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An investigation of components of variance and tachyphylaxis in a placebo-controlled intravenous tyramine study.

Abstract：

AIMS:To explore inter- and intra-volunteer variability for the dose of intravenous tyramine eliciting a 20 mmHg increase in systolic blood pressure from baseline (TYR20) and to evaluate potential tachyphylaxis. METHODS:Twelve healthy volunteers received blinded placebo-controlled ascending and descending sequences of intravenous tyramine injections on two separate occasions. The TYR20 was derived by linear interpolation, using three interventions to deal with missing data. RESULTS:Analysis of covariance (ancova) demonstrated no significant difference in TYR20 between sequences, regardless of the missing data methodology applied. Inter-volunteer variability was 2.4-3.4 times larger than within-volunteer variability. No evidence of tachyphylaxis was seen using either the sign test or generalized additive models. CONCLUSIONS:Since inter-volunteer variability was greater than intra-volunteer variability, a crossover study design would be a more efficient study design, and the descending sequence of injections could be omitted since tachyphylaxis was not demonstrated.

journal_name

Br J Clin Pharmacol

journal_title

British journal of clinical pharmacology

authors

Cantarini MV,Watkins CL,Growcott J,Hughes AM

doi

10.1111/j.1365-2125.2004.02069.x

keywords:

subject

Has Abstract

pub_date

2004-05-01 00:00:00

pages

657-60

issue

5

eissn

0306-5251

issn

1365-2125

pii

BCP2069

journal_volume

57

pub_type

临床试验,杂志文章,随机对照试验

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