Guerriero Fabio, Sgarlata Carmelo, Marcassa Claudio, Ricevuti Giovanni, Rollone Marco
Azienda di Servizi alla Persona of Pavia, Istituto di Cura Santa Margherita, Pavia, Italy ; Department of Internal Medicine and Medical Therapy, University of Pavia, Pavia, Italy.
Department of Internal Medicine and Medical Therapy, University of Pavia, Pavia, Italy.
Clin Interv Aging. 2014 Dec 16;10:1-11. doi: 10.2147/CIA.S72521. eCollection 2015.
Chronic pain is highly prevalent in older adults. Increasing evidence indicates strong opioids as a valid option for chronic pain management in geriatrics. The aim of this study was to evaluate efficacy and safety of low-dose oral prolonged-release oxycodone-naloxone (OXN-PR) in patients aged ≥70 years.
This open-label prospective study assessed older patients naïve to strong opioids presenting with moderate-to-severe chronic pain. Patients were prescribed OXN-PR at an initial dose of 10/5 mg/day for 28 days. In case of insufficient analgesia, the initial daily dose could be increased gradually. The primary efficacy measure was change in pain intensity from baseline, assessed by a ten-point Numeric Rating Scale (NRS) at day 28 (T28). Changes in cognitive state, daily functioning, quality of life, constipation, and other adverse events were assessed.
Of 53 patients enrolled (mean 81.7±6.2 years [range 70-92 years]), 52 (98.1%) completed the 28-day observation. At T28, the primary end point (≥30% reduction in mean pain from baseline in the absence of bowel function deterioration) was achieved in 38 patients (71.7%). OXN-PR significantly relieved pain (NRS score -3.26; P<0.0001), as well as daily need for rescue paracetamol (from 86.8% at baseline to 40.4% at T28; P<0.001), and reduced impact of pain on daily activities (Brief Pain Inventory Short Form from 6.2±1.5 to 3.4±2.1; P<0.0001). OXN-PR was also associated with significant improvement in daily functioning (Barthel Index from 53.3±14.1 to 61.3±14.3; P<0.01). No changes were observed in cognitive status and bowel function. OXN-PR was well tolerated; only one patient (1.9%) prematurely withdrew from treatment, due to drowsiness.
Findings from this open-label prospective study suggest that low-dose OXN-PR may be effective and well tolerated for treatment of moderate-to-severe chronic pain in older patients. Besides its effectiveness, these data indicate that low-dose OXN-PR may be considered a safe analgesic option in this fragile population and warrants further investigation in randomized controlled studies.
慢性疼痛在老年人中极为普遍。越来越多的证据表明，强效阿片类药物是老年慢性疼痛管理的有效选择。本研究的目的是评估低剂量口服缓释羟考酮 - 纳洛酮（OXN-PR）在70岁及以上患者中的疗效和安全性。
这项开放标签的前瞻性研究评估了初次使用强效阿片类药物且患有中度至重度慢性疼痛的老年患者。患者初始剂量为10/5毫克/天的OXN-PR，持续服用28天。若镇痛效果不足，初始每日剂量可逐渐增加。主要疗效指标是第28天（T28）时疼痛强度相对于基线的变化，通过十点数字评定量表（NRS）进行评估。评估认知状态、日常功能、生活质量、便秘及其他不良事件的变化。
53名入组患者（平均年龄81.7±6.2岁[范围70 - 92岁]）中，52名（98.1%）完成了28天的观察。在T28时，38名患者（71.7%）达到主要终点（在无肠道功能恶化的情况下，平均疼痛较基线降低≥30%）。OXN-PR显著缓解疼痛（NRS评分 -3.26；P<0.0001），以及对急救对乙酰氨基酚的每日需求（从基线时的86.8%降至T28时的40.4%；P<0.001），并减轻疼痛对日常活动的影响（简明疼痛问卷简表从6.2±1.5降至3.4±2.1；P<0.0001）。OXN-PR还与日常功能的显著改善相关（Barthel指数从53.3±14.1升至61.3±14.3；P<0.01）。认知状态和肠道功能未观察到变化。OXN-PR耐受性良好；仅有一名患者（1.9%）因嗜睡而提前退出治疗。
这项开放标签前瞻性研究的结果表明，低剂量的OXN-PR可能对老年患者中度至重度慢性疼痛的治疗有效且耐受性良好。除了其有效性外，这些数据表明低剂量的OXN-PR在这个脆弱人群中可能被视为一种安全的镇痛选择，值得在随机对照研究中进一步研究。
