河南省结核病耐药监测实验室质控分析  

Analysis on quality control of drug susceptibility testing in the surveillance of drug resistance in tuberculosis in Henan

作　　者：徐吉英[1] 彭义利[1] 王国斌[1] 张莉[1] 杜思和[1] 李爱华[1] 赵玉玲[1] 杨立涛 

机构地区：[1]河南省结核病防治研究所

出　　处：《中华结核和呼吸杂志》1998年第12期724-726,共3页Chinese Journal of Tuberculosis and Respiratory Diseases

摘　　要：目的评价河南省结核病耐药监测中实验室工作质量。方法南朝鲜西太区跨国参比室（ＳＲＬ）对河南省结核病防治研究所参比室（ＰＲＬ）先后进行了３次自ＳＲＬ至ＰＲＬ及１次自ＰＲＬ至ＳＲＬ的药敏试验质控，菌株是含耐药及敏感的结核分支杆菌临床分离菌株。试验的４种药物为链霉素、异烟肼、利福平及乙胺丁醇，采用ＬＪ培养基、比例法。结果３次自ＳＲＬ至ＰＲＬ的质控试验中，４药大部分敏感性大于特异性，且异烟肼及利福平的敏感性均为１００％；异烟肼在３次试验中平均准确性达９８％，利福平虽然在第一次质控中准确性仅７０％，但在随后两次质控中均达９３％。与西太区同步质控的其他国家参比室结果（含河南ＰＲＬ）相比，除西太区链霉素特异性较河南高外（８４％比７５％，Ｐ＜０．０５），余特异性之间、敏感性之间无显著性差异。自ＰＲＬ至ＳＲＬ的质控试验显示出与自ＳＲＬ至ＰＲＬ类似的特征，链霉素、异烟肼及利福平的一致性均达９０％以上。结论河南省耐药监测的实验室工作质量符合监测指南要求。Objective To evaluate the working quality of Henan province reference laboratory(PRL) in the surveillance of drug resistance (DRS) in Henan. Method West Pacific Regional (WPR) Supranation Reference Laboratory(SRL)in South Korea conducted three times of quality control of drug susceptibility testing (DST) from SRL to PRL and to national reference laboratories(NRLs) in the region at the same time, and once of which from PRL to SRL. The exchanging strains of M. tuberculosis, which were clinical isolated ones containing both drug susceptible and drug resistant cultures, were tested for resistance to SM, INH, RFP and EMB. The DST procedure was proportion method, and L-J medium was used. Result It was shown that the sensitivities for most of the four drugs in the three times of DST quality control from SRL to PRL were higher than their specificities,and that the sensitivities for both INH and RFP were 100%. And the accuracy, or agreement, for both INH and RFP was more than 90%, except for that of RFP in the first time. Compared with the results from SRL to NRLs (including Henan PRL), except for the specificity for SM in WPR being higher than that in Henan (84% versus 70%, P <0.05), there was no significant difference between Henan and WPR on the specificity and sensitivity of the other drugs. Similar characteristics can be found in the results from PRL to SRL. And the efficiency for SM, INH and RFP was all higher than 90%. Conclusion The quality control on Henan PRL meet the requirement of the WHO/IUATLD guidelines for surveillance of drug resistance in tuberculosis(1997).

关 键 词：结核病 药物疗法 耐药性 监测 药敏试验 

分 类 号：R521.05[医药卫生—内科学] R969.4[医药卫生—临床医学]