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Open Access Study protocol

Design of the Anti-tuberculosis Drugs induced Adverse Reactions in China National Tuberculosis Prevention and Control Scheme Study (ADACS)

Yin Yin Xia1, Dai Yu Hu2, Fei Ying Liu3, Xiao Meng Wang4, Yan Li Yuan5, De Hua Tu6, Yi Xin Chen7, Lin Zhou8, Li Zhen Zhu9, Wei Wei Gao9, Hong Yuan Wang1, Da Fang Chen1, Li Yang10, Ping Ping He1, Xiao Ting Li1, Ying Jian He1, Feng Sun1 and Si Yan Zhan1*

Author Affiliations

1 Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China

2 Center for Disease Control and Prevention in Chongqing Municipality, Chongqing, China

3 Center for Disease Control and Prevention in Guangxi Zhuang Autonomous Region, Nanning, China

4 Center for Disease Control and Prevention in Zhejiang Province, Hangzhou, China

5 Center for Disease Control and Prevention in Jilin Province, Changchun, China

6 Beijing Institute for Tuberculosis Control, Beijing, China

7 Center for Drug Reassessment, State Food and Drug Administration, Beijing, China

8 Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China

9 Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China

10 Department of Health Policy and Management, School of Public Health, Peking University, Beijing, China

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BMC Public Health 2010, 10:267  doi:10.1186/1471-2458-10-267

Published: 21 May 2010

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/Design

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.

Discussion

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.