Department of Medicine, Orthopedic and Traumatology Unit, University of Perugia, Perugia, Italy.
Eur Rev Med Pharmacol Sci. 2024 Apr;28(8):3227-3240. doi: 10.26355/eurrev_202404_36051.
This study aimed to evaluate pain control, functioning, and quality of life (QoL) recovery in patients with chronic low back pain (cLBP) or post-traumatic osteoarthritis (OA) pain in the ankle/foot area, treated with tapentadol prolonged release and unresponsive to other treatments.
Two observational retrospective studies were conducted using clinical practice datasets of patients with chronic pain in cLBP and OA foot/ankle at different time points (total follow-up=60-90 days). The studies assessed pain intensity by the Numerical Rating Scale (NRS) pain scale (patients were classified as responder in case of ≥30% pain reduction), QoL by the 5-level EQ-5D (EQ-5D-5L) questionnaire, patient satisfaction by the 7-point Patients' Global Impression of Change (PGIC) scale; cLBP health status by the Roland Morris Disability Questionnaire (RMDQ); foot and ankle functional status by European Foot and Ankle Society (EFAS) score; and treatment-related AEs.
For the cLBP setting, 37 patients were enrolled, of which 86.50% were classified as responders (n=32; CI: 75.5% ÷ 97.5%). For the foot/ankle OA pain setting, 21 patients were enrolled. Pain assessment at final follow-up was available only for 11 patients, of which 72.73% (n=8; CI: 39.0% ÷ 94.0%) were classified as responders. Statistically significant improvements were seen in the RMDQ, EQ-5D-5L, and PGIC scores in cLBP. Improvements in the EFAS, EQ-5D-5L, and PGIC scores were seen in OA as well. The incidence of treatment-related adverse reactions was low in both studies.
In the study population, tapentadol prolonged release was effective and well tolerated in treating cLBP and post-traumatic foot/ankle OA chronic pain when used in a multimodal manner. The reduction in pain was accompanied by clinically relevant improvements in patients' functionality and QoL.
本研究旨在评估慢性下背痛(cLBP)或创伤后踝关节/足部骨关节炎(OA)疼痛患者的疼痛控制、功能和生活质量(QoL)恢复情况,这些患者对其他治疗无反应,接受了盐酸他喷他多缓释片治疗。
使用慢性疼痛患者的临床实践数据集进行了两项观察性回顾性研究,这些患者患有 cLBP 和 OA 足部/踝关节,研究时间点不同(总随访时间为 60-90 天)。研究通过数字评分量表(NRS)疼痛量表评估疼痛强度(患者被归类为疼痛减轻≥30%的应答者),通过 5 级 EQ-5D(EQ-5D-5L)问卷评估 QoL,通过 7 点患者整体印象变化量表(PGIC)评估患者满意度;通过 Roland Morris 残疾问卷(RMDQ)评估 cLBP 健康状况;通过欧洲足部和踝关节协会(EFAS)评分评估足部和踝关节功能状况;并评估与治疗相关的不良事件。
在 cLBP 组中,纳入了 37 名患者,其中 86.50%(n=32;CI:75.5%至 97.5%)被归类为应答者。在足部/踝关节 OA 疼痛组中,纳入了 21 名患者。只有 11 名患者在最终随访时进行了疼痛评估,其中 72.73%(n=8;CI:39.0%至 94.0%)被归类为应答者。在 cLBP 中,RMDQ、EQ-5D-5L 和 PGIC 评分均有显著改善。OA 中也观察到 EFAS、EQ-5D-5L 和 PGIC 评分的改善。两项研究中与治疗相关的不良反应发生率均较低。
在研究人群中,盐酸他喷他多缓释片在多模式治疗慢性下背痛和创伤后足部/踝关节 OA 慢性疼痛时有效且耐受良好。疼痛的减轻伴随着患者功能和 QoL 的临床相关改善。