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扁桃体切除术或腺样体扁桃体切除术与非手术治疗对儿童阻塞性睡眠呼吸障碍的疗效比较

Tonsillectomy or adenotonsillectomy versus non-surgical management for obstructive sleep-disordered breathing in children.

作者信息

Venekamp Roderick P, Hearne Benjamin J, Chandrasekharan Deepak, Blackshaw Helen, Lim Jerome, Schilder Anne G M

机构信息

Julius Center for Health Sciences and Primary Care & Department of Otorhinolaryngology, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, Netherlands, 3508 GA.

出版信息

Cochrane Database Syst Rev. 2015 Oct 14;2015(10):CD011165. doi: 10.1002/14651858.CD011165.pub2.

Abstract

BACKGROUND

Obstructive sleep-disordered breathing (oSDB) is a condition that encompasses breathing problems when asleep, due to an obstruction of the upper airways, ranging in severity from simple snoring to obstructive sleep apnoea syndrome (OSAS). It affects both children and adults. In children, hypertrophy of the tonsils and adenoid tissue is thought to be the commonest cause of oSDB. As such, tonsillectomy - with or without adenoidectomy - is considered an appropriate first-line treatment for most cases of paediatric oSDB.

OBJECTIVES

To assess the benefits and harms of tonsillectomy with or without adenoidectomy compared with non-surgical management of children with oSDB.

SEARCH METHODS

We searched the Cochrane Register of Studies Online, PubMed, EMBASE, CINAHL, Web of Science, Clinicaltrials.gov, ICTRP and additional sources for published and unpublished trials. The date of the search was 5 March 2015.

SELECTION CRITERIA

Randomised controlled trials comparing the effectiveness and safety of (adeno)tonsillectomy with non-surgical management in children with oSDB aged 2 to 16 years.

DATA COLLECTION AND ANALYSIS

We used the standard methodological procedures expected by The Cochrane Collaboration.

MAIN RESULTS

Three trials (562 children) met our inclusion criteria. Two were at moderate to high risk of bias and one at low risk of bias. We did not pool the results because of substantial clinical heterogeneity. They evaluated three different groups of children: those diagnosed with mild to moderate OSAS by polysomnography (PSG) (453 children aged five to nine years; low risk of bias; CHAT trial), those with a clinical diagnosis of oSDB but with negative PSG recordings (29 children aged two to 14 years; moderate to high risk of bias; Goldstein) and children with Down syndrome or mucopolysaccharidosis (MPS) diagnosed with mild to moderate OSAS by PSG (80 children aged six to 12 years; moderate to high risk of bias; Sudarsan). Moreover, the trials included two different comparisons: adenotonsillectomy versus no surgery (CHAT trial and Goldstein) or versus continuous positive airway pressure (CPAP) (Sudarsan). Disease-specific quality of life and/or symptom score (using a validated instrument): first primary outcomeIn the largest trial with lowest risk of bias (CHAT trial), at seven months, mean scores for those instruments measuring disease-specific quality of life and/or symptoms were lower (that is, better quality of life or fewer symptoms) in children receiving adenotonsillectomy than in those managed by watchful waiting:- OSA-18 questionnaire (scale 18 to 126): 31.8 versus 49.5 (mean difference (MD) -17.7, 95% confidence interval (CI) -21.2 to -14.2);- PSQ-SRBD questionnaire (scale 0 to 1): 0.2 versus 0.5 (MD -0.3, 95% CI -0.31 to -0.26);- Modified Epworth Sleepiness Scale (scale 0 to 24): 5.1 versus 7.1 (MD -2.0, 95% CI -2.9 to -1.1).No data on this primary outcome were reported in the Goldstein trial.In the Sudarsan trial, the mean OSA-18 score at 12 months did not significantly differ between the adenotonsillectomy and CPAP groups. The mean modified Epworth Sleepiness Scale scores did not differ at six months, but were lower in the surgery group at 12 months: 5.5 versus 7.9 (MD -2.4, 95% CI -3.1 to -1.7). Adverse events: second primary outcomeIn the CHAT trial, 15 children experienced a serious adverse event: 6/194 (3%) in the adenotonsillectomy group and 9/203 (4%) in the control group (RD -1%, 95% CI -5% to 2%).No major complications were reported in the Goldstein trial.In the Sudarsan trial, 2/37 (5%) developed a secondary haemorrhage after adenotonsillectomy, while 1/36 (3%) developed a rash on the nasal dorsum secondary to the CPAP mask (RD -3%, 95% CI -6% to 12%). Secondary outcomesIn the CHAT trial, at seven months, mean scores for generic caregiver-rated quality of life were higher in children receiving adenotonsillectomy than in those managed by watchful waiting. No data on this outcome were reported by Sudarsan and Goldstein.In the CHAT trial, at seven months, more children in the surgery group had normalisation of respiratory events during sleep as measured by PSG than those allocated to watchful waiting: 153/194 (79%) versus 93/203 (46%) (RD 33%, 95% CI 24% to 42%). In the Goldstein trial, at six months, PSG recordings were similar between groups and in the Sudarsan trial resolution of OSAS (Apnoea/Hypopnoea Index score below 1) did not significantly differ between the adenotonsillectomy and CPAP groups.In the CHAT trial, at seven months, neurocognitive performance and attention and executive function had not improved with surgery: scores were similar in both groups. In the CHAT trial, at seven months, mean scores for caregiver-reported ratings of behaviour were lower (that is, better behaviour) in children receiving adenotonsillectomy than in those managed by watchful waiting, however, teacher-reported ratings of behaviour did not significantly differ.No data on these outcomes were reported by Goldstein and Sudarsan.

AUTHORS' CONCLUSIONS: In otherwise healthy children, without a syndrome, of older age (five to nine years), and diagnosed with mild to moderate OSAS by PSG, there is moderate quality evidence that adenotonsillectomy provides benefit in terms of quality of life, symptoms and behaviour as rated by caregivers and high quality evidence that this procedure is beneficial in terms of PSG parameters. At the same time, high quality evidence indicates no benefit in terms of objective measures of attention and neurocognitive performance compared with watchful waiting. Furthermore, PSG recordings of almost half of the children managed non-surgically had normalised by seven months, indicating that physicians and parents should carefully weigh the benefits and risks of adenotonsillectomy against watchful waiting in these children. This is a condition that may recover spontaneously over time.For non-syndromic children classified as having oSDB on purely clinical grounds but with negative PSG recordings, the evidence on the effects of adenotonsillectomy is of very low quality and is inconclusive.Low-quality evidence suggests that adenotonsillectomy and CPAP may be equally effective in children with Down syndrome or MPS diagnosed with mild to moderate OSAS by PSG.We are unable to present data on the benefits of adenotonsillectomy in children with oSDB aged under five, despite this being a population in whom this procedure is often performed for this purpose.

摘要

背景

阻塞性睡眠呼吸障碍(oSDB)是一种睡眠时由于上呼吸道阻塞而出现呼吸问题的病症,严重程度从单纯打鼾到阻塞性睡眠呼吸暂停综合征(OSAS)不等。它影响儿童和成人。在儿童中,扁桃体和腺样体组织肥大被认为是oSDB最常见的原因。因此,扁桃体切除术(伴或不伴腺样体切除术)被视为大多数小儿oSDB病例的合适一线治疗方法。

目的

评估扁桃体切除术(伴或不伴腺样体切除术)与oSDB患儿非手术治疗相比的益处和危害。

检索方法

我们检索了Cochrane在线研究注册库、PubMed、EMBASE、CINAHL、科学引文索引、Clinicaltrials.gov、ICTRP以及其他来源,以查找已发表和未发表的试验。检索日期为2015年3月5日。

选择标准

比较(腺)扁桃体切除术与2至16岁oSDB患儿非手术治疗的有效性和安全性的随机对照试验。

数据收集与分析

我们采用了Cochrane协作网期望的标准方法程序。

主要结果

三项试验(562名儿童)符合我们的纳入标准。两项试验存在中度至高偏倚风险,一项试验存在低偏倚风险。由于存在实质性临床异质性,我们未合并结果。这些试验评估了三组不同的儿童:通过多导睡眠图(PSG)诊断为轻度至中度OSAS的儿童(453名5至9岁儿童;低偏倚风险;CHAT试验)、临床诊断为oSDB但PSG记录为阴性的儿童(29名2至14岁儿童;中度至高偏倚风险;Goldstein试验)以及通过PSG诊断为轻度至中度OSAS的唐氏综合征或黏多糖贮积症(MPS)儿童(80名6至12岁儿童;中度至高偏倚风险;Sudarsan试验)。此外,这些试验包括两种不同的比较:腺扁桃体切除术与不手术(CHAT试验和Goldstein试验)或与持续气道正压通气(CPAP)(Sudarsan试验)。疾病特异性生活质量和/或症状评分(使用经过验证的工具):首个主要结局在偏倚风险最低的最大试验(CHAT试验)中,七个月时,接受腺扁桃体切除术的儿童在那些测量疾病特异性生活质量和/或症状的工具上的平均得分低于接受观察等待的儿童(即生活质量更好或症状更少):

  • OSA - 18问卷(18至126分):31.8对49.5(平均差(MD) - 17.7,95%置信区间(CI) - 21.2至 - 14.2);

  • PSQ - SRBD问卷(0至1分):0.2对0.5(MD - 0.3,95% CI - 0.31至 - 0.26);

  • 改良爱泼沃斯嗜睡量表(0至24分):5.1对7.1(MD - 2.0,95% CI - 2.9至 - 1.1)。

Goldstein试验未报告该主要结局的数据。在Sudarsan试验中,腺扁桃体切除术组和CPAP组在12个月时的平均OSA - 18得分无显著差异。改良爱泼沃斯嗜睡量表平均得分在六个月时无差异,但在12个月时手术组得分更低:5.5对7.9(MD - 2.4,95% CI - 3.1至 - 1.7)。不良事件:第二个主要结局在CHAT试验中,15名儿童发生严重不良事件:腺扁桃体切除术组6/194(3%),对照组9/203(4%)(风险差(RD) - 1%,95% CI - 5%至2%)。Goldstein试验未报告重大并发症。在Sudarsan试验中,2/37(5%)在腺扁桃体切除术后发生继发性出血,而1/36(3%)因CPAP面罩在鼻背部出现皮疹(RD - 3%,95% CI - 6%至12%)。次要结局在CHAT试验中,七个月时接受腺扁桃体切除术的儿童在一般照顾者评定的生活质量方面的平均得分高于接受观察等待的儿童。Sudarsan试验和Goldstein试验未报告该结局的数据。在CHAT试验中,七个月时,通过PSG测量,手术组睡眠期间呼吸事件正常化的儿童比分配到观察等待组的儿童更多:153/194(79%)对93/203(46%)(RD 33%,95% CI 24%至42%)。在Goldstein试验中,六个月时两组的PSG记录相似,在Sudarsan试验中,腺扁桃体切除术组和CPAP组在OSAS缓解(呼吸暂停/低通气指数得分低于1)方面无显著差异。在CHAT试验中,七个月时,手术并未改善神经认知表现、注意力和执行功能:两组得分相似。在CHAT试验中,七个月时,接受腺扁桃体切除术的儿童在照顾者报告的行为评定方面的平均得分更低(即行为更好),然而,教师报告的行为评定无显著差异。Goldstein试验和Sudarsan试验未报告这些结局的数据。

作者结论

在年龄较大(5至9岁)、无综合征且通过PSG诊断为轻度至中度OSAS的健康儿童中,有中等质量证据表明腺扁桃体切除术在照顾者评定的生活质量、症状和行为方面有益,且有高质量证据表明该手术在PSG参数方面有益。同时,高质量证据表明与观察等待相比,在客观的注意力和神经认知表现测量方面无益处。此外,近一半接受非手术治疗的儿童在七个月时PSG记录已正常化,这表明医生和家长应在这些儿童中仔细权衡腺扁桃体切除术与观察等待的益处和风险。这是一种可能随时间自发恢复的病症。对于仅基于临床诊断为oSDB但PSG记录为阴性的非综合征儿童,腺扁桃体切除术效果的证据质量非常低且尚无定论。低质量证据表明,对于通过PSG诊断为轻度至中度OSAS的唐氏综合征或MPS儿童,腺扁桃体切除术和CPAP可能同样有效。尽管五岁以下oSDB儿童是经常接受此手术的人群,但我们无法提供腺扁桃体切除术对其益处的数据。

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