Background:The diagnosis of active pulmonary tuberculosis(TB)remains a challenge in clinic,especially for sputum negative pulmonary TB.Bronchoalveolar lavage fluid(BALF)has higher sensitivity than sputum for detection...Background:The diagnosis of active pulmonary tuberculosis(TB)remains a challenge in clinic,especially for sputum negative pulmonary TB.Bronchoalveolar lavage fluid(BALF)has higher sensitivity than sputum for detection of Mycobacterium tuberculosis(Mtb).However,bronchoscopy is invasive and costly,and not suitable for all patients.In order to make TB patients get more benefit from BALF for diagnosis,we explore which indicator might be used to optimize the choice of bronchoscopy.Methods:A total of 1539 sputum-smear-negative pulmonary TB suspects who underwent bronchoscopy were recruited for evaluation.The sensitivity,specificity and accuracy of Mtb detection in sputum and BALF were compared.Odds ratios and 95%confidence intervals were used to assess variables that associated with positive acid-fast bacilli(AFB)smear,Mtb culture and nucleic acid amplification test(NAAT)of BALF in sputum-negative and non-sputum-producing pulmonary TB suspects.Results:BALF has significantly higher sensitivity(63.4%)than sputum(43.5%)for Mtb detection by culture and NAAT.19.7%(122/620)sputum-negative and 40.0%(163/408)non-sputum-producing suspects had positive bacteriological results in BALF.Among sputum-negative and non-sputum-producing pulmonary TB suspects,the positivity of Mtb detection in BALF is associated with a younger age,the presence of pulmonary cavities and a positive result of interferon-gamma release assay(IGRA).Sputum-negative patients under 35 years old with positive IGRA and pulmonary cavity had 84.8%positivity of Mtb in BALF.Conclusions:Our study indicated that combination of age,the presence of pulmonary cavity,and the result of IGRA is useful to predict the positivity of Mtb detection in BALF among sputum-negative and non-sputum producing pulmonary TB suspects.Those who are under 35 years old,positive for the presence of pulmonary cavity and IGRA,should undergo bronchoscopy to collect BAFL for Mtb tests,as they have the highest possibility to get bacteriologically confirmation of TB.展开更多
Background:China is the second highest pulmonary tuberculosis(PTB)burden country worldwide.However,retreatment of PTB has often developed resistance to at least one of the four first-line anti-TB drugs.The cure rate(a...Background:China is the second highest pulmonary tuberculosis(PTB)burden country worldwide.However,retreatment of PTB has often developed resistance to at least one of the four first-line anti-TB drugs.The cure rate(approximately 50.0–73.3%)and management of retreatment of PTB in China needs to be improved.Qinbudan decoction has been widely used to treat PTB in China since the 1960s.Previously clinical studies have shown that the Qinbudan tablet(QBDT)promoted sputum-culture negative conversion and lesion absorption.However,powerful evidence from a randomized controlled clinical trial is lacking.Therefore,the aim of this study was to compare the efficacy and safety of QBDT as an adjunct therapy for retreatment of PTB.Methods:We conducted a multicenter,randomized,double-blind,placebo-controlled clinical trial in China.People diagnosed with PTB were enrolled who received previous anti-TB treatment from April 2011 to March 2013.The treatment group received an anti-TB regimen and QBDT,and the control group was administered an anti-TB regimen plus placebo.Anti-TB treatment options included isoniazid,rifampicin,pyrazinamide,ethambutol,streptomycin for 2 months(2HRZES),followed by isoniazid,rifampicin,ethambutol for 6 months(6HRE),daily for 8 months.Primary outcome was sputum-culture conversion using the MGIT 960 liquid medium method.Secondary outcomes included lung lesion absorption and cavity closure.Adverse events and reactions were observed after treatment.A structured questionnaire was used to record demographic information and clinical symptoms of all subjects.Data analysis was performed by SPSS 25.0 software in the full analysis set(FAS)population.Results:One hundred eighty-one cases of retreatment PTB were randomly divided into two groups:the placebo group(88 cases)and the QBDT group(93 cases).A total of 166 patients completed the trial and 15 patients lost to follow-up.The culture conversion rate of the QBDT group and placebo group did not show a noticeable improvement by using the covariate sites to correct the rate differences(79.6%vs 69.3%;rate difference=0.10,95%confidence interval(CI):-0.02–0.23;F=2.48,P=0.12)after treatment.A significant 16.6%increase in lesion absorption was observed in the QBDT group when compared with the placebo group(67.7%vs 51.1%;rate difference=0.17,95%CI:0.02–0.31;χ2=5.56,P=0.02).The intervention and placebo group did not differ in terms of cavity closure(25.5%vs 21.1%;rate difference=0.04,95%CI:-0.21–0.12;χ2=0.27,P=0.60).Two patients who received chemotherapy and combined QBDT reported pruritus/nausea and vomiting.Conclusions:No significant improvement in culture conversion was observed for retreatment PTB with traditional Chinese medicine plus standard anti-TB regimen.However,QBDT as an adjunct therapy significantly promoted lesion absorption,thereby reducing lung injury due to Mycobacterium tuberculosis infection.Trial registration:This trial is registered at ClinicalTrials.gov,NCT02313610.展开更多
基金This study was supported by National Nature Science Foundation of China(81525016,81772145,81770013)Shenzhen Science&Technology Grant(JSGG20160427104724699,JCYJ20170412101048337,JCYJ20170412151620658)Sanming Project of Medicine in Shenzhen(GCZX2015043015340574).
文摘Background:The diagnosis of active pulmonary tuberculosis(TB)remains a challenge in clinic,especially for sputum negative pulmonary TB.Bronchoalveolar lavage fluid(BALF)has higher sensitivity than sputum for detection of Mycobacterium tuberculosis(Mtb).However,bronchoscopy is invasive and costly,and not suitable for all patients.In order to make TB patients get more benefit from BALF for diagnosis,we explore which indicator might be used to optimize the choice of bronchoscopy.Methods:A total of 1539 sputum-smear-negative pulmonary TB suspects who underwent bronchoscopy were recruited for evaluation.The sensitivity,specificity and accuracy of Mtb detection in sputum and BALF were compared.Odds ratios and 95%confidence intervals were used to assess variables that associated with positive acid-fast bacilli(AFB)smear,Mtb culture and nucleic acid amplification test(NAAT)of BALF in sputum-negative and non-sputum-producing pulmonary TB suspects.Results:BALF has significantly higher sensitivity(63.4%)than sputum(43.5%)for Mtb detection by culture and NAAT.19.7%(122/620)sputum-negative and 40.0%(163/408)non-sputum-producing suspects had positive bacteriological results in BALF.Among sputum-negative and non-sputum-producing pulmonary TB suspects,the positivity of Mtb detection in BALF is associated with a younger age,the presence of pulmonary cavities and a positive result of interferon-gamma release assay(IGRA).Sputum-negative patients under 35 years old with positive IGRA and pulmonary cavity had 84.8%positivity of Mtb in BALF.Conclusions:Our study indicated that combination of age,the presence of pulmonary cavity,and the result of IGRA is useful to predict the positivity of Mtb detection in BALF among sputum-negative and non-sputum producing pulmonary TB suspects.Those who are under 35 years old,positive for the presence of pulmonary cavity and IGRA,should undergo bronchoscopy to collect BAFL for Mtb tests,as they have the highest possibility to get bacteriologically confirmation of TB.
基金This study was supported by the Eleventh Five-Year Support Project of the Ministry of Science and Technology from Ministry of Public Health of China(2010ZX09101-107)。
文摘Background:China is the second highest pulmonary tuberculosis(PTB)burden country worldwide.However,retreatment of PTB has often developed resistance to at least one of the four first-line anti-TB drugs.The cure rate(approximately 50.0–73.3%)and management of retreatment of PTB in China needs to be improved.Qinbudan decoction has been widely used to treat PTB in China since the 1960s.Previously clinical studies have shown that the Qinbudan tablet(QBDT)promoted sputum-culture negative conversion and lesion absorption.However,powerful evidence from a randomized controlled clinical trial is lacking.Therefore,the aim of this study was to compare the efficacy and safety of QBDT as an adjunct therapy for retreatment of PTB.Methods:We conducted a multicenter,randomized,double-blind,placebo-controlled clinical trial in China.People diagnosed with PTB were enrolled who received previous anti-TB treatment from April 2011 to March 2013.The treatment group received an anti-TB regimen and QBDT,and the control group was administered an anti-TB regimen plus placebo.Anti-TB treatment options included isoniazid,rifampicin,pyrazinamide,ethambutol,streptomycin for 2 months(2HRZES),followed by isoniazid,rifampicin,ethambutol for 6 months(6HRE),daily for 8 months.Primary outcome was sputum-culture conversion using the MGIT 960 liquid medium method.Secondary outcomes included lung lesion absorption and cavity closure.Adverse events and reactions were observed after treatment.A structured questionnaire was used to record demographic information and clinical symptoms of all subjects.Data analysis was performed by SPSS 25.0 software in the full analysis set(FAS)population.Results:One hundred eighty-one cases of retreatment PTB were randomly divided into two groups:the placebo group(88 cases)and the QBDT group(93 cases).A total of 166 patients completed the trial and 15 patients lost to follow-up.The culture conversion rate of the QBDT group and placebo group did not show a noticeable improvement by using the covariate sites to correct the rate differences(79.6%vs 69.3%;rate difference=0.10,95%confidence interval(CI):-0.02–0.23;F=2.48,P=0.12)after treatment.A significant 16.6%increase in lesion absorption was observed in the QBDT group when compared with the placebo group(67.7%vs 51.1%;rate difference=0.17,95%CI:0.02–0.31;χ2=5.56,P=0.02).The intervention and placebo group did not differ in terms of cavity closure(25.5%vs 21.1%;rate difference=0.04,95%CI:-0.21–0.12;χ2=0.27,P=0.60).Two patients who received chemotherapy and combined QBDT reported pruritus/nausea and vomiting.Conclusions:No significant improvement in culture conversion was observed for retreatment PTB with traditional Chinese medicine plus standard anti-TB regimen.However,QBDT as an adjunct therapy significantly promoted lesion absorption,thereby reducing lung injury due to Mycobacterium tuberculosis infection.Trial registration:This trial is registered at ClinicalTrials.gov,NCT02313610.