Prevention of allergoid (cutaneous anaphylactoid) reactions to polygeline (Haemaccel) in orthopaedic patients by premedication with H1- and H2-receptor antagonists.
"Purified" polygeline (Haemaccel) was examined for its anaphylactoid and allergoid reactions in a controlled clinical trial on a homogenous sample of orthopaedic patients. In two test groups histamine H1- and H2-receptor antagonists were applied, in the control group saline as a placebo premedication. Unexpectedly no anaphylactoid reaction associated with histamine release greater than or equal to 1 ng/ml plasma occurred in the trial. Clinically unimportant allergoid reactions restricted to the skin occurred with a lower frequency (18%) than observed in previous trials. The specific premedication was highly effective in preventing these reactions in the two test groups (p less than 0.0005). Due to the apparent improvement of the product a general premedication with histamine H1- and H2-receptor antagonist seems not to be necessary before polygeline is administered to patients. For reasons of safety, however, it seems to be indicated in patients at risk, such as those with carcinoma, a proven allergic diathesis and in those who have already suffered from an incident to plasma substitutes.
D000707:Anaphylaxis / Q000209:etiology; D002986:Clinical Trials as Topic; D006632:Histamine / Q000097:blood; D006634:Histamine H1 Antagonists / Q000008:administration & dosage*; D006635:Histamine H2 Antagonists / Q000008:administration & dosage*; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000517:prevention & control*; D011097:Polygeline / Q000009:adverse effects* / Q000592:standards; D011108:Polymers / Q000009:adverse effects*; D011786:Quality Control; D011897:Random Allocation; D012306:Risk; D013997:Time Factors
D006634:Histamine H1 Antagonists; D006635:Histamine H2 Antagonists; D011108:Polymers; D006632:Histamine; D011097:Polygeline