[Effect and side effects of a depot theophylline preparation within the scope of a clinical trial].
Effects and side effects of the Aminophylline-retard-preparation V 37 are studied during a four week period of monotherapy on 50 patients suffering from obstructive lung disease. Treating with a standard dosis (2 X 700 mg daily) the concentrations of Theophylline in serum were in the therapeutical range in 50% of patients. A dosis correction was not proposed. Therefore 9 patients have to be excluded from the trial (5 unsufficient effects, 4 unreasonable side effects). Two further patients must be excluded because of an acute exacerbation of their disease. An optimization of therapy is possible by a stepwise increase of the dosis and by an adaptation of the dosis considering the body weight, the effects (estimating the FEV1) and the side effects. Clinical aspects are more relevant for dosis correction than the estimation of the Theophylline concentration in serum. Its measurement should be performed in special cases.
D000628:Aminophylline / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations; D006801:Humans; D007700:Kinetics; D008173:Lung Diseases, Obstructive / Q000097:blood / Q000188:drug therapy*; D008176:Lung Volume Measurements
D003692:Delayed-Action Preparations; D000628:Aminophylline
Wirkung und Nebenwirkung eines Theophyllin-Retard-Präparates im Rahmen der klinischen Prüfung.