一项关于新型正畸矫治器改善Pierre Robin序列婴儿上气道阻塞的随机临床试验。

A randomized clinical trial of a new orthodontic appliance to improve upper airway obstruction in infants with Pierre Robin sequence.

作者信息

Buchenau Wolfgang, Urschitz Michael S, Sautermeister Judit, Bacher Margit, Herberts Tina, Arand Joerg, Poets Christian F

机构信息

Department of Neonatology, University Hospital Tuebingen, Tuebingen, Germany.

出版信息

J Pediatr. 2007 Aug;151(2):145-9. doi: 10.1016/j.jpeds.2007.02.063. Epub 2007 Jun 22.

DOI:10.1016/j.jpeds.2007.02.063

PMID:17643765

Abstract

OBJECTIVE

To test the hypothesis that a new orthodontic appliance with a velar extension that shifts the tongue anteriorly would reduce upper airway obstruction in infants with Pierre Robin sequence (PRS).

STUDY DESIGN

Eleven infants with PRS (median age, 3 days) and an apnea index (AI) >3 were studied. The effect of the new appliance on the AI was compared with that of a conventional appliance without a velar extension by using a crossover study design with random allocation.

RESULTS

Compared with baseline (mean AI, 13.8), there was a significant decrease in the AI with the new appliance (3.9; P value <.001), but no change with the conventional appliance (14.8; P = .842). Thus, the relative change in AI was -71% (95% CI, -84--49) for the new appliance and +8% (95% CI, -52-142) for the conventional appliance, which was significantly different (P = .004). No severe adverse effects were observed.

CONCLUSION

This new orthodontic appliance appears to be safe and effective in reducing upper airway obstruction in infants with PRS.

摘要

目的

检验一种带有软腭延伸装置且能使舌头向前移位的新型正畸矫治器可减少皮埃尔·罗宾序列征（PRS）婴儿上气道阻塞的假说。

研究设计

对11名患有PRS（中位年龄3天）且呼吸暂停指数（AI）>3的婴儿进行研究。采用随机分配的交叉研究设计，将新型矫治器对AI的影响与不带软腭延伸装置的传统矫治器进行比较。

结果

与基线水平（平均AI为13.8）相比，新型矫治器使AI显著降低（降至3.9；P值<.001），而传统矫治器则无变化（为14.8；P = .842）。因此，新型矫治器AI的相对变化为-71%（95%CI，-84至-49），传统矫治器为+8%（95%CI，-52至142），二者差异有统计学意义（P = .004）。未观察到严重不良反应。