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木糖醇预防 1-5 岁儿童急性中耳炎发作的随机对照试验。

Xylitol for the prevention of acute otitis media episodes in children aged 1-5 years: a randomised controlled trial.

机构信息

Department of Family and Community Medicine, St Michael's Hospital, Toronto, Ontario, Canada

Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.

出版信息

Arch Dis Child. 2024 Jan 22;109(2):121-124. doi: 10.1136/archdischild-2023-325565.

DOI:10.1136/archdischild-2023-325565
PMID:37890960
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10850643/
Abstract

OBJECTIVE

To investigate the regular use of xylitol, compared with sorbitol, to prevent acute otitis media (AOM), upper respiratory tract infections (URTIs) and dental caries.

DESIGN

Blinded randomised controlled trial with a 6-month study period.

SETTING

Enrolment took place at 11 primary care practices in Ontario, Canada.

PATIENTS

Children aged 1-5 years who did not use xylitol or sorbitol at enrolment.

INTERVENTIONS

Children were randomly assigned to use a placebo syrup with sorbitol or xylitol syrup two times per day for 6 months.

MAIN OUTCOME MEASURES

Primary outcome was the number of clinician-diagnosed AOM episodes over 6 months. Secondary outcomes were caregiver-reported URTIs and dental caries.

RESULTS

Among the 250 randomised children, the mean (SD) age was 38±14 months and there were 124 girls (50%). There were three clinician-diagnosed AOM episodes in the 125 placebo group participants and six in the 125 xylitol group participants (OR 2.04; 95% CI 0.43, 12.92; p=0.50). There was no difference in number of caregiver-reported URTI episodes (rate ratio (RR) 0.88; 95% CI 0.70, 1.11) between the placebo (4.2 per participant over 6 months; 95% CI 3.6, 5.0) and xylitol (3.7; 95% CI 3.2, 4.4) groups. Dental caries were reported for four participants in the placebo group and two in the xylitol group (OR 0.42; 95% CI 0.04, 3.05; p=0.42). In a post-hoc analysis of URTIs during the COVID-19 pandemic, the rate among the 59 participants receiving placebo was 2.3 per participant over 6 months (95% CI 1.8, 3.0) and for the 55 receiving xylitol, 1.3 over 6 months (95% CI 0.92, 1.82; RR 0.56; 95% CI 0.36, 0.87). The most common adverse event was diarrhoea (28% with placebo; 34% with xylitol).

CONCLUSIONS

Regular use of xylitol did not prevent AOM, URTIs or dental caries in a trial with limited statistical power. A post-hoc analysis indicated that URTIs were less common with xylitol exposure during the COVID-19 pandemic, but this finding could be spurious.

TRIAL REGISTRATION NUMBER

NCT03055091.

摘要

目的

研究木糖醇相对于山梨糖醇在预防急性中耳炎(AOM)、上呼吸道感染(URTI)和龋齿方面的常规使用。

设计

为期 6 个月的盲法随机对照试验。

地点

加拿大安大略省 11 个初级保健诊所进行入组。

患者

入组时未使用木糖醇或山梨糖醇的 1-5 岁儿童。

干预措施

儿童被随机分配每天使用安慰剂糖浆加山梨糖醇或木糖醇糖浆两次,持续 6 个月。

主要结局测量

主要结局为 6 个月内临床诊断的 AOM 发作次数。次要结局为护理人员报告的 URTI 和龋齿。

结果

在 250 名随机儿童中,平均(SD)年龄为 38±14 个月,有 124 名女孩(50%)。在 125 名安慰剂组参与者中,有 3 例临床诊断的 AOM 发作,在 125 名木糖醇组参与者中,有 6 例(比值比(OR)2.04;95%置信区间(CI)0.43,12.92;p=0.50)。在护理人员报告的 URTI 发作次数方面,安慰剂组(6 个月内每名参与者 4.2 次;95%CI 3.6,5.0)与木糖醇组(3.7;95%CI 3.2,4.4)之间没有差异(率比(RR)0.88;95%CI 0.70,1.11)。在安慰剂组中,有 4 名参与者报告了龋齿,在木糖醇组中有 2 名(OR 0.42;95%CI 0.04,3.05;p=0.42)。在 COVID-19 大流行期间 URTI 的事后分析中,接受安慰剂的 59 名参与者中,6 个月内每例参与者 URIT 发作率为 2.3 次(95%CI 1.8,3.0),而接受木糖醇的 55 名参与者中,6 个月内 URIT 发作率为 1.3 次(95%CI 0.92,1.82;RR 0.56;95%CI 0.36,0.87)。最常见的不良事件是腹泻(安慰剂组 28%;木糖醇组 34%)。

结论

在一项统计能力有限的试验中,常规使用木糖醇并不能预防 AOM、URTI 或龋齿。事后分析表明,在 COVID-19 大流行期间,暴露于木糖醇时 URTI 较少,但这一发现可能是虚假的。

试验注册号

NCT03055091。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6ae9/10850643/31640b6b50e3/archdischild-2023-325565f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6ae9/10850643/31640b6b50e3/archdischild-2023-325565f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6ae9/10850643/31640b6b50e3/archdischild-2023-325565f01.jpg

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