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Transcript of P. Dawson - rd.springer.com
Contrast Media in Practice
Springer-Verlag Berlin Heidelberg New York London Paris Tokyo Hong Kong Barcelona Budapest
Dr. Peter Dawson Department of Radiology Hammersmith Hospital Ducane Road, London W12 OHS United Kingdom
Dr. Wolfram ClauB Schering AG, Klinische Entwicklung Diagnostika Miillerstr. 170 -178 13353 Berlin
ISBN-13: 978-3-540-57187-2 e-ISBN-13: 978-3-642-97530-1 DOl: 10.1007/978-3-642-97530-1
Library of Congress Cataloging-in-Publication Data
Contrast media in practice / P. Dawson. W. Clauss, (hrsg.) p. cm.
1. Contrast media. I. Dawson, Peter H. II. Clauss, W. (Wolfram), 1940- RC78.7.C65C665 1993 616.0T54--dc20
This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concemed, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilm or in other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current version, and permis;ion for use must always be obtained from Springer-Verlag. Violations are liable for prosecution under the German Copyright Law.
© Springer-Verlag Berlin Heidelberg 1993
Softcover reprint of the hardcover 1 st edition 1993
The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use.
Product liability: The publishers cannot guarantee the accuracy of any information about dosage and application contained in this book. In every individual case the user must check such information by consulting the relevant literature.
Typesetting: Cicero Lasersatz, 86167 Augsburg, Germany 21/3145-543210 - Printed on acid-free paper
Contents
1 General Fundamentals
1.1 A Historical Overview of the Development of Contrast Media for Diagnostic Imaging Procedures in Radiology H. J. Maurer and W. Clauj3 . . . . . . . . . . . . . . . . . .. 1
1.2 Chemistry of X-Ray Contrast Media T. Gulbrandsen .......... .
1.3 Structure - Toxicity Relationships and Molecule Design P. Dawson ." ...................... .
1.4 Results of Toxicological Tests Assessing the Risk of Nonionic Contrast Media in Humans
6
11
1.5 Physicochemical Properties of Contrast Media: Osmotic Pressure, Viscosity, Solubility, Lipophilicity, Hydrophilicity, Electrical Charge U. Speck . ...................... .
1.6 Pharmacokinetics of Contrast Media W. Krause and G. Schuhmann-Gampieri
1.7 Clinical Documentation of the Tolerance, Safety and Efficacy of X-Ray Contrast Media
20
26
E. Andrew, W. Clauj3, A. Alhassan and H. P. Bohn . . . .. 34
2 Pharmaceutical Quality and Stability of Contrast Media
2.1 What Are the Steps in the Production of Contrast Media? B. Wolden . . . . . . . . . . . . . . . . . . . . . . . 39
2.2 Which Chemical Degradation Products Are Formed? D. Herrmann 39
VI Contents
2.3 What Additives Do Contrast Media Formulations Contain? B. Wolden . . . . . . . . . . . . . . . . . . . . . . . . . 40
2.4 What Is the Importance of Additives in Contrast Medium Formulations? P. Dawson. . . . . . . . . . . . . . . . . . . . . . . . . 41
2.5 How Is the Sterility or Microbial Purity of Contrast Media Checked? B. Wolden . . . . . . . . . . . . . . . . . . . . . . . . . . 42
2.6 How Is the Chemical Stability of Contrast Media Checked? B. Wolden . . . . . . . . . . . . . . . . . . . . . . . . . . 42
2.7 How Are Contrast Media Checked for Freedom from Pyrogens? B. Wolden . . . . . . . . . . . . . . . . . . . . . . . . . . .. 43
2.8 To What Are Colour Changes of Contrast Media Attributable?
2.9
D. Herrmann and B. Wolden .....
Does Particulate Contamination Occur, and How Important Is It? B. Wolden .............. .
2.10 Which Factors Reduce the Stability of Contrast Media, and What Are the Implications of Storage Recommendations? D. Herrmann
2.11 What Precautions Are Necessary in Drawing Up Contrast Media into Syringes and in Administering Them Using Infusion Devices? D. Herrmann
2.12 How Long Do Contrast Media Remain Usable After the Original Container Has Been Opened? D. Herrmann
2.13 May Contrast Media Be Diluted or Mixed with Other Drugs? D. Herrmann
2.14 Is the Resterilization and Reuse of Disposable Angiography Catheters Justified?
43
44
44
47
48
49
Contents VII
2.15 Is There an Increased Risk of Coagulation when Catheters Are Reused? P. Dawson . . . . . . . . . . . . . . . . . . . . . . . . . . .. 51
3 3.1
Influence of Contrast Media on Organs and Vessels
What Are the Mechanisms of Toxicity Associated with Contrast Media? P. Dawson . ................... .
3.2 Do Contrast Media Affect the Viscosity of Blood? N. H. Strickland . . . . . . . . . . . . . . . . . .
3.3 Are There Any Differences Between Ionic and Nonionic Contrast Media in Their Effect on Coagulation? P. Dawson . .................... .
3.4 Do Contrast Media Affect Carciovascular Function? P. Dawson . .................. .
3.5 Do Contrast Media Affect Pulmonary Function? P. Dawson . ................. .
3.6 Do Contrast Media Affect Hepatic Function? V. Taenzer ................. .
3.7 Do Contrast Media Affect Renal Function? 1. E. Scherb erich . . . . . . . . . . . . . . .
3.8 Do Iodinated X-Ray Contrast Media Affect Thyroid Function?
53
54
57
58
59
60
61
B. GlObel ........................... 63
3.9 What Is the Relationship Between Iodinated Contrast Media and the Blood-Brain Barrier? P. Dawson . ...................... .
3.10 Do Contrast Media Affect the Central Nervous System? M.R. Sage . .................. .
3.11 Do Contrast Media Affect Blood Vessel Walls? F. Laerum ................... .
64
64
67
VIII
Determination of Risk Factors Regarding the Administration of Contrast Media
What Are the Known Risks of Contrast Media Use? W. Clauf3 ....................... .
Does Known X-Ray Contrast Media Hypersensitivity and a History of Allergies Mean Increased Risk in Examinations Using X-Ray Contrast Media?
W. Clauf3 ......................... .
Does an Existing Iodine Allergy Mean Increased Risk in Examinations Using X-Ray Contrast Media?
W. Clauf3 ......................... .
Why Does the Administration of Iodinated Contrast Media to Patients with Manifest or Latent Hyperthyroidism Represent a Risk? B. Globel
Why Does the Administration of Iodinated Contrast Media Represent a Risk to Patients with Bland Nodular Goitre? B. Globel ....................... .
4.6 Does Underlying Cardiovascular Disease Constitute an Increased Risk in Contrast Media Administration? P. Dawson . .................. .
4.7 Why Is Pre-existing Lung Disease a Risk for the Administration of Contrast Media?
4.8
4.9
P. Dawson . .................. .
Why Is Pre-existing Renal Impairment a Risk in the Administration of Contrast Media? J. E. Scherberich . . . . . . . . . . . . . . . . . . .
Why Is Pre-existing Diabetes Mellitus a Risk in the Administration of Contrast-Media? J. E. Scherberich . . . . . . . . . . . . . . . . . . .
4.10 Why Is Pre-existing Paraproteinaemia a Risk in the Administration of Contrast Media?
J. E. Scherberich . . . . . . . . . . . . . . . . . . .
Contents IX
4.11 How Can the Risk of Provoking a Hypertensive Crisis in Patients with Phaeochromocytoma Be Reduced? P. Dawson . . . . . . . . . . . . . . . . . . . . . . . . . 78
4.12 Can Dehydration Before Contrast Media Administration Be Recommended Today? 1. E. Scherberich . . . . . . . . . . . . . . . . . . . . . . . 79
4.13 Are Patients with Autoimmune Disorders at Any Particular Risk on Contrast Media Administration? P. Dawson . . . . . . . . . . . . . . . . . . . . . . . . . 80
4.14 Does the Administration of Iodinated Contrast Media to Patients with Sickle Cell Anaemia Result in Further Change in Erythrocytic Shape? R. Dickerhoff . . . . . . . . . . . . . . . . . . . . . . . . .. 81
4.15 Are Contrast Media-Induced Side Effects Dependent on Age? H. Katayama . . . . . . . . . . . . . . . . . . . . . . . . . .. 82
4.16 Does Weather Influence the Rate of Undesirable Reactions to Contrast Media Administration? D. Zuckert . . . . . . . . . . . . . . . . . . . . . . . . . 83
4.17 Can Contrast Media Procedures Be Carried Out Despite Defined Risks? P. Dawson . . . . . . . . . . . . . . . . . . . . . . . . . 84
4.18 What Interactions Are Known Between the Administration of Contrast Media and Other Medications? P. Dawson . . . . . . . . . . . . . . . . . . . . . . . . . 85
4.19 What Is the Role of X-Ray Contrast Media Administered During Pregnancy or in Nursing Mothers?
5 5.1
Prophylactic Measures
What Is the Place of Fasting and Dehydration Before Contrast Media Administration? w. Clauf3 . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 89
X Contents
5.2 Can Hypersensitivity Reactions to Contrast Media Be Predicted Through Preliminary Testing?
W. ClaufJ and V. Taenzer .............. .
5.3 Is Sedation Indicated Before Administering Contrast Media? G. Wisser
5.4 Does General Anaesthesia Prevent the Occurrence of Contrast Media-Induced Side Effects? G. Wisser
5.5 Can the Rate of Contrast Media-Induced Side Effects Be Lowered by Premedication with Antihistamines? R. Tauber .................... .
5.6 Can the Adverse Reactions Rate/Be Reduced by Administration of Corticosteroids?
W. ClauB
6 Informing the Patient Prior to Contrast Media Administration
6.1 What Is the Patient's "Right to Know" Prior to an X-Ray Examination Using Contrast Media?
91
91
92
93
94
H. 1. Maurer and W. Spann . . . . . . . . . . . . . . . . 97
6.2 What Special Information Should a Healthy Volunteer/Patient Receive Who Is Participating in a Clinical Study of a New Drug? W. ClaufJ and E. Andrew . . . . . . . . . . . . . . . . . 98
7 7.1
Administration of Contrast Media
Are Contrast Media Heated to Body Temperature Better Tolerated? P. Dawson . ................... .
7.2 Are There Any Guidelines for Maximum Doses in Angiography? P. Dawson . ................... .
101
102
Contents XI
7.3 Are There Any Guidelines for Maximum Doses in Myelography? l. O. Skalpe ................... .
7.4 Are There Any Guidelines for Maximum Doses in Cholegraphy?
102
7.5 Can "Maximum" Doses Be Exceeded? P. Dawson . ............. . . ........ 103
7.6 Does the Injection Rate Affect the Tolerance? P. Dawson . ................. . 104
7.7 What Fluids Can be Recommended for Flushing Catheters?
8
Adverse Reactions and Their Pathophysiology and Management
8.1 What Adverse Reactions Can be Expected After Administration of Contrast Media?
.. 105
8.2 Do Late-Occurring Adverse Reactions to Contrast Media Necessitate Longer Supervision of the Patient? P. Davies
8.3 Do Late Reactions Occur More Frequently After Administration of Nonionic Contrast Media?
109
P. Davies . . .. 111
8.4 What Are the Mediators of Anaphylactoid Reactions to Iodinated Contrast Media? P. Dawson . . . . . . . . . . . . . . . . . . . . . . . . . . .. 112
8.5 What Adverse Reactions to Contrast Media Are Dose Independent or Dependent? H. Katayama . . . . . . . . . . . . . . . . . . . . . .
8.6 Are Antibodies to Radiographic Contrast Media Known?
... 113
XII Contents
8.7 Are There Allergies to Contrast Media? R. C. Brasch . . . . . . . . . . . . . . . . . . . .. 115
8.8 Can Sensitization Due to Frequent Contrast Media Administration Be Observed? R. C. Brasch . . . . . . . . . . . . . . . . . . . . . .. 116
8.9 Can Epileptogenicity and Arachnoiditis Be Observed After Myelography with Nonionic Contrast Media? l. O. Skalpe ........................... 116
8.10 Are Contrast Media Dialysable?
9
J. E. Scherb erich . . . . . . . . .
Clinical Use of Iodinated Contrast Media for the Visualization of Vessels, Organs and Organ Systems
9.1 Carotid and Vertebral Arteries and Cerebral Vessels
117
9.3 Angiography of the Extremities H. J. Maurer . ................. 128
9.4 Phlebography B. Hagen . .. . . .. 133
9.5 Direct Lymphography and Indirect Lymphangiography H. Weissleder ............. . .... 138
9.6 Angiography and Thoracic Aortography P. Romaniuk. . . . . . . . . . . . . . .
9.7 Angiographic Procedures for the Liver, Spleen, Pancreas and Portal Venous System
. 144
W. Rodl ............................. 161
9.8 Computed Tomography in the Liver, Pancreas and Spleen A. Adam . ............................ 169
Contents XIII
9.9 The Gastrointestinal Tract W. Dihlmann and L. Hering ....... 176
9.10 Contrast Media in the Gallbladder and Bile Ducts v. Taenzer ...... . . ...... 190
9.11 Intravenous Urography P. Dawson . ..... .
9.12 Urethrography and Micturating Cystography, Cavernosogra phy, and Seminal Vesiculography and Vasography
. 192
9.13 The Kidneys and Adrenal Glands G. P. Krestin . . . . . . . . .. ................ 202
9.14 Contrast Media in Gynaecology H. 1. Maurer and 1. G. Heep ................. 208
9.15 Arthrography v. Papassotiriou ... 213
9.16 What Advantages Do Nonionic Contrast Media Have for Paediatric Patients? H. 1. Kaufmann and C. Bassir. . . . . . . . . . . . . . .
9.17 What Is the Role of Newer Contrast Media in Interventional Radiology?
. 222
"'0' Contrast Media for Magnetic Resonance Imaging ~ and Ultrasound
10.1 Contrast Media for Clinical Magnetic Resonance Imaging H. P. Niendorf and 1. C. Dinger . . . . . . . . . . . . . . . .. 227
10.2 Ultrasonographic Contrast Media R. Schlief, R. Schiirmann, and H. P. Niendorf . . . . . . . .. 234
Snbject Index ............................. 243
Contributors
Adam, A., Prof., Dept. of Radiology, Guy's Hospital, London Bridge, London SE1 9 RT, UK
Alhassan, A., Dr., Schering AG, Arzneimittelsicherheit, MiillerstraBe 170-178,13342 Berlin, Germany
Andrew, E., Dr., Nycomed AS Imaging, Slemdalsveien 37,0301 Oslo 3, Norway
Bassir, c., Dr., Univ.-Klinikum RudolfVirchow, FUB, Padiatrische Radiologie, KA VH, Heubnerweg 6, 12487 Berlin, Germany
Bohn, H. P., Dr., Nycomed AS Imaging, Slemdalsveien 37,0301 Oslo 3, Norway
Brasch, Robert c., Prof., University of California, Department of Radiology, Contrast Media Laboratory, Third and Parnassus Street, San Francisco, CA 94143, USA.
Clauj3, Wolfram, Dr., Schering AG, Klinische Entwicklung Diagnostika, MiillerstraBe 170-178, 13342 Berlin, Germany
Davies, Peter, Dr., F.R. C.R., Department of Radiology, City Hospital, Nottingham, UK
Dawson, Peter, Dr., Dept. of Radiology, Univ. of London, Royal Postgraduate Medical School, Hammersmith Hospital, Ducane Road, London W12 OHS, UK
Dickerhoff, Roswitha, Dr., Kinderklinik, St. Augustin, Arnold-lanssen-StraBe 29, 53757 St. Augustin, Germany
Dihlmann, W., Prof., Rontgeninstitut, Allgemeines Krankenhaus Barmbek, Riibenkamp 148, 22307 Hamburg, Germany
Dinger, 1. c., Dr., Schering AG, GCP Methologie, MiillerstraBe 170-178,13353 Berlin, Germany
GlObel, B., Prof. Dr., Univ.-Kliniken des Saarlandes, Abteilung Medizintechnik und Strahlenschutz, 66424 Homburg, Germany
XVI Contributors
Grainger, Ronald G., Prof., Royal Hallamshire Hospital, Department of Radiology, Glossop Road, Sheffield SlO 2JF, UK
Giinzel, P., Dr., Schering AG, Experimentelle Toxikologie, MiillerstraBe 170-178, 13342 Berlin, Germany
Gulbrandsen, Trygve, Dr., Nycomed AS Imaging, Slemdalsveien 37, 0301 Oslo 3, Norway
Hagen, Bernd, Dr., Martin-Luther-Krankenhaus, Rontgen- und Strahlenabteilung, Caspar-Theyss-StraBe 27-31,14194 Berlin, Germany
Heep, Josef, Prof., Josefskrankenhaus, Gynakologische Abteilung, LandhausstraBe 25,69115 Heidelberg, Germany
Hering, L., Dr., Rontgeninstitut, Allgemeines Krankenhaus Barmbek, Riibenkamp 148, 22307 Hamburg, Germany
Herrmann, Dirk, Dr., Schering AG, MiillerstraBe 170--178,13342 Berlin, Germany
Imhof, H., Prof., Zentrales Inst. fUr Radiodiagnostik, Allgemeines Krankenhaus Wien, Lazarettgasse 14,1090 Wien, Austria
Katayama, Hitoshi, Prof., Department of Radiology, Juntendo University, Hongo 3-1-3, Brunkyo-ku, Tokyo 113, Japan
Kaufmann, Herbert J., Prof., SchwerinstraBe 14, 10783 Berlin, Germany
Krause, Werner, Dr., Schering AG, Forschung Rontgenkontrastmittel, MiillerstraBe 170-178, 13342 Berlin, Germany
Krestin, G., Dr., Med. Einrichtungen d. Univ., Radiologische Inst. und Poliklinik, Joseph-Stelzmann-StraBe 9,50931 KOln, Germany
Laerum, Frode, Prof., Section for Experimental Radiology, Department of Diagnostic Radiology, Rikshospitalet, 0027 Oslo 1, Norway
Maurer, H.-J., Prof., Obere FlurstraBe 11, 88131 Lindau-Bodolz, Germany
Niendorf, Hans-Peter, Dr., Schering AG, Klinische Entwicklung Diagnostika, MiillerstraBe 170--178,13342 Berlin, Germany
Papassotiriou, V., Dr., Wenckebach-Krankenhaus, Rontgenabteilung, WenckebachstraBe 23,12099 Berlin, Germany
Contributors XVII
Romaniuk, Paul, Prof., Inst. flir KardiovaskuHire Diagnostik, Charite Humboldt-Universitat, SchumannstraBe 20-21,10117 Berlin, Germany
Sage, Michael R., Prof., Dept. of Radiology, The Flinders University of South Australia, Flinders Medical Centre, Bedford Park, South Australia 5042, Australia
Scherberich, 1. E., Dr., Klinikum der J.-W.-Goethe-Universitat, Zentrum der Inneren Medizin, Theodor-Stem-Kai 7, 60596 Frankfurt, Germany
Schlief, Reinhard, Dr., Schering AG, Klinische Entwicklung Diagnostika, MiillerstraBe 170-178, 13342 Berlin, Germany
SchObel, Christel, Dr., Schering AG, Experimentelle Toxikologie, MiillerstraBe 170-178,13342 Berlin, Germany
Schiirmann, R., Dr., Schering AG, Klinische Entwicklung Diagnostika, MiillerstraBe 170-178, 13342 Berlin, Germany
Schuhmann-Gampieri, Gabriele, Dr., Schering AG, Forschung Rontgenkontrastmittel, MiillerstraBe 170-178,13342 Berlin, Germany
Skalpe, l. 0., Prof., Rikshospitalet, Rontgen-Radium-Avd., Pilestredet 32, 0027 Oslo 1, Norway
Spann, W., Prof., Ludwig-Maximilians-Univ., Fachbereich Medizin, BavariastraBe 19, 80336 Miinchen, Germany
Speck, Ulrich, Prof., Schering AG, Diagnostika Forschung, MiillerstraBe 170-178,13342 Berlin, Germany
Strickland, Nicola Hilary, Dr., Dept. of Radiology, Royal Postgraduate Medical School, Hammersmith Hospital, Ducane Road, London W12 OHS, UK
Taenzer, V., Prof., Krankenhaus Moabit, Rontgenabteilung, TurmstraBe 21, 10559 Berlin, Germany
Tauber, R., Prof., Allgemeines Krankenhaus Barmbek, Urologische Abteilung, Riibenkamp 148, 22307 Hamburg, Germany
XVIII Contributors
Thron, A., Prof., Neurologische Klinik der RWTH, Abteilung Neuroradiologie, PauwellsstraBe, 52074 Aachen, Germany
Vergesslich, Klara, Dr., Universitatskinderklinik Wien, Wahringer GurteI18-20, 1090 Wien, Austria
Weiss leder, H., Prof., Kreiskrankenhaus, Abt. fur Rontgendiagnostik, GartenstraBe 40, 70312 Emmendingen, Germany
Wisser, Gregor, Dr., Klinikum der Johannes-Gutenberg-Universitat, Klinik fur Anasthesiologie, LangenbeckstraBe 1, 55131 Mainz, Germany
Wolden, Brit, Dr., Nycomed AS Imaging, Sl~mdalsveien 37, 0301 Oslo 3, Norway
Zuckert, Dieter, Dr., Kissinger-StraBe 57,14199 Berlin, Germany
Springer-Verlag Berlin Heidelberg New York London Paris Tokyo Hong Kong Barcelona Budapest
Dr. Peter Dawson Department of Radiology Hammersmith Hospital Ducane Road, London W12 OHS United Kingdom
Dr. Wolfram ClauB Schering AG, Klinische Entwicklung Diagnostika Miillerstr. 170 -178 13353 Berlin
ISBN-13: 978-3-540-57187-2 e-ISBN-13: 978-3-642-97530-1 DOl: 10.1007/978-3-642-97530-1
Library of Congress Cataloging-in-Publication Data
Contrast media in practice / P. Dawson. W. Clauss, (hrsg.) p. cm.
1. Contrast media. I. Dawson, Peter H. II. Clauss, W. (Wolfram), 1940- RC78.7.C65C665 1993 616.0T54--dc20
This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concemed, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilm or in other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current version, and permis;ion for use must always be obtained from Springer-Verlag. Violations are liable for prosecution under the German Copyright Law.
© Springer-Verlag Berlin Heidelberg 1993
Softcover reprint of the hardcover 1 st edition 1993
The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use.
Product liability: The publishers cannot guarantee the accuracy of any information about dosage and application contained in this book. In every individual case the user must check such information by consulting the relevant literature.
Typesetting: Cicero Lasersatz, 86167 Augsburg, Germany 21/3145-543210 - Printed on acid-free paper
Contents
1 General Fundamentals
1.1 A Historical Overview of the Development of Contrast Media for Diagnostic Imaging Procedures in Radiology H. J. Maurer and W. Clauj3 . . . . . . . . . . . . . . . . . .. 1
1.2 Chemistry of X-Ray Contrast Media T. Gulbrandsen .......... .
1.3 Structure - Toxicity Relationships and Molecule Design P. Dawson ." ...................... .
1.4 Results of Toxicological Tests Assessing the Risk of Nonionic Contrast Media in Humans
6
11
1.5 Physicochemical Properties of Contrast Media: Osmotic Pressure, Viscosity, Solubility, Lipophilicity, Hydrophilicity, Electrical Charge U. Speck . ...................... .
1.6 Pharmacokinetics of Contrast Media W. Krause and G. Schuhmann-Gampieri
1.7 Clinical Documentation of the Tolerance, Safety and Efficacy of X-Ray Contrast Media
20
26
E. Andrew, W. Clauj3, A. Alhassan and H. P. Bohn . . . .. 34
2 Pharmaceutical Quality and Stability of Contrast Media
2.1 What Are the Steps in the Production of Contrast Media? B. Wolden . . . . . . . . . . . . . . . . . . . . . . . 39
2.2 Which Chemical Degradation Products Are Formed? D. Herrmann 39
VI Contents
2.3 What Additives Do Contrast Media Formulations Contain? B. Wolden . . . . . . . . . . . . . . . . . . . . . . . . . 40
2.4 What Is the Importance of Additives in Contrast Medium Formulations? P. Dawson. . . . . . . . . . . . . . . . . . . . . . . . . 41
2.5 How Is the Sterility or Microbial Purity of Contrast Media Checked? B. Wolden . . . . . . . . . . . . . . . . . . . . . . . . . . 42
2.6 How Is the Chemical Stability of Contrast Media Checked? B. Wolden . . . . . . . . . . . . . . . . . . . . . . . . . . 42
2.7 How Are Contrast Media Checked for Freedom from Pyrogens? B. Wolden . . . . . . . . . . . . . . . . . . . . . . . . . . .. 43
2.8 To What Are Colour Changes of Contrast Media Attributable?
2.9
D. Herrmann and B. Wolden .....
Does Particulate Contamination Occur, and How Important Is It? B. Wolden .............. .
2.10 Which Factors Reduce the Stability of Contrast Media, and What Are the Implications of Storage Recommendations? D. Herrmann
2.11 What Precautions Are Necessary in Drawing Up Contrast Media into Syringes and in Administering Them Using Infusion Devices? D. Herrmann
2.12 How Long Do Contrast Media Remain Usable After the Original Container Has Been Opened? D. Herrmann
2.13 May Contrast Media Be Diluted or Mixed with Other Drugs? D. Herrmann
2.14 Is the Resterilization and Reuse of Disposable Angiography Catheters Justified?
43
44
44
47
48
49
Contents VII
2.15 Is There an Increased Risk of Coagulation when Catheters Are Reused? P. Dawson . . . . . . . . . . . . . . . . . . . . . . . . . . .. 51
3 3.1
Influence of Contrast Media on Organs and Vessels
What Are the Mechanisms of Toxicity Associated with Contrast Media? P. Dawson . ................... .
3.2 Do Contrast Media Affect the Viscosity of Blood? N. H. Strickland . . . . . . . . . . . . . . . . . .
3.3 Are There Any Differences Between Ionic and Nonionic Contrast Media in Their Effect on Coagulation? P. Dawson . .................... .
3.4 Do Contrast Media Affect Carciovascular Function? P. Dawson . .................. .
3.5 Do Contrast Media Affect Pulmonary Function? P. Dawson . ................. .
3.6 Do Contrast Media Affect Hepatic Function? V. Taenzer ................. .
3.7 Do Contrast Media Affect Renal Function? 1. E. Scherb erich . . . . . . . . . . . . . . .
3.8 Do Iodinated X-Ray Contrast Media Affect Thyroid Function?
53
54
57
58
59
60
61
B. GlObel ........................... 63
3.9 What Is the Relationship Between Iodinated Contrast Media and the Blood-Brain Barrier? P. Dawson . ...................... .
3.10 Do Contrast Media Affect the Central Nervous System? M.R. Sage . .................. .
3.11 Do Contrast Media Affect Blood Vessel Walls? F. Laerum ................... .
64
64
67
VIII
Determination of Risk Factors Regarding the Administration of Contrast Media
What Are the Known Risks of Contrast Media Use? W. Clauf3 ....................... .
Does Known X-Ray Contrast Media Hypersensitivity and a History of Allergies Mean Increased Risk in Examinations Using X-Ray Contrast Media?
W. Clauf3 ......................... .
Does an Existing Iodine Allergy Mean Increased Risk in Examinations Using X-Ray Contrast Media?
W. Clauf3 ......................... .
Why Does the Administration of Iodinated Contrast Media to Patients with Manifest or Latent Hyperthyroidism Represent a Risk? B. Globel
Why Does the Administration of Iodinated Contrast Media Represent a Risk to Patients with Bland Nodular Goitre? B. Globel ....................... .
4.6 Does Underlying Cardiovascular Disease Constitute an Increased Risk in Contrast Media Administration? P. Dawson . .................. .
4.7 Why Is Pre-existing Lung Disease a Risk for the Administration of Contrast Media?
4.8
4.9
P. Dawson . .................. .
Why Is Pre-existing Renal Impairment a Risk in the Administration of Contrast Media? J. E. Scherberich . . . . . . . . . . . . . . . . . . .
Why Is Pre-existing Diabetes Mellitus a Risk in the Administration of Contrast-Media? J. E. Scherberich . . . . . . . . . . . . . . . . . . .
4.10 Why Is Pre-existing Paraproteinaemia a Risk in the Administration of Contrast Media?
J. E. Scherberich . . . . . . . . . . . . . . . . . . .
Contents IX
4.11 How Can the Risk of Provoking a Hypertensive Crisis in Patients with Phaeochromocytoma Be Reduced? P. Dawson . . . . . . . . . . . . . . . . . . . . . . . . . 78
4.12 Can Dehydration Before Contrast Media Administration Be Recommended Today? 1. E. Scherberich . . . . . . . . . . . . . . . . . . . . . . . 79
4.13 Are Patients with Autoimmune Disorders at Any Particular Risk on Contrast Media Administration? P. Dawson . . . . . . . . . . . . . . . . . . . . . . . . . 80
4.14 Does the Administration of Iodinated Contrast Media to Patients with Sickle Cell Anaemia Result in Further Change in Erythrocytic Shape? R. Dickerhoff . . . . . . . . . . . . . . . . . . . . . . . . .. 81
4.15 Are Contrast Media-Induced Side Effects Dependent on Age? H. Katayama . . . . . . . . . . . . . . . . . . . . . . . . . .. 82
4.16 Does Weather Influence the Rate of Undesirable Reactions to Contrast Media Administration? D. Zuckert . . . . . . . . . . . . . . . . . . . . . . . . . 83
4.17 Can Contrast Media Procedures Be Carried Out Despite Defined Risks? P. Dawson . . . . . . . . . . . . . . . . . . . . . . . . . 84
4.18 What Interactions Are Known Between the Administration of Contrast Media and Other Medications? P. Dawson . . . . . . . . . . . . . . . . . . . . . . . . . 85
4.19 What Is the Role of X-Ray Contrast Media Administered During Pregnancy or in Nursing Mothers?
5 5.1
Prophylactic Measures
What Is the Place of Fasting and Dehydration Before Contrast Media Administration? w. Clauf3 . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 89
X Contents
5.2 Can Hypersensitivity Reactions to Contrast Media Be Predicted Through Preliminary Testing?
W. ClaufJ and V. Taenzer .............. .
5.3 Is Sedation Indicated Before Administering Contrast Media? G. Wisser
5.4 Does General Anaesthesia Prevent the Occurrence of Contrast Media-Induced Side Effects? G. Wisser
5.5 Can the Rate of Contrast Media-Induced Side Effects Be Lowered by Premedication with Antihistamines? R. Tauber .................... .
5.6 Can the Adverse Reactions Rate/Be Reduced by Administration of Corticosteroids?
W. ClauB
6 Informing the Patient Prior to Contrast Media Administration
6.1 What Is the Patient's "Right to Know" Prior to an X-Ray Examination Using Contrast Media?
91
91
92
93
94
H. 1. Maurer and W. Spann . . . . . . . . . . . . . . . . 97
6.2 What Special Information Should a Healthy Volunteer/Patient Receive Who Is Participating in a Clinical Study of a New Drug? W. ClaufJ and E. Andrew . . . . . . . . . . . . . . . . . 98
7 7.1
Administration of Contrast Media
Are Contrast Media Heated to Body Temperature Better Tolerated? P. Dawson . ................... .
7.2 Are There Any Guidelines for Maximum Doses in Angiography? P. Dawson . ................... .
101
102
Contents XI
7.3 Are There Any Guidelines for Maximum Doses in Myelography? l. O. Skalpe ................... .
7.4 Are There Any Guidelines for Maximum Doses in Cholegraphy?
102
7.5 Can "Maximum" Doses Be Exceeded? P. Dawson . ............. . . ........ 103
7.6 Does the Injection Rate Affect the Tolerance? P. Dawson . ................. . 104
7.7 What Fluids Can be Recommended for Flushing Catheters?
8
Adverse Reactions and Their Pathophysiology and Management
8.1 What Adverse Reactions Can be Expected After Administration of Contrast Media?
.. 105
8.2 Do Late-Occurring Adverse Reactions to Contrast Media Necessitate Longer Supervision of the Patient? P. Davies
8.3 Do Late Reactions Occur More Frequently After Administration of Nonionic Contrast Media?
109
P. Davies . . .. 111
8.4 What Are the Mediators of Anaphylactoid Reactions to Iodinated Contrast Media? P. Dawson . . . . . . . . . . . . . . . . . . . . . . . . . . .. 112
8.5 What Adverse Reactions to Contrast Media Are Dose Independent or Dependent? H. Katayama . . . . . . . . . . . . . . . . . . . . . .
8.6 Are Antibodies to Radiographic Contrast Media Known?
... 113
XII Contents
8.7 Are There Allergies to Contrast Media? R. C. Brasch . . . . . . . . . . . . . . . . . . . .. 115
8.8 Can Sensitization Due to Frequent Contrast Media Administration Be Observed? R. C. Brasch . . . . . . . . . . . . . . . . . . . . . .. 116
8.9 Can Epileptogenicity and Arachnoiditis Be Observed After Myelography with Nonionic Contrast Media? l. O. Skalpe ........................... 116
8.10 Are Contrast Media Dialysable?
9
J. E. Scherb erich . . . . . . . . .
Clinical Use of Iodinated Contrast Media for the Visualization of Vessels, Organs and Organ Systems
9.1 Carotid and Vertebral Arteries and Cerebral Vessels
117
9.3 Angiography of the Extremities H. J. Maurer . ................. 128
9.4 Phlebography B. Hagen . .. . . .. 133
9.5 Direct Lymphography and Indirect Lymphangiography H. Weissleder ............. . .... 138
9.6 Angiography and Thoracic Aortography P. Romaniuk. . . . . . . . . . . . . . .
9.7 Angiographic Procedures for the Liver, Spleen, Pancreas and Portal Venous System
. 144
W. Rodl ............................. 161
9.8 Computed Tomography in the Liver, Pancreas and Spleen A. Adam . ............................ 169
Contents XIII
9.9 The Gastrointestinal Tract W. Dihlmann and L. Hering ....... 176
9.10 Contrast Media in the Gallbladder and Bile Ducts v. Taenzer ...... . . ...... 190
9.11 Intravenous Urography P. Dawson . ..... .
9.12 Urethrography and Micturating Cystography, Cavernosogra phy, and Seminal Vesiculography and Vasography
. 192
9.13 The Kidneys and Adrenal Glands G. P. Krestin . . . . . . . . .. ................ 202
9.14 Contrast Media in Gynaecology H. 1. Maurer and 1. G. Heep ................. 208
9.15 Arthrography v. Papassotiriou ... 213
9.16 What Advantages Do Nonionic Contrast Media Have for Paediatric Patients? H. 1. Kaufmann and C. Bassir. . . . . . . . . . . . . . .
9.17 What Is the Role of Newer Contrast Media in Interventional Radiology?
. 222
"'0' Contrast Media for Magnetic Resonance Imaging ~ and Ultrasound
10.1 Contrast Media for Clinical Magnetic Resonance Imaging H. P. Niendorf and 1. C. Dinger . . . . . . . . . . . . . . . .. 227
10.2 Ultrasonographic Contrast Media R. Schlief, R. Schiirmann, and H. P. Niendorf . . . . . . . .. 234
Snbject Index ............................. 243
Contributors
Adam, A., Prof., Dept. of Radiology, Guy's Hospital, London Bridge, London SE1 9 RT, UK
Alhassan, A., Dr., Schering AG, Arzneimittelsicherheit, MiillerstraBe 170-178,13342 Berlin, Germany
Andrew, E., Dr., Nycomed AS Imaging, Slemdalsveien 37,0301 Oslo 3, Norway
Bassir, c., Dr., Univ.-Klinikum RudolfVirchow, FUB, Padiatrische Radiologie, KA VH, Heubnerweg 6, 12487 Berlin, Germany
Bohn, H. P., Dr., Nycomed AS Imaging, Slemdalsveien 37,0301 Oslo 3, Norway
Brasch, Robert c., Prof., University of California, Department of Radiology, Contrast Media Laboratory, Third and Parnassus Street, San Francisco, CA 94143, USA.
Clauj3, Wolfram, Dr., Schering AG, Klinische Entwicklung Diagnostika, MiillerstraBe 170-178, 13342 Berlin, Germany
Davies, Peter, Dr., F.R. C.R., Department of Radiology, City Hospital, Nottingham, UK
Dawson, Peter, Dr., Dept. of Radiology, Univ. of London, Royal Postgraduate Medical School, Hammersmith Hospital, Ducane Road, London W12 OHS, UK
Dickerhoff, Roswitha, Dr., Kinderklinik, St. Augustin, Arnold-lanssen-StraBe 29, 53757 St. Augustin, Germany
Dihlmann, W., Prof., Rontgeninstitut, Allgemeines Krankenhaus Barmbek, Riibenkamp 148, 22307 Hamburg, Germany
Dinger, 1. c., Dr., Schering AG, GCP Methologie, MiillerstraBe 170-178,13353 Berlin, Germany
GlObel, B., Prof. Dr., Univ.-Kliniken des Saarlandes, Abteilung Medizintechnik und Strahlenschutz, 66424 Homburg, Germany
XVI Contributors
Grainger, Ronald G., Prof., Royal Hallamshire Hospital, Department of Radiology, Glossop Road, Sheffield SlO 2JF, UK
Giinzel, P., Dr., Schering AG, Experimentelle Toxikologie, MiillerstraBe 170-178, 13342 Berlin, Germany
Gulbrandsen, Trygve, Dr., Nycomed AS Imaging, Slemdalsveien 37, 0301 Oslo 3, Norway
Hagen, Bernd, Dr., Martin-Luther-Krankenhaus, Rontgen- und Strahlenabteilung, Caspar-Theyss-StraBe 27-31,14194 Berlin, Germany
Heep, Josef, Prof., Josefskrankenhaus, Gynakologische Abteilung, LandhausstraBe 25,69115 Heidelberg, Germany
Hering, L., Dr., Rontgeninstitut, Allgemeines Krankenhaus Barmbek, Riibenkamp 148, 22307 Hamburg, Germany
Herrmann, Dirk, Dr., Schering AG, MiillerstraBe 170--178,13342 Berlin, Germany
Imhof, H., Prof., Zentrales Inst. fUr Radiodiagnostik, Allgemeines Krankenhaus Wien, Lazarettgasse 14,1090 Wien, Austria
Katayama, Hitoshi, Prof., Department of Radiology, Juntendo University, Hongo 3-1-3, Brunkyo-ku, Tokyo 113, Japan
Kaufmann, Herbert J., Prof., SchwerinstraBe 14, 10783 Berlin, Germany
Krause, Werner, Dr., Schering AG, Forschung Rontgenkontrastmittel, MiillerstraBe 170-178, 13342 Berlin, Germany
Krestin, G., Dr., Med. Einrichtungen d. Univ., Radiologische Inst. und Poliklinik, Joseph-Stelzmann-StraBe 9,50931 KOln, Germany
Laerum, Frode, Prof., Section for Experimental Radiology, Department of Diagnostic Radiology, Rikshospitalet, 0027 Oslo 1, Norway
Maurer, H.-J., Prof., Obere FlurstraBe 11, 88131 Lindau-Bodolz, Germany
Niendorf, Hans-Peter, Dr., Schering AG, Klinische Entwicklung Diagnostika, MiillerstraBe 170--178,13342 Berlin, Germany
Papassotiriou, V., Dr., Wenckebach-Krankenhaus, Rontgenabteilung, WenckebachstraBe 23,12099 Berlin, Germany
Contributors XVII
Romaniuk, Paul, Prof., Inst. flir KardiovaskuHire Diagnostik, Charite Humboldt-Universitat, SchumannstraBe 20-21,10117 Berlin, Germany
Sage, Michael R., Prof., Dept. of Radiology, The Flinders University of South Australia, Flinders Medical Centre, Bedford Park, South Australia 5042, Australia
Scherberich, 1. E., Dr., Klinikum der J.-W.-Goethe-Universitat, Zentrum der Inneren Medizin, Theodor-Stem-Kai 7, 60596 Frankfurt, Germany
Schlief, Reinhard, Dr., Schering AG, Klinische Entwicklung Diagnostika, MiillerstraBe 170-178, 13342 Berlin, Germany
SchObel, Christel, Dr., Schering AG, Experimentelle Toxikologie, MiillerstraBe 170-178,13342 Berlin, Germany
Schiirmann, R., Dr., Schering AG, Klinische Entwicklung Diagnostika, MiillerstraBe 170-178, 13342 Berlin, Germany
Schuhmann-Gampieri, Gabriele, Dr., Schering AG, Forschung Rontgenkontrastmittel, MiillerstraBe 170-178,13342 Berlin, Germany
Skalpe, l. 0., Prof., Rikshospitalet, Rontgen-Radium-Avd., Pilestredet 32, 0027 Oslo 1, Norway
Spann, W., Prof., Ludwig-Maximilians-Univ., Fachbereich Medizin, BavariastraBe 19, 80336 Miinchen, Germany
Speck, Ulrich, Prof., Schering AG, Diagnostika Forschung, MiillerstraBe 170-178,13342 Berlin, Germany
Strickland, Nicola Hilary, Dr., Dept. of Radiology, Royal Postgraduate Medical School, Hammersmith Hospital, Ducane Road, London W12 OHS, UK
Taenzer, V., Prof., Krankenhaus Moabit, Rontgenabteilung, TurmstraBe 21, 10559 Berlin, Germany
Tauber, R., Prof., Allgemeines Krankenhaus Barmbek, Urologische Abteilung, Riibenkamp 148, 22307 Hamburg, Germany
XVIII Contributors
Thron, A., Prof., Neurologische Klinik der RWTH, Abteilung Neuroradiologie, PauwellsstraBe, 52074 Aachen, Germany
Vergesslich, Klara, Dr., Universitatskinderklinik Wien, Wahringer GurteI18-20, 1090 Wien, Austria
Weiss leder, H., Prof., Kreiskrankenhaus, Abt. fur Rontgendiagnostik, GartenstraBe 40, 70312 Emmendingen, Germany
Wisser, Gregor, Dr., Klinikum der Johannes-Gutenberg-Universitat, Klinik fur Anasthesiologie, LangenbeckstraBe 1, 55131 Mainz, Germany
Wolden, Brit, Dr., Nycomed AS Imaging, Sl~mdalsveien 37, 0301 Oslo 3, Norway
Zuckert, Dieter, Dr., Kissinger-StraBe 57,14199 Berlin, Germany
