1

Introduction

In the otorhinolaryngological field, endoscopic sinus surgery (ESS) for chronic rhinosinusitis is one of the most popular surgical procedures used under general anesthesia. A number of studies have shown that the major pathogens appear to be the following: Staphylococus aureus , anaerobes, and Streptococcus pneumoniae . Furthermore, the presence of bacteria in venous blood samples has been transiently recognized in 7% of the patients undergoing ESS , which suggests the possibility of serious postoperative sepsis especially in at-risk patients such as those with cardiac diseases, immunodeficiency, and immunocompromised diseases. Based on bacteriological studies, broad-spectrum antibiotics covering both aerobic and anaerobic bacteria are suitable for the prevention of postoperative infection. However, there is no current consensus on the protocol for antibiotic prophylaxis in ESS.

The clinical efficacy and cost benefit of oral antimicrobial prophylaxis with levofloxacin (LVFX) has been proved at several surgical sites . Tissue and serum concentrations and the antibacterial spectrum of orally administered ofloxacin suggest effective protection against perioperative infection . The administration of oral LVFX was demonstrated to ensure appropriate therapeutic exposure in the sinonasal tissue of patients with chronic rhinosinusitis, which corresponded to the concentration being almost always higher than the minimum inhibitory concentration (90%) against the major bacterial pathogens responsible for upper respiratory tract infections . Although respiratory fluoroquinolones are recommended for the treatment of mild to moderate acute bacterial rhinosinusitis , the clinical efficacy and cost effectiveness of oral antimicrobial prophylaxis with LVFX on ESS have not yet been evaluated.

The present study was designed to compare the clinical effectiveness and the bacteriological change resulting from the administration of the oral antibiotic LVFX with those of intravenous administration of flomoxef (FMOX, second-generation cephalosporin).

2

Materials and methods

From September 2006 to May 2007, 93 patients with chronic rhinosinusitis undergoing ESS were prospectively enrolled in the present study. Any patients associated with fungal sinusitis were excluded from this study. All the patients were selected on the basis of a history of more than 3 months of chronic rhinosinusitis with one or more of the following symptoms: purulent nasal and postnasal drip, nasal obstruction, headache, hyposmia, and sneezing, and all underwent identical sinus investigations. Anterior rhinoscopy was performed for signs of mucopurulent nasal discharge, nasal hyperemia, nasal edema, and nasal polyposis. Computed tomography scans in the coronal planes were obtained. The diagnosis of chronic rhinosinusitis was based on the following findings: having one or more of the symptoms described above for at least 3 months, an abnormal imaging examination with evidence of either mucoperiosteal thickening of at least 6 mm, or complete or near complete opacification of both the ethmoid and maxillary sinuses.

The patients were randomly divided into 2 groups, LVFX and FMOX. Patients were excluded if they were less than 14 years of age, had a history of hypersensitivity to LVFX or FMOX, or had had antimicrobial therapy within at least 14 days before surgery. The operative procedure of ESS was performed according to our previous report . The nasal packing included a finger sac and beschitin gauze (Unitika Ltd, Tokyo, Japan).

Two hundred mg of LVFX was orally given 2 hours before the start of surgery and 6 hours after the end of surgery, which was followed by the administration of 200 mg every 12 hours for 2 days. One gram of FMOX was dissolved in 100 ml of physiological saline and given intravenously at the induction of anesthesia and 6 hours after the end of surgery, followed by infusion twice daily for 2 days.

Before surgery, the lateral wall of the nasal cavity inside the middle meatus was cultured immediately after the sterilization of the nasal vestibule with alcohol swabs. On postoperative day 2, a part of the nasal packing beschitin gauze was removed and used for bacterial culture. All the cultures were processed in the clinical microbiology laboratory using standard techniques. The white blood cell count and C-reactive protein (CRP) were examined on postoperative day 2. The core body temperature, pulse rate, and respiratory rate were recorded at least 4 times a day during the first 3 postoperative days.

The patient’s profile and clinicopathologic factors of the preoperative and postoperative courses were evaluated by a Student t test or the Mann-Whitney U method. The comparison of the culture was analyzed by a χ ² test. A P value less than .05 was considered to be significant.

2

Materials and methods

From September 2006 to May 2007, 93 patients with chronic rhinosinusitis undergoing ESS were prospectively enrolled in the present study. Any patients associated with fungal sinusitis were excluded from this study. All the patients were selected on the basis of a history of more than 3 months of chronic rhinosinusitis with one or more of the following symptoms: purulent nasal and postnasal drip, nasal obstruction, headache, hyposmia, and sneezing, and all underwent identical sinus investigations. Anterior rhinoscopy was performed for signs of mucopurulent nasal discharge, nasal hyperemia, nasal edema, and nasal polyposis. Computed tomography scans in the coronal planes were obtained. The diagnosis of chronic rhinosinusitis was based on the following findings: having one or more of the symptoms described above for at least 3 months, an abnormal imaging examination with evidence of either mucoperiosteal thickening of at least 6 mm, or complete or near complete opacification of both the ethmoid and maxillary sinuses.

The patients were randomly divided into 2 groups, LVFX and FMOX. Patients were excluded if they were less than 14 years of age, had a history of hypersensitivity to LVFX or FMOX, or had had antimicrobial therapy within at least 14 days before surgery. The operative procedure of ESS was performed according to our previous report . The nasal packing included a finger sac and beschitin gauze (Unitika Ltd, Tokyo, Japan).

Two hundred mg of LVFX was orally given 2 hours before the start of surgery and 6 hours after the end of surgery, which was followed by the administration of 200 mg every 12 hours for 2 days. One gram of FMOX was dissolved in 100 ml of physiological saline and given intravenously at the induction of anesthesia and 6 hours after the end of surgery, followed by infusion twice daily for 2 days.

Before surgery, the lateral wall of the nasal cavity inside the middle meatus was cultured immediately after the sterilization of the nasal vestibule with alcohol swabs. On postoperative day 2, a part of the nasal packing beschitin gauze was removed and used for bacterial culture. All the cultures were processed in the clinical microbiology laboratory using standard techniques. The white blood cell count and C-reactive protein (CRP) were examined on postoperative day 2. The core body temperature, pulse rate, and respiratory rate were recorded at least 4 times a day during the first 3 postoperative days.

The patient’s profile and clinicopathologic factors of the preoperative and postoperative courses were evaluated by a Student t test or the Mann-Whitney U method. The comparison of the culture was analyzed by a χ ² test. A P value less than .05 was considered to be significant.