Seguridad clínica y reclamaciones por responsabilidad profesional en Cirugía Ortopédica y Traumatología / Clinical safety and professional liability claims in Orthopaedic Surgery and Traumatology

El especialista de cirugía ortopédica y traumatología, como cualquier facultativo, está sujeto en su ejercicio profesional a la normativa legal vigente y resulta imprescindible su formación en los aspectos médico-legales de obligado cumplimiento en la asistencia. Las reclamaciones contra los médicos son una realidad y la especialidad de cirugía ortopédica y traumatología ocupa el primer lugar en frecuencia de reclamaciones según los datos del Consejo General de Colegios de Médicos de Cataluña. Los profesionales deben conocer los aspectos fundamentales de la responsabilidad profesional médica, así como de la medicina defensiva y la seguridad clínica en su especialidad. La comprensión de estos aspectos médico-legales en la práctica clínica habitual puede ayudar a allanar el camino hacia una carrera profesional satisfactoria y segura. Con este trabajo de revisión queremos contribuir a esta formación en beneficio de profesionales y pacientes (AU)

The specialist in orthopaedic and traumatological surgery, like any other doctor, is subject to the current legal provisions while exercising their profession. Mandatory training in the medical-legal aspects of health care is essential. Claims against doctors are a reality, and orthopaedic and traumatological surgery holds first place in terms of frequency of claims according to the data from the General Council of Official Colleges of Doctors of Catalonia. Professionals must be aware of the fundamental aspects of medical professional liability, as well as specific aspects, such as defensive medicine and clinical safety. The understanding of these medical-legal aspects in the routine clinical practice can help to pave the way towards a satisfactory and safe professional career. The aim of this review is to contribute to this training, for the benefit of professionals and patients (AU)

[Clinical safety and professional liability claims in Orthopaedic Surgery and Traumatology]. / Seguridad clínica y reclamaciones por responsabilidad profesional en Cirugía Ortopédica y Traumatología.

The specialist in orthopaedic and traumatological surgery, like any other doctor, is subject to the current legal provisions while exercising their profession. Mandatory training in the medical-legal aspects of health care is essential. Claims against doctors are a reality, and orthopaedic and traumatological surgery holds first place in terms of frequency of claims according to the data from the General Council of Official Colleges of Doctors of Catalonia. Professionals must be aware of the fundamental aspects of medical professional liability, as well as specific aspects, such as defensive medicine and clinical safety. The understanding of these medical-legal aspects in the routine clinical practice can help to pave the way towards a satisfactory and safe professional career. The aim of this review is to contribute to this training, for the benefit of professionals and patients.

Estrategias para la detección de infección por virus de la hepatitis C en población general / Strategies for the detection of hepatitis C viral infection in the general population

Objetivo: Evaluar cual de las 3 estrategias ensayadas es más efectiva para detectar nuevos casos de infección por virus de la hepatitis C (VHC) en atención primaria. Métodos: Estudio observacional, prospectivo y multicéntrico. Se evaluaron 3 estrategias: Estrategia 1: carta explicativa dirigida a personas adultas adscritas a 2 equipos de atención primaria (EAP), invitándoles a realizar un examen serológico. Estrategia 2: colocación en los EAP de pósteres y dípticos explicativos, ofreciendo la posibilidad de realizar un examen analítico. Estrategia 3: revisar el resultado de anti-VHC en los pacientes con hipertransaminasemia detectada en los últimos 2 años mediante la historia electrónica y efectuar determinación del anti-VHC en los casos en quienes no se había determinado. Resultados: Participaron 598 personas (51% mujeres con una media de edad de 50,6±13 años). Con la estrategia 1 se captaron 238 personas (4,1% de participación), con la estrategia 2, 69 personas (0,3%) y con la estrategia 3, 291 pacientes (100%). La detección de VHC oculto fue de un caso en las estrategias 1 y 2, representando una prevalencia del 0,4 y 1,4%, respectivamente, y de 2 casos en la estrategia 3 lo que representa una prevalencia de 0,7%. Conclusiones La búsqueda activa de casos ocultos de infección por VHC ha sido poco efectiva con los métodos ensayados, atendiendo al coste y esfuerzo que comportan (AU)

Objective: To evaluate which of the three studied strategies is the most effective to detect new cases of Hepatitis C virus (HCV) infections in primary care. Methods: This is an observational, prospective, and multicentre study evaluating three strategies. Strategy 1: provide an explanatory letter to adults assigned to two primary care teams (PCTs), inviting them to have a blood test. Strategy 2: place posters and leaflets in PCTs advertising the possibility of laboratory tests. Strategy 3: reexamine HCV antibody test results in patients with hypertransaminasemia diagnosed within the last two years through electronic records, and determine anti-HCV status in undiagnosed cases. Results: There were a total 598 participants (51% female with an average age of 50.6±13 years). There were 238 people (4.1% of letters sent) in Strategy 1, 69 people (0.3% of potential participation) in Strategy 2, and 291 people (100% participation) from Strategy 3. One new case of HCV was found in both Strategy 1 and Strategy 2, representing a prevalence of 0.4 and 1.4%, respectively. Two new cases of HCV were found in Strategy 3, representing a prevalence of 0.7%. Conclusions: The three studied strategies for detecting new cases of HCV infection are ineffective, especially in regards to their cost and effort (AU)

Strategies for the detection of hepatitis C viral infection in the general population.

OBJECTIVE: To evaluate which of the three studied strategies is the most effective to detect new cases of Hepatitis C virus (HCV) infections in primary care. METHODS: This is an observational, prospective, and multicentre study evaluating three strategies. Strategy 1: provide an explanatory letter to adults assigned to two primary care teams (PCTs), inviting them to have a blood test. Strategy 2: place posters and leaflets in PCTs advertising the possibility of laboratory tests. Strategy 3: reexamine HCV antibody test results in patients with hypertransaminasemia diagnosed within the last two years through electronic records, and determine anti-HCV status in undiagnosed cases. RESULTS: There were a total 598 participants (51% female with an average age of 50.6 ± 13 years). There were 238 people (4.1% of letters sent) in Strategy 1, 69 people (0.3% of potential participation) in Strategy 2, and 291 people (100% participation) from Strategy 3. One new case of HCV was found in both Strategy 1 and Strategy 2, representing a prevalence of 0.4 and 1.4%, respectively. Two new cases of HCV were found in Strategy 3, representing a prevalence of 0.7%. CONCLUSIONS: The three studied strategies for detecting new cases of HCV infection are ineffective, especially in regards to their cost and effort.

Reconocimiento profesional a médicos y médicas / Professional recognition of female and male doctors

Antecedentes y objetivo: Los premios a la excelencia del Colegio Oficial de Médicos de Barcelona (COMB) fueron instituidos en 2004 para reconocer la excelencia en el ejercicio profesional. Los premiados son elegidos anualmente por jurados nombrados por la junta de gobierno, cuyos miembros proponen médicos que en su opinión tienen un comportamiento profesional y humano ejemplar. Sujetos y métodos: Hemos analizado el número de médicos y médicas que han obtenido este reconocimiento y la relación entre el número de varones y mujeres premiados con la distribución por géneros en los jurados. Asimismo se han comparado las edades de médicos y médicas premiados y la de colegiados y colegiadas de más de 45 años. Resultados: La relación de varones y mujeres entre los premiados fue de 2,7/1 (rango: 1,2/1 para los premiados en Atención Primaria y 6/1 en el apartado Investigación), con una correlación directa no estadísticamente significativa entre la relación varones/mujeres premiados y jurados. La relación entre varones y mujeres colegiados con más de 45 años fue de 1,4/1, mientras que en los premiados fue de 2,7/1. En los últimos 4 años ha incrementado la proporción de mujeres en los jurados y de forma paralela ha aumentado el número de médicas premiadas. Conclusión: El predomino de varones entre los premiados parece relacionarse con la mayor proporción de varones en la composición de los jurados (AU)

Precedents and aim: The awards for the excellence of the Official College of Physicians of Barcelona (COMB) were instituted in 2004 to recognize the excellence of the professional exercise. The winners are yearly chosen by juries appointed by the board of government, whose members propose for the award doctors who, in their opinion, have an exemplary professional and human behaviour. Subjects and methods: The number of male and female doctors who have obtained this recognition has been analysed in relation with the sex distribution in the juries. Likewise it has been compared the ratios men-to-women of those who have been rewarded and this ratio among physicians of more than 45 years. Results: Between the awarded physicians the ratio men-to-women was of 2.7/1 (range, from 1.2/1 for awardees in primary care to 6/1 in research). The men-to-women ratio among those who were awarded was in parallel to the man-to-women ratios of the juries. The ratio between men and women among members of the COMB of more than 45 years was 1.4/1, whereas in those who were awarded it was of 2.7/1. The increase in the proportion of women in the juries in the last four years has been followed by an increase in the number of female physicians awarded. Conclusion: This data demonstrates that the predominance of male doctors among those who were awarded does not depend so much on the age factor, but basically on the proportion of male and female doctors in the juries (AU)

Professional recognition of female and male doctors.

PRECEDENTS AND AIM: The awards for the excellence of the Official College of Physicians of Barcelona (COMB) were instituted in 2004 to recognize the excellence of the professional exercise. The winners are yearly chosen by juries appointed by the board of government, whose members propose for the award doctors who, in their opinion, have an exemplary professional and human behaviour. SUBJECTS AND METHODS: The number of male and female doctors who have obtained this recognition has been analysed in relation with the sex distribution in the juries. Likewise it has been compared the ratios men-to-women of those who have been rewarded and this ratio among physicians of more than 45 years. RESULTS: Between the awarded physicians the ratio men-to-women was of 2.7/1 (range, from 1.2/1 for awardees in primary care to 6/1 in research). The men-to-women ratio among those who were awarded was in parallel to the man-to-women ratios of the juries. The ratio between men and women among members of the COMB of more than 45 years was 1.4/1, whereas in those who were awarded it was of 2.7/1. The increase in the proportion of women in the juries in the last four years has been followed by an increase in the number of female physicians awarded. CONCLUSION: This data demonstrates that the predominance of male doctors among those who were awarded does not depend so much on the age factor, but basically on the proportion of male and female doctors in the juries.

Guía para prevenir las reclamaciones por presunta mala praxis médica, de cómo actuar cuando se producen y cómo defenderse judicialmente / Guideline to prevent claims due to medical malpractice, on how to act when they do occur and how to defend oneself through the courts

Las reclamaciones por presunta mala praxis médica aumentan en todos los países desarrollados, y muchas de ellas no tienen fundamento. Para prevenir las reclamaciones judiciales los médicos deberían conocer las razones por las que son reclamados por sus pacientes y adoptar las medidas preventivas adecuadas. En caso de reclamación es indispensable seguir unas normas que permitan una defensa jurídica adecuada, así como una actuación del médico ante el juez que inspire confianza y credibilidad. El riesgo de reclamaciones puede reducirse con una adecuada información al paciente, el seguimiento de las guías clínicas, el control de los factores de riesgo, y la adopción de listas de verificación en cada procedimiento invasivo. En caso de complicación o efecto adverso grave debe procederse a dar explicaciones al paciente y a sus familiares, y comunicarlo a la institución donde trabaja y a la compañía de seguros. Si el médico recibe una reclamación, debe comunicarlo a su compañía de seguros para que esta designe el abogado responsable de la defensa jurídica, que asesorará al médico para su comparecencia ante el juez(AU)

Claims due to presumed medical malpractice are increasing in all developed countries and many of them have no basis. To prevent legal complaints, the physicians should know the reasons why complaints are made by their patients and adopt the adequate preventive measures. In the case of a complaint, it is essential to follow the guidelines that allow for adequate legal defense and the action of the physician before the judge that inspires confidence and credibility. The risk of the claims can be reduced with adequate information to the patient, the following of the clinical guidelines, control of the risk factors and adoption of verification lists in each invasive procedure. In case of complication or serious adverse effect, explanations should be given to the patient and family and it should be reported to the facility where one works and to the insurance company. of the physician received a claim, he/she should report it to the insurance compare so that it can name a lawyer responsible for the legal defense who will advise the physician regarding the appearance in court before the judge(AU)

[Guideline to prevent claims due to medical malpractice, on how to act when they do occur and how to defend oneself through the courts]. / Guía para prevenir las reclamaciones por presunta mala praxis médica, de cómo actuar cuando se producen y cómo defenderse judicialmente.

Claims due to presumed medical malpractice are increasing in all developed countries and many of them have no basis. To prevent legal complaints, the physicians should know the reasons why complaints are made by their patients and adopt the adequate preventive measures. In the case of a complaint, it is essential to follow the guidelines that allow for adequate legal defense and the action of the physician before the judge that inspires confidence and credibility. The risk of the claims can be reduced with adequate information to the patient, the following of the clinical guidelines, control of the risk factors and adoption of verification lists in each invasive procedure. In case of complication or serious adverse effect, explanations should be given to the patient and family and it should be reported to the facility where one works and to the insurance company. If the physician received a claim, he/she should report it to the insurance compare so that it can name a lawyer responsible for the legal defense who will advise the physician regarding the appearance in court before the judge.

Assessment of liver fibrosis before and after antiviral therapy by different serum marker panels in patients with chronic hepatitis C.

BACKGROUND: Liver biopsy is the reference standard to assess liver fibrosis in chronic hepatitis C. AIM: To validate and compare the diagnostic performance of non-invasive tests for prediction of liver fibrosis severity and assessed changes in extracellular matrix markers after antiviral treatment. METHODS: The performances of Forns' score, AST to platelet ratio index (APRI), FIB-4 index and Enhanced Liver Fibrosis (ELF) score were validated in 340 patients who underwent antiviral therapy. These scores were determined 24 weeks after treatment in 161 patients. RESULTS: Forns' score, APRI, FIB-4 and ELF score showed comparable diagnostic accuracies for significant fibrosis [area under the receiver operating characteristic curve (AUROC) 0.83, 0.83, 0.85 and 0.81, respectively]. To identify cirrhosis, FIB-4 index showed a significantly better performance over APRI and ELF score (AUROC 0.89 vs. 0.83 and 0.82, respectively). ELF score decreased significantly in patients with sustained virological response (SVR) (P < 0.0001) but remained unchanged in nonresponders. Non-1 hepatitis C virus (HCV) genotype, baseline lower HCV RNA, glucose, hyaluronic acid and higher cholesterol levels were independently associated with SVR. CONCLUSIONS: Simple panel markers and ELF score are accurate at identifying significant fibrosis and cirrhosis in chronic hepatitis C. A decrease in ELF score after antiviral treatment reflects the impact of viral clearance in hepatic extracellular matrix and probably in the improvement of liver fibrosis.

Long-term experience with kidney transplantation from hepatitis C-positive donors into hepatitis C-positive recipients.

Kidney transplantation from hepatitis C virus (HCV) antibody positive donors (HCVD+) into HCV antibody positive recipients (HCVR+) is controversial. We implemented this policy in our units in 1990. Herein, we report the long-term safety of this strategy. From March 1990 to March 2007, 162 HCVR+ received a kidney from HCVD+ (group 1) and 306 from HCVD- (group 2) in our units. Mean follow-up was 74.5 months. Five-and 10-year patient survival was 84.8% and 72.7% in group 1 vs. 86.6% and 76.5% in group 2 (p = 0.250). Three deaths in group 1 and two in group 2 were liver-disease related. Five- and 10-year graft survival was 58.9% and 34.4% versus 65.5% and 47.6% respectively (p = 0.006) while death-censored graft survival was 69% and 47% versus 72.7% and 58.5% (p = 0.055). Decompensated chronic liver disease was similar: 10.3% versus 6.2%. Cox-regression analysis could not identify the donor's HCV serology as a significant risk factor for death, graft failure and severe liver disease in HCVR+. In conclusion, long-term outcome of HCVR+ transplanted with kidneys from HCVD+ seems good in terms of patient survival, graft survival and liver disease. HCVD+ was not a significant risk factor for mortality, graft failure and liver disease among HCVR+. These data strongly suggest that the use of kidneys from HCVD+ in HCVR+ is a safe long-term strategy that helps to prevent kidney loss.

ATG-Fresenius treatment and low-dose tacrolimus: results of a randomized controlled trial in liver transplantation.

We report the results of a prospective randomized controlled trial in liver transplantation assessing the efficacy and safety of antithymocyte globulin (ATG-Fresenius) plus tacrolimus monotherapy at gradually decreasing doses. Patients were randomized to either: (a) standard-dose tacrolimus plus steroids;or (b) peritransplant ATG-Fresenius plus reduced-dose tacrolimus monotherapy followed by weaning of tacrolimus starting 3 months after transplantation. The primary end-point was the achievement of very low-dose tacrolimus (every-other-day or once daily dose with <5 ng/mL trough levels) at 12 months after transplantation. Acute rejection occurring during the first 3 months after transplantation was more frequent in the ATG group (52.4% vs. 25%). Moreover, late acute rejection episodes occurred in all recipients in whom weaning was attempted and no recipients reached the primary end-point. This motivated the premature termination of the trial. Tacrolimus trough levels were lower in the ATG-Fresenius group but no benefits in terms of improved renal function, lower metabolic complications or increased prevalence of tolerance-related biomarkers were observed. In conclusion, the use of ATG-Fresenius and tacrolimus at gradually decreasing doses was associated with a high rate of rejection, did not allow for the administration of very low doses of tacrolimus and failed to provide detectable clinical benefits. ClinicalTrials.gov identifier: NCT00436722.

Adverse reactions during transfusion of thawed haematopoietic progenitor cells from apheresis are closely related to the number of granulocyte cells in the leukapheresis product.

BACKGROUND AND OBJECTIVES: The infusion of thawed haematopoietic progenitor cells from apheresis (HPC-A) is associated with minor but frequent adverse reactions (ARs), which has been mainly attributed to dimethyl sulphoxide (DMSO). Nevertheless, other factors may play a role in the pathogenesis of such toxicity. MATERIALS AND METHODS: The ARs on a cohort of 423 cryopreserved HPC-A infusions for 398 patients in HPC transplantation program were analysed. RESULTS: ARs were reported in 105 graft infusions (24·8%) and most of them were graded as mild to moderate. The most frequently reported ARs were gastrointestinal and respiratory, and three patients presented epileptic seizure. The volume of DMSO/kg (P < 0·001), volume of red-blood-cells/kg (P = 0·02), number of nuclear cells (NCs)/kg (P <0·001) and number of granulocytes/kg (P<0·001) in the infused graft were significant in the univariate analysis for the occurrence of ARs. The amount of granulocytes/kg remained significant in the multivariate analysis (P<0·001). The grade of ARs also correlated with the amount of cryopreserved granulocytes. CONCLUSION: The incidence and grade of ARs during infusion of cryopreserved HPC-A are related to the amount of granulocytes in the graft.

Hepatotoxicidad secundaria a “productos naturales”: análisis de los casos notificados al Registro Español de Hepatotoxicidad / No disponible

Introducción: la toxicidad hepática asociada al uso crecientede productos de “remedios naturales” es un fenómeno emergente.Objetivos: valoración de las características epidemiológicas,clínicas y demográficas de los casos de hepatotoxicidad secundariosa productos herbales (PH) y suplementos dietéticos(SD).Pacientes y métodos: análisis de los casos de hepatotoxicidaddebida a PH y SD incluidos en el Registro Español de Hepatotoxicidad.Resultados: trece casos de un total de 521 casos (2%) dereacciones adversas hepáticas incluidas en el registro entre1994 y 2006, eran secundarios a PH/SD, representando el décimogrupo terapéutico responsable por orden de frecuencia,por delante de analgésicos, ansiolíticos y antipsicóticos. Nuevepacientes (69%) eran mujeres y la edad media fue de 45 años.Nueve pacientes (69%) presentaron ictericia. El tipo de dañomás frecuente fue el hepatocelular (12; 92%) y un 31% de loscasos presentaron datos de hipersensibilidad. La sustancia máscomúnmente involucrada en los casos de daño hepático fue laCamellia sinensis (23%) seguida de Rhamnus purshianus eisoflavonas (Fitosoja®, Biosoja®) con dos casos cada uno (15%).Tres casos (23%) presentaron re-exposición positiva.Conclusiones: la hepatotoxicidad originada por PH/SD noes excepcional, y su perfil es la hepatitis aguda hepatocelular ictéricapredominantemente en mujeres. La frecuente ocurrenciade reexposición positiva en estos pacientes indica un bajo índicede sospecha y un retraso o ausencia de diagnóstico de estetipo de reacción adversa

Background: toxic liver damage associated with the use ofnatural remedies is a growing health problem.Objectives: to analyze the demographics, and clinical andepidemiological characteristics of patients developing liver injuryrelated to these remedies.Patients and methods: all DILI cases associated with the useof herbal remedies (HR) or dietary supplements (DS) submitted tothe Spanish Registry were analyzed. Type of liver damage, severity,and outcome were specifically evaluated.Results: thirteen cases out of 521 DILI cases (2%) submittedto the Spanish Liver Toxicity Registry between 1994 and2006 were related to HR/DS, which ranked as the 10th therapeuticgroup with a greater number of cases and above painkillers, anxiolytics, and antipsychotic drugs. Nine patients (69%)were female (mean age 45 years). Nine cases (69%) had jaundiceat presentation. The predominating type of liver damagewas hepatocellular (12; 92%), and 31% of cases exhibited thecommon features of hypersensitivity. Camellia sinensis (3,23%) was the main causative herb, followed by Rhamnus purshianusand isoflavones (Fitosoja®, Biosoja®) (2 cases each,15%). Three cases (23%) were rechallenged with the offendingproduct.Conclusions: the incidence of hepatic damage related toHR/DS is not so rare, the most common profile of affected patientsbeing a woman with acute hepatocellular hepatitis. Lowsuspicion regarding the putative role of herbs in hepatotoxicitymakes diagnosis more difficult, and probably increases the incidenceof inadvertent rechallenge in these patients

[Hepatotoxicity induced by herbs and medicines used to induce weight loss]. / Hepatotoxicidad inducida por el uso de hierbas y medicamentos para perder peso.

In the last few years, a considerable number of reports have been published on hepatotoxicity associated with herbal products attributed with weight-reducing properties. Clinical expression of hepatotoxicity has ranged from symptoms of self-limiting hepatitis, indistinguishable from those caused by the hepatitis viruses, to forms of fulminant hepatitis causing death or requiring liver transplantation. These products, which are sold as dietary products or supplements, do not undergo the safety tests required of drugs before their release on to the market. To prevent the toxic effects of herbal products, the general public should be made aware of their harmful effects and since the benefits of these products have not been demonstrated avoid their use, while physicians should strongly discourage patients from taking these products. Authorization of the commercialization of all these natural products should be strictly regulated to minimize the harm they can cause.

Hepatotoxicidad inducida por el uso de hierbas y medicamentos para perder peso / Hepatotoxicity induced by herbs and medicines used to induce weight loss

En los últimos años ha aparecido un considerable númerode publicaciones en la literatura médica sobre la hepatotoxicidadasociada a productos herbarios a los que se ha atribuidoun efecto adelgazante. La expresión clínica de hepatotoxicidadha oscilado entre cuadros de hepatitis autolimitada,indistinguibles de los causados por los virus de la hepatitis,hasta formas de hepatitis fulminante que han causadomuerte o han requerido un trasplante hepático. Estos productos,que se venden como productos dietéticos o suplementosdietéticos, no pasan los controles de seguridad a quese somete a los fármacos antes de su comercialización, por loque la prevención de sus efectos tóxicos exige un mejor conocimientodel público para que evite su empleo, ya que susbeneficios nunca han sido comprobados, y una actuación decididade los médicos para que contribuyan a disuadir de suempleo a sus pacientes. Una regulación estricta de la autorizaciónde la comercialización de todos estos productos, denominadosnaturales, es muy necesaria para minimizar losdaños que pueden causar (AU)

In the last few years, a considerable number of reports havebeen published on hepatotoxicity associated with herbalproducts attributed with weight-reducing properties. Clinicalexpression of hepatotoxicity has ranged from symptomsof self-limiting hepatitis, indistinguishable from those causedby the hepatitis viruses, to forms of fulminant hepatitiscausing death or requiring liver transplantation.These products, which are sold as dietary products or supplements,do not undergo the safety tests required of drugsbefore their release on to the market. To prevent the toxiceffects of herbal products, the general public should bemade aware of their harmful effects and – since the benefitsof these products have not been demonstrated – avoid theiruse, while physicians should strongly discourage patientsfrom taking these products. Authorization of the commercializationof all these “natural” products should be strictlyregulated to minimize the harm they can cause (AU)

Hepatotoxicidad inducida por el uso de hierbas y medicamentos para perder peso / Hepatotoxicity induced by herbs and medicines used to induce weight loss

En los últimos años ha aparecido un considerable númerode publicaciones en la literatura médica sobre la hepatotoxicidadasociada a productos herbarios a los que se ha atribuidoun efecto adelgazante. La expresión clínica de hepatotoxicidadha oscilado entre cuadros de hepatitis autolimitada,indistinguibles de los causados por los virus de la hepatitis,hasta formas de hepatitis fulminante que han causadomuerte o han requerido un trasplante hepático. Estos productos,que se venden como productos dietéticos o suplementosdietéticos, no pasan los controles de seguridad a quese somete a los fármacos antes de su comercialización, por loque la prevención de sus efectos tóxicos exige un mejor conocimientodel público para que evite su empleo, ya que susbeneficios nunca han sido comprobados, y una actuación decididade los médicos para que contribuyan a disuadir de suempleo a sus pacientes. Una regulación estricta de la autorizaciónde la comercialización de todos estos productos, denominadosnaturales, es muy necesaria para minimizar losdaños que pueden causar

In the last few years, a considerable number of reports havebeen published on hepatotoxicity associated with herbalproducts attributed with weight-reducing properties. Clinicalexpression of hepatotoxicity has ranged from symptomsof self-limiting hepatitis, indistinguishable from those causedby the hepatitis viruses, to forms of fulminant hepatitiscausing death or requiring liver transplantation.These products, which are sold as dietary products or supplements,do not undergo the safety tests required of drugsbefore their release on to the market. To prevent the toxiceffects of herbal products, the general public should bemade aware of their harmful effects and – since the benefitsof these products have not been demonstrated – avoid theiruse, while physicians should strongly discourage patientsfrom taking these products. Authorization of the commercializationof all these “natural” products should be strictlyregulated to minimize the harm they can cause

Impact and effectiveness of a mass hepatitis A vaccination programme of preadolescents seven years after introduction.

AIM: To investigate the impact of a mass hepatitis A vaccination programme in preadolescents seven years after introduction in terms of its effectiveness and the prevented fraction. SETTING: The age distribution of notified cases and incidence rates in Catalonia (Spain) in the periods before (1992-1998) and after (1999-2005) introduction of the vaccination programme were compared. MAIN RESULTS: The incidence rates in the whole population were 5.51 per 100,000 person-years in the 1992-1998 period and 2.98 in the 1999-2005 period. The rate reduction in the 10-19 years age group was 72.43% and was more than 45% in the 5-9 years and 20-29 years age groups. The effectiveness of the vaccination programme was 99.04 (95% CI: 93.11-99.88) and the prevented fraction in the 12-19 years age group was 90.13% (95% CI: 84.47-90.89). CONCLUSIONS: The universal vaccination programme of preadolescents has had an important impact on hepatitis A in Catalonia, not only in vaccinated cohorts but also in non-vaccinated age groups due to a herd immunity effect.

La biopsia hepática en 2008: indicaciones y limitaciones / No disponible

No disponible

[Liver injury induced by "natural remedies": an analysis of cases submitted to the Spanish Liver Toxicity Registry]. / Hepatotoxicidad secundaria a "productos naturales": análisis de los casos notificados al Reigstro Español de Hepatotoxicidad.

BACKGROUND: toxic liver damage associated with the use of natural remedies is a growing health problem. OBJECTIVES: to analyze the demographics, and clinical and epidemiological characteristics of patients developing liver injury related to these remedies. PATIENTS AND METHODS: all DILI cases associated with the use of herbal remedies (HR) or dietary supplements (DS) submitted to the Spanish Registry were analyzed. Type of liver damage, severity, and outcome were specifically evaluated. RESULTS: thirteen cases out of 521 DILI cases (2%) submitted to the Spanish Liver Toxicity Registry between 1994 and 2006 were related to HR/DS, which ranked as the 10th therapeutic group with a greater number of cases and above pain killers, anxiolytics, and antipsychotic drugs. Nine patients (69%) were female (mean age 45 years). Nine cases (69%) had jaundice at presentation. The predominating type of liver damage was hepatocellular (12; 92%), and 31% of cases exhibited the common features of hypersensitivity. Camellia sinensis (3, 23%) was the main causative herb, followed by Rhamnus purshianus and isoflavones (Fitosoja(R), Biosoja(R)) (2 cases each, 15%). Three cases (23%) were rechallenged with the offending product. CONCLUSIONS: the incidence of hepatic damage related to HR/DS is not so rare, the most common profile of affected patients being a woman with acute hepatocellular hepatitis. Low suspicion regarding the putative role of herbs in hepatotoxicity makes diagnosis more difficult, and probably increases the incidence of inadvertent rechallenge in these patients.