基于纸片扩散法在幽门螺杆菌药物敏感试验的临床应用研究  

Clinical application study of disk diffusion method in susceptibility testing of helicobacter pylori

作　　者：王超 闫利娟 郜恒骏[3] 张小燕[4] 梁林荣 张静茹 袁曼玉 胡夷 宁姣 WANG Chao;YAN Lijuan;GAO Hengjun;ZHANG Xiaoyan;LIANG Linrong;ZHANG Jingru;YUAN Manyu;HU Yi;NING Jiao(Shanghai Outdo Biotech Co.Ltd.Shanghai 201203,China;China Center for Helicobacter Pylori Molecular Medicine,Shanghai 201318,China;Tongji University Affiliated Tongji Hospital/Institute of Digestive Diseases,Tongji University School of Medicine,Shanghai 200072,China;National Engineering Research Center,Shanghai 201318,China)

机构地区：[1]上海芯超生物科技有限公司,201203 [2]中国幽门螺杆菌分子医学中心,上海201318 [3]同济大学附属同济医院/同济大学医学院消化疾病研究所,上海200072 [4]国家工程研究中心,上海201318

出　　处：《中国医药生物技术》2025年第S1期10-15,共6页Chinese Medicinal Biotechnology

摘　　要：目的 比较纸片扩散法(K-B试验)和E-Test试验检测幽门螺杆菌对克拉霉素、左氧氟沙星、阿莫西林、呋喃唑酮、四环素、甲硝唑六种抗生素药物敏感试验结果的一致性,进行纸片扩散法检测的临床应用研究。方法 用纸片扩散法和E-Test试验同时进行223株幽门螺杆菌对克拉霉素、左氧氟沙星、阿莫西林、呋喃唑酮、四环素、甲硝唑六种抗生素的药物敏感试验,采用配对卡方检验(McNemar Test)和Kappa系数评价两种方法的一致性,并通过ROC曲线建立纸片扩散法的判读标准。结果 纸片扩散法和E-Test试验检测幽门螺杆菌对克拉霉素、左氧氟沙星、阿莫西林、呋喃唑酮、四环素、甲硝唑等六种抗生素药物敏感试验结果完全一致,没有差异。根据ROC曲线克拉霉素、左氧氟沙星、阿莫西林、甲硝唑的抑菌圈直径分别为≤16 mm、≤12 mm、≤16 mm、≤19 mm判为耐药,且以此折点判断值重新判读纸片扩散法结果,与纸片扩散法原判读结果、E-Test试验结果均一致。结论 纸片扩散法与E-Test试验的一致性非常好,可以替代E-Test试验开展药物敏感试验,易于在临床中应用。Objective To compare the result consistency of susceptibility testing for helicobacter pylori to six antibiotics,namely,clarithromycin,levofloxacin,amoxicillin,furazolidone,tetracycline,and metronidazole by Kirby-Bauer disk diffusion(K-B test)and E-Test,and to conduct clinical application study of disk diffusion detection.Methods Disk diffusion and E-Test were simultaneously applied in susceptibility testing of 223 Helicobacter pylori strains to clarithromycin,levofloxacin,amoxicillin,furazolidone,tetracycline,and metronidazole.McNemar Test and Kappa coefficient were used to evaluate the consistency of the two methods and the receiver operating characteristic curve(ROC curve)was established for the interpretation criteria for disk diffusion method.Results The results of helicobacter pylori susceptibility testing to six antibiotics,namely clarithromycin,levofloxacin,amoxicillin,furazolidone,tetracycline,and metronidazole,detected by disk diffusion and E-Test,showed high conformance.Based on the ROC curve,the breakpoints for Helicobacter pylori drug resistance were determined.If the diameter of the inhibition zone of clarithromycin,levofloxacin,amoxicillin,or metronidazole was≤16 mm,≤12 mm,≤16 mm,or≤19 mm,respectively,the antibiotic was judged as resistance.Based on those breakpoints,re-interpretion of disk diffusion results were consistent with both original interpretion of disk diffusion and the results of E-Test.Conclusion The consistency between disk diffusion and E-Test is excellent.Disk diffusion can be used as substitute for E-Test in susceptibility testing and it's easier to be used in clinical practice.

关 键 词：幽门螺杆菌 纸片扩散法 E-Test试验 药物敏感试验 判读标准 

分 类 号：R446[医药卫生—诊断学]