title: [Prophylaxis of invasive fungal infection with different administration regimens of itraconazole in patients with acute myeloid leukemia: a report from a randomized, controlled trial].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of antifungal prophylaxis of itraconazole in patients with acute myeloid leukemia (AML) to probe the relationship of the antifungal effect and the adverse events with serum concentration.
  
  
  METHODS
  From April 2009 to May 2011, a total of 310 courses from 112 patients referred to our institute were enrolled in this study; of them, 297 courses were eligible for analysis. Eligible cases were randomized into oral group and injection/oral group according to different chemotherapy of induction and consolidation. Blood samples were collected at different time points for measurements of serum itraconazole levels. The morbidity of IFI and the adverse events were analyzed.
  
  
  RESULTS
  The morbidities of IFI in injection/oral and oral groups were 10.1% and 20.9%, respectively (P=0.010). 7 and 9 cases in injection/oral and oral groups, respectively were withdrawn from the study because of adverse events, and the difference between these two groups was of no significance. Serum itraconazole levels of injection/oral and oral groups were 672(299-1097) μg/L and 534(210-936) μg/L, respectively (P<0.01).
  
  
  CONCLUSIONS
  Antifungal prophylaxis with itraconazole in AML patients was effective and safe. Prophylactic effect with injection/oral itraconazole was superior to oral itraconazole solution; moreover, prophylactic effect of itraconazole was highly correlated with its serum level.
authors.affiliation: Institute of Hematology and Blood Disease Hospital ,CAMS & PUMC, Tianjin 300020, China.
authors.forename: Xin
authors.initials: X
authors.lastname: Liu
authors.forename: Yong
authors.initials: Y
authors.lastname: Huang
authors.forename: Dong-lin
authors.initials: DL
authors.lastname: Yang
authors.forename: Jia-lin
authors.initials: JL
authors.lastname: Wei
authors.forename: Yi
authors.initials: Y
authors.lastname: He
authors.forename: Qiao-ling
authors.initials: QL
authors.lastname: Ma
authors.forename: Ai-ming
authors.initials: AM
authors.lastname: Pang
authors.forename: Si-zhou
authors.initials: SZ
authors.lastname: Feng
authors.forename: Ming-zhe
authors.initials: MZ
authors.lastname: Han
mesh_terms: D000293:Adolescent; D000328:Adult; D019072:Antibiotic Prophylaxis; D000935:Antifungal Agents / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D017964:Itraconazole / Q000097:blood / Q000627:therapeutic use*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000382:microbiology; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000209:etiology / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D017964:Itraconazole