丁丙诺啡透皮贴剂治疗慢性腰背痛患者的阿片类药物治疗。
Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain.
机构信息
Mount Sinai Hospital, Toronto, Ontario, Canada.
出版信息
Pain Res Manag. 2010 May-Jun;15(3):169-78. doi: 10.1155/2010/216725.
OBJECTIVE
The present randomized, double-blinded, crossover study compared the efficacy and safety of a seven-day buprenorphine transdermal system (BTDS) and placebo in patients with low back pain of moderate or greater severity for at least six weeks.
METHODS
Prestudy analgesics were discontinued the evening before random assignment to 5 microg/h BTDS or placebo, with acetaminophen 300 mg/codeine 30 mg, one to two tablets every 4 h to 6 h as needed, for rescue analgesia. The dose was titrated to effect weekly, if tolerated, to 10 microg/h and 20 microg/h BTDS. Each treatment phase was four weeks.
RESULTS
Fifty-three patients (28 men, 25 women, mean [+/- SD] age 54.5+/-12.7 years) were evaluable for efficacy (completed two weeks or more in each phase). Baseline pain was 62.1+/-15.5 mm (100 mm visual analogue scale) and 2.5+/-0.6 (five-point ordinal scale). BTDS resulted in lower mean daily pain scores than in the placebo group (37.6+/-20.7 mm versus 43.6+/-21.2 mm on a visual analogue scale, P=0.0487; and 1.7+/-0.6 versus 2.0+/-0.7 on the ordinal scale, P=0.0358). Most patients titrated to the highest dose of BTDS (59% 20 microg/h, 31% 10 microg/h and 10% 5 microg/h). There were improvements from baseline in pain and disability (Pain Disability Index), Pain and Sleep (visual analogue scale), Quebec Back Pain Disability Scale and Short-Form 36 Health Survey scores for both BTDS and placebo groups, without significant differences between treatments. While there were more opioid-related side effects with BTDS treatment than with placebo, there were no serious adverse events. A total of 82% of patients chose to continue BTDS in a long-term open-label evaluation, in whom improvements in pain intensity, functionality and quality of life were sustained for up to six months without analgesic tolerance.
CONCLUSION
BTDS (5 microg/h to 20 microg/h) represents a new treatment option for initial opioid therapy in patients with chronic low back pain.
目的
本随机、双盲、交叉研究比较了 7 天丁丙诺啡透皮贴剂（BTDS）和安慰剂在至少 6 周内中重度腰痛患者中的疗效和安全性。
方法
在随机分组前一天晚上，停止使用预研究的镇痛药，患者随机接受 5μg/h BTDS 或安慰剂，同时给予对乙酰氨基酚 300mg/可待因 30mg，每 4-6 小时按需服用 1-2 片，作为解救性镇痛药。如果耐受，每周滴定剂量，将 BTDS 剂量增至 10μg/h 和 20μg/h。每个治疗阶段为 4 周。
结果
53 例患者（28 例男性，25 例女性，平均年龄 54.5+/-12.7 岁）可评估疗效（每个阶段完成 2 周或更长时间）。基线疼痛为 62.1+/-15.5mm（100mm 视觉模拟评分）和 2.5+/-0.6（五分序贯评分）。BTDS 组的平均每日疼痛评分低于安慰剂组（视觉模拟评分分别为 37.6+/-20.7mm 和 43.6+/-21.2mm，P=0.0487；序贯评分分别为 1.7+/-0.6 和 2.0+/-0.7，P=0.0358）。大多数患者滴定至 BTDS 的最高剂量（59%为 20μg/h，31%为 10μg/h，10%为 5μg/h）。BTDS 和安慰剂组的疼痛和残疾（疼痛残疾指数）、疼痛和睡眠（视觉模拟评分）、魁北克腰痛残疾评分和健康调查简表 36 评分均较基线改善，治疗组之间无显著差异。虽然 BTDS 治疗组比安慰剂组出现更多的阿片类药物相关副作用，但没有严重的不良事件。在为期 6 个月的长期开放标签评估中，82%的患者选择继续使用 BTDS，在此期间，疼痛强度、功能和生活质量持续改善，且无镇痛耐受。
结论
BTDS（5μg/h 至 20μg/h）为慢性腰痛患者的初始阿片类药物治疗提供了一种新的治疗选择。
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