title: A double-blinded, placebo-controlled, multicenter clinical trial of N-acetylcysteine for preventing amphotericin B-induced nephrotoxicity.
abstract: OBJECTIVE
  To evaluate the effectiveness of oral N-acetylcysteine (NAC) co-treatment in preventing amphotericin B (AmB)-induced nephrotoxicity (AIN), including creatinine clearance and biomarkers of renal function (cystatin C [Cys C] and kidney injury molecule-1 [KIM-1]).
  
  
  METHODS
  Either placebo or 600 mg oral NAC was given twice daily during the treatment course of AmB. Renal function test, serum as well as urinary level of Cys C and urinary KIM-1 were determined.
  
  
  RESULTS
  Among the study population (n = 54), 23 (42.59%) patients developed AmB nephrotoxicity during their treatment course. NAC co-treatment was significantly associated with mitigating AmB nephrotoxicity (OR = 0.286, 95% CI: 0.082 - 0.993; p = 0.049). No statistically significant difference regarding accuracy of measured biomarkers including serum creatinine, serum and urine Cys C and urine KIM-1 at days 0 and 7 of treatment in predicting and detecting AmB nephrotoxicity was identified. The changes in mean serum and urine Cys C and urine KIM during AmB treatment within and between treatment groups were not statistically significant.
  
  
  CONCLUSIONS
  Co-treatment with 600 mg oral NAC twice a day during AmB treatment, after adjusting for multiple variables, was associated with prevention of AIN. However, significantly higher adverse reactions developed in the patients who were treated with NAC.
authors.affiliation: a 1 Shiraz University of Medical Sciences, Department of Clinical Pharmacy, Faculty of Pharmacy , Shiraz, Iran.
authors.forename: Iman
authors.initials: I
authors.lastname: Karimzadeh
authors.forename: Hossein
authors.initials: H
authors.lastname: Khalili
authors.forename: Mohammad Mahdi
authors.initials: MM
authors.lastname: Sagheb
authors.forename: Shadi
authors.initials: S
authors.lastname: Farsaei
mesh_terms: D000111:Acetylcysteine / Q000008:administration & dosage / Q000627:therapeutic use*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000666:Amphotericin B / Q000009:adverse effects* / Q000627:therapeutic use; D000935:Antifungal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D055316:Cystatin C / Q000652:urine; D004311:Double-Blind Method; D005260:Female; D000072596:Hepatitis A Virus Cellular Receptor 1; D006801:Humans; D007674:Kidney Diseases / Q000139:chemically induced / Q000517:prevention & control*; D007677:Kidney Function Tests; D008297:Male; D008562:Membrane Glycoproteins / Q000652:urine; D008875:Middle Aged; D011991:Receptors, Virus; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D055316:Cystatin C; C491143:HAVCR1 protein, human; D000072596:Hepatitis A Virus Cellular Receptor 1; D008562:Membrane Glycoproteins; D011991:Receptors, Virus; D000666:Amphotericin B; D000111:Acetylcysteine
keywords: N-acetylcysteine; amphotericin B; nephrotoxicity; prevention