三种快速检测法用于口腔念珠菌病诊断的准确性研究

Accuracy of three methods for the rapid diagnosis of oral candidiasis

目的：探索适用于口腔念珠菌病临床诊断的简便、快速、高效的检测方法。方法2015年3至7月于北京大学口腔医学院·口腔医院口腔黏膜科纳入临床表现疑似口腔念珠菌病的患者124例，采集其口腔黏膜脱落细胞及唾液（或含漱液）两种标本，应用3种快速检测法（10%KOH涂片镜检、革兰染色涂片镜检、刚果红负染涂片镜检）进行口腔念珠菌病的诊断，同时与诊断金标准（临床表现＋唾液培养＋专家意见）对比，计算每种检测方法的诊断效能，包括灵敏度、特异度、约登指数、似然比、符合率、预测值及受试者工作特征曲线（receiver operator characteristic curve，ROC）下面积。结果唾液（或含漱液）革兰染色涂片镜检的灵敏度（82.3%）最高，脱落细胞10%KOH涂片镜检的特异度（93.5%）最高，唾液（或含漱液）刚果红负染涂片镜检的综合诊断效能最高：灵敏度79.0%、特异度80.6%、约登指数0.60、阳性似然比4.08、阴性似然比0.26、符合率80%、阳性预测值80.3%、阴性预测值79.4%、ROC曲线下面积0.80。结论唾液（或含漱液）刚果红负染涂片镜检可作为口腔念珠菌病诊断的快速检测法，其临床应用价值高。临床试验注册中国临床试验注册中心，ChiCTR-DDD-16008118。

Objective To explore a simple, rapid and efficient method for the diagnosis of oral candidiasis in clinical practice. Methods Totally 124 consecutive patients with suspected oral candidiasis were enrolled from Department of Oral Medicine, Peking University School and Hospital of Stomatology, Beijing, China. Exfoliated cells of oral mucosa and saliva or concentrated oral rinse） obtained from all participants were tested by three rapid smear methods（10%KOH smear, gram-stained smear, Congo red stained smear）. The diagnostic efficacy（sensitivity, specificity, Youden＆#39;s index, likelihood ratio, consistency, predictive value and area under curve（AUC） of each of the above mentioned three methods was assessed by comparing the results with the gold standard（combination of clinical diagnosis, laboratory diagnosis and expert opinion）. Results Gram-stained smear of saliva（or concentrated oral rinse） demonstrated highest sensitivity（82.3%）. Test of 10%KOH smear of exfoliated cells showed highest specificity（93.5%）. Congo red stained smear of saliva（or concentrated oral rinse） displayed highest diagnostic efficacy（79.0% sensitivity, 80.6% specificity, 0.60 Youden＆#39;s index, 4.08 positive likelihood ratio, 0.26 negative likelihood ratio, 80%consistency, 80.3% positive predictive value, 79.4% negative predictive value and 0.80 AUC）. Conclusions Test of Congo red stained smear of saliva（or concentrated oral rinse） could be used as a point-of-care tool for the rapid diagnosis of oral candidiasis in clinical practice. Trial registration Chinese Clinical Trial Registry, ChiCTR-DDD-16008118.