结核病患者异烟肼治疗依从性现场检测方法的建立与验证  

An innovative method for field measuring adherence to treatment with isoniazid

作　　者：黄曙海[1] 区进[1] 刘毅[2] 刘飞鹰[1] 

机构地区：[1]广西壮族自治区疾病预防控制中心,广西南宁530028 [2]北海市结核病防治院,广西北海536000

出　　处：《应用预防医学》2016年第6期477-480,485,共5页Applied Preventive Medicine

摘　　要：目的建立尿中异烟肼代谢产物现场快速定性检测方法,评估结核病患者治疗依从性。方法建立氰化物-氯胺T-巴比妥酸定性检测异烟酸法,通过北海市结核病防治院住院53例服用异烟肼的在治患者和51例未服药病人尿液检测对方法进行验证。结果所建立方法的检测原理:氰化物溶液与氯胺T溶液混合,再与待检物、巴比妥酸溶液混合,在室温下产生显色反应,目视判读结果,蓝紫色为阳性,异烟酸检出限约为0.5μg/m L。在104名临床住院患者的验证试验中,53例服用异烟肼的结核病患者服药后6h、24h尿液检测结果全部阳性,灵敏度100.0%;51例未服药对照组尿检结果全部阴性,特异度100.0%。结论建立了尿异烟肼代谢产物现场快速定性检测方法,经临床验证该方法的灵敏度、特异度均可达100.0%。Objective To establish a rapid point-of-care qualitive test method detectingTB patient＇s urine for the presence of isoniazid metabolites in order to help assessing adherence to treatment. Methods A method was designed to measure qualitatively the isonicotinic acid, a kind of isoniazid metabolites at laboratory.A clinic trial was carried out to evaluate the method in a hospital in Beihai,Guangxi of China.Fifty-three in-patients with daily isoniazid intake were included, and another 51 in-patients without receiving INH as negative control. All patients’ urine with daily isoniazid intake was sampled at 6h, 24h and examined as well as control patients’urine samples were collected on the same day. Results A rapid point-of-care method detectingTB patient＆#39;s urine for the presence of isoniazid metabolites was established. It was a chemical color reaction of potassium cyanide, chloramine-T, tested sample isonicotinic acid and barbituric acid proceeding at room temperature and then result was read by visual interpretation of the blue/purple. Results of clinical verification test showed that both sensitivity and specificity of the test were 100.0%. Conclusion A new point-of-care qualitative test was established to detect patient’s urine for the presence of isoniazid metabolites, and both sensitivity and specificity of the test were 100.0%.

关 键 词：结核病 异烟肼 代谢产物 尿 定性检测 

分 类 号：R521.5[医药卫生—内科学]