Open-label trial on efficacy and security of treatment with gemcitabine and oral modulation with tegafur and levofolinic acid (GEMTG) in patients with advanced pancreatic cancer

AIM: Advanced pancreatic cancer has a bad prognosis, with a median overall survival (OS) no longer than 4-6 months. Since the end of last century, monotherapy with gemcitabine has remained the elective therapy, but new schedules are needed in order to improve these results. We aim to evaluate the efficacy of tegafur and levofolinic acid (LV) associated with gemcitabine, as well as its toxicity, progression-free survival and OS in advanced pancreatic cancer. PATIENTS AND METHODS: An open-label, multicentric, prospective, non-controlled trial was carried out on patients with advanced or disseminated pancreatic cancer. Gemcitabine 1250 mg/m² was administered on the 1st and 8th days of the cycle, tegafur 750 mg/m²/day for 21 consecutive days and LV 25 mg/day continuously, every 28 days, with a maximum of six cycles. The primary variable was tumour overall response rate (ORR). Secondarily, time to progression (TTP), OS and scheme toxicity were determined. RESULTS: Forty patients were recruited; the male/female ratio was 30:10, with a mean age of 61 years. Forty percent had a Karnofsky index of 90% or 100%. Only 11 patients (27%) completed the six cycles of treatment, but more than 50% received three or more cycles. Dose intensity was 89.56% for gemcitabine and 87.36% for tegafur. Efficacy ORR was 22.5% (CI 95%, 6-37%). TTP was 3.87 months (CI 95%, 2.1-5.6), time to treatment failure was 2.97 months (CI 95%, 2.43-4.67) and OS 6.3 months (CI 95%, 4-7). The chemotherapeutic combination was well accepted; most haematologic and non-haematologic toxicities were grade 1 or 2. The most prevalent grade 3/4 toxicities were asthenia (30%), liver biochemistry disorders (25%), diarrhoea (15%) and stomatitis (12%). CONCLUSIONS: The administration of gemcitabine, associated with oral tegafur and leucovorin, has activity against advanced pancreatic cancer, with an adequate toxicity profile (AU)

Effectiveness of virosomal subunit influenza vaccine in preventing influenza-related illnesses and its social and economic consequences in children aged 3-14 years: a prospective cohort study.

To evaluate the effectiveness of a virosomal subunit influenza vaccine in preventing influenza-related illnesses and its social and economic consequences in children aged 3-14 years, a prospective cohort study was carried out during the 2004-2005 influenza season in 11 private pediatric clinics in the Barcelona metropolitan area. One dose of a virosomal subunit inactivated influenza vaccine (Inflexal V Berna) was given during September and October 2004 to healthy children aged 3-14 years attended in 5 of the 11 clinics. Who comprised the vaccinated cohort (n=966). The non-vaccinated cohort (n=985) was comprised of children attended in the other six clinics. Informed consent was obtained from all parents. The follow up was performed between 1 November 2004 and 31 March 2005. Using a self-administered questionnaire, information was collected from parents or guardians on any type of acute, febrile respiratory illness suffered by their children during the study period, including antibiotic use, and absence from school or work-loss of parents as a result of the illness. RT-PCR (influenza A+B+C) was carried out on pharyngeal and nasal samples obtained from children attended by pediatricians during this period in these clinics with the following symptoms: fever> or =38.5 degrees lasting at least 72h, cough or sore throat (influenza-like illness). Adjusted vaccination effectiveness was 58.6% (95% CI 49.2-66.3) in preventing acute febrile respiratory illnesses, 75.1% (95% CI 61.0-84.1) in preventing cases of influenza-like illnesses and 88.4% (95% CI 49.2-97.3) in preventing laboratory-confirmed cases of influenza A. The adjusted vaccination effectiveness in reducing antibiotic use (18.6%, 95% CI -4.2 to 3.64), absence from school (57.8%, 95% CI 47.9-65.9) and work-loss of parents (33.3%, 95% CI 8.9-51.2) in children affected by an acute febrile respiratory illness was somewhat lower. Vaccination of children aged 3-14 years in pediatric practices with one dose of virosomal subunit inactivated influenza vaccine has the potential to considerably reduce the health and social burdens caused by influenza-related illnesses.

Delavirdine in combination with zidovudine in treatment of human immunodeficiency virus type 1-infected patients: evaluation of efficacy and emergence of viral resistance in a randomized, comparative phase III trial. The M/3331/0013B Study Group.

We compared the activity of delavirdine (DLV) plus zidovudine (AZT) (n = 300) with that of AZT (n = 297) against human immunodeficiency virus type 1 in a randomized, double-blind, placebo-controlled trial. DLV exerted a transient antiviral effect, and mutations for resistance to DLV were found in more than 90% of subjects at week 12. The K103N mutation, which confers nonnucleoside reverse transcriptase inhibitor cross-resistance, was found in 85% of the patients.

[The pediatric prescription according to its origin and the motive for the consultation in a basic rural health area]. / Prescripción pediátrica según origen y motivo de consulta en un área básica de salud rural.

OBJECTIVE: To describe the paediatric prescription in a rural health district in terms of the origin and reason for consultation. DESIGN: Cross-sectional descriptive study. SETTING: Garraf Rural Health District, Barcelona. PARTICIPANTS: The 3 basic care paediatrics units in the district. MEASUREMENTS AND MAIN RESULTS: 1068 attendances of children of both sexes under 15 were collected. Recorded on each visit to the paediatrics clinic were: age, sex, reason for consultation (RC), and, if medicine was given, the product prescribed and the origin of the prescription. The number of children receiving treatment increased progressively with age. 87% +/- 2.8% of prescriptions originated with the paediatrician. Therapeutic groups of respiratory apparatus and systemic anti-infection drugs accounted for 69% +/- 2.9% of all prescriptions. Only 2.3% +/- 0.5% had fixed-dose associations. The most common RC was upper-tract respiratory infection, mainly treated with a single therapy (76.6% +/- 6.1%). In the case of the second most common RC, acute bronchitis, 94.6% +/- 4.2% of all cases received drugs treatment with single therapy or two simultaneous treatments. Acute tonsillitis was mainly treated with antibiotics (86.4% +/- 6.6%). CONCLUSIONS: The frequencies of the pathology groups detected in the Health District correlate with other studies' findings. Analysis of the origin of prescriptions shows the high decision-making capacity of the Health District's paediatricians. The pharmacological profile employed is good, though it could be improved.

[Lesions of the laryngotracheal axis due to prolonged intubation and/or tracheotomy. Preliminary data of a follow-up guidelines]. / Lesiones del eje laringotraqueal por intubación prolongada y/o traqueotomía. Datos preliminares de un protocolo de seguimiento.

Lesions caused by prolonged intubation and tracheostomy when performed in critically ill patients to keep the airways opened are a permanent topic of discussion between intensive care professionals and otolaryngologists. We present a prospective study of such complications following the guidelines elaborated by the intensive care unit and the otolaryngology department of our hospital. The outcomes obtained in the first-year follow up allow us to verify a high incidence of such lesions in the initial period (87%) and a markedly decreased frequency in the following twelve months (17%). Results also show the relation between prolonged intubation and the appearance of laryngotracheal lesions. We conclude that it is very important to reduce the intubation period by performing an earlier tracheostomy.

[Candidiasis in an intensive care unit]. / Estudio de candidosis en un servicio de medicina intensiva.

The risk of being infected by candidiasis in an Intensive Care Unit (ICU) is evaluated, using an algorithm which allows the establishment of an early fungicidal treatment. This is a study which includes 34 patients with a mortality of 35%. Yeasts are detected from the second week at ICU, related with the long stay of patients at ICU and the relationship between mortality and age. The first positive sample usually does not indicate disseminate candidiasis (9%) or a positive blood culture (6%). Population defined as high risk for disseminated candidiasis (HRDC) with a negative blood culture has the worst prognosis (18 cases, 50% mortality rate). The six cases with HRDC with positive blood culture showed a mortality of 17%. In seven cases there were no HRDC criteria (mortality of 14%). With said study the existence or not of a HRDC could be determined, establishing the adequate antifungal treatment.

[Cerebral malaria and multiple organ failure. A case report]. / Paludismo cerebral y fallo multiorgánico. Presentación de un caso.

It is discussed the case of cerebral paludism due to Plasmodium falciparum in a patient who travelled frequently to Ivory Coast and who had done an incorrect prophylaxis of paludism. It is underlined the relationship of cerebral presentation with the presence of multisystemic failure, which was characterized by respiratory distress, hyperdynamic shock, acute renal failure and hematological and digestive disorders. Shock forced the administration of vasoactive drugs (such as dopamine, dobutamine and methoxamine), respiratory failure to establish mechanical ventilation and coagulation disorders to transfuse platelets and plasma. Clinical evolution was favorable in few days thanks to an early symptomatic and etiology therapy.

[Acute lithium poisoning. Treatment with continuous arteriovenous hemofiltration. Apropos of a case]. / Intoxicación aguda por litio. Tratamiento con hemofiltración arteriovenosa continua. A propósito de un caso.

We report a suicide attempt with lithium, chlorpromazine and flunitrazepam. In case of intoxication, renal excretion of lithium can be facilitated with forced diuresis by the administration of large volumes of saline solution, peritoneal dialysis or hemodialysis. In the case of our patient, treatment with saline solution was not effective, so continuous arteriovenous hemofiltration (CAVH) was performed achieving a decrease in serum lithium and obtaining a prompt clinical improvement. No secondary effects or serum lithium rebound effect were observed. We have not found any previous record of the use of CAVH in the treatment of acute lithium intoxication.

[Acute hypertension and sustained arterial hypertension after unilateral intracranial lesion or section of the glossopharyngeus (author's transl)]. / Crisis hipertensiva e hipertensión arterial mantenida tras sección o lesión unilateral intracraneal del glosofaríngeo.

Some inflammatory processes of the 9th cranial nerve may provoke disturbances of the autonomic nervous system, with parasympathetic irritation. A unilateral intracranial lesion or section of the glossopharyngeus may produce adverse reactions such as sinus tachycardia and transitory hypertension, due to a cut-off in physiological feedback. The two cases presented developed acute hypertension after either lesion or section of the 9th cranial nerve. In one case the hypertension was of a few days duration only, while the second was rather unusual in that it was sustained over a four-month period. The physiopathologic mechanisms are described as well as the favorable response to treatment with drugs. The hypothesis that arterial hypertension is caused by an over-stimulation of the beta-adrenergic system, in particular in its effect on cardiac output is, at least in part, supported by the favorable response to propranolol. In order to either confirm or discard this hypothesis, the measurement of cardiac output in successive patients after lesion or section of the glossopharyngeus is considered to be of special interest.