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每日一次的渗透泵控释氢吗啡酮用于慢性非恶性疼痛的管理:一项剂量转换与滴定研究。

Once-daily OROS hydromorphone for the management of chronic nonmalignant pain: a dose-conversion and titration study.

作者信息

Wallace M, Rauck R L, Moulin D, Thipphawong J, Khanna S, Tudor I C

机构信息

San Diego Medical Center, University of California, La Jolla, CA, USA.

出版信息

Int J Clin Pract. 2007 Oct;61(10):1671-6. doi: 10.1111/j.1742-1241.2007.01500.x.

Abstract

BACKGROUND

The use of opioid analgesics for patients with chronic nonmalignant pain is becoming more widely accepted, and long-acting formulations are an important treatment option.

AIM

To assess conversion to extended-release OROS hydromorphone from previous stable opioid agonist therapy in patients with chronic nonmalignant pain of moderate-to-severe intensity.

METHODS

In this open-label multicentre trial, patients were stabilised on their previous opioid therapy before being switched to OROS hydromorphone at a ratio of 5 : 1 (morphine sulphate equivalent to hydromorphone hydrochloride). The OROS hydromorphone dose was titrated over 3-16 days to achieve effective analgesia, and maintenance treatment continued for 14 days.

RESULTS

Study medication was received by 336 patients; 66% completed all study phases. Stabilisation of OROS hydromorphone was achieved by 94.6% of patients, the majority in two or fewer titration steps (mean time, 4.2 days). Mean pain intensity scores, as determined by the Brief Pain Inventory, decreased during OROS hydromorphone treatment (p <or= 0.001). The percentage of patients rating their pain relief as 'good' or 'complete' increased, and the use of rescue analgesics for breakthrough pain decreased. The interference of pain with everyday activities (e.g. walking or work), and the effects on mood and enjoyment of life, also improved during the study (all p < 0.001). OROS hydromorphone was well tolerated, and adverse events were those expected for opioid agonist therapy.

CONCLUSION

Patients with chronic nonmalignant pain who had been receiving opioid therapy easily underwent conversion to OROS hydromorphone, with no loss of efficacy or increase in adverse events.

摘要

背景

阿片类镇痛药用于慢性非恶性疼痛患者正越来越被广泛接受,长效制剂是一种重要的治疗选择。

目的

评估中重度慢性非恶性疼痛患者从先前稳定的阿片类激动剂治疗转换为缓释羟吗啡酮口服渗透泵片(OROS hydromorphone)的情况。

方法

在这项开放标签的多中心试验中,患者在先前的阿片类治疗中达到稳定状态后,以5:1的比例(硫酸吗啡当量换算为盐酸羟吗啡酮)转换为OROS hydromorphone。OROS hydromorphone剂量在3 - 16天内滴定以实现有效镇痛,维持治疗持续14天。

结果

336例患者接受了研究药物治疗;66%完成了所有研究阶段。94.6%的患者实现了OROS hydromorphone的稳定,大多数患者在两个或更少的滴定步骤内(平均时间为4.2天)。根据简明疼痛量表确定,在OROS hydromorphone治疗期间平均疼痛强度评分下降(p≤0.001)。将疼痛缓解评为“良好”或“完全缓解”的患者百分比增加,用于突破性疼痛的解救镇痛药使用减少。在研究期间,疼痛对日常活动(如行走或工作)的干扰以及对情绪和生活乐趣的影响也有所改善(所有p < 0.001)。OROS hydromorphone耐受性良好,不良事件为阿片类激动剂治疗预期出现的事件。

结论

接受阿片类治疗的慢性非恶性疼痛患者能够轻松转换为OROS hydromorphone,且疗效未丧失,不良事件未增加。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccd4/2040191/ed032b21c208/ijcp0061-1671-f1.jpg

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