Studies on meropenem for treatment of paransal sinusitis

Abstract

Safety and efficacy of meropenem (MEPM) in the treatment of paranasal sinusitis were evaluated in a multicenter clinical study using a standard protocol. Sensitivity of bacterial isolates to MEPM and distribution of the drug into maxillary sinus mucosa, sinus secretion and ethmoid mucosa were aslo investigated. The MIC₈₀ of MEPM was 0.39μg/ml, comparable to IPM, and showed the most potent antibacterial activity of drugs tested on the 29 stains isolated from patients with paranasal sinusitis. MEPM concentrations in paranasal tissues after intravenous administration of 500mg of MEPM were 0.35-8.10μg/g in maxillary sinus mucosa, 0.47-6.29μg/ml in sinus secretion, 0.40-6.50μg/g in ethmoid mucosa and 1.71-68.1μg/ml in serum or plasma. A total 29 patients were evaluated by the Efficacy Assessment Committee. The clinical efficacy of MEPM was rated as excellent in 13 patient, good in 14, fair in one, and poor in one, with an overall efficacy rate of 93.1%. Physicianassessed clinical efficacy was rated as excellent in seven patients, good in 15, fair in six, and poor in one patients, with an overall efficacy rate of 7.59%. The pathogen eradication rate was 100% for cases (eradicated in 21 and replaced in 2 of 23 cases), and 100% for strains (eradicated in 30 and replaced in two of 32 strains). No side effects were observed although elevations of GOT and GPT in one patient, GPT in two patients, and GOT, GPT, ALP, and LDH in one patient were noted. The results of these studies indicate that MEPM is highly effective in the treatment of paranasal sinusitis.