Regionales Schmerzzentrum Berlin Prenzlauer Berg der DGS e.V , Ostseestr. 107, 10409 Berlin , Germany.
Expert Opin Pharmacother. 2012 Feb;13(3):299-311. doi: 10.1517/14656566.2012.648615. Epub 2012 Jan 6.
Opioids have shown consistent efficacy in neuropathic pain, but opioid-induced bowel dysfunction is a relevant problem. In controlled clinical trials, a fixed-dose combination of prolonged-release (PR) oxycodone/PR naloxone was superior to oxycodone alone in bowel function, while providing effective analgesia. The present report is an analysis of its efficacy and safety in a subgroup of patients with severe chronic neuropathic pain who were treated in a large observational study under real-life conditions.
Dosed according to pain severity, 1488 patients with chronic severe neuropathic pain received PR oxycodone/PR naloxone for up to 4 weeks. Variables included pain severity, patient-reported bowel function (Bowel Function Index; BFI) and quality of life.
During treatment with PR oxycodone/PR naloxone, mean pain intensity decreased in opioid-naive and opioid-pretreated patients. After 4 weeks on treatment, mean BFI scores were reduced from 41.6 ± 31.6 at the initiation visit to 16.5 ± 19.6 (p < 0.001), reflecting normal bowel function. Quality of life was improved by 47%.
Treatment of severe neuropathic pain with PR oxycodone/PR naloxone provided effective analgesia with the added benefit of favorable effects on bowel function and quality of life.
阿片类药物在治疗神经性疼痛方面具有一致性疗效，但阿片类药物引起的肠道功能紊乱是一个相关问题。在对照临床试验中，与单独使用羟考酮相比，持续释放（PR）羟考酮/PR 纳洛酮固定剂量组合在改善肠道功能方面具有优势，同时提供有效的镇痛作用。本报告分析了其在一项大型真实世界观察性研究中治疗严重慢性神经性疼痛亚组患者的疗效和安全性。
根据疼痛严重程度，1488 例慢性严重神经性疼痛患者接受 PR 羟考酮/PR 纳洛酮治疗，最长达 4 周。变量包括疼痛严重程度、患者报告的肠道功能（肠道功能指数；BFI）和生活质量。
在接受 PR 羟考酮/PR 纳洛酮治疗期间，阿片类药物初治和预处理患者的平均疼痛强度均有所下降。治疗 4 周后，BFI 评分从起始访视时的 41.6 ± 31.6 降至 16.5 ± 19.6（p < 0.001），反映了正常的肠道功能。生活质量提高了 47%。
PR 羟考酮/PR 纳洛酮治疗严重神经性疼痛可提供有效的镇痛作用，且对肠道功能和生活质量具有有利影响。
