[Steering committees in drug trials].
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Biomedical subjects
Publications and source records attributed to H Kleinsorge.
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Changes in the gastroduodenal mucosa caused by 250 mg ticlopidine twice daily (group 1; n = 12) or 300 mg aspirin daily (group 2; n = 12) were compared in a randomized double-blind trial of 24 healthy men, aged 20 to 35 years. An oesophago-gastroduodenoscopy was performed before and after either drug had been taken for 7 days. Results were tabulated according to a uniform scoring system (normal mucosa, erythema, petechiae, erosions, ulcer, and blood in the lumen). Both groups had identical scores at the start of the trial (group 1: 0.9 +/- 0.1; group 2: 0.8 +/- 0.1). After the seven days, the score in group 2 had risen to 9.7 +/- 1.5 (median 9.0), while it had hardly changed in group 1 (1.7 +/- 0.5; median 1.0), a statistically significant difference (P < 0.05). The data indicate that ticlopidine is better tolerated by the gastroduodenal mucosa than low dosage aspirin.
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The article reports on 4 patients with rare modeling defects of the long bones. These defects are metaphyseal dysplasia, craniometaphyseal dysplasia, frontometaphyseal dysplasia, and osteodysplasty (osteodysplasty of Melnick and Needles). The differential diagnostic criteria are shown in a table to allow diagnosis already in children. This appears important in respect of the therapy to be employed (corrective surgery) and for prognosis, as well as for giving patients proper genetic and vocational advice.
The classical case of a Gorlin-Cohen-Syndrom (= fronto-metaphyseal dysplasis=FMD) is presented. The disease has been mentioned in literature for the first time in 1969 and has been described four times up to now. The characteristic features of this syndrome are very prominent supraorbital ridges with generalized bone dysplasia and joint deformities.