Schwittay A, Schumann C, Litzenburger B C, Schwenke K
Practice for General Medicine, Special Pain Therapy & Palliative Medicine, Böohlen, Germany.
J Pain Palliat Care Pharmacother. 2013 Aug;27(3):225-34. doi: 10.3109/15360288.2013.816406. Epub 2013 Aug 19.
This noninterventional, prospective study investigated the administration of tapentadol prolonged release (PR; the dosage form described in this article is commercially available in Germany as Palexia retard; Grünenthal GmbH, Aachen) for severe chronic pain in routine clinical practice over a 3-month period. Effectiveness analyses included data from 3134 patients; 1331 received World Health Organization (WHO) Step III pretreatment. A total of 97.8% of patients received long-term analgesic pretreatment (42.5% with strong opioids). Switching to tapentadol PR produced a 3.9-point mean pain reduction (baseline, 7.0 ± 1.5; end of observation, 3.1 ± 1.8; 11-point numerical rating scale; descriptive P value ≤.001); 72.1% of patients experienced clinically relevant pain relief (≥50%) at the end of observation. Significant decreases in pain-related impairment of daily activities and improvements in quality of life (descriptive P value ≤.001) were observed with tapentadol PR with good tolerability. Tapentadol PR was effective for various pain indications in patients previously receiving strong opioids (67.2% achieved clinically relevant pain relief). Tapentadol PR can be considered an alternative therapy to classical opioids for treatment of severe chronic pain.
这项非干预性前瞻性研究调查了曲马多缓释制剂(PR;本文所述剂型在德国作为Palexia retard上市销售;德国亚琛的Grünenthal GmbH公司)在常规临床实践中用于治疗重度慢性疼痛3个月的情况。有效性分析纳入了3134例患者的数据;其中1331例患者接受了世界卫生组织(WHO)三阶梯预处理。共有97.8%的患者接受了长期镇痛预处理(42.5%使用强阿片类药物)。改用曲马多缓释制剂后,平均疼痛评分降低了3.9分(基线时为7.0±1.5;观察结束时为3.1±1.8;采用11分数字评分量表;描述性P值≤0.001);72.1%的患者在观察结束时获得了临床相关的疼痛缓解(≥50%)。使用曲马多缓释制剂时,疼痛相关的日常活动障碍显著减轻,生活质量得到改善(描述性P值≤0.001),且耐受性良好。曲马多缓释制剂对先前接受强阿片类药物治疗的患者的各种疼痛指征均有效(67.2%的患者获得了临床相关的疼痛缓解)。曲马多缓释制剂可被视为治疗重度慢性疼痛的经典阿片类药物的替代疗法。