This review reports data on the general and renal tolerance of the paramagnetic contrast agent Gd-DTPA after intravenous administration. Gd-DTPA was administered usually at a dose level of 0.1-0.2 mmol/kg body wt (range: 0.005-0.25 mmol/kg body wt) in cranial, spinal and body MR indications. In phase I-IIIa studies a total of 2154 healthy volunteers and patients were investigated, usually at a dose of 0.1 mmol/kg body wt. From the obtained results it was concluded that adverse events (AEs) may be expected in the order of magnitude of 1%. In phase IIIb-IV studies 13,439 patients were investigated at 0.1 or 0.2 mmol/kg body wt. Tolerance data were collected according to a standardized protocol and metaanalysis of obtained data was performed. AEs, irrespective of their drug relationship, were observed in 1.15% of the patients. The observed AEs were comparable to those after intravenous administration of iodinated nonionic X-ray contrast media. There was no correlation between patient age and the incidence of AEs. In patients with a known history of allergy the incidence of AEs increased to 2.6%. In pediatric use no added risk was observed in a total of 826 neonates, children, and adolescents up to 18 years of age. Gd-DTPA showed good renal tolerance in patients with and without preexisting impairment of renal function. A prospective open safety and pharmacokinetic study was conducted in patients with hemodialysis. Gd-DTPA was shown to be eliminated completely by hemodialysis. Fast bolus injections were tolerated without added risk. Presented data from postmarketing surveillance (up to March 31, 1991) cover an estimated total of more than 2,000,000 applications.(ABSTRACT TRUNCATED AT 250 WORDS)

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To investigate the safety, patient tolerance, and efficacy with 0.3 mmol/kg gadopentetate dimeglumine in magnetic resonance (MR) imaging of the central nervous system (CNS), a phase 3 trial was conducted in 199 patients with suspected CNS lesions. Patients received either 0.1 or 0.3 mmol/kg gadopentate dimeglumine (injection time, 15 seconds and 45 seconds, respectively). T1- and T2-weighted spin-echo sequences were performed at either 0.5 T or 1.5 T. In 80 patients with enhancing brain lesions, contrast-to-noise ratios (C/Ns) were calculated, and lesion-to-brain contrast was evaluated visually. Six patients (6%) in each dose group reported adverse events. Eight adverse events occurred with 0.1 mmol/kg and seven with 0.3 mmol/kg. Vital signs and laboratory values did not change significantly. C/N (P < .05) and visual assessment ratings were higher with 0.3 mmol/kg than with 0.1 mmol/kg. According to these preliminary results, 0.3 mmol/kg gadopentetate dimeglumine is safe and well tolerated when administered at approximately 1 mL/sec.

The EM study of the mouse embryonic cornea from the 12th to the 19th day of gestation as well as on postnatal days 2 and 18 and on adult animals allow the following conclusions to be drawn: 1. Immediately after the separation of the lens vesicle, the mesenchyme cells migrate into the cornea anlage. 2. There is no collagenous primary stroma in the mouse embryo. 3. During days 12-14 the stroma cells (fibroblasts) differentiate and develop the organelles required for ICS (intercellular substance) secretion. 4. In the posterior region of the stroma, the collagen fibrils are deposited in bundles approximately perpendicular to each other. 5. The adult mouse stroma is divided into 2 zones. In zone I the subepithelial fibrils are randomly distributed and are not bundled (rudimentary Bowman's membrane). In zone II the fiber bundles lie in the plane of the cornea and form a highly ordered three-dimensional network. Basic differences between the mouse and other species are discussed.

The higher dose of contrast material allowed much better results. Dose comparison studies are also recommended for other techniques.

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