Table of Content

10 September 2020, Volume 42 Issue 9

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Guideline·Standard·Consensus

Expert consensus of clinical application of fixed-dose combination formulations

Academic Working Committee of Chinese Antituberculosis Association, Editorial Board of Chinese Journal of Antituberculosis

Chinese Journal of Antituberculosis. 2020, 42(9):  885-893.  doi:10.3969/j.issn.1000-6621.2020.09.001

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The global modern tuberculosis control strategy puts forward that the anti-tuberculosis drugs should be continuously supplied to the patients with pulmonary tuberculosis, and the standardized short-term chemotherapy regimen and the whole-course management should be implemented to the patients with new pulmonary tuberculosis. The purpose is to improve the regular treatment rate and cure rate of the patients with pulmonary tuberculosis. In order to further improve the treatment compliance of patients with tuberculosis, reduce the number of drugs taken by patients each time, simplify the prescription of medicine prescribed by doctors, and prevent the occurrence of drug-resistant tuberculosis caused by unreasonable prescription and dosage. In 1994, WHO and IUATLD recommended the use of fixed dose combination (FDC) of anti-tuberculotic drugs in patients with tuberculosis. Since the beginning of this century, China had carried out a number of implementation studies on the application of FDC consecutively in different provinces. The results show the feasibility and effectiveness of FDC in the treatment of tuberculosis, and provide an important scientific basis for FDC to be included in the national tuberculosis control program. This consensus has been repeatedly discussed by experts in the fields of tuberculosis prevention and control, clinicians and researchers. Based on the significance of use, pharmacodynamics and pharmacokinetics, a number of application research results of FDC, preparation types and specifications of FDC, and suggestions for clinical use of FDC in China, the experts formed ‘the consensus on clinical use of fixed dose combinations of anti-tuberculosis drugs’ which provides reference for formulating the use strategy of anti-tuberculosis drugs and the treatment of tuberculosis patients in China.

Special Article

The construction of tuberculosis prevention and control service system at county level in China needs to be strengthened urgently —— Comments and suggestions of an old tuberculosis control and prevention worker

JIN Hong-jian

Chinese Journal of Antituberculosis. 2020, 42(9):  896-902.  doi:10.3969/j.issn.1000-6621.2020.09.003

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Tuberculosis (TB) control and prevention service system at county level in China is an important part of the public health service system, especially the disease prevention and control service system. Especially in the context of the global End TB in 2035, the construction of the county, township and village three-level prevention and control service system will play a crucial role in overcoming the difficulties and end tuberculosis in China. The author puts forward some thoughts and suggestions on the construction of county-level TB control and prevention service system, hoping to attract the attention, discussion and attention of colleagues in the industry, and provide scientific basis for the government to formulate relevant policies in line with China’s actual situation.

Testing and reporting requirements for Class Ⅱ biosafety cabinet in tuberculosis laboratory

ZHANG Can-you, XIA Hui, CHENG Jun

Chinese Journal of Antituberculosis. 2020, 42(9):  903-909.  doi:10.3969/j.issn.1000-6621.2020.09.004

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The biosafety cabinet is one of the primary barriers to ensure the biological safety of the laboratories, and has been used in tuberculosis laboratory widely. In China, there are problems in the use of biosafety cabinets, such as the lack of attention to maintenance, irregular on-site testing and test reports. Based on international and domestic biosafety cabinet standards and the authors’on-site experiences, this article briefly summarizes the requirements and points for attention of on-site and daily testing of biosafety cabinets, and also provides model essay of test report, in order to help laboratories staff and special testing institutions.

Evaluation of the quality of pulmonary tuberculosis diagnosis after the implementation of the newly revised WS 288-2017 Diagnosis for pulmonary tuberculosis standards

ZHOU Lin, LIU Er-yong, MENG Qing-lin, CHEN Ming-ting, ZHOU Xin-hua, GAO Wei-wei, LIN Ming-gui, XIE Ru-ming

Chinese Journal of Antituberculosis. 2020, 42(9):  910-915.  doi:10.3969/j.issn.1000-6621.2020.09.005

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Objective To understand the status of pulmonary tuberculosis (TB) diagnosis after the implementation of the newly revised WS 288-2017 Diagnosis for pulmonary tuberculosis standard (hereinafter referred to as “new standard”), and the effect in improving the proportion of pathogenic positive in the patients registered for treatment and the quality of diagnosis in the patients with negative pathogen.Methods In accordance with the principle of voluntary assessment, eight provinces (Qinghai, Gansu, Xinjiang, Guizhou, Hubei, Guangxi, Shandong and Liaoning) were assessed, with one municipal specific hospital and three county-level institutions in each province. Assessment contents: the local tuberculosis registration data, tuberculosis imaging diagnosis and tuberculosis laboratory related tests before (2017) and after (2018) the implementation of the new standard were reviewed; the pathogenic negative pulmonary tuberculosis medical records, 50 cases in each site and each year were checked, as well as the laboratory register and retained sputum smear slides. A total of 3532 medical records of pathogenic negative pulmonary tuberculosis patients and 3260 sputum smears retained in the laboratory were checked. Chi-square test was used to compare the count data, with P＜0.05 as the difference statistically significant.Results After the implementation of the new standard, the detection ability of mycobacterium molecular biology increased from 18.2% (6/33) to 60.0% (15/25), the difference was statistically significant (χ²=9.035, P=0.003). The isolation and culture of mycobacterium increased from 93.9% (31/33) to 96.0% (24/25), with no significant difference (χ²=0.061, P=0.804). Through laboratory test quality assessment, we found that the quality of sputum specimen was not improved, 40.1% (384/957) of unqualified sputum samples in 2017 and 40.0% (922/2303) in 2018, and the difference was not statistically significant (χ²=0.000, P=0.993). The pathogenic positive rate of registered tuberculosis patients increased from 21.6% (4806/22258) to 24.7% (4026/16300), and the difference was statistically significant (χ²=51.200, P=0.000). The detection rate of tuberculosis antigen and antibody increased from 36.5% (871/2389) to 37.3% (426/1143), without statistically significant difference (χ²=0.186, P=0.667). The positive rate of tuberculosis antigen and antibody increased from 25.7% (224/871) to 41.3% (176/426), the difference was statistically significant (χ²=31.900, P=0.000). The detection rate of tuberculin test increased from 23.0% (549/2389) to 47.2% (539/1143), and the positive rate increased from 57.9% (318/549) to 73.3% (395/539), the difference was statistically significant (χ²=210.900, P=0.000; χ²=27.730, P=0.000). The detection rate of IFN-γ release test increased from 2.3% (54/2389) to 17.2% (197/1143), the difference was statistically significant (χ²=260.400, P=0.000). Patients met the clinical TB diagnosis standard increased from 23.8% (569/2389) to 48.1% (550/1143), the difference was statistically significant (χ²=209.800, P=0.000).Conclusion The implementation of the new standard has increased the pathogenic positive rate of registered pulmonary tuberculosis patients and improved the diagnostic quality of pathogenic negative pulmonary tuberculosis.

Original Articles

Analysis of diagnostic quality of pulmonary tuberculosis with negative etiology in some areas of China

LIU Er-yong, WANG Qian, ZHOU Lin, ZHANG Guo-qin, ZHANG Xiu-lei, MA Yong-cheng, YANG Shu-min, WANG Cui, MENG Qing-lin, CHEN Ming-ting, LIN Ming-gui, TU De-hua.

Chinese Journal of Antituberculosis. 2020, 42(9):  916-920.  doi:10.3969/j.issn.1000-6621.2020.09.006

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【Abstract】 Objective To analyze the status of diagnosis of pulmonary tuberculosis with negative etiology testing results in China, and to provide scientific basis for improving the diagnosis strategy of etiology negative tuberculosis. Methods According to the voluntary principle of each province, 1761 TB patients with negative etiology testing results were collected from 8 designated TB medical institutions in Shandong, Qinghai, Gansu and Liaoning Provinces registered from June 1, 2017 to May 31, 2018. The medical records, chest films including X-ray photography, digital X-ray photography, CT and laboratory examination results of the patients were reviewed to analyze the diagnosis status in receiving etiological examination, laboratory auxiliary examination and imaging examination. Results Among the 1761 patients, 2.3% (40/1761) of the patients did not carry out sputum smear, 4.9% (87/1761) of the patients only carried out sputum smear one or two times. Patients received sputum culture and molecular biology test accounted for 27.1% (478/1761) and 24.5% (431/1761), respectively. Only 40.2% (708/1761) of patients underwent tuberculin skin test, 34.8% (612/1761) of interferon gamma release test and 44.5% (784/1761) of tuberculosis antibody test. 53.5% (942/1761) of the cases only relied on chest X-ray for diagnosis without any auxiliary laboratory examinations. 16.8% (296/1761) of the chest radiographs were unqualified, and the main problems were blurred image, inappropriate voltage, damage caused by improper preservation, etc. After reviewed by experts, 9.7% (170/1761) of them were misdiagnosed or over diagnosed. Among them, 88.3% (150/170) were inactive tuberculosis, the remaining 11.7% (20/170) were inflammation, tumor and other diseases. Conclusion The standardization of sputum examination for newly diagnosed patients in county tuberculosis designated medical institutions needs to be improved, and the efforts of etiological examination of patients and the ability of distinguishing tuberculosis from inflammation and tumor need to be improved; and the diagnostic process of tuberculosis with negative etiology detection should be standardized.

Analysis of the awareness about knowledge on the updated TB diagnosis standard among the practitioners in TB control institutions

MENG Qing-lin, LI Jin-lan, LIN Ding-wen, MA Yong-cheng, HOU Shuang-yi, LIU Nian-qiang, ZHOU Lin

Chinese Journal of Antituberculosis. 2020, 42(9):  921-925.  doi:10.3969/j.issn.1000-6621.2020.09.007

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Objective To learn the understanding on the major contents of Standard WS 196—2017 Classification of tuberculosis and WS 288—2017 Diagnosis for pulmonary tuberculosis among parctitioners in the TB control, or medical staff in designated medical institutions and/or TB control staff in the center for disease control and prevention at the survey sites, and propose measures to further implement the new standards.Methods This was a cross-sectional study, including 5 provinces (autonomous region) selected according to geographical distribution and previous work on TB control, including 4 prefectures (cities), 9 counties (districts). A questionnaire was used to investigate staff working on management and clinical diagnosis in designated medical institutions and center for disease control and prevention. The main content of the questionnaire was about technical updates on the two new standards, involving a total of 10 questions related to core information. Totally 325 questionnaires were distributed, 325 were retrieved. Collected data were statistically analyzed and verified using χ². P<0.05 was considered statistically significant difference.Results The results showed that the total awareness rate of staff in center for disease control and prevention (87.8%, 202/230) and doctors in designated medical institutions (85.1%, 1455/1710) were higher than other personnel (76.3%, 1000/1310), and the difference was statistically significant (χ² value were 15.078, 37.357 respectively; All P value were 0.000 respectively). The total awareness rate of all the information was 81.8% (2657/3250), of which the awareness rate of the 10th piece “Which part of the tuberculosis lesions in the new diagnostic criteria need to be registered and reported in accordance with the principles of tuberculosis management” was the highest, at 93.5% (304/325), while awareness rate of the 6th piece “How to diagnose non-active tuberculosis” was the lowest, at 73.2% (238/325).Conclusion This study showed that staff in 13 designated medical institutions and center for disease control and prevention did not fully understand these two new standards. In order to effectively control TB epidemic in China, it is essential to strengthen the effective promotion and implementation of the new standards.

A survey on the diagnostic ability of tuberculosis in the county-level medical institutions in China

WANG Qian, ZHOU Lin, LIU Er-yong, ZHAO Yan-lin, LI Tao, CHEN Ming-ting, YANG Li-jia, WANG Jia.

Chinese Journal of Antituberculosis. 2020, 42(9):  926-930.  doi:10.3969/j.issn.1000-6621.2020.09.008

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Objective To analyze the TB diagnostic capacity in county level TB designated hospitals, and to provide a basis for formulating strategies and measures in TB prevention and control. Methods From July to December, 2019, the research team conducted a survey on the current situation of TB diagnosis service capacity in China’s county level TB designated hospitals, and described the number and distribution of medical personnel engaged in TB clinical, imaging and laboratory work in 2316 county-level TB designated medical institutions (excluding Tibet Autonomous Region, Hong Kong, Macao and Taiwan), as well as the implementation of TB auxiliary examination. Results Among 2316 county-level TB designated medical hospitals, the doctors engaged in TB clinical, imaging and laboratory were mainly undergraduate and junior college education background, accounting for 64.14% (24014/37439) and 23.57% (8823/37439), respectively. The professional titles were mainly junior and intermediate, accounting for 44.07% (16501/37439) and 36.15% (13533/37439) respectively. Among 2316 county-level TB designated medical institutions, 29.79% (690/2316), 88.77% (2056/2316) and 75.86% (1757/2316) could carry out TB computer radiography (CR), digital radiography (DR) and CT/MRI, respectively; 70.73% (1638/2316), 23.01% (533/2316), 66.02% (1529/2316), 36.10% (836/2316) and 81.26% (1882/2316) could carry out tuberculin test (PPD test), interferon gamma release test (IGRA) and antibody test, respectively. Conclusion County-level designated tuberculosis medical institutions are in shortage of professional health care workers in TB prevention and control as well as high-level professionals. TB diagnosis capacity in laboratory and imaging need to be improved.

Value of tuberculin test in screening tuberculosis infection in HIV infected/AIDS patients in Butuo County, Sichuan Province

LI Ting, HE Jin-ge, SU Qian, LI Jing, LI Yun-kui, GAO Wen-feng, GAO Yuan, YANG Wen

Chinese Journal of Antituberculosis. 2020, 42(9):  931-936.  doi:10.3969/j.issn.1000-6621.2020.09.009

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Objective To analyze the application value of tuberculin (PPD) test in screening tuberculosis infection in HIV infected/AIDS patients in Butuo, Liangshan Yi Autonomous Prefecture. Methods A total of 688 patients who were followed up and had taken immunosuppressant therapy >1 month were enrolled, among 2159 HIV/AIDS patients managed in the “Thirteenth Five-Year Plan” National Science and Technology Major Project in Jiudu, Mu’er and Te Muli Town in Butuo between December 2018 and August 2019. Questionnaire, PPD test, X-ray chest and CD4⁺ T lymphocyte count were conducted. MTB etiology test was performed on eligible subjects. Of the 688 cases, 175 were without verification of PPD test results, 40 were not examed by X-ray and had no etiology basis, 7 were infected by nontuberculous mycobacteria, and 466 cases were included finally. SPSS 21.0 software was used to analyze the PPD test results (the average diameter of skin scleroma ≥5 mm was positive) and the status of active pulmonary tuberculosis or latent tuberculosis infection (LTBI) judged by the expert group, to detect the efficiency of PPD test for active pulmonary tuberculosis (including sensitivity, specificity, positive predictive value, negative predictive value, agreement rate) based on diagnosed active pulmonary tuberculosis cases. The relationship between positive rate of PPD test and whether complicated with active pulmonary tuberculosis or not, as well as comparison of different CD4⁺ T lymphocyte counts and prevalence, were detected by χ² test. P<0.05 was statistically significant. Results Among the 466 patients, 377 (80.90%) were negative in PPD test, 14 (3.00%) were generally positive, 29 (6.23%) were moderately positive, 46 (9.87%) were strongly positive and the positive rate was 19.10% (89/466), all of them were consistent with tuberculosis infection. By tuberculosis screening and diagnosis from expert group, 89 cases (19.10%) were active pulmonary tuberculosis, including 57 LTBI cases (12.23% (57/466)). Based on diagnosis from expert group, the sensitivity, specificity and consistent rate of PPD test for active tuberculosis were 35.96% (32/89), 84.88% (320/377), and 75.54% (352/466), respectively. The positive rate of PPD test in HIV/AIDS patients complicated with active pulmonary tuberculosis was significantly higher than that in patients without active pulmonary tuberculosis (35.96% (32/89) vs. 15.12% (57/377);χ²=20.827, P=0.000). Furthermore, only when CD4⁺ T lymphocyte count was more than 500 count/μl, the complicated rate was significantly higher (52.00% (13/25) vs. 16.67% (19/114); χ²=14.444, P=0.000). Conclusion As the sensitivity of PPD test to detect active tuberculosis was not high, other examinations should be combined.But the positive rates of PPD test was positively correlated with the count of CD4⁺T lymphocytes,and the specificity was high, negative results may also indicate non-tuberculosis infection. Therefore, it may still be used as an effective method in areas with high HIV prevalence and limited health resources.

Value of tuberculin test in screening tuberculosis infection in HIV infected/AIDS patients in Butuo County, Sichuan Province

LI Yun-kui, HE Jin-ge, SU Qian, LI Ting, LI Jing, GAO Wen-feng, YANG Wen, MAO Guang-yu

Chinese Journal of Antituberculosis. 2020, 42(9):  937-941.  doi:10.3969/j.issn.1000-6621.2020.09.010

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Objective To explore the role of tuberculosis (TB) symptom screening in the diagnosis and exclusion of active tuberculosis in HIV/AIDS patients, so as to provide reference for grassroots doctors. Methods A total of 688 HIV/AIDS patients were screened for tuberculosis in “two townships and one town” of Butuo County, Liangshan Yi Autonomous Prefecture, Sichuan Province. A multi-phase screening method was used. Six hundred and eighty-eight TB suspicious symptom screening questionnaire were sent out, 628 were recovered and 623 were effective.TB suspicious symptoms in the questionnaire were: (1) coughing and expectoration lasting for at least 2 weeks; (2) repeatedly coughing with bloody sputum; (3) recurrent fever lasting for more than 2 weeks; (4) frequent sweating at night; (5) unexplained weight loss; (6) frequent fatigue or shortness of breath; (7) lymphadenopathy. Having one or more symptoms of the above (1)~(7) lymphadenopathy. Having one or more symptoms of the above (1)~(7) were defined as positive for TB symptom screening. Basing on suspicious symptom questionnaire screening, sputum smear microscopy, chest X-ray film, sputum culture, tuberculin test and T-lymphocyte spot test (T-SPOT.TB), an expert group made TB diagnosis decisions for those 623 patients. The sensitivity, specificity, positive predictive value, negative predictive value, Youden index and Kappa value of TB symptom screening in the diagnosis of active TB were calculated with the diagnosis result of the expert group as reference standard, and the application value of TB symptom screening in HIV/AIDS patients was evaluated. Results In the field TB symptom screening, the positive rate of TB symptom was 66.29% (413/623). A total of 113 active TB patients were diagnosed by the expert group. Sensitivity, specificity, positive predictive value, negative predictive value, Youden index and Kappa value were 69.03% (78/113), 34.31%(175/510),18.89%(78/413),83.33%(175/210),0.03 and -0.76,respectively. Conclusion The Youden index and Kappa value of TB symptom screening positive in HIV/AIDS patients were relatively low comparing with expert group diagnosis result. However, because of the low cost, simple and effective operation, symptom screening can be used as an early warning indicator for TB screening in remote areas and ethnic minority areas where medical resources are particularly scarce.

Analysis on the epidemiological characteristics of pulmonary tuberculosis among children aged 0-14 in Sichuan Province from 2009 to 2018

SU Qian, XIA Yong, LU Jia, WANG Dan-xia, HE Jin-ge

Chinese Journal of Antituberculosis. 2020, 42(9):  942-947.  doi:10.3969/j.issn.1000-6621.2020.09.011

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Objective To analyze the epidemiological characteristics of pulmonary tuberculosis (PTB) among children aged 0-14 in Sichuan Province from 2009 to 2018, and provide scientific evidence for strengthening prevention and control of PTB in children. Methods Based on the reported incidence data and population data of childhood PTB patients aged 0-14 years reported in the Infectious Disease Reporting Information Management System and Basic Information System of the China Disease Prevention and Control Information System from 2009 to 2018 in Sichuan Province, the Joinpoint regression model was used for trend analysis. Results From 2009 to 2018, a total of 10981 childhood PTB cases aged 0-14 years were reported, accounting for 1.79% (10981/612506) of the reported PTB cases in the whole population. The actual reported incidence rate of PTB in children increased from 8.91/100000 (1349/15140100) in 2009 to 9.35/100000 (1229/13141100) in 2018, with an average annual growth rate of 0.50%; Joinpoint regression analysis showed that the standardized reported incidence of childhood PTB showed a periodic change during 2009—2015 (annual percentage change (APC)=-1.98%, P=0.196) and 2015—2018 (APC=10.13%, P=0.061), but both of them tended to be stable. The reported cases of PTB in boys aged 0-14 was 6011, with an average reported incidence of 8.43/100000 (6011/71339600), and 4970 reported in girls with an average reported incidence of 7.64/100000 (4970/65071300). The reported incidence of PTB in boys was generally higher than that in girls (χ²=26.261, P<0.001). Among different age groups, there were significant differences in the incidence of PTB (χ²=3629.827, P<0.001); the reported incidence of PTB was generally higher in children aged 0- years old (9.08/100000, 774/8523100) and 10-14 years old (14.37/100000, 6575/45769900)than that in children aged 1-4 years old (4.09/100000, 1423/34833900) and 5-9 years old (4.67/100000, 2209/47284100). Joinpoint regression analysis revealed that the reported incidence of childhood PTB aged 0- years rapidly decreased from 13.32/100000 (132/991000) in 2009 to 3.73/100000 (31/831900) in 2018 (APC=-10.80%, P=0.002), and the reported incidence of childhood PTB aged 10-14 years significantly increased after 2016, from 13.39/100000 (760/5676700) to 18.88/100000 (786/4162100) (APC=17.99%, P=0.042). Conclusion Although the reported incidence of PTB among children in Sichuan Province tends to be stable in recent years, there is still an upward trend. It is necessary to strengthen the BCG vaccination of newborns, the prevention and control of tuberculosis in students, and the screening of close contacts of PTB patients and children in families.

Temporal and spatial clustering analysis of pulmonary tuberculosis incidence in Shaanxi Province from 2014 to 2018

DENG Ya-li, ZHANG Tian-hua, LIU Wei-ping, ZHANG Hong-wei, MA Yu, LI Peng.

Chinese Journal of Antituberculosis. 2020, 42(9):  948-955.  doi:10.3969/j.issn.1000-6621.2020.09.012

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Objective To analyze the distribution characters of space-time specific incidence of pulmonary tuberculosis (PTB) in Shaanxi Province and to provide scientific basis for strategies and measures development on TB control and prevention. Methods ArcGIS 10.7 software was used to create a geographic information database with counties (districts) as the unit, including regional code, longitude, latitude, population and incidence number. Numbers of permanent residents in Shaanxi were 37.64 million, 37.75 million, 37.93 million, 37.98 million and 38.83 million respectively from 2014 to 2018. There were 21596 cases, 21388 cases, 21355 cases, 22517 cases and 21442 cases reported in Shaanxi Province from 2014 to 2018. GeoDa 1.14.0 and SaTScan 9.6 were used for spatial and temporal aggregation analysis of tuberculosis incidence, and ArcGIS 10.7 software was used for geographic data processing and aggregation area display. Results The incidence of PTB in Shaanxi showed significant space clusters from 2014 to 2018. The Moran I index was 0.362, 0.516, 0.597, 0.562 and 0.484 respectively, and the Z value was 8.202, 11.441, 13.404, 12.850 and 10.843 respectively, all of the P values were 0.001. From 2014 to 2018, there were 15, 19, 18, 20 and 20 counties in “high-high” region, which were mainly in the north and south of Shaanxi, especially in Yulin and Ankang. By space-time analysis, the first level cluster was distributed in Ankang and 5 counties of bordering city. The second level cluster was mainly distributed in Yulin and 7 counties of Yan’an. Except for September to November of 2015, the first level clustering time was from January to April of each year. Conclusion The incidence of PTB has obvious space-time clustering in Shaanxi Province. The clustering time is in spring, and the clustering areas are mainly distributed in Yulin and Ankang city, which should be regarded as the key area for prevention and control.

Analysis of the finding characteristics of pulmonary tuberculosis in the elderly population in Xinjiang Uygur Autonomous Region during 2009—2017

DONG Xiao, ZHAO Zhen, LIU Nian-qiang, WANG Sen-lu, CUI Yan

Chinese Journal of Antituberculosis. 2020, 42(9):  956-961.  doi:10.3969/j.issn.1000-6621.2020.09.013

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Objective To investigate the finding characteristics of pulmonary tuberculosis (PTB) in the elderly population in Xinjiang Uygur Autonomous Region (“Xinjiang”) from 2009 to 2017, in order to provide a scientific basis for the prevention and control management. Methods Clinical data, including the number of registered patients, age, gender, occupation, pathogen detection results (positive, negative and absent), how to find the patients, and the delayed diagnosis, etc., of PTB patients who aged ≥60 years and lived in Xinjiang, and registered from January 1, 2009 to December 31, 2017 were oained through Tuberculosis Information Management System, a subsystem of China Disease Prevention and Control Information System; and demographic data in each year from Xinjiang Annual Statistic were also collected. These data were analyzed using SPSS 25.0. P<0.05 was considered statistically significant. Results From 2009 to 2017, a total of 268765 PTB patients in Xinjiang were registered, of which 117125 were elderly (43.58% (117125/268765)), the proportion of PTB was increased from 36.94% (8753/23692) in 2009 to 50.17% (19810/39486) in 2017 (χ²_趋势=2257.798, P=0.000); and the rate of registered elderly patients was increased from 431.96/100000 (8753/2026328) in 2009 to 795.80/10⁵ (19810/2489318) in 2017 (χ²_趋势=4740.593, P=0.000). Of the 117125 elderly cases, etiology test was negative in 86013 (73.44%), the proportion was increased from 50.14% (4389/8753) in 2009 to 83.01% (16444/19810) in 2017 (χ²_趋势=6713.849, P=0.000). Mainly of the elderly PTB patients were male (54.98% (64400/117125)). The registered rate was lowest in patients aged 60-<65 years old (501.32/100000, 33365/6655379), and highest in patients aged 65-<70 years old (628.48/100000, 34315/5460043). The way of was mainly based on referral, seeing a doctor and recommendation were the main ways to find elderly PTB patients (75.50%,88433/117125). The delayed rate of PTB diagnosis in elderly patients in Xinjiang was 77.42% (90675/117125), while that of all aged cases was 52.89% (142150268765)). Conclusion The prevention and control situation of the elderly PTB in Xinjiang was serious, the registered incidence in aged was higher than that in all population. The case number, registered incidence and negative etiology patients increased year by year. Patients were mainly males, and found by referral, seeing a doctor or recommendation. The delayed rate of PTB diagnosis was high. Early prevention and control for elderly PTB should be managed.

Study on CT manifestations of non-tuberculous mycobacterium pulmonary disease patients with and without diabetes mellitus

LIANG Rui-yun, FANG Wei-jun, REN Hui-li, LI Hui-ru, ZHANG Hui

Chinese Journal of Antituberculosis. 2020, 42(9):  962-967.  doi:10.3969/j.issn.1000-6621.2020.09.014

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Objective To explore the difference of CT manifestations between non-tuberculosis mycobacterium (NTM) lung disease patients with diabetes mellitus (DM) and those without DM,in order to improve the differential diagnosis of these two diseases. Methods A retrospective analysis of CT findings of 59 patients with NTM lung disease with DM (group A) and 59 patients with NTM lung disease without DM (group B) who were confirmed by clinical and laboratory tests in Guangzhou Chest Hospital from January to December 2018. The distribution of lesions and CT findings were compared between these two groups.SPSS 21.0 software was used for statistical analysis. χ² test or continuous correction χ² test were used for categorical data, statistical significance was set at P<0.05. Results (1) Lesion distribution: The incidence of lesions located in ≥3 lobes in group A (83.05%, 49/59) was higher than that in group B (66.10%, 39/59), the difference was statistically significant (χ²=4.470, P=0.035). (2) CT manifestations:The incidence of nodule and tree bud sign in group B were 88.14% (52/59) and 71.19% (42/59) respectively,higher than those in group A (67.80% (40/59), 52.54% (31/59)),differences were statistically significant (χ²=7.104, 4.346; P=0.008, 0.037).The incidence of solid shadow, cavity shadow, globular/lumpy shadow and honeycombing shadow in group A were 35.59% (21/59), 67.80% (40/59), 38.98% (23/59) and 25.42% (15/59) respectively, which were higher than those in group B (13.56%(8/59),49.15%(29/59),11.86%(7/59),3.39%(2/59)),differences were statistically significant (χ²=7.726,4.223,8.139,11.614;P=0.005,0.040,0.004,0.001).(3) Cavity lesions: The incidence of thick walled cavity in group A (55.93%, 33/59) was higher than that in group B (20.34%, 12/59), the incidence of thin walled cavity in group B (38.98%, 23/59) was higher than that in group A (22.03%, 13/59),these differences were both statistically significant (χ²=15.841, 3.997; P=0.000, 0.046). Cavities located in ≥3 lobes or the number of cavities ≥3 in group A accounted for 59.32% (35/59) and 57.63% (34/59) respectively, which were significantly higher than those in group B (28.81% (17/59) and 35.59% (21/59)), differences were statistically significant (χ²=11.140, 5.755; P=0.001,0.016). Conclusion Chest CT scan for patients with NTM lung disease with DM is more likely to show lesions with wide distribution, solid shadows, thick walled cavities, globular/lumpy shadows and honeycombing shadows;thin walled cavity, nodule and tree bud sign are more likely to be seen in patients without DM.Those CT manifestations are helpful for differential diagnosis.

Clinical observation on treatment effectiveness of transdermal ultrasound-mediated drug delivery combined with oral anti-tuberculosis drug in patients with chest wall tuberculosis

MA Ting-long, HAN Yi, CHENG Xu, LIU Zhi-dong

Chinese Journal of Antituberculosis. 2020, 42(9):  968-972.  doi:10.3969/j.issn.1000-6621.2020.09.015

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Objective To observe the treatment efficacy of drug transdermal delivery by electro-phonophoresis combined with oral anti-tuberculosis drugs in patients with tuberculosis of chest wall. Methods The prospective research method was adopted. A total of 192 patients with tuberculosis of chest wall, who received initial anti-tuberculosis treatment in the Beijing Chest Hospital from July 2012 to February 2019, were enrolled into this study. Using the random number table, those patients were randomly divided into two groups: orally taking anti-tuberculosis drugs (2H-R-Z-E/7H-R-E)+ultrasonic transdermal delivery of isoniazid and rifampin (abbreviated as “EP group”); orally taking anti-tuberculosis drugs (2H-R-Z-E/7H-R-E; abbreviated as “control group”). There were 97 patients in the EP group, 2 patients lost follow-up, and finally 95 patients were evaluated; 95 patients were enrolled in the control group, 10 patients lost follow-up, and finally 85 patients were evaluated. The therapeutic effects of the patients with chest wall tuberculosis in the two groups receiving different treatment schemes were analyzed. Results In the EP group, 64 patients were cured and the treatment efficacy was significant in additional 13 patients, so the total treatment effective rate was 81.1% (77/95). In the control group, 18 patients were cured and the treatment efficacy was significant in 2 patients, so the total treatment effective rate was 23.5% (20/85). The total treatment effective rate of the patients in the EP group was higher than that in the control group, and the difference was statistically significant (χ²=59.738, P<0.001). Conclusion The therapeutic effectiveness of transdermal ultrasound-mediated drug delivery combined with oral anti-tuberculosis drugs treatment in the patients with chest wall tuberculosis is much better than that of traditional treatment only with oral anti-tuberculosis drugs, and it can be used as an adjuvant treatment method in the patients with chest wall tuberculosis in their perioperative period.

Meta-analysis on the diagnostic value of GeneXpert MTB/RIF for bone and joint tuberculosis

NAN Hai, ZHANG Yun, YANG Xin-ting, DUAN Hong-fei

Chinese Journal of Antituberculosis. 2020, 42(9):  973-980.  doi:10.3969/j.issn.1000-6621.2020.09.016

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Objective To systematically evaluate the diagnostic value of GeneXpert MTB/RIF assay for bone and joint tuberculosis. Methods Relevant literatures on the diagnosis of bone and joint tuberculosis by GeneXpert MTB/RIF assay were collected by searching Wanfang, VIP, China National Knowledge Infrastructure, PubMed, Embase, and Cochrane Library databases from establishment to May 2020, and then literature screening, data extraction and quality evaluation were performed independently by two researchers. Reman 5.3 and MetaDisc 1.4 software were used for literature quality evaluation and Meta-analysis, respectively. Results A total of 350 literatures were retrieved, and 24 literatures from 4 countries were screened out according to the inclusion and exclusion criteria, including 3966 clinical specimens. Meta-analysis showed that compared to the comprehensive clinical diagnosis (CRS) as the reference standard, the pooled sensitivity and specificity of GeneXpert MTB/RIF assay for diagnosing the bone and joint tuberculosis were 82.9% (95%CI: 81.4%-84.3%) and 86.3% (95%CI: 84.3%-88.2%), respectively. Based on MTB culture and absolute concentration method drug sensitivity test (DST) as the gold standard, the pooled sensitivity and specificity were 93.9% (95%CI: 92.2%-95.2%) and 52.3% (95%CI: 49.9%-54.6%), respectively. GeneXpert MTB/RIF assay also had high sensitivity (89.5%, 95%CI: 87.5%-91.4%) and specificity (89.9%, 95%CI: 85.6%-93.2%) in the diagnosis of rifampin (RIF)-resistant bone and joint tuberculosis. Conclusion GeneXpert MTB/RIF assay has a high diagnostic value for bone and joint tuberculosis and RIF-resistant bone and joint tuberculosis. It can be used as an effective method for the rapid diagnosis of bone and joint tuberculosis.

Value of clinical pathway table of enhanced recovery cluster nursing in patients with spinal tuberculosis during perioperative period

ZHANG Li-juan, TAO Xiao, XIA Li-li, WEI Fen-fen, ZHENG Qi

Chinese Journal of Antituberculosis. 2020, 42(9):  981-986.  doi:10.3969/j.issn.1000-6621.2020.09.017

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Objective To investigate the application effect of clinical pathway table of enhanced recovery cluster nursing in patients with spinal tuberculosis during perioperative period. Methods Forty-two patients who met the inclusion criteria and underwent surgery for spinal tuberculosis from Zhejiang Integrated Traditional and Western Medicine Hospital, between July 2018 and December 2018, were selected as the control group. Forty patients who met the inclusion criteria and underwent surgery for spinal tuberculosis from the same hospital between July 2018 and December 2018 were selected as the observation group. Patients in the control group were treated with traditional perioperative nursing measures, and those in the observation group were treated with clinical pathway table of enhanced recovery cluster nursing designed by ourselves. The postoperative Numerical Rating Scale (NRS score), occurrence of breakthrough pain, recovery time of gastrointestinal function, time of first getting out of bed and eating, occurrence of adverse reactions, satisfaction with hospitalization, cost of hospitalization and so on, were compared between the two groups. Results The NRS score of 24, 48 and 72 hours after operation were 3.75±0.81, 3.48±0.93 and 2.63±0.74, respectively in the observation group. All of them were significantly lower than those in the control group (4.26±1.06, 4.12±0.83 and 3.26±0.83, respectively). The differences were statistically significant (t=2.449, 3.301 and 3.665, respectively; P=0.017, 0.001 and 0.000, respectively). In the observation group, 1 patient (2.4%) experienced breakthrough pain, the rate was significantly lower than the control group (6 patients (14.3%)) (χ²=4.178, P=0.041). In the observation group, the times of first passing gas, getting out of bed and eating after operation were significantly earlier than those in the control group ((23.65±7.76) h vs. (32.38±11.50) h, t=4.008, P=0.000; (10.20±2.87) d vs. (13.90±1.45) d, t=7.444, P=0.000; (19.58±10.43) h vs. (30.81±9.81) h, t=5.024, P=0.000). The incidence rate of nausea and vomiting in the observation group (20.0%, 8/40) was significantly lower than that in the control group (64.3%, 27/42) (χ²=16.424, P=0.000). The postoperative satisfaction rate of the observation group was 100.0% (40/40), which was significantly higher than that of the control group (88.1%, 37/42) (χ²=6.531, P=0.038). The hospitalization expense in the observation group was RMB (90.2±14) thousand yuan, which was significantly lower than that in the control group (RMB (101.8±16) thousand yuan) (t=3.486, P=0.001). Conclusion The clinical pathway table of enhanced recovery cluster nursing for spinal tuberculosis patients could promote recovery of the patients, reduce the cost of hospitalization, improve satisfaction, and improve the overall efficacy, it is worthy of promotion in clinic.

Interpretation of Standards

Interpretation of the Specification of tuberculosis examination for student entrance physical examination

CHENG Jun

Chinese Journal of Antituberculosis. 2020, 42(9):  987-989.  doi:10.3969/j.issn.1000-6621.2020.09.018

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Specification of tuberculosis examination for student entrance physical examination, one of association standards launched by Chinese Antituberculosis Association, is put into force from July 7th, 2020. Requirement for facilities qualified for conducting entrance physical examination including tuberculosis check, methods and procedures, feedback of results, files management and post-treatment for all kinds of schools are included in this standard. The author describes its background, main content and application in order to make the potential users understand this standard well.

Interpretation of the Guidelines on management of close contacts of active pulmonary tuberculosis cases in schools

SHEN Xin, XIAO Xiao, BAI Li-qiong, PAN Qi-chao

Chinese Journal of Antituberculosis. 2020, 42(9):  990-991.  doi:10.3969/j.issn.1000-6621.2020.09.019

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Guidelines on management of close contacts of active pulmonary tuberculosis cases in schools is instructive and operable for managing tuberculosis epidemics in schools. This article introduces the background, objective, main content and characteristics, especailly points out the improvements based on current policies and guidelines, in order to clarify the application and the significance, and then to strengthen the ability of tuberculosis prevention and control in schools.

Short Articles

Analysis of the service capability in city/county tuberculosis designated hospital in Hainan

CHEN Yu-mei, LUO Xing-xiong, CHEN Cheng-jiang, SU Ping, WANG Chun-lei.

Chinese Journal of Antituberculosis. 2020, 42(9):  992-993.  doi:10.3969/j.issn.1000-6621.2020.09.020

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To understand the status of service capability in city/county tuberculosis (TB) designated hospital in Hainan, the questionnaire design by Chinese Center for Disease Control and Prevention was used, the data of educational background and professional title of clinical staff and laboratory staff, as well as the usage of TB auxiliary examination from 18 city/county TB designated hospital in Hainan in 2019. It was found that there were 347 clinical and laboratory staff in the 18 city/county TB designated hospital. The average service population was 26900 per staff,and service radius of 5.68 km per staff. The mainly of the staff were bachelor (65.7%, 228/347), only 11 (3.2%) were master or higher. There was no staff with master’s degree or higher in counties/ethnic minority autonomous counties. Mainly staff were with junior or other professional titles (53.0%, 184/347), and the senior titles only accounted for 15.0% (52/347). The digital X-ray (DR), CT or MRI were carried out for 94.4% (17/18) and 77.8% (14/18), respectively from the 18 TB designated hospitals. However, the proportions of CR, tuberculin skin test, interferon gamma ralease assays and fiber bronchoscopy were not high, which were 33.3% (6/18), 33.3% (6/18), 11.1% (2/18) and 11.1% (2/18), respectively. The Gini coefficients of distribution based on the number of permanent residents and land area were both 0.38. It was found that the staff with high academic qualifications and high professional titles were not enough, the auxiliary tests were carried out imbalanced, the staff need to be further strengthened in city/county TB designated hospitals in Hainan.

Characteristics of the tuberculosis epidemic in schools in Qingdao in 2010—2019

SUN Hai-yan, LI Shuo, WANG Zhong-dong, REN Zhi-sheng, SONG Song, XUE Bai, ZHANG Hua-qiang, DAI Xiao-qi

Chinese Journal of Antituberculosis. 2020, 42(9):  994-997.  doi:10.3969/j.issn.1000-6621.2020.09.021

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The data of patients registered as “students”, the number of registered cases of tuberculosis (excluding tuberculous pleurisy) in 2010—2019 from Tuberculosis Management Information System (TBIMS) and the population data of Qingdao Statistical Yearbook were collected to analyze the registration status and epidemiological characteristics of tuberculosis among students. In 2019, the registration rate was 11.91/100000 (175/1468777), decreased by 27.95% in comparison with that in 2010 (16.53/100000, 212/1282589). The overall trend was downward and the difference was statistically significant (Z_trend=-6.567, P<0.001). Annually, March and April were the peak periods for student’s registered cases (24.42%, 443/1814). In the constituent ratio for all age groups in the reported cases in students from 2010 to 2019, the highest proportion was at college and junior college stage (19- <22 age groups) with an average of 43.16% (783/1814). One thousand six hundred and fifty cases (90.96%, 1650/1814) were detected by passive methods. The patient delay rate of patients was 62.24% (1129/1814). The registration rate of tuberculosis among students in Qingdao was at a low level. It is still necessary to continue to pay attention to the prevention and control of tuberculosis among students, strengthen health education, and improve the awareness of disease prevention among students.

Value of fluorescence PCR probe melting curve method in detecting resistance of Mycobacterium tuberculosis

LI Ai-fang, CUI Xiao-li, KANG Lei, LEI Jing, DANG Li-yun, YANG Han

Chinese Journal of Antituberculosis. 2020, 42(9):  998-1001.  doi:10.3969/j.issn.1000-6621.2020.09.022

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A total of 546 patients with pulmonary tuberculosis who were hospitalized in Xi’an Chest Hospital between September 2017 to August 2019 were selected as subjects to evaluate the clinical application value of fluorescence PCR probe melting curve method (melting curve method) in detecting drug resistance of Mycobacterium tuberculosis (MTB). The sputum samples of the subjects with the amount larger than 2 ml were collected. After strain identification, 531 cases (strains) were finally included as the research objects. The same sputum sample of each subjects was performed drug resistance gene detection using BACTEC MGIT 960 liquid culture drug susceptibility test (960 liquid drug susceptibility test) and fluorescence PCR probe melting curve method. For subjects with inconsistent results of MGIT 960 drug sensitivity test and melting curve method for rifampicin and isoniazid resistance, the melting curve method was verified by gene chip method to detect drug resistance gene. Based on the results of MGIT 960 liquid drug susceptibility test as reference standard, the sensitivity, specificity, coincidence rate and Kappa value of the melting curve method in detecting streptomycin resistance were 86.67% (39/45), 99.38% (483/486), 98.31% (522/531) and 0.887; the sensitivity, specificity, coincidence rate and Kappa value of the melting curve method for detecting isoniazid resistance were 69.23% (54/78), 98.68% (447/453), 94.35% (501/531) and 0.751; the sensitivity, specificity, coincidence rate and Kappa value of the melting curve method for the detection of rifampicin resistance were 87.50% (42/48), 96.89% (468/483), 96.05% (510/531) and 0.778; the sensitivity, specificity, coincidence rate and Kappa value of the melting curve method for detecting ethambutol resistance were 50.00% (9/18), 98.83% (507/513), 97.18% (516/531) and 0.531. Among the 30 cases that were resistant by the melting curve method and sensitive by the MGIT 960 liquid drug sensitivity method, the melting curve method showed that the 6 cases resistant to isoniazid were katG 315 codon mutation; among the 15 cases resistant to rifampicin, the mutations at codons of ropB 507-512, ropB 521-528, and ropB 529-533 were 3 cases, 3 cases, 9 cases, respectively; the 3 cases resistant to streptomycin were rrs 513-517 codon mutation; the 6 cases resistant to ethambutol were embB 306 codon mutation. The results of gene chip detection of drug resistance genes revealed that among the 6 cases of resistance to isoniazid, there were 3 cases of katG 315 (AGC→ACC) mutation and 3 cases of katG 315 (AGC→AAC) mutation; and among the 15 cases of resistance to rifampicin, there were 3 cases of ropB 511 CTG→CCG mutation, 3 cases of ropB 526 CAC→TAC mutation and 9 cases of ropB 531 TCG→TGG mutation, which were consistent with the results of melting curve method. Fluorescence PCR probe melting curve method has good efficiency for the detection of streptomycin, isoniazid, rifampicin, ethambutol resistance mutation sites, and it can be used for rapid screening of clinical resistance to first-line anti-tuberculosis drugs.

Study on the relationship of stigma and social support of tuberculosis patients

LIU Xiao-li, LEI Li-mei, GUO Zhou-li, HUANG Yin, XU Jing, ZHAO Xia, WANG Yan, FU Li

Chinese Journal of Antituberculosis. 2020, 42(9):  1002-1008.  doi:10.3969/j.issn.1000-6621.2020.09.023

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Two hundred and one tuberculosis patients visiting Chengdu Public Health Clinical Center from July to December 2019 were enrolled as study objects. Stigma scale and perceived social support scale were used for investigation. The total scores of stigma and social support were 10 (7,12) and 62 (54,71) respectively in 201 tuberculosis patients. There was a negative correlation between stigma and social support (r=-0.461,P<0.001). After the patients were diagnosed with tuberculosis, they all had different degrees of stigma. Occupation, duration of illness and the number of complications were the main factors affecting the stigma of tuberculosis patients, and education level affected the understanding of social support.