Table of Content

10 April 2020, Volume 42 Issue 4

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Expert Consensus

Expert consensus on a standard of activity judgment of pulmonary tuberculosis and its clinical implementation

Clinical Research Center for Infectious Disease, the Third People’s Hospital of Shenzhen, Editorial Board of Chinese Journal of Antituberculosis National

Chinese Journal of Antituberculosis. 2020, 42(4):  301-307.  doi:10.3969/j.issn.1000-6621.2020.04.001

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The epidemic situation of pulmonary tuberculosis in China is challenging. Pathogenic test of Mycobacterium tuberculosis is the “golden indicator” for the diagnosis of pulmonary tuberculosis, but the activity judgment becomes difficult when the etiological examination is negative. In addition, evaluation of activity of pulmonary tuberculosis post-treatment also encounters the pathogenic problem. This expert consensus introduces the current evaluation methods for activity judgment of pulmonary tuberculosis, and sets standards of clinical comprehensive evaluation of activity. Meanwhile, it points out the existing problems of activity judgment and its clinical implementation and discusses its future development.

Expert Forum

Revelation of novel coronavirus pneumonia epidemic prevention and control mechanism to tuberculosis prevention and control

XIAO He-ping,LIU Yi-dian

Chinese Journal of Antituberculosis. 2020, 42(4):  311-315.  doi:10.3969/j.issn.1000-6621.2020.04.003

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The positive measures taken in China have played a huge role in the control of the novel coronavirus pneumonia outbreak, and have achieved phasic results. Study the measures of prevention and treatment of novel coronavirus pneumonia and to learn from experience is of great significance to improve the status of TB prevention and control, and to promote and improve the current TB prevention and control measures in China. It will accelerate the realization of the grand goal of ending the tuberculosis epidemic.

Special Articles

Scientific preventive treatment to accelerate the process of tuberculosis control

LU Peng,CHENG Jun,LU Xi-wei,LIU Er-yong,ZHOU Lin,LU Wei

Chinese Journal of Antituberculosis. 2020, 42(4):  316-321.  doi:10.3969/j.issn.1000-6621.2020.04.004

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World Health Organization (WHO) have set a grand goal of eliminating tuberculosis (TB) by 2035, however, it is unrealistic to achieve this only relying on the measure of early detection and cure TB patients. Measures such as cutting off transmission routes and protecting susceptible populations are particularly important. There are a large number of people in China who are potentially infected with TB, and it is impossible for all the people to receive the preventive treatment. WHO has recommended people to identify at-risk populations for latent tuberculosis infection testing and treatment, but considering China’s national conditions, WHO’s recommendations are not entirely applicable to China. Therefore, it is of great significance to identify high TB risk population scientifically among people infected with Mycobacterium tuberculosis in our country and carry out preventive treatment.

Original Articles

Epidemiological characteristics of newly reported pulmonary tuberculosis from 2008 to 2018 in Guangzhou

SHEN Hong-cheng,DU Yu-hua,WU Gui-feng,LEI Yu,LI Tie-gang,LIU Jian-xiong

Chinese Journal of Antituberculosis. 2020, 42(4):  322-326.  doi:10.3969/j.issn.1000-6621.2020.04.005

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Objective To understand the trend and epidemiological characteristics of newly reported pulmonary tuberculosis (PTB) cases in Guangzhou from 2008 to 2018. Methods Totally, 144473 information of newly reported PTB cases were collected from “China Information System for Disease Control and Prevention” from 2008 to 2018 in Guangzhou, including gender, age, occupation, regional distribution and pathogen classification. The annual and district resident population data of Guangzhou from 2008 to 2018 was derived from Guangzhou statistical yearbook. Descriptive analysis was conducted on the epidemiological characteristics of newly reported PTB in Guangzhou from 2008 to 2018. Results A total of 144473 PTB cases were newly reported from 2008 to 2018 in Guangzhou with an average annual newly reported incidence rate of 100.14/100000. The newly reported incidence declined from 148.44/100000 (16556/11153400) in 2008 to 67.58/100000 (10072/14904400) in 2018, which showed significant statistical difference ( {\chi }_{\mathrm{trend}}^2 =6849.75, P<0.05). Among the newly reported PTB cases in Guangzhou from 2008 to 2018, the male average annual newly reported incidence was 135.65/100000 (100003/73722700) with an annual decline rate of 7.56%, whereas the female average annual newly reported incidence was 63.04/100000 (44470/70547300) with an annual decline rate of 7.38%, which showed significant statistical difference (χ ²=18999.59, P<0.05). The 25- years old group reported the most cases in each age group, accounting for 23.88% (34505/144473). House worker and unemployed population were the most common occupations of all the newly reported cases, accounting for 23.82% (34416/144473) of the total cases. The newly reported incidence of smear positive PTB declined year by year, from 41.31/100000 (4608/11153400) in 2008 to 23.14/100000 (3449/14904400) in 2018. Conclusion Newly reported PTB cases in Guangzhou shows a decreasing trend year by year. It is necessary to strengthen the prevention and control of tuberculosis among male, young adults, house worker and unemployed population.

Analysis of spatial distribution characteristics of tuberculosis in Guangzhou from 2014 to 2018

LAI Keng,WU Gui-feng,LEI Yu,XIE Wei,WANG Ting,ZHONG Min-er,DU Yu-hua

Chinese Journal of Antituberculosis. 2020, 42(4):  327-334.  doi:10.3969/j.issn.1000-6621.2020.04.006

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Objective To analyze the spatial distribution characteristics of tuberculosis (TB) at the street/township level in Guangzhou from 2014 to 2018. Methods The information of 54213 TB patients who reported on the TB infectious disease report card in Guangzhou City from 2014 to 2018 was collected through “China Disease Prevention and Control Information System and Infective Diseases Management Information System”. Based on the street/township level, the spatial distribution map was drawn, and then the trend analysis as well as the global and local spatial autocorrelation analysis were conducted to explore the spatial distribution pattern and hot areas of TB. Results The average annual reported incidence rate of TB was 79.87/100000 (54213/67876663) in Guangzhou from 2014 to 2018. The three-dimensional trend analysis chart showed that the average annual reported incidence of TB in Guangzhou from 2014 to 2018 gradually decreased from the west to the east, and showed a weak “n” shape in the north-south distribution, that was, high in the middle and low in the north and south. At the street/township level, the overall incidence of TB in Guangzhou from 2014 to 2018 showed spatial clustering. The values of Moran’s I were 0.093, 0.275, 0.137, 0.091 and 0.107, respectively, and Z values were 2.028, 5.879, 2.949, 2.156 and 2.619, respectively, with P values of 0.034, 0.001, 0.008, 0.027, and 0.005, respectively. General Getis-Ord G index was 0.006, Z value was 2.632, and P value was 0.008, which suggested that the spatial distribution of the annual reported incidence of TB in Guangzhou presented a “high-high” clustering. According to the local spatial autocorrelation index aggregation map, the high-high clusters included 7 streets as follows: Zhuguang, Hongqiao, Datang and Beijing Streets in Yuexiu District, Zhuji, Xintang and Chebei Streets in Tianhe District. Partial hot/cold spot analysis showed that there were 29 hotspot streets, mainly concentrated in Tianhe and Yuexiu Districts. Conclusion Incidence rates of TB displayed spatial clustering at the street/township level in Guangzhou during 2014 to 2018, with the overall performance of “high-high” clustering pattern, and the incidence hotspots were mainly concentrated in Tianhe and Yuexiu Districts.

Evaluation of effectiveness of applying Mobile integrated management system in school TB prevention and control

WENG Jian-feng,PENG Jian-ming,LIU Zhi-dong,ZHAN Mei-quan,LI Xiao-fen,CHEN Wen-jie

Chinese Journal of Antituberculosis. 2020, 42(4):  335-338.  doi:10.3969/j.issn.1000-6621.2020.04.007

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Objective To evaluate effectiveness of using Mobile integrated management system (referred to as “integrated system”) in school tuberculosis prevention and control, so as to provide scientific evidence for upgrading the integrated system in the future. Methods Data from TB patient registration book, national TB information management system and integrated system in Huizhou City from 2018 to 2019 were extracted, 1462 schools were investigated. Before the integrated system were used(2018), 220 suspected cases of TB and 114 confirmed cases of TB were found, while after using the system(2019), 198 suspected cases and 116 confirmed cases were detected. Thus, we analyzed effectiveness of the system by conducting before and after study. χ ² test was used to compare various “rates” before and after the implementation of the integrated system, with a statistical significance of 0.05. Results The accuracy rate of information for referring suspected tuberculosis patients in schools before using the integrated system was 83.2% (183/220), lower than 97.0% (192/198) after using the integrated system (χ ²=21.446, P<0.01); the rate of prompt information exchange (within 1 hour) before using the integrated system was 58.2% (128/220), which was lower than 98.0% (194/198) after using the integrated system (χ ²=93.295, P<0.01); the tracking rate of suspected TB patients before using the integrated system was 70.9% (156/220), which was lower than 97.0% (192/198) after using the integrated system (χ ²=50.764, P<0.01); Before using the integrated system, the accuracy rate of school TB management notice which were pushed from CDC to school was 86.0% (98/114), lower than 99.1% (115/116) after using the integrated system (χ ²=14.576, P<0.01); the rate of prompt information exchange (within 1 hour) for those management notice before using the integrated system was 57.0% (65/114), lower than 98.3% (114/116) after using the integrated system (χ ²=56.714, P<0.01); the rate of prompt information exchange (within 1 hour) for notice of suspension(resuming) of schooling before using the integrated system was 57.9% (66/114), lower than 99.1% (115/116) after using the integrated system (χ ²=58.334, P<0.01); the school coverage rate of verifying the student status before using the integrated system was 86.0% (1257/1462), which was lower than 99.0% (1447/1462) after using the integrated system (χ ²=177.442, P<0.01). Conclusion After using the integrated system, the performance of referral and tracking of suspected patients in campus, treatment management of students with pulmonary tuberculosis, management of suspension(resuming) of schooling, and coverage of schools which could verify student status and identity are better than before. The effect is obvious.

Prevalence and influencing factors of rifampicin resistance among high-risk group of drug-resistant tuberculosis in Fujian Province

ZHOU Yin-fa,ZHANG Shan-ying,DAI Zhi-song,CHEN Dai-quan,LI Wei-lin,ZHAO Yong,LIN Shu-fang

Chinese Journal of Antituberculosis. 2020, 42(4):  339-344.  doi:10.3969/j.issn.1000-6621.2020.04.008

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Objective To understand the prevalence and influencing factors of rifampicin resistance (RR) in high-risk group of drug-resistant tuberculosis (TB) in Fujian Province and to provide references for the development of appropriate TB control strategies. Methods The information of 650 high-risk group of drug resistant TB registered in Fujian in 2018 was collected from the TB management information system of the Chinese Center for Disease Control and Prevention, including rifampicin resistance, age, gender, ethnicity, occupation, household registration, and registration classification. The prevalence of rifampicin resistance in high-risk group of drug-resistant TB was analyzed, and the influencing factors of RR in high-risk group were analyzed by univariate and multivariate logistic regression. Results Among 650 high-risk group of drug resistant TB, there were 143 cases of RR-TB, with a drug resistance rate of 22.0%. Univariate analysis showed that the RR rates of the high-risk groups with aged ≥65, male, local resident, occupation as migrant worker and registration classification as other were significantly lower than those with aged <25 (12.2% (22/180) <46.2% (12/26), χ ²=21.57, P<0.05), female (20.1% (109/541) <31.2% (34/109), χ ²=6.45, P<0.05), foreign household registration (17.8% (81/455) <31.8% (62/195), χ ²=15.58, P<0.05), occupation as housekeeping/housework/unemployed workers (18.4% (78/425) <33.6% (42/125), χ ²=13.15, P<0.05) and registration classification as retreatment failure/chronic patients (6.2% (1/16) <77.8% (7/9), χ ²=54.80, P<0.05), respectively. Multivariate logistic regression analysis showed that the risk of RR in the high-risk group with aged 25-34 and ≥65 (referenced as aged <25, OR (95%CI) were 0.32 (0.11-0.95), 0.24 (0.09-0.65)) was lower, while the risks of RR in the high-risk group with foreign household registration (referenced as local resident, OR (95%CI)=1.87 (1.19-2.93)), occupation as housekeeping/housework/unemployed workers (referenced as migrant worker, OR (95%CI)=2.01 (1.21-3.34)), and registration classification’s relapse, initial treatment failure and retreatment failure/chronic patients (referenced as other, OR (95%CI) were 10.90 (1.34-88.68), 23.69 (2.67-209.87) and 133.89 (9.50-1887.37)) were higher. Conclusion The RR rate in high-risk group of drug-resistant TB was high in Fujian. Aged <25, foreign household registration, occupation as housekeeping/housework/unemployed workers, and registration classification as relapse, initial treatment failure and retreatment failure/chronic patients were risk factors of RR in high-risk group of drug resistant TB.

The characteristics and analysis of influencing factors of tuberculosis registered dead patients in Songjiang City, Shanghai

QIN Nan,XU Chun-ze,GUAN Ying,LU Li-ping,WANG Wei-bing,JIANG Yong-gen

Chinese Journal of Antituberculosis. 2020, 42(4):  345-352.  doi:10.3969/j.issn.1000-6621.2020.04.009

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Objective To explore the risk factors of death in tuberculosis patients and to provide a scientific reference for reducing the mortality of tuberculosis patients. Methods According to the Tuberculosis Information Management System of Chinese Center for Disease Control and Prevention, 782 patients with active tuberculosis were registered and diagnosed in Songjiang District of Shanghai from January 1, 2004 to December 31, 2008. A total of 765 patients were included in the study, excluding rural areas, floating population and patients who lost their visits. The end point of this study was June 1, 2019, with an average follow-up time of (9.7±3.2) years. A retrospective cohort study was used to collect basic demographic information, survival time and survival status of patients. Risk factors of all-cause death of tuberculosis patients and TB-caused deaths were analyzed by Cox proportional hazard regression model. P<0.05 was considered statistically significant. Results From 2004 to 2008, 32 cases died of tuberculosis, with a mortality rate of 4.2%. Two hundred and thirty-three cases died of all causes, with a mortality rate of 30.5%. The mortality rate of all causes and TB-caused deaths in the first year after diagnosis were the highest ( {\chi }_{\mathrm{trend}}^2 =20.16 and 3.00,respectively, P values were all <0.05). Cox multivariate analysis showed that the risk factors of patients who died from all causes of death were male (aHR=0.12, 95%CI=0.03-0.77), 41-60 years old group (aHR=1.52, 95%CI=1.23-1.88), ≥61 years old group (aHR=1.60, 95%CI=1.37-1.73), lung cavity (aHR=2.12, 95%CI=1.57-2.83), sputum smear positive (aHR=1.76, 95%CI=1.52-1.91) and other underlying diseases (diabetes: aHR=1.35,95%CI=1.26-1.47;tumor: aHR=1.78,95%CI=1.48-1.96). The risk factors of death due to tuberculosis included age which over 61 years old (aHR=1.34, 95%CI=0.08-1.85), lung cavity (aHR=2.95, 95%CI=1.26-6.71), retreatment (aHR=1.43, 95%CI=0.18-1.85), sputum smear positive (aHR=1.17, 95%CI=0.48-2.15), multidrug-resistant tuberculosis (aHR=1.20, 95%CI=1.01-1.56), and other underlying diseases (diabetes: aHR=1.23, 95%CI=1.04-1.25; tumor: aHR=13.72, 95%CI=1.78-95.75). Conclusion Medical and health institutions should pay attention to the influence factors such as age over 40 years old, male, lung cavity, sputum smear positive, diabetes and tumor on all causes of death in patients with tuberculosis, and age over 61 years old, lung cavity, retreatment, sputum smear positive, MDR-TB, diabetes and tumor on death due to tuberculosis. Special attention should be paid to the treatment after the first year of diagnosis to reduce the risk of death.

Analysis on the effect of active screening of tuberculosis among local people aged 65 or older in Songjiang District of Shanghai in 2018

LI Jin,GUO Xiao-qin,LI Yong,ZOU Jin-yan,LU Li-ping

Chinese Journal of Antituberculosis. 2020, 42(4):  353-359.  doi:10.3969/j.issn.1000-6621.2020.04.010

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Objective To analyze the effect of active screening of tuberculosis (TB) among local people aged 65 or older in Songjiang District of Shanghai, and provide scientific basis for active detection strategies for the elderly TB patients in a low epidemic area. Methods The current status of active screening of TB in local elderly aged 65 or older were collected from physical examination data of local elderly aged 65 or older via the health management platform between April 1st and August 31st 2018 performed in 15 community health service centers. The medical record information of all local elderly aged 65 or older with active TB who registered from January 1st 2018 to August 31st 2019 were collected from Tuberculosis Information Management System and Infectious Diseases Reporting Information Management System, and then compared with the data of active screening this year to acquire the morbidity of TB within one year after screening. Moreover, the effect of active screening for TB among elderly population was evaluated by screening rate and detection rate. Results A total of 129008 local elderly aged 65 or older were registered in 2018 in Songjiang District. The total screening rate for active screening of TB in the elderly was 57.48% (74150/129008), with the highest screening rate in the 70-74 age group (65.51% (21446/32736)), and the lowest screening rate in the ≥85 age group (22.61% (3074/13596)). The rate of conducting X-ray screening was 98.31% (72899/74150), of which 5050 had chest X-ray abnormalities (6.93%, 5050/72899), including 3 cases diagnosed as new TB with the new detection rate of 4.12/100000 (3/72899), 3 registered TB patients under treatment, 524 cases (0.72%, 524/72899) with old TB, and 4520 cases (6.20%, 4520/72899) diagnosed as other abnormalities, such as pulmonary nodule, pulmonary infection, pleural thickening, patchy shadow and so on. A total of 57 local TB elderly aged 65 or older were registered in Songjiang in 2018, with the registration rate of 44.18/100000 (57/129008), among which, the patients over 85 years old had the highest registration rate (73.55/100000 (10/13596)); the passive discovery rate was significantly higher than active detection rate (41.86/100000 (54/129008) vs. 4.12/100000, χ²=24.00, P<0.001); the morbidity of patients who received active screening (21.58/100000 (16/74150)) was significantly lower than that of unscreened patients (74.74/100000 (41/54858)) (χ²=20.16, P<0.001). And 32 elderly cases who received active screening were diagnosed with active TB within a year after screening (13 of them registered in 2018 and 19 registered in 2019). Conclusion The detection rate of active screening for TB in the elderly is low in low epidemic area, but it has clinical significance for screening chest abnormalities. In addition, it can improve the awareness of diagnosis and treatment of TB in elderly people, and they will more timely receive diagnosis and treatment. TB screening can be carried out in combination with the project of elderly chronic disease management.

Analysis of influencing factors of Mycobacterium tuberculosis infection in HIV/AIDS patients

ZHANG Xing,WANG Feng-ming,LYU Xu-feng,HUA Tian-qi,ZHANG Xue-jun,JIANG Jing-yi,DING Chen-li,ZHU Wei,XIA Guo-dong,JI Jun-min,ZHAO Fei

Chinese Journal of Antituberculosis. 2020, 42(4):  360-365.  doi:10.3969/j.issn.1000-6621.2020.04.011

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Objective To analyze the MTB infection and its influencing factors in HIV/AIDS patients. Methods From January to July 2017, 3 community hospitals were selected by a random cluster sampling method in Changzhou, in which HIV/AIDS patients by the 10-year cumulative registration were used as the research subjects. As a result, a total of 475 subjects were included, with an average age (44.44±13.85) years, including 378 males (79.58%) and 97 females (20.42%); 273 HIV-infected patients (57.47%) and 202 AIDS patients (42.53%). The sociodemographic information and clinically relevant information of the subjects were collected. Peripheral venous blood from subjects was tested for HIV viral load, then the subjects with CD4 ⁺ T cell counts>200 cells/μl were selected for MTB infection detection using QuantiFERON ^®-TB Gold (QFT). The MTB infection status of the subjects was analyzed and influencing factors of MTB infection were analyzed by multivariate non-conditional logistic regression. Results There were 429 subjects with CD4 ⁺ T cell counts>200 cells/μl, and the MTB infection rate was 10.02% (43/429). Univariate analysis showed that the MTB infection rate of subjects with CD4 ⁺ T cell counts>200 cells/μl who had a history of tuberculosis exposure was higher than that of subjects without history of tuberculosis exposure (30.30%(10/33) vs. 8.33% (33/396); χ ²=16.30, P<0.05); and the MTB infection rate of subjects with CD4 ⁺ T cell counts >500 cells/μl was higher than that of subjects with CD4 ⁺ T cell counts from 200 to 500 cells/μl (13.15% (33/251) vs. 5.62% (10/178); χ ²=6.55, P<0.05). Further unconditional logistic regression analysis showed that among HIV/AIDS patients with CD4 ⁺ T cell counts>200 cells/μl, the risk of MTB infection in the subjects with history of tuberculosis exposure was 4.61 times of subjects without history of tuberculosis exposure (adjusted OR=4.61, 95%CI=2.00-10.63); and the MTB infection risk of HIV/AIDS patients with CD4 ⁺ T cell counts>500 cells/μl was 2.47 times of the HIV/AIDS patients with CD4 ⁺ T cell counts from 200 to 500 cells/μl (adjusted OR=2.47, 95%CI=1.17-5.21). Conclusion The detection rate of MTB infection is low in HIV/AIDS patients with low immune level. The history of tuberculosis exposure and immune level are important influencing factors of MTB infection in HIV/AIDS patients.

Psychological health status of 308 patients with MDR-PTB and its influencing factors

FU Ting,HUANG Li-ju,YANG Jin-jun,ZHUO Yue,XIAO Hua

Chinese Journal of Antituberculosis. 2020, 42(4):  366-371.  doi:10.3969/j.issn.1000-6621.2020.04.012

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Objective The mental health status and its influencing factors of multidrug-resistant pulmonary tuberculosis (MDR-PTB) patients were investigated and analyzed by questionnaire, so as to provide scientific basis for improving the mental health level of patients. Methods From January 2012 to June 2018, 316 MDR-PTB patients admitted to Sanya Central Hospital, Sanya People’s Hospital and Sanya Hospital of Traditional Chinese Medicine were investigated with Symptom Checklist-90 (SCL-90), including 9 factors of somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobia, paranoia and psychosis. Three hundred and sixteen questionnaires were sent out and 308 qualified questionnaires were finally collected, with a qualified rate of 97.5%. Logistic regression analysis were used to analyze the univariate and multivariate variables influencing mental health of MDR-PTB patients. Results Anxiety, depression, paranoia and fear were the most common negative psychology in MDR-PTB patients, accounting for 43.5% (134/308), 40.6% (125/308), 16.9% (52/308) and 9.7% (30/308), respectively. Among 308 MDR-PTB patients, 225 had negative psychology (poor mental health group), 83 had no negative psychology (good mental health group).The total average score of SCL-90 in poor mental health group(1.83±0.68)was higher than that in the good mental health group(1.20±0.26), the difference was statistically significant (t=5.317,P<0.05). Univariate analysis showed that in the group with poor mental health, 61.8% (139/225) were married, 34.2% (77/225) lived alone, 65.3% (147/225) had average or poor sleep quality, 63.6% (143/225) had income less than 30000/year, 61.3% (138/225) had tuberculosis cavities, 57.8% (130/225) had adverse reactions to anti-tuberculosis drugs, 64.0% (144/225) had no improvement in the treatment effect, which compared with (74.7% (62/83), 19.3% (16/83), 45.8% (38/83), 37.3% (31/83), 34.9% (29/83), 74.7% (62/83), 42.2% (35/83)) in the group with good mental health, and the differences were statistically significant (χ ²=4.465,P=0.035;χ ²=6.425,P=0.011;χ ²=9.661,P=0.002;χ ²=16.942,P<0.001;χ ²=17.017,P<0.001;χ ²=7.394,P=0.007;χ ²=11.872,P=0.001). Logistic regression analysis showed that sleep quality was average or poor (OR=2.813, 95%CI: 1.718-6.529,P=0.018), income was less than 30000/year (OR=2.390, 95%CI: 1.604-5.748,P<0.001), tuberculosis cavity (OR=1.975, 95%CI: 1.416-4.530,P=0.037), adverse reactions to antituberculosis drugs (OR=3.517, 95%CI: 2.135-8.762,P=0.024) and no improvement in treatment (OR=6.113, 95%CI: 4.835-16.204,P=0.006) were risk factors affecting mental health of MDR-PTB patients. Conclusion The mental health of MDR-PTB patients is poor, and the risk factors affecting their mental health are average or poor sleep quality, economic income less than 30000/year, tuberculosis cavity, adverse reactions of anti-tuberculosis drugs and no improvement in treatment. Psychological support and care for MDR-PTB patients should be strengthened.

Establishment and application of pharmacodynamics and pharmacokinetics model in vitro

ZHAO Jiao-jie,FU Lei,WANG Bin,ZHANG Lei,HU Ming-hao,LU Yu

Chinese Journal of Antituberculosis. 2020, 42(4):  372-379.  doi:10.3969/j.issn.1000-6621.2020.04.013

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Objective To establish hollow-fiber pharmacodynamic model of tuberculosis(HFM-TB) for the pharmacokinetics/pharmacodynamics (PK/PD) study in vitro, and the method will be used to obtain the isoniazid PK/PD parameters, the HFM-TB provides a tool for the PK/PD study of new drugs in vitro. Methods The hollow fiber system was assembled, and the H37Rv strain in the logarithmic phase of growth was inoculated into the outer comparment of the hollow fiber culture tube at a concentration of 1×10 ⁶ colony forming units (CFU)/ml for a total of 15 ml. The concentration-time distribution of isoniazid in the system were simulated in human patients at doses of 25, 50, 150, 300 and 1200 mg/d, Samples were taken at 0.5, 1, 3.5, 6.5, 9.5,13, 24, 24.5, 25, 27.5, 30.5, 33.5, 37 and 48 h,after administration. The concentrations of isoniazid were determined by high-performance liquid chromatographic (HPLC). The total bacteria load and isoniazid resistance in the system were monitored through the samples taken from the outer compartment of the culture tube daily for 7 days after administration. The PK/PD parameters were calculated by PKSolver plug-in. Results In the HFM-TB, isoniazid showed significant early bactericidal activity on the first day of administration, while the time when the bactericidal effect ceased was 3-5 days after administration. After 7 days of administration, the proportion of drug-resistant TB at the 50-1200 mg/d dose group accounted for ≥39% of all. AUC_0-24/MIC was the best fitting effect of PK/PD parameters for isoniazid. The maximum effect (E_max) was 3.02 CFU/ml, and EC₅₀ reached when AUC_0-24/MIC=52.23, after 2 days of administration. Conclusion The HFM-TB was successfully established in China for the first time. AUC_0-24/MIC is the target PK/PD parameter of isoniazid for H37Rv.

Value of MicroDST test in detecting sensitivity of first-line anti-tuberculosis drugs

YANG Han,YANG Jing-fen,WU Hao,CUI Xiao-li,DANG Li-yun

Chinese Journal of Antituberculosis. 2020, 42(4):  380-384.  doi:10.3969/j.issn.1000-6621.2020.04.014

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Objective To explore the value of Micropore-plate method (Microdrug sensitivity, MicroDST) test in detecting sensitivity of first-line anti-tuberculosis drugs. Methods A total of 1086 specimens cultured positively by the MGIT 960 method were collected from Xi’an Chest Hospital from January to June 2019, and 331 bacterial liquids were selected which were identified as Mycobacterium tuberculosis and were tested for drug snensitivity by MicroDST and MGIT 960 method. Results of the two methods were analyzed and the detection efficiency of was evaluated with the gold standard-MGIT 960 test. Melting curve method were used to verify the resistant genotypes when test results of bacterial liquids were different. Results Based on MGIT 960 test, the sensitivity, specificity and Kappa values of MicroDST for streptomycin, isoniazid, rifampicin and ethambutol were 88.7% (63/71), 100.0% (260/260), 0.93; 93.9% (77/82), 98.8% (246/249), 0.94; 93.8% (45/48), 99.6% (282/283), 0.95; and 66.7% (14/21), 99.0% (307/310), 0.72 respectively. Among the inconsistent results of the four drug resistance tests using the MicroDST method and the MGIT 960 method, there were 10 for streptomycin, 8 for isoniazid, 6 for rifampicin, and 16 for ethambutol. In the 10 specimens (3.0%, 10/331) which were medium sensitive for MicroDST and resistant for MGIT 960 test, drug resistance gene were mutant (2 for streptomycin, 2 for rifampicin, and 6 for ethambutol). Only one specimen (0.3%, 1/331) was medium sensitive for ethambutol in MicroDST and sensitive in MGIT 960 test, the drug resistance gene was mutant. In the 23 specimens (6.9%, 23/331) which were sensitive in MicroDST and resistant in MGIT 960 test, there were 10 specimens which drug resistance gene were wild type (6 for streptomycin and 4 for isoniazid) and 13 specimens which drug resistance gene were mutant (2 for streptomycin, 1 for isoniazid, 3 for rifampicin, and 7 for ethambutol). In the 6 specimens (1.8%, 6/331) which were resistant in MicroDST and sensitive in MGIT 960 test, there were 3 specimens which drug resistance gene were wild type (1 for isoniazid, 1 for rifampicin, and 1 for ethambutol, respectively) and 3 specimen which drug resistance gene were mutant (2 for isoniazid and 1 for ethambutol). Conclusion The MicroDST method is simple and convenient for the detection of first-line anti-tuberculosis drugs. It is highly consistent with the MGIT 960 method and can detect drug resistance at low concentrations, which can provide a reference for clinical drug dosage selection.

Clinical analysis of 11 patients with severe tuberculosis in pregnancy or puerperium

KANG Yi,FU Man-jiao

Chinese Journal of Antituberculosis. 2020, 42(4):  385-390.  doi:10.3969/j.issn.1000-6621.2020.04.015

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Objective To explore the clinical characteristics and treatment outcomes of the patients with severe tuberculosis in pregnancy or puerperium. Methods A retrospective analysis was done among eleven patients who got severe tuberculosis in pregnancy or puerperium (9 cases were in pregnancy while 2 cases were in puerperium) and hospitalized in the Severe Tuberculosis Department of Changsha Central Hospital (Changsha Pulmonary Hospital) from September 2017 to September 2019. The clinical characteristics and the treatment outcomes of those enrolled patients and the situation of infants were analyzed and summarized. Results Two patients were in the early stage of pregnancy and all of them were terminated timely. Four patients were in the mid-term stage of pregnancy, one continued pregnancy and the baby were full-termly delivered; one was terminated timely; one aborted during treatment; and one died (the fetus also died) due to rapid deterioration of her condition. Three patients were in the late stage of pregnancy, one continued pregnancy and the baby were full-termly delivered; the other two continued pregnancy and the babies were prematurely delivered during treatment. Six patients were in puerperium (2 cases delivered before admission and 4 cases delivered after admission) and all of them got treatment and were separated from their newborns. All eleven patients were given active anti-tuberculosis treatment and corresponding supportive treatment, ten of them improved and were discharged from the hospital, one died. Six newborns were delivered successfully in eleven cases, two newborns were full-term while four were premature. All six newborns were not infected tuberculosis and breastfeeding were not given. Conclusion It is extremely harmful to the health of mother and infant when woman gets severe tuberculosis in pregnancy or puerperium. The awareness and understanding to the clinical characteristics of severe tuberculosis in pregnant and puerperal woman should be strengthened. The favorable treatment outcomes can be achieved if proper treatment regimen is given.

Management of latent tuberculosis infection in China: Exploring solutions suitable for high-burden countries. Int J Infect Dis, 2020.

Cui X,Gao L,Cao B

Chinese Journal of Antituberculosis. 2020, 42(4):  390-390.  doi:10.3969/j.issn.1000-6621.2020.04.016

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Original Articles

Disseminated tuberculosis induced by adalimumab in the treatment of ankylosing spondylitis: one case report and literature review

FAN Xin-xin,WU Di,LIN You-fei,CHEN Xiao-hong

Chinese Journal of Antituberculosis. 2020, 42(4):  391-397.  doi:10.3969/j.issn.1000-6621.2020.04.017

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Objective To explore the clinical characteristics, main points of diagnosis and treatment, and treatment outcomes of disseminated tuberculosis induced by the application of adalimumab in the treatment of ankylosing spondylitis. Methods The clinical data, diagnosis and treatment, and follow-up of one patient with disseminated tuberculosis induced by the application of adalimumab in the treatment of ankylosing spondylitis who admitted to Fuzhou Pulmonary Hospital of Fujian Province on June 10, 2019 were retrospectively analyzed, and then literature review was performed. The PubMed database was searched with “adalimumab” and “disseminated tuberculosis” as the key words, and the Chinese literature was searched from Wanfang and China National Knowledge Infrastructure database with the key words of “adalimumab” and “disseminated tuberculosis”. The search period was up to September 2019. After screening and eliminating, a total of 34 related literatures were obtained, including 0 in Chinese and 34 in English. The repeated literatures were deleted, and the reports of disseminated tuberculosis caused by tumor necrosis factor α (TNF-α) other than adalimumab and other disseminated diseases caused by TNF-α were excluded. A total of 8 literatures with detailed case data were selected and a total of 8 patients were obtained. Afterwards, combined with the patients collected in this study, the clinical characteristics, diagnosis and treatment of these 9 cases were analyzed. Results A 28-year-old male received adalimumab treatment due to ankylosing spondylitis, and cough, shortness of breath, abdominal distension and fever occurred 2 months after treatment. After admission, patient was diagnosed with “disseminated tuberculosis (double lung, right bronchus, chest cavity, abdominal cavity, pericardium, mediastinal lymph node, supraclavicular lymph node, abdominal lymph node, pelvic lymph node, and spleen)” by chest CT, pleural biopsy and bronchoscopy. Symptoms of patient was improved after treatment with “3H-R-Z-E/9H-R-E” regimen, supplemented by local inhalation of isoniazid by bronchial nebulizer, and anti-tuberculous drug treatment. At the 5th month of treatment, CT reexamination suggested that lung lesions were reduced, partial lymph node enlargement in the mediastinum was smaller, thickened bronchial tube wall was thinner, lumen was more unobtrusive, and effusion in chest and abdominal cavity was significantly absorbed. As of December 2019, patient was still on regular anti-tuberculous drug treatment. After literature search, 8 patients were obtained, and there were 9 patients after adding this case, including 3 males and 6 females; they aged 9 to 75 years, with an average age of (50.44±25.19) years. Among these 9 patients, 5 cases were negative for tuberculous screening test before beginning treatment with adalimumab, 1 case had a previous history of anti-tuberculous treatment, and 1 case had a history of prophylactic anti-tuberculous treatment, and 3 cases had a history of close contact with tuberculous patients. Five patients had a good outcome after a clear diagnosis and anti-tuberculosis treatment. The outcome was poor in 3 cases, of which 1 continued to progress with gastrointestinal bleeding; 1 continued to develop intracranial lesions; 1 developed acute respiratory distress syndrome and eventually died. One patient had unknown outcome. Conclusion Adalimumab can cause disseminated tuberculosis. Patients who are going to receive adalimumab treatment should be screened for tuberculosis before administration. During treatment, they should be alert to the conversion of latent tuberculosis infection to active tuberculosis and new tuberculosis infection. Discontinuation of adalimumab and timely anti-tuberculosis treatment are the keys to a good prognosis.

Review Articles

Advances in the application of anti-tuberculosis nanoscale drug delivery system targeting macrophages

XIANG Hai-bin,LIANG Qiu-zhen,LI Xin-xia,SONG Xing-hua

Chinese Journal of Antituberculosis. 2020, 42(4):  398-403.  doi:10.3969/j.issn.1000-6621.2020.04.018

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Mycobacterium tuberculosis (MTB) is a facultative intracellular parasite of macrophages, traditional anti-TB therapy have limitations such as long course of treatment, low bio-availability, high systemic toxicity and even may induce drug resistance. As a new method of anti-tuberculous drug administration, the nanoscale drug delivery system can deliver low-cost drugs into macrophages actively or passively to inhibit the replicate or latent MTB. This review explores the active and passive targeting mechanism of anti-tuberculosis nanoscale drug delivery system to macrophages, and advanced materials for assembling nanoscale delivery system. In addition, factors affecting targeted delivery efficiency and challenges are summarized.

Experience Introduction

Measures of hospital operation and patient treatment management under the epidemic of coronavirus disease 2019 in tuberculosis hospital

REN Fei,ZHANG Meng-tao,DANG Li-yun

Chinese Journal of Antituberculosis. 2020, 42(4):  404-405.  doi:10.3969/j.issn.1000-6621.2020.04.019

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After the outbreak of coronavirus disease 2019 (COVID-19), how to carry out medical treatment and management of patients with tuberculosis has become a new issue and challenge. As a designated medical institution of COVID-19 in Shaanxi Province and Xi’an City, Xi’an Chest Hospital has successfully completed the treatment and management of patients with tuberculosis through seven comprehensive measures during the epidemic period. This paper provides management ideas for other tuberculosis prevention and control institutions.