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. 2014 Sep 4;2014(9):CD000239. doi: 10.1002/14651858.CD000239.pub2

1. Other harms.

Trial Experimental drug Control Number of patients Harms
Anaissie 1996 Fluconazole: 400 mg/d iv Amphotericin B: 25‐50 mg/d iv 75 versus 67 Chills or fever: 0 versus 3; Hepatic toxicity: 2 (1 withdrawn) versus 3; Rash: 0 versus 2; Nausea, vomiting or diarrhoea: 0 versus 2
Bodey 1994 Fluconazole: 400 mg/d orally Amphotericin B: 0.2 mg/kg/d iv 41 versus 36 Doubling of S‐creatinine: 0 versus 4 (1 haemodialysis); Liver enzyme increase: 1 (patient withdrawn) versus 0; Nausea, vomiting: 2 versus 4; Diarrhoea: 4 versus 4
Koh 2002 Fluconazole: 200 mg/d orally Amphotericin B: 0,2 mg/kg/d iv 100 versus 86 Renal dysfunction: 0 versus 3 (withdrawn); Liver dysfunction: 3 (withdrawn) versus 0; Increase in S‐creatinine to more than 1.5 times baseline: 13 versus 18
Lake 1996 Fluconazole: 200 mg/d orally Amphotericin B: 0.3 mg/kg/d iv 16 versus 15 Vomiting: 2 (1 withdrawn) versus 2; Rigors/fever: 0 versus 5
Malik 1998 Fluconazole: 400 mg/d orally Amphotericin B: 0.5 mg/kg/d iv 52 versus 48 Chills and fever: 1 versus 4; Rash: 1 versus 0; Bronchospasm: 0 versus 2; Nephrotoxicity: 3 versus 9 (but defined as an increase in S‐creatinine that was only 50% of baseline values)
Marie 1993 Fluconazole: 400 mg/d iv Amphotericin B: 0.5 mg/kg/d iv 65 versus 66 Rigors: 18 versus 1; Fever: 12 versus 1; Liver enzyme increase: 2 (withdrawn) versus 0; Renal impairment: 0 versus 3 (withdrawn)
Silling 1999 Fluconazole: 5.7 mg/kg/d iv Amphotericin B: 0.75 mg/kg/d iv + 5‐flucytosine 150 mg/kg/d iv 51 versus 47 Side effects suspected to be drug‐related: 19.6% versus 97.6% [sic] of the patients
Viscoli 1996 Fluconazole: 6 mg/kg/d iv Amphotericin B: 0.8 mg/kg/d iv 56 versus 56 Chills or fever: 0 versus 42; Nephrotoxicity: 7 versus 10 (3 withdrawn, one of whom underwent haemodialysis); Liver enzyme increase: 6 versus 10; Rash: 2 versus 2
Winston 2000 Fluconazole: 400 mg/d iv Amphotericin B: 0.5 mg/kg/d iv 158 versus 159 Chills: 1 versus 79 (3 withdrawn); Renal impairment: 1 versus 53 (7 withdrawn); Liver dysfunction: 2 (1 withdrawn) versus 1 (withdrawn); Rash: 7 versus 1: Diarrhoea: 4 versus 0
Wolff 2000 Fluconazole: 400 mg/d orally Amphotericin B: 0.2 mg/kg/d iv 196 versus 159 Toxicity leading to treatment discontinuation: 1 (rash) versus 20 (13 renal, 3 underwent haemodialysis)
Akiyama 1993 Fluconazole: 200 mg/d orally Amphotericin B: 2.4 g/d orally 40 versus 36 episodes Data not reliable, 99% of the patients received fluconazole 'without any difficulty', but there were only 51 patients in total in the trial
Menichetti 1994 Fluconazole: 150 mg/d orally Amphotericin B: 2 g/d orally 420 versus 400 Gastrointestinal disturbances: 3 versus 28; Liver enzyme increases: 2 versus 0; Rash: 1 versus 0
Meunier 1991 Fluconazole: 200 mg/d orally Amphotericin B: 400 mg/d orally + 30 mg/d sucking 30 versus 29 Altered liver function tests: 10 versus 8
Powles 1990 Fluconazole: 200 mg/d orally Amphotericin B: 800 mg orally and 40 mg lozenges, and nystatin 1.2 MIU mouthwash daily No data No data
Teshima 1994 Fluconazole: 400 mg/d orally Amphotericin B: 2.4 g/d orally 53 versus 55 Article in Japanese
Ninane 1994 Fluconazole: 3 mg/kg/d orally Amphotericin B: 25 mg/kg/d orally and/or nystatin 4 MIO IU orally 236 versus 249 ('polyenes') Possible drug‐related side effects: 38 (8 withdrawn) versus 21 (3 withdrawn); Gastrointestinal effects: 27 versus 16
Philpott‐Howard 1993 Fluconazole: 50 mg/d orally Amphotericin B: 2 g/d orally and/or nystatin 4 MIO IU orally 269 versus 267 ('polyenes') Skin reactions: 6 versus 2; GI effects: 7 versus 12; Biliary system: 2 versus 0; Generalized reaction: 1 versus 0; Change in hepatic function: '12‐15% of patients in each group'; Change in renal function: 'about 3%' in each group. Treatment withdrawn due to abnormal laboratory values: 10 versus 0