van Dongen V C P C, Vanelderen P J L, Koopmans-Klein G, van Megen Y J B, Van Zundert J, Huygen F J P M
Department of Anesthesiology and Pain Medicine, Orbis Medisch Centrum, Sittard-Geleen, The Netherlands.
Int J Clin Pract. 2014 Nov;68(11):1364-75. doi: 10.1111/ijcp.12468. Epub 2014 May 23.
The aim of this study was to assess patient preference in terms of quality of life (QoL), analgesia and bowel function for patients with moderate to severe chronic non-malignant pain, when treated with oxycodone PR/naloxone PR compared with the previous WHO-step I and/or WHO-step II analgesic treatment .
This was a 3-week open-label phase 3b study conducted in Belgium and the Netherlands, after 3 weeks patients could enter an extension phase. Patient preference with respect to QoL for oxycodone PR/naloxone PR treatment compared with previous WHO-step I and/or WHO-step II analgesics was assessed. A patient was considered a responder with respect to QoL if this assessment was 'better' or 'much better' compared with previous WHO-step I or II analgesics at any time point.
Response rate with respect to QoL was 59.2% (95% CI: 51.7-66.8%) for the Full Analysis (FA)-population, for the Per Protocol-population response rate was 71.7% (95% CI: 63.1-80.3%). Explorative analysis showed that response rate with respect to QoL was highest in constipated patients pretreated with WHO-step II analgesics (73.8%). Mean ± SD pain score in the FA-population at start was 74.7 ± 16.6 decreasing to 53.9 ± 24.3 after a median (range) treatment period of 173.5 (31-771) days. For constipated subjects the significant reduction in constipation [improvement of the Bowel Function Index (BFI)], was -24.8 points (95% CI: -17.1 to -32.5). BFI for non-constipated subjects remained well below 28.8. Adverse events with oxycodone PR/naloxone PR treatment were well-known opioid-related adverse events.
This study shows that the studied patients previously treated with WHO-step I and/or WHO-step II analgesics prefer treatment with oxycodone PR/naloxone PR with respect to QoL. Moreover, the study shows that treatment with oxycodone PR/naloxone PR significantly reduces OIC in constipated patients and that non-constipated patients do not develop OIC during treatment with oxycodone PR/naloxone PR.
本研究旨在评估中重度慢性非恶性疼痛患者在接受羟考酮控释片/纳洛酮控释片治疗时，相较于之前的WHO阶梯I和/或WHO阶梯II镇痛治疗，在生活质量（QoL）、镇痛效果和肠道功能方面的患者偏好。
这是一项在比利时和荷兰进行的为期3周的开放标签3b期研究，3周后患者可进入延长期。评估了与之前的WHO阶梯I和/或WHO阶梯II镇痛药相比，患者对羟考酮控释片/纳洛酮控释片治疗的生活质量偏好。如果在任何时间点，与之前的WHO阶梯I或II镇痛药相比，该评估为“更好”或“好得多”，则该患者在生活质量方面被视为有反应者。
全分析（FA）人群的生活质量反应率为59.2%（95%CI：51.7 - 66.8%），符合方案人群的反应率为71.7%（95%CI：63.1 - 80.3%）。探索性分析表明，在接受WHO阶梯II镇痛药预处理的便秘患者中，生活质量反应率最高（73.8%）。FA人群开始时的平均±标准差疼痛评分为74.7±16.6，在中位（范围）治疗期173.5（31 - 771）天后降至53.9±24.3。对于便秘患者，便秘的显著减轻[肠道功能指数（BFI）改善]为 - 24.8分（95%CI： - 17.1至 - 32.5）。非便秘患者的BFI仍远低于28.8。羟考酮控释片/纳洛酮控释片治疗的不良事件是众所周知的阿片类药物相关不良事件。
本研究表明，之前接受WHO阶梯I和/或WHO阶梯II镇痛药治疗的研究患者在生活质量方面更倾向于接受羟考酮控释片/纳洛酮控释片治疗。此外，该研究表明，羟考酮控释片/纳洛酮控释片治疗可显著降低便秘患者的阿片类药物引起的便秘（OIC），且非便秘患者在接受羟考酮控释片/纳洛酮控释片治疗期间不会发生OIC。
