Agustin J Cabrera, Dongdong Li, Susan Redline, Ronald D Chervin, Stacey L Ishman, Cristina M Baldassari, Ron B Mitchell, Raouf Amin, Fauziya Hassan, Sally Ibrahim, Kristie R Ross, Erin M Kirkham, David A Zopf, Christopher M Cielo, Lisa R Young, Susan L Furth, Susan Garetz, Carol L Rosen, Rui Wang, Ignacio E Tapia
{"title":"轻度阻塞性睡眠呼吸障碍儿童的腺扁桃体切除术与血压：PATS随机临床试验的探索性分析","authors":"Agustin J Cabrera, Dongdong Li, Susan Redline, Ronald D Chervin, Stacey L Ishman, Cristina M Baldassari, Ron B Mitchell, Raouf Amin, Fauziya Hassan, Sally Ibrahim, Kristie R Ross, Erin M Kirkham, David A Zopf, Christopher M Cielo, Lisa R Young, Susan L Furth, Susan Garetz, Carol L Rosen, Rui Wang, Ignacio E Tapia","doi":"10.1001/jamaoto.2025.2555","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>The impact of adenotonsillectomy on blood pressure (BP) in children with mild obstructive sleep-disordered breathing (oSDB) remains unclear.</p><p><strong>Objective: </strong>To compare BP trajectories in children with mild oSDB randomized to early adenotonsillectomy (eAT) vs watchful waiting with supportive care (WWSC).</p><p><strong>Design, setting, and participants: </strong>This was a secondary outcome exploratory analysis of the Pediatric Adenotonsillectomy Trial for Snoring (PATS), a randomized clinical trial where children aged 3 to 12.9 years with snoring and mild oSDB (Obstructive Apnea-Hypopnea Index <3 with tonsillar hypertrophy [Brodsky scale grade ≥2]) were randomized to eAT vs WWSC and followed up for 12 months. PATS was conducted across 7 tertiary pediatric centers in the US. Participants were recruited from June 29, 2016, to February 1, 2021. Data were analyzed between July and November 2024.</p><p><strong>Interventions: </strong>eAT vs WWSC.</p><p><strong>Main outcomes and measures: </strong>The outcomes of interest were 12-month changes in BP percentiles from baseline and the moderating effect of covariates on these changes. BP was measured with an automated oscillometric BP device at baseline, 6 months, and 12 months after randomization. The treatment effect on BP trajectories was evaluated using mixed-effect models.</p><p><strong>Results: </strong>Of 458 participants included in the analysis, the mean (SD) age was 6.1 (2.3) years, 230 (50.2%) were female, and 169 (36.9%) had overweight/obesity. Mean (SD) baseline systolic BP (SBP) and diastolic BP (DBP) percentiles were 60.62 (25.22) and 53.86 (21.05), respectively, and 231 participants (50.4%) underwent eAT. From baseline to 12 months, SBP and DBP decreased in the eAT group but increased in the WWSC group. The between-group difference in changes from baseline for SBP was -9.02 (95% CI, -14.77 to -3.28) and for DBP was -6.53 (95% CI, -11.02 to -2.03). Moderation analysis showed that the effect of eAT on DBP was greater among children with body mass index higher than the 85th percentile, with an interaction effect estimate of -10.40 (95% CI, -19.69 to -1.12; P = .03).</p><p><strong>Conclusion and relevance: </strong>In this exploratory analysis of the PATS randomized clinical trial, BP trajectories differed by treatment arm. eAT led to decreases in SBP and DBP percentiles, while WWSC led to increases. Children with overweight/obesity benefited more from eAT than children without.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT02562040.</p>","PeriodicalId":14632,"journal":{"name":"JAMA otolaryngology-- head & neck surgery","volume":" ","pages":""},"PeriodicalIF":5.6000,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12395361/pdf/","citationCount":"0","resultStr":"{\"title\":\"Adenotonsillectomy and Blood Pressure in Children With Mild Obstructive Sleep-Disordered Breathing: An Exploratory Analysis of the PATS Randomized Clinical Trial.\",\"authors\":\"Agustin J Cabrera, Dongdong Li, Susan Redline, Ronald D Chervin, Stacey L Ishman, Cristina M Baldassari, Ron B Mitchell, Raouf Amin, Fauziya Hassan, Sally Ibrahim, Kristie R Ross, Erin M Kirkham, David A Zopf, Christopher M Cielo, Lisa R Young, Susan L Furth, Susan Garetz, Carol L Rosen, Rui Wang, Ignacio E Tapia\",\"doi\":\"10.1001/jamaoto.2025.2555\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>The impact of adenotonsillectomy on blood pressure (BP) in children with mild obstructive sleep-disordered breathing (oSDB) remains unclear.</p><p><strong>Objective: </strong>To compare BP trajectories in children with mild oSDB randomized to early adenotonsillectomy (eAT) vs watchful waiting with supportive care (WWSC).</p><p><strong>Design, setting, and participants: </strong>This was a secondary outcome exploratory analysis of the Pediatric Adenotonsillectomy Trial for Snoring (PATS), a randomized clinical trial where children aged 3 to 12.9 years with snoring and mild oSDB (Obstructive Apnea-Hypopnea Index <3 with tonsillar hypertrophy [Brodsky scale grade ≥2]) were randomized to eAT vs WWSC and followed up for 12 months. PATS was conducted across 7 tertiary pediatric centers in the US. Participants were recruited from June 29, 2016, to February 1, 2021. Data were analyzed between July and November 2024.</p><p><strong>Interventions: </strong>eAT vs WWSC.</p><p><strong>Main outcomes and measures: </strong>The outcomes of interest were 12-month changes in BP percentiles from baseline and the moderating effect of covariates on these changes. BP was measured with an automated oscillometric BP device at baseline, 6 months, and 12 months after randomization. The treatment effect on BP trajectories was evaluated using mixed-effect models.</p><p><strong>Results: </strong>Of 458 participants included in the analysis, the mean (SD) age was 6.1 (2.3) years, 230 (50.2%) were female, and 169 (36.9%) had overweight/obesity. Mean (SD) baseline systolic BP (SBP) and diastolic BP (DBP) percentiles were 60.62 (25.22) and 53.86 (21.05), respectively, and 231 participants (50.4%) underwent eAT. From baseline to 12 months, SBP and DBP decreased in the eAT group but increased in the WWSC group. The between-group difference in changes from baseline for SBP was -9.02 (95% CI, -14.77 to -3.28) and for DBP was -6.53 (95% CI, -11.02 to -2.03). Moderation analysis showed that the effect of eAT on DBP was greater among children with body mass index higher than the 85th percentile, with an interaction effect estimate of -10.40 (95% CI, -19.69 to -1.12; P = .03).</p><p><strong>Conclusion and relevance: </strong>In this exploratory analysis of the PATS randomized clinical trial, BP trajectories differed by treatment arm. eAT led to decreases in SBP and DBP percentiles, while WWSC led to increases. 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Adenotonsillectomy and Blood Pressure in Children With Mild Obstructive Sleep-Disordered Breathing: An Exploratory Analysis of the PATS Randomized Clinical Trial.
Importance: The impact of adenotonsillectomy on blood pressure (BP) in children with mild obstructive sleep-disordered breathing (oSDB) remains unclear.
Objective: To compare BP trajectories in children with mild oSDB randomized to early adenotonsillectomy (eAT) vs watchful waiting with supportive care (WWSC).
Design, setting, and participants: This was a secondary outcome exploratory analysis of the Pediatric Adenotonsillectomy Trial for Snoring (PATS), a randomized clinical trial where children aged 3 to 12.9 years with snoring and mild oSDB (Obstructive Apnea-Hypopnea Index <3 with tonsillar hypertrophy [Brodsky scale grade ≥2]) were randomized to eAT vs WWSC and followed up for 12 months. PATS was conducted across 7 tertiary pediatric centers in the US. Participants were recruited from June 29, 2016, to February 1, 2021. Data were analyzed between July and November 2024.
Interventions: eAT vs WWSC.
Main outcomes and measures: The outcomes of interest were 12-month changes in BP percentiles from baseline and the moderating effect of covariates on these changes. BP was measured with an automated oscillometric BP device at baseline, 6 months, and 12 months after randomization. The treatment effect on BP trajectories was evaluated using mixed-effect models.
Results: Of 458 participants included in the analysis, the mean (SD) age was 6.1 (2.3) years, 230 (50.2%) were female, and 169 (36.9%) had overweight/obesity. Mean (SD) baseline systolic BP (SBP) and diastolic BP (DBP) percentiles were 60.62 (25.22) and 53.86 (21.05), respectively, and 231 participants (50.4%) underwent eAT. From baseline to 12 months, SBP and DBP decreased in the eAT group but increased in the WWSC group. The between-group difference in changes from baseline for SBP was -9.02 (95% CI, -14.77 to -3.28) and for DBP was -6.53 (95% CI, -11.02 to -2.03). Moderation analysis showed that the effect of eAT on DBP was greater among children with body mass index higher than the 85th percentile, with an interaction effect estimate of -10.40 (95% CI, -19.69 to -1.12; P = .03).
Conclusion and relevance: In this exploratory analysis of the PATS randomized clinical trial, BP trajectories differed by treatment arm. eAT led to decreases in SBP and DBP percentiles, while WWSC led to increases. Children with overweight/obesity benefited more from eAT than children without.
期刊介绍：
JAMA Otolaryngology–Head & Neck Surgery is a globally recognized and peer-reviewed medical journal dedicated to providing up-to-date information on diseases affecting the head and neck. It originated in 1925 as Archives of Otolaryngology and currently serves as the official publication for the American Head and Neck Society. As part of the prestigious JAMA Network, a collection of reputable general medical and specialty publications, it ensures the highest standards of research and expertise. Physicians and scientists worldwide rely on JAMA Otolaryngology–Head & Neck Surgery for invaluable insights in this specialized field.
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