不同尿素[^(14)C]呼气试验产品诊断幽门螺杆菌感染的效果评估

Evaluation of the effects of different ^(14)C-urea breath test products in the diagnosis of Helicobacter pylori infection

目的评价卡式尿素[^(14)C]呼气试验药盒、闪烁采样瓶(固体闪烁法)、液体闪烁式(以下简称液闪式)尿素[^(14)C]呼气试验药盒诊断幽门螺杆菌(H.pylori)感染的效果。方法纳入2020年1月7日至10月28日在上海交通大学医学院附属仁济医院、浙江大学医学院附属第二医院、南昌大学第一附属医院就诊的239例患者。所有受试者均先接受^(14)C尿素呼气试验,气体收集结束后>1~<7 d于胃镜下取黏膜组织行金标准检测,即活体组织检查(以下简称活检)和快速尿素酶检查(RUT),活检与RUT均提示H.pylori阳性则判定金标准检测结果为H.pylori阳性,均提示H.pylori阴性则判定金标准检测结果为H.pylori阴性,活检与RUT结果不一致则不纳入后续分析。以金标准检测结果为参照,分析卡式尿素[^(14)C]呼气试验药盒、闪烁采样瓶、液闪式尿素[^(14)C]呼气试验药盒诊断H.pylori感染的灵敏度、特异度、准确度、阳性预测值、阴性预测值,评价其诊断效果。记录检测过程中有无出现检测相关不良事件以评估试验的安全性。采用描述性方法进行统计学分析。结果239例受试者中,12例未完成试验,最终227例受试者完成检测,试验完成率为95.0%(227/239),其中第008号受试者缺少液闪式呼气检测结果,仅纳入卡式尿素[^(14)C]呼气试验药盒和闪烁采样瓶结果分析。金标准检测结果显示,227例患者中,87例呈H.pylori阳性,118例呈阴性,22例活检与RUT结果不一致故不纳入后续分析;除去008号受试者,金标准检测结果中86例呈H.pylori阳性,118例呈阴性。以金标准检测结果为参照,卡式尿素[^(14)C]呼气试验药盒、闪烁采样瓶、液闪式尿素[^(14)C]呼气试验药盒诊断H.pylori感染的灵敏度、特异度、准确度、阳性预测值、阴性预测值分别为91.9%、100.0%、96.6%、100.0%、94.4%,95.4%、97.5%、96.6%、96.5%、96.6%,96.5%、99.2%、98.0%、98.8%、97.5%。试验过程中仅发生1例不良事件(进食后右上腹疼痛),结合患者病情判定为慢性胆囊炎发作,与试验药物可能无关。结论卡式尿素[^(14)C]呼气试验药盒、闪烁采样瓶、液闪式尿素[^(14)C]呼气试验药盒3个产品性能可靠,诊断H.pylori感染的灵敏度、特异度、准确度均较高,安全性好,值得临床推广应用。

Objective To evaluate the effects of the cassette ^(14)C-urea breath test kit,scintillation sampling bottle(solid-state scintillation method)and liquid scintillation ^(14)C-urea breath test kit in the diagnosis of Helicobacter pylori(H.pylori)infection.Methods From January 7 to October 28,2020,239 patients were enrolled who visited Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine,the Second Affiliated Hospital of Zhejiang University School of Medicine and the First Affiliated Hospital of Nanchang University.All subjects first received ^(14)C-urea breath test.Within>1 to<7 days after gas collection,mucosal tissues were taken under gastroscopy for gold standard test,including biopsy and rapid urease test(RUT).If both biopsy and RUT indicated H.pylori positive,the result of gold standard test was H.pylori positive,and if both were negative,the result of gold standard test was H.pylori negative.If the results of biopsy and RUT were inconsistent,they were not included in the subsequent analysis.Based on the results of gold standard test,the sensitivity,specificity,accuracy,positive predictive value and negative predictive value of the cassette ^(14)C-urea breath test kit,scintillation sampling bottle,and liquid scintillation ^(14)C-urea breath test kit in the diagnosis of H.pylori infection were analyzed.The safety of the test was evaluated by whether there were any adverse events during the test.Descriptive methods were used for statistical analysis.Results Among the 239 subjects,12 cases did not complete the test,227 subjects finally completed the test.The test completion rate was 95.0%(227/239).No.008 patient was only included in the analysis of cassette ^(14)C-urea breath test kit and scintillation sampling bottle because of lacking the result of liquid scintillation breath test.The results of gold standard test showed that among 227 patients,87 cases were H.pylori positive,118 cases were H.pylori negative.The results of biopsy and RUT were inconsistent in 22 cases,so they were not included in the subsequent analysis.Excluding No.008 patient,the results of gold standard test showed that 86 cases were H.pylori positive and 118 cases were negative.Based on the results of gold standard test,the sensitivity,specificity,accuracy,positive predictive value,and negative predictive value of cassette ^(14)C-urea breath test kit,scintillation sampling bottle,and the liquid scintillation ^(14)C-urea breath test kit in the diagnosis of H.pylori infection were 91.9%,100.0%,96.6%,100.0%and 94.4%,respectively;95.4%,97.5%,96.6%,96.5%and 96.6%,respectively;and 96.5%,99.2%,98.0%,98.8%and 97.5%,respectively.Only one adverse event(right upper abdominal pain after eating)occurred.Combined with the patients condition,the adverse event was determined as the onset of chronic cholecystitis and it might not be related to the test medication.Conclusions Cassette ^(14)C-urea breath test kit,scintillation sampling bottle,and liquid scintillation ^(14)C-urea breath test kit have reliable performance,good safety,and high sensitivity,specificity and accuracy in the diagnosis of H.pylori infection,which are worthy of clinical application.