Abstract
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.
Publication types
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Clinical Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adolescent
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Adult
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Animals
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Antiviral Agents / pharmacology
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Blood Pressure / drug effects
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Body Temperature / drug effects
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Detergents / pharmacology*
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Dizziness / chemically induced
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Female
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Headache / chemically induced
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Humans
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Immunoglobulins, Intravenous / administration & dosage*
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Immunoglobulins, Intravenous / drug effects*
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Immunoglobulins, Intravenous / toxicity
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Male
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Middle Aged
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Models, Biological
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Prospective Studies
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Pulse
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Rats
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Rats, Wistar
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Respiration / drug effects
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Solvents / pharmacology
Substances
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Antiviral Agents
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Detergents
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Immunoglobulins, Intravenous
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Solvents