Download Haemostatic Drugs: A critical appraisal by M. Verstraete M. D. (Leuven), F.R.C.P. (Edin.), F. A. C. P. PDF

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 lots of the following minimal necessities: (1) Quantitation ofthe measured blood loss used to be required, and never only a scientific influence of the volume of blood misplaced, if the rfile pertained to a deliberate yet «open» scientific trial. (2) in simple terms double-blind trials with random allocation of the placebo and experimental drug to preselected sufferers have been thought of compatible for dialogue, if the blood loss had no longer been quantitated in a potential trial. (3) Defmition and acceptable collection 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 (4) as soon as incorporated within the trial, sufferers will be withdrawn simply at the foundation of strict standards for withdrawal which were outlined prematurely. (5) A double-blind trial needed to be persisted for an sufficient size of time if the haemostatic agent was once being assessed within the prevention of bleeding in sufferers with an enduring bleeding ailment . (6) a transparent and particular statistical research of the implications used to be required. in addition, 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 easy sickness and people with a bleeding illness e.g. : continual thrombocytopenia, haemophilia, Rendu-Osler telangiectasia ... basic statements now not substantiated by means of experimental information, even if issued by means of famous professionals, weren't thought of an inexpensive foundation for discussion.

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It is excreted unchanged in the urine (66 to 94 percent of the administered dose within 12 hours), whereas faecal elimination is very slight. No correlation could be established between the pharmacological action of the product and its plasma levels. These data, available as a manuscript (Guidicelli, 1969), have been obtained using radioactive [14C] ethamsy-. late; they suffer, therefore from the limitations inherent in this kind of study. Clinical efficacy in patients with a bleeding disorder Renal insujficiency.

The pharmacodynamics and pharmacokinetics of Sangostop® have not been investigated. The investigations on record do not meet any of the requirements necessary for recognition of Sangostop® as a haemostatie. In view ofthe 52 SANGOSTOp® fact that Sangostop® contains pectin and thus of the possibility that it might act as an inhibitor of fibrinolysis, further investigation might be of interest. REFERENCES ALMAY K. (1938) Application of Sangostop® in cases of profuse bleeding after teeth extraction.

PRATO V. and FIORINA L. (1968) Richerche cliniche e rilievi sperimentali sull'attivita antiemorragica dei cicloesadienolone (Dicynone). Minerva med. 59, 1653. RABY C. and COUPlER J. (1965) Nouvel hemostatique et antihemorragique de synthese. R. Xe Congr. Soc. Int. Transfusion Sanguine, Stockholm, 1964. Vol. 5, pp. 1 - 7, Karger, Basel. , SYKES P. and ÜUVANT J. M. (1977) Multi-centre trial of Dicynene in dental surgery. Submitted for publication. P. M. (1975) The effect of Dicynene on blood loss during and after transurethral resection of the prostate.

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