Document Detail


Serious anaphylactic reactions due to protamine sulfate: a systematic literature review.
MedLine Citation:
PMID:  18816305     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Anaphylactic reactions caused by injection of protamine sulfate during cardiac surgery are a well-known complication. A systematic literature review was therefore conducted to gather evidence of the knowledge concerning these side effects, and to see if any prospective randomized studies supported this. Studies investigating the effect of protamine sulfate in human beings were extracted from MEDLINE, Embase and the Cochrane Library, retrieving 487 articles. Abstracts were evaluated by both authors, and referred articles not found in the primary search were furthermore extracted from reviews and case reports, resulting in a total of 272 relevant articles. Of these, 9 retrospective studies and 16 prospective studies were performed in an evidence-based manner. However, only 3 of the 16 prospective articles had an optimal design as far as inclusion criteria, randomization, and description of symptoms were concerned. Incidence of anaphylactic reactions in the prospective studies was 0.69% compared to 0.19% in the retrospective studies, but caution should be taken due to a pronounced heterogeneity of those studies. One study found heparinase I unsuitable as replacement for protamine sulfate. Overall, our findings support the low incidence of anaphylactic reactions reported in previous studies, but of note only few prospective investigations was conducted on the subject. Our study also emphasizes the need for critical appraisal of many routine procedures: in all aspects of medical care, systematic literature review conducted in a well-structured, repeated manner should be given high priority.
Authors:
Mads Nybo; Jonna Skov Madsen
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Basic & clinical pharmacology & toxicology     Volume:  103     ISSN:  1742-7843     ISO Abbreviation:  Basic Clin. Pharmacol. Toxicol.     Publication Date:  2008 Aug 
Date Detail:
Created Date:  2008-09-25     Completed Date:  2008-11-12     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101208422     Medline TA:  Basic Clin Pharmacol Toxicol     Country:  Denmark    
Other Details:
Languages:  eng     Pagination:  192-6     Citation Subset:  IM    
Affiliation:
Department of Biochemistry, Pharmacology and Genetics, Odense University Hospital, Odense, Denmark. mads.nybo@ouh.regionsyddanmark.dk
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MeSH Terms
Descriptor/Qualifier:
Anaphylaxis / chemically induced*,  prevention & control
Heparin Antagonists / adverse effects*
Humans
Prospective Studies
Protamines / adverse effects*
Randomized Controlled Trials as Topic
Chemical
Reg. No./Substance:
0/Heparin Antagonists; 0/Protamines

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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