Table of Content

10 December 2014, Volume 36 Issue 12

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Development and prospects of children’s tuberculosis prevention and control strategy

CHENG Shi-ming

Chinese Journal of Antituberculosis. 2014, 36(12):  1003-1007.  doi:10.3969/j.issn.1000-6621.2014.12.001

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Towards zero childhood tuberculosis deaths: are we ready？

LU Shui-hua

Chinese Journal of Antituberculosis. 2014, 36(12):  1008-1010.  doi:10.3969/j.issn.1000-6621.2014.12.002

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According to WHO estimation, there are more than half a million cases of tuberculosis in children occurring globally each year. Every day, more than 200 children under the age of 15 die of tuberculosis—a disease that is curable. WHO chart the roadmap for childhood tuberculosis: towards zero deaths. However, diagnosis of childhood tuberculosis remains difficult because of the atypical clinical symptoms and lack of sputum production in young children. Rates of progression from latent infection to active disease (including severe forms of the disease, such as meningitis, disseminated disease, or death as a result of M. tuberculosis) are higher in infants and young children. China ranks second among the high-burden countries for tuberculosis, children tuberculosis epidemic situation in China is not optimistic. Only by focusing on the common challenges for diagnosis, treatment, prevention and control of children tuberculosis, we can achieve the goal of zero tuberculosis deaths among children.

Attention to quantitative research and evaluation of the quality of life of patients with TB

BAI Li-qiong，ZHOU Lin，ZHONG Qiu，ZHANG Chuan-fang，LIU Er-yong，CHENG Shi-ming

Chinese Journal of Antituberculosis. 2014, 36(12):  1011-1014.  doi:10.3969/j.issn.1000-6621.2014.12.003

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In the late 1970 of the 20th century, the gradual introduction of the quality of life in the field of medical research and the formation of new research boom, but there is still no uniform definition of quality of life standards, and the research on quality of life in patients with pulmonary tuberculosis is relatively less. Currently, there has no mature dedicated TB quality of life scale both at home and abroad. Most of the foreign mature, universal scale, such as SF-36, WHOQOL-100 and WHOQOL-BREF was used for patients with tuberculosis after direct translation or some modification. Some dedicated quality of life scale for tuberculosis is still in exploration.

Analysis on national pulmonary tuberculosis epidemic characteristics of children under 14 years old

LIU Er-yong, MA Yan, LI Tao, DU Xin, ZHOU Lin, CHENG Shi-ming

Chinese Journal of Antituberculosis. 2014, 36(12):  1015-1020.  doi:10.3969/j.issn.1000-6621.2014.12.004

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Objective To analyze the national characteristics and change trend of tuberculosis in children under the age of 14, provide the basis for children’s TB control strategies.  Methods We obtained the TB infection rate and the prevalence rate from the 1979, 1990 and 2000 national epidemiological sampling survey of tuberculosis. We also used pulmonary TB incidence data from 2001 to 2010 to analyze the trend of childhood TB incidence.  Results In 1979, the tuberculosis infection rate in children under 14 years old is 8.8%, and tuberculosis prevalence rate was 247.1/100 000, smear positive prevalence rate was 7.5/100 000. In 2000, these rates are 9.0%, 91.8/100 000 and 6.7/100 000 respectively. The national average children reported incidence of tuberculosis decreased from 9.3/100 000 （26 563/284 520 000）in 2001 to 4.0/100 000（9751/246 550 000） in 2010. In different age groups of children, in 2001, the 0－4 year old group was highest of 11.6/100 000（7995/68 970 000）. In 2010 the 10－14 year age group was highest to 7.3/100 000（5932/81 630 000）. The percentage of reported incidence cases of childhood pulmonary tuberculosis in tuberculosis cases among total population declined by year from 4.7%（26 563/570 527） in 2001 to 1.0%（9751/991 350） in 2010. Conclusion There has no decline in the children Mycobacterium tuberculosis infection rate nationwide; the prevalence of active tuberculosis and smear positive cases decreased rapidly; the reported incidence of childhood tuberculosis showed the decreasing trend.

Clinical analysis of 7 cases of pediatric tuberculosis with hematological malignancy

LI Tao，XI Xiu-hong，LI Feng，LIU Xu-hui，JIANG Hui，LU Shui-hua

Chinese Journal of Antituberculosis. 2014, 36(12):  1021-1024.  doi:10.3969/j.issn.1000-6621.2014.12.005

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Objective To explore the clinical characteristics，diagnosis，treatment and prognosis of pediatric tuberculosis (TB) with hematological malignancy. Methods A retrospective study was performed on 7 children diagnosed with tuberculosis and hematological malignancy（including 6 cases of acute lymphoblastic leukemia and 1 of pleural lymphoma, 5 were male and 2 were female； the median age was 8 years old ranging from 3 years to 11 years）at Shanghai Public Health Clinical Center from April 2010 to September 2014. The diagnosis，clinical features, treatment and prognosis were evaluated.  Results Of the 7 patients, 6 children had acute lymphoblastic leukemia, and 1 had pleural lymphoma. Two of all patients were diagnosed TB before hematological malignancy, 5 patients during acute lymphoblastic leukemia chemotherapy. Clinical manifestations included fever, night sweats and hepatosplenomegaly in all cases, cough in 6 cases, losing weight and loss of appetite in 5 cases, joint pain in 1 case, breathing difficulty and superficial lymphadenopathy in 2 cases. IGRA was positive only in 5 patients (5/7). Anti-tuberculosis combined with chemotherapy was applied to 5 cases, and 2 cases gived up treatments, including 1 case of acute lymphoblastic leukemia and 1 of pleural lymphoma. During follow-up，2 case who gived up treatment died, other 5 patients showed tuberculosis cured，and 3 of 5 patients completed leukemia treatment and achieved continuous complete remission(they were in CCR for 3 years, 18 months and 6 months, respectively), 1 of the 5 patients just completed maintenance treatment, and 1 patient was still in maintenance treatment for leukemia.  Conclusion Early diagnosis of children TB combined hematological malignancy remains a challenge for clinicians, and anti-tuberculosis combined with chemotherapy is required that this isn’t going to affect their prognosis.

Case and literature analysis of patient with chronic granulomatous disease and Lymph node tuberculosis

ZHANG Ai-mei, LI Feng, LU Shui-hua

Chinese Journal of Antituberculosis. 2014, 36(12):  1025-1028.  doi:10.3969/j.issn.1000-6621.2014.12.006

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Objective To discuss the clinical manifestation, diagnosis and treatment of the primary immunode-ficiency disease (PIDs), especially CGD and PIDs complicated by Mtb or BCG infection, in order to improve the recognition, diagnosis and treatment. Methods Keywords: “primary immunodeficiency diseases”, “chronic granulomatous disease”, “Mycobacterium tuberculosis (Mtb), BCG”, “chronic granulomatous disease” in Chinese and “Mycobacterium tuberculosis” in Chinese were used to retrieve the articles in PubMed, Web of Science, CNKI and Wanfang of recent fourteen years and 21 articles were retrieved finally. We explored the characteristics, clinical presentation, diagnosis and treatment of primary immunodeficiency diseases (PIDs) complicated by Mtb or BCG and reviewed the literature on this topic in order to improve the capacity of diagnosis and treatment of the disease. Results PIDs often began with repeated or multiple infections while Mtb infection was the most common one. Children who infected with Mtb often got diagnosis through pathology or bacteriological, while the diagnosis of PIDs was based on genetic detection. Treatment of the disease was mainly anti-infection and symptomatic treatment. In our case, the child had CGD, EB virus associated lymphoproliferative diseases and lymph node tuberculosis, his condition improved after chemotherapy, anti-infection, anti-tuberculosis treatment. Conclusion Due to the clinical manifestation, laboratory examination, imaging features of PIDs combined with BCG or Mtb infection are lack of specificity, and the children who have the diseases always have a poor prognosis, early diagnosis and treatment of the diseases are important.

Assessment of X-ray screening for active case finding in the general rural population of Jiangsu province

PENG Hong, XU Wei-guo, ZHAI Xiang-jun, ZHU Li-guo, ZHU Ye-fei, JIANG Wei, ZHU Tao, JI Ming, LU Wei, JIANG Jie, ZHU Feng-cai

Chinese Journal of Antituberculosis. 2014, 36(12):  1029-1035.  doi:10.3969/j.issn.1000-6621.2014.12.007

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Objective To assess the TB prevalence in rural Jiangsu province, in order to provide scientific evidence for appropriate active screening strategies and intervention measures. Methods With stratified cluster random sampling method，50 out of 887 villages（communities) in Zhangjiagang, Danyang and Taixing cities were sampled. Questionnaire survey and physical examination were conducted for all investigated population, chest X-ray was applied to population ≥15 years old except pregnant women. Totally 157 168 population were investigated and 116 796 were conducted X-ray screening. EpiData 3.1 and Excel 2007 software was used to set up database and SPSS 17.0 for statistic analysis. Results In the investigated population, 1557 people suffered with TB suspicious symptoms, among them 62.4%（972/1557）had cough for more than 2 weeks, and 1622 had chest X-ray abnormality. A total of 165 active TB cases was detected with the crude prevalence rate（detection rate) of active PTB of 141.3/100 000（165/116 796）. Among them, 134 were initial treatment cases (including 78 cases of smear positive) accounting for 81.2%, 31 were retreatment cases(including 31 cases of smear positive) accounting for 18.8%, and 124 were male and 41 were female with the ratio of 3.02 to 1; the prevalence rate of age group ≥65 years（335.1/100 000,61/18 205）was significantly higher than other age groups(15-: 43.6/100 000,16/36 685；40-: 143.0/100 000,88/61 532)(χ²=73.05，P<0.001); 153 cases（92.7%） had chest X-ray abnormality; 79(47.9%) cases got access to timely diagnosis and medical care without delay（within 1 week); 155(93.9%) cases got treatment success; the economic analysis found that the direct cost for detecting one active TB cases by chest X-ray screening is about 31 000 RMB on average.  Conclusion Chest X-ray screening plays an important role in active tuberculosis early detection and treatment, is an important intervention and a useful complement to the passive discovery.

Epidemic characteristics of pulmonary tuberculosis in Chongqing from 2009 to 2013

YU Ya，LIU Ying，HU Dai-yu，ZHANG Shun

Chinese Journal of Antituberculosis. 2014, 36(12):  1036-1042.  doi:10.3969/j.issn.1000-6621.2014.12.008

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Objective To learn the epidemic characteristics of pulmonary tuberculosis (PTB) in Chongqing and provide a data support to improve the tuberculosis prevention and control strategy. Methods We got the data of reported PTB patients from Chinese Infectious Disease Report Information System and abstracted population data from Chongqing Statistical Yearbook and The Fifth Census of Chongqing, then the incidence of reported PTB patients was calculated. The numbers of resident population in Chongqing from 2009 to 2013 were 28 390 000 in 2009, 28 590 000 in 2010, 28 846 200 in 2011, 29 190 000 in 2012 and 29 450 000 in 2013 respectively. The cumulative number of population were 73 091 900 in male and 71 374 300 in female. The descriptive epidemiological methods were used to analyze distribution of PTB from 2009 to 2013. Chi square test was used to analyze the reported incidence rate of PTB patients with different year, different gender and different age, with P<0.05 as the statistical difference. Results The average reported PTB incidence was 88.8/100 000 (128 346/144 466 200), the incidence rates were 96.9/100 000 (27 509/28 390 000) in 2009, 89.9/100 000 (25 702/28 590 000) in 2010, 88.8/100 000 (25 622/28 846 200) in 2011, 85.6/100 000 (24 977/29 190 000) in 2012 and 83.3/100 000 (24 536/29 450 000) in 2013 respectively, which showed a downward trend by year (χ²_trend=347.8, P<0.01).The cases mainly concentra-ted in January and March (accounted for 21.3%, (13 738+13 617)/128 346). Epidemic situation of PTB in different regions was uneven, the top five regions were Pengshui county (161.7/100 000, 4352/2 690 600), Chengkou county (156.2/100 000, 1489/953 300), Qianjiang district (152.7/100 000, 3382/2 214 900), Wuxi county (142.9/100 000, 3008/2 104 900) and Wulong county (141.3/100 000, 2455/1 737 900). The incidence rate in male (124.7/100 000, 91 173/73 091 900) was higher than in female (52.1/100 000, 37 173/71 374 300)(χ²=21 476.1, P<0.01). There was a statistical difference between different age groups in reported incidence (χ²=12 639.5, P<0.01), peaked in 75- age group (179.2/100 000, 774/431 918). Most cases in all occupations was farmer (accounted for 55.9%, 71 791/128 346). Conclusion The PTB epidemic in Chongqing has steadily declined in recent years. As the epidemic situation of PTB in different area of different demographic characteristics is imbalance, we need to improve control strategy according to the actual situation to control the epidemic of PTB better.

Evaluation of the effect of isoniazid tuberculosis preventive therapy among eligible HIV-infected people and AIDS patients in compulsory isolation detoxification center

HE Jin-ge,ZHOU Lin,LIU Er-yong,LI Ting,CHANG Rang-dan,XIE Xing-wen,LI Yun-kui,WU Jian-lin

Chinese Journal of Antituberculosis. 2014, 36(12):  1043-1046.  doi:10.3969/j.issn.1000-6621.2014.12.009

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Objective To explore the mechanism and effect of isoniazid preventive therapy for among eligible HIV/AIDS in compulsory isolation detoxification center. Methods A compulsory isolation detoxification center in Ziyang city of Sichuan province was selected as the research field via a typical survey method. We established me-chanism of communication, coordination and technology guarantee between CDC and compulsory isolation detoxification hospital, strengthened training and health promotion, and we carried out TB screening to 553 HIV/AIDS patients under the management of the detoxification hospital. Meanwhile, they were administered questionnaires survey, X-ray, sputum smear, liver and kidney function and blood tests. After ruling out the active TB, 305 HIV/AIDS patients with normal liver and kidney function and consented to the preventive therapy received the isoniazid directly observed preventive therapy for 6 months, and were followed in the 1st, 2nd,4th,6th month of treatment and 6th and 12th month after treatment completion. The provincial expert group was responsible for quality control with all the abnormal chest X-ray, sputum smear results review and follow-up work supervision. Results There were a total of 553 HIV/AIDS patients and 23 cases were confirmed active TB patients, with the detection rate of 4.2%（23/553）;43 cases （7.8%,43/553）had abnormal liver function; 89 cases（16.1%,89/553）would soon end the compulsory detoxification;93 cases（23.4%,93/398）did not sign the consent form among those 398 cases who eligible for the isoniazid therapy;305 cases（76.6%,305/398）were given directly observed isoniazid preventive therapy, 297 completed six months of therapy with good medication compliance, treatment completion rate of 97.4%(297/305). Eight quited due to adverse reactions due to adverse reaction, the adverse reaction rate was 2.6%(8/305).None TB patients occurred during the 12-months follow-up after treatment completion. Conclusion Compulsory isolation detoxification center is an important place to carry out INH preventive therapy for among eligible HIV/AIDS, and the experience deserved extension.

Survey on the awareness status of key messages on TB among people in Erlangmiao town, Jiangyou city, Sichuan province

LI Yang-yang, CHENG Jun, CAO Jie, XIA Lan, ZHANG Pei-ru, WU Jian-lin, CHEN Wei, WANG Li-xia

Chinese Journal of Antituberculosis. 2014, 36(12):  1047-1054.  doi:10.3969/j.issn.1000-6621.2014.12.010

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Objective To understand and evaluate the awareness level of key tuberculosis (TB) messages in Erlangmiao town, Jiangyou city, Sichuan province, in order to inform tailored interventions for future health promotion and health education. Methods Part of data was collected from “tuberculosis incidence and intervention pattern” study. Subjects were interviewed face-to-face with the same questionnaire designed by for all permanent residents who were 15 years old and above in Erlangmiao town, 10 840 questionnaires were sent out while 10 726(98.95%) returned. Then awareness level was analyzed among different characteristics people. Results The overall awareness rates of key TB messages in Erlangmiao town was 25.29%(13 561/53 630). Of those who are doctors, cadre staff, workers, teachers or college educated, the awareness rates were higher than 75%，respectively were 90.60%（453/500）, 87.38%（450/515）, 85.45%（1457/1705）, 77.93%（339/435）and 75.13%（1450/1930）. Of those elderly widowers, aged over 75 or illiterate or semi-illiterate group, the rates were lower than 10%, respectively are 5.60%（258/4605）, 8.81%（270/3065）and 8.48%（1100/12 970）. Among TB high-risk groups, awareness rates were highest in previous TB infected person（45.15%, 219/485）. While low in old aged（10.35%, 1228/11 860） or people in close contact with TB patients（12.50%, 30/240）. Conclusion The awareness level of key TB messages is still low in Erlangmiao town. In order to improve the awareness rates to a higher level，it’s essential to strengthen localized health promotion and health education to the public, especially to those TB high risk population．

Systematic review on impact of different medical institutions mix model on tuberculosis case detection

MA Yan, DU Jian, LI Liang, LIU Yu-hong

Chinese Journal of Antituberculosis. 2014, 36(12):  1055-1061.  doi:10.3969/j.issn.1000-6621.2014.12.011

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Objective Systematic review on impact of different international medical institutions mix model on tuberculosis case detection. Methods We determined the key words by experts’ discussion, and searched 12 database, 3 health agencies websites(World Health Organization network, National Health and Family Planning Commission of the People’s Republic of China and the United States Centers for Disease Control and Prevention) and Google Scholar. Our inclusion criteria were research papers that reported describing public-private, public-public (general hospital and TB dispensary) mix, Non-governmental organizations (NGO)-private mix, case detection, effect evaluation. Eight hundred and three studies (published in 2000-2013)were retrieved, except perspective-related articles, letters, news, editorials, reviews, bibliography and conference summary, 27 full-text studies were included and analyzed. Results The results showed that there are mainly 3 kinds of mixes: public-public (general hospital and TB dispensary) mix, which implement mainly in China, improved the case detection rate ranging from 24.4% to 50.1% through mix; Public-private mix, mainly in India, Indonesia, and Vietnam, Kenya, Nepal, South Korea and the United States and other countries, case detection rate increased 7%-57% through mix; Non-governmental organization-private mix, mainly in India, the case detection rate increased 12%-40% through mix. Conclusion We should further perfect the existing general hospital and TB dispensary mix in China, bring the non-governmental organizations and private institutions into general hospital and TB dispensary mix system, to improve the tuberculosis case detection in China.

The value of drug-induced lymphocyte stimulation test for the diagnosis of anti-tuberculous drug-induced hypersensitivity reaction

SUN Qin, SHA Wei, GUI Xu-wei, ZENG Wei-hong, XIAO Yang-jiong,XIAO He-ping

Chinese Journal of Antituberculosis. 2014, 36(12):  1062-1066.  doi:10.3969/j.issn.1000-6621.2014.12.012

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Objective To evaluate the value of drug-induced lymphocyte stimulation test (DLST) for the dia-gnosis of anti-tuberculosis (TB) drug-induced hypersensitivity reaction. Methods One hundred and fourteen patients with first treatment pulmonary tuberculosis who had adverse drug reactions were served as case group. Ninety-six patients without adverse drug reactions were served as control group. After the DLST was completed, the sensitivity, specificity, false positive rate and false negative rate were compared with “gold standard” drug provocation test (DPT) for each reaction event and each drug. Results Of 114 patients in case group, a total of 127 times of anti-TB drug-associated adverse reactions occurred, including 37 cases of drug rash, 65 cases of drug-induced liver injury, and 25 cases of drug-associated fever. The sensitivities of DLST in the diagnosis of hypersensitivity reactions induced by isoniazid (INH), rifampicin (RFP), ethambutol (EMB), and pyrazinamide (PZA) were 64.5% (20/31), 48.3% (28/58), 54.2% (13/24) and 31.6% (6/19), respectively. Their specificities were 93.3% (167/179), 94.7% (144/152), 97.3% (181/186) and 98.4% (188/191), respectively. Their false-positive rates were 6.7% (12/179), 5.3% (8/152), 2.7% (5/186) and 1.6% (3/191), respectively. Their false-negative rates were 35.5% (11/31), 51.7% (30/58), 45.8% (11/24) and 68.4% (13/19), respectively. Conclusion DLST have high specificity and limited sensitivity in the diagnosis of anti-TB drug-induced hypersensitivity reaction, and is helpful for the clinicians to predict the causative drugs.

The change of T lymphocytes and interleukin-2 in pleural fluid of the patients with tuberculous pleurisy

SHI Xiang，TANG Liang，SU Bo

Chinese Journal of Antituberculosis. 2014, 36(12):  1067-1070.  doi:10.3969/j.issn.1000-6621.2014.12.013

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Objective To analyze the differences of T lymphocytes, interleukin-2 (IL-2), soluble interleukin-2 receptor (sIL-2R) between in the sera and pleural effusions of patients with tuberculous pleurisy, and to explore the immune mechanism of tuberculous pleurisy. Methods Sandwich enzyme-linked immunosorbent assay (ELISA) were used to detect the IL-2, sIL-2R in peripheral bloods and pleural effusions of 150 patients, who were hospitalized in Shanghai Pulmonary Hospital from June 2010 to December 2011, and diagnosed as tuberculous pleurisy of initial treatment, meeting the inclusion criteria. The ratios of T lymphocytes of peripheral blood and pleural effusion were detected in these 150 tuberculous pleurisy patients with the flow cytometers. Statistical analysis was performed with SPSS 16.0 statistical software. Using paired samples statistics (t test) to compare the test results of peripheral blood and pleural fluid.  Results (1) Of the patients with tuberculous pleurisy, the ratios of CD3⁺ and CD4⁺ T cells in pleural effusions（（85.11±7.70）%,（55.67±12.94）%） significantly higher than those in peripheral bloods （（70.91±10.33）%,（42.87±11.12）%）（t=－9.846, P=0.03; t=－7.455, P=0.001）. While the ratio of CD8⁺ T cells in pleural fluid（（17.92±7.63）%） significantly lessthan that in peripheral blood （（22.74±6.78）%）（t=4.372, P=0.012）. The ratio of CD4⁺/CD8⁺ in pleural effusion（3.77±2.07）significantly higher than that in peripheral blood（2.13±1.16）（t=－6.542, P=0.001）. (2) The concentrations of IL-2, sIL-2R in pleurisy fluids（（68.55±41.40）pg/ml，（1672.25±713.75）pmol/L）were significantly higher than those in the peripheral bloods from the patients with tuberculous pleurisy（（32.97±32.30）pg/ml，(193.89±87.30）pmol/L)（t=－7.282, P=0.000; t=－15.783, P=0.000）. (3) The level of IL-2 in pleural effusions（（68.55±41.40）pg/ml） was 2.079 times higher than that in the peripheral bloods（（32.97±32.30）pg/ml）. The level of sIL-2R in pleural effusion（（1672.25±713.75）pmol/L） was 8.625 times higher than that in the peripheral bloods（（193.89±87.30）pmol/L）. Conclusion (1)CD3⁺ T cell, CD4⁺T cell, IL-2, and sIL-2R played an important role in the occurrence and development of tuberculous pleurisy. (2)The immune response was stronger in the pleura. It was more difficult to the control of the infection in the pleura because of significantly higher concentration of sIL-2R in pleural effusion.

Study on the diagnostic value of adenosine deaminase in the tuberculous pleurisy

LIANG Qing-tao, RAO Hai-tao, GUO Chao，YANG Yang，LI Hua，BU Jian-ling，YANG Xin-ting，CHEN Xiao-you

Chinese Journal of Antituberculosis. 2014, 36(12):  1071-1074.  doi:10.3969/j.issn.1000-6621.2014.12.014

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Objective To explore the diagnostic value of adenosine deaminase(ADA) in the tuberculous pleurisy. Methods One hundred and sixty patients with pleural effusion admitted in Beijing Chest Hospital, Capital Medical University from January 2012 to December 2013 were recruited. In which 130 cases were confirmed as tuberculous pleural effusion and 30 cases were confirmed as malignant pleural effusion. The ADA in pleural effusion(p) and serum(s) were detected simultaneously both in tuberculous pleural effusion(TPE) and malignant pleural effusion(MPE). The ratio of pADA and sADA was figured out. Statistical analysis were done by SPSS 19.0, P<0.05 is considered statistically significant.  Results （1）The pADA, sADA and pADA/sADA in TPE ((55.8±19.5) U/L,(19.6±8.8) U/L,(3.1±1.2), respectively) were significantly higher than those in MPE ((11.1±5.0) U/L,(11.0±5.7) U/L,(1.1±0.5), respectively), the difference is statistically significant(t=21.5, 5.6 and 12.8，P<0.001). (2) The TPE patients were divided into two groups by 55 years old. The pADA value ((49.0±22.6) U/L) in patients ≥55 years old was lower than that in patients <55 years old ((57.8±18.5) U/L), the difference is statistically significant (t=2.3,P<0.05). (3) When the cut-off was set as 30U/L for the diagnosis of TPE, its sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were 95.4%(124/130), 96.7%(29/30), 99.2%(124/125) and 82.9%(29/35), respectively. (4) If the critical value of pADA/sADA was set as ≥1.8 in TPE diagnosis, its sensitivity, specificity, PPV, NPV was 89.2%(116/130), 93.3%(28/30), 98.3%(116/118), and 66.7%(28/42), respectively. Conclusion The cut-off set as 30 U/L for pleural effusion has a very high sensitivity and specificity for the diagnosis of TPE. The value of pADA/sADA set as≥1.8 is helpful to diagnose differentially TPE from MPE.

Study on pharmacokinetics and bioequivalence of rifampicin in fixed-dose combination

GUO Shao-chen，ZHU Hui，XU Jian,HAO Lan-hu,WANG Bin, FU Lei,CHEN Ming-ting,ZHOU Lin,CHI Jun-ying, LU Yu

Chinese Journal of Antituberculosis. 2014, 36(12):  1075-1079.  doi:10.3969/j.issn.1000-6621.2014.12.015

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 Objective To study the pharmacokinetics and relative bioavailability and to assess the bioequivalence of compound rifampicin in two kinds of fixed-dose combination (FDC) formulations containing four anti-tuberculosis agents for ensuring its quality of FDC formulations for rational drug use.  Methods The randomized, crossover study was conducted in 18 healthy male volunteers for each FDC formulation (FDC1 for study1 and FDC2 for study2). Totally, 36 individuals were enrolled in these 2 studies. There were 2 groups for each study, every 9 volunteers for each group. Using FDC formulation for tested preparation and separated formulation (rifampicin capsules) as reference preparation, a single oral dose of two preparations (reference preparation and FDC) was given to 2 groups’ volunteers respectively. The rifampicin concentrations in plasma of volunteers were determined by LC-MS/MS. The pharmacokinetic parameters and relative bioavailability were calculated by DAS 3.1.5 software and the bioequivalence of each FDC formulation was evaluated. Results The major pharmacokinetics parameters of compound rifampicin of two FDC formulations were showed respectively. For FDC1 and FDC2, C_max were (11.4±3.4)mg·L^-1 and (12.2±3.8)mg·L^-1, T_1/2 were (3.7±1.2)h and (3.6±1.3)h, AUC_(0-t) were (91.4±30.8)mg·L^-1·h^-1 and (92.1±25.3)mg·L^-1·h^-1, AUC_(0-∞) were (93.3±31.3)mg·L^-1·h^-1 and (94.1±26.5)mg·L^-1·h^-1. The relative bioavailability of AUC _(0-t) was 94.7%(CI=89.5%－100.2%), 91.4%(CI=81.4%－95.6%), respectively. Conclusion The pharmacokinetics parameters shows that these two FDC formulations are both bioequivalent for rifampicin to the reference preparation. There is no significant difference for C_max, T_max between these two kinds of FDC formulations and the reference preparation.

Clinical significance of serum fibrosis index detection in 62 patients with pulmonary tuberculosis

FU Li-xian，LIN Shao-mei

Chinese Journal of Antituberculosis. 2014, 36(12):  1080-1083.  doi:10.3969/j.issn.1000-6621.2014.12.016

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Objective To explore the clinical significance of serum fibrosis markers detection among new patients with pulmonary tuberculosis(PTB). Methods The radioimmunoassay for detection of serum fibrosis mar-kers, including hyaluronic acid(HA), laminin(LN), type Ⅲ procollagen peptide(PC Ⅲ) and collagen type Ⅳ(C-Ⅳ), were performed among 62 new PTB patients who once stayed at the Infectious Disease Department of our hospital and 62 healthy people who received health check-up at the Outpatient Department of our hospital; the same tests were repeated among 62 PTB patients when they completed the 6 months anti-TB treatment, and those patients were divided into two groups according to their treatment outcomes: effective treatment group and ineffective treatment group. The test results from PTB patients (before and after treatment) and healthy people were compared. SPSS 13.0 software was used for statistical analysis. t test was calculated and P＜0.05 was regarded as statistically significant difference. Results The results of HA, LN, PC Ⅲ and C-Ⅳ among PTB patients before treatment were (131.64±40.92)μg/L, (99.61±42.63)μg/L, (24.30±10.58)μg/L and (60.76±23.15)μg/L, which were significantly higher than those indexes among healthy group of people (58.66±15.42)μg/L, (44.19±10.43)μg/L, (14.32±4.56)μg/L, and (39.60±10.30)μg/L)(t=9.3, 6.22, 5.13, 3.9, all P values were <0.01). After received 6 months standard anti-TB treatment, the results of HA, LN, PC Ⅲ and C-Ⅳ among 46 PTB patients who had effective treatment outcomes were (61.31±19.27)μg/L, (45.62±12.34)μg/L, (13.52±4.83)μg/L and (35.27±16.36)μg/L, which had no significant difference compared to those results among the healthy group (t=2.04, 1.83, 1,25 and -1.07; all P value was＞0.05). The level of HA, LN, PC Ⅲ and C-Ⅳ among 16 PTB patients who had ineffective treatment outcomes were (104.31±18.53)μg/L, (69.94±16.71)μg/L, (13.63±4.07)μg/L and (40.64±9.79)μg/L, which had significant difference compared to the health group (t=6.87, 5.07, 3.75 and 3.12; all P values were ＜0.05). Conclusion Detection of serum fibrosis index has important clinical value on early diagnosis of fibrosis among pulmonary tuberculosis patients and prediction of their treatment outcomes.

Electromagnetic navigation bronchoscopy in the diagnosis of sputum-negative pulmonary tuberculosis: 3-case-report and literature review

GU Ye，HAO Xiao-hui，SHEN Yun，LOU Hai，WANG Hao，XIAO He-ping，SHA Wei

Chinese Journal of Antituberculosis. 2014, 36(12):  1084-1088.  doi:10.3969/j.issn.1000-6621.2014.12.017

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Objective Electromagnetic navigation bronchoscopy (ENB) has been developed as a novel diagnostic tool of peripheral pulmonary nodules. To evaluate the potential value of ENB on diagnosis of sputum-negative pulmonary tuberculosis (PTB), we presented 3 PTB cases who were diagnosed by ENB and then reviewed the relative literatures. Methods During July to September in 2014, 3 adults suspected for PTB underwent ENB at Shanghai Pulmonary Hospital. The sputum smear and culture were repeatedly negative before ENB. And then the previous literatures were reviewed by searching Medline. From 2006 till now, 13 papers from clinical trials that were scientifically designed, containing >10 cases and completed data presented. Results All of 3 patients had been treated with standardized regimen for at least 4 months and had poor effects. CT showed that the lesions were located in the apicoposterior segment of the upper lobes, beyond the reach of conventional bronchoscopes. After being successfully navigated, the lesion locations were confirmed by peripheral ultrasound and specimens were sampled under X-ray assistant. The diagnosis yielded in all the cases with bacterial or pathologic technique. No procedure-rela-ted complications were observed. The results from previous research showed that the diagnose yield and accurate rate for peripheral pulmonary lesions by ENB were as high as 59.0%－98.0% and 59.0%－94.0%, respectively. For malignant lesions, the diagnostic accuracy reached 60.0%－89.5%.  However, little data is available about the clinical utilization of this technique in the diagnosis of pulmonary tuberculosis. Conclusion The ENB may have good applications in diagnosis of atypical pulmonary tuberculosis.

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Chinese Journal of Antituberculosis. 2014, 36(12):  1098-1100.  doi:10.3969/j.issn.1000-6621.2014.12.021

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