ABSTRACT
Estos últimos años han aparecido alertas de seguridad, no siempre bien sustentadas, que cuestionan el uso de algunas alternativas farmacológicas a la transfusión de sangre alogénica y/o lo restringen en indicaciones establecidas. Asistimos también a la preconización de otras alternativas, incluyendo productos hemáticos y fármacos antifibrinolíticos, sin que haya una base científica sólida que lo justifique. Por iniciativa del Grupo de Estudios Multidisciplinares sobre Autotransfusión y del Anemia Working Group España se reunió a un panel multidisciplinar de 23 expertos del área de cuidados de la salud en un foro de debate para: 1) analizar las diferentes alertas de seguridad en torno a ciertas alternativas a la transfusión; 2) estudiar los antecedentes que las han propiciado, la evidencia que las sustentan y las consecuencias que conllevan para la práctica clínica, y 3) emitir una valoración argumentada de la seguridad de cada alternativa a la transfusión cuestionada, según el uso clínico de la misma. Los integrantes del foro mantuvieron contactos por vía telemática y una reunión presencial en la que presentaron y discutieron las conclusiones sobre cada uno de los elementos examinados. Se elaboró un primer documento que fue sometido a 4 rondas de revisión y actualización hasta alcanzar un consenso, unánime en la mayoría de los casos. Presentamos la versión final del documento, aprobada por todos los miembros del panel, esperando sea de utilidad para nuestros colegas
In recent years, several safety alerts have questioned or restricted the use of some pharmacological alternatives to allogeneic blood transfusion in established indications. In contrast, there seems to be a promotion of other alternatives, based on blood products and/or antifibrinolytic drugs, which lack a solid scientific basis. The Multidisciplinary Autotransfusion Study Group and the Anemia Working Group España convened a multidisciplinary panel of 23 experts belonging to different healthcare areas in a forum for debate to: 1) analyze the different safety alerts referred to certain transfusion alternatives; 2) study the background leading to such alternatives, the evidence supporting them, and their consequences for everyday clinical practice, and 3) issue a weighted statement on the safety of each questioned transfusion alternative, according to its clinical use. The members of the forum maintained telematics contact for the exchange of information and the distribution of tasks, and a joint meeting was held where the conclusions on each of the items examined were presented and discussed. A first version of the document was drafted, and subjected to 4 rounds of review and updating until consensus was reached (unanimously in most cases). We present the final version of the document, approved by all panel members, and hope it will be useful for our colleagues
Subject(s)
Humans , Blood Transfusion, Autologous/methods , Blood Transfusion/methods , Postoperative Hemorrhage/therapy , Critical Care/methods , Intensive Care Units/organization & administration , Erythropoiesis/physiology , Factor VIII/pharmacokinetics , Colloids/pharmacokinetics , Patient SafetyABSTRACT
In recent years, several safety alerts have questioned or restricted the use of some pharmacological alternatives to allogeneic blood transfusion in established indications. In contrast, there seems to be a promotion of other alternatives, based on blood products and/or antifibrinolytic drugs, which lack a solid scientific basis. The Multidisciplinary Autotransfusion Study Group and the Anemia Working Group España convened a multidisciplinary panel of 23 experts belonging to different healthcare areas in a forum for debate to: 1) analyze the different safety alerts referred to certain transfusion alternatives; 2) study the background leading to such alternatives, the evidence supporting them, and their consequences for everyday clinical practice, and 3) issue a weighted statement on the safety of each questioned transfusion alternative, according to its clinical use. The members of the forum maintained telematics contact for the exchange of information and the distribution of tasks, and a joint meeting was held where the conclusions on each of the items examined were presented and discussed. A first version of the document was drafted, and subjected to 4 rounds of review and updating until consensus was reached (unanimously in most cases). We present the final version of the document, approved by all panel members, and hope it will be useful for our colleagues.
Subject(s)
Anemia/therapy , Critical Illness/therapy , Hemorrhage/therapy , Anemia/drug therapy , Antifibrinolytic Agents/adverse effects , Antifibrinolytic Agents/therapeutic use , Aprotinin/adverse effects , Aprotinin/therapeutic use , Blood Coagulation Factors/adverse effects , Blood Coagulation Factors/therapeutic use , Blood Transfusion/standards , Clinical Trials as Topic , Crystalloid Solutions , Erythropoietin/adverse effects , Erythropoietin/therapeutic use , Hematinics/adverse effects , Hematinics/therapeutic use , Humans , Hydroxyethyl Starch Derivatives/adverse effects , Hydroxyethyl Starch Derivatives/therapeutic use , Iron/adverse effects , Iron/therapeutic use , Isotonic Solutions/adverse effects , Isotonic Solutions/therapeutic use , Meta-Analysis as Topic , Observational Studies as Topic , Plasma Substitutes/adverse effects , Plasma Substitutes/therapeutic use , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Tranexamic Acid/adverse effects , Tranexamic Acid/therapeutic use , Transfusion ReactionABSTRACT
INTRODUCTION: Intravenous steroid therapy is the standard treatment in severe attacks of ulcerative colitis (UC), but 20% to 60% of patients fail to respond and require colectomy. Cyclosporine (CyA) has shown efficacy in steroid failures and could avoid surgery, but controversy remains. AIM: The objective of this study was to conduct a systematic review to evaluate the effectiveness and safety of CyA in inducing remission in patients with a severe attack of UC. METHODS: We did a systematic review using Cochrane methodology, including data from published (in English, French, Spanish or German) clinical trials done in adults using intravenous or oral CyA in UC. Data on efficacy are obtained from controlled and observational clinical trials, and for safety issues case reports are also considered. RESULTS: 31 studies were identified which met the inclusion criteria, 22 (18 uncontrolled, 4 controlled) with intravenous CyA, and 9 (all uncontrolled) using oral CyA. Only 4 controlled trials (one in abstract form) are available, and only one compares CyA to placebo. However, efficacy results are very consistent in these 4 trials, and very similar to those in observational studies. CyA achieves remission in 91,4% and 71.4% of patients in controlled and uncontrolled studies using intravenous route, and in 71,2% using oral route. Two mg/kg/day seems so efficacious and safer as previous standard 4 mg/kg/day dose. Minor side effects are rather common but do not seriously limit therapy. Severe side effects, specially infections, are uncommon but clinically relevant with several deaths reported. CONCLUSION: CyA (intravenous, 2 mg/kg/day) constitutes an efficacious and relatively safe alternative in the treatment of severe, steroid-refractory, attack of UC. To optimize treatment, the correct selection of patients, a standardized protocol and clinical surveillance are recommended.
Subject(s)
Colitis, Ulcerative/drug therapy , Cyclosporine/therapeutic use , Immunosuppressive Agents/therapeutic use , Administration, Oral , Adrenal Cortex Hormones/therapeutic use , Azathioprine/therapeutic use , Clinical Trials as Topic , Controlled Clinical Trials as Topic , Cyclosporine/administration & dosage , Cyclosporine/adverse effects , Disease Susceptibility , Drug Resistance , Drug Therapy, Combination , Humans , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/adverse effects , Infections/etiology , Infusions, Intravenous , Research Design , Seizures/chemically induced , Treatment OutcomeABSTRACT
Introducción: La administración intravenosa de esteroides es el tratamiento habitual en los episodios graves de colitis ulcerosa (CU), aunque el 20-60% de los pacientes no responde a él y precisa intervención quirúrgica mediante colectomía. La ciclosporina (CyA) ha demostrado ser eficaz en los cuadros de falta de respuesta a los esteroides y podría evitar la intervención quirúrgica; no obstante, existe controversia a este respecto. Objetivo: El objetivo del presente estudio ha sido efectuar una revisión sistemática con objeto de evaluar la eficacia y seguridad de la CyA para conseguir la remisión en pacientes con un episodio grave de CU. Métodos: Revisión sistemática mediante la metodología Cochrane, incluyendo los datos correspondientes a los ensayos clínicos publicados en inglés, francés, español o alemán, y referidos a pacientes adultos con CU tratados mediante la administración intravenosa u oral de CyA. Los datos de eficacia se obtuvieron a partir de los ensayos clínicos efectuados con controles y de los estudios de observación; también se consideraron los casos aislados respecto a las cuestiones de seguridad. Resultados: Se identificaron 31 estudios que cumplían los criterios de inclusión en la revisión, 22 (18 sin control y 4 con control) en los que se administró CyA intravenosa y 9 (todos ellos sin grupo control) en los que se administró CyA por vía oral. Sólo se hallaron 4 ensayos clínicos realizados con controles (uno de ellos publicado en forma de resumen), y en sólo uno de ellos se comparó la CyA con placebo. No obstante, los resultados de eficacia fueron muy similares en los 4 ensayos clínicos y también en los estudios de observación. En los estudios realizados con y sin controles, la CyA intravenosa dio lugar a remisión en el 91,4 y el 71,4% de los pacientes, respectivamente, mientras que el porcentaje correspondiente a la CyA oral fue del 71,2%. La dosis de 2 mg/kg/día pareció tener una eficacia y una seguridad similares a las de la dosis habitual utilizada previamente, de 4 mg/kg/día. Los efectos adversos de carácter menor fueron bastante frecuentes, pero no limitaron gravemente el tratamiento. Los efectos adversos graves, en especial las infecciones, fueron infrecuentes pero potencialmente graves; en los estudios publicados se produjeron varios fallecimientos por esta causa. Conclusión: La CyA intravenosa en dosis de 2 mg/kg/día constituye una opción eficaz y relativamente segura en el tratamiento de los episodios graves de CU refractarios a los esteroides. Para optimizar el tratamiento, se recomiendan una selección correcta de los pacientes y la aplicación de un protocolo estandarizado de tratamiento y de seguimiento clínico
Introduction: Intravenous steroid therapy is the standard treatment in severe attacks of ulcerative colitis (UC), but 20% to 60% of patients fail to respond and require colectomy. Cyclosporine (CyA) has shown efficacy in steroid failures and could avoid surgery, but controversy remains. Aim: The objective of this study was to conduct a systematic review to evaluate the effectiveness and safety of CyA in inducing remission in patients with a severe attack of UC. Methods: We did a systematic review using Cochrane methodology, including data from published (in English, French, Spanish or German) clinical trials done in adults using intravenous or oral CyA in UC. Data on efficacy are obtained from controlled and observational clinical trials, and for safety issues case reports are also considered. Results: 31 studies were identified which met the inclusion criteria, 22 (18 uncontrolled, 4 controlled) with intravenous CyA, and 9 (all uncontrolled) using oral CyA. Only 4 controlled trials (one in abstract form) are available, and only one compares CyA to placebo. However, efficacy results are very consistent in these 4 trials, and very similar to those in observational studies. CyA achieves remission in 91,4% and 71.4% of patients in controlled and uncontrolled studies using intravenous route, and in 71,2% using oral route. Two mg/kg/day seems so efficacious and safer as previous standard 4 mg/kg/day dose. Minor side effects are rather common but do not seriously limit therapy. Severe side effects, specially infections, are uncommon but clinically relevant with several deaths reported. Conclusion: CyA (intravenous, 2 mg/kg/day) constitutes an efficacious and relatively safe alternative in the treatment of severe, steroid-refractory, attack of UC. To optimize treatment, the correct selection of patients, a standardized protocol and clinical surveillance are recommended
Subject(s)
Humans , Cyclosporins/administration & dosage , Colitis, Ulcerative/drug therapy , Cyclosporins/pharmacokinetics , Evidence-Based MedicineABSTRACT
El descubrimiento de Helicobacter pylori (H. pylori) ha sido el avance más importante de la gastroenterología en la última década. La implicación de este microorganismo en diversas patologías, fundamentalmente digestivas, pero también extradigestivas, Hacen que el tratamiento de esta infección constituya uno de los aspectos fundamentales relacionados con la bacteria. Sin embargo, el ritmo vertiginoso con el que se desarrollan los conocimientos y el elevado número de trabajos llevados a cabo en los últimos años, con resultados a menudo discordantes, hacen que exista cierto grado de confusión en el manejo de esta infección, lo que conduce con frecuencia a una mala praxis médica. El objetivo de este capítulo es, en primer lugar, revisar las indicaciones del tratamiento erradicador, y posteriormente las pautas erradicadoras recomendadas en la actualidad. Finalmente serán considerados los factores predictores del éxito terapéutico y las perspectivas futuras en el tratamiento de esta infección tan prevalente Un tratamiento adecuado de la enfermedad exige no sólo el conocimiento de los medios terapéuticos disponibles, sino también disponer de información sobre los criterios diagnósticos y la historia natural. La úlcera péptica es una entidad, o grupo de entidades, con un curso clínico crónico, y riesgo de complicaciones, especialmente en consumidores de antiinflamatorios no esteroideos (AINE) y en fumadores. Sin embargo, el factor causal fundamental en la mayoría de los pacientes es la presencia de una infección por Helicobacter pylori. La curación de la infección determina un cambio radical en la historia natural de la enfermedad, que puede considerarse curada clínicamente, aunque el paciente sigue mostrando un riesgo mayor cuando toma AINE. Los objetivos del tratamiento son eliminar la mortalidad por úlcera péptica, reducir al mínimo la tasa de complicaciones, controlar los síntomas y aproximar la calidad de vida del paciente a la normal (AU)
Subject(s)
Humans , Peptic Ulcer , Peptic Ulcer/diagnosis , Peptic Ulcer/drug therapy , Helicobacter pyloriABSTRACT
Crohn's disease may involve any area of the digestive tract, but its localization in the duodenum is rare. The clinical, radiological or endoscopic findings may simulate those of peptic ulcer and histologic examination is not diagnostic. In contrast with Crohn's disease of any other localization, the formation of fistulas is exceptional. The authors present one case of duodenal Crohn's disease the unspecific symptomatology of which deviated the original orientation towards the more common diseases. Steroid treatment was not sufficient to control the disease which led to complications with the formation of an enterocutaneous fistula. The association of azathioprine was very effective not only in achieving remission of the process, but also in resolving the complications.
Subject(s)
Crohn Disease , Duodenal Diseases , Adolescent , Anti-Inflammatory Agents/therapeutic use , Azathioprine/therapeutic use , Crohn Disease/diagnosis , Crohn Disease/drug therapy , Diagnosis, Differential , Duodenal Diseases/diagnosis , Duodenal Diseases/drug therapy , Female , Follow-Up Studies , Humans , Immunosuppressive Agents/therapeutic use , Methylprednisolone/therapeutic use , Time FactorsABSTRACT
Interferon is becoming the most important therapy for chronic hepatitis due to hepatitis C virus. Secondary effects are frequent and sometimes so important to stop the therapy. Autoimmune disorders, specially autoimmune thyroid diseases may occur. We report two out of 69 chronic hepatitis C patients treated with interferon who developed hypothyroidism, that required definitive substitutive therapy.
Subject(s)
Antiviral Agents/adverse effects , Hepatitis C/therapy , Hypothyroidism/etiology , Interferon-alpha/adverse effects , Adult , Female , HumansABSTRACT
Five patients with hepatitis C virus infection of different severity and evolution following the administration of intravenous (i.v.) immunoglobulins (Igs) are presented. The important morbidity of hepatitis C virus infection and the need for adequate donor screening are discussed, as is accurate indication of these drugs in the management of patients with immunosuppression and other diseases.
Subject(s)
Hepatitis C/transmission , Immunoglobulins, Intravenous/adverse effects , Adolescent , Adult , Blood Donors , Diagnosis, Differential , Female , Hepatitis C/diagnosis , Humans , Male , Middle AgedABSTRACT
Coeliac disease is the most frequent malabsortive syndrome in daily practice. However, its true prevalence is not exactly known. The symptoms vary from patient to patient, ranging from the classic presentation with diarrhea, weight loss and fatigue to oligosymptomatic forms, being the latter more common in adults. We report two patients in which urinary and skin spontaneous hemorrhage were the only symptoms, and led to the diagnosis. We insist on the importance of considering the diagnosis of coeliac disease in patients with this kind of clinical manifestations. The early diagnosis will allow us to reduce both the morbidity and mortality in coeliac patients.
Subject(s)
Celiac Disease/diagnosis , Hemorrhagic Disorders/etiology , Adult , Celiac Disease/complications , Female , Humans , MaleABSTRACT
OBJECT: To study the frequency of inflammatory bowel disease in our area. MATERIAL AND METHODS: A retrospective, hospital-based analysis identifying potential cases, with a posterior study of case records following a predefined protocol, according to international standards in diagnosis. PATIENTS: All patients with a confirmed diagnosis of Crohn's disease, ulcerative colitis, or indeterminate colitis established between 1975 and 1992 at our Hospital. RESULTS: 222 cases (ulcerative colitis: 109; Crohn's disease 93; indeterminate colitis 20) were identified and a clear trend for an increased incidence was found for the three diagnoses; with annual incidence below 1 for them all in the 1975-1977 period versus 3.66; 3.33; and 1 respectively in the 1990-1992 period. This trend was evident both for ulcerative colitis and Crohn's disease. CONCLUSIONS: The global frequency of inflammatory bowel disease has increased in the last years in Zaragoza (Spain), and its incidence in now very similar to that reported in northern European countries. Possible factors associated with this phenomenon should be pursued in future studies.
Subject(s)
Inflammatory Bowel Diseases/epidemiology , Adolescent , Adult , Age Distribution , Aged , Child , Female , Humans , Incidence , Inflammatory Bowel Diseases/diagnosis , Male , Middle Aged , Prevalence , Retrospective Studies , Sex Distribution , Spain/epidemiologyABSTRACT
Acid is an influencing factor in most peptic diseases, including peptic ulcers. Acid inhibition, whatever the means used to obtain it, is followed by healing of most peptic ulcers. If acid inhibition is maintained recurrences are prevented (or diminished). A quantitative correlation between the degree of acid inhibition obtained and the effectiveness of treatment has been suggested in different studies. However, it is not possible to predict in the individual subject which rate of acid inhibition is needed for healing, and which rate is needed for avoiding relapse. Acid inhibition, apart from intrinsic toxicity of the drugs used to obtain it, is not without theoretical risks, particularly bacterial overgrowth and gastric carcinogenesis. To date, these effects lack practical importance at least with the doses and durations of treatments reported. Empirical data on acid inhibition and treatment of peptic ulcers, especially duodenal ulcers, are abundant. However, pathophysiological studies are scarce. Pathophysiological data should be studied in the future in groups of patients in order to design new strategies of treatment, particularly individual treatments. Acid inhibition by drugs or surgery remains the most important treatment of peptic ulcer disease. Long-term acid inhibition by drugs is safe and effective.