1-60月龄儿童胃食管反流病及相关共病的临床特征：一项前瞻性观察性研究

文献信息

中文摘要

背景： 幼儿胃食管反流病（GERD）可引起令人困扰的症状和并发症，影响生长、喂养和生活质量，但基于症状的诊断与客观反流严重程度相关性差。来自南印度5岁以下儿童的当代临床特征数据以及伴随的营养和共病负担资料匮乏。
方法： 在南印度一家三级保健儿科中心进行的前瞻性观察性研究（2023年6月至2025年3月）。连续纳入1-60月龄临床怀疑GERD的儿童。记录临床特征、放射性核素胃食管反流（GER）闪烁显像分级、印度儿科学会年龄别体重营养状况和确诊的共病；通过预先设定的操作标准（令人困扰的症状持续超过8周，加上至少一项ESPGHAN和NASPGHAN危险信号，加上闪烁显像分级为轻度或以上）区分生理性反流与病理性GERD。单变量逻辑回归确定严重反流的预测因素和随访时无临床改善的预测因素。预先设定的敏感性分析仅限于128例闪烁显像结果阳性的儿童。
结果： 158例儿童中，40.5%（95% CI 33.2%至48.3%）年龄为1-6个月，62.0%（95% CI 54.3%至69.2%）为男性。食管外呼吸道症状占主导（咳嗽76.6%，95% CI 69.4%至82.5%；喘息67.1%），超过呕吐（48.7%）。GER闪烁显像显示严重反流占35.4%（95% CI 28.4%至43.2%），轻度29.7%，中度15.8%，正常19.0%。严重反流集中在较年幼婴儿（中位年龄4个月 vs 轻度反流12个月；Kruskal-Wallis p<0.05）。蛋白质-能量营养不良占39.9%（95% CI 32.6%至47.7%），任何共病占81.0%（95% CI 74.2%至86.4%），主要为呼吸系统（反复喘息45.3%，细支气管炎18.8%，反复肺炎10.9%，哮喘6.3%）。症状严重程度与闪烁显像分级不 correspond（χ2 p=0.40）。在78例有随访的儿童中，与轻度反流相比，严重反流独立预测无临床改善（OR 4.00，95% CI 1.01至15.77，Fisher精确检验 p=0.047）。每项主要发现在确诊GERD的敏感性分析中均得到重现（n=128）。
结论： 在这个南印度5岁以下儿童的三级转诊队列中，GERD主要影响年幼婴儿，以呼吸道症状为主，并伴有高负担的蛋白质-能量营养不良和呼吸系统共病。尽管症状严重程度与客观闪烁显像严重程度无相关性，但客观闪烁显像严重程度独立预测治疗无反应。研究结果支持结构化营养和共病筛查、使用ESPGHAN和NASPGHAN危险信号标准进行有针对性的客观诊断评估，并警告不要反射性地经验性抑酸治疗；三级转诊设计限制了向初级保健人群的推广。
试验注册： CTRI/2023/07/055893。

英文摘要

BACKGROUND: Gastro-oesophageal reflux disease (GERD) in young children causes troublesome symptoms and complications affecting growth, feeding and quality of life, but symptom-based diagnosis correlates poorly with objective reflux severity. Contemporary clinical-profile data from South Indian children under 5 years and the accompanying nutritional and comorbidity burden are sparse.
METHODS: Prospective observational study at a tertiary-care paediatric centre in South India (June 2023 to March 2025). Children aged 1-60 months with clinically suspected GERD were enrolled consecutively. Clinical profile, radionuclide gastro-oesophageal reflux (GER) scintigraphy grade, Indian Academy of Paediatrics weight-for-age nutritional status and confirmed comorbidities were documented; physiological reflux was distinguished from pathological GERD by predefined operational criteria (troublesome symptoms beyond 8 weeks plus at least one ESPGHAN and NASPGHAN red flag plus a scintigraphy grade of mild or above). Univariable logistic regression identified predictors of severe reflux and of no clinical improvement at follow-up. A prespecified sensitivity analysis was restricted to the 128 children with a positive scintigraphy result.
RESULTS: Of 158 children, 40.5% (95% CI 33.2% to 48.3%) were aged 1-6 months and 62.0% (95% CI 54.3% to 69.2%) were male. Extraoesophageal respiratory symptoms predominated (cough 76.6%, 95% CI 69.4% to 82.5%; wheezing 67.1%), exceeding vomiting (48.7%). GER scintigraphy showed severe reflux in 35.4% (95% CI 28.4% to 43.2%), mild 29.7%, moderate 15.8% and normal 19.0%. Severe reflux clustered in younger infants (median age 4 vs 12 months in mild reflux; Kruskal-Wallis p<0.05). Protein-energy malnutrition was present in 39.9% (95% CI 32.6% to 47.7%) and any comorbidity in 81.0% (95% CI 74.2% to 86.4%), predominantly respiratory (recurrent wheezing 45.3%, bronchiolitis 18.8%, recurrent pneumonia 10.9%, asthma 6.3%). Symptom severity did not correspond to scintigraphic grade (χ2 p=0.40). Among 78 children with follow-up, severe reflux independently predicted no clinical improvement compared with mild reflux (OR 4.00, 95% CI 1.01 to 15.77, Fisher exact p=0.047). Every principal finding was reproduced in the confirmed-GERD sensitivity analysis (n=128).
CONCLUSIONS: In this tertiary-referral cohort of South Indian children under 5 years, GERD predominantly affected young infants with a respiratory-dominant symptom profile and a high burden of protein-energy malnutrition and respiratory comorbidity. Objective scintigraphy severity was independently prognostic of treatment non-response despite the absence of a symptom-severity correlation. The findings support structured nutritional and comorbidity screening, targeted objective diagnostic evaluation using the ESPGHAN and NASPGHAN red-flag criteria, and caution against reflexive empirical acid suppression; the tertiary-referral design limits generalisability to primary-care populations.
TRIAL REGISTRATION: CTRI/2023/07/055893.