Short course therapy with cefuroxime axetil for acute otitis media: results of a randomized multicenter comparison with amoxicillin/clavulanate.

BACKGROUND: Otitis media is a common infection of childhood. Increasing antibiotic resistance rates among the principal causative pathogens, Streptococcus pneumoniae and Haemophilus influenzae, are associated with failure of first line agents. OBJECTIVE: This open, randomized, multicenter study compared the clinical efficacy of a short 5-day course of cefuroxime axetil (CAE) suspension with that of amoxicillin/clavulanate (A/CA) suspension for 8 or 10 days. METHODS: Children age 6 to 36 months with acute otitis media with effusion, diagnosed by tympanocentesis and microbiologic culture, were randomized to receive CAE (30 mg/kg/day in two divided doses for 5 days) or A/CA 40 mg/kg/day in three divided doses for 10 days (A/CA-10). In French centers A/CA was given at 80 mg/kg/day in three divided doses for 8 days (A/CA-8). Patients were assessed 1 to 4 days after completing the course (posttreatment) and followed up at 21 to 28 days after completing the course. RESULTS: Of the 716 patients randomized, 252 were treated with CAE, 255 with A/CA-10 and 209 with A/CA-8. In the clinically evaluable population, the proportions of patients with clinical cure at posttreatment were 175 of 203 (86%), 181 of 205 (88%) and 145 of 164 (88%) in the CAE, A/CA-10 and A/CA-8 groups, respectively, demonstrating equivalence among the three treatments. For patients <18 months old, clinical cures were 111 of 134 (83%), 116 of 131 (89%) and 83 of 99 (84%) in the CAE, A/CA-10 and A/CA-8 groups, respectively; equivalence was also demonstrated. At follow-up, 130 of 175 (74%) CAE, 121 of 172 (70%) A/CA-10, and 112 of 142 (79%) A/CA-8 had maintained cure. A total of 837 pretreatment pathogens were isolated from middle ear fluid in 73% (522 of 716) patients, the majority of isolates were S. pneumoniae (30%) and H. influenzae (27%). The most common adverse events were gastrointestinal, the incidence of drug-related diarrhea being higher in the A/CA-10 group (18%) than in either the CAE or A/CA-8 groups (10%). CONCLUSIONS: A 5-day course of CAE, given twice daily, was shown to be equivalent to the two regimens of A/CA for treatment of acute otitis media with effusion in children.

Transverse coloplasty pouch and colonic J-pouch for rectal cancer--a comparative study.

OBJECTIVES: The introduction of the colonic J-pouch has markedly improved the functional outcome of restorative rectal cancer surgery. However colonic J-pouch surgery can be problematic and may present some late evacuatory problems. To overcome these limitations a novel pouch has been proposed: the transverse coloplasty pouch. The purpose of our study was to compare the functional outcomes of these two different types of pouches--the transverse coloplasty pouch (TCP) and the colonic J-pouch (CJP)--during the first 12 months postoperatively. PATIENTS AND METHODS: A prospective randomized trial was conducted in which a total of 30 patients with mid and low rectal cancer were submitted either to a transverse coloplasty pouch or a colonic J-pouch. Clinical defaecatory function was assessed and anorectal physiological assessment was carried out, pre-operatively and at 3, 6 and 12 months postoperatively, by means of a standard clinical questionnaire and by anorectal manometry. RESULTS: No statistically significant differences were found between the two groups regarding bowel function. The postoperative frequency of daily bowel movements was lower in the TCP group in all the phases of the study (3.9 vs. 4.1 at 3 months; 3.1 vs. 3.4 at 6 months; 2.1 vs. 2.8 at 12 months), the same occurring with fragmentation (33% vs. 40% at 3 months; 26.6%vs. 33.3% at 6 months; 7.1%vs. 14.3% at 12 months). Less urgency was also seen in the TCP group during the first 6 months (20%vs. 26.7%), with identical values at 12 months (14.3% vs. 14.3%). No significant differences were also found concerning incontinence grading and scoring, with TCP patients having less nocturnal leaks. At one year two CJP patients (14.3%) needed the use of enemas to evacuate the pouch and provoke defaecation, a problem never seen in TCP patients. The anorectal manometry data was similar in both types of pouches. The local complication rates were also identical in the two groups (20%); more anastomotic leaks were seen in TCP patients (13.2% vs. 6.6%), without reaching a statistical significance. CONCLUSION: The transverse coloplasty pouch has similar functional results but fewer evacuation problems than the J-Pouch, making it a safe and reliable alternative to the colonic J-pouch.