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腺样体扁桃体切除术与腺样体切除术治疗小儿阻塞性睡眠呼吸暂停:一项 RCT 研究。

Adenotonsillotomy Versus Adenotonsillectomy in Pediatric Obstructive Sleep Apnea: An RCT.

机构信息

Department of Otorhinolaryngology, Karolinska University Hospital, and Department of Clinical Science, Intervention and Technology, CLINTEC, Karolinska Institute, Stockholm, Sweden

Department of Otorhinolaryngology, Karolinska University Hospital, and Department of Clinical Science, Intervention and Technology, CLINTEC, Karolinska Institute, Stockholm, Sweden.

出版信息

Pediatrics. 2017 Apr;139(4). doi: 10.1542/peds.2016-3314. Epub 2017 Mar 20.

DOI:10.1542/peds.2016-3314
PMID:28320866
Abstract

BACKGROUND

Adenotonsillectomy (ATE) is a well-established and effective treatment of pediatric obstructive sleep apnea (OSA). In recent years, a more conservative method, adenotonsillotomy (ATT), has gained popularity because it is associated with less postoperative morbidity. Yet no previous randomized study has compared these 2 methods regarding their effectiveness in treating pediatric OSA in terms of polysomnographic data, which was the primary aim of this study. The hypothesis was that ATT is noninferior to ATE after 1 year.

METHODS

Seventy-nine children, aged 2 to 6 years, with OSA (Apnea-Hypopnea Index [AHI] 5-30) were randomized to ATT ( = 40) or ATE ( = 39). Polysomnography (PSG) and questionnaire OSA-18 were assessed at baseline and 1 year postsurgery.

RESULTS

Mean difference between groups in the primary outcome, change in AHI, was 0.83, 95% confidence interval -3.2 to 4.9, not exceeding the noninferiority margin of 5. After ATE, AHI decreased from median 12.7 (interquartile range 8.3-19.1) to 2.0 (1.2-3.1) and after ATT from 15.8 (8.5-21.2) to 4.0 (1.2-5.1). For both groups, significant improvements of PSG and OSA-18 questionnaire outcomes were observed, with no significant differences between groups. Five children (13%) in the ATT group needed repeated surgery for tonsil regrowth and recurrence of OSA.

CONCLUSIONS

The results suggest that ATT is noninferior to ATE in treating pediatric OSA regarding PSG outcomes after 1 year. ATT could be considered an alternative to ATE for treatment of pediatric OSA. However, after ATT, there is a nonnegligible risk of recurrence of OSA, and this should be taken into account when selecting surgical method.

摘要

背景

腺样体扁桃体切除术(ATE)是治疗小儿阻塞性睡眠呼吸暂停(OSA)的一种成熟且有效的方法。近年来,一种更为保守的方法——腺样体切开术(ATT)因其术后发病率较低而受到青睐。然而,之前的随机研究并没有比较这两种方法在治疗小儿 OSA 方面的有效性,其主要目的是评估多导睡眠图数据。该研究假设 ATT 在 1 年后与 ATE 相比非劣效。

方法

79 例年龄在 2 至 6 岁之间的 OSA 患儿(呼吸暂停低通气指数[AHI]为 5-30)被随机分为 ATT 组(n=40)和 ATE 组(n=39)。分别在基线和术后 1 年进行多导睡眠图(PSG)和 OSA-18 问卷评估。

结果

主要结局(AHI 变化)的组间平均差异为 0.83,95%置信区间为-3.2 至 4.9,未超过 5 的非劣效性边界。ATE 后 AHI 从中位数 12.7(四分位间距 8.3-19.1)降至 2.0(1.2-3.1),ATT 后从 15.8(8.5-21.2)降至 4.0(1.2-5.1)。两组的 PSG 和 OSA-18 问卷结果均有显著改善,组间无显著差异。ATT 组有 5 例患儿(13%)因扁桃体再次生长和 OSA 复发而需要再次手术。

结论

研究结果表明,ATT 在治疗小儿 OSA 方面与 ATE 相比,1 年后 PSG 结果非劣效。ATT 可作为治疗小儿 OSA 的 ATE 替代方法。然而,ATT 后 OSA 复发的风险不可忽视,在选择手术方法时应予以考虑。

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