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基于食管高分辨率测压参数的成人胃食管反流病诊断模型的建立

[A diagnostic model establishment of adult gastroesophageal reflux disease based on high-resolution manometry parameters of the esophagus].

作者信息

Hu S W, Xiong W J, Yu T, Jiang Y, Tang Y R

机构信息

Department of Gastroenterology, Jiangsu Province Hospital (the First Affiliated Hospital of Nanjing Medical University), Nanjing 210029, China.

出版信息

Zhonghua Yi Xue Za Zhi. 2025 Sep 2;105(33):2866-2873. doi: 10.3760/cma.j.cn112137-20250310-00578.

DOI:10.3760/cma.j.cn112137-20250310-00578
PMID:40873091
Abstract

To establish a diagnostic model for adult gastroesophageal reflux disease (GERD) based on the high-resolution manometry (HRM) parameters of the esophagus. The clinical data of patients who underwent HRM and 24-hour esophageal pH+impedance examination due to suspected GERD at Jiangsu Province Hospital from January 2021 to October 2024 were retrospectively collected. According to the diagnostic criteria and examination results of GERD, the patients were divided into the GERD group [acid exposure time percentage (AET)>4.2% or total reflux times>80 times] and the non-GERD group, and the HRM parameters of the two groups were compared. Patients were randomly divided into the training set and the validation set in a ratio of 7∶3 using R 4.4. The Youden index maximization method was used to determine the optimal diagnostic cut-off value of a single HRM parameter for diagnosing GERD. The multivariate logistic regression model was used to analyze and screen the influencing factors for diagnosing GERD, and the nomogram of the GERD diagnostic model was drawn. The diagnostic ability and accuracy of the model were evaluated respectively by the area under the receiver operating characteristic curve (AUC) and the calibration curve. Finally, the clinical applicability of the model was determined by the decision curve analysis (DCA). A total of 326 patients were included, among which 77 were in the GERD group, including 48 males and 29 females, with an age of [ (, )] 57 (42, 64) years. There were 249 cases in the non-GERD group, including 90 males and 159 females, with an age of 53 (42, 59) years. The age, proportion of males, body mass index (BMI), proportion of cases classified by gastroesophageal junction (EGJ), proportion of cases with ineffective esophageal motility (IEM), and proportion of ineffective swallowing times in the GERD group were all higher than those in the non-GERD group. The gastroesophageal junction contraction index (EGJ-CI), the resting pressure of the lower esophageal sphincter (LESP), and the distal contraction score (DCI) were all lower than those in the non-GERD group (all 0.05).The HHRM related parameters for diagnosing GERD were EGJ-CI, LESP, DCI, the proportion of ineffective swallowing times and failed peristalsis times. The corresponding optimal cut-off values (sensitivity and specificity) were 23 mmHg·cm (1 mmHg=0.133 kPa) (48%, 86%), 13.4 mmHg (81%, 59%), 1 130 mmHg·s·cm (66%, 60%), 0.15 (53%, 66%), 0.35 (24%, 89%), respectively. The results of the multivariate logistic regression model analysis showed that gender (3.82, 95: 1.69-8.61), BMI (1.28, 95: 1.12-1.46), and EGJ-CI (0.95, 95: 0.92-0.97), EGJ classification type Ⅲ EGJ (6.66, 95: 1.51-29.40), and IEM (6.69, 95: 1.27-35.27) were the influencing factors for the diagnosis of GERD. Model 1 was established by referring to the "Milan Score". The AUC, sensitivity, and specificity of the training set for diagnosing GERD were 0.78 (95: 0.71-0.85), 56%, and 92%, respectively. The AUC, sensitivity, and specificity of the validation set for diagnosing GERD were 0.77 (95: 0.66-0.89), 61%, 82%, respectively; The calibration curves of the training set and the validation set indicate that the model had good calibration ability. The DCA curves of the training set and the validation set suggest that the diagnostic model had good clinical applicability. Model 2 was established based on the data of the Chinese population and the above parameters. The AUC, sensitivity, and specificity of the training set for diagnosing GERD were 0.88 (95: 0.83-0.92), 78%, and 82%, respectively. The AUC, sensitivity, and specificity of the validation set for diagnosing GERD were 0.87 (95: 0.76-0.97), 89%, 80%, respectively. The calibration curves of the training set and the validation set indicate that the model had good calibration ability. The DCA curves of the training set and the validation set suggest that the diagnostic model had good clinical applicability. Gender, BMI, EGJ-CI, EGJ morphological classification, LESP, IEM, DCI and the proportion of failed peristalsis times are the influencing factors for diagnosing GERD. The nomogram model incorporating the above factors can diagnose GERD more intuitively.

摘要

基于食管高分辨率测压(HRM)参数建立成人胃食管反流病(GERD)的诊断模型。回顾性收集2021年1月至2024年10月在江苏省医院因疑似GERD接受HRM及24小时食管pH+阻抗检查患者的临床资料。根据GERD的诊断标准和检查结果,将患者分为GERD组[酸暴露时间百分比(AET)>4.2%或总反流次数>80次]和非GERD组,比较两组的HRM参数。采用R 4.4软件按7∶3的比例将患者随机分为训练集和验证集。采用约登指数最大化法确定单个HRM参数诊断GERD的最佳诊断截断值。采用多因素logistic回归模型分析并筛选诊断GERD的影响因素,绘制GERD诊断模型的列线图。分别通过受试者操作特征曲线(AUC)下面积和校准曲线评估模型的诊断能力和准确性。最后,通过决策曲线分析(DCA)确定模型的临床适用性。共纳入326例患者,其中GERD组77例,包括男性48例、女性29例,年龄[(,)]57(42,64)岁。非GERD组249例,包括男性90例、女性159例,年龄53(42,59)岁。GERD组的年龄、男性比例、体重指数(BMI)、胃食管交界(EGJ)分类病例比例、食管动力无效(IEM)病例比例及无效吞咽次数比例均高于非GERD组。胃食管交界收缩指数(EGJ-CI)、食管下括约肌静息压(LESP)及远端收缩积分(DCI)均低于非GERD组(均P<0.05)。诊断GERD的HRM相关参数为EGJ-CI、LESP、DCI、无效吞咽次数比例及蠕动失败次数。相应的最佳截断值(灵敏度和特异度)分别为23 mmHg·cm(1 mmHg=0.133 kPa)(48%,86%)、13.4 mmHg(81%,59%)、1 130 mmHg·s·cm(66%,60%)、0.15(53%,66%)、0.35(24%,89%)。多因素logistic回归模型分析结果显示,性别(3.82,95%CI:1.69-8.61)、BMI(1.28,95%CI:1.12-1.46)、EGJ-CI(0.95,95%CI:0.92-0.97)、EGJ形态学分类Ⅲ型EGJ(6.66,95%CI:1.51-29.40)及IEM(6.69,95%CI:1.27-35.27)是诊断GERD的影响因素。参照“米兰评分”建立模型1。诊断GERD训练集的AUC、灵敏度和特异度分别为0.78(95%CI:0.71-0.85)、56%和92%。诊断GERD验证集的AUC、灵敏度和特异度分别为0.77(95%CI:0.66-0.89)、61%、82%;训练集和验证集的校准曲线表明模型具有良好的校准能力。训练集和验证集的DCA曲线表明诊断模型具有良好的临床适用性。基于中国人群数据及上述参数建立模型2。诊断GERD训练集的AUC、灵敏度和特异度分别为0.88(95%CI:0.83-0.92)、78%和82%。诊断GERD验证集的AUC、灵敏度和特异度分别为0.87(95%CI:0.76-0.97)、89%、80%。训练集和验证集的校准曲线表明模型具有良好的校准能力。训练集和验证集的DCA曲线表明诊断模型具有良好的临床适用性。性别、BMI、EGJ-CI、EGJ形态学分类、LESP、IEM、DCI及蠕动失败次数比例是诊断GERD的影响因素。纳入上述因素的列线图模型可更直观地诊断GERD。

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