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Chills or fever: 0 versus 3; Hepatic toxicity: 2 (1 withdrawn) versus 3; Rash: 0 versus 2; Nausea, vomiting or diarrhoea: 0 versus 2 |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Doubling of S‐creatinine: 0 versus 4 (1 haemodialysis); Liver enzyme increase: 1 (patient withdrawn) versus 0; Nausea, vomiting: 2 versus 4; Diarrhoea: 4 versus 4 |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Renal dysfunction: 0 versus 3 (withdrawn); Liver dysfunction: 3 (withdrawn) versus 0; Increase in S‐creatinine to more than 1.5 times baseline: 13 versus 18 |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Vomiting: 2 (1 withdrawn) versus 2; Rigors/fever: 0 versus 5 |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Rigors: 18 versus 1; Fever: 12 versus 1; Liver enzyme increase: 2 (withdrawn) versus 0; Renal impairment: 0 versus 3 (withdrawn) |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Chills or fever: 0 versus 42; Nephrotoxicity: 7 versus 10 (3 withdrawn, one of whom underwent haemodialysis); Liver enzyme increase: 6 versus 10; Rash: 2 versus 2 |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Chills: 1 versus 79 (3 withdrawn); Renal impairment: 1 versus 53 (7 withdrawn); Liver dysfunction: 2 (1 withdrawn) versus 1 (withdrawn); Rash: 7 versus 1: Diarrhoea: 4 versus 0 |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 |