Long-term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer chronic pain.
Long-term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer chronic pain.
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DOI：
10.1111/j.1742-1241.2010.02360.x
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发表时间：
2010-05
影响因子：
2.6
通讯作者：
Reimer K
中科院分区：
文献类型：
--
作者：
Sandner-Kiesling A;Leyendecker P;Hopp M;Tarau L;Lejcko J;Meissner W;Sevcik P;Hakl M;Hrib R;Uhl R;Dürr H;Reimer K
本研究的目的是评估固定复方羟考酮缓释剂（PR）/纳洛酮PR在慢性非癌症疼痛成人中镇痛和改善阿片类药物诱导的肠功能障碍（OIBD）及相关症状（如阿片类药物诱导的便秘（OIC））方面的安全性和疗效。这些是开放标签扩展研究，其中先前完成12周双盲研究的患者接受羟考酮PR/纳洛酮PR长达52周。镇痛研究使用改良的简明疼痛量表-简表（BPI-SF）评估疼痛。肠功能研究使用肠功能指数（BFI）评估便秘的改善。在镇痛研究（n = 379）的开放标签基线时，BPI-SF项目“过去24小时内的平均疼痛”的平均评分[±标准差（SD）]为3.9 ± 1.52，在6个月（3.7 ± 1.59）和12个月（3.8 ± 1.72）时仍较低。在整个52周的研究中，BPI-SF项目“睡眠干扰”、BPI-SF“疼痛”和“活动干扰”子量表的平均评分也保持较低。在肠功能研究（n = 258）中，平均BFI评分（± SD）从扩展研究开始时的35.6 ± 27.74降至羟考酮PR/纳洛酮PR治疗12个月后的20.6 ± 24.01。本研究期间疼痛评分也保持较低且稳定。两个扩展阶段的不良事件与阿片类药物治疗相关的不良事件一致;未观察到其他安全性问题。这两项开放标签扩展研究的结果证明了羟考酮PR/纳洛酮PR固定复方制剂治疗慢性疼痛的长期疗效和耐受性。患者在接受有效镇痛治疗时，OIBD出现临床相关改善。
The aim of this study was to assess safety and efficacy of fixed combination oxycodone prolonged release (PR)/naloxone PR in terms of both analgesia and improving opioid-induced bowel dysfunction (OIBD) and associated symptoms, such as opioid-induced constipation (OIC), in adults with chronic non-cancer pain. These were open-label extension studies in which patients who had previously completed a 12-week, double-blind study received oxycodone PR/naloxone PR for up to 52 weeks. The analgesia study assessed pain using the modified Brief Pain Inventory-Short Form (BPI-SF). The bowel function study assessed improvements in constipation using the Bowel Function Index (BFI). At open-label baseline in the analgesia study (n = 379), mean score [± standard deviation (SD)] for the BPI-SF item ‘average pain over the last 24 h’ was 3.9 ± 1.52, and this remained low at 6 months (3.7 ± 1.59) and 12 months (3.8 ± 1.72). Mean scores for BPI-SF item ‘sleep interference’, and the BPI-SF ‘pain’ and ‘interference with activities’ subscales also remained low throughout the 52-week study. In the bowel function study (n = 258), mean BFI score (± SD) decreased from 35.6 ± 27.74 at the start of the extension study to 20.6 ± 24.01 after 12 months of treatment with oxycodone PR/naloxone PR. Pain scores also remained low and stable during this study. Adverse events in both extension phases were consistent with those associated with opioid therapy; no additional safety concerns were observed. Results from these two open-label extension studies demonstrate the long-term efficacy and tolerability of fixed combination oxycodone PR/naloxone PR in the treatment of chronic pain. Patients experienced clinically relevant improvements in OIBD while receiving effective analgesic therapy.
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DOI：
10.1016/s1090-3801(98)90020-9
发表时间：
1998-01-01
期刊：
EUROPEAN JOURNAL OF PAIN-LONDON
影响因子：
--
作者：
Mucci-LoRusso, P;Berman, BS;Reder, RF
通讯作者：
Reder, RF
影响因子：
2.7
作者：
HANDELSMAN, L;COCHRANE, KJ;KANOF, PD
通讯作者：
KANOF, PD
影响因子：
2.3
作者：
Simpson, K.;Leyendecker, P.;Reimer, K.
通讯作者：
Reimer, K.
影响因子：
3.6
作者：
Meissner, Winfried;Leyendecker, Petra;Reimer, Karen
通讯作者：
Reimer, Karen
影响因子：
3.2
作者：
Smith, Kevin;Hopp, Michael;Reimer, Karen
通讯作者：
Reimer, Karen