The safety and efficacy of cefozopran (CZOP) in the treatment of lacunar tonsillitis, peritonsillitis, peritonsillar abscess, and other infectious diseases of the upper aerodigestive tract were ...evaluated in a multicenter clinical study using a standard protocol. In addition, the sensitivity of bacterial isolates to CZOP and distribution of the drug into tonsillar tissues and submandibular salivary gland tissues were also investigated. The MIC90 of CZOP was 0.78μg/ml on the 153 strains isolated from patients with tonsillitis and other infectious deseases of the upper aerodigestive tract was found to have a more potent antibacterial activity than ceftazidime. The CZOP concentrations after the intravenous administration of ig of CZOP were 0.7 to 31.9μg/g in tonsillar tissues at 0.5 to 6 hours, and 3.7 to 30.5μg/g in the submandibular salivary gland tissues at 0.58 to 5.08 hours. The clinical efficacy of CZOP was evaluated in 134 of the 142 patients, while safety was assessed in 141 patients. The majority of the patients were given a 1g dose twice daily for longer than 4 days, but not exceeding 7 days. The clinical efficacy rate (“Excellent” plus “Good”) were 90% (130/134) by the doctors in charge, and 88% by the Efficacy Assessment Committee, while the bacteriological eradication rate was 97% (135/139). In addition, no adverse reaction was observed. Abnormal laboratory findings were observed in 18 cases, increase or decrease of white blood cells, an increase of eosinophile or lymphocyte, an elevation of serum transaminase, γ-GTP, LDH, BUN, and serum potassium respectively.
The safety and efficacy of cefozopran (CZOP) in the treatment of paranasal sinusitis were evaluated in a multicenter clinical study using a standard protocol. The sensitivity of bacterial isolates to ...CZOP and the distribution of the drug into the maxillary sinus mucosa, a nasal polyp and rhinorrhea were investigated. The MIC90 of CZOP was 1.56μg/ml in the 42 strains isolated from patients with paranasal sinusitis, and it showed a more potent antibacterial activity than ceftazidime. There were three different CZOP concentrations after the intravenous administration of lg of CZOP including: 3.9-44.3μg/g in the maxillary sinus mucosa, 1.6-39.6μg/g in a nasal polyp and 1.3-26.2μg/g in rhinorrhea. The clinical efficacy of CZOP was evaluated in 40 of the 44 patients, while safety was assessed in 42 patients. The majority of the patients were given a dose of 1g, twice daily for longer than 4 days, but not exceeding 7 days. The clinical efficacy rate (“Excellent” plus “Good”) was considered to be 68% by the doctors in charge, and 78% by the Efficacy Assessment Committee. The bacteriological eradication rate was 93% (26/28 cases) for all cases, and94% (30/32 strains) for strains. No adverse reaction was observed. Regarding the laboratory findings, a slightly increased amount of prothronbin was observed in one patient.