Department of Anaesthesiology - Ullevaal, Oslo University Hospital, Oslo, Norway.
Acta Anaesthesiol Scand. 2013 Apr;57(4):509-17. doi: 10.1111/aas.12051. Epub 2013 Jan 10.
Targiniq®, an oxycodone prolonged-release (PR) formulation combined with the opioid antagonist naloxone PR, aims to prevent opioid-induced constipation without impairing the analgesic efficacy. This has been confirmed during prolonged use in chronic pain or cancer patients. The purpose of our study was to compare clinical effects of oxycodone PR with oxycodone PR + naloxone PR for short-term post-operative pain management.
This randomised, double-blind, prospective study included 85 women undergoing laparoscopic hysterectomy. The two groups received either oxycodone PR 10 mg or oxycodone PR 10 mg + naloxone PR 5 mg as pre-medication and twice daily for 3 days. As rescue analgesic, the patients received oxycodone intravenous during the first 24 h post-operatively and oxycodone tablets in the 24-72-h period. Constipation, other side effects, pain and satisfaction were registered during the first 7 post-operative days.
Demographic, pre- and perioperative variables and the use of rescue analgesics were similar in the groups. There were no significant differences in variables related to constipation. In the oxycodone PR + naloxone PR group, 25% had no defecation during the first 72 h post-operatively, compared with 20% in the oxycodone PR group (mean 1.2 ± 1.1 vs. 2.1 ± 2.4 defecations). Other opioid-induced effects and side effects showed no significant differences. Only 7% were dissatisfied with their oral pain treatment.
Addition of naloxone to oxycodone PR tablets in a pain regimen administered twice daily the first three post-operative days had no significant clinical effects on constipation or other variables during the first week after hysterectomy.
Targiniq® 是一种羟考酮控释（PR）制剂，与阿片类拮抗剂纳洛酮 PR 联合使用，旨在预防阿片类药物引起的便秘而不影响镇痛效果。这在慢性疼痛或癌症患者的长期使用中得到了证实。我们的研究目的是比较羟考酮 PR 与羟考酮 PR + 纳洛酮 PR 在短期术后疼痛管理中的临床效果。
这是一项随机、双盲、前瞻性研究，纳入了 85 名接受腹腔镜子宫切除术的女性。两组患者分别接受羟考酮 PR 10mg 或羟考酮 PR 10mg + 纳洛酮 PR 5mg 作为术前用药，术后连续 3 天每日两次用药。作为解救性镇痛药，患者在术后 24 小时内接受静脉注射羟考酮，在 24-72 小时期间服用羟考酮片剂。在术后第 1 天至第 7 天期间记录便秘、其他副作用、疼痛和满意度。
两组患者的人口统计学、术前和围手术期变量以及解救性镇痛药的使用情况相似。与便秘相关的变量无显著差异。在羟考酮 PR + 纳洛酮 PR 组中，25%的患者在术后第 72 小时内没有排便，而羟考酮 PR 组为 20%（平均 1.2±1.1 次 vs. 2.1±2.4 次）。其他阿片类药物引起的副作用无显著差异。只有 7%的患者对口服疼痛治疗不满意。
在术后第 1 天至第 3 天每日两次给予的疼痛治疗方案中，羟考酮 PR 片剂中加入纳洛酮对术后第 1 周的便秘或其他变量无显著临床影响。
