[Infusions emergencies following the administration of plasma substitutes -- analysis of case reports to the committee on drugs. The problems of medical statistics, prophylaxis and immediate therapy (author's transl)]

Abstract

In the period 1967 to 1976 the Adverse Drug Reaction Committee of the Medical Association of the Federal Republic of Germany (AMK) received 323 reports of transfusion emergencies following the administration of colloid plasma expanders (dextran, gelatin, starch). The reports ranged from medium to severe cases. Nine percent of the reported cases had a fatal outcome. The data contained in these case reports could only be statistically analyzed within certain limitations as the reports were incomplete and other parameters necessary for a definite statistical evaluating were missing. Furthermore the results do not cover the following points: 1. What percentage of reactions to plasma expanders in W. Germany was reported? --2. What percentage can be attributed to the individual colloids within the entirety of these undesirable side effects? --3. What percentage of the individual colloids can be allocated to the varying degrees of severity of these reactions? -- Further limitations which complicated the analysis of the case reports are discussed individually. Despite these difficulties an attempt was made to analyse the parameters necessary in the diagnosis of acute transfusion emergencies and to compile a guide for the clinical symptomatology. Grading of reactions into four degrees of severity has proved useful both in terms of diagnosis and immediate therapy. The medical statistical evaluation presented in this paper gives an indication as to the significance of the observed side-effects and confirms the statement and recommendations made elsewhere in the literature. In these emergency cases life-threatening incidents appear to be more common than is generally assumed and the user is aware of. The incidence of product-specific emergencies can only be determined to some degree of accuracy by randomized prospective studies. These would have to be conducted with numerous strict guidelines. On the basis of the results presented here, these studies should be attended to with a sense of urgency. Regardless of the difficulties encountered in the evaluation of the case reports, guidelines as to the recognition of reactions, prophylaxis and immediate remedial therapy could be established. These would appear to suffice as urgently required comprehensive information for the nursing staff as well as all doctors. Recognizing side-effects and instituting immediate remedial therapy along the principles laid down in these guidelines can in most cases of severe reactions remove the acute threat to life.