PMID- 16720865
OWN - NLM
STAT- MEDLINE
DCOM- 20060726
LR  - 20151119
IS  - 0033-8419 (Print)
IS  - 0033-8419 (Linking)
VI  - 240
IP  - 1
DP  - 2006 Jul
TI  - Adverse events after unenhanced and monomeric and dimeric contrast-enhanced CT: a 
      prospective randomized controlled trial.
PG  - 56-64
AB  - PURPOSE: To prospectively evaluate adverse events (AEs) in patients who underwent 
      nonionic monomeric or dimeric contrast media-enhanced computed tomography (CT) 
      and to compare these effects with AEs in patients who underwent unenhanced CT. 
      MATERIALS AND METHODS: Local ethics committee approval and written informed 
      consent were obtained. Patients were randomly assigned to the dimeric group, 
      monomeric group, or concurrent control group. Acute (occurring during or within 1 
      hour after contrast agent injection) and delayed (occurring between 1 hour and 7 
      days after contrast agent injection) AEs were evaluated and categorized (mild, 
      not requiring treatment; moderate, self-limiting AE requiring simple treatment; 
      severe, AE requiring extensive treatment or endangering life). The two-sided 
      Fisher exact test and the Mann-Whitney U and Wilcoxon signed rank tests were used 
      for statistical analysis. RESULTS: A total of 895 patients were recruited. Acute 
      AEs were noted significantly (P < .05) more often in the monomeric group (44.8% 
      [133 of 297 patients]) than in the dimeric (23.7% [71 of 300 patients]) or 
      control (9.4% [28 of 298 patients]) groups. Two moderate acute AEs were noted in 
      one patient in each contrast agent group; all other acute AEs were mild. There 
      was no significant difference in the overall incidence of delayed AEs between the 
      dimeric and monomeric groups (53.1% [139 of 262 patients] vs 50.8% [131 of 258 
      patients]). Delayed cutaneous AEs were noted significantly (P < .05) more often 
      in the dimeric group. A total 16 AEs (2.0%) were moderate; no AE was severe. 
      CONCLUSION: The dimeric contrast agent caused fewer acute AEs than the monomeric 
      contrast agent; however, the dimeric and monomeric agents caused a similar 
      overall number of delayed AEs. Delayed cutaneous symptoms were noted more often 
      with the dimeric contrast agent. Both contrast agents were safe in that no severe 
      AEs and only a few moderate AEs were observed.
CI  - RSNA, 2006
FAU - Schild, Hans H
AU  - Schild HH
AD  - Department of Radiology, University of Bonn, Hospital and Medical School, Sigmund 
      Freud Str 25, 53105 Bonn, Germany. schild@uni-bonn.de
FAU - Kuhl, Christiane K
AU  - Kuhl CK
FAU - Hubner-Steiner, Ute
AU  - Hubner-Steiner U
FAU - Bohm, Ingrid
AU  - Bohm I
FAU - Speck, Ulrich
AU  - Speck U
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20060523
PL  - United States
TA  - Radiology
JT  - Radiology
JID - 0401260
RN  - 0 (Contrast Media)
RN  - 0 (Triiodobenzoic Acids)
RN  - 16FL47B687 (iotrolan)
RN  - 4419T9MX03 (Iohexol)
RN  - 712BAC33MZ (iopromide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Contrast Media/*adverse effects/chemistry
MH  - Female
MH  - Humans
MH  - Hypersensitivity, Delayed/*chemically induced
MH  - Iohexol/adverse effects/*analogs & derivatives
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Single-Blind Method
MH  - Surveys and Questionnaires
MH  - Tomography, X-Ray Computed/*adverse effects/methods
MH  - Triiodobenzoic Acids/*adverse effects
EDAT- 2006/05/25 09:00
MHDA- 2006/07/27 09:00
CRDT- 2006/05/25 09:00
PHST- 2006/05/25 09:00 [pubmed]
PHST- 2006/07/27 09:00 [medline]
PHST- 2006/05/25 09:00 [entrez]
AID - 2393050560 [pii]
AID - 10.1148/radiol.2393050560 [doi]
PST - ppublish
SO  - Radiology. 2006 Jul;240(1):56-64. doi: 10.1148/radiol.2393050560. Epub 2006 May 
      23.