Haemostatic Drugs: A Critical Appraisal

ISBN-13: 9789024720200 / Angielski / Miękka / 1977 / 165 str.

M. Verstraete

Opis

clinical efficacy of haemostatic agents had to be published work and had to fulftl most of the following minimum requirements: (1) Quantitation ofthe measured blood loss was required, and not merely a clinical impression of the amount of blood lost, if the document pertained to a planned but "open" clinical trial. (2) Only double-blind trials with random allocation of the placebo and experimental drug to preselected patients were considered suitable for discussion, if the blood loss had not been quantitated in a prospective trial. (3) Defmition and appropriate selection of patients admitted to the trial: all inclusion and exclusion criteria used to select patients had to be mentioned in detail. (4) Once included in the trial, patients could be withdrawn only on the basis of strict criteria for withdrawal which had been defined in advance. (5) A double-blind trial had to be continued for an adequate length of time if the haemostatic agent was being assessed in the prevention of bleeding in patients with a long lasting bleeding disorder . (6) A clear and detailed statistical analysis of the results was required. Moreover, a clear distinction between the therapeutic and prophylactic value of the haemostatic agent had to be made and applied separately to the group of patients without any major basic disorder and those with a bleeding disorder e.g. : chronic thrombocytopenia, haemophilia, Rendu-Osler telangiectasia ...General statements not substantiated by experimental data, even when issued by well-known authorities, were not considered a reasonable basis for discussion.

Spis treści

The correction of a bleeding defect.- Report on a tissue extract: Clauden®.- Report on a preparation of phospholipids: Tachostyptan®.- Comments by the manufacturer of Tachostyptan®.- Report on a preparation of oxalic acid and malonic acid: Koagamin®.- Report on a preparation of butyl alcohol: Haemostypticum Revici®.- Report on sodium 4-aminonaphthalene-l-sulphonate: Naphthionin®.- Report on ethamsylate.- Comments by the manufacturer of Dicynene®.- Report on aminaphtone.- Comments by the manufacturer of Capillarema®.- Report on a preparation of pectin: Sangostop®.- Report on naftazone.- Comments by the manufacturer of Karbinone®.- Report on adrenochrome monosemicarbazide and carbazochrome salicylate.- Comments on adrenochrome.- Report on 5-hydroxytryptamine creatinine sulphate: Antemovis®.- Report on a preparation of conjugated oestrogens: Premarin®.- Comments by the manufacturer of Premarin®.- Report on a preparation of oestriol succinate: Styptanon®.- Comments by the manufacturer of Styptanon®.- Report on a preparation of snake venom: Botropase®.- Comments on Botropase®.- Report on a preparation of snake venom: Reptilase®.- Comments by the manufacturer of Reptilase®.- Report on aprotinin: Trasylol®.- Report on epsilon aminocaproic acid.- Report on p-aminomethyl-benzoic acid.- Report on tranexamic acid..- Comments by the manufacturer of Cyklokapron®.- Haemostatic agents for topical use.- A note on vitamin C and bioflavonoids.- Recommendations for clinical trials with systemic haemostatic agents.- Conclusions on the clinical efficacy of general haemostatic drugs.- List of haemostatic drugs mentioned in the text.