腭裂初次手术时机。
Timing of Primary Surgery for Cleft Palate.
机构信息
From the University of Liverpool (C.G., R.C., E.C., L.P., P.R.W.) and Alder Hey Children's NHS Foundation Trust (S.M.), Liverpool, Royal Hospital for Sick Children (G.C., N.L.) and the University of Edinburgh (F.M.), Edinburgh, Northern and Yorkshire Regional Cleft Lip and Palate Service (S.C.) and Leeds General Infirmary (C.L.), Leeds, Cleft Care Scotland, Glasgow (L.C.), Bristol Dental Hospital, Bristol (L.A.), the University of Manchester (J.C.-S., A.E.-A., G.S., K.M., T.W., W.S.) and Manchester University NHS Foundation Trust (M.B., K.P.), Manchester, Birmingham Children's Hospital (B.F.) and Birmingham Women's and Children's NHS Foundation Trust (I.U.), Birmingham, Salisbury District Hospital, Salisbury (G.P.), Royal Victoria Infirmary, Newcastle upon Tyne (L.R., S.E.), and Oxford University Hospitals NHS Foundation Trust, Oxford (L.S.) - all in the United Kingdom; the University of Gothenburg (C.P.) and Sahlgrenska University Hospital (C.H.), Gothenburg, Uppsala University Hospital, Uppsala (M.A., E.L.), Linköping University Hospital, Linköping (P.B., A.-S.B.T.), Umeå University (K.B.) and Norrlands University Hospital (J.E.W.), Umeå, Skåne University Hospital, Malmö (K.K., M.S.), Karolinska Institutet, Solna (A.L., J.N.), and Karolinska University Hospital, Stockholm (L.R.W.) - all in Sweden; the University of Copenhagen (E.W., L.D.J.) and Copenhagen Cleft Palate Center (H.S.A., L.D.J.), Copenhagen, and the Cleft Palate Center, Aarhus (B.K.E., L.L., J.B.N.) - all in Denmark; the University of São Paulo, Bauru, Brazil (M.Z.A., A.P.F., C.G.A.B.G., H.C.M., S.H.A.P.-P., I.E.K.T., R.P.Y.); and Statped (R.A., A.K.H., M.B.K., J.L.) and Statped Sørøst (M.M.), Oslo, and Statped Vest, Bergen (N.-H.P., J.T.) - all in Norway.
出版信息
N Engl J Med. 2023 Aug 31;389(9):795-807. doi: 10.1056/NEJMoa2215162.
BACKGROUND
Among infants with isolated cleft palate, whether primary surgery at 6 months of age is more beneficial than surgery at 12 months of age with respect to speech outcomes, hearing outcomes, dentofacial development, and safety is unknown.
METHODS
We randomly assigned infants with nonsyndromic isolated cleft palate, in a 1:1 ratio, to undergo standardized primary surgery at 6 months of age (6-month group) or at 12 months of age (12-month group) for closure of the cleft. Standardized assessments of quality-checked video and audio recordings at 1, 3, and 5 years of age were performed independently by speech and language therapists who were unaware of the trial-group assignments. The primary outcome was velopharyngeal insufficiency at 5 years of age, defined as a velopharyngeal composite summary score of at least 4 (scores range from 0 to 6, with higher scores indicating greater severity). Secondary outcomes included speech development, postoperative complications, hearing sensitivity, dentofacial development, and growth.
RESULTS
We randomly assigned 558 infants at 23 centers across Europe and South America to undergo surgery at 6 months of age (281 infants) or at 12 months of age (277 infants). Speech recordings from 235 infants (83.6%) in the 6-month group and 226 (81.6%) in the 12-month group were analyzable. Insufficient velopharyngeal function at 5 years of age was observed in 21 of 235 infants (8.9%) in the 6-month group as compared with 34 of 226 (15.0%) in the 12-month group (risk ratio, 0.59; 95% confidence interval, 0.36 to 0.99; P = 0.04). Postoperative complications were infrequent and similar in the 6-month and 12-month groups. Four serious adverse events were reported (three in the 6-month group and one in the 12-month group) and had resolved at follow-up.
CONCLUSIONS
Medically fit infants who underwent primary surgery for isolated cleft palate in adequately resourced settings at 6 months of age were less likely to have velopharyngeal insufficiency at the age of 5 years than those who had surgery at 12 months of age. (Funded by the National Institute of Dental and Craniofacial Research; TOPS ClinicalTrials.gov number, NCT00993551.).
背景
对于单纯腭裂的婴儿，6 月龄时行初次手术是否优于 12 月龄时行初次手术，目前尚不清楚哪种方案在言语结局、听力结局、牙颌面发育和安全性方面更具优势。
方法
我们采用 1:1 随机分组的方法，将患有非综合征型单纯腭裂的婴儿分为两组，分别在 6 月龄（6 月龄组）或 12 月龄（12 月龄组）时接受标准化初次腭裂修复手术。在 1 岁、3 岁和 5 岁时，由不了解试验分组的言语治疗师独立进行经过质量检查的视频和音频记录的评估。主要结局为 5 岁时的腭咽闭合不全，定义为腭咽复合总评分至少为 4 分（评分范围为 0 分至 6 分，评分越高表示严重程度越重）。次要结局包括言语发育、术后并发症、听力灵敏度、牙颌面发育和生长。
结果
我们在欧洲和南美洲的 23 个中心将 558 名婴儿随机分为 6 月龄组（281 名婴儿）或 12 月龄组（277 名婴儿）。在 6 月龄组的 235 名婴儿（83.6%）和 12 月龄组的 226 名婴儿（81.6%）中，有 235 名婴儿（83.6%）和 226 名婴儿（81.6%）的语音记录可进行分析。在 6 月龄组中，21 名（8.9%）婴儿在 5 岁时存在腭咽闭合不全，而在 12 月龄组中，34 名（15.0%）婴儿存在腭咽闭合不全（风险比，0.59；95%置信区间，0.36 至 0.99；P=0.04）。在 6 月龄组和 12 月龄组中，术后并发症均较为少见且相似。报告了 4 例严重不良事件（3 例发生在 6 月龄组，1 例发生在 12 月龄组），且在随访时已解决。
结论
在资源充足的环境中，对于身体状况良好的单纯腭裂婴儿，在 6 月龄时行初次腭裂修复手术在 5 岁时发生腭咽闭合不全的可能性低于 12 月龄时手术的婴儿。（由国立牙科和颅面研究所资助；TOPS ClinicalTrials.gov 编号，NCT00993551。）
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