随机分配接受透皮丁丙诺啡贴片（5、10 和 20μg/h）或舌下丁丙诺啡（200 和 400μg 片剂）。根据疼痛控制情况调整他们的药物剂量，并治疗长达七周。主要观察指标为疼痛强度（主要结局）、睡眠障碍、生活质量和安全性评估。
两组患者的 Box Scale-11 疼痛评分在入组和评估时均有所下降。在 28 天评估期间，估计的平均治疗差异（95%置信区间）分别为 0.00（-0.68,0.69）、-0.11（-0.85,0.63）和-0.13（-0.95,0.68），用于清晨、中午和傍晚评分。所有置信区间均在等效性（-1.5,1.5）的预设范围内。使用解救药物的情况较低。在两组治疗中，疼痛引起的睡眠障碍在入组和评估时均有所改善。患者的生活质量在研究期间有所提高。接受透皮丁丙诺啡贴片治疗的患者报告恶心（P=0.035）、头晕（P=0.026）和呕吐（P=0.039）的发生率明显较低。
总之，七天低剂量透皮丁丙诺啡贴片与舌下丁丙诺啡一样有效，且具有更好的耐受性。
