Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study. / [Artículo traducido] Sonidegib para el tratamiento del carcinoma basocelular avanzado en práctica clínica real: estudio nacional multicéntrico.

BACKGROUND: Basal cell carcinoma (BCC) is the most prevalent cancer. A minority of BCCs have an aggressive behaviour (laBCC) and may require hedgehog pathway inhibitors such as sonidegib as its treatment. OBJECTIVE: To describe the use of sonidegib in a large number of patients and provide more data on its real-life efficacy and safety profile. METHODS: We conducted a retrospective and multicentric study that included patients treated with sonidegib. Epidemiological, effectiveness and safety data were collected. RESULTS: A total of 82 patients with a mean age of 73.9 years were included. Ten patients had Gorlin syndrome. Median treatment duration was 6 months. Median follow-up duration was 34.2 months. Globally, 81.7% of the patients showed clinical improvement (52.4% partial response and 29.3% complete response), 12.2% clinical stability and 6.1% disease progression. There was no statistically significant difference in clinical improvement between the 24 h and 48 h sonidegib posology. After 6 months of treatment, 48.8% of the patients discontinued sonidegib. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. At 6 months of treatment, 68.3% of the patients experienced at least one adverse effect. CONCLUSION: Sonidegib shows good effectiveness and acceptable safety profile in usual clinical practice.

Sonidegib as a Locally Advanced Basal Cell Carcinoma Therapy in Real-life Clinical Setting: A National Multicentre Study.

BACKGROUND: Basal cell carcinoma (BCC) is the most prevalent cancer. A minority of BCCs have an aggressive behaviour (laBCC) and may require hedgehog pathway inhibitors such as sonidegib as its treatment. OBJECTIVE: To describe the use of sonidegib in a large number of patients and provide more data on its real-life efficacy and safety profile. METHODS: We conducted a retrospective and multicentric study that included patients treated with sonidegib. Epidemiological, effectiveness and safety data were collected. RESULTS: A total of 82 patients with a mean age of 73.9 years were included. Ten patients had Gorlin syndrome. Median treatment duration was 6 months. Median follow-up duration was 34.2 months. Globally, 81.7% of the patients showed clinical improvement (52.4% partial response and 29.3% complete response), 12.2% clinical stability and 6.1% disease progression. There was no statistically significant difference in clinical improvement between the 24h and 48h sonidegib posology. After 6 months of treatment, 48.8% of the patients discontinued sonidegib. Prior vismodegib treatment and recurrent primary BCC were associated with a poorer response to sonidegib. At 6 months of treatment, 68.3% of the patients experienced at least one adverse effect. CONCLUSION: Sonidegib shows good effectiveness and acceptable safety profile in usual clinical practice.

Management of Biologic Therapy in Moderate to Severe Psoriasis in Surgical Patients: Data From the Spanish Biobadaderm Registry. / Manejo de los tratamientos biológicos en pacientes con psoriasis moderada-grave sometidos a intervenciones quirúrgicas en el registro español Biobadaderm.

BACKGROUND AND OBJECTIVE: We now have considerable experience in the use of biologic agents to treat psoriasis, but doubts about management arise in certain clinical settings. Surgery is one of them. Although treatment guidelines advise that biologics be suspended before major surgery, data about actual clinical practices and associated complications are lacking. We aimed to analyze current practice in the clinical management of these cases. METHODS: Retrospective study of cases in the Biobadaderm database. We analyzed the management of biologic therapy in patients with psoriasis who underwent surgical procedures. RESULTS: Forty-eight of the 2113 patients registered in Biobadaderm underwent surgery. The largest percentage of procedures (31%) involved skin lesions. Biologic treatment was interrupted in 42% of the cases. No postsurgical complications were significantly related to treatment interruption. Likewise we detected no associations between treatment interruption and other variables, such as sex, age, or duration or severity of psoriasis. CONCLUSION: Continuity of biologic treatment and the risk of postsurgical complications were not associated in this study, although conclusions are limited by the small sample size.

[A firm court resolution against malpractice in the treatment of obesity]. / Una sentencia firme contra la mala práctica en el tratamiento de la obesidad.

Inappropriate dietary treatments against obesity may worsen patients' metabolic and cardiovascular risk, lead to malnutrition, facilitate the appearance in predisposed individuals of eating disorders and ultimately favor the recovery of previously lost weight. Nonetheless, incorrect therapies aimed at reducing weight, sometimes accompanied by promises of miraculous results, are still rather frequent in our country. The public criticism by Drs. Monereo and Vazquez of a concrete method used by several very popular clinics in Madrid, resulted in the director of those centers suing them for libel. In this special article, we summarize the facts, analyze the methods used in those clinics and their likely negative consequences as well as sketch the content of the verdict of one of the trials, already concluded. Its main conclusions are the following: 1) Health education and the defense of public health is a professional duty; 2) The incorrect treatment of obesity can increase the risks associated with it; 3) There is a sufficient spanish and international consensus as well as Guidelines that clearly specifies the requisites of good medical practice with regard to obesity; 4) In spite of that, there are still treatments that constitute deception and fraud of different kinds and that respond more to business motivations rather than professional ones; 5) The fact of being sued as a result of activities that make part of a responsible behavior within an institution and whose purpose is the public benefit has entailed a serious, difficult and painful situation. We consider that the relevance and interest of the verdict warrants its diffusion because it constitutes a reference for professionals and may be decisive in the struggle against bad practices in obesity treatment.

Event-related potentials (ERPs) in ecstasy (MDMA) users during a visual oddball task.

Ecstasy is the common name for a drug mainly containing a substance identified as 3,4-methylenedioxymethamphetamine (MDMA). It has become popular with participants in "raves", because it enhances energy, endurance and sexual arousal, together with the widespread belief that MDMA is a safe drug [Byard, R.W., Gilbert, J., James, R., Lokan, R.J., 1998. Amphetamine derivative fatalities in South Australia. Is "ecstasy" the culprit? Am. J. Forensic Med. Pathol. 19, 261-265]. However, it is suggested that this drug causes a neurotoxicity to the serotonergic system that could lead to permanent physical and cognitive problems. In order to investigate this issue, and during an ERP recording with 32 channels, we used a visual oddball design, in which subjects (14 MDMA abusers and 14 paired normal controls) saw frequent stimuli (neutral faces) while they had to detect as quickly as possible rare stimuli with happy or fearful expression. At a behavioral level, MDMA users imply longer latencies than normal controls to detect rare stimuli. At the neurophysiological level, ERP data suggest as main result that the N200 component, which is involved in attention orienting associated to the detection of stimulus novelty (e.g. [Campanella, S., Gaspard, C., Debatisse, D., Bruyer, R., Crommelinck, M., Guerit, J.M., 2002. Discrimination of emotional facial expression in a visual oddball task: an ERP study. Biol. Psychol. 59, 171-186]), shows shorter latencies for fearful rare stimuli (as compared to happy ones), but only for normal controls. This absence of delay was interpreted as an attentional deficit due to MDMA consumption.

[Sublingual immunotherapy in seasonal allergic rhinitis. Review of 30 cases]. / Inmunoterapia sublingual en la rinitis alérgica estacional. Revisión de 30 pacientes.

INTRODUCTION: Specific immunotherapy consists in administering increasing doses of antigen, to which the patient is sensitive, to determine a protective immune response. PATIENTS AND METHODS: A descriptive and retrospective review of 30 patients diagnosed of seasonal allergic rhinitis, all treated with specific immunotherapy. Data on age, gender, symptoms, prick test before and after the immunotherapy administration, drugs, efficacy and side effects, were recorded using the SPSS statistical program. RESULTS: 90% had moderated symptoms and 10% had severe symptoms and asthma. 33% were sensitized to grass pollen. 60% needed antihistamines and intranasal corticosteroids before the immunotherapy. In a lot of cases (80%) there were no side effects. The complete desensitization occurred in 53.3% and the reduction of symptoms in 73% of the cases. 54% of the patients didn't need treatment after specific immunotherapy. CONCLUSIONS: The specific immunotherapy is the only curative therapy. Sublingual therapy is one of the most accepted because is well tolerated, it uses a higher allergen concentration, it reduces the symptoms and the needs of drugs and side effects are uncommon.

Human gender differences in an emotional visual oddball task: an event-related potentials study.

Pictures from the Ekman and Friesen series were used in an event-related potentials study to define the timing of occurrence of gender differences in the processing of positive (happy) and negative (fear) facial expressions. Ten male and 10 female volunteers were confronted with a visual oddball design, in which they had to detect, as quickly as possible, deviant happy or fearful faces amongst a train of standard stimuli (neutral faces). Behavioral results suggest that men and women detected fearful faces more quickly than happy ones. The main result is that the N2b component, functionally considered as an attentional orienting mechanism, was delayed in men for happy stimuli as compared with fearful ones. Gender differences observed in the processing of emotional stimuli could then originate at the attentional level of the information processing system.

[Nutritional value of the diet in healthy pregnant women. Results of a nutrition survey of pregnant women]. / Valor nutricional de la dieta en embarazadas sanas. Resultados de una encuesta dietética en gestantes.

GOAL: The purpose of the present paper is to describe the level of nutritional adequacy of the regular diet of pregnant women belonging to our health-care area. SCOPE: Health-care area of Valme Hospital, Seville. DESIGN: Randomized transversal descriptive study. SUBJECTS: Forty-nine pregnant women during their first trimester. INTERVENTIONS: The daily intake was assessed by means of a 24-hour reminder sheet and a weekly consumption survey. The data obtained were compared with the recommended daily intake of nutrients and with the recommended daily allowances for various foods. At the same time, an anthropometric and basic analysis were also carried out. RESULTS: The calorie intake was as recommended (2,208 +/- 475 kcal/day). The diet contained excessive amounts of proteins (88 +/- 21 g/day) and fat (97 +/- 27 g/day), with a predominance of monounsaturated fats (46.9 +/- 5.5%) over saturated (36.6 +/- 7.2%) or polyunsaturated fats (15.1 +/- 7%), (p < 0.0005). Nonetheless, the diet was short on carbohydrates (44%), fibre (18 +/- 4.9 g/day), calcium (948 +/- 353 mg/day), iron (13.4 +/- 3.1 mg/day) and vitamin B6 (1.1 +/- 0.8 mg/day) (p < 0.0005), and extremely short on folic acid (172 +/- 101 micrograms/day), (p < 0.0005). In the assessment of the diet in terms of daily allowances, this was sufficient in fruit (2.3 +/- 1.8/day), but short on dairy products (1.9 +/- 1.1/day) and extremely short on vegetables (1 +/- 0.4/day), (p < 0.0005). Only 2% of the subjects fulfilled with the recommended daily intake for key vitamins and minerals. The prevalence of obesity (BMI > 30 kg/m2) was 18.4%. CONCLUSIONS: The normal diet of pregnant women in our health-care area is short on calcium, iron, folic acid and dietary fibre, although with an excess of animal protein and fat.

[Artificial nutrition in the home. Annual information 1996.Group NADYA-SENPE]. / Nutrición artificial domiciliaria. Informe Anual 1996. Grupo NADYA-SENPE.

Using a simplified questionnaire from the NADYA group, data referring to age, sex, diagnosis, access route, duration, form of administration, complications, and quality of life have been gathered from 1,400 patients (57% male, 43% female) who receive home enteral nutrition, and from 38 patients (20% male and 18% female) who receive home parenteral nutrition. All of these patients come from the 1996 national registry. The most common indication for home enteral nutrition are neoplasias (39%) followed by neurological alterations (33%). The most common access route is oral (48%), followed by a nasogastric tube in 34%, PEG in 10% and surgical ostomies in 7%. The average treatment duration is 6 months. There is an index of 0.74 complications/patient-year (gastrointestinal 0.28 and mechanical alterations 0.19). At the end of the year 58% of the patients continued to use at home enteral nutrition, with a death rate of 17%. The majority of the treated patients presented a severe social disability (28%) or was bed-ridden (22%). The most common indications for home parenteral nutrition are: neoplasia (42%), Crohn_s disease (10%), and mesenteric ischemia (10%). AIDS (8%), radical enteritis (5%), and motility disorders (5%) are less common. In 42% of the cases tunneled catheters are used, and port-a-cath are used in 53%. The average treatment duration is 6.9 months. 1.06 hospitalizations/patient-year have been registered in relation to the nutritional treatment (mainly catheter sepsis). A mortality of 29% is registered, and there is recovery of the oral route in 7.9% of the cases. 50% of the patients present a severe social disability.

Myocardial perfusion scintigraphy using Tc99m labelled compounds: correlations with coronary angiography.

The increasing incidence of ischaemic heart disease with high mortality rate and the recent introduction of Tc99m labelled myocardial perfusion imaging agents, along with the advent of a Coronary Angiography programme in Trinidad and Tobago, prompted the comparison of the sensitivity and specificity of myocardial perfusion scintigraphy (MPS) with coronary angiography (CA). Using a standard one-day code-differential imaging protocol Single Photon Emission Computed Tomography (SPECT), images of the left ventricular myocardium of 30 patients were obtained at rest and following exercise: These images were analyzed for perfusion defects to assess each of the three main coronary arteries; the left anterior descending artery (LAD), the right coronary artery (RCA) and the left circumflex artery (LCx). The data were then correlated with the angiographic findings. MPS yielded an overall sensitivity of 97.5% and a specificity of 83.6% when compared to CA. Discordant data were obtained in the analysis of nine vascular territories with scintigraphy producing eight false positives and one false negative. The false positive cases were seen in two males and four females. Of the males, one was discovered to have intramyocardial tunnelling of the LAD artery and the other demonstrated differential perfusion between the LAD and LCx arteries. Of the females, one was classified as having Syndrome X and another demonstrated differential perfusion between the LAD and LCx arteries; the other two cases were attributed to breast attenuation. The one false negative was obtained in a patient who demonstrated good collateral circulation on angiography. MPS thus compares very well with CA in assessing the three main myocardial vascular territories.

[Role of the primary care physician in the diagnosis and treatment of thyroid diseases]. / Papel del médico de atención primaria en el diagnóstico y seguimiento de la patología tiroidea.

OBJECTIVE: To determine the participation of the primary care physician in the diagnosis and follow-up of thyroid pathology. DESIGN: A descriptive study of a crossover type. SETTING: The Isabel II Health centre at Parla (Madrid). PATIENTS: All those diagnosed with thyroid pathology registered with the two primary care teams at the Isabel II Health Centre up to august 1992. Data were obtained from the morbidity records and the District's Endocrinology Clinic. MAIN RESULTS: 196 patients, with 250 diagnoses overall, were located. The main ones were: hypothyroidism (27.6%), normally functioning goitres (24.4%) and hyperthyroidism (23.2%). The general practitioner was aware of the illness in 87% of cases, as against the specialist in 97%. The provisional diagnosis was carried out at the primary care level in 56% of cases; the final one only in 18%. With respect to patients' subsequent treatment, it was exclusively specialist in 72% of cases and joint in 19%. CONCLUSIONS: The primary care doctor is aware of the majority of his/her patients' thyroid illnesses, but not all. We recommend greater participation of primary care in the initial diagnostic approach to these conditions; and, in particular, a closer involvement in the treatment of these pathologies, which requires that the primary care doctor must have access to precise diagnostic methods.

One year treatment with clonidine in children with constitutional growth delay.

The therapeutic potential of clonidine was evaluated in 112 prepubertal children with short stature, delayed bone age and a growth velocity of 4.1 +/- 0.4 cm/yr in boys and 4.2 +/- 0.5 cm/yr in girls. The alpha 2 agonist was orally administered at 0.075 mg/m2 to 51 boys and 39 girls over a period of at least one year, and the effect compared to a vitamin treatment given to 10 age matched boys and 12 age matched females showing similar growth velocities. After one year of treatment growth velocity was increased to 6.6 +/- 1.2 cm/yr in boys and 6.50 +/- 1.0 cm/yr in girls treated with the drug, whereas in those given vitamins only 4.9 +/- 0.7 cm/yr in boys and 5 +/- 0.6 cm/yr in girls was recorded. Bone age remained 1.5 +/- 0.3 yr behind chronological age in both vitamin and clonidine treated groups. If only the 65% of patients that show a growth velocity increment of more than 2 cm/yr are considered the growth velocity reaches 7.20 +/- 0.82 cm/yr in boys and 6.68 +/- 0.75 cm/yr in girls, indicating that clonidine may be a useful pharmacological agent in the treatment of some patients with constitutional growth delay. The remaining 35% patients do not show any significant increase in growth velocity.

Myocardial perfusion scintigraphy using Tc99m labelled compounds: correlation with coronary angiography

The increasing incidence of ischaemic heart disease with high mortality rate and the recent introduction of Tc99m labelled myocardial perfusion imaging agents, along with the advent of a coronary angiography programme in Trinidad and Tobago, prompted the comparison of the sensitivity and specificity of myocardial perfusion scintigraphy (MPS) with coronary angiography (CA). Using a standard one-day code-differential imaging protocol single photon emission computed tomography (SPECT), images of the left ventricular myocardium of 30 patients were obtained at rest and following exercise: These images were analyzed for perfusion defects to assess each of the three main coronary arteries; the left anterior descenting artery (LAD), the right coronary artery (RCA) and the left circumflex artery (LCx). The data were then correlated with the angiographic findings. MPS yielded an overall sensitivity of 97.5 percent and a specificity of 83.6 percent when compared to CA. Discordant data were obtained in the analysis of nine vascular territories with scintigraphy producing eight false positive and one false negative. The false positive cases were seen in two males and four females. Of the males, one was discovered to have intramyocardial tunnelling of the LAD artery and the other demonstrated differential perfusion between the LAD and LCx arteries. Of the females, one was classified as having Syndrome X and another demonstrated differential perfusion between the LAD and LCx arteries; the other two cases were attributed to breast attenuation. The one false negative was obtained in a patient who demonstrated good collateral circulation on angiography. MPS thus compares very well with CA in assessing the three main myocardial vascular territories