ABSTRACT. Objective. To determine the efficacy and safety of topical ciprofloxacin/dexamethasone otic suspension compared with ofloxacin otic solution in the treatment of acute otitis media with otorrhea through tympanostomy tubes (AOMT) in pediatric patients.Methods. This multicenter, prospective, randomized, observer-masked, parallel-group study was conducted at 39 sites in 599 children aged >6 months to 12 years with an AOMT episode of <3 weeks' duration. The mean age of patients was 2.5 years (standard deviation: 2.37 years). Patients received either ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension 4 drops twice daily for 7 days or ofloxacin 0.3% otic solution 5 drops twice daily for 10 days. Clinical signs and symptoms of AOMT were evaluated at clinic visits on days 1 (baseline), 3 (on therapy), 11 (end of therapy), and 18 (test of cure). A patient diary was used to measure time to cessation of otorrhea. Principal pretherapy pathogens included Streptococcus pneumoniae (16.8%), Staphylococcus aureus (13.0%), Pseudomonas aeruginosa (12.7%), Haemophilus influenzae (12.4%), S epidermidis (10.2%), and Moraxella catarrhalis (4.1%).Results. Ciprofloxacin/dexamethasone is superior to ofloxacin for clinical cure (90% vs 78%) and microbiologic success (92% vs 81.8%) at the test-of-cure visit, produces fewer treatment failures (4.4% vs 14.1%), and results in a shorter median time to cessation of otorrhea (4 days vs 6 days). Ciprofloxacin/dexamethasone treatment is also superior to improvement in clinical response by visit, absence of otorrhea by visit, and reduction of otorrhea volume by visit. Both topical otic preparations are safe and well tolerated in pediatric patients. No change in speech recognition threshold or decrease in hearing from baseline, based on audiometric testing, was noted with either regimen.Conclusion. Topical ciprofloxacin/dexamethasone treatment is superior to topical ofloxacin in the treatment of AOMT. Pediatrics 2004;113:e40 -e46. URL: http://www. pediatrics.org/cgi/content/full/113/1/e40; ciprofloxacin, dexamethasone, ofloxacin, otorrhea, AOM, tympanostomy tubes.ABBREVIATIONS. AOMT, acute otitis media with otorrhea through tympanostomy tubes; CSOM, chronic suppurative otitis media; TOC, test of cure; ITT, intention-to-treat.T he most common surgery performed in children for treatment of recurrent otitis media with effusion is the insertion of a tympanostomy tube into the eardrum. 1 However, otorrhea is a common complication after their insertion. The vast majority (90%-95%) of cases of acute otitis media with otorrhea through tympanostomy tubes (AOMT) occur in children aged 1 to 12 years, and typically 2 to 6 episodes of AOMT are experienced. 2,3 Topical ciprofloxacin is an effective and safe therapy for AOMT 4,5 and chronic suppurative otitis media (CSOM). 6 -8 Bacteria commonly isolated from patients with AOMT include Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, and Pseudomonas aeruginosa. 3 Because of the inflammatory response indu...

Pregnancy profoundly influenced the composition of serous body cells in women by significantly lowering mesothelial cells and lymphocytes and elevating polymorphonuclear leukocytes when compared to nonpregnant and postpartum women (1-3). In order to make possible useful comparisons with women, the present study was undertaken to determine the effect of pregnancy on the cytology of mouse peritoneal fluid. To our knowledge, no similar studies have been reported.Materials and Methods. We cohabited adult female mice (CF-1; 25-30 gm) with adult males (301 gm) of the same strain in a 3: 1 ratio under standard animal room conditions. Every morning, we inspected the females for a vaginal plug to establish day 1 of pregnancy. The serous fluid from the abdominal cavity of pregnant females was aspirated by us on days 3, 9, and 17 of gestation as well as 1 week postpartum by means of a Not. 2 7 gauge needle attached to a 1-ml tuberculin syringe. In order not to penetrate the viscera, we introduced the needle into the abdominal cavity with the animal's ventral surface facing upward. By holding the needle firmly in place, we rotated the mouse back to its normal position so that fluid would drain !toward the needle. We spread the aspirated specimen on an albumin-coated slide and stained it by Papanicolaou's procedure ( 4 ) . Two hundred consecutive cells were counted by us and were grouped as mesothelial cells, lymphocytes, pulymorphonuclear leukocytes, histiocytes, mast cells, and "other cells". The last category was less then 1% of the total sample and contained nuclei without cyto-plasm which could not be further identified. Abdominal /fluid was aspirated from nonpregnant control mice on the same days as the pregnant females so that 60 normal control counts from 15 animals were averaged to oibtain the mean normal control values.The significance of difference between counts taken on different days of gestation was computed using the formula, SE = [~d ' / j N ( N --l ) ]~ and Student's t test. We calculated the standard error for each mean cell count and the probability values ( p ) . To characterize the cells of the mouse peritoneal cavity, standard morphologic criteria were used by us (4).ResuEts. The inlfluence of each stage of pregnancy and 1 week postpartum on motuse peritoneal fluid cytodifferential counts is seen in Table I. In normal control cytologic aspirations, the percentage of mesothelial cells, lymphocytes, polymorphonuclear leukocytes, histiocytes, mast cells, and "other cells" were 516.0, 33.7, 3.2, 4.1, 0.4, and 2.6%, respectively. The number of mesothelial cells were significantly low ( p = 0.02) in cytologic specimens obtained on day 9 of gelstation when compared to day 3 . Lymphocytes decreased on day 17 (p