Collado Valérie, Nicolas Emmanuel, Faulks Denise, Hennequin Martine
Univ Clermont1, EA 3847, Faculté d'Odontologie, 11 bvd Charles de Gaulle, F-63000 Clermont-Ferrand, France.
Expert Opin Drug Saf. 2007 Sep;6(5):559-71. doi: 10.1517/14740338.6.5.559.
Few studies into conscious sedation with 50% nitrous oxide/oxygen premix (50% N2O/O2) have been conducted in accordance with Good Clinical Practice in Clinical Trials. Of the 140 articles retained in this review, the incidence of adverse events (AEs) varied in the range of 0-68% according to the indications. When other drugs and/or local anaesthesia were used concomitantly, the relative risk for nausea and vomiting increased whereas it decreased for vertigo or hallucinations. Only one study examined potential causal relationship between serious AEs and the 50% N2O/O2 gas itself, giving a risk for a serious AE directly due to the gas of 3/10,000 administrations. No analysis of the effect of the method of administration was possible, nor could conclusions be drawn relating to the risk of occupational exposure.
很少有关于使用50%氧化亚氮/氧气预混剂（50% N₂O/O₂）进行清醒镇静的研究是按照临床试验的良好临床实践开展的。在本综述纳入的140篇文章中，不良事件（AE）的发生率根据适应证不同在0%至68%的范围内变化。当同时使用其他药物和/或局部麻醉时，恶心和呕吐的相对风险增加，而眩晕或幻觉的相对风险降低。只有一项研究考察了严重不良事件与50% N₂O/O₂气体本身之间的潜在因果关系，得出因该气体直接导致严重不良事件的风险为每10000次给药中有3次。无法对给药方法的效果进行分析，也无法得出与职业暴露风险相关的结论。
