胃蛋白酶免疫组织化学与胃蛋白酶检测试剂盒在咽喉反流诊断中的一致性分析

Consistency analysis of pepsin immunohistochemistry and pepsin test box in the diagnosis of laryngopharyngeal reflux

目的:分析胃蛋白酶检测试剂盒、胃蛋白酶免疫组织化学及反流症状指数量表(RSI)、反流体征评分量表(RFS)评分在诊断咽喉反流性疾病(LPRD)中的一致性。方法:回顾性分析2020年5月-2021年12月就诊于昆明医科大学第一附属医院耳鼻咽喉科61例喉科疾病住院患者的临床资料,记录患者的RSI、RFS量表的评分数值、胃蛋白酶免疫组织化学Formwitz评分数值,胃蛋白酶检测试剂盒结果,采用ICC组内相关系数、Kappa一致性分析三种检测方法。结果:61例患者中胃蛋白酶检测试剂盒阳性30例,阴性31例,阳性率49.18%;胃蛋白酶免疫组织化学检测阳性率45.90%(28/61),两者间诊断一致率为70.49%,且两者间一致性较高(κ=0.409);RSI、RFS量表诊断LPRD阳性率62.30%(38/61),与胃蛋白酶检测试剂盒一致率为73.77%,且两者间一致性较高(κ=0.486)。以胃蛋白酶免疫组织化学为参考标准,胃蛋白酶检测试剂盒的敏感度为71.43%(20/28)、特异度为69.70%(23/33)、阳性预测值为66.67%(20/30)、阴性预测值为74.19%(23/31);以RSI、RFS量表诊断为参考标准,胃蛋白酶检测试剂盒的敏感度为89.29%(25/28)、特异度为60.61%(20/33)、阳性预测值为65.79%(25/38)、阴性预测值为86.96%(20/23)。ICC组内相关系数分析:ICC值为0.628,95%可信区间(0.497~0.741),三种方法一致性较好。结论:RSI、RFS量表评分与胃蛋白酶检测试剂盒结果的一致性较高,胃蛋白酶检测试剂盒与胃蛋白酶免疫组织化学同样有较好的一致性,胃蛋白酶检测试剂盒作为非侵入性诊断技术,可以联合胃蛋白酶免疫组织化学及RSI、RFS量表广泛应用于咽喉反流的诊断。

Objective:To analyze the consistency of pepsin assay kit,pepsin IHC,reflux symptom index(RSI) and reflux finding score(RFS) in the diagnosis of laryngopharyngeal reflux disease(LPRD).Methods:The clinical data of 61 inpatients with laryngeal diseases who were admitted to the Department of Otolaryngology,the First Affiliated Hospital of Kunming Medical University from May 2020 to December 2021 were retrospectively analyzed.The RSI and RFS scores,the Formwitz score of pepsin immunohistochemistry,and the results of pepsin detection kit were recorded.ICC group correlation coefficient and Kappa consistency analysis was used for three detection methods.Results:Among 61 patients,30 cases were positive and 31 cases were negative for the pepsin test kit,with a positive rate of 49.18%.The positive rate of pepsin immunohistochemistry was 45.90%(28/61),and the diagnostic agreement rate between the two was 70.49%.The consistency between them was high(κ=0.409).The positive rate of RSI and RFS in diagnosing LPRD was 62.30%(38/61),and the consistency rate was 73.77% with pepsin detection kit.The consistency between them was high(κ=0.486).Taking pepsin IHC as the reference standard,the sensitivity,specificity,positive predictive value and negative predictive value of pepsin detection kit were 71.43%(20/28),69.70%(23/33),66.67%(20/30) and 74.19%(23/31),respectively.Using RSI and RFS scales as reference criteria,the sensitivity,specificity,positive predictive value and negative predictive value of pepsin detection kit were 89.29%(25/28),60.61%(20/33),65.79%(25/38) and 86.96%(20/23),respectively.Analysis of correlation coefficient within ICC group:ICC value was 0.628,95% confidence interval(0.497-0.741),the three methods have good consistency.Conclusion:The RSI and RFS scale scores were in good agreement with the pepsin test kit,and the pepsin test kit was also in good agreement with pepsin immunohistochemistry.As a non-invasive diagnostic technique,the pepsin test kit can be widely used in the diagnosis of pharyngeal reflux in combination with pepsin immunohistochemistry and RSI and RFS scale.