T-SPOT.TB在诊断中国菌阴肺结核患者中应用价值的Meta分析
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摘要
目的系统评价T细胞酶联免疫斑点法(T-SPOT.TB)在诊断中国菌阴肺结核的应用价值。方法计算机检索Pub Med、CBM、CNKI、Wan Fang Data和VIP数据库中关于T-SPOT.TB诊断中国菌阴肺结核患者的相关文献,检索时限均为建库至2015年12月31日。由2位研究员分别独立筛选文献、提取资料,并评价纳入研究的偏倚风险后,采用Stata 12.1和Meta-Di Sc 1.4软件进行Meta分析。结果共纳入11个研究,包括病例组1 413例,对照组1 256例。Meta分析结果显示T-SPOT.TB诊断中国菌阴肺结核患者的Sen_(合并)、Spe_(合并)、+LR_(合并)、–LR_(合并)、DOR_(合并)、AUC分别为83%[95%CI(0.81,0.85)]、86%[95%CI(0.84,0.88)]、5.73[95%CI(4.99,6.59)]、0.20[95%CI(0.18,0.23)]、31.09[95%CI(25.11,38.49)],AUC=0.92。结论 T-SPOT.TB作为一种较快速、较准确的诊断菌阴肺结核的方法,对我国菌阴肺结核患者诊断有较高的应用价值。
Objective To systematically review the diagnosis value of T cell ELISA Spot(T-SOPT.TB) in for bacterium negative pulmonary tuberculosis in Chinese. Methods We electronically searched databases including Pub Med, CBM, CNKI, Wan Fang Data and VIP from inception to December 31 st, 2015 to collect studies about T-SPOT.TB in diagnosis bacterium negative pulmonary tuberculosis in Chinese. Two researchers independently screened literatures, extracted data, and assessed the risk of bias of included studies, and then meta-analysis was performed by using Stata 12.1 and Meta-Di Sc 1.4 software. Results A total of 11 studies including 1 413 patients and 1 256 controls were included. The results of meta-analysis showed that the pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnosis odds ratio and area under SROC curve for T-SPOT.TB diagnosis bacterium negative pulmonary tuberculosis was 83%(95%CI 0.81 to 0.85), 86%(95%CI 0.84 to 0.88), 5.73(95%CI 4.99 to 6.59), 0.20(95%CI 0.18 to 0.23), 31.09(95%CI 25.11 to 38.49), and 0.92, respectively. Conclusion As a rapid and accurate method for diagnosis of bacterium negative pulmonary tuberculosis, T-SPOT.TB has a high diagnostic efficiency for bacterium negative pulmonary tuberculosis in Chinese.
Objective To systematically review the diagnosis value of T cell ELISA Spot(T-SOPT.TB) in for bacterium negative pulmonary tuberculosis in Chinese. Methods We electronically searched databases including Pub Med, CBM, CNKI, Wan Fang Data and VIP from inception to December 31 st, 2015 to collect studies about T-SPOT.TB in diagnosis bacterium negative pulmonary tuberculosis in Chinese. Two researchers independently screened literatures, extracted data, and assessed the risk of bias of included studies, and then meta-analysis was performed by using Stata 12.1 and Meta-Di Sc 1.4 software. Results A total of 11 studies including 1 413 patients and 1 256 controls were included. The results of meta-analysis showed that the pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnosis odds ratio and area under SROC curve for T-SPOT.TB diagnosis bacterium negative pulmonary tuberculosis was 83%(95%CI 0.81 to 0.85), 86%(95%CI 0.84 to 0.88), 5.73(95%CI 4.99 to 6.59), 0.20(95%CI 0.18 to 0.23), 31.09(95%CI 25.11 to 38.49), and 0.92, respectively. Conclusion As a rapid and accurate method for diagnosis of bacterium negative pulmonary tuberculosis, T-SPOT.TB has a high diagnostic efficiency for bacterium negative pulmonary tuberculosis in Chinese.
引文
1 World Health Organization.Global Tuberculosis Report 2015Geneva:World Health Organization,2015.
2中华医学会结核病学分会.肺结核诊断和治疗指南.中华结核病和呼吸杂志,2001,24(1):70-74.
3 Carrara S,Vincenti D,Petros ilo N,et al.Use of a T cell-based assay for monitoring ei cacy of antituberculosis therapy.Clin Infect Dis2004,38(5):754-756.
4 Colangeli R,Spencer JS,Bifani P,et al.MTSA-10,the product of the Rv3874 gene of Mycobacterium tuberculosis,elicits tuberculosisspecii c,delayed-type hypersensitivity in guinea pigs.Infect Immun2000,68(2):990-993.
5 Berthet FX,Rasmussen PB,Rosenkrands I,et al.A Mycobacterium tuberculosis operon encoding ESAT-6 and a novel low-molecularmass culture filtrate protein(CFP-10).Microbiology,1998,144(Pt11):3195-3203.
6 Mazurek GH,Jereb J,Lobue P,et al.Guidelines for using the Quanti FERON-TB Gold test for detecting Mycobacterium tuberculosis infection,United States.MMWR Recomm Rep,200554(RR-15):49-55.
7 Lalvani A.Diagnosing tuberculosis infection in the 21st century new tools to tackle an old enemy.Chest,2007,131(6):1898-1906.
8刘红,黄永杰,王静,等.结核感染T细胞斑点试验在疑似结核病患者诊断中的价值研究.中华结核和呼吸杂志,2014,37(3):192-196.
9潘丽萍,贾红彦,刘菲,等.γ-干扰素释放试验对不同年龄组疑似肺结核的辅助诊断价值.中华结核和呼吸杂志,2015,38(12):892-896.
10 Lee YM,Park KH,Kim SM,et al.Risk factors for false-negative results of T-SPOT.TB and tuberculin skin test in extrapulmonary tuberculosis.Infection,2013,41(6):1089-1095.
11 Meier T,Eulenbruch HP,Wrighton-Smith P,et al.Sensitivity of a new commercial enzyme-linked immunospot assay(T-SPOT.TB)for diagnosis of tuberculosis in clinical practice.Eur J Clin Microbio Infect Dis,2005,24(8):529-536.
12霍霏霏,张丽帆,刘晓清.评价γ干扰素释放分析T-SPOT.TB在肺外结核病诊断中的敏感性.中国医学科学院学报,2009,31(4)449-452.
13 Sattah MV,Aye SS,Azen C,et al.Interferon-gamma release assay T-SPOT.TB and HIV-related tuberculosis.Int J Tuberc Lung Dis2012,16(2):281-282.
14曾谊,林云霞,宋梅梅,等.T-SPOT.TB快速检测在菌阴肺结核中的诊断价值.中华医学会结核病学分会2012年学术大会论文集2012:150-152.
15李悦,吴琦.T-SPOT.TB在菌阴肺结核诊断中的价值研究.医学信息,2015,(42):65-65.
16李婷,时代强.T细胞斑点试验在痰菌涂阴肺结核中的诊断价值中华临床感染病杂志,2014,7(3):255-257.
17崔丹,赵杰,李志惠,等.γ-干扰素释放试验与结核菌素试验对菌阴肺结核的诊断价值.解放军医药杂志,2015,27(7):89-91.
18曾谊,冯枭,宋梅梅,等.酶联免疫斑点试验在菌阴肺结核诊断中的价值.中国防痨杂志,2012,34(2):100-102.
19李红,方勇,郝晓辉,等.外周血T-SPOT试验对菌阴肺结核诊断价值的研究.中华医学会结核病学分会2011年学术会议论文集2011:24-29.
20杜岩青,张立,冯爽,等.探讨T-SPOT.TB、CA125、TB-Ab在痰菌阴性肺结核诊断中的价值.中国现代医生,2014,52(32):43-45.
21赵冬梅,李婷,何彦清,等.结核感染的T细胞血液检测对菌阴肺结核诊断意义.中华医学会结核病分会2013年学术大会论文集2013:223-224.
22刘荣梅,马丽萍,张立群.γ-干扰素释放分析试验在肺结核病中的诊断价值.北京医学,2015,37(2):112-114.
23 Qiu Y,Wang Y,Lin N,et al.Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in China.Int J Infect Dis,2015,40:108-112.
24 Zhu C,Liu Z,Li Z,et al.The performance and limitation of T-SPOTTB for the diagnosis of TB in a high prevalence setting.J h orac Dis2014,6(6):713-719.
25 Whiting PF,Rutjes AW,Westwood ME,et al.QUADAS-2:a revised tool for the quality assessment of diagnostic accuracy studies.Ann Intern Med,2011,155(8):529-536.
26张天嵩,钟文昭.Meta-Di Sc软件在诊断试验Meta分析中的应用循证医学,2008,8(2):97-100.
27 Lalvani A,Pathan AA,Mc Shane H,et al.Rapid detection of Mycobacterium tuberculosis infection by enumeration of antigenspecii c T cells.Am J Respir Crit Care Med,2001,163(4):824-828.
28 Metcalfe JZ,Everett CK,Steingart KR,et al.Interferon-gamma release assays for active pulmonary tuberculosis diagnosis in adults in low and middle-income countries:systematic review and metaanalysis.J Infect Dis,2011,204(4):1120-1129.
29 Dai Y,Feng Y,Xu R,et al.Evaluation of interferon-gamma release assays for the diagnosis of tuberculosis:an updated metaanalysis Eur J Clin Microbiol Infect Dis,2012,31(11):3127-3137.
30林玲,刘厚明,邓群益,等.γ-干扰素释放试验在肺结核和非结核分枝杆菌肺病鉴别诊断中的应用价值.中国防痨杂志,201436(6):477-481.
31刘佳庆,张立,孙海柏,等.γ-干扰素释放试验在肺结核早期诊断中的应用.山东医药,2013,53(3):82-84.
32章淑梦,周华,符一骐,等.γ-干扰素释放试验在活动性结核病诊断中的临床价值.中华结核和呼吸杂志,2014,37(5):372-373.
2中华医学会结核病学分会.肺结核诊断和治疗指南.中华结核病和呼吸杂志,2001,24(1):70-74.
3 Carrara S,Vincenti D,Petros ilo N,et al.Use of a T cell-based assay for monitoring ei cacy of antituberculosis therapy.Clin Infect Dis2004,38(5):754-756.
4 Colangeli R,Spencer JS,Bifani P,et al.MTSA-10,the product of the Rv3874 gene of Mycobacterium tuberculosis,elicits tuberculosisspecii c,delayed-type hypersensitivity in guinea pigs.Infect Immun2000,68(2):990-993.
5 Berthet FX,Rasmussen PB,Rosenkrands I,et al.A Mycobacterium tuberculosis operon encoding ESAT-6 and a novel low-molecularmass culture filtrate protein(CFP-10).Microbiology,1998,144(Pt11):3195-3203.
6 Mazurek GH,Jereb J,Lobue P,et al.Guidelines for using the Quanti FERON-TB Gold test for detecting Mycobacterium tuberculosis infection,United States.MMWR Recomm Rep,200554(RR-15):49-55.
7 Lalvani A.Diagnosing tuberculosis infection in the 21st century new tools to tackle an old enemy.Chest,2007,131(6):1898-1906.
8刘红,黄永杰,王静,等.结核感染T细胞斑点试验在疑似结核病患者诊断中的价值研究.中华结核和呼吸杂志,2014,37(3):192-196.
9潘丽萍,贾红彦,刘菲,等.γ-干扰素释放试验对不同年龄组疑似肺结核的辅助诊断价值.中华结核和呼吸杂志,2015,38(12):892-896.
10 Lee YM,Park KH,Kim SM,et al.Risk factors for false-negative results of T-SPOT.TB and tuberculin skin test in extrapulmonary tuberculosis.Infection,2013,41(6):1089-1095.
11 Meier T,Eulenbruch HP,Wrighton-Smith P,et al.Sensitivity of a new commercial enzyme-linked immunospot assay(T-SPOT.TB)for diagnosis of tuberculosis in clinical practice.Eur J Clin Microbio Infect Dis,2005,24(8):529-536.
12霍霏霏,张丽帆,刘晓清.评价γ干扰素释放分析T-SPOT.TB在肺外结核病诊断中的敏感性.中国医学科学院学报,2009,31(4)449-452.
13 Sattah MV,Aye SS,Azen C,et al.Interferon-gamma release assay T-SPOT.TB and HIV-related tuberculosis.Int J Tuberc Lung Dis2012,16(2):281-282.
14曾谊,林云霞,宋梅梅,等.T-SPOT.TB快速检测在菌阴肺结核中的诊断价值.中华医学会结核病学分会2012年学术大会论文集2012:150-152.
15李悦,吴琦.T-SPOT.TB在菌阴肺结核诊断中的价值研究.医学信息,2015,(42):65-65.
16李婷,时代强.T细胞斑点试验在痰菌涂阴肺结核中的诊断价值中华临床感染病杂志,2014,7(3):255-257.
17崔丹,赵杰,李志惠,等.γ-干扰素释放试验与结核菌素试验对菌阴肺结核的诊断价值.解放军医药杂志,2015,27(7):89-91.
18曾谊,冯枭,宋梅梅,等.酶联免疫斑点试验在菌阴肺结核诊断中的价值.中国防痨杂志,2012,34(2):100-102.
19李红,方勇,郝晓辉,等.外周血T-SPOT试验对菌阴肺结核诊断价值的研究.中华医学会结核病学分会2011年学术会议论文集2011:24-29.
20杜岩青,张立,冯爽,等.探讨T-SPOT.TB、CA125、TB-Ab在痰菌阴性肺结核诊断中的价值.中国现代医生,2014,52(32):43-45.
21赵冬梅,李婷,何彦清,等.结核感染的T细胞血液检测对菌阴肺结核诊断意义.中华医学会结核病分会2013年学术大会论文集2013:223-224.
22刘荣梅,马丽萍,张立群.γ-干扰素释放分析试验在肺结核病中的诊断价值.北京医学,2015,37(2):112-114.
23 Qiu Y,Wang Y,Lin N,et al.Multicenter clinical evaluation of three commercial reagent kits based on the interferon-gamma release assay for the rapid diagnosis of tuberculosis in China.Int J Infect Dis,2015,40:108-112.
24 Zhu C,Liu Z,Li Z,et al.The performance and limitation of T-SPOTTB for the diagnosis of TB in a high prevalence setting.J h orac Dis2014,6(6):713-719.
25 Whiting PF,Rutjes AW,Westwood ME,et al.QUADAS-2:a revised tool for the quality assessment of diagnostic accuracy studies.Ann Intern Med,2011,155(8):529-536.
26张天嵩,钟文昭.Meta-Di Sc软件在诊断试验Meta分析中的应用循证医学,2008,8(2):97-100.
27 Lalvani A,Pathan AA,Mc Shane H,et al.Rapid detection of Mycobacterium tuberculosis infection by enumeration of antigenspecii c T cells.Am J Respir Crit Care Med,2001,163(4):824-828.
28 Metcalfe JZ,Everett CK,Steingart KR,et al.Interferon-gamma release assays for active pulmonary tuberculosis diagnosis in adults in low and middle-income countries:systematic review and metaanalysis.J Infect Dis,2011,204(4):1120-1129.
29 Dai Y,Feng Y,Xu R,et al.Evaluation of interferon-gamma release assays for the diagnosis of tuberculosis:an updated metaanalysis Eur J Clin Microbiol Infect Dis,2012,31(11):3127-3137.
30林玲,刘厚明,邓群益,等.γ-干扰素释放试验在肺结核和非结核分枝杆菌肺病鉴别诊断中的应用价值.中国防痨杂志,201436(6):477-481.
31刘佳庆,张立,孙海柏,等.γ-干扰素释放试验在肺结核早期诊断中的应用.山东医药,2013,53(3):82-84.
32章淑梦,周华,符一骐,等.γ-干扰素释放试验在活动性结核病诊断中的临床价值.中华结核和呼吸杂志,2014,37(5):372-373.