A noncomparative study of cefprozil at two dose levels in the treatment of acute uncomplicated bacterial sinusitis.

The efficacy and safety of cefprozil at two dose levels were evaluated in 110 patients with acute uncomplicated bacterial sinusitis in an uncontrolled, noncomparative, Phase II trial. Ninety patients received 250 mg of cefprozil (low-dose group) and 20 patients received 500 mg of cefprozil (high-dose group) every 12 hours for ten days. Evaluable patients had symptoms consistent with acute sinusitis, pathogens isolated at pretreatment susceptible to cefprozil, and a radiograph positive for sinusitis within 48 hours before treatment. A satisfactory clinical response was achieved in 34 of 39 evaluable patients (87%) in the low-dose group and in all 16 evaluable patients (100%) in the high-dose group. Pathogens were eradicated in 35 of 39 patients (90%) in the low-dose group and in 15 of 16 patients (94%) in the high-dose group. A total of 140 of 155 pathogens (90%) isolated pretreatment were susceptible to cefprozil. Six patients (7%) in the low-dose group and one patient (5%) in the high-dose group reported at least one adverse clinical event.

A follow-up study in a family with dominant progressive inner ear deafness.

A family with dominant progressive inner ear deafness beginning in the high tones has been examined in 1962, 1968 and 1978. The audiometric data of 86 affected members (376 audiograms) were studied by 1) determination of averages, 2) principal component and factor analysis, and 3) curve fitting procedures. The hearing appeared to deteriorate in six characteristic phases with a separate deterioration for the high and the low frequencies. The hearing loss was equal for the R and L ear; in females low tone loss was greater than in males; in branch II the hearing loss proceeded more rapidly than in other branches. No abnormal excretion of organic acids in the urine could be established.

Follow-up study in a family with dominant progressive hereditary sensorineural hearing impairment. I. Analysis of hearing deterioration.

An autosomal-dominant progressive hereditary sensorineural hearing loss with onset in the high frequencies was studied in a Dutch family with 105 affected individuals. The hearing loss was analyzed by a curve-fitting procedure. A hyperbolic tangent was fitted into the audiogram. Five characteristics were distinguished: the high-frequency plateau, the low-frequency plateau, the slope, the low cut-off frequency and the high cut-off frequency. Six phases are recognizable in the development of the hearing loss, which is characterized by a two-step progression, first in the high and then in the low frequencies. Great differences in the rate of the deterioration were observed. The age of onset is between 5 and 15 years.

Assessment of the efficacy and safety of three dose levels of cetirizine given once daily in children with perennial allergic rhinitis.

The present study compared the efficacy and safety of three dose levels of cetirizine (2.5, 5, and 10 mg) once a day with placebo over 14 days in 6-12-year-old children with perennial allergic rhinitis. The design was a double-blind, randomized, multicenter, parallel-group study. Five symptoms (sneezing, nasal discharge, nasal obstruction, nasal pruritus, and ocular pruritus) were rated according to severity by investigators at the visits and daily by patients. Eighty-three patients were randomized to placebo, 84 to 2.5 mg cetirizine, 85 to 5 mg cetirizine, and 76 to 10 mg cetirizine. Groups were comparable at inclusion. The primary efficacy variable was the percentage of days with no or only mild symptoms: at all doses, cetirizine appeared to be more effective than placebo, but a significant difference was reached only in the 10-mg group (difference in medians of 22%; P = 0.016). The test of linearity was significant (P = 0.026) for the percentage of asymptomatic days. The investigators' assessments at each visit scored the symptoms in the placebo group higher, i.e., more severe, than in the active groups, the 10-mg dose causing the greatest reduction in symptoms. Adverse events were infrequent and generally mild or moderate in severity. It was concluded that cetirizine at a 10-mg, once daily dose could be used to treat effectively 6-12-year-old children with perennial allergic rhinitis.

Methods of analysis of large numbers of audiograms.

The analysis of large numbers of audiograms raises the question if and how we can reduce the amount of data without discarding essential information. The present paper compares two ways of data reduction: principal-component analysis and curve fitting. The methods are tested on the audiograms of a large family suffering from a dominant hereditary, progressive hearing loss, beginning in the high frequencies. It is shown that principal-component analysis rejects information on the shape of the audiogram, as do all methods generally referred to as factor analysis. The information concerned is essential for our understanding of the patient's ability to discriminate speech. Curve-fitting procedures are shown to be effective in data reduction.

Follow-up study in a family with dominant progressive hereditary sensorineural hearing impairment. II. Clinical aspects.

An autosomal-dominant progressive sensorineural hearing loss in six generations of a large family with 105 affected members was studied. The pattern of inheritance is autosomal dominant with an almost complete penetrance. The age of onset is between 5 and 15 years. Individuals with a normal audiogram at the age of 15 and over will not develop the disorder. Different generations show an identical pattern of progression. Because the age of onset is the same, anticipation is excluded. The hearing loss is symmetrical. Over 40 years, low-frequency losses are greater in females than in males. Epistasis possibly plays a role since affected individuals in branch II of this family have a more severe expression than those in the other two affected branches. No abnormal excretion of organic acids in the urine could be established.