Access to quality diagnosis and rational treatment for tuberculosis: real-world evidence from China-Gates Tuberculosis Control Project Phase III.

Background: China has successfully reduced tuberculosis (TB) incidence rate over the past three decades, however, challenges remain in improving the quality of TB diagnosis and treatment. In this paper, we assess the effects of the implementation of "China National Health Commission (NHC) and Gates Foundation TB Prevention and Control Project" on the quality of TB care in the three provinces.

Methods: We conducted the baseline study in 2016 and the final evaluations in 2019 in the 12 selected project counties.

Impacts of a comprehensive tuberculosis control model on the quality of clinical services and the financial burden of treatment for patients with drug-resistant tuberculosis in China: a mixed-methods evaluation.

Background: The China National Health Commission-Gates TB Project Phase III implemented a comprehensive TB control model including multiple interventions to address the burden of drug-resistant TB (DRTB). This study aims to evaluate the quality of DRTB clinical services and assess the financial burden of DRTB patients during the intervention period.

Methods: A mixed-methods approach was used to evaluate the effectiveness of interventions in the three project provinces: Zhejiang, Jilin and Ningxia Hui Autonomous Region.

Prolonged use of bedaquiline in two patients with pulmonary extensively drug-resistant tuberculosis: Two case reports.

Background: Bedaquiline is among the prioritized drugs recommended by the World Health Organization for the treatment of extensively drug-resistant tuberculosis (XDR-TB). Many patients have not achieved better clinical improvement after bedaquiline is stopped at 24 wk. However, there is no recommendation or guideline on bedaquiline administration beyond 24 wk, which is an important consideration when balancing the benefit of prognosis for XDR-TB against the uncertain safety concerning the newer antibiotics.

Bedaquiline-containing regimens in patients with pulmonary multidrug-resistant tuberculosis in China: focus on the safety.

Background: World Health Organization recommends countries introducing new drug and short treatment regimen for drug resistant tuberculosis (DR-TB) should develop and implement a system for active pharmacovigilance that allows for detection, reporting and management of adverse events. The aim of the study is to evaluate the frequency and severity of adverse events (AEs) of bedaquiline-containing regimen in a cohort of Chinese patients with multidrug-resistant (MDR)/extensively drug-resistant (XDR)-TB based on active drug safety monitoring (aDSM) system of New Drug Introduction and Protection Program (NDIP).

Methods: AEs were prospectively collected with demographic, bacteriological, radiological and clinical data from 54 sites throughout China at patient enrollment and during treatment between February, 2018 and December, 2019.

Performance of the Xpert® MTB/RIF assay in the rapid diagnosis of tracheobronchial tuberculosis using bronchial washing fluid.

Objective: To assess the diagnostic value of the Xpert® MTB/RIF (GeneXpert) assay for tracheobronchial tuberculosis (TBTB) using bronchial washing fluid (BWF).

Methods: This retrospective study enrolled patients suspected of having TBTB and patients with non-TB pulmonary disease as controls. BWF were used to undertake acid-fast bacillus (AFB) smears, the GeneXpert assay and the Lӧwenstein-Jensen (LJ) culture method.

Case Report: Primary Tuberculosis of the Bilateral Breast.

Primary breast tuberculosis is rare. We report a case of bilateral primary breast tuberculosis. The patient received incisional drainage and debridement of both breasts.

Preclinical study and phase I clinical safety evaluation of recombinant Mycobacterium tuberculosis ESAT6 protein.

Background: To investigate the ability of rESAT6 to identify different mycobacteria-sensitized guinea pigs and its safety in preclinical and phase I clinical study.

Material And Methods: Guinea pigs were sensitized with different Mycobacteria. After sensitization, all animals were intradermally injected with rESAT6 and either PPD or PPD-B.

[The comparison of different antigens in enzyme-linked immunospot assay for the diagnosis of tuberculosis.].

Objective: To compare different Mycobacterium tuberculosis antigens in enzyme-linked immunospot assay (ELISPOT) for the auxiliary diagnosis of active tuberculosis.

Methods: The peripheral blood mononuclear cells (PBMC) from patients with tuberculosis and controls were co-cultured with the following antigens: purified protein derivative (PPD), early secretory antigenic target-6 (ESAT-6) and early secretory antigenic target-6/culture filtrate protein-10 fusion protein (ESAT-6/CFP-10). Spot forming cells (SFC) were enumerated by ELISPOT.

[Role of enzyme-linked immunospot assay and tuberculin skin test in the auxiliary diagnosis of initial pulmonary tuberculosis].

Objective: To compare enzyme-linked immunospot assay (ELISPOT) and tuberculin skin test (TST) and explore their roles in the auxiliary diagnosis of initial pulmonary tuberculosis.

Methods: Totally 123 patients with initial pulmonary tuberculosis (tuberculosis group) and 102 patients with non-tuberculosis pulmonary disease (control group) were enrolled. The peripheral blood mononuclear cells of all participants were co-cultured with early secretiny antigen target-6/culture filtrate protein-10 fusion protein (ESAT-6/CFP-10), and spot forming cells (SFCs) were enumerated by ELISPOT (ESAT-6/CFP-10-ELISPOT).

[The clinical significance of serum tuberculosis specific antigen antibody in the diagnosis of tuberculosis].

Objective: To evaluate the significance of serum tuberculosis specific antigen (TB-SA) antibody detection in the diagnosis of tuberculosis.

Methods: TB-SA antibody in the serum samples from 829 cases of tuberculosis, 278 patients with non-tuberculosis lung diseases and 125 healthy volunteers were detected using enzyme-linked immunosorbent assay (ELISA). Tuberculosis was confirmed by clinical, bacteriology, X-ray examination and pathology studies.

[A study on in vitro and in vivo models of Mycobacterium tuberculosis persistence].

Objective: To establish in vivo and in vitro models of persistent Mycobacterium tuberculosis infection, and therefore to study the persisters in different conditions and periods of chemotherapy, and to explore the relationship between the persisters and chemotherapy.

Methods: The persisters in the two models were examined by culturing Mycobacterium tuberculosis in oxygen-starved condition and determining the mRNA expression of isocitrate lyase (ICL), alpha-crystallin chaperone (Acr) and 85B through quantitative PCR.

Results: The bacteria which could be cultured in oxygen-starved condition were discovered in both models.