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[Clinical study on intravenous infusion of micronomicin]
Abstract:
In recent years, aminoglycoside agents as well as beta-lactam antibiotics have been increasingly used with increased incidence of opportunistic infection caused mainly by Gram-negative bacteria. Therefore, we administered micronomicin sulfate (MCR), reportedly lower in nephrotoxicity, at doses of 60 and 120 mg by intravenous drip infusion for 1 and 2 hours to healthy male volunteers and determined the blood level and the urinary recovery rate. The peak of blood level after 1 hour infusion of MCR was 7.3 micrograms/ml in the 60 mg group and 9.5 micrograms/ml in the 120 mg group. T 1/2 (beta) was 3.34 and 2.48 hours respectively. The peak of blood level after 2 hours infusion of MCR was 5.7 micrograms/ml in the 60 mg group and 8.7 micrograms/ml in the 120 mg group. T 1/2 (beta) was 3.36 and 3.71 hours respectively. In the 120 mg group, the urinary recovery rate for the first 24 hours was 53.5% after 1 hour infusion and 60.9% after 2 hours infusion. In the 60 mg group, the rate was higher, 90.1 and 98.6% respectively. It was suggested that intravenous drip infusion of 120 mg of MCR for 1 hour is comparable to intramuscular injection of the same dose. Further, safety and effectiveness of this drug were studied in 7 clinical cases of urological infection. Good results were obtained in 7 clinical cases given 60 or 120 mg of MCR by intravenous drip infusion. Neither side effects nor abnormal laboratory findings were observed in clinical cases.
Insights
Micronomicin sulfate (MCR) intravenous infusion showed favorable blood levels and urinary recovery rates in healthy volunteers. Clinical cases of urological infections demonstrated good efficacy and safety for MCR treatment.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Infectious Diseases
Context:
- Increasing incidence of Gram-negative bacterial infections necessitates effective antibiotic therapies.
- Aminoglycoside and beta-lactam antibiotics are widely used, raising concerns about opportunistic infections.
- Micronomicin sulfate (MCR) is investigated for its potential lower nephrotoxicity compared to other aminoglycosides.
Purpose:
- To evaluate the pharmacokinetic profile of micronomicin sulfate (MCR) administered via intravenous drip infusion in healthy male volunteers.
- To determine blood levels and urinary recovery rates of MCR at different doses (60 mg and 120 mg) and infusion durations (1 and 2 hours).
- To assess the safety and efficacy of MCR in treating clinical cases of urological infections.
Summary:
- Healthy volunteers received MCR (60 or 120 mg) via 1- or 2-hour IV infusion. Peak blood levels and elimination half-lives (T 1/2 beta) were recorded.
- Urinary recovery rates for MCR were higher in the 60 mg group (90.1-98.6%) compared to the 120 mg group (53.5-60.9%) within 24 hours.
- A 120 mg MCR IV infusion over 1 hour was found comparable to intramuscular injection. Seven urological infection cases showed good outcomes with MCR IV infusion, with no observed adverse effects.
Impact:
- The study provides crucial pharmacokinetic data for micronomicin sulfate, informing optimal dosing strategies for intravenous administration.
- Findings suggest that MCR is a potentially safer alternative with good efficacy for treating Gram-negative bacterial infections, particularly in urological cases.
- This research contributes to the understanding of MCR's therapeutic potential and supports its clinical application in managing infections.