By M. Verstraete M. D. (Leuven), F.R.C.P. (Edin.), F. A. C. P. (Hon.) (auth.)
clinical efficacy of haemostatic brokers needed to be released paintings and needed to fulftl many of the following minimal requisites: (1) Quantitation ofthe measured blood loss was once required, and never in simple terms a medical effect of the quantity of blood misplaced, if the rfile pertained to a deliberate yet «open» medical trial. (2) merely double-blind trials with random allocation of the placebo and experimental drug to preselected sufferers have been thought of appropriate for dialogue, if the blood loss had now not been quantitated in a potential trial. (3) Defmition and acceptable choice of sufferers admitted to the trial: all inclusion and exclusion standards used to choose sufferers needed to be pointed out intimately. (4) as soon as incorporated within the trial, sufferers should be withdrawn in basic terms at the foundation of strict standards for withdrawal which have been outlined prematurely. (5) A double-blind trial needed to be persevered for an enough size of time if the haemostatic agent was once being assessed within the prevention of bleeding in sufferers with an enduring bleeding affliction . (6) a transparent and certain statistical research of the implications was once required. additionally, a transparent contrast among the healing and prophylactic worth of the haemostatic agent needed to be made and utilized individually to the gang of sufferers with none significant uncomplicated affliction and people with a bleeding affliction e.g. : power thrombocytopenia, haemophilia, Rendu-Osler telangiectasia ... basic statements no longer substantiated by way of experimental info, even if issued by way of recognized professionals, weren't thought of an affordable foundation for discussion.
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Extra info for Haemostatic Drugs: A critical appraisal
1, 19. M. (1973) Result of Capillarema administration to dogs previously treated with a coumarin derivative. Quad. Coagul. 15, 32. A. and BARTOLI G. (1973) Ricerche sull'azione antihemorragica dell'Aminaphtone. Quad. Coagul. 15,38. Comments by the manufacturer of Capillarema® by U. Baldacci, Laboratori Baldacci, Pisa Aminaphtone is the generic name of 2-hydroxymethyl-l,4naphthohydroquinone-2- (p-aminobenzoate), C1S H 1s 04N. 33 and the structural formula is: OH 0 O-C Tni CH3 V NH 2 OH Aminaphtone is insoluble in water, soluble in acetone, ethanol and propylene glycol, and very sparingly soluble in ether, chloroform and benzene.
Animal and human pharmacology In rabbits, aminaphtone is excreted in the urine, mainly in the oxidized form. When the drug was given orally, 70-80% of the administered dose (100 mglkg) was recovered in the urine between 58 and 144 ho urs (Pepeu, 1975). No data are available about its absorption and metabolism in man. The toxicology of aminaphtone has been studied by Pepeu (1975) in mice, rats, rabbits and dogs. From these experiments it appears that the drug has a very low acute and long-term toxicity.
V. 01 Clinical experiments Amato et al. (in press) investigated quantitatively and with a double-blind procedure the effect of aminaphtone on the blood loss in a group of patients of both sexes undergoing oral surgery. The patients, all without bleeding disorders, were randomly allocated to two groups; one received aminaphtone per os 2 mg/kg for 4 days ; the second was not treated with aminaphtone. All patients were intubated and underwent general anaesthesia; they were also treated with atropine in order to reduce salivation.