Böhme K
Group Practice for Anaesthesia, Burgfeld Hospital, Kassel, Germany.
Clin Rheumatol. 2002 Feb;21 Suppl 1:S13-6. doi: 10.1007/s100670200031.
Advanced patch technology has yielded a novel transdermal therapeutic system (TDS) for the rate-controlled systemic delivery of buprenorphine. Buprenorphine TDS is available in three strengths with release rates of 35, 52.5 and 70 microg/h over 72 h, corresponding to daily doses of 0.8, 1.2 and 1.6 mg, respectively. In total, 445 patients with chronic pain of malignant or non-malignant origin requiring long-term treatment with potent opioid analgesics were enrolled in the clinical trial programme. The patients were treated with buprenorphine TDS in one of three dosage strengths or with placebo TDS in a randomised double-blind setting. Greater pain relief was documented in patients treated with buprenorphine TDS than in those treated with placebo. The benefit of buprenorphine TDS was further reflected in the larger number of patients who slept for longer than 6 h per night. Patients switching from Step 2 or Step 3 opioids to buprenorphine TDS encountered no problems with the conversion. Typical opioid-related adverse events were reported with a low incidence and mild intensity. In an open follow-up study 239 patients elected to continue treatment with buprenorphine TDS. The confirmation of clinical benefit, coupled with a high level of patient compliance and improved quality of life, substantiate the usefulness of buprenorphine TDS in a practical setting.
先进的贴片技术已产生一种用于丁丙诺啡控速全身给药的新型透皮治疗系统（TDS）。丁丙诺啡TDS有三种规格，在72小时内的释放速率分别为35、52.5和70微克/小时，分别对应于每日剂量0.8、1.2和1.6毫克。总共有445名患有恶性或非恶性起源慢性疼痛且需要长期使用强效阿片类镇痛药治疗的患者参加了临床试验项目。患者在随机双盲环境中接受三种剂量规格之一的丁丙诺啡TDS或安慰剂TDS治疗。与接受安慰剂治疗的患者相比，接受丁丙诺啡TDS治疗的患者疼痛缓解更明显。丁丙诺啡TDS的益处还体现在每晚睡眠时间超过6小时的患者数量更多。从第二步或第三步阿片类药物转换为丁丙诺啡TDS的患者在转换过程中未遇到问题。典型的阿片类药物相关不良事件报告发生率低且强度轻。在一项开放性随访研究中，239名患者选择继续使用丁丙诺啡TDS治疗。临床益处的证实，加上高水平的患者依从性和生活质量的改善，证实了丁丙诺啡TDS在实际应用中的有效性。
