Table of Content

10 December 2021, Volume 43 Issue 12

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Guideline·Standard·Consensus

Expert consensus on the diagnosis and treatment of retreatment pulmonary tuberculosis

Shanghai Clinical Research Center for Infectious Disease (Tuberculosis)/Shanghai Pulmonary Hospital, Tongji University School of Medicine, Beijing Chest Hospital , Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Chinese Antituberculosis Association, Editorial Board of Chinese Journal of Antituberculosis

Chinese Journal of Antituberculosis. 2021, 43(12):  1226-1238.  doi:10.3969/j.issn.1000-6621.2021.12.002

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Retreatment pulmonary tuberculosis is an important part of the national tuberculosis control plan, and it is also a difficult point of tuberculosis control in China. The situation of patients with retreatment pulmonary tuberculosis is complex, and the previous treatment regimen is now outdated, and the classification and diagnosis of retreatment pulmonary tuberculosis should be reassessed. Therefore, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Beijing Chest Hospital, Capital Medical University, Chinese Antituberculosis Association, and Editorial Board of Chinese Journal of Antituberculosis organized domestic experts to repeatedly discuss the classification, diagnosis and treatment of retreatment pulmonary tuberculosis and then formed the “Expert consensus on the diagnosis and treatment of retreatment pulmonary tuberculosis” to standardize the diagnosis and treatment of retreatment pulmonary tuberculosis in China and improve the treatment effect.

Expert advice on anti-novel coronavirus vaccination for tuberculosis patients

Tuberculosis Branch of Chinese Medical Association

Chinese Journal of Antituberculosis. 2021, 43(12):  1239-1242.  doi:10.3969/j.issn.1000-6621.2021.12.003

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The epidemic of Corona Virus Disease 2019 (COVID-19) is still widespread in the world. As an important measure to control the epidemic, the COVID-19 vaccine is being promoted worldwide. Tuberculosis (TB) patients are high risk group to be infected by COVID-19 and suffer severe, therefore, priority vaccinate should be given to them. However, at present, there is not enough evidence of high quality evidence-based medicine for whether TB patients could be vaccinated and how to vaccinated COVID-19 vaccine. Based on WHO recommendations and related technical guidelines in China, as well as combined with the actual situation of TB patients, the Tuberculosis Branch of Chinese Medical Association, put forward the expert advice on vaccination for this special group. It is recommended that all TB patients should be vaccinated except for active TB patients in the course of anti-tuberculosis reinforcement or combined with other unstable chronic diseases.

Expert Note

Interpretation of Four-month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis

HE Xiao-xin, LI Bo, ZHOU Lin

Chinese Journal of Antituberculosis. 2021, 43(12):  1243-1247.  doi:10.3969/j.issn.1000-6621.2021.12.004

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In May 2021, the New England Journal of Medicine published a multi-center, open, randomized controlled non-inferiority phase Ⅲ clinical trial study of the Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis. World Health Organization recommended this chemotherapy regimen to all of the world in June 2021. Upon review and analysis, the clinical trial study was with rigorous and reasonable research design,systematic and comprehensive quality control measures, and the research results were credible. The study results showed that the 4-month anti-tuberculosis chemotherapy regimen was not inferior to the 6-month standard chemotherapy regimen in terms of therapeutic effect, safety and tolerability. The dosage of rifapentine (1200 mg/d) in this regimen is 7-14 times of that recommended by Chinese Pharmacopoeia (600 mg per time for adults, 1-2 times per week). Usage of anti-tuberculosis drugs is one of the important cause of drug-induced liver damage in China. At present, a certain proportion of rifampicin in China does not reach the current recommended dose (600 mg/d), mainly due to medical staff’s concerns about liver injury. Combined with the comprehensive analysis of Chinese Pharmacopoeia regulations, national rifampicin use and influencing factors, this short-course regimen needs to be piloted before it is promoted and applied in China, and relevant professional guidance should be issued.

Original Articles

Evaluation of the effectiveness of community-based pulmonary tuberculosis active case-finding among key populations: a multicenter prospective cohort study

ZHANG Hui, CHENG Jun, YU Yan-ling, SHEN Xin, LU Wei, WANG Xiao-meng, YAO Yu-xia, HOU Shuang-yi, LI Jian-wei, ZHAO Jin-ming, XIA Lan, XU Lin, ZHANG Can-you, ZHAO Fei, XIA Yin-yin, CHEN Hui, WANG Li-xia

Chinese Journal of Antituberculosis. 2021, 43(12):  1248-1259.  doi:10.3969/j.issn.1000-6621.2021.12.005

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Objective To evaluate the implementation effectiveness of community-based pulmonary tuberculosis (PTB) active case-finding(ACF) interventions among key populations. Methods A multi-center prospective cohort study was conducted in 2013-2015 among five key populations of tuberculosis (1.Residents aged 65 and above; 2.Residents with diabetes mellitus; 3.Residents with HIV/AIDS; 4.Residents with a history of TB; 5.Close contacts of active PTB patients) in selected 27 townships/communities in 10 provinces located in eastern, central and western regions of China. TB health promotion and education, TB symptom screening, and chest X-ray examination were carried out annually. The sensitivity and specificity of different screening approaches, the effectiveness of ACF among different key populations, and factors that influenced ACF contributions were analyzed. Results During 2013-2015, the intervention coverage of health education and TB symptom screening were 97.8% (42684/43654), 91.2% (41732/45768), and 88.1% (42441/48178) respectively; the intervention coverage of chest X-ray examination were 86.0% (37538/43654), 81.0% (37070/45768), and 75.7% (36483/48178), respectively. The TB key message awareness rate increased from 34.2% (73066/213420) in 2013 to 67.2% (142629/212205) in 2015, showing an upward trend year by year (Z_trend=215.568, P<0.01). The sensitivities of symptom screening only were low which could find 11.6% (69/596)of TB cases by using national TB control program defining symptoms and 11.7% (70/596) by using symptoms defined by this study, while specificities were quite high (99.1% (125123/126261) and 99.0% (125008/126261) respectively). The sensitivities of only using chest X-ray examination and study-defined symptom screening plus chest X-ray were both 90.7% (594/655),the specificities were 94.2% (104004/110436) and 93.3% (103 062/110436), respectively. Among all diagnosed PTB cases, 84.9% (556/655) were detected through ACF. The contribution rates of ACF in 2013, 2014, and 2015 were 95.7% (244/255), 81.0% (200/247), and 73.2% (112/153), showing a downward trend year by year (Z_trend=-6.403, P<0.01). The results of multi-variable analysis showed that compared with age group 15-24, the contribution rates of ACF in age group 55-64 (OR=7.18; 95%CI: 1.59-32.39) and age group ≥65 (OR=13.52; 95%CI: 3.31-55.16) were higher; compared with eastern regions, the contribution rate of ACF in western regions (OR=2.44; 95%CI: 1.38-4.29) was higher. Conclusion Carrying out an annual community-based ACF activity among key populations could significantly increase PTB case detection. The contribution rates of ACF were significantly higher in older people and western regions. However, they showed decreasing trends year by year in the three years’ implementation phase. Therefore, whether to take ACF activities every year for the same group of people should be considered under this group’s specific ACF contribution rate.

Study on the prevalence and incidence of pulmonary tuberculosis in high-risk populations in China

ZHANG Can-you, CHEN Bin, YE Jian-jun, HOU Jing-long, LI Hong-hai, YAO Yu-xia, ZHOU Fang-jing, ZHAO Jin-ming, LI Ting, YAN Hui-qin, LENG Dan-jing, ZHAO Fei, XIA Yin-yin, CHEN Hui, CHENG Jun, ZHANG Hui, WANG Li-xia

Chinese Journal of Antituberculosis. 2021, 43(12):  1260-1268.  doi:10.3969/j.issn.1000-6621.2021.12.006

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Objective To obtain the prevalence,incidence of tuberculosis (TB) and influencing factors among elderly people aged 65 years and older, diabetic patients, people with TB history, close contacts of active TB patients, and HIV/AIDS patients(referred as “five key populations” hereafter) in China through continuous screening, and to provide basic evidence for developing screening strategies in key populations. Methods In 27 townships/communities of 10 counties selected from 10 provinces located in eastern, middle and western regions of China, face-to-face questionnaire surveys and chest X-ray examination were performed on all participants every year for 3 consecutive years. TB prevalence and incidence density of the five key populations were calculated, and univariate and multivariate analysis of different demographic characteristics were also conducted. Results From 2013 to 2015, 38193, 35305 and 30295 participants were screened respectively. After 3 years of continuous screening, the prevalence of bacteriologically confirmed TB in all key populations dropped by 28.9% ((246.1-174.9)/246.1×100%), and the annual decline rate was 15.7% ($\big(\sqrt \frac{246.1}{174.9}-1 \big)$×100%); the prevalence of active TB dropped by 32.3% ((746.2-505.0)/746.2×100%), and the annual decline rate was 17.7% ($\big(\sqrt \frac{746.2}{505.0}-1 \big)$×100%). Taking survey of 2013 as the baseline, the incidence density of bacteriologically confirmed TB and active TB with 1-year follow-up (2014) in all key populations were 132.3 per 100000 person years (36/27202.4) and 143.7 per 100000 person years (71/49393.8), while with 2-years follow-up (2015), they were 488.9 per 100000 person years (133/27202.4) and 475.8 per 100000 person years (235/49393.8). Multivariate analysis found: male, advanced age (group ‘aged 75-84’ and group ‘aged 85 and older’), living in rural areas, ethnic minorities, unmarried/divorced/widowed, low family income per capita (2300-9999 yuan) and malnutrition (body mass index BMI<18.5) were risk factors for TB (OR (95%CI) were 3.4 (2.6-4.5), 1.6 (1.2-2.2) and 2.2 (1.3-3.5), 2.0 (1.5-2.8), 2.2 (1.6-3.0), 1.4 (1.1-1.9), 1.8 (1.3-2.4) and 1.9 (1.4-2.6) respectively), and overweight (body mass index ≥24) was a protective factor for TB (OR (95%CI)=0.3 (0.2-0.5)). Male, ethnic minorities and family with low annual income per capita (2300-9999 yuan) were risk factors for the onset of TB (aHR (95%CI) were 2.5 (1.9-3.5), 6.8 (4.8-9.6), 1.4 (1.0-1.9)), and overweight (BMI≥24) was a protective factor for the onset of TB (aHR (95%CI) was 0.5(0.4-0.7)). Conclusion The five key populations are high-risk populations of TB in China. Continuous active screening should be carried out in those key populations to quickly reduce the tuberculosis epidemic. Through identify people with different combinations of risk factors, we can set high-risk populations to target at them, thereby to increase the screening benefits.

Effect of sputum sample quality intervention on the positive detection rate of etiology in newly diagnosed pulmonary tuberculosis patients

SU Wei, LI Ren-zhong, RUAN Yun-zhou, JIANG Jia-wen, WANG Meng, XIE Tian, WANG Zhong-sheng, XU Wan-guang, FANG Guan-chen, ZENG Yan, TANG Wen-fang

Chinese Journal of Antituberculosis. 2021, 43(12):  1269-1274.  doi:10.3969/j.issn.1000-6621.2021.12.007

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Objective To explore the effect of improvement of the sputum sample quality on the positive detection rate of etiology in newly diagnosed pulmonary tuberculosis (PTB) patients through sputum retention interventions. Methods Five counties (districts) in Ganzhou, Jiangxi were selected as the research pilot areas. Using the method of community intervention trial, 771 newly diagnosed PTB patients diagnosed from March to July 2020 were selected as the control group, 645 newly diagnosed PTB patients from August to December 2020 were selected as the intervention group. In the control group, sputum samples were collected by the patients according to the doctor’s instructions, and intervention measures were implemented in the intervention group (medical staff instructed patients to collect sputum, and if patients had no sputum, heat-steam absorbing, climbing stairs or walking, patting back, or aerosol inhalation will be carried out to collect sputum samples). The difference of positive detection rate of etiology between the two groups were compared. The proportion and quality of 3 sputum specimens, including immediate sputum, morning sputum, and night sputum, collected in the intervention group, as well as the implementation of various sputum retention interventions were analyzed. Results The positive rate in the control group was 53.7% (414/771), which was significantly lower than that in the intervention group (64.3%, 415/645; χ²=16.396, P=0.000). The positive rates of sputum smear microscopy and GeneXpert MTB/RIF (“Xpert”) in the intervention group were 51.6% (316/612) and 62.4% (394/631) respectively, which were significantly higher than those in the control group (42.1%, (313/743) and 55.0% (396/720), respectively; χ ² values were 12.196 and 7.667, P values were 0.000 and 0.006, respectively). Among them, the positive rate of Xpert test of patients in the intervention group with negative sputum smear microscopy was 28.3% (93/329), which was significantly higher than that in the control group (20.3% (93/458); χ ²=4.114, P=0.043). The percentage of immediate sputum retention in the intervention group was 99.5% (642/645), and the qualified rate was 90.0% (578/642); the percentages of morning and night sputum retentions were 95.5% (616/645) and 88.7% (572/645), and the qualified rates were 88.1% (543/616) and 88.6% (507/572). In the intervention group, 77.1% (495/642) of the patients were directly retained sputum after doctors’ sputum retention education and nurses’ on-site guidance, 10.1% (65/642) through heat-steam absorbing, 4.7% (30/642) by climbing stairs, 4.7% (30/642) by patting backs, and 3.6% (23/642) by aerosol inhalation. Conclusion Improving the quality of sputum samples through sputum retention intervention could significantly increase the positive detection rate of etiology in newly diagnosed PTB patients. Medical staff should provide patients with appropriate sputum retention education and guidance on sputum retention.

The effect of case finding of pulmonary tuberculosis and rifampicin resistance tuberculosis with GeneXpert MTB/RIF test in economic undeveloped areas

RUAN Yun-zhou, SU Wei, JIANG Jia-wen, LI Ren-zhong

Chinese Journal of Antituberculosis. 2021, 43(12):  1275-1279.  doi:10.3969/j.issn.1000-6621.2021.12.008

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Objective To explore the effect of applying GeneXpert MTB/RIF (Xpert for short) test to improve the case finding of pulmonary tuberculosis (PTB) and rifampicin-resistant tuberculosis in economic undeveloped areas. Methods Medical records of PTB patients in Ganzhou Prefecture Jiangxi Province between 2017 and 2020 were derived from the Tuberculosis Management Information System, a subsystem of China Disease Control and Prevention Information System. The effects of intervention measures using Xpert test before (2017-2018) and after (2019-2020) intervention were analyzed. The changes of the proportion of bacteriologically confirmed of tuberculosis, the proportion of rifampicin resistance tested of that, the number of PTB patients with rifampicin resistance, and the number of days for rifampicin resistance test before and after the application of Xpert test were compared and evaluated. Results After the intervention, the proportion of PTB patients received Xpert test increased from 25.89% (3611/13945) to 88.22% (9270/10508) (χ ²=9337.32,P=0.000); the proportion of bacteriologically confirmed PTB cases increased from 44.07% (6146/13945) to 56.12% (5897/10508) (χ²=347.90, P=0.000); the proportion of rifampicin resistance tested of the bacteriologically confirmed cases increased significantly from 52.29% (3214/6146) to 93.18% (5495/5897) (χ ²=2511.49, P=0.000); rifampicin-resistant PTB increased from 207 cases to 305 cases, of which 13.11% (40/305) came from smear-negative patients; the drug susceptibility test was shortened from 63.0 days to the same day. Conclusion The application of Xpert test can significantly improve the case finding of the proportion of bacteriologically confirmed PTB cases and drug-resistant tuberculosis in economic undeveloped areas.

Analysis of the application of nucleic acid detection technology for tuberculosis molecular biology in Linfen, Shanxi from 2019 to 2020

FAN Yue-ling, WANG Chun-pu, GAO Jian-wei, DENG Jun-ping, SONG Hong, FENG Miao, SHANG Ya-li, LI Qing-tao, ZHANG Chong-hui, ZHANG Yan-ping, LI Ren-zhong

Chinese Journal of Antituberculosis. 2021, 43(12):  1280-1286.  doi:10.3969/j.issn.1000-6621.2021.12.009

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Objective To analyze the application of nucleic acid detection technology for tuberculosis(TB) molecular biology in the project of “Explore and improve the level of tuberculosis detection in poor areas” implemented in Linfen, Shanxi from 2019 to 2020, to provide evidence for optimizing the strategy of TB prevention and control in Linfen. Methods Data of China’s Disease Prevention and Control Information System and its subsystem TB Management Information System, and the monthly report of the “Explore and improve the level of tuberculosis detection in poor areas” project were collected. Data of 2018 were selected as baseline, active pulmonary TB patients, detection of TB patients and drug sensitivity screening in Linfen from 2019 to 2020 were analyzed. Results The positive rates of etiology in Linfen increased year by year and were 29.6% (442/1495), 36.4% (476/1307) and 50.5% (652/1292), respectively, from 2018 to 2020, the difference was statistically significant ($χ{^{2}_{trend}}$=152.410, P=0.000). By 2020, in 17 counties and districts, 50% of the active pulmonary TB patients and pulmonary TB patients with positive etiology in Fushan, Hongdong, Anze and Yicheng counties (76.2% (32/42), 64.7% (174/269), 60.0% (9/15), 55.9% (38/68), respectively; and 76.5% (13/17), 70.4% (81/115), 7/7, 66.7% (24/36), respectively) were diagnosed by municipal hospital (Linfen Third People’s Hospital), while the rates in Daning and Yonghe were not (69.4% (25/36), 81.8% (18/22) and 59.3% (16/27), 66.7% (8/12)). From 2018 to 2020, the drug sensitivity screening rates in Linfen were yearly increased (75.1% (229/(442-137), 88.5% (339/(476-93) and 90.7% (489/(652-113), respectively), the difference was statistically significant ($χ{^{2}_{trend}}$=25.505, P=0.000). From 2018 to 2020, the positive rates of etiology in Daning and Yonghe were 31.2% (15/48), 25.0% (14/56) and 54.0% (34/63), respectively, with significant difference (χ ²=170.407, P=0.000); the proportion of newly diagnosed patients in Daning and Yonghe by municipal hospital increased from 38.4% (106/276) to 43.4% (75/173) and 56.3% (98/174) ($χ{^{2}_{trend}}$=36.564, P=0.000). Conclusion Linfen Third People’s Hospital provides Linfen a full range of TB molecular biological test. The diagnosis and treatment process should continue optimized to achieve the goal of graded diagnosis and treatment of common TB patients in the county, and the municipal diagnosis could work as a regional molecular biological diagnostic laboratory for TB.

Analysis of the epidemiological characteristics of rifampicin-resistant pulmonary tuberculosis in Ganzhou, Jiangxi from 2019 to 2020

WANG Meng, WAN Yi-you, XIE Tian, LI Jian-hua, RUAN Yun-zhou, LIU Yue-yuan, HU Jia, FENG De-an, GUO Hui-ying, LI Ren-zhong

Chinese Journal of Antituberculosis. 2021, 43(12):  1287-1291.  doi:10.3969/j.issn.1000-6621.2021.12.010

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Objective Analysis of the epidemic characteristics of rifampicin-resistant pulmonary tuberculosis (“RR-TB” for short) in Ganzhou, Jiangxi from 2019 to 2020. Methods The data of medical record information and drug resistance of registered patients with tuberculosis in Ganzhou City from January 1, 2019 to December 31, 2020 were derived from the Tuberculosis Management Information System, a subsystem of China Disease Control and Prevention Information System. The status of cases tested for resistance and epidemiological characteristics of RR-TB cases were analyzed. Results Among the 10508 pulmonary tuberculosis patients who registered in Ganzhou from 2019 to 2020, there were 5897 bacteriologically confirmed cases. The proportion of bacteriologically confirmed tuberculosis cases tested for rifampicin resistance was 93.18% (5495/5897), and the prevalence of rifampicin resistance was 5.55% (305/5495). The proportion of RR-TB cases from new bacteriologically confirmed retreatment bacteriologically confirmed tuberculosis cases and from retreatment bacteriologically confirmed tuberculosis cases were 49.51% (151/305) and 50.49% (154/305), respectively. The prevalence of rifampicin resistance among who aged 20-59 years (6.25% (199/3186)) was significantly higher than that among who aged 0-19 years (3.74% (8/214)) and who aged greater than 60 years (4.68% (98/2095));the prevalence of rifampicin resistance among Nankang District (9.06% (30/331)) of urban and neighboring suburbs was significantly higher than that among Shicheng County (1.35% (3/222)) of outside suburban district. The differences were statistically significant (the Chi Squares were 7.324,766.858, and the P values were 0.026,0.001). Conclusion Rifampicin resistant tuberculosis has became an important challenge in the prevention and control of tuberculosis in economic undeveloped areas. Standard treatment and infection control should be further strengthened to reduce the occurrence of drug resistance,young and middle-aged population and cases in urban and neighboring suburbs should be the key populations.

Analysis of visit behavior of pulmonary tuberculosis patients in underdeveloped areas of Shaanxi

ZHANG Hong-wei, RUAN Yun-zhou, ZHANG Tian-hua, DENG Ya-li, XIONG De-ming, LIU Xi-bo

Chinese Journal of Antituberculosis. 2021, 43(12):  1292-1296.  doi:10.3969/j.issn.1000-6621.2021.12.011

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Objective To analyzed the visit behavior of pulmonary tuberculosis (PTB) patients in the areas where the project of “Exploring and improving the detection level of tuberculosis in underdeveloped areas” were implemented, to provide basis for formulating the detection measures of PTB patients in underdeveloped areas. Methods Data of 875 PTB cases, whose “current address” were Qingjian and Zizhou registered from 2017 to 2020, were collected from TB Management Information System. Of these cases, 441 were registered before the implementation of the project (January 1, 2017-December 31, 2018), and 434 were registered during the project (January 1, 2019-December 31, 2020). Information of patients from Infectious Disease Reporting Information System and TB Management Information System were matched using Excel 2016. The non-local diagnosis rate (NDR), delayed rate (PDR) of visit and delayed rate (DDR) of diagnosis before and during the implementation of project were analyzed. Results The NDR of PTB during the implementation of the project was significantly higher than that before the implementation of the project (84.10% (365/434) vs. 62.81% (277/441), χ ²=50.74, P=0.000). From 2017 to 2020, PDR was 48.34% (423/875) and DDR was 18.63% (163/875) in Qingjian and Zizhou. The PDR during the implementation of the project was significantly higher than that before the implementation of the project (52.76% (229/434) vs. 43.99% (194/441), χ ²=6.74, P=0.009); the DDR before the implementation of the project was significantly lower than that during the implementation (23.36% (103/441) vs. 13.82% (60/434), χ ²=13.11, P=0.000). DDR of PTB whose first visit were non-local before the implementation of the project was significantly higher than that during the significantly (33.94% (94/277) vs. 15.07% (55/365), χ ²=31.45, P=0.000). PDR of PTB whose first visit in Qingjian and Zizhou were significantly higher than before the implementation (73.91% (51/69) vs. 48.78% (80/164), χ ²=12.46, P=0.000). As to patients first diagnosed in designated hospitals, the DDR before the implementation of the project was significantly higher than that during the implementation (16.53% (60/363) vs. 7.58% (27/356), χ ²=13.52, P=0.000); in the other hospital, the PDR during the implementation of the project was significantly higher than before the implementation (32.05% (25/78) vs. 24.36% (19/78),χ ²=29.82, P=0.000). Conclusion During the implementation of the project, the NDR of PTB patients in underdeveloped areas increased, visit delay was not significantly improved, while diagnosis delay was improved. Comprehensive measures should be taken to improve visit behavior, graded diagnosis and treatment should be strengthened, and visit delay should be reduced.

Analysis of pulmonary tuberculosis surveillance results of entry-exit population at Shanghai port from 2014 to 2020

XIA Jing, CHEN Lei, QIN Jia, ZHU Xi, LI Jun

Chinese Journal of Antituberculosis. 2021, 43(12):  1297-1301.  doi:10.3969/j.issn.1000-6621.2021.12.012

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Objective To understand the screening results of tuberculosis among entry-exit applicants at Shanghai ports, and to find solutions for preventing cross-border transmission of tuberculosis through ports. Methods We collected data of pulmonary tuberculosis (PTB) screening which were performed on each entry or exit applicant at Shanghai port between January 2014 and December 2020. Presumptive tuberculosis patients were identified through medical history query, physical examination and chest X-ray examination. Subsequently, sputum bacteriological tests were performed to confirm the diagnosis. PTB positive rate and sex and age distributions of PTB patients were analyzed. Results A total of 539397 individuals were screened for PTB at Shanghai port from 2014 to 2020, among which 795 cases were detected, with a detection rate of 147.39/100000, highest in 2016 (319.89/100000,268 cases) and lowest in 2020 (20.45/100000,8 cases). Most tuberculosis patients came from East Asia countries (575 cases, accounting for 72.33%), while Latin America countries occupied the least share (4 cases, accounting for 0.50%). There were more males (479 cases, accounting for 60.25%) than females (316 cases, accounting for 39.75%). The male-female ratio was 1.52:1. For different age groups, patients aged ≥60 years old (246 cases, 30.94%) accounted for the most, while those aged 50-59 years old (107 cases, 13.46%) accounted for the least. Conclusion PTB surveillance should be strengthened in high-risk populations at Shanghai port, especially for male,elderly people(≥60 years) and people from East Asia. Also subsequent supervision should be strengthened to prevent and control the transmission of PTB.

Preliminary study on clarithromycin resistance gene of Mycobacterium abscessus complex

WANG Yi-ting, ZHENG Hui-wen, ZHAO Bing, XIA Hui, WANG Sheng-fen, OU Xi-chao, ZHOU Yang, SONG Yuan-yuan, ZHENG Yang, ZHAO Yan-lin, SHEN A-dong

Chinese Journal of Antituberculosis. 2021, 43(12):  1302-1307.  doi:10.3969/j.issn.1000-6621.2021.12.013

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Objective To analyze the characteristics of clarithromycin resistance against Mycobacterium abscessus complex, and further to provide the basis for the adequate application and effective control of clarithromycin resistance in clinical. Methods A total of 385 Mycobacterium abscessus complex clinical isolates strains stored in National Tuberculosis Reference Laboratory of Chinese Center for Disease Control and Prevention for the national drug resistance surveillance from 2016 to 2017 were finally collected. Isolates were characterized using multilocus sequence analysis of various genes. Meanwhile, the drug susceptibility testing was determined using the broth microdilution method and the drug resistance genes were analyzed. Results Of all the 385 Mycobacterium abscessus complex isolates, 185 possessed the erm(41) T28 sequevar, 33 possessed the erm(41) C28 sequevar, 163 were M.massiliense, while the other four isolates belonged to M.bolletii. The resistance rate of amikacin against M.abscessus and M.massiliense was 2.8% (6/218) and 6.4% (14/218), respectively. For clarithromycin, the resistance rate was 4.3% (7/163) and 10.4% (17/163) for M.abscessus and M.massiliense, respectively.The resistance rate of clarithromycin against erm(41) C28 sequevar isolates was 9.1% (3/33) on day 3 and day 14 and no inducible resistance was occurred, however, the resistance rate was increased from 5.9% (11/185) on day 3 to 98.4% (182/185) on day 14 with 171 inducible resistant isolates of erm(41) T28 sequevar. Among the 31 acquired resistant isolates, 10 M.abscessus and 10 M.massiliense isolates possed an rrl 2058/2059 mutation with A2058C and A2058G the most common mutation type. Of the 9 amikacin resistant isolates with an A1408G rrs mutation, there were 7 isolates resistant to both clarithromycin and amikacin. Conclusion erm(41) T28 sequevar was more likely to induce clarithromycin resistance. The most common acquired resistance mutation site was A2058C for M.abscessus, which was A2058G in M.massiliense.

Correlation between pyrazinamidase activity and the short-term clinical efficacy of multidrug-resistant pulmonary tuberculosis

WU Bi-tong, CAI Xing-shan, KUANG Hao-bin, LIU Zhi-hui, MENG Fan-rong, WANG Nan, GAO Jun-wen, TAN Shou-yong

Chinese Journal of Antituberculosis. 2021, 43(12):  1308-1313.  doi:10.3969/j.issn.1000-6621.2021.12.014

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Objective To explore the correlation between pyrazinamidase (PZase) activity and the short-term efficacy of multidrug-resistant pulmonary tuberculosis (MDR-PTB), and to provide guidance for the choice of chemotherapy for MDR-PTB patients. Methods A prospective cohort study was conducted on 85 MDR-PTB patients admitted to Guangzhou Chest Hospital from July 2018 to December 2019. All the patients received 6Am-Mfx-PZA-Pto-Cs/18Mfx-PZA-Pto-Cs (Am: amikacin; Mfx: moxifloxacin; PZA: pyrazinamide; Pto: protionamide; Cs: cycloserine) regimen recommended by WHO. Of the 85 MDR-PTB patients, 9 patients were excluded, including those who lost, interrupted treatment or lost to follow-up, and 76 patients were included in the final study. Wayne method was used to detect PZase activity, and BACTEC MGIT 960 system was used to detect the drug sensitivity to PZA. The sputum negative conversion, lesion absorption and cavity closure in patients positive or negative for PZase at the end of 2, 4 and 6 months after treatment were compared. Results Of the 76 patients, PZase was positive in 32 cases (42.1%) and negative in 44 cases (57.9%); 36 cases (47.4%) PZA were with phenotypic resistance and 40 cases (52.6%) were with PZA phenotypic sensitivity. High consistency was found between PZA drug sensitivity test and PZase activity test (Kappa=0.687, P=0.000). At the end of the 4th month of the treatment, the lesion absorption rate in PZase-positive patients were significantly higher than those in PZase-negative patients (59.4% (19/32) vs 36.4% (16/44), χ²=3.949, P=0.047; 65.5% (19/29) vs 36.8% (14/38), χ ²=5.411, P=0.020). After 6-month treatment, the effective rate of cavity closure in PZase-positive patients was significantly higher than that in PZase-negative patients (86.2% (25/29) vs 63.2% (24/38), χ ²=4.447, P=0.035). Conclusion The efficacy of MDR-PTB patients is related to PZase activity. The effect of lesion absorption and cavity closure in PZase-positive patients treated with standard regimen of MDR-PTB containing PZA is better than that in PZase-negative patients.

Pharmacokinetics and safety of high-dose isoniazid and rifapentine in healthy han population: A bio-equivalence trial

YUAN Yuan, MA Jia-ye, LIU Xu-hui, XIA Lu, LIU Ping, JIA Xiao-long, LU Shui-hua

Chinese Journal of Antituberculosis. 2021, 43(12):  1314-1321.  doi:10.3969/j.issn.1000-6621.2021.12.015

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Objective To evaluate the pharmacokinetic performance and safety of high does of isoniazid and rifapentine in healthy Han population, to provide clinical evidence for preventive therapy of tuberculosis. Methods From October to December 2019, a pharmacokinetic clinical trial was carried out at the Shanghai Public Health Clinical Center. 36 healthy subjects were randomly allocated into a domestic drug group (T) and a reference drug group (R) at a ratio of 1:1. Subjects in Group T were given a single dose oral administration of 900 mg domestic isoniazid and 900 mg domestic rifapentine, Subjects in Group R were given 900 mg reference isoniazid and 900 mg reference rifapentine. Half of the patients in each group were randomly chosen to take those drugs before meals (T1, R1), and the other half would take drugs after meals (T2, R2). After taking the drug, venous blood samples were collected at specified time points and the plasma were separated. Liquid chromatography-tandem mass spectrometry (LC-MS) was used to determine the concentration of drugs and their metabolites in the plasma. Phoenix WinNonlin 8.1 was used to calculate the pharmacokinetic parameters and record all adverse events during the observation period for 72 hours. Results For T1 and R1 group, the peak concentration (C_max) of rifapentin were (21.2±7.3) μg/ml and (15.2±2.8) μg/ml, respectively (t=3.256,P=0.003); area under the plasma concentration curve from administration to last observed concentration at time t (AUC_0-t) were (624.3±327.4) μg·h/ml and (479.3±141.8) μg·h/ml (t=1.724,P=0.094); C_max of isoniazid were (29.9±4.5) μg/ml and (25.2±6.8) μg/ml (t=2.445,P=0.020); AUC_0-t were (80.7±21.4) μg·h/ml and (80.4±12.7) μg·h/ml (t=0.051,P=0.960). For T2 and R2 groups, the C_max of rifapentine were (25.4±6.8) μg/ml and (26.5±5.2) μg/ml (t=-0.545,P=0.589); AUC_0-t were (756.4±253.2) μg·h/ml and (779.7±175.5) μg· h/ml (t=-0.321,P=0.750); the C_max of isoniazid were (11.5±1.6) μg/ml and (10.9±1.5) μg/ml (t=1.161, P=0.253); AUC_0-t were (54.2±9.3) μg·h/ml and (55.8±8.9) μg·h/ml (t=-0.527,P=0.602). The 90% confidence intervals of the T1/R1 geometric mean ratio of C_max and AUC_0-t of rifapentin were 102.7%-158.9% and 87.4%-169.0%,the 90% confidence intervals of the T1/R1 geometric mean ratio of C_max and AUC_0-t of isoniazid were 100.0%-147.8% and 80.9%-120.4%. The 90% confidence intervals of the T2/R2 geometric mean ratio of C_max and AUC_0-t of rifapentin were 78.3%-113.6% and 74.3%-119.5%,the 90% confidence intervals of the T2/R2 geometric mean ratio of C_max and AUC_0-t of isoniazid were 91.8%-120.8% and 82.1%-114.6%.There were no reports of serious adverse events. Conclusion According to the 90% confidence intervals of C_max and AUC_0-t for the test/reference geometric mean ratio in T and R groups, the pharmacokinetics of domestic isoniazid and domestic rifapentine were similar to the reference drugs, but they were not equivalent exactly.Single dose of administration could be stood with good safety.

Clinical Case Discussion

Analysis of diagnosis and treatment for a tuberculous damaged lung patient complicated with parvovirus B19 infection and severe thrombocytopenia

QIU Jun-ke, PAN Xiao-hong, WANG Cai-hong, MAO Min-jie

Chinese Journal of Antituberculosis. 2021, 43(12):  1322-1326.  doi:10.3969/j.issn.1000-6621.2021.12.016

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The clinical diagnosis and treatment process of a case of 20-year-old female admitted to the tuberculosis ICU department of Affiliated Hangzhou Chest Hospital, Zhejiang University School of Medicine on January 16,2021 were analyzed. The patient with tuberculous damaged lung complicated with parvovirus B19 infection and severe thrombocytopenia caused by suspected hemophagocytic syndrome. The patient was admitted to the hospital with chief complaint of cough with weight loss for 3 months, black stool for 15 days, aggravation with epistaxis for 2 days. Based on laboratory test, imaging,bone marrow biopsy and metagenomic detection of pathogenic microorganisms of bone marrow fluid, the patient was diagnosed as severe anemia, left tuberculous damaged lung, respiratory failure, cellular immune dysfunction, severe thrombocytopenia with unknown cause, parvovirus B19 infection and suspected hemophagocytic syndrome (suspected after death). After anti-tuberculosis, anti-infection, infusion of erythrocyte suspension, platelet, plasma and immunoglobulin pulse therapy, the condition was not improved. On the 5th day of admission, the condition was relieved after the application of extracorporeal membrane oxygenation due to aggravation of respiratory failure. However, respiratory failure aggravated due to pneumothorax in the right lung on the next day. In the condition of persistent thrombocytopenia and failure to improve coagulation function,the patient eventually died of respiratory failure and massive hemorrhage of airway and digestive tract. We believe that when tuberculous damaged lung is complicated with obvious thrombocytopenia, the cause of thrombocytopenia should be actively find; when combined with inhibition of cellular immune function, it shoule be considered whether opportunistic infection is complicated; when with the cause of thrombocytopenia is unknown and difficult to correct, and complicated with opportunistic infection, the occurrence of hemophagocytic syndrome should be highly vigilant.

Review Articles

The research progress of biomarkers in cerebrospinal fluid for diagnosis of tuberculous meningitis

CHEN Meng-meng, DONG Jing, JIA Hong-yan, ZHAGN Zong-de, PAN Li-ping

Chinese Journal of Antituberculosis. 2021, 43(12):  1327-1331.  doi:10.3969/j.issn.1000-6621.2021.12.017

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The non-specific clinical manifestations and imaging changes of tuberculous meningitis (TBM) as well as the lack of efficient laboratory diagnostic approaches make the diagnosis of TBM extremely difficult. However, early diagnosis of TBM is extremely crucial for timely treatment and improvement of prognosis. There are many biomarkers in cerebrospinal fluid (CSF) which have potential value for early diagnosis of TBM. In this paper, we mainly reviewed and discussed the study progresses and challenges of using host biomarkers in CSF on TBM diagnosis.

Research progress of relationship between CRISPR-Cas system and Mycobacterium tuberculosis

YANG Rui-fang, LI Chuan-you

Chinese Journal of Antituberculosis. 2021, 43(12):  1332-1335.  doi:10.3969/j.issn.1000-6621.2021.12.018

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Clustered regularly interspaced short palindromic repeats (CRISPR) and their related proteins (Cas) form a new acquired immune defense system distributed in Mycobacterium tuberculosis (MTB). In addition, CRISPR-Cas system may have an important relationship with the virulence, drug resistance and targeted gene editing of MTB. This paper reviews the immune function of CRISPR-Cas system in MTB and its related research progress, in order to provide a new idea for further study of MTB pathogenicity and anti-tuberculosis treatment.