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目的了解酸反流指数(RI)在儿童病理性胃食管反流(GER)诊断中的价值,探讨儿童病理性GER的诊断标准。方法对在浙江大学医学院附属儿童医院进行食管pH值监测的数据进行归纳和整理,并除外复查和少数未能完成监测的数据。根据Boix-Ochoa标准(金标准)综合评分>11.99诊断病理性GER,对RI进行受试者工作特征(ROC)曲线分析,获得最佳诊断界点值(cutoff value)。通过McNemar卡方检验和Kappa检验,评价各种以RI为基准的病理性GER诊断标准所得结果的差异及其吻合度,并进一步评价各种标准诊断GER的敏感度、特异度等指标的差异。结果1994年9月至2006年5月有5000例患儿进行食管pH值监测,有效数据者4109例进入分析,其中男性2692例,女性1417例。新生儿476例,~1岁1553例,~3岁658例,~7岁837例,~12岁513例,~16岁72例。病种构成有13类,依次为:支气管哮喘366例,支气管炎468例,支气管肺炎385例,迁延性肺炎143例,慢性咳嗽184例,慢性咽炎29例,新生儿呼吸暂停102例,新生儿呕吐283例,新生儿肺炎105例,呕吐或伴腹痛1817例,食管裂孔疝140例,非心源性胸痛55例,营养不良32例。ROC曲线分析显示RI最佳诊断界点为2.9,其敏感度为90.4%,特异度为95.6%(假阳性率<5.0%)。ROC曲线下面积为0.981(95%CI:0.977~0.984),sx-为0.002,用于诊断病理性GER有统计学意义(P=0.000)。分别以RI≥4.0%(RI 4.0标准)、RI≥2.9%(RI 2.9标准)为病理性GER诊断标准,以手术确诊的140例食管裂孔疝患儿进行分析,与Boix-Ochoa标准进行比较。RI 2.9标准的总体吻合度高于RI 4.0标准(κ系数分别为0.892、0.715,P均=0.000)。除了特异度,RI 2.9标准诊断病理性GER的敏感度、准确性和阴性预测值均明显高于RI 4.0标准,而阳性预测值两者相近。结论RI 2.9标准诊断病理性GER有显著意义,与RI 4.0标准相比,有助于提高儿童病理性GER诊断的敏感度和准确性。
Objective To understand the value of acid reflux index (RI) in the diagnosis of pathological gastroesophageal reflux (GER) in children and to explore the diagnostic criteria of pathological GER in children. Methods The data of esophageal pH monitoring at Children’s Hospital Affiliated to Medical College of Zhejiang University were summarized and sorted out, with the exception of the review and the few data that failed to complete the monitoring. According to the Boix-Ochoa standard (gold standard) comprehensive score> 11.99, pathological GER was diagnosed, and receiver operating characteristic (ROC) curve analysis of RI was performed to obtain the best diagnostic cutoff value. The differences of the diagnostic criteria of various pathological GERs based on RI and their concordance were evaluated by McNemar’s Chi-square test and Kappa test, and the differences of the sensitivity, specificity and other indicators of various diagnostic GERs were further evaluated. Results From September 1994 to May 2006, 5000 children underwent esophageal pH monitoring. There were 4,109 valid data, including 2692 males and 1417 females. 476 cases of newborns, 1553 cases of ~ 1 year old, 658 cases of ~ 3 years old, 837 cases of ~ 7 years old, 513 cases of ~ 12 years old and 72 cases of ~ 16 years old. There were 13 types of diseases, including 366 cases of bronchial asthma, 468 cases of bronchitis, 385 cases of bronchial pneumonia, 143 cases of persistent pneumonia, 184 cases of chronic cough, 29 cases of chronic pharyngitis, 102 cases of neonatal apnea, 102 cases of newborns 283 cases of vomiting, 105 cases of neonatal pneumonia, 1817 cases of vomiting or with abdominal pain, 140 cases of hiatal hernia, 55 cases of non-cardiac chest pain, 32 cases of malnutrition. ROC curve analysis showed that the best diagnostic cutoff point of RI was 2.9, with a sensitivity of 90.4% and a specificity of 95.6% (false positive rate <5.0%). The area under the ROC curve was 0.981 (95% CI: 0.977-0.984) and sx- was 0.002, which was statistically significant for the diagnosis of pathological GER (P = 0.000). Respectively with 140 cases of hiatal hernia diagnosed by surgery, RI ≥ 4.0% (RI 4.0 standard) and RI ≥ 2.9% (RI 2.9 standard) as diagnostic criteria of GER were compared with Boix-Ochoa standard. RI 2.9 standard overall agreement is higher than the RI 4.0 standard (κ coefficient were 0.892,0.715, P = 0.000). In addition to specificity, the sensitivity, accuracy, and negative predictive value of RI 2.9 for diagnosing pathologic GER were significantly higher than those for RI 4.0, and the positive predictive values were similar. Conclusion RI 2.9 standard diagnosis of pathological GER has significant significance, compared with the RI 4.0 standard, contribute to the diagnosis of pathological GER in children with increased sensitivity and accuracy.