Karlsson J, Söderström A, Augustini B G, Berggren A C
Sahlgrenska University Hospital, Sahlgrenska Academy, Gothenburg University , Gothenburg , Sweden.
Curr Med Res Opin. 2014 Apr;30(4):575-87. doi: 10.1185/03007995.2013.873714. Epub 2013 Dec 23.
A recent pharmacokinetic study with buprenorphine transdermal patches showed similar systemic exposures of buprenorphine in subjects aged ≥75 and 50-60 years. The current prospective, open-label study aimed to verify this in a clinical setting by evaluating efficacy and safety of buprenorphine patches in patients with chronic osteoarthritis (OA) pain.
Patients with chronic, moderate to severe osteoarthritic pain (hip and/or knee) were enrolled: 50-60 years (younger group, N = 65) and ≥75 years (elderly group, N = 57). After 2 weeks on paracetamol only, patients received buprenorphine patches (5-40 µg/h) for 12 weeks. Paracetamol rescue was provided. Primary endpoint was the Box-Scale-11 (BS-11) score for pain on average over the last week. WOMAC OA Index, EQ-5D, Patients' and Investigators' Global Assessment of Pain Relief, rescue medication use, sleep disturbance and quality of sleep were secondary efficacy endpoints.
Both groups showed a statistically significant (p < 0.0001) and clinically relevant change from baseline to last visit in BS-11 score, with no significant difference between groups. The least squares (LS) mean change from baseline was 2.20 in elderly and 1.87 in younger patients, with an age group difference of 0.33 (95% CI: -0.42, 1.07). Non-inferiority of the elderly versus the younger group was shown. Both age groups showed a significant improvement in WOMAC total score, patients' overall health state (EQ-5D visual analogue scale) and sleep quality, and a significant reduction in rescue use and nights woken due to pain, with no significant differences between groups. Elderly patients tolerated buprenorphine patches at least as well as younger patients.
Efficacy and tolerability of buprenorphine patches was demonstrated in chronic pain patients, regardless of age, supporting the conclusion that no age-related dose adjustment of transdermal buprenorphine is needed. A study limitation is lack of active control but no other opioid was appropriate in elderly patients or this indication.
近期一项关于丁丙诺啡透皮贴剂的药代动力学研究表明，年龄≥75岁和50 - 60岁的受试者中丁丙诺啡的全身暴露量相似。当前这项前瞻性、开放标签研究旨在通过评估丁丙诺啡贴剂对慢性骨关节炎（OA）疼痛患者的疗效和安全性，在临床环境中验证这一结果。
纳入患有慢性中重度骨关节炎疼痛（髋关节和/或膝关节）的患者：50 - 60岁（较年轻组，N = 65）和≥75岁（老年组，N = 57）。仅服用对乙酰氨基酚2周后，患者接受丁丙诺啡贴剂（5 - 40μg/h）治疗12周。提供对乙酰氨基酚解救用药。主要终点为过去一周平均疼痛的Box - Scale - 11（BS - 11）评分。WOMAC OA指数、EQ - 5D、患者和研究者的疼痛缓解总体评估、解救药物使用情况、睡眠障碍及睡眠质量为次要疗效终点。
两组从基线到末次访视的BS - 11评分均有统计学显著差异（p < 0.0001）且具有临床相关性变化，组间无显著差异。老年患者从基线的最小二乘（LS）平均变化为2.20，较年轻患者为1.87，年龄组差异为0.33（95%CI：-0.42，1.07）。显示老年组不劣于较年轻组。两个年龄组在WOMAC总分、患者总体健康状况（EQ - 5D视觉模拟量表）和睡眠质量方面均有显著改善，解救用药使用及因疼痛醒来的夜晚数显著减少，组间无显著差异。老年患者对丁丙诺啡贴剂的耐受性至少与较年轻患者一样好。
丁丙诺啡贴剂在慢性疼痛患者中显示出疗效和耐受性，无论年龄如何，支持无需对丁丙诺啡透皮贴剂进行与年龄相关的剂量调整这一结论。研究的局限性在于缺乏活性对照，但在老年患者或该适应症中没有其他阿片类药物适用。
