Once- versus twice-daily amikacin regimen: efficacy and safety in systemic Gram-negative infections
| Autor: | I Lausen, J Smedjegård, Rolf Maller, L E Nilsson, H Ahrne, C Holmen |
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| Rok vydání: | 1993 |
| Předmět: |
Pharmacology
Microbiology (medical) medicine.medical_specialty Nausea business.industry Surgery law.invention Regimen Infectious Diseases Pharmacotherapy Randomized controlled trial Amikacin law Internal medicine Ampicillin medicine Pharmacology (medical) medicine.symptom business Piperacillin medicine.drug Antibacterial agent |
| Zdroj: | Journal of Antimicrobial Chemotherapy. 31:939-948 |
| ISSN: | 1460-2091 0305-7453 |
| Popis: | Three hundred and sixteen patients with serious infections verified or suspected to be of Gram-negative aetiology were treated in an open, randomized, comparative multicentre study with amikacin 15 mg/kg/day given either as a single dose or in two divided doses at 12 h intervals. Two hundred patients were evaluated for efficacy and all 316 for safety. The efficacy of both dosage regimens was very good with a satisfactory clinical response in 90% of the patients. There were no significant differences between the two regimens regarding efficacy and safety. This was also confirmed in an analysis according to the principle of 'intention-to-treat' including all randomized patients. In 218 patients additional therapy, most commonly with piperacillin or ampicillin, was considered necessary. The mean peak serum concentration of amikacin was 40.9 mg/L in the once-daily group, which is 10 x MIC for most Gram-negative bacteria, compared to 24.4 mg/L in the twice-daily group, which is 6 x MIC. Mean trough serum concentrations after 24 h were 1.8 mg/L in the once-daily group and 3.1 mg/L after 12 h in the twice-daily group. These serum concentrations were often close to or just below the MICs of the isolated pathogens. Drug related adverse reactions were seen in 40 (13%) of the patients. Among the adverse reactions with possible or probable relation to amikacin were 20 nephrotoxic events, nine in the once-daily group and 11 in the twice-daily group. A multivariate analysis of selective causative factors and nephrotoxic events gave a low correlation for once- vs twice-daily amikacin therapy. Five ototoxic events were observed, three in the once-daily group and two in the twice-daily group. One patient in the once-daily group experienced nausea in connection with amikacin infusions. |
| Databáze: | OpenAIRE |
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