Lange Thomas, Krings Doris, Waldmann-Rex Susanne
Anästhesie und Schmerztherapie, Rudolstadt, Deutschland.
MMW Fortschr Med. 2015 Apr;157(157 Suppl 4):12-21. doi: 10.1007/s15006-015-2932-6. Epub 2015 Apr 8.
To assess effectiveness and tolerability of tapentadol prolonged release (PR, Palexia® retard) for the treatment of severe chronic pain under routine clinical practice conditions in Germany.
In this prospective non-interventional study, data regarding previous and concomitant analgesic treatment, tapentadol dosage, pain intensity, functionality, quality of life, and tolerability of tapentadol PR were collected over a 3-month observation period. A total of 5,002 patients were included in the effectiveness analysis; a subgroup analysis assessed effectiveness for all patients receiving tapentadol monotherapy (n = 1476).
Nearly all patients of the total study population (95.9%) had already received analgesic long-term treatment (31.7% strong opioids) prior to the start of the study. Treatment with tapentadol PR (mean daily dose 216 ± 103 mg at end of observation) resulted in a reduction in pain intensity of 3.9 points from 7.2 ± 1.4 at baseline (95%CI -3.93; -3.83; p ≤ 0.001; NRS-11); clinically relevant pain relief ≥ 50% was documented for 65.1% of the patients. All 4 evaluated aspects regarding pain-related functionality, and quality of life of the patients also improved significantly. Compared to the total patient population, pain relief was greater in the subgroup receiving tapentadol monotherapy; baseline pain intensity was comparable between the groups. Pain-related functional impairment also declined to a slightly greater extent, and quality of life was rated more positively at end of observation.
Analgesic treatment with tapentadol PR in routine clinical practice resulted in a marked reduction of severe chronic pain with significant improvements of functionality and quality of life. On the basis of these results and the favourable safety profile, tapentadol PR can thus be considered an alternative to classical opioids in the treatment of severe chronic pain.
评估在德国常规临床实践条件下，曲马多缓释片（PR，Palexia® retard）治疗重度慢性疼痛的有效性和耐受性。
在这项前瞻性非干预性研究中，在3个月的观察期内收集了有关既往和同时进行的镇痛治疗、曲马多剂量、疼痛强度、功能、生活质量以及曲马多缓释片耐受性的数据。共有5002例患者纳入有效性分析；亚组分析评估了所有接受曲马多单药治疗患者（n = 1476）的有效性。
几乎所有研究总体患者（95.9%）在研究开始前已接受过长期镇痛治疗（31.7%使用强阿片类药物）。曲马多缓释片治疗（观察期末平均日剂量216±103 mg）使疼痛强度从基线时的7.2±1.4分降低了3.9分（95%CI -3.93；-3.83；p≤0.001；NRS - 11）；65.1%的患者记录到临床相关疼痛缓解≥50%。患者疼痛相关功能和生活质量的所有4个评估方面也有显著改善。与总体患者相比，接受曲马多单药治疗的亚组疼痛缓解更大；两组间基线疼痛强度相当。疼痛相关功能损害也有稍大程度的下降，观察期末生活质量评分更积极。
在常规临床实践中，曲马多缓释片镇痛治疗可显著减轻重度慢性疼痛，功能和生活质量有显著改善。基于这些结果和良好的安全性，曲马多缓释片可被视为治疗重度慢性疼痛时经典阿片类药物的替代药物。
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