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PMID: 6133153 Published · ppublish English Clinical Trial Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Randomised, controlled trial of the comparative efficacy, auditory toxicity, and nephrotoxicity of tobramycin and netilmicin.

Lancet (London, England) ·Vol. 1 ·No. 8334 ·1983-05-21 ·Pages 1123-6

Lerner AM, Reyes MP, Cone LA, Blair DC, Jansen W, Wright GE, Lorber RR

Abstract

254 patients with serious gram-negative bacillary infections were enrolled into a multicentre, randomised, blind clinical trial and treated with tobramycin-ticarcillin or netilmicin-ticarcillin. The two treatment groups were similar as to sex, age, and weight. The mean daily dose of netilmicin (237 mg) was higher than that of tobramycin (211 mg), p less than 0.01, but the mean duration of therapy was longer with tobramycin (9.4 days versus 8.7 days), p less than 0.01. The netilmicin cohort also had more serious underlying diseases, p less than 0.028. Clinical (tobramycin, 93% and netilmicin, 91%) and bacteriological responses (tobramycin, 87% and netilmicin, 89%) were similar. 84 tobramycin and 73 netilmicin patients had serial audiograms. Eighth nerve deficits developed in 10 (12%) tobramycin and two (3%) netilmicin patients, p = 0.037. Drug-related renal dysfunction developed in 5 (4%) of 114 tobramycin patients whose renal function was monitored and in 1 (1%) of 116 netilmicin patients, p = 0.12.

MeSH Terms
Anti-Bacterial Agents/therapeutic use Bacterial Infections/drug therapy Clinical Trials as Topic Double-Blind Method Drug Resistance, Microbial Ear/drug effects Female Gentamicins/therapeutic use Humans Kidney/drug effects Male Netilmicin/adverse effects,pharmacology,therapeutic use Pseudomonas aeruginosa/drug effects Random Allocation Tobramycin/adverse effects,pharmacology,therapeutic use Vestibulocochlear Nerve/drug effects
Chemicals
Anti-Bacterial Agents Gentamicins Netilmicin Tobramycin
Authors & Affiliations
7 authors, click to expand affiliations / ORCID
Lerner A M
Reyes M P
Cone L A
Blair D C
Jansen W
Wright G E
Lorber R R
Article Info
Journal
Lancet (London, England)
Abbr.
Lancet
ISSN
0140-6736
Published
1983-05-21
Pages
1123-6
Language
English
Region
England
NLM ID
2985213R
Subset
IM
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