title: Incidence, clinical features and impact on anti-tuberculosis treatment of anti-tuberculosis drug induced liver injury (ATLI) in China.
abstract: BACKGROUND
  Anti-tuberculosis drug induced liver injury (ATLI) is emerging as a significant threat to tuberculosis control in China, though limited data is available about the burden of ATLI at population level. This study aimed to estimate the incidence of ATLI, to better understand its clinical features, and to evaluate its impact on anti-tuberculosis (TB) treatment in China.
  
  
  RESULTS
  In a population-based prospective study, we monitored 4,304 TB patients receiving directly observed treatment strategy (DOTS) treatment, and found that 106 patients developed ATLI with a cumulative incidence of 2.55% (95% Confidence Interval [CI], 2.04%-3.06%). Nausea, vomiting and anorexia were the top three most frequently observed symptoms. There were 35 (33.02%) ATLI patients with no symptoms, including 8 with severe hepatotoxicity. Regarding the prognosis of ATLI, 84 cases (79.25%) recovered, 18 (16.98%) improved, 2 (1.89%) failed to respond to the treatment with continued elevation of serum alanine aminotransferase, and 2 (1.89%) died as result of ATLI. Of all the ATLI cases, 74 (69.81%) cases changed their anti-TB treatment, including 4 (3.77%) cases with medication administration change, 21 (19.81%) cases with drugs replacement, 54 (50.94%) cases with therapy interruption, and 12 (11.32%) cases who discontinued therapy. In terms of treatment outcomes, 53 (51.46%) cases had TB cured in time, 48 (46.60%) cases had therapy prolonged, and 2 (1.94%) cases died. Compared with non-ATLI patients, ATLI patients had a 9.25-fold (95%CI, 5.69-15.05) risk of unsuccessful anti-TB treatment outcomes and a 2.11-fold (95%CI, 1.23-3.60) risk of prolonged intensive treatment phase.
  
  
  CONCLUSIONS
  ATLI could considerably impact the outcomes of anti-TB treatment. Given the incidence of ATLI and the size of TB population in China, the negative impact is substantial. Therefore, more research and efforts are warranted in order to enhance the diagnosis and the prevention of ATLI.
authors.affiliation: Department of Epidemiology and Bio-Statistics, School of Public Health, Peking University Health Science Centre, Beijing, China.
authors.forename: Penghui
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authors.lastname: Shang
authors.forename: Yinyin
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authors.lastname: Xia
authors.forename: Feiying
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authors.lastname: Liu
authors.forename: Xiaomeng
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authors.forename: Yanli
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authors.forename: Daiyu
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authors.forename: Dehua
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authors.forename: Yixin
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authors.lastname: Chen
authors.forename: Peiyuan
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authors.lastname: Cheng
authors.forename: Lin
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authors.lastname: Zhou
authors.forename: Yu
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authors.lastname: Ma
authors.forename: Lizhen
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authors.lastname: Zhu
authors.forename: Weiwei
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authors.forename: Hongyuan
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authors.forename: Dafang
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authors.forename: Pingping
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authors.lastname: He
authors.forename: Shanshan
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authors.forename: Shaowen
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authors.lastname: Tang
authors.forename: Xiaozhen
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authors.lastname: Lv
authors.forename: Zheng
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authors.lastname: Shu
authors.forename: Yuan
authors.initials: Y
authors.lastname: Zhang
authors.forename: Zhirong
authors.initials: Z
authors.lastname: Yang
authors.forename: Yan
authors.initials: Y
authors.lastname: Chen
authors.forename: Na
authors.initials: N
authors.lastname: Li
authors.forename: Feng
authors.initials: F
authors.lastname: Sun
authors.forename: Xiaoting
authors.initials: X
authors.lastname: Li
authors.forename: Yingjian
authors.initials: Y
authors.lastname: He
authors.forename: Paul
authors.initials: P
authors.lastname: Garner
authors.forename: Siyan
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mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000855:Anorexia / Q000139:chemically induced; D000995:Antitubercular Agents / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury / Q000097:blood / Q000453:epidemiology / Q000209:etiology*; D002681:China / Q000453:epidemiology; D016903:Drug Monitoring / Q000379:methods / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000097:blood / Q000139:chemically induced* / Q000453:epidemiology; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011446:Prospective Studies; D018570:Risk Assessment / Q000379:methods / Q000706:statistics & numerical data; D012307:Risk Factors; D014376:Tuberculosis / Q000188:drug therapy*; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000995:Antitubercular Agents; D000410:Alanine Transaminase