Br J Surg:羟考酮-纳洛酮对腹腔镜结直肠癌手术后胃肠功能早期恢复的影响

2016-10-24 MedSci MedSci原创

口服缓释羟考酮-纳洛酮可减少术后阿片类药物诱导的肠道功能障碍。本研究调查了羟考酮-纳洛酮增强复苏背景下腹腔镜结直肠癌切除术的可行性。在一个单中心的开放标签的二期可行性研究中,患者接受基于羟考酮-纳洛酮或羟考酮镇痛。主要终点是招聘、保留和协议遵从性,次要终点包括肠道功能的复合终点(固体食物耐受性低,恶心/呕吐评分、排气或排便)。81例患者进行了筛选,62例(76%)进行随机研究,损耗率为19%(12

口服缓释羟考酮-纳洛酮可减少术后阿片类药物诱导的肠道功能障碍。本研究调查了羟考酮-纳洛酮增强复苏背景下腹腔镜结直肠癌切除术的可行性。

在一个单中心的开放性二期可行性研究中,患者接受基于羟考酮-纳洛酮或羟考酮镇痛。主要终点是招聘、保留和协议遵从性,次要终点包括肠道功能的复合终点(固体食物耐受性低,恶心/呕吐评分、排气或排便)。

81例患者进行了筛选,62例(76%)进行随机研究,损耗率为19%(12/62),留下了50例患者接受分配的干预,随访率100%,进行ITT分析。协议符合率超过90%。3天恢复肠道功能在两组是相似的:羟考酮-纳洛酮组为13/27(48%),对照组为15/23(65%)(差值的95% CI为-10.0到40.7%;P = 0.264)。羟考酮-纳洛酮组患者首次肠道运动间隔时间更短(平均(SD) 87(38)小时 vs 111[37]小时;差值的95% CI为 2.3 to 45.4小时,P = 0.031),羟考酮-纳洛酮组患者的总阿片样物质(口服加肠外)使用量减少(平均[SD]78[36] vs 94[56]mg;差值的95% CI为 -10.2 to 42.8 mg, P = 0.222)。

高参与、保留和协议合规性确认了这项策略的可行性。羟考酮-纳洛酮减少排便间隔时间、减少总阿片类药物使用的潜在好处需要一个随机试验来验证。

原始出处:


Creamer F1, Balfour A1, Nimmo S2, Foo I2, Norrie JD3, Williams LJ4, Fearon KC1, Paterson HM5.Randomized open-label phase II study comparing oxycodone-naloxone with oxycodone in early return of gastrointestinal function after laparoscopic colorectal surgery.Br J Surg. 2016 Oct 20. doi: 10.1002/bjs.10322. [Epub ahead of print]

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    2018-03-30 owlhealth

    不错耶.学习了

    0

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