title: Adverse reactions due to directly observed treatment strategy therapy in Chinese tuberculosis patients: a prospective study.
abstract: BACKGROUND
  More than 1 million tuberculosis (TB) patients are receiving directly observed treatment strategy (DOTS) therapy in China every year. As to the profile of adverse drug reactions (ADRs) due to DOTS therapy, no consensus has been reached. There is no report regarding ADRs due to DOTS therapy with a large Chinese TB population. This study aimed to determine the incidence and prognosis of ADRs due to DOTS therapy, and to evaluate their impact on anti-TB treatment in China.
  
  
  METHODS
  A prospective population-based cohort study was performed during 2007-2008. Sputum smear positive pulmonary TB patients who received DOTS therapy were included and followed up for six to nine months in 52 counties of four regions in China. The suspected ADRs were recorded and reviewed by Chinese State Food and Drug Administration.
  
  
  RESULTS
  A total of 4304 TB patients were included in this study. 649 patients (15.08%) showed at least one ADR and 766 cases in total were detected. The incidence (count) of ADR based on affected organ was: liver dysfunction 6.34% (273), gastrointestinal disorders 3.74% (161), arthralgia 2.51% (108), allergic reactions 2.35% (101), neurological system disorders 2.04% (88), renal impairment 0.07% (3) and others 0.05% (2). Most cases of ADRs (95%) had a good clinical outcome, while two with hepatotoxicity and one with renal impairment died. Compared with patients without ADRs, patients with ADRs were more likely to have positive smear test results at the end of the intensive phase (adjusted OR, 2.00; 95%CI, 1.44-2.78) and unsuccessful anti-TB outcomes (adjusted OR, 2.58; 95%CI, 1.43-4.68).
  
  
  CONCLUSIONS
  The incidence of ADRs due to DOTS therapy was 15.08%. Those ADRs had a substantial impact on TB control in China. This highlighted the importance of developing strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely.
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Centre, Beijing, China.
authors.forename: Xiaozhen
authors.initials: X
authors.lastname: Lv
authors.forename: Shaowen
authors.initials: S
authors.lastname: Tang
authors.forename: Yinyin
authors.initials: Y
authors.lastname: Xia
authors.forename: Xiaomeng
authors.initials: X
authors.lastname: Wang
authors.forename: Yanli
authors.initials: Y
authors.lastname: Yuan
authors.forename: Daiyu
authors.initials: D
authors.lastname: Hu
authors.forename: Feiying
authors.initials: F
authors.lastname: Liu
authors.forename: Shanshan
authors.initials: S
authors.lastname: Wu
authors.forename: Yuan
authors.initials: Y
authors.lastname: Zhang
authors.forename: Zhirong
authors.initials: Z
authors.lastname: Yang
authors.forename: Dehua
authors.initials: D
authors.lastname: Tu
authors.forename: Yixin
authors.initials: Y
authors.lastname: Chen
authors.forename: Peiyuan
authors.initials: P
authors.lastname: Deng
authors.forename: Yu
authors.initials: Y
authors.lastname: Ma
authors.forename: Ru
authors.initials: R
authors.lastname: Chen
authors.forename: Siyan
authors.initials: S
authors.lastname: Zhan
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000009:adverse effects* / Q000627:therapeutic use; D044466:Asian People; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D016896:Treatment Outcome; D014376:Tuberculosis / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D000995:Antitubercular Agents