title: Design of the anti-tuberculosis drugs induced adverse reactions in China National Tuberculosis Prevention and Control Scheme Study (ADACS).
abstract: BACKGROUND
  More than 1 million tuberculosis (TB) patients are receiving the standard anti-TB treatment provided by China National Tuberculosis Prevention and Control Scheme (CNTS) in China every year. Adverse reactions (ADRs) induced by anti-TB drugs could both do harm to patients and lead to anti-TB treatment failure. The ADACS aimed to explore ADRs' incidences, prognoses, economical and public health impacts for TB patients and TB control, and build a DNA bank of TB patients.
  
  
  METHODS
  Multiple study designs were adopted. Firstly, a prospective cohort with 4488 sputum smears positive pulmonary tuberculosis patients was established. Patients were followed up for 6-9 months in 52 counties of four regions. Those suspected ADRs should be checked and confirmed by Chinese State Food and Drug Administration (SFDA). Secondly, if the suspected ADR was anti-TB drug induced liver injury (ATLI), a nested case-control study would be performed which comprised choosing a matched control and doing a plus questionnaire inquiry. Thirdly, health economical data of ADRs would be collected to analyze financial burdens brought by ADRs and cost-effectiveness of ADRs' treatments. Fourthly, a drop of intravenous blood for each patient was taken and saved in FTA card for DNA banking and genotyping. Finally, the demographic, clinical, environmental, administrative and genetic data would be merged for the comprehensive analysis.
  
  
  CONCLUSIONS
  ADACS will give an overview of anti-TB drugs induced ADRs' incidences, risk factors, treatments, prognoses, and clinical, economical and public health impacts for TB patients applying CNTS regimen in China, and provide suggestions for individualized health care and TB control policy.
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
authors.forename: Yin Yin
authors.initials: YY
authors.lastname: Xia
authors.forename: Dai Yu
authors.initials: DY
authors.lastname: Hu
authors.forename: Fei Ying
authors.initials: FY
authors.lastname: Liu
authors.forename: Xiao Meng
authors.initials: XM
authors.lastname: Wang
authors.forename: Yan Li
authors.initials: YL
authors.lastname: Yuan
authors.forename: De Hua
authors.initials: DH
authors.lastname: Tu
authors.forename: Yi Xin
authors.initials: YX
authors.lastname: Chen
authors.forename: Lin
authors.initials: L
authors.lastname: Zhou
authors.forename: Li Zhen
authors.initials: LZ
authors.lastname: Zhu
authors.forename: Wei Wei
authors.initials: WW
authors.lastname: Gao
authors.forename: Hong Yuan
authors.initials: HY
authors.lastname: Wang
authors.forename: Da Fang
authors.initials: da F
authors.lastname: Chen
authors.forename: Li
authors.initials: L
authors.lastname: Yang
authors.forename: Ping Ping
authors.initials: PP
authors.lastname: He
authors.forename: Xiao Ting
authors.initials: XT
authors.lastname: Li
authors.forename: Ying Jian
authors.initials: YJ
authors.lastname: He
authors.forename: Feng
authors.initials: F
authors.lastname: Sun
authors.forename: Si Yan
authors.initials: SY
authors.lastname: Zhan
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury / Q000517:prevention & control; D002681:China; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D009313:National Health Programs; D012107:Research Design; D013048:Specimen Handling; D013183:Sputum / Q000382:microbiology; D011795:Surveys and Questionnaires; D014376:Tuberculosis / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents