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      Dolor lumbar persistente tras la administración de [131I]Iodo-6-β-iodometil-19-norcolesterol: a propósito de un caso Translated title: Lower back pain after iodine-131-6-β-iodomethyl-19-norcholesterol injection: a case report

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          Abstract

          Resumen El [131I]Iodo-6-β-iodometil-19-norcolesterol ([131I]Norcolesterol), radiofármaco indicado en el diagnóstico del estado funcional de tejido cortical suprarrenal, en la detección del tejido funcional en el hiperadrenocorticalismo así como en el aldosteronismo primario. Presentamos el caso de una mujer de 54 años de edad, remitida para la evaluación de una sospecha de aldosteronismo, y que inmediatamente después de la administración intravenosa de [131I]Norcolesterol sufrió una fuerte reacción adversa al medicamento, con mareo, rubor, aumento de la presión arterial, opresión en el pecho, dolor lumbar y sarpullido eritematoso hasta 9 días postinyección. Los síntomas se resolvieron satisfactoriamente tras la administración de antihistamínicos y corticoides. Se sospechó que esta reacción estuviera relacionada con la administración del [131I]Norcolesterol causada por una reacción alérgica de tipo I.

          Translated abstract

          Abstract The [131I]Iodine-6-β-iodomethyl-19-norcholesterol ([131I]Norcholesterol; NP-59), is indicated in the diagnosis of the functional state of adrenal cortical tissue, in the detection of functional tissue in hyperadrenocorticalism as well as in primary aldosteronism. We present the case of a 54-year-old woman, referred for evaluation of suspected aldosteronism, and who immediately after intravenous administration of [131I]Norcholesterol suffered a strong adverse drug reaction, with dizziness, flushing, increased blood pressure, chest tightness, low back pain and erythematous rash up to 9 days after injection. Symptoms resolved satisfactorily after administration of antihistamines and corticosteroids. This reaction was suspected to be related to the administration of [131I]Norcholesterol caused by a type I allergic reaction.

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          Most cited references7

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          Prevalence of adverse reactions in nuclear medicine. Pharmacopeia Committee of the Society of Nuclear Medicine.

          This investigation sought to determine the prevalence of adverse reactions to radiopharmaceuticals and to nonradioactive drugs used in interventional nuclear medicine. We also tabulated all adverse reactions reported to manufacturers of radiopharmaceuticals commercially available in the United States.
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            Frequency of adverse reactions to radiopharmaceuticals in Europe.

            A prospective survey was performed in 17 nuclear medicine departments during 1996 in an attempt to provide reliable data on the prevalence of adverse reactions to radiopharmaceuticals. All adverse events following radiopharmaceutical administration were recorded, irrespective of the severity or likelihood of causality, and subsequently analysed using an algorithm developed by Silberstein et al., designed to establish a cause-effect relationship. A prevalence of 11 events per 10(5) administrations was obtained (95% confidence limits 3.3-19.2). No serious of life-threatening events were reported. This rate is slightly higher than that obtained in a larger scale study in the United States (2.3 events per 10(5) administrations, 95% confidence limits 1.2-3.4). The difference may be due to the decision to include or exclude vasovagal events from the analysis, the way in which the algorithm was used and the comparative size and time scale of the two studies. The prevalence of adverse reactions is approximately 1000-fold than less that occurring with iodinated contrast media and drugs.
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              Diagnostic accuracy and pitfalls of [iodine-131]6-beta-iodomethyl-19-norcholesterol (NP-59) imaging.

              NP-59 concentrates in steroid hormone synthesizing tissues, enabling scintigraphic localization and characterization of endocrine dysfunction in the adrenal cortex and ovary. Studying 108 consecutive cases from 1982 to 1985 and using clinical, biochemical, radiographic, and pathologic data, we performed a rigorous assessment of the accuracy and pitfalls of NP-59 scintigraphy. The evaluation was divided into categories of abnormal hormone secretion: Cushing's syndrome, primary aldosteronism, and hyperandrogenism. Additional categories included euadrenal tumors (without detectable hormone dysfunction) and sites of residual adrenal cortical tissue. The accuracy of NP-59 scintigraphy ranged from 71% in primary aldosteronism and 75% in euadrenal tumors, to 100% for Cushing's syndrome and hyperandrogenism. However, more than in most nuclear medicine studies, NP-59 imaging requires well-defined indications to be met for it to be efficacious, including the fulfillment of clear clinical, biochemical, and radiographic criteria. The high reproducibility of NP-59 scintigraphic interpretation was demonstrated when 40 random cases underwent interinstitutional exchange and through interobserver evaluation at the University of Michigan. Responses of 85/126 medical centers to questionnaires revealed the high level of NP-59 safety.
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                Author and article information

                Journal
                ars
                Ars Pharmaceutica (Internet)
                Ars Pharm
                Universidad de Granada (Granada, Granada, Spain )
                2340-9894
                June 2022
                : 63
                : 2
                : 173-177
                Affiliations
                [1] Madrid orgnameHospital Universitario Ramón y Cajal orgdiv1Servicio de Medicina Nuclear España
                [2] Madrid orgnameHospital Universitario Ramón y Cajal orgdiv1Servicio de Radiofarmacia España
                Article
                S2340-98942022000200173 S2340-9894(22)06300200173
                10.30827/ars.v63i2.23505
                6944909b-13f9-4012-ac41-c8f922cb6e31

                This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

                History
                : 16 December 2021
                : 06 February 2022
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 7, Pages: 5
                Product

                SciELO Spain

                Categories
                Notas Clínicas

                reacción adversa,pharmacovigilance,adverse drug reaction,NP-59,farmacovigilancia

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