出 处:《中国防痨杂志》2015年第1期56-65,共10页Chinese Journal of Antituberculosis
摘 要:目的对基因芯片方法在检测耐利福平结核分枝杆菌的准确性进行系统评价,为基因芯片技术应用于临床检测耐药结核分枝杆菌的必要性提供证据。方法计算机检索The Cochrane Library(2014年第1期)、PubMed、EMbase、Wanfang Data、CNKI数据库,检索时限均为建库至2014年2月。由2位研究者根据纳人与排除标准独立筛选文献、提取资料,采用评价诊断准确性质量研究(quality assessment of diagnostic accuracy studies,QUADAS)条目评价纳入研究论文的方法学质量,检出相关文献223篇,按照标准纳入22篇文献。采用Meta-DiSc1.4软件对其敏感度(SEN)、特异度(SPE)、阳性似然比(+LR)、阴性似然比(-LR)、诊断比值比(DOR)进行异质性检验和合并分析,绘制汇总受试者工作特征(SROC)曲线,计算曲线下面积(AUC)。结果共纳入22篇文献(包括一篇多中心研究文献),25个研究,包括4879株经传统药敏试验鉴定结核分枝杆菌菌株,其中耐RFP菌株(1314株)、敏感菌株(3565株)。基因芯片技术检测Mtb对RFP耐药的SEN△并为0.89[95%CI(0.87-0.91)]、SPF合并为0.98[95%CI(0.97-0.98)]、+LR为30.891-95%CI(22.15-43.06)]、-LR为0.10[95%CI(0.07-0.15)]、DOR合并为354.06[95%CI(212.09-591.07)]、AUC为0.9833。结论基因芯片方法具有较好的诊断价值;以传统药敏法为金标准,基因芯片方法特异度、敏感度,诊断OR值均较高,说明其在Mtb对RFP耐药检出率较高,可作为临床结核分枝杆菌耐药检测的辅助手段。Objective To systematically review the diagnostic accuracy of gene chip in identifying rifampicin (RFP) resistance Mycobacterium tuberculosis (Mtb), and to provide the evidence for the clinical use of gene chip in detection of RFP-resistance Mtb. Methods We electronically searched The Cochrane Library (Issue 1, 2014), PubMed, EMbase, Wanfang Data, CNKI from the date that the database was established to February 2014. In order to find any publications which are related to detection of RFP resistance Mtb by using gene chip, the search key terms in English and Chinese were designed as follows: tuberculosis, tuberculosis and drug resistance, tuberculosis and drug resistance and gene chip, tuberculosis and drug resistance and gene chip and rifampicin. Two reviewers in- dependently screened literatures according to the inclusion and exclusion criteria, extracted data and assessed the quality of methodology of the included studies according to the QUADAS items. The Meta-DiSc software (version 1.4) was used to conduct pooling on sensitivity (SEN), specificity (SPE), positive likelihood ratio (+LR), and negative likelihood ratio (-LR). Heterogeneity test was performed and the summary receiver operating characteristic (SROC) curve was drawn and area under curve (AUC) was calculated. Results A total of 223 publications were found. Finally, 22 articles (including one article from multicenter study) and 25 studies were included into the review,which involved 4 879 Mtb isolates (including 1314 RFP-resistant strains, 3565 susceptible strains and the standard strain H37Rv). The results of Meta-analysis showed that, compared with the traditional drug sensitivity test, SEN of gene chip in detection of RFP-resistance Mtb was 0. 89 (95%CI (0. 87-0. 91)), SPE was 0. 98 (95%CI (0. 97-0. 98)), +LR was 30.89 (95%CI (22.15-43.06)), -LR was 0.10 (95%CI (0. 07-0.15)), diagnostic OR was 354.06 (95%CI (212.09-591.07)), AUC was 0. 9833. Conclusion Ge
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