Anesthesiology and Intensive Medicine, Department of Medicine-DIMED, Padua University, Via Giustiniani 2, 35128, Padua, Italy.
Aging Clin Exp Res. 2021 Apr;33(4):973-982. doi: 10.1007/s40520-020-01586-0. Epub 2020 May 16.
Chronic low back pain (CLBP) is a highly prevalent and disabling condition in the elderly, and yet it is undertreated and understudied in this patient population. Tapentadol is a central analgesic with an improved tolerability profile that may be particularly beneficial to the elderly CLBP.
We performed an observational retrospective study to comparatively assess the efficacy and tolerability of tapentadol in young and elderly patients with severe CLBP. Sixtyfive young patients (< 65 years) and 87 elderly patients (≥ 65 years) were titrated on tapentadol extended release to their optimal dose (25-250 mg bid) over 1 month and, then, maintained at that dose for 3 months. The primary endpoint were changes from baseline in 24-h pain intensity on a 0-10 Numerical Rating Scale (NRS) at month-4 of treatment (titration plus maintenance periods). Patients were assessed for several efficacy and tolerability outcomes using a battery of scales and tests for neuropathic pain intensity, quality of life and sleep, and cognitive and gastrointestinal functions.
At pretreatment, young and elderly patients had similar pain intensities with younger patients presenting with more intense depressive and neuropathic pain symptoms, and lesser comorbidities and durations of pain (P < 0.05). Thirty-eight patients discontinued treatment because of adverse events occurring mostly during titration. Treatment with tapentadol was associated with comparable and clinically meaningful pain reductions in 24-h NRS from baseline to treatment month-4 both in young and elderly patients (- 5.3 ± 1.4 and - 4.8 ± 2.1; P < 0.01); a 50% pain relief was achieved in 66% and 58% of young and elderly patients. The percentage of patients with a neuropathic component decreased similarly in young and elderly patients (from 38 to 0% and from 19 to 3%; P < 0.01). Quality of life and sleep improved. The performances in global cognition and sustained attention tasks remained stable or improved across all age group.
These findings indicate that tapentadol extended release maintains efficacy and good tolerability in CLBP patients with advancing age.
慢性下腰痛（CLBP）是老年人中一种高发且致残性疾病，但在该人群中治疗不足且研究较少。曲马多是一种中枢性镇痛药，具有改善的耐受性，可能对老年 CLBP 患者特别有益。
我们进行了一项观察性回顾性研究，比较评估曲马多在年轻和老年重度 CLBP 患者中的疗效和耐受性。65 名年轻患者（<65 岁）和 87 名老年患者（≥65 岁）接受曲马多缓释片滴定至最佳剂量（25-250mg bid），为期 1 个月，然后维持该剂量 3 个月。主要终点为治疗第 4 个月（滴定加维持期）时 24 小时疼痛强度的变化，使用 0-10 数字评定量表（NRS）进行评估。使用一系列量表和测试评估患者的神经病理性疼痛强度、生活质量和睡眠、认知和胃肠道功能等多项疗效和耐受性指标。
在治疗前，年轻和老年患者的疼痛强度相似，年轻患者的抑郁和神经病理性疼痛症状更严重，合并症和疼痛持续时间更少（P<0.05）。38 名患者因不良反应而停止治疗，这些不良反应主要发生在滴定期。曲马多治疗与年轻和老年患者的 24 小时 NRS 基线至治疗第 4 个月的疼痛显著减轻相关（分别为-5.3±1.4 和-4.8±2.1；P<0.01）；分别有 66%和 58%的年轻和老年患者达到了 50%的疼痛缓解。年轻和老年患者的神经病理性成分百分比均相似地降低（从 38%降至 0%和从 19%降至 3%；P<0.01）。生活质量和睡眠均得到改善。在所有年龄组中，整体认知和持续注意力任务的表现保持稳定或改善。
这些发现表明，曲马多缓释片在老年 CLBP 患者中维持疗效和良好的耐受性。
