Table of Content

10 October 2021, Volume 43 Issue 10

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Guideline·Standard·Consensus

Expert consensus on the study of early bactericidal activity of new anti-tuberculosis drugs

Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute , Editorial Board of Chinese Journal of Antituberculosis

Chinese Journal of Antituberculosis. 2021, 43(10):  987-992.  doi:10.3969/j.issn.1000-6621.2021.10.002

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The tuberculosis epidemic is still severe, and new anti-tuberculosis drugs are urgently needed. Clinical trials of new drugs are the most important stage of new drug development. Early bactericidal activity (EBA) is the first step in clinical study of new anti-tuberculosis drugs used in the treatment of tuberculosis patients, and it is also the key of clinical evaluation of the single anti-tuberculosis drug and a new regimen. In order to standardize and better promote the development of new anti-tuberculosis drugs in China, after repeated discussions by experts in the field of tuberculosis clinical and basic research organized by Beijing Chest Hospital affiliated to Capital Medical University and the Editorial Board of Chinese Journal of Antituberculosis, the Expert consensus on the study of early bactericidal activity of new anti-tuberculosis drugs has been formulated on the significance, design, implementation, and influencing factors of the EBA study on the new anti-tuberculosis drugs.

Expert Note

Current situation and prospect of prevention and control of tuberculosis in humans, livestock and poultry

XU Cai-hong, ZHOU Xiang-mei, FAN Wei-xing, ZHAO Yan-lin

Chinese Journal of Antituberculosis. 2021, 43(10):  993-997.  doi:10.3969/j.issn.1000-6621.2021.10.003

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Tuberculosis is a chronic infectious disease that is common to humans, livestock and poultry. It has been found that 50 species of mammals and 25 species of poultry can be infected with the disease. Bovine tuberculosis is a disease that must be notified according to the regulations of OIE and is the second category of animal infectious diseases in China. It not only causes economic losses to the cattle industry, but also seriously threatens the health of people. It is an obstacle and challenge to end the epidemic of tuberculosis and eliminate the harm of tuberculosis. The epidemic situation of zoonotic tuberculosis among animals and humans, the current situation of prevention and control of zoonotic tuberculosis (including mechanism, prevention and control awareness, prevention and control measures, etc.), and the prospect of prevention and control of zoonotic tuberculosis were reviewed to initiative multiple departments, such as agriculture and rural areas, animal husbandry, animal epidemic prevention, and disease control, etc., to aware the negative epidemic situation of zoonotic tuberculosis and the current situation of prevention and control. Actions should be taken as soon as possible, multi-sectoral joint prevention and control is also needed to help achieving the strategic goal of ending the tuberculosis epidemic.

Interpretation of Standards

Interpretation of the Quality Evaluation on Tuberculosis Prevention and Control in Designated Medical Institutions

WANG Wei, CAI Qing-shan, WANG Xiao-meng

Chinese Journal of Antituberculosis. 2021, 43(10):  998-1000.  doi:10.3969/j.issn.1000-6621.2021.10.004

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The group standard of Quality Evaluation on Tuberculosis Prevention and Control in Designated Medical Institutions stipulates the method of on-site evaluation of tuberculosis prevention and control work in designated medical structures, which is suitable for designated tuberculosis medical institutions at all levels in the country. The article introduced the background and demand of evaluation, as well as the main points of content, so as to facilitated the use of this standard at all levels to carry out on-site evaluation of designated medical institutions for tuberculosis. This is needed to promote the gradual improvement of the quality of tuberculosis prevention and control.

Original Articles

Analysis of the correlation between sensitivity of drugs in the treatment and the outcome of treatment in pulmonary tuberculosis patients retreated for the first time

YING Ruo-yan, HUANG Xiao-chen, WANG Jie, LIU Yi-dian, SHA Wei, YANG Hua

Chinese Journal of Antituberculosis. 2021, 43(10):  1001-1005.  doi:10.3969/j.issn.1000-6621.2021.10.005

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Objective To analyze the predictive value of single-drug minimum inhibitory concentration (MIC) and fractional inhibitory concentration index (FICI) to the outcome of treatment in pulmonary tuberculosis patients firstly retreated with ultra-short course treatment. Methods Forty-eight drug-resistant tuberculosis patients firstly retreated with the ultra-short course treatment for pulmonary (Mfx-Pa-Rft-E-Z; 6 months; Mfx: moxifloxacin; Pa: isoniazid para amino salicylic acid; Rft: rifapentine; E: ethambutol; Z: pyazinamide) from Shanghai Pulmonary Hospital Affiliated to Tongji University were selected. All the patients completed the treatment and were divided into successful group (n=38, sputum was negative after treatment) and failure group (n=10, sputum was not negative after treatment). In the successful group, 18 patients were extensive-drug resistance (XDR) and 20 patients were multidrug-drug resistance (MDR). Patients in failure groups were all XDR. Strains were isolated from sputum specimens preserved before treatment. In vitro drug sensitivity test was performed on Mfx, Pa, Rft and Mfx-Pa, Pa-Rft, Mfx-Pa-Rft by three-dimensional checkboard method. The correlation between MIC and FICI and prognosis was analyzed. Results MIC values (median (quartile)) of Mfx, Pa and Rft were 0.50 (0.06, 1.00), 8.0 (3.5, 16.0) and 32.0 (4.0, 64.0) mg/L, respectively, in the successful group, and 1.00 (0.50, 1.00), 16.0 (3.5, 28.0) and 48.0 (24.5, 64.0) mg/L, respectively, in the failure group. The MIC value of Mfx in the successful group was significantly lower than that in the failure group (Z=-2.251, P=0.026). The results of the combined drug sensitivity test of Mfx-Pa and Pa-Rft showed that the synergistic rates of the successful group were 2.6% (1/38) and 44.7% (17/38), and of the failure group were 1/10 and 6/10, respectively. No antagonism was found, and the difference between the two groups was not statistically significant (Fisher’s exact probability method, P values were 0.377 and 0.487, respectively). The results of Mfx-Pa-Rft combined drug sensitivity test showed that the synergistic rates were 26.3% (10/38) in the successful group and 1/10 in the failure group. The antagonism rates were 13.2% (5/38) in the successful group and 3/10 in the failure group. There was no significant difference between the two groups (χ²=2.221, P=0.136). The results of Mfx-Pa-Rft combined drug sensitivity test for XDR patients showed that in the successful group, the synergy rate was 38.9% (7/18), higher than that in the failed group (1/10); the antagonism rate was 5.6% (1/18), lower than that in the failure group (3/10), and the difference was statistically significant (χ²=4.480, P=0.034). The FICI values (median (quartile)) of Mfx-Pa combined drug sensitivity test were 1.50 (1.00, 2.00) in the successful group and 1.75 (1.05, 2.02) in the failure group. FICI values of Pa-Rft combined drug sensitivity test were 0.51 (0.47, 0.63) in the successful group and 0.44 (0.28, 0.65) in the failure group. FICI values of Mfx-Pa-Rft combined drug sensitivity test were 1.25 (0.75, 2.50) in the successful group and 2.31 (1.47, 4.25) in the failure group. There were no significant differences (Z values were -0.662, -1.134, -1.168, P values were 0.523, 0.263, 0.097, respectively). Conclusion The better the drug synergy of the core drugs in the treatment regimen of the first retreatment for tuberculosis patients, the greater the sputum negative conversion rate at the end of treatment; the combined drug sensitivity test of treatment regimen drugs should be performed before the application of different treatment combination regimens, and the treatment regimen should be optimized by judging the sensitivity of patients to drugs and the synergy of drugs, so as to improve the success rate of treatment.

Clinical characteristics of retreated bacterial negative pulmonary tuberculosis patients

CHENG Wu, TAN Shou-yong, LI Yan, LI Qiong

Chinese Journal of Antituberculosis. 2021, 43(10):  1006-1009.  doi:10.3969/j.issn.1000-6621.2021.10.006

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Objective To analyze the clinical characteristics of retreated bacterial negative pulmonary tuberculosis in order to improve the diagnosis. Methods A retrospective study was conducted in 201 patients with retreated pulmonary tuberculosis diagnosed and hospitalized in Guangzhou Chest Hospital from February 1, 2020 to July 31, 2020. According to the results of the acid-fast bacilli smear or culture of secretions before treatment, these patients were divided into bacterial positive group (n=146) and bacterial negative group (n=55). The treatment history and clinical data were collected, age, gender, treatment history, drug resistance, clinical symptoms, imaging findings and complications in the two groups were compared. Results (1) Treatment history: among the 201 subjects, 148 (73.6%) patients needed retreatment after drug withdrawal, and 53 (26.4%) patients failed in the initial treatment. Of the 148 patients needed retreatment, 110 (75.3%) in bacterial positive group and 38 (69.1%) in bacterial negative group, the difference of distribution was no statistically significant (χ²=0.804, P=0.375). (2) Clinical symptoms: cough were found 100.0% (n=55) in the bacteria negative group, significantly higher than that in the bacteria positive group (n=127, 87.0%) (χ²=7.905, P=0.005). Fourteen (25.5%) patients in bacterial negative group were found with symptoms of tuberculosis poisoning, significantly lower than that in bacterial positive group (n=61, 41.8%)(χ²=4.553, P=0.033). (3) Imaging findings: 23.6% (13/55) in bacterial negative group had ≥3 cavities in lung lesions, significantly lower than that in bacterial positive group (53.4%, 78/146) (χ²=14.308, P<0.001). (4) Complications: the main type of bronchial tuberculosis in the two groups was scar stenosis. It occurred in 85.7% (12/14) patients of the bacterial negative group, significantly higher than in the bacterial positive group (60.0%, 33/55) (χ²=3.996, P=0.046). Serum albumin ≤40 g/L in 29.1% (16/55) patients in bacterial negative group, significantly lower than in bacterial positive group (54.1%, 79/146)(χ²=10.033, P=0.002). Conclusion Compared with retreated bacterial positive pulmonary tuberculosis, retreated bacterial negative pulmonary tuberculosis patients suffer more cough, less tuberculosis poisoning symptoms, less extensive cavity and hypoproteinemia, and more likely to complicated with scar narrow bronchial tuberculosis.

Individualized treatment for retreatment smear-positive pulmonary tuberculosis patients based on molecular drug susceptibility testing and its short-term effectiveness

LIU Zhi-bin, WU Min, WU Xiao-cui, HAN Min, ZHANG Qing, SHA Wei

Chinese Journal of Antituberculosis. 2021, 43(10):  1010-1015.  doi:10.3969/j.issn.1000-6621.2021.10.007

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Objective To evaluate individualized treatment of retreatment smear-positive pulmonary tuberculosis (PTB) patients based on molecular drug susceptibility testing (DST) and its short-term effectiveness. Methods A prospective, randomized and controlled study was conducted, and 400 retreatment PTB patients diagnosed and treated in Shanghai Pulmonary Hospital from March 2016 to January 2020 were enrolled. Sputum or bronchoalveolar lavage fluid of each patient was collected and cultured for mycobacterium. Then strains which were isolated from positive culture and identified as Mycobacterium tuberculosis were tested for phenotypic DST using Micropore-plate method (MicroDST). Meanwhile, 200 patients were randomly selected according to visiting time sequence and random number table, specimen of those patients were tested for molecular DST using PCR-reverse dot blot (RDB) hybridization, thus drug resistance related genes of isoniazid (H) and rifampicin(R) were detected. Before the results of MicroDST were reported, patients with H and (or) R resistance detected by PCR-RDB were treated with H- and (or) R-resistant chemotherapy regimen, while other patients were treated with H- and R-susceptible retreatment chemotherapy regimen; after the results of MicroDST were reported, the chemotherapy regimens of all patients were adjusted according to the results of MicroDST. The sputum smear negative conversion rates and bacterial load of smear-positive specimen at the time of MicroDST results being reported, and the sputum smear negative conversion rates at the end of 3, 6, 9 and 12 months after drug-resistant chemotherapy started, were compared between patients with PCR-RDB and patients without PCR-RDB among rifampicin-resistant patients diagnosed by MicroDST. Results For patients with PCR-RDB and patients without PCR-RDB among rifampicin-resistant patients diagnosed by MicroDST, the sputum smear negative conversion rates at the time of MicroDST results being reported were 18.9% (10/53) and 5.9% (3/51) respectively, the difference was statistically significant (χ²=4.007, P=0.045); the graded counts ”+, ++, +++, ++++” of acid-fast bacilli in smear-positive specimens of patients with PCR-RDB were 48.8% (21/43), 25.6% (11/43), 16.3% (7/43) and 9.3% (4/43), while for patients without PCR-RDB were 16.7% (8/48), 35.4% (17/48), 33.3% (16/48) and 14.6% (7/48) at the time of MicroDST results being reported, the difference of smear positive grading was significant statistically (χ²=11.212, P=0.011), and sputum bacterial load of smear-positive specimen of the former was lower. Sputum negative conversion rates of patients with PCR-RDB at the end of 3, 6, 9 and 12 months after treatment with rifampicin-resistant chemotherapy regimen were 64.0% (32/50),84.8% (39/46), 82.9% (34/41),84.2% (32/38), higher than those of patients without PCR-RDB (58.8% (30/51), 81.0% (34/42), 81.6% (31/38), 81.6% (31/38)), all differences were not statistically significant (χ²=0.285,P=0.593;χ²=0.593,P=0.218;χ²=0.025,P=0.874;χ²=0.093,P=0.761). Conclusion Patients treated with rifampicin-resistant chemotherapy regimen based on PCR-RDB could have sputum smear negative conversion rate increasing and sputum bacteria load decreasing earlier among retreatment smear-positive PTB patients diagnosed by MicroDST.

Clinical characteristics and drug resistance of retreated smear positive pulmonary tuberculosis patients with diabetes mellitus

WU Gui-hui, TANG Xian-zhen, HUANG Tao, MA Yao, FU Xiao-yan, QIAN Kun, YI Yan-ling, ZHANG Xu-lin

Chinese Journal of Antituberculosis. 2021, 43(10):  1016-1021.  doi:10.3969/j.issn.1000-6621.2021.10.008

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Objective To analyze the clinical characteristics and drug resistance of retreated smear positive pulmonary tuberculosis (PTB) patients with diabetes mellitus (DM), so as to provide reference for treatment. Methods We collected 287 retreated smear positive PTB patients hospitalized in Public Health Clinical Center of Chengdu from December 2018 to January 2021, including 169 cases in DM group and 118 cases in non-DM group. The gender, age, body mass index (BMI), hemoptysis, fever, frequency of retreatment, self-medication withdrawal, pulmonary lesions, lung cavity and drug resistance were collected and analyzed. The drug resistance of patients was tested by microplate phenotypic methods. Results Compared with the non-DM group, DM group had more male patients (88.8% (150/169), 73.7% (87/118)), older patients (55.0 (47.5,63.0) years old, 37.0 (27.0,50.0) years old), higher BMI (21.1 (18.9,24.1),19.0 (17.6,21.2)), more patients with hemoptysis or pulmonary cavity >3 (46.2% (78/169),30.5% (36/118);57.4% (97/169),42.4% (50/118)), and broader lung lesions sites (4.0 (3.0,6.0),3.0 (2.0,4.0)), all with a statistically significant difference (χ²=10.909, P=0.001; Z=-7.548, P<0.001; Z=-4.366, P<0.001; χ²=7.103, 6.277,P=0.008, 0.012; Z=-3.810, P<0.001). The top three drug resistance rates in the DM group were isoniazid (INH)(50.3% (85/169)), rifampin (RFP)(41.4% (70/169)) and Streptomycin (Sm)(27.8% (47/169)), and in non-DM group the top three were also INH (27.1% (32/118)), RFP (22.9% (27/118)) and Sm (17.8% (21/118)). Compared with the non-DM group, the rate of multi-drug resistance (MDR) was higher in the DM group (35.5% (60/169),22.0% (26/118)), the difference was statistically significant (χ²=6.007, P=0.014). There was no significant difference in the resistance rates of MDR plus second-line injection (7.7% (13/169),4.2% (5/118)),MDR plus fluoroquinolone (6.5% (11/169),4.2% (5/118)) and extensive drug-resistant (4.7% (8/169), 1.7% (2/118)) between the two groups (χ²=1.411, 0.681, 1.908, P=0.235, 0.409, 0.167). Conclusion The retreated smear positive PTB patients with DM had higher incidence of hemoptysis, more extensive lung lesions, more cavities and possibly higher drug resistance rates. We should pay attention to the screening and treatment of TB and DM comorbidities, and understand the results of drug sensitivity tests, then formulate accurate anti-tuberculosis regimen.

Evaluation of single utility port video-assisted thoracoscopic surgery combined with ERAS in the treatment of tuberculous empyema

CHENG Peng, LI Jun-xiao, LIU Xin, CUI Yuan-bo, CHEN Qi-liang, HUO Xue-e

Chinese Journal of Antituberculosis. 2021, 43(10):  1022-1026.  doi:10.3969/j.issn.1000-6621.2021.10.009

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Objective To evaluate the effect of single utility port video-assisted thoracoscopic surgery (SP-VATS) combined with enhanced recovery after surgery (ERAS) in the treatment of tuberculous empyema. Methods Clinical data of 113 tuberculous pustular chest patients admitted to Tuberculosis Hospital of Shaanxi Province from December 2017 to December 2020 were retrospectively studied. Fifty-four patients who underwent SP-VATS only from December 2017 to December 2019 were selected as the SP-VATS group, and 59 patients who underwent SP-VATS and perioperative ERAS from January 2020 to December 2020 were selected as the SP-VATS+ERAS group, the time to leave bed, recovery time of bowel sounds, hospital stay, extubation time, postoperative pain and surgical complications in the two groups were compared. Results The time to leave bed, recovery time of bowel sounds, hospital stay, extubation time, incidence rate of complications, pain scores 1, 12 and 24 h after operation in the SP-VATS+ERAS group were significantly shorter or lower than those in the SP-VATS group (10 (8,13) h vs. 13 (10,17) h, Z=3.777, P=0.000; (18.25±3.52) h vs. (20.35±3.45) h, t=3.198, P=0.002; (17.75±3.68) d vs. (19.45±3.56) d, t=2.491, P=0.014; 6 (5, 7) d vs. 7(5, 9) d, Z=3.342, P=0.001; 20.34% (12/59) vs. 38.89% (21/54), χ²=4.690, P=0.030; 3.26±1.32 vs. 5.58±1.68, t=8.198,P=0.000; 5.59±1.54 vs. 6.35±1.57, t=2.596,P=0.011; 4.0 (3.5,5.0) vs. 5.5(4.0,7.0), Z=3.191, P=0.001). Conclusion Compared to the SP-VATS treated with the SP-VATS combined with the ERAS,the tuberculous empyema patients will recover faster, suffer less pain and fewer postoperative complications,and the hospitalization stay is shorter. The SP-VATS combined with the ERAS is safe and effective in the tuberculosis surgery.

Analysis of the therapeutic effect of probiotics combined with enteral nutrition on patients with comorbidity of tuberculosis and type 2 diabetes with malnutrition

TANG Han-mei, ZHANG Sheng-kang, YAN Mi, YUAN Dan, CAO Han-juan, ZHANG Xiao-bing, BAI Li-qiong, YI Heng-zhong, TANG Xi-liang

Chinese Journal of Antituberculosis. 2021, 43(10):  1027-1031.  doi:10.3969/j.issn.1000-6621.2021.10.010

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Objective To assess the effects of probiotics combined with enteral nutrition on patients with comorbidity of pulmonary tuberculosis-type 2 diabetes mellitus (PTB-T2DM) with malnutrition. Methods Since January 5, 2018, patients with PTB-T2DM and malnutrition admitted in Hunan Chest Hospital were randomly allocated in observation group and control group using random number table. By December 15, 2020, 150 patients were enrolled in the study, 75 in the observation group (age: (60.8±8.6) years) and 72 in the control group (age: (57.9±10.6) years).The control group was treated with conventional anti-tuberculosis treatment, hypoglycemic diet and low GI enteral nutrition solution; the observation group was prescribed with probiotics additionally. Hemoglobin (Hb), albumin (Alb) and body mass index (BMI) were assessed before and after 14 days’ nutritional treatment. The occurrences of gastrointestinal adverse reactions such as nausea and vomiting during the nutritional treatment of those two groups were observed. Results After 14 days’ nutritional treatment, a significantly higher proportion of patients in the observation group had meaningful clinical response than in the control group based on the Hb, Alb and BMI ((104.69±16.37) g/L, (32.80±6.76) g/L and 19.23±3.04 vs (100.80±15.59) g/L, (32.44±4.77) g/L and 20.38±3.11, t values were 2.667, 2.023, 2.288, and P values were 0.008, 0.046, 0.023, respectively). The incidence of abdominal distension, diarrhea and constipation were lower in the observation group compared with the control group (5.33% (4/75), 2.67% (2/75) vs 18.06% (13/72), 12.50% (9/72), respectively, χ² of abdominal distension and constipation were 5.841 and 5.131, P values were 0.016, 0.024, respectively). The incidence of diarrhea was using performed by Fisher’s exact test, it shown that the observation group had lower incidence than control group (1.33% (1/75) vs 9.72% (7/72)). Conclusion Probiotics combined with enteral nutrition can significantly improve the nutritional status and prognosis of PTB-T2DM patients with malnutrition.

Analysis of the implementation effect of active tuberculosis screening strategy in permanent residents aged 5 and older in Lianjiangkou Town, Guangdong in 2019

WU Hui-zhong, ZHOU Fang-jing, LIAO Qing-hua, CHEN Liang, LAI Xiao-yu, YU Mei-ling, WEN Wen-pei, ZHOU Lin

Chinese Journal of Antituberculosis. 2021, 43(10):  1032-1038.  doi:10.3969/j.issn.1000-6621.2021.10.011

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Objective To evaluate the effect of different active screening strategies on the detection of pulmonary tuberculosis (PTB) patients. Methods Cluster random sampling method was used to select 2 units from 11 communities (villages) in Lianjiangkou Town, Yingde City, Qingyuan City, Guangdong Province as the study site in December 2019. Basic information was collected from 2800 permanent residents aged 5 and older at the study site. Screening for tuberculosis symptoms,screening for Mycobacterium tuberculosis infection (interferon-gamma release test (IGRA)) and chest digital radiography (DR) were performed. Sputum samples from patients with positive results from any of the above screenings were examined by smear, culture and molecular biology tests. Using clinical diagnosis as a reference standard, performance of different screening strategies were evaluated by sensitivity, specificity and area under the receiver operating characteristic curve (AUC). Results Among the 2800 people undergoing active screening, there were 272 cases (9.71%) with suspected symptoms of tuberculosis, 301 cases (10.75%) with abnormal chest DR, and 617 cases (22.04%) with positive IGRA results. Among them, 67 cases (22.26%) with abnormal chest DR were presumptive tuberculosis patients. A total of 8 active pulmonary tuberculosis patients were diagnosed and the discovery rate was 285.71/100000.Except for 1 patient who had been registered and receiving treatment, the other 7 patients were all newly detected from aged 15 and older population with abnormal chest DR. With clinical diagnosis as the reference standard, chest DR screening had the best sensitivity and specificity (7/8 and 88.28% (2207/2500), respectively), and the highest AUC (0.88). Conclusion Among different active screening strategies, chest DR has the highest diagnostic value and can be used as the priority choice of active screening strategy

Application of a dynamic model on the prediction of pulmonary tuberculosis incidence and control strategy evaluation in Tianjin, China

YU She-gen, JIA Zhong-wei

Chinese Journal of Antituberculosis. 2021, 43(10):  1039-1045.  doi:10.3969/j.issn.1000-6621.2021.10.012

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Objective A dynamic model was established to predict the pulmonary tuberculosis (PTB) reporting incidence rate in Tianjin, and to provide scientific evidences for optimizing PTB control strategies. Methods Based on PTB transmission mechanism, a dynamic transmission model of TB was established and the basic regeneration number ?₀ was calculated. Fitting the model with the PTB reporting incidence rates in Tianjin from 2008 to 2015, the trends of PTB reporting incidence rate in Tianjin were predicted, and the relative errors between the predicted value and the validation data of PTB reporting incidence rates from 2016 to 2018 were calculated. The effects of different TB prevention and control strategies were evaluated by adjusting the value of parameters: reducing the infection rate of susceptible people (β₁, β₂); reducing the progressing rate of latent infection to active tuberculosis patients (κ₁, κ₂); reducing the recurrence rate of patients with successful treatment (ω₁, ω₂). Results The basic regeneration number ?₀ of PTB transmission in Tianjing was 0.259 <1, the disease-free equilibriums was global asymptotically stable. The relative errors between predicted values and validation data of reporting incidence rates were 0.76%, 1.30% and -1.54% in 2016, 2017 and 2018, respectively, which were relatively accurate. The PTB reporting incidence rate in Tianjin will decline to 18.3 per 100000 in 2035. Keeping other parameter values unchanged, the PTB reporting incidence rate in Tianjin will be 17.8 per 100000 in 2035 if β₁ and β₂ declined by 50%; the PTB reporting incidence rate will be 9.86 per 100000 in 2035 if κ₁ and κ₂ declined by 50%; and the PTB reporting incidence rate will be 17.9 per 100000 in 2035 if ω₁ and ω₂ declined by 50%. Conclusion The WHO End TB Strategies target in 2035 (incidence rate <10 per 100000) is hard to be achieved in Tianjin under current prevention and control strategies. It is suggested to enhance effective management of latent TB infection population.

Analysis of the effect of patients care on the level of sputum specimens submitted for examination among outpatient follow-up of rifampicin-resistant pulmonary tuberculosis patients

LUO Hui, RUAN Yun-zhou, ZHAO A-li, YUAN Rong, HE Xiao-mou, LI Ren-zhong

Chinese Journal of Antituberculosis. 2021, 43(10):  1046-1051.  doi:10.3969/j.issn.1000-6621.2021.10.013

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Objective To assess the effect of the patients care on the level of sputum specimens submitted for examination among the outpatient follow-up of rifampicin-resistant pulmonary tuberculosis (RR-PTB) patients. Methods The RR-PTB outpatients followed-up in Drug-Resistant TB Department of Xi’an Chest Hospital were taken as objects. The RR-PTB outpatients followed-up from July to September 2019 were taken as the intervention group 1 (249 cases) who received 3 care services in the first phase. The intervention group 2 (239 cases) were the RR-PTB outpatient followed-up from July to September 2020 who received 6 care services in the second-phase. Meanwhile, RR-PTB outpatients who followed-up from July to September 2018 received routine outpatient expectoration guidance were retrospectively analyzed as the control group (127 cases). The changes of the rate of sputum specimens submitted for examination of the 3 groups were compared. Results The overall rate of sputum specimens submitted for examination in the control group, intervention group 1 and intervention group 2 were 35.8% (77/215), 51.7% (209/404) and 78.6% (276/351) separately, the difference was statistically significant (χ²=111.249, P<0.001). The rate in the intervention group 1 received the first intervention (47.0%, 117/249) and the group 2 received the first intervention (73.6%,176/239) were significantly higher than that of control group (29.9%, 38/127), the difference was statistically significant (χ²=10.110, 65.278;P<0.017). The rate of the intervention group 2 was significantly higher than the group 1 (χ²=36.106, P<0.001). The rates of intervention group 1 after receiving the first intervention, the second intervention and third intervention were 47.0% (117/249), 57.4% (78/136) and 73.7% (14/19), respectively, and the differences were significant (χ_trends²=7.448, P=0.006). The rates of the intervention group 2 received first intervention and the second intervention were 73.6% (176/239) and 89.3% (100/112) respectively, and the difference was significant (χ²=11.111, P=0.001). Conclusion Patient care services can increase the rate of sputum specimens submitted for examination among the followed-up RR-PTB outpatients, and the effects of 6 care services were better than that of 3 care services.

Impact of intervention measures for COVID-19 epidemic on tuberculosis prevention and control in Huizhou

LI Xiang-wu, CHEN Wen-jie, ZHONG Qiu, CHENG Shi-ming, PENG Jian-ming, LIU Zhi-dong.

Chinese Journal of Antituberculosis. 2021, 43(10):  1052-1055.  doi:10.3969/j.issn.1000-6621.2021.10.014

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Objective To explore the influence of COVID-19 intervention measures on tuberculosis prevention and control in Huizhou, Guangdong Province. Methods The registration information, drug resistance screening and treatment outcome of tuberculosis patients in Huizhou, Guangdong from January to June in 2019 and 2020 were collected through the Tuberculosis Management Information System in Chinese Disease Prevention and Control Information System. Tuberculosis patients’ supervision visits and regular medication were obtained through the Huizhou basic public health service project (tuberculosis patients’ health management) report. According to the actual situation of COVID-19 in China, January to June 2020 was set as the epidemic period and January to June 2019 was set as the baseline period. The changes of discovery, follow-up examination, medication management and supervision visit of pulmonary tuberculosis patients in Huizhou during the two periods were compared. Results During the COVID-19 epidemic period, the detection rate of tuberculosis in Huizhou increased from 26.32% (881/3347) to 27.45% (794/2893), but the difference was not statistically significant (χ²=0.997, P=0.318); the screening rate of drug resistance in patients with pathogenic positive pulmonary tuberculosis increased from 95.66% (375/392) to 99.73% (372/373), the difference was statistically significant (χ²=13.771, P=0.000); the follow-up examination rate of confirmed patients decreased from 96.37% (849/881) to 96.10% (763/794), the difference was not statistically significant (χ²=0.085, P=0.770); the supervision visit rate increased from 99.16% (8037/8105) to 99.25% (7290/7345), the difference was not statistically significant (χ²=0.529, P=0.397); the regular medication rate increased from 95.46% (841/881) to 96.10% (763/794), the difference was not statistically significant (χ²=0.416, P=0.519). Conclusion The intervention measures for COVID-19 did not affect tuberculosis prevention and control in Huizhou, the tuberculosis prevention and control service system is running well. In the future, we should continue to strengthen the system to guarantee that the tuberculosis service system can provide normal diagnosis and treatment management services in any circumstance.

Preliminary study on pharmacokinetics/pharmacodynamics of five new anti-tuberculosis drugs in mice

ZHU Hui, FU Lei, ZHANG Wei-yan, WANG Bin, CHEN Xi, LU Yu

Chinese Journal of Antituberculosis. 2021, 43(10):  1056-1065.  doi:10.3969/j.issn.1000-6621.2021.10.015

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Objective To evaluate the pharmacokinetic/pharmacodynamics (PK/PD) of five anti-tuberculosis drugs including pretomanid (PA-824), delamanid (Dlm), clofazimine (Cfz), bedaquiline (Bdq) and PBTZ-169 in BALB/c mice tuberculosis model at different doses. Methods BALB/c mice were infected with Mycobacterium tuberculosis (H37Rv) by aerosol. Five drugs were divided into high, middle and low dose groups. After 4 and 8 weeks of treatment, the mice were dissected and the colony forming unit (CFU) of spleens and lungs were counted. At the same time, the lungs and spleens homogenate were inoculated on the plate containing 4×minimum inhibitory concentration (MIC) to observe the colony growth. Three hours after the last dose was given to each group, the orbital blood was collected and the drug concentration were determined by HPLC-MS/MS. Results The lowest effective dose of each drug was PA-824 30 mg/kg, Dlm 5 mg/kg, Cfz 5 mg/kg, Bdq 6.25 mg/kg, PBTZ-169 20 mg/kg, which obtained according to the significant difference of lung CFU count between treatment and control groups. From the lowest effective dose, the CFU counts in the lungs of mice were decreased in all treatment groups. At the high-dose of Bdq and PA-824, the CFU counts in the lungs of mice decreased by 2.99 and 2.66 log₁₀ values respectively. At 8 weeks, the plasma concentrations (C_3h) of each drug at the lowest effective dose were PA-824 (7.60±1.28) μg/ml, Dlm (0.20±0.05) μg/ml, Cfz (0.26±0.02) μg/ml, Bdq (0.22±0.07) μg/ml, PBTZ-169 (74.56±17.80) ng/ml, respectively. At high dose, when C_max/MIC was higher than the specific value (PA-824 100 mg/kg, C_max/MIC>147; Dlm 10 mg/kg, C_max/MIC>100; Cfz 20 mg/kg, C_max/MIC>2; Bdq 25 mg/kg, C_max/MIC>13.6; PBTZ-169 20 mg/kg, C_max/MIC>150), drug tolerance/phenotypic resistance was not easy to occur. Conclusion At the effective dose of the five anti-tuberculosis durgs, the plasma concentration increased with the increase of the dosage, but the CFU count was negatively correlated with the dosage. Our study showed that C_max/MIC was a good PK/PD parameter correlation with treatment effect, which could provide guidance for the clinical use of these drugs.

Meta-analysis on the diagnostic value of metagenomic next-generation sequencing on cerebrospinal fluid for detecting tuberculous meningitis

CHEN Wen, YAO Li, CHEN Kang, DAI Xi-yong

Chinese Journal of Antituberculosis. 2021, 43(10):  1066-1072.  doi:10.3969/j.issn.1000-6621.2021.10.016

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Objective To evaluate the diagnostic value of metagenomic next-generation sequencing (mNGS) on cerebrospinal fluid for detecting tuberculous meningitis (TBM). Methods Literature on diagnosing TBM by mNGS assay on cerebrospinal fluid were collected by searching PubMed, Embase, Cochrane Library, CNKI, WanFang and VIP databases, enrolling literature recorded from database establishment to April 30, 2021.Both Chinese and English key words were “metagenomic next-generation sequencing”“mNGS”“next-generation sequencing”“tuberculosis”“tuberculosis meningitis” and “tuberculous meningitis”. Then two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted data and assessed the quality of included studies. MetaDisc 1.4 were used to conduct meta-analysis. Results Six hundred and twenty-eight articles were retrieved, and 7 articles were finally included according to the inclusion and exclusion criteria, involving 477 cases among whom 231 cases were diagnosed as TBM patients. Meta analysis showed that the pooled sensitivity and specificity of mNGS on cerebrospinal fluid in the diagnosis of TBM were 62.0% (95.0%CI: 55.0%-68.0%) and 97.0% (95.0%CI: 94.0%-99.0%), while the pooled positive likelihood ratio, negative likelihood ratio and diagnostic odds ratio were 10.57 (95%CI:4.84-23.11), 0.41 (95%CI:0.27-0.60), 21.39 (95%CI:10.18-44.95) respectively. The pooled area under the curve of receiver operating characteristic was 0.956. Conclusion mNGS on cerebrospinal fluid plays a valuable role in the diagnosis of TBM and can be used as an effective method for rapid diagnosis.

Diagnostic value of immunological test combined with sputum smear and sputum culture in clinical diagnosis of active pulmonary tuberculosis

TIAN Li-li, YANG Xin-yu, DAI Xiao-wei, CHEN Shuang-shuang, ZHAO Yan-feng, WANG Nen-han, ZHANG Jie, YI Jun-li, REN Yi-xuan, CHEN Hao, FAN Rui-fang, SHI Wei-xian, WU Wen-qing, HUANG Chun, DING Bei-chuan

Chinese Journal of Antituberculosis. 2021, 43(10):  1073-1078.  doi:10.3969/j.issn.1000-6621.2021.10.017

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Objective To analyze the diagnostic value of combining tuberculosis infection T cell spot test (T-SPOT.TB), tuberculosis antibody,sputum smear and culture tests in detecting active pulmonary tuberculosis. Methods A total of 715 cases with suspected active pulmonary tuberculosis admitted to Beijing Tuberculosis Control Institute from January 2014 to December 2019 were examined, and 412 cases of active pulmonary tuberculosis (TB group) and 303 cases of non-tuberculosis patients (non-TB group) were finally diagnosed. All of them were tested with T-SPOT.TB, tuberculosis antibody, sputum smear and culture tests, to analyze the diagnostic performance of single test and combined tests with those four methods. Results In the TB group, the positive rate of T-SPOT.TB was 83.7% (345/412), while in the non-TB group, it was 20.8% (63/303). The difference was statistically significant (χ²=2.823, P=0.000). The sensitivity, specificity, positive and negative predictive value and accuracy of T-SPOT.TB were 83.7% (345/412), 79.2% (240/303), 84.6% (345/408),78.2% (240/307) and 81.8% ((345+240)/715), respectively, while for combining four methods, they were 93.7% (386/412), 50.8% (154/303), 72.1% (386/535), 85.6% (154/180) and 75.5% ((386+154)/715), respectively. The area under ROC curve (AUC) of T-SPOT.TB, tuberculosis antibody, sputum smear and culture tests were 0.815, 0.575, 0.593 and 0.715, respectively, and the AUC of combining those four tests was 0.894. Conclusion The sensitivity and negative predictive value of T-SPOT.TB test are high, T-SPOT.TB combined with tuberculosis antibody and traditional sputum smear, culture tests has better sensitivity and AUC. Combined tests can improve the efficiency for diagnosing pulmonary tuberculosis.

Analysis of pyrazinamide resistance and pncA mutation in 125 multidrug-resistant Mycobacterium tuberculosis isolates

ZHAO Yong, LIN Shu-fang, LIN Jian, DAI Zhi-song, WEI Shu-zhen

Chinese Journal of Antituberculosis. 2021, 43(10):  1079-1083.  doi:10.3969/j.issn.1000-6621.2021.10.018

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Objective To investigate the pyrazinamide (PZA) resistance of 125 multidrug-resistant (MDR) Mycobacterium tuberculosis isolates and the characteristics of mutation in pncA gene, to provide references for the rapid diagnosis of PZA resistance. Methods A total of 125 MDR strains were simple randomly selected from 9 drug-resistant surveillance sites in Fujian, 2010—2019. The PZA susceptibility was tested using the MGIT 960 system, and the pncA target gene was amplified by PCR to analyze the resistance of MDR strains to PZA and the mutation of pncA gene. Results A total of 50 MDR strains were resistant to PZA, and the PZA resistance rate was 40.0% (50/125). There was no statistical difference of the PZA resistance rate between the male (39.0% (37/95)) and the female (43.3% (13/30);χ²=0.183, P=0.669). The PZA resistant rates in the age-group of 15-25, 26-45, 46-60 and 61-80 years were 58.3% (7/12), 32.7% (16/49), 39.5% (17/43)and 47.6% (10/21), respectively, the difference was no statistically significant (χ²=3.294, P=0.348). There was no statistical difference of the PZA resistance rates between the new cases (41.5% (21/65)) and the retreatment cases (38.3% (23/60);χ²=0.134, P=0.715). The mutation of pncA gene was found in 30 PZA resistant MDR strains, and the types of mutations was 22. The mutation rate of pncA gene in PZA resistant MDR strain was 60.0% (30/50), which was significantly higher than that of the PZA sensitive strains (5.3% (4/75), χ²=45.276, P=0.000). Conclusion The PZA resistance rate of MDR Mycobacterium tuberculosis is high in Fujian, and the mutation of pncA gene is also high, attention should be paid to the drug resistance of PZA in clinic.

Evaluation of clinical application of automatic acid-fast staining microscopic scanning system

DING Bei-chuan, ZHOU Fu, YANG Xin-yu, MENG Xian-jie, YI Jun-li, YE Jian-miao, WU Wen-qing

Chinese Journal of Antituberculosis. 2021, 43(10):  1084-1088.  doi:10.3969/j.issn.1000-6621.2021.10.019

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Objective To evaluate the application value of the automatic acid-fast staining microscopic scanning system (AFB-AS) in detecting sputum specimens of pulmonary tuberculosis patients. Methods A total of 462 pulmonary tuberculosis patients diagnosed at the Beijing Tuberculosis Control Institute from January to August 2019 were collected. Each patient retained 3 newly diagnosed sputum samples (n_total=1386). All specimens were stained by Ziehl-Neelsen (ZN) and double-blindly tested by traditional acid-fast bacillus staining microscopy and AFB-AS inspection; 2 sputum samples from each patient were selected for mycobacterial isolation and culture, a total of 924 were completed; the other one of sputum samples was tested by GeneXpert MTB/RIF (Xpert) simultaneously, and a total of 462 samples were completed. The results of different methods for detecting sputum specimens of pulmonary tuberculosis patients were compared. The efficacy of traditional acid-fast bacillus staining microscopy and AFB-AS for detecting sputum specimens of pulmonary tuberculosis patients was analyzed based on the results of mycobacterial isolation and culture, so was the level correlation between the traditional acid-fast bacillus staining microscopic examination and AFB-AS test for positive results. Results The positive rates of sputum specimens of pulmonary tuberculosis patients detected by various methods, from high to low, were Xpert (69.26%, 320/462), mycobacterial isolation and culture (43.61%, 403/924), AFB-AS (43.22%, 599/1386) and traditional acid-fast bacilli staining microscopic examination (38.24%, 530/1386). The positive rate of sputum specimens detected by AFB-AS was significantly higher than that by traditional acid-fast bacilli staining microscopy (χ²=67.015, P<0.01). The correlation coefficient between AFB-AS and traditional acid-fast bacilli staining microscopy to judge the positive result level was 0.954. Taking the results of mycobacterial isolation and culture as the reference, the sensitivity, specificity, positive predictive value and negative predictive value of AFB-AS were 94.29% (380/403), 90.40% (471/521), 88.37% (380/430) and 95.34% (471/494), respectively, and the Kappa value was 0.841. Conclusion AFB-AS has good application value in detecting sputum specimens of pulmonary tuberculosis patients. The inspection performance can meet the requirements of the project of monitoring acid-fast bacilli by Z-N.

Application of diagnostic procedures containing molecular biology detection technology in pulmonary tuberculosis case finding

MA Jian-jun, ZHANG Tie-juan, HOU Wei, PAN Yan, LIU Xin

Chinese Journal of Antituberculosis. 2021, 43(10):  1089-1095.  doi:10.3969/j.issn.1000-6621.2021.10.020

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Objective To analyze the effect of the diagnosis process with molecular biology detection technology on the pulmonary tuberculosis case finding after the third phase of the “China National Health and Family Planning Commission-Bill and Melinda Gates Foundation Tuberculosis Prevention and Control Cooperation Project” (referred to as the “China-Gates Project Phase Ⅲ”) ending in Jilin Province. Methods Data of Mycobacterium tuberculosis detection and its drug resistance by using diagnostic process containing molecular biology detection technology in persons with suspected tuberculosis symptoms registered in all designated tuberculosis medical institutions in Jilin Province in 2019 were retrospectively collected and analyzed after finishing the third phase of the China-Gates Project. Results A total of 10278 (18.36%) suspected active pulmonary tuberculosis patients were identified by the molecular biology testing process among 55983 persons with suspected pulmonary tuberculosis symptoms, of which 3895 were smear positive and 6383 were smear negative. The proportion of Mycobacterium tuberculosis tested by using molecular biology technology was 98.35% (8885/9034), with detection rate being 54.25% (4820/8885). Among them, the proportion of Mycobacterium tuberculosis detected in smear-negative patients and the detection rate were 97.67% (6234/6383) and 35.15% (2191/6234), respectively, and another 13 tuberculosis patients were culture-positive. A total of 6099 pathogenic positive tuberculosis patients were identified, with a pathogenic positive rate of 59.34% (6099/10278), and all received molecular biology rapid drug-resistance testing. Detection rates of rifampicin resistance and multidrug resistance were 17.02% (1038/6099) and 6.48% (395/6099) among all pathogenic positive tuberculosis patients. In initial and retreated tuberculosis patients, rifampicin resistant rates were 11.37% (594/5222) and 50.63% (444/877), and multidrug resistant rates were 4.00% (209/5222) and 21.21% (186/877), respectively. Conclusion The third phase of the China-Gates Project in Jilin Province comprehensively promoted the new diagnostic process containing molecular biology technology, which significantly increased the pathogenic positive rate of suspected pulmonary tuberculosis patients and the detection level of rifampicin-resistant patients.

Review Articles

Progress of local drug therapy in tracheobronchial tuberculosis

LI Ying, CAO Yi-rui, TAO Hong-zhu, YUAN Hao, YU Yu-juan

Chinese Journal of Antituberculosis. 2021, 43(10):  1096-1101.  doi:10.3969/j.issn.1000-6621.2021.10.021

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The tracheobronchial tuberculosis (TBTB) lacks typical and clinical presentation, and misdiagnosis is common. In recent years,with the development of bronchoscopy and bronchial intervention technology, the detection rate of TBTB has increased significantly. Besides systemic antituberculosis therapy, there are more and more treatment methods, such as local drug therapy in airway, balloon dilatation, cryotherapy, thermal ablation and stent placement. However, there is no uniform and normative guideline at present. In order to provide a rapid and effective combination scheme for the local treatment of TBTB, the author summarizes the local antituberculosis treatment of TBTB, the common methods to prevent airway stenosis and the local medication strategies of multidrug-resistant TBTB, as well as the research progress of new local medication methods and new inhalation drugs.

Short Articles

Application of GeneXpert MTB/RIF combined with linear probe detection technology in the diagnosis of drug-resistant tuberculosis

LI Jing, YU Chen-lei, ZHANG Yang-yi, WANG Li-li, SHEN Xu-hui, CHEN Wei, JIANG Yuan

Chinese Journal of Antituberculosis. 2021, 43(10):  1102-1106.  doi:10.3969/j.issn.1000-6621.2021.10.022

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Between December 2017 and December 2018, a total of 3903 sputum samples from suspected primary tuberculosis patients from 19 designated tuberculosis hospitals in Shanghai were simultaneously tested by sputum smear, BACTEC MGIT 960 liquid culture (liquid culture) and GeneXpert MTB/RIF (GeneXpert) assay, to compare the efficacy of GeneXpert in detecting Mycobacterium tuberculosis. Of the clinical strain from tuberculosis patients diagnosed in the same period, 707 were tested for rifampicin resistance using linear probe assays (LPA). If the results were inconsistent with those of GeneXpert, the sputum samples were then re-tested with the minimum inhibitory concentration (MIC) for culture-positive strains and GeneXpert. The consistency between the rifampicin resistance detected by GeneXpert in sputum samples of the same patient and the rifampicin resistance detected by LPA in culture positive strains were compared. The positive detection rates of sputum smear, liquid culture and GeneXpert were 19.63% (766/3903), 25.93% (1012/3903) and 25.16% (982/3903), respectively. The positive detection rate of GeneXpert was significantly higher than that of sputum smear (χ²=34.390, P<0.001), but lower than that of liquid culture (χ²=0.610, P=0.436). Take liquid culture results (MTB positive) as the standard, the sensitivity and specificity were 81.23% (822/1012) and 94.47% (2731/2891) of the GeneXpert assay, and 64.92% (657/1012) and 96.23% (2782/2891) of sputum smear. GeneXpert was used to detect rifampicin resistance in sputum samples, and LPA was used to detect rifampicin resistance in cultured positive strains of the same patient. The coincidence rate of the two molecular detection techniques was 98.30% (695/707). The coincidence rate of GeneXpert and LPA in detecting rifampicin resistance was high, however, there still might be missed detection or over diagnosis. If the results were inconsistent, other test methods should be used to provide laboratory basis for accurate diagnosis.