[Gastroduodenal tolerance of methylprednisolone. Study of oral versus intravenous administration in healthy volunteers].
OBJECTIVE
To endoscopically evaluate the tolerance of gastroduodenal mucosa to methylprednisolone given orally and intravenously.


METHODS
Thirty two healthy volunteers (age range 18-39 years) were divided randomly into two groups of 16 each (8 males and 8 females). All were Caucasians, gave their informed consent and were considered normal after a complete clinical and laboratory work-up including gastroduodenal fibroscopy. Methylprednisolone (500 mg) was administered for three consecutive days at 9 a.m., orally in one group and intravenously in the second group. No other drugs were being taken and alcohol and smoking were prohibited from day 0 to day 11. Tolerance was evaluated on days 4 and 11 based on clinical examination, blood pressure, heart rate, oral temperature, body weight, blood and urine chemistry and by video-recorded gastroduodenal endoscopy. Two independent endoscopists, uninformed of the patient's regimen, scored lesions from 0 (normal) to 5 (more than 25 lesions including at least 2 erosions). In case of abnormal findings, follow-up was continued to normalization.


RESULTS
Endoscopically detectable lesions (stage I) attributed to corticosteroid therapy were observed in 4 subjects in the oral group and in 5 in the intravenous group. All regressed spontaneously. Duodenal lesions were observed only after oral administration while lesions of gastric mucosa were mostly found after intravenous administration. Systemic effects included abdominal pain after oral intake, 1 case of insomnia and bitter taste in the mouth after intravenous administration.


CONCLUSIONS
These findings suggest that the effect of corticosteroid therapy, on the gastric mucosa, is basically systemic, and on the duodenal mucosa, basically local. No severe manifestations were observed after high-dose methylprednisolone given orally or by intravenous injection.
Institut Aster, Paris.
D
D
Chassard
O
O
Banzet
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F
Lamy
J
J
Gordin
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Viveash
J J
JJ
Thébault
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D004341:Drug Evaluation; D004386:Duodenum / Q000000981:diagnostic imaging / Q000187:drug effects*; D016145:Endoscopy, Digestive System; D005260:Female; D005753:Gastric Mucosa / Q000000981:diagnostic imaging / Q000187:drug effects*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D011859:Radiography; D012016:Reference Values
D008775:Methylprednisolone
Tolérance gastro-duodénale de la méthylprednisolone. Etude de la voie orale versus voie veineuse chez le volontaire sain.