Clinical experience with a new solvent detergent-treated intravenous immunoglobulin free of hypotensive effects.
OBJECTIVE
To see if modifications to the processing of intravenous immunoglobulin to include a virus inactivation stage alter immunoglobulin G (IgG) resulting in hypotension in patients.


METHODS
Clinical trials were done involving extensive patient monitoring during infusion: in vitro - testing for markers of hypotension, and in vivo - an animal model which closely simulates clinical use.


RESULTS
No hypotensive response was seen in the animal model or clinical trial.


CONCLUSIONS
The production process used does not damage IgG or create vaso-active kinins as the preparation was free of hypotensive effects.
Chidwick
K
K
Bio Products Laboratory, Elstree, UK. KC22113@bpl.co.uk
Matejtschuk
P
P
Gascoigne
E
E
Briggs
N
N
More
J E
JE
Dash
C H
CH
D000293:Adolescent; D000328:Adult; D000818:Animals; D000998:Antiviral Agents / Q000494:pharmacology; D001794:Blood Pressure / Q000187:drug effects; D001831:Body Temperature / Q000187:drug effects; D003902:Detergents / Q000494:pharmacology*; D004244:Dizziness / Q000139:chemically induced; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000187:drug effects* / Q000633:toxicity; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D011446:Prospective Studies; D011674:Pulse; D051381:Rats; D017208:Rats, Wistar; D012119:Respiration / Q000187:drug effects; D012997:Solvents / Q000494:pharmacology
D000998:Antiviral Agents; D003902:Detergents; D016756:Immunoglobulins, Intravenous; D012997:Solvents