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    10 January 2018, Volume 40 Issue 1
    Expert Note
    Tuberculosis infection——though fiercer than tiger, still can be tamed
    Yong FANG,He-ping. XIAO
    Chinese Journal of Antituberculosis. 2018, 40(1):  14-16.  doi:10.3969/j.issn.1000-6621.2018.01.005
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    Tuberculosis is the ninth leading cause of death worldwide,even ranking above HIV/AIDS. The incidence is high now. China is ranking third in high TB burden countries in the world. There have been several campus TB outbreaks in China recently. Many TB-affected patients and their households are experiencing catastrophic attacks in bodies, mental and economy. Facing the threat from TB infection, we can contain it through “active prevention and control from functional departments”; “strengthening management of patients”; “stress and supportive systems from government and community” and “legislation to the administration of TB infectious sources”.

    Discussion on the problems related to Mycobacterium tuberculosis antibody detection reagents
    Rong-zhi. LIU
    Chinese Journal of Antituberculosis. 2018, 40(1):  17-19.  doi:10.3969/j.issn.1000-6621.2018.01.006
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    The role of Mycobacterium tuberculosis antibody detection reagents in the diagnosis of tuberculosis has been involved in the related guidelines. The application of Mycobacterium tuberculosis antibody detection reagents in clinic has been questioned by the World Health Organization (WHO). This paper analyzes the current status of the registration of Mycobacterium tuberculosis antibody detection reagents in China and the possible reasons. Meanwhile, we expound the key issues of main raw materials, performance analysis and clinical trial in the registration and declaration of Mycobacterium tuberculosis antibody detection reagents.

    Original Articles
    Analysis of the diagnostic efficacy of serum tuberculosis antibody in active tuberculosis
    Shao-jun ZHANG,Chi YANG,Lin. FAN
    Chinese Journal of Antituberculosis. 2018, 40(1):  20-25.  doi:10.3969/j.issn.1000-6621.2018.01.007
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    Objective To investigate the diagnostic value of serum tuberculosis(TB) antibody, which relative molecular mass is 38000 (38kD-IgG) for active tuberculosis and compare it with T-SPOT.TB.Methods Two thousand one hundred and forty-six patients with active TB and 1671 patients with non-TB pulmonary disease were retrospectively included, analyzed and compared diagnostic value of serum TB antibodies for bacteriological confirmed TB, clinically diagnosed TB and extrapulmonary TB by receiver operating characteristic curve (ROC), compared sensitivity, specificity, and area under the curve (AUC) of T-SPOT.TB and serum TB antibody, finally evaluated auxiliary diagnostic value of serum TB antibody for active TB.Results Our data showed that sensitivity of serum TB antibody for patients with bacteriological confirmed TB (47.1%,246/522) was higher than that for patients with clinically diagnosed (25.9%,388/1499) and extrapulmonary TB (24.8%,31/125) χ 2=81.15 and 20.53, respectively; Ps<0.001. The sensitivity of patients with clinically diagnosed patients and extrapulmonary TB had no statistical difference,χ 2=0.07, P=0.790. The sensitivity (30.6%,657/2146) of serum TB antibody for active TB was lower than that of T-SPOT.TB (76.2%,1635/2146),χ 2=799.00,P=0.000, its AUC (0.619,95%CI:0.604-0.635) was lower than that of T-SPOT.TB (0.781,95%CI:0.768-0.794), χ 2=14.00,P=0.000. However, the specificity of serum TB antibody (93.2%,1557/1671) was higher than that of T-SPOT.TB (70.1%,1171/1671),χ 2=316.00,P=0.000. Conclusion The sensitivity of serum TB antibody applied in clinics needs to get improved, much more sensitive TB antibody diagnostic kit should be developed in order to provide better diagnostic tools for clinics.

    Evaluation of two serological tests and T-SPOT.TB method for tuberculosis diagnosis
    Jia-wen LIU,Hong-yan. LYU
    Chinese Journal of Antituberculosis. 2018, 40(1):  26-30.  doi:10.3969/j.issn.1000-6621.2018.01.008
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    Objective To explore the value of tuberculosis antibody (TB-Ab) detection and T-SPOT.TB test in TB diagnosis. Methods Between January 1, 2016 and April 12, 2017 in Beijing Geriatric Hospital, 961 TB patients (defined as TB group; including 364 smear positive pulmonary TB cases (bacteriologically diagnosed) and 597 smear negative pulmonary TB cases (clinically diagnosed)) and 1046 non-TB patients (defined as control group) were included in this study. All subjects conducted serological TB-Ab detection by using TB-DOT (Shanghai Upper Bio-Tech Pharma Co., LTD) and ASSURE TB (MP Biomedicals Asia Pacific Pte Ltd. in Singapore) kits; among them, 574 patients in the TB group and 664 patients in the non-TB control group received both T-SPOT.TB test and TB-Ab detections using the two gold standard reagents. The sensitivity and specificity of those three kinds of laboratory detection techniques or joint detection (including tandem detection and parallel detection) were analyzed.Results The sensitivity and specificity of TB-DOT test were 52.86% (508/961) and 74.95% (784/1046), and those of ASSURE TB test were 45.99% (442/961) and 76.00% (795/1046). The sensitivity of TB-DOT and ASSURE TB were 64.84% (236/364) and 62.09% (226/364) for smear positive pulmonary TB patients versus 45.56% (272/597) and 36.18% (216/597) for smear negative pulmonary TB patients, which indicated that the sensitivity of TB-DOT and ASSURE TB was higher for smear positive patients compared with smear negative ones; the differences were statistically significant (χ2=60.99 and 33.69, all P<0.05). Tandem detection of two TB-Ab detections and T-SPOT.TB showed a sensitivity of 24.04% (138/574) and a high specificity of 89.91% (597/664). The parallel detection had a specificity of 21.23% (141/664) and a high sensitivity of 89.55% (514/574). 24.04% (138/574) patients in the TB group and 10.09% (67/664) patients in the non-TB control group reacted positively in all of the three tests including ASSURE TB, TB-DOT and T-SPOT.TB detection, while 10.45% (60/574) cases in the TB group and 21.23% (141/664) cases in the non-TB control group reacted negatively; the differences were statistically significant (χ2=43.37 and 26.32, all P<0.05).Conclusion Tandem of two TB-Ab detections and T-SPOT.TB test can improve the specificity, whereas parallel detection can improve the sensitivity in TB diagnosis. All positive and all negative profile in all of the three detections has an auxiliary value in serological diagnosis of TB.

    The value of tuberculosis IgG antibody detection in diagnosis assisting of tuberculosis
    Jing-qiu WU,Hong-xia FANG,Ming WEI,Bao-qing ZHANG,Peng YAN,Xue JIANG,Xin-xin XU,Yu-qin LIU,Yan-jie. HOU
    Chinese Journal of Antituberculosis. 2018, 40(1):  31-36.  doi:10.3969/j.issn.1000-6621.2018.01.009
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    Objective To explore the value of tuberculosis (TB) IgG antibody detection in assisting the diagnosis of tuberculosis.Methods The related clinical materials of 1494 inpatients and outpatients, who visited the Infectious Disease Hospital of Heilongjiang Province from July 2015 to May 2016, were collected. Among those patients, 1020 patients had pulmonary tuberculosis (PTB group), 54 patients had extra pulmonary TB (extra-PTB group) and 420 had other lung diseases excluding TB (other lung disease group). The clinical related materials of those patients were analyzed, including the results of TB IgG antibody detection, acid-fast bacillus smear microscopy, mycobacterium liquid culture, CT manifestations and clinical diagnosis.Results The sensitivity of TB IgG antibody detection in 1020 cases with PTB was 73.33% (748/1020) and there was statistically significant difference compared with the sensitivity of sputum smear (43.24%, 441/1020) and liquid culture (61.37%, 626/1020) (χ 2=190.02, P<0.001; χ 2=33.18, P<0.001). The sensitivity of TB IgG antibody detection in 54 cases with extra PTB was 62.96% (34/54) and there was statistically significant difference compared with the sensitivity of sputum smear (20.37%,11/54) and liquid culture (29.63%,16/54) (χ 2=20.15, P<0.001; χ 2=12.07, P=0.001). The sensitivity of TB IgG antibody detection had statistically significant difference (χ 2=553.47, P<0.001) between the PTB group and other lung disease group (6.90%, 29/420). The clinical diagnosis results was regarded as the diagnosis standard and a total of 1440 patients with PTB and other lung diseases were analyzed, the sensitivity, specificity and accuracy of TB IgG antibody detection were 73.33% (748/1020), 93.10% (391/420) and 79.10% (1139/1440), respectively. Among 1020 patients with PTB, the positive rate of TB IgG antibody detection was 86.85% (383/441) in the patients with smear-positive and 63.04% (365/579) in the patients with smear-negative, respectively (χ 2=72.56, P<0.001); the positive rate of TB IgG antibody detection was 80.51% (504/626) in the patients with liquid culture positive and 61.93% (244/394) in the patients with liquid culture negative (χ 2=42.70, P<0.001). The sputum smear and liquid culture results were regarded as the diagnosis standard and 1020 patients with PTB were analyzed, the sensitivity, specificity and accuracy of TB IgG antibody detection were 86.85% (383/441) and 80.51% (504/626), 36.96% (214/579) and 38.07% (150/394), 58.53% (597/1020) and 64.12% (654/1020). Among 1020 patients with PTB, 372 (36.47%) cases were smear negative and liquid culture negative. The positive rate of TB IgG antibody detection in 372 cases was 61.29% (228/372); In most of the patients (83.77%, 191/228) with positive for TB IgG antibody, their image findings by CT scan were “patch-like” or “strip-like”. The false positive rate of TB IgG antibody detection was 6.90% (29/420) in 420 patients with other lung diseases excluding TB and it mainly happened in the patients with pneumonia (62.07%, 18/29) and cancer (13.79%, 4/29). Conclusion TB IgG antibody detection plays a valuable role in assisting the diagnosis of tuberculosis, especially in smear and culture negative PTB and extra pulmonary tuberculosis.

    Evaluation of three tuberculosis antibody kits in tuberculosis diagnosis
    Nan-nan LIU,Jian-qin LIANG,Jin-he WANG,Zhi CHEN,Li-hong WU,Jing-yang. LIU
    Chinese Journal of Antituberculosis. 2018, 40(1):  37-40.  doi:10.3969/j.issn.1000-6621.2018.01.010
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    Objective To evaluate the application value of three tuberculosis (TB) antibody kits in tuberculosis diagnosis.Methods Of 601 patients treated by PCR-reverse dot blot hybridization (PCR-RDB) to identify the tissue species mycobacteria strains (referred to as molecular pathology) at Department of Pathology, the 309th Hospital of PLA between January 2015 and December 2015, the patients who did not meet inclusion criteria were excluded. Finally, 205 cases were included, and the results of peripheral blood tuberculosis antibody by three TB antibody kits were detected from records. The McNemar test and Kappa test results were used to decide the difference and consistency by SPSS 20.0.Results Compared with molecular pathological results, the sensitivities of TB-IgG, SD Rapid TB, TB-DOT were 26.6% (34/128), 20.3% (26/128), 97.7% (125/128); the specificities were 90.9% (70/77), 98.7% (76/77), 3.9% (3/77); the positive predictive values were 82.9% (34/41), 96.3% (26/27), 62.8% (125/199); the negative predictive values were 42.7% (70/164), 42.7% (76/178), 50.0% (3/6); the jaden indexes were 0.18, 0.19, 0.02, respectively. Compared with the molecular pathology group, diagnosis differences in TB-IgG and SD Rapid TB kits groups were statistically significant (χ 2=9.17, P<0.001; χ Correct 2 =13.58, P<0.001). TB-IgG and SD Rapid TB kits were found weak consistency with the molecular pathology (Kappa=0.14, 0.15, Ps<0.001);while diagnosis difference between the molecular pathology and TB-DOT kit was not statistically significant (χ 2=0.04, P=0.833), and consistency was not sure (Kappa=0.02, P=0.523). Conclusion The detection results of three TB antibody kits were different to some extent; SD Rapid TB was relatively better than the other two; multiple antigen detection could improve sensitivity and specificity, and might be assist to the diagnosis of tuberculosis.

    Application of tuberculosis antibody tests in the diagnosis of tuberculosis
    Fang HUANG,Li-yun. DANG
    Chinese Journal of Antituberculosis. 2018, 40(1):  41-46.  doi:10.3969/j.issn.1000-6621.2018.01.011
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    Objective To explore the value of applying Mycobacterium tuberculosis IgG antibody test kit in the diagnosis of tuberculosis.Methods A total of 795 confirmed patients with tuberculosis diagnosed in Xi’an Chest Hospital from January 2013 to December 2016 were selected as the TB group; 185 patients with other lung diseases (except NTM) were selected as the control group, and 36 patients with non-tuberculosis mycobacteria (NTM) were selected as the NTM group. The sensitivity, specificity, positive predictive value and negative predictive value of TB antibody test kit in all patients were analyzed retrospectively in comparison with the clinical diagnosis and culture of the Mycobacterium tuberculosis as the gold standard. The positive rate of TB group versus NTM and control group was analyzed by chi-square test, and the application value of the method was evaluated.Results Using the clinical diagnosis standard as the standard, the sensitivity, specificity, positive predictive value, negative predictive value, missed diagnosis rate, misdiagnosis rate, prevalence rate, accuracy and Youden index were 42.01% (334/795), 82.81% (183/221), 89.78% (334/372), 28.42% (183/644), 57.99% (461/795), 17.19% (38/221), 78.25% (795/1016), 50.89% (517/1016), 0.25. Using tuberculosis culture results as the reference, the sensitivity, specificity, positive predictive value, negative predictive value, missed diagnosis rate, misdiagnosis rate, prevalence rate, accuracy and Youden index were 51.12% (160/313), 69.84% (491/703), 43.01% (160/372), 76.24% (491/644), 48.88% (153/313), 30.16% (212/703), 30.81% (313/1016), 64.07% (651/1016), 0.21. The positive rate of tuberculosis antibody test kit in the TB group, NTM group, and groups with smear positive pulmonary tuberculosis, smear negative pulmonary tuberculosis, tuberculous meningitis, tuberculous pleurisy/peritonitis, tuberculous pericarditis were 42.01% (33.4/795), 61.11% (22/36), 50.00% (80/160), 41.99% (97/231), 46.43% (13/28), 38.76% (138/356), 30.00% (6/20); no statistically significant difference was found between the positive rate of tuberculosis antibody testing between these different groups (χ 2=7.14, P=0.128). The positive rate of Mycobacterium tuberculosis IgG antibody test in TB group (42.01%,334/795), NTM group (61.11%,22/36) and control group (8.65%,16/185) was statistically different (χ 2=81.63, P=0.000) but the highest rate belonged to the NTM group, which might easily lead to misdiagnosis. Conclusion Because the sensitivity and accuracy of Mycobacterium tuberculosis IgG antibody test kit in detecting tuberculosis antibody are comparatively low, while the missed diagnosis and misdiagnosis rates are comparatively high, it is not recommended for clinical application anymore.

    Evaluation of the serodiagnostic value by using tuberculosis antibody test in diagnosis of active pulmonary tuberculosis
    Song YANG,Xiao-feng YAN,Xiao-gang ZENG,Shun TAN,Jian-qiong. GUO
    Chinese Journal of Antituberculosis. 2018, 40(1):  47-52.  doi:10.3969/j.issn.1000-6621.2018.01.012
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    Objective To evaluate the serodiagnostic value with tuberculosis (TB) antibody test in diagnosis of active pulmonary tuberculosis (PTB).Methods The clinical data and the results of serum Mycobacterium tuberculosis (MTB) antibody test based on IgG, IgM, LAM, 16kD, 38kD were collected from 495 patients with active PTB (experimental group) and 158 patients with non-tuberculosis respiratory diseases (control group), who hospitalized at Chongqing Public Health Medical Center during August 2016 to August 2017. Serodiagnosis was commenced in those patients after active PTB was confirmed by the comprehensive measures, including clinical manifestations, chest imaging, sputum bacteriological results or diagnostic anti-TB treatment responses. The sensitivity, specificity, positive predictive value and negative predictive value of the serum-tuberculosis antibody test in diagnosis of active PTB were evaluated.Results Out of 495 cases with active PTB, 340 cases showed positive sera TB antibody response (positive rate 68.7%); whereas, 55 out of 158cases with non-tuberculosis respiratory diseases revealed positive serum TB antibody detection test (positive rate 34.8%). The positive rate of serum TB antibody test in the experimental group was significantly higher than that in the control group (χ 2=57.50, P<0.01). The positive rate of serum TB antibody test (64.0%, 210/328) in the patients with bacteriologically negative pulmonary TB was lower than that (77.8%, 130/167) in the patients with bacteriologically positive PTB, and this difference was statistically significant (χ 2=9.83, P<0.01). In the experimental group, among 340 cases with positive TB antibody test results, 210 cases (61.8%, 210/340) were found to be positive with anti-LAM, 38kD and IgG antibodies at the same. The sensitivity, specificity, positive predictive value and negative predictive value of the serum TB antibody detection test based on IgG, IgM, LAM, 16kD, 38kD was 68.7% (340/495), 65.2% (103/158), 86.1% (340/395) and 39.9% (103/258) respectively; the Youden index and the overall consistent rate was 0.34 and 67.8% (443/653) respectively. Conclusion This study suggests that the serum TB antibody test has excellent accuracy and auxiliary diagnosis value in the diagnosis of patients with active PTB. The sensitivity of serum TB antibody test among the bacteriologically positive PTB patients is higher than that in the bacteriologically negative patients. The diagnostic sensitivity of PTB may be improved by the united detection of anti-LAM, 38kD and IgG antibodies.

    Clinical value of IgG and IgM antibody detection reagents for Mycobacterium tuberculosis
    Jun-xian ZHANG,You-rong YANG,Jie WANG,Jian-qin LIANG,Hui-ru AN,Yan-bo LING,Yan LIANG,Lan WANG,Xue-qiong. WU
    Chinese Journal of Antituberculosis. 2018, 40(1):  53-57.  doi:10.3969/j.issn.1000-6621.2018.01.013
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    Objective To study the clinical value of Mycobacterium tuberculosis IgG and IgM antibody detection reagents.Methods The clinical value was detected in two study periods. In the first study period, the patients who visited the 309th Hospital of Chinese PLA in May 2014 were included. By retrospectively analyzing the medical records, there were 92 patients with pulmonary tuberculosis (TB) and 99 patients without TB. Ninety-four healthy volunteers in the same period were selected as controls. In the second study period, 118 patients who visited the 309th Hospital of Chinese PLA between December 2016 and March 2017 were collected, including 62 cases with pulmonary TB and 56 patients without TB. The samples of all subjects were collected for smear detection and evaluation using Mycobacterium tuberculosis IgG and IgM antibody detection kit (i.e. Immune colloidal gold technique).Results In the first study, the sensitivity, specificity, positive predictive value, negative predictive value and consistency rate of IgG and IgM antibody detection were 64.1% (59/92), 89.1% (172/193), 73.8% (59/80), 83.9% (172/205) and 81.1% (231/285), respectively. Of the 92 pulmonary TB cases, the positive rate of IgG antibody detection was 64.1%. The positive rate was 73.8% (31/42) in the smear-positive pulmonary TB cases and 56.0% (28/50) in the smear-negative pulmonary TB cases; the difference was not statistical significant (χ 2=3.15, P=0.076). All pulmonary TB cases were detected as negative by IgM antibody detection. In the second study, the sensitivity, specificity, positive predictive value, negative predictive value and consistency rate of IgG and IgM antibody detection for the TB diagnosis were 45.2% (28/62), 78.6% (44/56), 70.7% (29/41), 57.1% (44/77) and 61.9% (73/118), respectively. Among the 62 pulmonary TB cases, the positive rate of IgG antibody detection was 45.2% (28/62). The positive rate was 56.3% (18/32) in the smear-positive pulmonary TB cases, which was significantly higher than that of 29.2% (7/24) in the smear-negative pulmonary TB cases (χ 2=4.07, P=0.044). Whereas there was only one case detected as positive by IgM antibody detection, yielding a positive rate of 1.6% (1/62). Conclusion The IgG in Mycobacterium tuberculosis IgG and IgM antibody tests had a better auxiliary diagnostic value for active TB, while the clinical value of IgM test requires to be further evaluated.

    Evaluation of Genechip for the detection of drug resistance of Mycobacterium tuberculosis
    Ming-guan LIN,Yuan-dong WU,Zhong-yuan ZHU,Chong LIN,Zhuo-lin CHEN,Shao-wen CHEN,Ying-xian SU,Wei-bin CHEN,Ye-teng. ZHONG
    Chinese Journal of Antituberculosis. 2018, 40(1):  58-62.  doi:10.3969/j.issn.1000-6621.2018.01.014
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    Objective To compare Genechip and the proportion method drug susceptibility test in detecting Mycobacterium tuberculosis resistance to rifampin and isoniazid.Methods A total of 598 sputum specimens of sputum smear-positive pulmonary tuberculosis inpatient cases from the Affiliated Hospital of Hainan Medical College between September 2013 and December 2016. Finally, 484 patients with the results of both traditional drug susceptibility test and Genechip were included. Genechip was used to detect the mutations and frequencies of rpoB, katG and inhA. The proportion method drug susceptibility test was used as the gold standard to evaluate the overall concordance.Results Compared with the proportion method drug susceptibility test, the coincidence rate of Mycobacterium tuberculosis resistance to rifampin and isoniazid detected by Genechip was 93.8% (454/484) and 89.0% (431/484), respectively, and that to multi-drug resistance was 95.5% (462/484). The rpoB mutations were detected in 118 strains, of which 56.8% (67/118) carried mutations at codon 531, 19.5% (23/118) at codon 526, 12.7% (15/118) at codon 516. Of all the 97 strains with katG and inhA mutations, the predominant mutation site of katG was codon 315 with the mutation rate of 82.5% (80/97), and 14.4% (14/97) carried mutations at inhA-15 (C→T).Conclusion The results of Genechip method were highly consistent with that of proportion method drug susceptibility test, and Genechip was a fast and effective method for screening for rifampin and isoniazid against Mycobacterium tuberculosis.

    The evaluation of the performance of fluorescence probe melting curve for NAT2 genotype detection in tuberculosis patients
    Su-ting CHEN,Ming-xiang HUANG,Yan-jie HU,Yuan-yuan SHANG,Qian LIANG,Yu-hong FU,Hai-rong. HUANG
    Chinese Journal of Antituberculosis. 2018, 40(1):  63-67.  doi:10.3969/j.issn.1000-6621.2018.01.015
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    Objective To evaluate the performance of fluorescent probe melting curve method for the detection of the gene polymorphism of arylamine N-acetyltransferases 2 (NAT2) in tuberculosis (TB) patients in China.Methods From 2015 to 2016, the primary TB patients who visited Fuzhou Pulmonary Hospital of Fujian (n=371) or Beijing Chest Hospital (n=355) were selected. Peripheral blood samples of all patients were collected. NAT2 genotypes of all patients were analyzed by four-SNP genotype panels (rs1801280 (341T→G),rs1799929 (481C→T), rs1799930 (590G→A) and rs1799931 (857G→A)) using fluorescent probe melting curve method and seven-SNP genotype panels (rs1801279 (191G→A), rs1041983 (282C→T), rs1801280(341T→C), rs1799929 (481C→T), rs1799930 (590G→A), rs1208 (803A→G) and 1799931 (857G→A)) using DNA sequencing. The NAT2 acetylation phenotypes were deduced from the NAT2 genotypes.Results The NAT2 acetylation phenotype for each individual inferred from four-SNP genotype panels using fluorescent probes melting curve method is consistent with that from seven-SNP genotype panels using DNA sequencing. The whole procedure of fluorescent probes melting curve method including DNA preparation, PCR amplification and melting curve analysis only took 2.5 hours. A total of 13 genotypes of NAT2 gene were detected as follow: NAT2 *4/*4, NAT2 *5/*4, NAT2 *6/*4, NAT2 *7/*4, NAT2 *5/*11, NAT2 *6/*11, NAT2 *7/*11, NAT2 *5/*6, NAT2 *6/*7, NAT2 *5/*5, NAT2 *6/*6, NAT2 *7/*7 and NAT2 *5/*7. TB patients from Fuzhou Pulmonary Hospital of Fujian with NAT2 rapid, intermediate or slow acetylators accounted for 37.20% (138/371), 42.32% (157/371) and 20.49% (76/371), respectively, while patients with tuberculosis from Beijing Chest Hospital accounted for 27.89% (99/355), 54.65% (194/355) and 17.46% (62/355), respectively. The distribution of NAT2 acetylation phenotypes of the above two groups was significantly different (χ 2=11.37, P=0.003). All patients with NAT2 rapid acetylators carried NAT2 *4/NAT2 *4 genotype (100.00% (237/237)), and most of the patients with NAT2 slow acetylators carried NAT2 *6 and NAT2 *7 haplotype (90.22% (249/276)). Conclusion The four-SNP genotype panels using fluorescent probe melting curve method is applicable for NAT2 genotyping in TB patients in China, with the advantage of easy to interpret result, fast and accurate.

    The values of SOD and common biomarkers in diagnosing secondary pulmonary tuberculosis complicated with respiratory failure
    Qiu-yue LIU,Li-ping PAN,Bao-jian LUO,Fen HAN,Zong-de ZHANG,Qi. LI
    Chinese Journal of Antituberculosis. 2018, 40(1):  68-72.  doi:10.3969/j.issn.1000-6621.2018.01.016
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    Objective To analyze the performance of superoxide dismutase (SOD) and the common clinical biomarkers for diagnosis of secondary pulmonary tuberculosis complicated with respiratory failure.Methods The peripheral blood of 143 cases with secondary pulmonary tuberculosis in Beijing Chest Hospital, Capital Medical University between March 2015 and December 2015 were collected in this study. Among the included patients, there were 71 cases with pulmonary tuberculosis (defined as pulmonary tuberculosis group) and 72 cases with secondary pulmonary tuberculosis complicated with respiratory failure (defined as respiratory failure group). The levels of concentrations of SOD, hypersensitive C reactive protein (HCRP), erythrocyte sedimentation rate (ESR) and NT-proBNP were tested.Results The level of SOD was 524.16±225.97mg/ml in respiratory failure group, which was lower than that in the pulmonary tuberculosis group (725.34±325.63mg/ml). The level of HCRP was 68.51±43.6mg/L in respiratory failure group, which was higher compared with the pulmonary tuberculosis group (56.07±39.56mg/L). The ESR was 50.05±29.03mm/1h in respiratory failure group, higher than that in pulmonary tuberculosis group (37.13±27.58mm/1h). The level of NT-proBNP was 882.19±182.36ng/L in respiratory failure group, which was higher than that in the in pulmonary tuberculosis group (360.26±73.99ng/L). The differences in the levels of SOD, HCRP, ESR and NT-proBNP were statistically significant (t=3.90, 1.78, 2.69 and 22.78; Ps<0.05). The logistic multivariate analysis showed that the risk of respiratory failure in pulmonary tuberculosis patients with a SOD level of ≥300mg/ml was 89% compared with patients with a SOD level of <300mg/ml (OR=0.89; 95%CI=0.76-0.92); the risk in patients with a NT-proBNP level of ≥80ng/L was 1.21 times of patients with a NT-proBNP of <80ng/L (OR=1.21; 95%CI=1.12-1.28). Receiver operating characteristic curves (ROC) analysis showed that area under curve (AUC) of SOD in diagnosing respiratory failure in pulmonary tuberculosis patients was 0.862, followed by NT-proBNP, HCRP and ESR. the sensitivity of SOD was 73.2% and specificity was 93.1%; the cut-off value was 478.51mg/ml. AUC of NT-proBNP was 0.764, the sensitivity of NT-proBNP was 72.5% and specificity was 82.7%, and the cut-off value was 340.20pg/ml.Conclusion The plasma levels of SOD and NT-proBNP have good clinical values in monitoring the occurrence of respiratory failure in secondary pulmonary tuberculosis patients.

    Analysis of adverse effects of linezolid in 47 cases of multidrug resistant pulmonary tuberculosis
    Hong ZHANG,Hao-bin KUANG,Hong-juan QIN,Min WANG,Yuan YUAN,Jin-quan YE,Zhi-yu. FENG
    Chinese Journal of Antituberculosis. 2018, 40(1):  73-79.  doi:10.3969/j.issn.1000-6621.2018.01.017
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    Objective To investigate the adverse effects of linezolid treated MDR-TB and to provide the opinion for rational drug use.Methods Fourty seven MDR-TB patients hospitaled in the Department of Tuberculosis, Guangzhou Chest Hospital from October 1, 2014 to March 20, 2017 treated by regiman including linezolid were enrolled and linezolid-related adverse drug reaction (ADR) were analyzed.Results The median time of treatment of linezolid in 47 patients was 150 (30-730)d, and 37 cases (78.7%) had 61 cases of ADR,which mainly involving the nervous system, digestive system, blood system and skin. The adverse reactions associated with linezolid were shown as follows: 24 cases of peripheral neuritis (51.1%, 24/47), nausea in 15 cases (31.9%, 15/47), decreased visual acuity in 11 cases (23.4%, 11/47), 3 cases of headache (6.4%, 3/47), as well as insomnia, dizziness, skin rash, and bone marrow suppression were found in each 2 cases (4.3%, 2/47). Most patients had peripheral neuritis (45.9%, 17/37) and nausea (29.7%, 11/37) within 0-6months of medication. More patients had a decrease in visual acuity within 0-8months (27.0%, 10/37). The number of patients with peripheral neuritis, nausea and hypoacuity gradually decreased with the prolongation of the use of drug. Patients with ADR can take symptomatic treatment (47 cases), dose reduction (11 cases), suspend medication (3 cases), and drug withdrawal (11 cases). Among them, 5 cases of peripheral neuritis, 4 cases of visual deterioration, 1 case of bone marrow suppression and 1 cases of nausea stopped taking medication in 37 patients with ADR, 22 cases (59.5%) were improved, 14 cases (37.8%) were not improved, 1 cases (2.7%) was aggravated.Conclusion Linezolid has a higher rate of ADR during the long course of treatment.But it can be used safely when ADR was treated in time.

    Preliminary study on anti-tuberculosis activity of Shenglu wan
    Bin WANG,Lei FU,Jian XU,Shao-chen GUO,Hui ZHU,Yu. LU
    Chinese Journal of Antituberculosis. 2018, 40(1):  80-83.  doi:10.3969/j.issn.1000-6621.2018.01.018
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    Objective To evaluate the anti-tuberculosis activity of traditional Chinese medicine named Shengluwan in vitro and in mouse tuberculosis model.Methods The minimal inhibitory concentration (MIC) of Shengluwan against Mycobacterium tuberculosis standard strain H37Rv was determined by 7H9 liquid medium and 7H10 solid medium. A mouse tuberculosis acute model was set up through aerosol infection to SPF BALB/C mice using Mycobacterium tuberculosis standard strain H37Rv. On the 10th day of infection, drug treatments were begun with 3g/kg of Shengluwan or 25mg/kg of isoniazid, respectively. Ten mice in each group were orally administered by gavage for 3 weeks or 6 weeks treatments. At the end of treatment, the mice were sacrificed, weighed, sterilized under sterile operation and lungs CFU counted. The CFU between the groups were compared.Results The MIC of Shengluwan against H37Rv was 2.5mg/ml in 7H9 liquid medium, and less than 5mg/ml in 7H10 solid medium. All mice were tolerant during the period of infection and treatment. There were no death mouse. After administration of 3 weeks, the CFU of the lungs in Shengluwan group were (6.81±0.71)lg CFU, which was 0.39lg CFU lower than that of the control group. After 6 weeks treatment, the CFU of the whole lungs was (4.33±0.51)lg CFU in the Shengluwan group, which was 1.10lg CFU lower than the control group.Conclusion In the mice tuberculosis model, Shengluwan shows the anti-tuberculosis activity in mice. It is worth further study in the future.

    The diagnosis value of simultaneous amplification and testing for tuberculous pleural effusion
    Lu-yan LIAO,Ming-wei ZHAO,Guo-feng. YANG
    Chinese Journal of Antituberculosis. 2018, 40(1):  84-86.  doi:10.3969/j.issn.1000-6621.2018.01.019
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    Objective To evaluate the diagnosis value of simultaneous amplification and testing (SAT-TB) for tuberculous pleural effusion.Methods Two hundred and ten cases with pleural effusion admitted from Liaocheng Infectious Disease Hospital from June 2014 to June 2016 were selected as the subjects. Among them, 143 patients were clinically diagnosed as tuberculous pleurisy (defined as tuberculous pleurisy group, while the remaining 67 patients were defined as the control group. The specimens of pleural effusion were collected from all subjects and analyzed by the smear test, modified Roche culture method and SAT-TB method. The detection performances of the three methods were compared.Results The sensitivity, specificity, positive predictive value, and negative predictive value of SAT-TB were 36.36% (52/143), 98.51% (66/67), 98.11 (52/53), and 42.04% (66/157). The sensitivity of SAT-TB was higher than that of the smear test (3.50%, 5/143) and modified Roche culture method (20.28%, 29/143); the differences were statistically significant (χ 2=19.08, P=0.021; χ 2=9.12, P<0.01). The detection time of SAT-TB was one to two hours, while the modified Roche culture method needed six to eight weeks. Conclusion SAT-TB is a rapid method for detection of Mycobacterium tuberculosis in pleural effusion, and its sensitivity is superior to the smear test and modified Roche culture method.

    A randomized clinical trial of Baihegujin Tablets for treatment of new pulmonary tuberculosis
    Hua LI,Lan-pin XIE,Ji-ling KANG,Xiu-qin CUI,Jian HUANG,Jian-ling BU,Xiao-you. CHEN
    Chinese Journal of Antituberculosis. 2018, 40(1):  87-93.  doi:10.3969/j.issn.1000-6621.2018.01.020
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    Objective To investigate efficacy and safety of Baihegujin Tablets in the adjunctive therapy for new pulmonary tuberculosis (yin deficiency syndrome of the lung and kidney).Methods By using the random number table,a randomized,double-blind,placebo-controlled,multi center clinical trial was conducted. 96 subjects with primary tuberculosis were divided into study group (72 cases) and control group (24 cases) respectively.The patients in the two groups were treated with conventional 2H-R-E-Z/4H-R-E,the study group was added with Baihegujin tablets, and the control group with Baihegujin simulation agent. The safety and the TCM syndromes were observed before treatment and after 2 weeks,4 weeks and 8 weeks treatment. The statistic analyses were performed using SAS 9.1,the Chi-square test and t test were used to anylyze the count and measurement data respectively,P value <0.05 was considered to be significantly different.Results The study group did not appear the adverse reaction of traditional Chinese medicine.Full analysis set (FAS) showed that the curative rates in study group and control group were 40.28% (29/72) and 25.00% (6/24) after 2 weeks respectively,there was no significant difference between the two groups (χ 2=1.95,P=0.1624); after 4 weeks and 8 weeks of treatment,the curative rates in study group were 70.83% (51/72) and 86.11% (62/72), which in control group were 45.83% (11/24) and 66.67% (16/24) respectively, there were significant differences between the two groups (after 4 weeks,χ 2=5.54,P=0.0186;after 8 weeks,χ 2=4.49,P=0.0341), the study group was better than the control group. After 2 weeks and 4 weeks treatment, the effective rates in study group were 93.06% (67/72) and 98.61% (71/72), which were 66.67% (16/24) and 83.33% (20/24) in control group respectively, there were significant differences between the two groups (after 2 weeks,χ 2=10.66,P=0.0011;after 4 weeks,χ 2=8.19,P=0.0042),the study group was better than the control group. The effective rates in study group and control group were 97.22% (70/72) and 91.67% (22/24) after 8 weeks respectively, there was no significant difference between the two groups (χ 2=1.33,P=0.2482). The cough disappearance time of study group and control group were 20.5 days and 28 days respectively,there were statistically significant (χ 2=6.25,P=0.0124). The curative effect of the group was better than that of the control group. There was no obvious adverse reaction related to traditional Chinese Medicine in study group. Conclusion Baihegujin Tablets can effectively improve the symptoms of tuberculosis,and effectively shorten the disappearance time of cough,and has good safety.

    Study on the association of different sites of tuberculous lesion in inpatients with tuberculosis from Tongzhou District, Beijing
    Wan-li KANG,Yang LIU,Shen-jie TANG,Su-hua. ZHENG
    Chinese Journal of Antituberculosis. 2018, 40(1):  94-97.  doi:10.3969/j.issn.1000-6621.2018.01.021
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    Objective To study the association of different kinds of tuberculous lesion in inpatients with tuberculosis from Tongzhou District of Beijing in order to provide information of tuberculosis for clinical physicians to decide diagnosis and treatment.Methods We analyzed retrospectively 638 inpatients admitted in Beijing Chest Hospital during 2006 to 2015. Questionnaire informaiton including sex, age, lesion kind were investigated and recorded from hospitalized records. The association of different kind of tuberculous lesion were analyzed using the Apriori algorithm of associated analysis.Results There were 39 kinds of tuberculous lesion involved in 863 sites in 638 inpatients with tuberculosis. The rates of 2 or more than 2 kinds of tuberculous lesion were 27.6% (176/638). Of 863 sites of tuberculous lesion, there were 459 (53.2%) sites in pulmonary tuberculosis, 145 (16.8%) sites in tuberculous pleurisy, 46 (5.3%) sites in lumbar tuberculosis,34 (3.9%) sites in tuberculous lymphadenitis,25 (2.9%) sites in endobronchial tuberculosis,21 (2.4%) sites in thoracic vertebrae tuberculosis. Fourteen associations were found when the confidence was set more than 10%.Conclusion About one fourth inpatients suffer from 2 or more than 2 kinds tuberculosis lesion in Tongzhou District of Beijing. When one kind tuberculosis is diagnosed, the other kind tuberculosis needs to be considered combination probably.

    Treatment outcomes and associated factors among smear-positive pulmonary tuberculosis patients in two counties of Xuzhou, Jiangsu Province and Urumqi, Xinjiang Uygur Autonomous Region
    Zhi-qi YANG,Yi HU,Qi ZHAO,Yang-gui CHEN,Jian-sheng SUN,Bao-ling RUI,Wei LU,Chang-ming ZHOU,Biao. XU
    Chinese Journal of Antituberculosis. 2018, 40(1):  98-105.  doi:10.3969/j.issn.1000-6621.2018.01.022
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    Objective This study aimed to understand the normalization of the sputum smear monitoring during anti-tuberculosis treatment, and to investigate treatment outcomes and associated factors among smear-positive pulmonary tuberculosis patients in two counties (Feng County and Pei County) of Xuzhou (Jiangsu Province) and Urumqi (Xinjiang Uygur Autonomous Region).Methods A prospective cohort study was conducted to collect the follow-up information and treatment outcomes of smear-positive tuberculosis patients diagnosed from 2014 to 2016 in Feng County and Pei County of Xuzhou and Urumqi. All statistical analyses were performed using SPSS software 22.0. The categorical data was described using proportions. Differences of two groups were compared using Pearson chi-square test or Fisher’s exact test. Multivariable analysis was conducted using binary logistic regression. A two-sided P value <0.05 was considered statistically significant. A total of 574 smear-positive pulmonary tuberculosis patients were included in this study, with an average age of (46±20.8) years old. Among all the subjects, 420 (73.2%) were males, 265 (46.2%) were from two counties of Xuzhou and 309 (53.8%) were from Urumqi.Results The treatment success proportion for 574 study participants was 88.2% (506/574), including 391 patients who were cured and 115 patients who completed the treatment, and the proportion in Feng County and Pei County of Xuzhou was significantly higher than in Urumqi (Feng County and Pei County: 92.8%, 246/265, Urumqi: 84.1%, 260/309, χ 2=10.310, P=0.001). A total of 48 (8.4%, 48/574) smear-positive patients missed at least one sputum smear test during treatment. Univariate analysis indicated that the proportions of adverse treatment outcomes among males (χ 2=4.342, P=0.037), non-local residents (χ 2=5.646, P=0.017) and patients with smear non-conversion after 2-month treatment (Fisher’s exact test: P=0.000) were significantly higher than females, local residents and patients with smear conversion after 2-month treatment. Multivariable analysis indicated that the risk for adverse treatment outcomes of smear-positive pulmonary tuberculosis among males and patients with smear non-conversion after 2-month treatment (OR=6.892, 95%CI=3.218-14.762, P=0.000) was significantly higher than females (OR=0.329, 95%CI=0.121-0.898, P=0.030) and patients with smear conversion after 2-month treatment. Conclusion The treatment success proportion among smear-positive tuberculosis patients was higher in two counties of Xuzhou than in Urumqi. Males and smear non-conversion after 2-month treatment will increase the risk of adverse treatment outcomes.

    Review Article
    The progress and evaluation of quality of life for tuberculosis patients
    Wan-qiu CHENG,Yue-ying CUI,Xiao-wan. WANG
    Chinese Journal of Antituberculosis. 2018, 40(1):  106-110.  doi:10.3969/j.issn.1000-6621.2018.01.023
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    As a chronic infectious disease, tuberculosis is a world-wide problem of public health for global concern. Although the effect of clinical treatment of anti-tuberculosis drugs is significant, except for the improvement of clinical symptoms, psychological and social status has become more and more important, along with the improvement of clinical concept. Therefore, the studies of quality of life for tuberculosis patients increase rapidly. Through the literature research about the quality of life assessment for tuberculosis patients, this paper is to understand the latest research status, concept definition, measurement scale and self-made scale of the situation, and to provide theoretical basis for the relevant research.

    Research progress of the nursing intervention on treatment compliance of patients with multi-drug resistant pulmonary tuberculosis
    Li-jun SONG,Lin ZHANG,Jing. ZHENG
    Chinese Journal of Antituberculosis. 2018, 40(1):  111-113.  doi:10.3969/j.issn.1000-6621.2018.01.024
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    The large scale of epidemic rising of multi-drug resistant tuberculosis (MDR-TB) is bringing a great threat to human health and causing a heavy socioeconomic loss. It becomes one of the major threats to global TB control and makes that the TB prevention and control is facing a critical challenge. In order to provide more scientific evidences for strengthening the research on nursing of MDR-TB, we did this comprehensive literature review, including the epidemic situation of MDR-TB and its reasons, MDR-TB control strategy, as well as the researches on improving treatment compliance of MDR-TB patients with the effective nursing methods.

    Short Articles
    Analysis of epidemiological characteristics of the new smear-positive pulmonary tuberculosis in Foshan of Guangdong Province from 2010 to 2016
    Ci-xi DENG,Qian-hong ZHONG,Zhi-long. WU
    Chinese Journal of Antituberculosis. 2018, 40(1):  114-118.  doi:10.3969/j.issn.1000-6621.2018.01.025
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    To investigate the epidemiological characteristics of the new smear-positive pulmonary tuberculosis in Foshan from 2010 to 2016, and to provide scientific evidence for the disease prevention and control, the data was collected through the China Information System for Disease Control and Prevention-Tuberculosis Information Management System and analyzed by descriptive epidemiological methods. A total of 9602 cases of new smear-positive pulmonary tuberculosis were registered in Foshan from 2010 to 2016, including 6802 men and 2800 women, and the male and female ratio was 2.43∶1.The annual average registration rate was 19.29/100000 (9602/49785900). Most of the patients were in the age of 15 to 54 years old, accounting for 75.05% (7206/9602). The occupational distribution was given priority to the workers (27.60%, 2650/9602), followed by housekeeper (27.14%, 2606/9602) and farmers (16.15%, 1551/9602). The numbers of patients among floating population and the registered population were 5387 cases and 4215 cases, and the ratio was 1.28∶1, respectively. Therefore, further tuberculosis prevention and control will be focus on the floating population and the young adults in Foshan.

Monthly, Established in Novembar 1934
ISSN 1000-6621
CN 11-2761/R

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