Randomised, controlled trial of the comparative efficacy, auditory toxicity, and nephrotoxicity of tobramycin and netilmicin.
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.
D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004352:Drug Resistance, Microbial; D004423:Ear / Q000187:drug effects*; D005260:Female; D005839:Gentamicins / Q000627:therapeutic use*; D006801:Humans; D007668:Kidney / Q000187:drug effects*; D008297:Male; D009428:Netilmicin / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D011550:Pseudomonas aeruginosa / Q000187:drug effects; D011897:Random Allocation; D014031:Tobramycin / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000159:Vestibulocochlear Nerve / Q000187:drug effects
D000900:Anti-Bacterial Agents; D005839:Gentamicins; D009428:Netilmicin; D014031:Tobramycin