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一项关于 50%氧化亚氮/氧气预混气体(Kalinox™)吸入镇静在普通实践中的疗效和安全性的临床试验。

A clinical trial of efficacy and safety of inhalation sedation with a 50% nitrous oxide/oxygen premix (Kalinox™) in general practice.

机构信息

Clermont Université, EA3847, Faculté de Chirurgie Dentaire, 11 bvd Charles d Gaulle, 63000 Clermont-Ferrand, France.

出版信息

Clin Oral Investig. 2012 Apr;16(2):633-42. doi: 10.1007/s00784-011-0550-y. Epub 2011 Mar 29.

DOI:10.1007/s00784-011-0550-y
PMID:22186944
Abstract

The current study aimed to verify if the safety and effectiveness of inhalation sedation with 50% nitrous oxide in oxygen (N(2)O/O(2)) is maintained when the premix is administrated by trained general practitioners in their dental surgeries compared to its use in the hospital. Success (completion of planned treatment), cooperation (modified Venham scale), and adverse events were recorded. The acceptability of the technique to the patients, the level of patient cooperation, the ease of use, and the satisfaction of the dentist were also evaluated. Thirty-three general practitioners included 549 patients and recorded 638 sessions of N(2)O/O(2) sedation for dental treatment. Of the sessions, 93.7% were successful in terms of both sedation and treatment. Patient cooperation was seen to improve under N(2)O/O(2) sedation, and for 91% of the sessions, the patients declared that they would like future treatment to be undertaken in the same way. No serious adverse events were recorded. Minor adverse events were noted for 10% of the sessions (behavioural, vagal, and digestive disorders). These results were similar to those found for sessions undertaken in hospital practice. The main difference was in the type of patient treated-more patients received N(2)O/O(2) sedation in general practice for a one-off indication or for dental phobia, and more patients with intellectual disability and more pre-cooperative children were treated in hospital practice. This study gives strong supporting evidence for the safety and effectiveness of inhalation sedation using 50% N(2)O/O(2) in general dental practice for healthy patients.

摘要

本研究旨在验证在牙医诊所中,由经过培训的全科医生在其牙科手术中使用预混气体(50%氧化亚氮/氧气,N(2)O/O(2))进行吸入镇静时,与在医院使用相比,其安全性和有效性是否保持不变。记录了成功(完成计划的治疗)、合作(改良 Venham 量表)和不良事件。还评估了患者对技术的接受程度、患者合作程度、易用性和牙医的满意度。33 名全科医生纳入了 549 名患者,并记录了 638 例 N(2)O/O(2)镇静用于牙科治疗的疗程。在这些疗程中,93.7%在镇静和治疗方面都取得了成功。在 N(2)O/O(2)镇静下,患者的合作度有所提高,91%的疗程中,患者表示希望未来的治疗以同样的方式进行。未记录到严重的不良事件。记录到 10%的疗程中出现轻微的不良事件(行为、迷走神经和消化系统障碍)。这些结果与在医院实践中发现的结果相似。主要区别在于治疗的患者类型——更多的患者在普通牙科实践中接受 N(2)O/O(2)镇静,用于单次治疗或牙科恐惧症,更多的智障患者和更多需要合作的儿童在医院实践中接受治疗。这项研究为在普通牙科实践中使用 50%N(2)O/O(2)进行吸入镇静治疗健康患者的安全性和有效性提供了强有力的支持证据。

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