The aim of this multicentre, randomized study was to compare the efficacy and safety of moxifloxacin (BAY 12-8039), a new 8-methoxy fluoroquinolone, with that of cefuroxime axetil for the treatment of acute bacterial sinusitis in adults. Diagnosis was made on a range of clinical signs and symptoms combined with radiology and microbiology. A 400 mg dose of moxifloxacin was administered once daily for 7 days to 242 patients and 250 mg twice daily of cefuroxime axetil was administered to 251 patients for 10 days. The clinical success rate at the end of treatment in the evaluable population was significantly higher (96.7%) in the moxifloxacin group (204/211) than in the cefuroxime axetil group (204/225, 90.7%; 95% confidence intervals 1.5%; 10.6%). At follow-up the success rate in the moxifloxacin group was 90.7% and that for the cefuroxime axetil group was 89.2% (95% confidence intervals -4.3%; 5.4%). The predominant pathogens isolated were Streptococcus pneumoniae and Haemophilus influenzae, followed by Moraxella catarrhalis and Staphylococcus aureus. The bacteriological eradication rates were higher for moxifloxacin (94.5%, 103/109) than for cefuroxime axetil (83.5%, 96/115; 95% CI 3.6%; 19.7%). Only one S. pneumoniae infection persisted following moxifloxacin therapy in contrast with three in individuals on cefuroxime axetil. There were slightly more adverse events in the moxifloxacin group than in the cefuroxime axetil group, but there were fewer serious adverse events following moxifloxacin treatment (three vs. eight). The drug was discontinued because of adverse events in 14 moxifloxacin patients and in 11 cefuroxime axetil patients. Overall, in all assessments, moxifloxacin was at least as effective clinically and bacteriologically, and as well tolerated, as cefuroxime axetil in the treatment of acute sinusitis.

A pharmacokinetic study was carried out to determine moxifloxacin concentrations in sinus tissue, after oral moxifloxacin 400 mg once daily for 5 days to patients with chronic sinusitis, undergoing elective sinus surgery. Patients were randomly allocated to one of seven treatment groups, in which tissues were sampled 2, 3, 4, 6, 12, 24 or 36 h post-dose. A control group with non-infected nasal polyps was also included. Forty-eight patients (13 female, 35 male, mean age 47.1 years) were allocated to one of each active treatment group (n = 42) or to the control group (n = 6). Tissue and plasma samples were taken simultaneously and stored frozen until assayed by HPLC. Thirty-nine patients were fully valid for pharmacokinetic analysis. The geometric mean moxifloxacin plasma concentration increased from 2.32 mg/L at 2 h to a maximum of 3.37 mg/L at 4 h post-dose, decreasing to 0.37 mg/L at 36 h post-dose. The moxifloxacin concentration in sinus mucosa was consistently greater than that in plasma being 4.56-5.73 mg/kg from 2 to 6 h and 2.81-1.25 mg/kg from 12 to 36 h post-dose. The elimination rates in plasma and sinus tissues were similar. The tissue/plasma ratio was c. 200% between 2 and 6 h, and up to 328.9% at 36 h. Results were similar whatever the site of tissue sampling (maxillary sinus, anterior ethmoid sinus or nasal polyps). Tissue levels exceeded the MIC(90) of all pathogens commonly causing acute sinusitis (e.g. 5-30 x MIC for Streptococcus pneumoniae: 0.25 mg/L). These results sup-port the use of moxifloxacin 400 mg once daily as a regimen for the treatment of sinus infections.

Diclofenac potassium administered as single doses of 12.5 and 25mg significantly reduced fever and throat pain in patients with acute febrile sore throat. The overall efficacy of these doses was rated significantly higher than that of paracetamol 1000mg or placebo. A dose-response relationship was seen between placebo and the three diclofenac doses. On most outcomes, paracetamol 1000mg was similar to or only slightly better than the diclofenac potassium 6.25mg dose. Diclofenac potassium 12.5mg is the lowest unit dose that could be recommended to provide reliable reduction of oral temperature and relief of throat pain.

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This multicentre, prospective study evaluated the efficacy and safety of 7-day oral moxifloxacin (400 mg/day) for treatment of acute maxillary sinusitis after first-line treatment failure (group 1), and acute sinusitis with high risk of complications (group 2). Two hundred and fifty-eight patients with radiologically confirmed acute sinusitis were enrolled by 52 investigators; 216 patients (83.7%) qualified for per protocol efficacy analysis (group 1, n = 175; group 2, n = 41), and 92 for bacteriological analysis. Samples were collected from the middle meatus. The clinical success rate 7 -10 days posttreatment was 92.6%. Bacteriological success rates were 95.7% after 3 -4 days of treatment, and 97.2% and 95.2%, in group 1 and group 2, respectively, at 7 -10 days post-treatment. Drug-related adverse events, including abdominal pain (2.4%), nausea (2.4%) and diarrhoea (1.2%), were reported in 12.2% of patients. Overall, moxifloxacin therapy resulted in rapid bacteriological eradication, with a high rate of clinical success.

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Determining bacterial aetiology of acute sinusitis is difficult without employing invasive procedures. • Most episodes of acute sinusitis resolve spontaneously. • Antibiotics have demonstrated efficacy for the treatment of acute bacterial sinusitis in clinical trials yet little is known of their effectiveness in real‐life treatment settings. WHAT THIS STUDY ADDS • Most cases of untreated acute sinusitis resolved spontaneously. Antibiotics were more effective when given within the first 10 days of treatment. This had no effect on later recurrence. • Patients with poor oro‐dental condition or recent antibiotic use may derive the most benefit from an antibiotic prescription and this should be considered by prescribers. • The antibiotics used were found to be equally effective. • Existing recommendations to identify acute sinusitis with high probability of bacterial origin, such as the French recommendations, fever or duration of symptoms fail to identify patients in whom antibiotics are more effective. AIMS To assess the effectiveness of antibiotics in acute bacterial sinusitis. METHODS This was a prospective cohort study with 2 months follow‐up of 5640 patients with acute sinusitis included by a random sample from 1174 GPs and 120 ENT specialists. Main outcomes were short‐term initial success, defined as the absence of prescription of (another) antibiotic or sinus lavage within 10 days, and lack of recurrence between the 11th and 60th day, after initial success. RESULTS Initial success was found in 88.7% (95% CI 85.1, 91.4%) of patients without antibiotic prescription at inclusion and 96.2% (95% CI 95.7, 96.7%) of patients prescribed antibiotics. The 10 day adjusted hazard ratio (HR) for treatment failure (new antibiotic prescription or sinus drainage) with initial antibiotics compared with no antibiotics was 0.30 (95% CI 0.21, 0.42) with no difference between antibiotics. Antibiotics were more effective in patients with poor oro‐dental condition (HR 0.04, 95% CI 0.01, 0.20) and in patients who had already used antibiotics during the previous 2 months (HR 0.09, 95% CI 0.03, 0.28). For patients without failure at 10 days, recurrence between the 11th and 60th day was similar whether or not they had initially been prescribed an antibiotic, 94.1% (95% CI 93.4, 94.7%) and 93.4% (95%CI 90.3, 95.5%), respectively. CONCLUSION Most acute sinusitis cases not prescribed antibiotics resolve spontaneously. Antibiotics reduced by 3.3‐fold the risk of failure within 10 days, without impact on later recurrence. The greatest benefit of antibiotics was found for patients with poor oro‐dental condition or with antibiotic use within the previous 2 months.

Malignant external otitis is a serious infection most frequently caused by Pseudomonas aeruginosa. Because of its antipseu-domonal activity and good tissue penetration, ciprofloxacin is an antibiotic which should, in theory, be effective in the treatment of this type of infection. Publications on the use of ciprofloxacin in the treatment of malignant external otitis are analysed below. This paper analyses 84 clinical case studies collected from 13 publications: ciprofloxacin, administered for the most part orally, was given in a dosage of 750 mg twice daily, apart from three studies where a lower dosage of 500 mg twice daily was used. When the drug was administered parenterally, the dosage was 200 mg b.i.d. In one publication, ciprofloxacin was used in combination with rifampicin. The average duration of treatment was 3 months. Ps. aeruginosa was isolated in 82 patients and sensitivity tests were carried out on 47 strains, none of which was resistant to ciprofloxacin. The clinical cure rate was 96.4% (84 patients). The rate of bacteriological eradication was close to 100% in the 76 evaluable patients. Long-term follow-up (between 2 and 44 months) showed that clinical and bacteriological cure was maintained in all but two patients. Ciprofloxacin thus seems to be a particularly useful antibiotic for the treatment of malignant external otitis, both because of its clinical and bacteriological efficacy and because it is well tolerated.