目的 评估Xpert结核分枝杆菌/利福平(MTB/RIF)试验对结核病的诊断价值.方法 检索PubMed、Medline、中国知网、万方数据库等,收集Xpert MTB/RIF试验对结核病诊断价值的文献,检索起止时间均为建库至2012年6月.2名研究者独立进行资料提取和文献质量评估.采用Meta-Disc 1.4软件进行Meta分析.结果 共纳入26篇文献,其中2篇文献涉及儿童病例,包含了13 270例来自临床患者的检测标本.Meta分析结果显示,Xpert MTB/RIF试验诊断结核病的汇总敏感度为87%(95%CI:86%~88%)、特异度为97%(95%CI:97%~97%).按照结核病的类型和患者年龄进行亚组分析,Xpert MTB/RIF试验诊断肺结核的敏感度高于肺外结核病,90%(95%CI:89%~91%) vs 76%(95%CI:72%~79%);诊断涂阴菌阳性和涂阳菌阳性结核病的敏感度分别为74%(95%CI:71%~76%)和99%(95%CI:98%~99%);对儿童肺结核的诊断敏感度比成人肺结核低,74%(95%CI:65%~83%) vs 90%(95%CI:89%~92%).Xpert MTB/RIF试验诊断耐多药结核病的敏感度为96%(95%CI:94%~97%),特异度为98%(95%CI:98%~99%).结论 Xpert MTB/RIF试验诊断结核病的价值较高,尤其是成人结核病及耐多药结核病.Xpert MTB/RIF试验在儿童结核病中的诊断价值由于纳入文献较少,尚待进一步研究.
Objective To evaluate the diagnostic value of Xpert MTB/RIF assay to tuberculosis systematically. Methods Studies about the diagnostic value of Xpert MTB/RIF assay to tuberculosis were searched in PubMed, Medline, CNKI and Wangfang database from establishment to June 2012. Two researchers fetched the data from included studies independently, and then Meta-Disc software( version 1.4)was used for meta-analysis. Results A total of 26 studies were recruited in the analysis, including 13 270 sediments from clinical patients. In all kinds of tuberculosis, the pooled sensitivity and specificity of Xpert MTB/ RIF were 87% (95% CI:86% - 88% ) and 97% (95% CI:97% - 97% ) respectively. Then subgroup analysis was made by the types of tuberculosis and the patients' age, showing that Xpert MTB/RIF assay was more sensitive in diagnosing pulmonary tuberculosis than in extrapulmonary tuberculosis, and in smear-negative tuberculosis. The pooled sensitivity of Xpert MTB/RIF assay reached 74% (95% CI: 71% -76% ), and the sensitivity in diagnosing pediatric tuberculosis was lower than adult tuberculosis. In multi-drug resistant tuberculosis, the pooled sensitivity and specificity were 96% (95% CI:94% -97% )and 98% (95%CI:98% -99%), respectively. Conclusions The diagnostic value of Xpert MTB/RIF assay to tuberculosis was very high, especially in adult tuberculosis. Because studies on pediatric tuberculosis were very few, the diagnostic value of Xpert MTB/RIF assay to pediatric tuberculosis should be confirmed by performing prospective cohort studies further.