Design of the anti-tuberculosis drugs induced adverse reactions in China National Tuberculosis Prevention and Control Scheme Study (ADACS).
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.
Xia
Yin Yin
YY
Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
Hu
Dai Yu
DY
Liu
Fei Ying
FY
Wang
Xiao Meng
XM
Yuan
Yan Li
YL
Tu
De Hua
DH
Chen
Yi Xin
YX
Zhou
Lin
L
Zhu
Li Zhen
LZ
Gao
Wei Wei
WW
Wang
Hong Yuan
HY
Chen
Da Fang
da F
Yang
Li
L
He
Ping Ping
PP
Li
Xiao Ting
XT
He
Ying Jian
YJ
Sun
Feng
F
Zhan
Si Yan
SY
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*
D000995:Antitubercular Agents