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OBJECTIVE: To determine the safety and efficacy of ofloxacin otic solution in the treatment of acute otorrhea in children with tympanostomy tubes. DESIGN: Multicenter study with an open-label, prospective ofloxacin arm and retrospective historical and current practice arms. SETTING: Ear, nose, and throat pediatric and general practice clinics and office-based practices. SUBJECTS: Children younger than 12 years with acute purulent otorrhea of presumed bacterial origin and tympanostomy tubes. INTERVENTION: Instillation of 0.3% ofloxacin, 0.25 mL, twice daily for 10 days in the prospective arm; review of medical records in the retrospective arms. MAIN OUTCOME MEASURES: The primary index of clinical efficacy was absence (cure) or presence (failure) of otorrhea at 10 to 14 days after therapy. The primary index of microbiologic efficacy (in the ofloxacin arm only) was eradication of pathogens isolated at baseline. Safety was evaluated in the ofloxacin arm only. RESULTS: Significantly more clinically evaluable ofloxacin-treated subjects were cured (84.4%; 119/141) than were historical practice subjects (64.2%; 140/218) (P< or =.001) or current practice subjects (70%; 33/47) (P< or =.03). All baseline pathogens were eradicated in 103 (96.3%) of 107 microbiologically evaluable ofloxacin subjects. Adverse events considered "possibly" or "probably" treatment related occurred in 29 (12.8%) of 226 ofloxacin-treated subjects. CONCLUSION: Ofloxacin is safe and significantly more effective than treatments used in historical or current practice for acute purulent otorrhea in children with tympanostomy tubes.

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A multicenter, open-label prospective trial was performed to determine the clinical and microbiologic efficacy of ofloxacin (OFLX) otic solution in the treatment of subjects > or =12 years with chronic suppurative otitis media (CSOM) and a chronically perforated tympanic membrane in the infected ear(s). A total of 207 patients at 27 centers in the United States and Central America received OFLX 0.5 mL instilled ototopically twice daily for 14 consecutive days. The primary clinical end point was cure (dry ear) or failure (not dry ear). The primary microbiologic end point was eradication of baseline pathogens. Because there was no comparator and there were few data in the literature regarding clinical efficacy in patients treated with other regimens, the efficacy of OFLX was compared with data recorded in the clinical records of historical-practice control (HPC) or current-practice control (CPC) subjects. The incidence of clinical cure in clinically evaluable OFLX-treated patients (91%; 148 of 162 subjects) was significantly higher than in HPC subjects (67%; 124 of 185 subjects) or CPC subjects (70%; 38 of 54 subjects). OFLX eradicated all baseline pathogens isolated in microbiologically evaluable subjects. These pathogens were predominantly Staphylococcus aureus, Pseudomonas aeruginosa, and Proteus mirabilis. The most common treatment-related adverse event, bitter taste, occurred in 17% (35 of 207) of OFLX-treated subjects. Thus OFLX 0.5 mL administered twice daily for 14 days was effective in resolving the signs and symptoms of CSOM in subjects > or =12 years, was significantly more effective than therapies used to treat HPC or CPC subjects, and was well tolerated.

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This article has overviewed complications of rhinoplasty. Generally, these complications fall into two categories: aesthetic (that is, cosmetic sequelae that may require a revision rhinoplasty) and nonaesthetic. Of the nonaesthetic complications, infection has the widest span of severity. A localized Staphylococcus aureus abscess or Pseudomonas infection of the nose may occur postoperatively. Owing to the proximity of the nose to the cranium, a cavernous sinus thrombosis or basilar meningitis may result. Postoperative toxic-shock syndrome is a rare occurrence that surgeons should be aware of; most cases have occurred with the presence of nasal packing, but a case using only plastic nasal splints has been reported also. Bacteremia seems to be uncommon during rhinoplasty. Infection after rhinoplasty is generally much less frequent than one would expect from an operation in an unsterile field. Antibiotics are frequently utilized electively. Postoperative nasal-periorbital edema and ecchymosis are regarded as unavoidable but may be lessened significantly by postoperative head elevation and cold packs. The possibility of postoperative bleeding must be evaluated by the surgeon preoperatively. This sequela usually occurs either within 72 hours postoperatively or at around 10 days postoperatively. Many different causes exist for chronic postoperative nasal obstruction, from poorly supported nasal valves closing upon inspiration to an enhanced allergic rhinitis leading to chronic nasal mucosal edema. The latter may be treated by injection of steroid into the turbinates. Among aesthetic complications, supratip prominence, saddle deformity, and persistent hump are among the more commonly reported. Supratip prominence--"polly-beak"--can be caused by inadequate reduction of tip cartilaginous or soft-tissue elements, especially in relation to the reduction of the dorsum. An over-reduced dorsum will leave an otherwise normal nasal tip with a relative prominence. An accumulation of blood or a mucous cyst occurring under the skin of the tip will produce a prominence. Poor tip projection, tip ptosis, and alar collapse are the result of overreduction of tip elements. A dislocated alar cartilage can appear as an asymmetric nasal bossa. Saddle-nose deformity occurs after overaggressive bony and/or cartilaginous hump removal. Infractured nasal bones that subsequently drop into the piriform aperture can create a bony saddle. Persistent hump is due to inadequate reduction of a bony or cartilaginous hump. If the septal cartilage reduction is disproportionate to the bony septum reduction, the appearance of either a hump or a saddle is possible.(ABSTRACT TRUNCATED AT 400 WORDS)

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