Guillain-Barré syndrome and influenza vaccines: current evidence.

OBJECTIVE: Guillain-Barré Syndrome (GBS) as a consequence of influenza vaccination is a relevant topic, yet to be clarified, which raises concern both amongst health care personnel and the general population. Every study and pharmacovigilance system point to need of further research and the importance of continuous monitoring of safety regarding influenza vaccines. The aim of the present study is to investigate the publication of new data since the realisation of our meta-analysis of GBS and influenza vaccines (published in 2015). METHODS: A systematic revision of PubMed, Embase, and Web of Knowledge (WOS) databases has been carried out. These report observational studies assessing GBS risk after the administration of influenza vaccines from May 2014 up to July 20th, 2017. RESULTS: The research yielded 107 articles. Only three studies met established inclusion criteria and referred to an estimation GBS risk after some influenza vaccine. Two studies investigated GBS risk by the pandemic A/H1N1 vaccine, while only one looked into season vaccines. CONCLUSIONS: The present systematic review, conducted after the publication of our previous meta-analysis, seems to confirm its previous results. Therefore, GBS should be considered an infrequent adverse effect of influenza vaccination, which should not negatively influence its acceptance. Unfortunately, very few of the systematically surveyed studies meeting inclusion criteria. This fact sharply contrasts with the current consensus as to the need of continuously monitoring the safety of influenza vaccines.

Impact of regulatory measures on antipsychotics drug consumption in Castilla y León, Spain.

OBJECTIVES: Antipsychotics are currently used to treat different diseases; even some off-labelled conditions are treated with this medication. Consumption and cost of antipsychotic drugs sharply increased in Spain after second-generation drugs were marketed; several regulatory measures were adopted to curb this trend. The aim of this study was to examine the impact of these measures upon the use and cost of antipsychotics. STUDY DESIGN: Study of drug use (SDU) from 1995 to 2012. Consumption and cost data were obtained from the CONCYLIA database; this database contains the retail community pharmacies sales of medicinal products reimbursed by the National Health System in Castilla y León (Spain). METHODS: Data are presented as defined daily doses per 1000 inhabitants per day (DID) and day treatment cost (DTC). RESULTS: First-generation antipsychotics prescriptions gradually decreased from 3.0 to 1.8 DID; meanwhile, prescriptions for second-generation antipsychotics considerably increased from 0.3 to 9.9 DID. The use of risperidone dropped after the marketing of its structural derivative paliperidone with a similar efficacy but with a substantially higher cost per day. In 2011 and thereafter, patients in Spain began to pay a part of the medications cost, but this did not decrease antipsychotics consumption. Global cost of antipsychotics only began to fall after measures were adopted to lower the price of medicines because of the economic collapse in Spain after May 2010. CONCLUSION: Several health policy measures have tried to reduce antipsychotics consumption in Spain, special ways of dispensing, marketing of generic drugs and special economic measures for patients. These measures eventually failed to avoid the increase in antipsychotics use. The cost only dropped when lowering prescription drug prices took place.

Hip fracture rates and bisphosphonate consumption in Spain. An ecologic study.

INTRODUCTION: Bisphosphonates are used worldwide to treat osteoporosis and, thus, to prevent fractures. Though they have been proven in clinical trials to avoid some fractures, their effectiveness in reducing hip fractures is unclear. The aim of the present study was to explore the relationship between bisphosphonate use and hip fracture trends in Spain. METHODS: For this purpose, an ecologic study spanning 2002 to 2008 was conducted in Spain. Consumption data were obtained from the Spanish Ministry of Health and Social Policy. The number of hip fractures was obtained from hospital discharges; annual hip fracture rates were determined and standardized using the Spanish 2002 population census. A linear regression was performed between fracture rate and use of bisphosphonates; R(2) and Pearson correlation coefficient were calculated. RESULTS: From 2002 to 2008, dispensed prescriptions of bisphosphonates in Spain increased from 3.28 to 17.66 DDD/1,000 inhabitants per day. In the same period, the crude hip fracture rate increased from 2.85 to 3.02 cases per 1,000 inhabitants older than 50 years; however, when age standardized rates were estimated, the rate declined from 2.85 to 2.79. Analyzed by sex, the standardized rate for men slightly increased from 1.45 to 1.48, while for women the rate significantly dropped from 4.00 to 3.91. CONCLUSION: A small effect of bisphosphonates on hip fracture rates can not be ruled out; however, other factors might partially explain this decline. Assuming this medication was the only cause for hip fracture rate reduction, the elevated medication cost to avoid a single hip fracture makes it necessary to explore less expensive interventions.

Drug neosensitization during anticonvulsant hypersensitivity syndrome.

Anticonvulsant hypersensitivity syndrome (AHS) is a rare, severe drug hypersensitivity reaction included in the drug-related rash with eosinophilia and systemic symptoms syndrome (DRESS), in which a transient state of immune suppression and reactivation of latent virus infections have been observed. We describe 5 patients who developed neosensitization to different drugs taken during a previous episode of anticonvulsant-related DRESS, in whom skin prick, intradermal and/or patch tests were performed to confirm the diagnosis of drug hypersensitivity. In 1 patient, transient hypogammaglobulinemia was observed during the AHS. Four of the 5 patients developed a delayed skin eruption or a delayed systemic hypersensitivity reaction after intake of a drug that they had also taken during a previous anticonvulsant DRESS which had occurred months or years earlier; in the fifth, a possible reaction was prevented thanks to the allergy workup. The diagnosis of drug allergy was demonstrated by positive delayed reaction to intradermal test with amoxicillin in 2 cases, positive patch tests to paracetamol and amitriptyline in 2 cases, and by clinical evidence of ceftriaxone erythroderma in one. The possibility of neosensitization to drugs administered during anticonvulsant-related DRESS should be considered. A transient state of immunosuppression induced during the anticonvulsant-related DRESS may trigger latent virus reactivation and massive nonspecific immune system response, which may lead to breakdown of tolerance to other drugs present at that time in the organism.

Allergic eosinophilic gastroenteritis in a child with Crohn's disease.

A case of a child with Crohn's disease who developed an eosinophilic gastroenteritis is reported. Although symptoms of eosinophilic gastroenteritis at age 8 could mimic those of Crohn's disease, laboratory, radiographic and histologically studies are clearly different. Peripheral blood eosinophilia (7,476 cells per mm3), high serum IgE level (1,050 kU/l) and normal C-reactive protein and erythrocyte sedimentation rate are common in eosinophilic gastroenteritis and uncommon in Crohn's disease. Eosinophilic gastroenteritis was due to bovine serum albumin (BSA) hypersensitivity, confirmed with skin tests, serum levels to specific IgE and a SDS-PAGE IgE-immunoblotting. A strict meat-free diet was started, with progressive relief of symptoms and decrease of eosinophil count twelve months later; the patient became fully symptom-free and eosinophil count was normal.

Effects of specific immunotherapy on the development of new sensitisations in monosensitised patients.

BACKGROUND: Specific immunotherapy (SIT) is the only treatment that interferes with the basic pathophysiological mechanisms of allergic disease and is widely used in the management of clinically significant respiratory IgE-mediated diseases. Nevertheless, until recently, information on the influence of SIT on the development of new allergic sensitisations has been scant. METHODS: One hundred consecutive patients (45 males and 55 females, aged 6 to 69 years) with respiratory allergic diseases and attending the allergy unit of a general hospital were selected. All had been diagnosed by clinical history and skin prick tests of allergic rhinitis and/or asthma, were monosensitised (71 to Dermatophagoides spp, 22 to Parietaria judaica pollen and 7 to grass pollen) and had been followed up as outpatients between 1990-98. Sixty-six patients had been treated with conventional SIT for at least 3 years, while thirty-four followed only environmental measures and drug treatment. Family atopy status (first-degree relatives), smoking, family pets (cat and/or dog), rhinitis and/or asthma symptom score and inhalant skin prick tests to the same aeroallergens were compared between baseline and after 3 to 5 years of treatment. RESULTS: No statistically-significant differences in the development of new sensitisations were observed between the two groups (36.4 % of SIT-treated patients versus 38.2 % in control group, RR = 0.97, CI 95 %: 0.72-1.3). Smoking, family atopy history and pets did not appear to be risk factors for the development of neosensitisations (p < 0.05). Nevertheless, SIT-treated patients presented a better clinical score than the control group, with improvements of 89.4 % and 61.8 %, respectively (p = 0.007). CONCLUSIONS: Three-year SIT did not protect against development of new sensitisations in monosensitised allergic rhinitis or asthma. Smoking, family atopy history and pets were not associated with development of new sensitisations. Clinical score improved significantly in the SIT-treated group compared with drug-treated patients.

Effects of specific immunotherapy on the development of new sensitisations in monosensitised patients

Background: Specific immunotherapy (SIT) is the only treatment that interferes with the basic pathophysiological mechanisms of allergic disease and is widely used in the management of clinically significant respiratory IgE-mediated diseases. Nevertheless, until recently, information on the influence of SIT on the development of new allergic sensitisations has been scant. Methods: One hundred consecutive patients (45 males and 55 females, aged 6 to 69 years) with respiratory allergic diseases and attending the allergy unit of a general hospital were selected. All had been diagnosed by clinical history and skin prick tests of allergic rhinitis and/or asthma, were monosensitised (71 to Dermatophagoides spp, 22 to Parietaria judaica pollen and 7 to grass pollen) and had been followed up as outpatients between 1990-98. Sixty-six patients had been treated with conventional SIT for at least 3 years, while thirty-four followed only environmental measures and drug treatment. Family atopy status (first-degree relatives), smoking, family pets (cat and/or dog), rhinitis and/or asthma symptom score and inhalant skin prick tests to the same aeroallergens were compared between baseline and after 3 to 5 years of treatment. Results: No statistically-significant differences in the development of new sensitisations were observed between the two groups (36.4 % of SIT-treated patients versus 38.2 % in control group, RR = 0.97, CI 95 %: 0.72-1.3). Smoking, family atopy history and pets did not appear to be risk factors for the development of neosensitisations (p < 0.05). Nevertheless, SIT-treated patients presented a better clinical score than the control group, with improvements of 89.4 % and 61.8 %, respectively (p = 0.007). Conclusions: Three-year SIT did not protect against development of new sensitisations in monosensitised allergic rhinitis or asthma. Smoking, family atopy history and pets were not associated with development of new sensitisations. Clinical score improved significantly in the SIT-treated group compared with drug-treated patients (AU)

Introducción: La inmunoterapia específica es el único tratamiento que actúa sobre los mecanismos fisiopatológicos de las enfermedades alérgicas y se utiliza frecuentemente en el manejo clínico de los pacientes con enfermedades respiratorias mediadas por IgE. Recientemente se ha sugerido que la inmunoterapia podría tener un efecto protector sobre el desarrollo de nuevas sensibilizaciones, siendo el objetivo de este estudio analizar este posible efecto. Pacientes y métodos: Se seleccionaron 100 pacientes consecutivos (45 hombres y 55 mujeres, con edades comprendidas entre los 6 y 69 años) con alergia respiratoria que consultaron en una unidad de alergia de un hospital general durante el período comprendido entre 1990 y 1998. Estos pacientes se diagnosticaron de rinitis y/o asma por historia clínica y prick test, siendo todos ellos monosensibles (71 a Dermatophagoides spp, 22 al polen de Parietaria judaica y 7 al polen de gramíneas). Sesenta y seis pacientes se trataron con inmunoterapia convencional durante un mínimo de 3 años (grupo inmunoterapia) y treinta y cuatro realizaron únicamente medidas ambientales y tratamiento farmacológico (grupo control).Al inicio del estudio y después de 3 a 5 años de tratamiento se realizó todos ellos un estudio que incluía la realización de pruebas cutáneas con la misma batería de aeroalergenos, valoración de la gravedad de la rinitis y/o asma mediante un baremo de síntomas e interrogatorio sobre la presencia de ciertos factores que pudieran influir en su evolución o en la aparición de nuevas sensibilizaciones (antecedentes familiares de atopia de primer grado, tabaquismo y exposición a los animales domésticos perro y/o gato). Resultados: No se observaron diferencias estadísticamente significativas en el desarrollo de nuevas sensibilizaciones entre los dos grupos (el 36,4 por ciento en el grupo tratado con inmunoterapia frente el 38,2 por ciento en el grupo control, RR = 0,97; IC 95 por ciento:0,72-1,3). La presencia de antecedentes familiares de atopia, el tabaquismo o la exposición a animales no fueron factores de riesgo para el desarrollo de nuevas sensibilizaciones (p< 0,05). Sin embargo, los pacientes tratados con inmunoterapia presentaron una mejor evolución clínica que el grupo control, con mejorías del 89,4 por ciento y del 61,8 por ciento respectivamente (p = 0,007).Conclusiones: La inmunoterapia específica durante un período mínimo de 3 años no protegió de la aparición de nuevas sensibilizaciones en pacientes monosensibles con rinitis y/o asma. Tampoco influyeron en la aparición de nuevas sensibilizaciones los antecedentes familiares de atopia, el tabaquismo o a la exposición a animales domésticos. El baremo clínico mejoró significativamente en el grupo tratado con inmunoterapia en relación al grupo control (AU)

Más de tabaquismo / More on tobacco dependency

No disponible

Edema palpebral recidivante de larga evolución / Long-lasting recurrent palpebral oedema

No disponible

Efficacy of the eradication of Helicobacter pylori infection in patients with chronic urticaria. A placebo-controlled double blind study.

Helicobacter pylori has been involved in the pathogenesis of chronic idiopathic urticaria (CIU) in patients suffering both CIU and H. pylori infection. We selected 49 patients with 13C urea breath test positive, long-lasting CIU and H. pylori infection; 20 remained symptomatic, had positive urease test or H. pylori histologic identification in gastric biopsy material and accepted to participate in a pacebo-controlled treatment trial. They were randomized for a 7-day, double-blind, placebo-controlled H. pylori eradication treatment with amoxicillin, clarithromycin and omeprazol or placebo. H. pylori eradication was assessed by a second 13C urea breath test six weeks after the end of treatment. We observed a significant improvement of more than 70 % of CIU; baseline clinical score was seen in 4 of the 9 (44 %) patients who eradicated H. pylori after active treatment and in 1 of the 7 (12,3 %) of those who did not (p = 0.19). No clinical differences in CIU characteristics were found between patients with and without improvement. No serious adverse effects were observed in either treatment group. We conclude that the eradication of H. pylori may be useful for patients suffering long-lasting CIU and H. pylori infection, although theses results did not reach statistical significance probably owing to the strict conditions of the recruitment.

Urticaria to cetirizine.

A patient with recurrent idiopathic urticaria reported exacerbations after treatment with cetirizine. Prick test to cetirizine was negative. Double-blind challenge tests with mizolastine, loratadine, fexofenadine, dexchlorpheniramine, ebastine, ketotifen, and placebo were negative, whereas hydroxyzine and its active metabolite, cetirizine, reproduced the urticaria. Identification of uncommon adverse reactions to H1 antihistamines is important, particularly because they may mimic the underlying disease.

Efficacy of the eradication of Helicobacter pylori infection in patients with chronic urticaria. A placebo-controlled double blind study

Helicobacter pylori has been involved in the pathogenesis of chronic idiopathic urticaria (CIU) in patients suffering both CIU and H. pylori infection. We selected 49 patients with 13C urea breath test positive, long-lasting CIU and H. pylori infection; 20 remained symptomatic, had positive urease test or H. pylori histologic identification in gastric biopsy material and accepted to participate in a pacebo-controlled treatment trial. They were randomized for a 7-day, double-blind, placebo-controlled H. pylori eradication treatment with amoxicillin, clarithromycin and omeprazol or placebo. H. pylori eradication was assessed by a second 13C urea breath test six weeks after the end of treatment. We observed a significant improvement of more than 70 % of CIU; baseline clinical score was seen in 4 of the 9 (44 %) patients who eradicated H. pylori after active treatment and in 1 of the 7 (12,3 %) of those who did not (p = 0.19). No clinical differences in CIU characteristics were found between patients with and without improvement. No serious adverse effects were observed in either treatment group. We conclude that the eradication of H. pylori may be useful for patients suffering long-lasting CIU and H. pylori infection, although theses results did not reach statistical significance probably owing to the strict conditions of the recruitment (AU)

La infección por Helicobacter pylori ha sido implicada en la patogénesis de la urticaria crónica idiopática (UCI), sin embargo los resultados de los diversos estudios publicados son contradictorios. Seleccionamos 49 pacientes con UCI de larga evolución y con una prueba del aliento con urea 13C positiva. De ellos 20 que estaban con síntomas activos y que presentaron una prueba de la ureasa positiva o identificación histológica de H. pylori en el material de la biopsia gástrica aceptaron participar en un estudio ciego con tratamiento activo controlado con placebo. Para ello se aleatorizaron para tratamiento erradicador de H. pylori con amoxicilina, claritromicina y omeprazol durante 7 días o para placebo. La erradicación de la infección por H. pylori fue valorada por una segunda prueba del aliento con urea 13C, 6 semanas después de acabado el tratamiento. Los resultados mostraron una mejoría superior al 70 per cent del baremo clínico basal en 4 de los 9 pacientes (44 per cent) que erradicaron la infección después de realizar el tratamiento activo y en uno de los 7 (12,3 per cent) que no lo hicieron (p=0,19). No encontramos características clínicas diferentes entre los pacientes que mejoraron y los que no. No se registraron reacciones adversas destacables en ninguno de los grupos de tratamiento. Concluimos que la erradicación de la infección por H. pylori puede ser útil en algunos pacientes afectados de UCI de larga evolución con infección por H. pylori, aunque los resultados no llegaron a ser estadísticamente significativos debido a las estrictas condiciones del reclutamiento (AU)