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Lancet:笑气用于非心脏外科大手术患者的全麻,安全有效(ENIGMA-II研究)

2014-10-18 MedSci译 MedSci原创

160多年前,一氧化二氮(即笑气)被用作麻醉剂,首次应用在外科病人身上。尽管笑气麻醉剂应用超过10亿人次,但出于对笑气麻醉剂副作用的忧虑,外科医生选择使用更新型、更昂贵的麻醉药物。不过这种情况也许随着墨尔本阿尔弗雷德医院公布的全新研究结果而彻底改变。该医院的迈尔斯教授表示,经过长达6年的研究,证实笑气是安全的麻醉用药。这是一项国际多中心,随机,评估者盲法试验。纳入患者大于45岁,已知或可疑冠脉疾病

160多年前,一氧化二氮(即笑气)被用作麻醉剂,首次应用在外科病人身上。尽管笑气麻醉剂应用超过10亿人次,但出于对笑气麻醉剂副作用的忧虑,外科医生选择使用更新型、更昂贵的麻醉药物。

不过这种情况也许随着墨尔本阿尔弗雷德医院公布的全新研究结果而彻底改变。该医院的迈尔斯教授表示,经过长达6年的研究,证实笑气是安全的麻醉用药。

这是一项国际多中心,随机,评估者盲法试验。纳入患者大于45岁,已知或可疑冠脉疾病,使用非心脏外科大手术患者( major non-cardiac surgery)。患者随机分为加笑气和不加笑气进行麻醉。主要终点是术后30天内死亡和心血管并发症的复合终点(包括非致死性心梗,卒中,肺栓塞和心脏骤停)。采用校正的ITT分析。这项研究注册号为NCT00430989.


研究共纳入10102人群,最终7112位患者进行随机,其中3543位患者加用笑气,3569位患者不添加笑气。主要终点方面,笑气组共评估了3483位,而未添加笑气组评估了3509位患者。主要终点事件发生在笑气组为283 (8%)患者,而在不添加笑气组为296例(8%)(相对风险RR=0.96, 95% CI 0·83—1·12; p=0·64)。手术部位感染,在笑气组发生率为321 (9%)例,在非笑气组为311 (9%)例(p=0.61)。严重呕吐和恶心在笑气组为506例(15%),在不添加笑气组为378 (11%)例 (p<0·0001)。

这项研究表明,在非心脏外科大手术患者中,笑气并不增加死亡和心血管并发症,以及手术部位感染的风险。一氧化二氮致吐作用可与止吐预防控制。这项研究能让病人及医院重新使用廉价且安全的麻醉药物。研究者说“我们如今能向全世界的麻醉师和接受外科手术的病人保证,笑气是安全且有效的麻醉药物。”

原始出处:
Myles PS, Leslie K, Chan MT, Forbes A, Peyton PJ, Paech MJ, Beattie WS, Sessler DI, Devereaux PJ, Silbert B, Schricker T, Wallace S; the ANZCA Trials Group for the ENIGMA-II investigators.The safety of addition of nitrous oxide to general anaesthesia in at-risk patients having major non-cardiac surgery (ENIGMA-II): a randomised, single-blind trial.Lancet. 2014 Aug 14. pii: S0140-6736(14)60893-X.

研究相关网站:http://www.enigma2.org.au/

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    2015-01-22 howi
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    2015-07-25 yhy100210
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    2014-11-02 匿名用户

    其实临床科研还是有蛮多发展方向的

    0

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