Bergamo, Italy
Bergamo, Italy

The Mario Negri Institute for Pharmacological Research is a nonprofit research institute dedicated to clinical and biomedical research. It was made possible by a special bequest of Milan philanthropist it:Mario Negri . It was founded in 1961 although it started working in Milan from 1st Feb 1963. There are branches of the institute in Bergamo, Ranica , and at Santa Maria Imbaro, near Chieti.Founder and director from 1961 is prof. it:Silvio Garattini. Wikipedia.

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Pandolfini C.,Mario Negri Institute | Kaguelidou F.,University Paris Diderot | Sequi M.,Mario Negri Institute | Jacqz-Aigrain E.,University Paris Diderot | And 4 more authors.
European Journal of Clinical Pharmacology | Year: 2013

Purpose: To describe the use of ciprofloxacin and fluconazole for the treatment of sepsis in European neonatal intensive care units (NICUs) in order to better orient research aimed at acquiring essential knowledge in this critical area. Methods: The survey consisted of an online questionnaire for all participating NICUs on treatment schemes employed, rationales behind drug choices and interest in participation in research involving the two drugs. Results: A total of 189 level II and III NICUs participated in the survey, representing 25 countries, with Italy, UK and France providing the greatest number of centres (54 % of total). Ciprofloxacin is used in 25 % of NICUs that responded, although the indications for administering it vary between centres and the dosage ranges vary considerably, with 25 % of NICUs giving ≤10 mg/kg/day and another 25 % giving ≥21 mg/kg/day. Factors given as affecting the decision to use ciprofloxacin are uncertainty about its safety and pharmacokinetics and level of penetration in the cerebrospinal fluid. Among the 70 % of responding units that use fluconazole to treat fungal infection, 45 % administer 6 mg/kg unit doses while 33 % administer 12 mg/kg; 41 % of NICUs use a 24-h interval between administrations while 20 % wait 72 h. Among the responding NICUs, 57 % were willing to participate in a project on ciprofloxacin and 59 % would consider participating in a randomized controlled trial evaluating fluconazole versus micafungin. Conclusions: Great variability in therapies exists within and between countries. Numerous centres are interested in participating in research on these drugs, highlighting the need for further knowledge on sepsis treatment and European centres' interest in off-patent medicine research. © 2012 The Author(s).

Scarfone G.,Gynecology and Neonatology | Bergamini A.,University of Milan | Noli S.,Gynecology and Neonatology | Villa A.,Gynecology and Neonatology | And 6 more authors.
Gynecologic Oncology | Year: 2014

Objective Endometrioid and clear cell ovarian tumors have been referred to as "endometriosis associated ovarian cancers". However, very few studies have compared clinical and prognostic features of endometriosis- associated cancers or cancers not associated with endometriosis according to specific histotypes. We have investigated clinical and histological features of the largest published series of clear cell ovarian cancers arising in endometriosis using a retrospective database. Methods Seventy three patients with a primary diagnosis of either pure clear cell ovarian cancer and mixed endometrioid-clear cell ovarian cancer have been divided into two groups according to the detection of cancer strictly arising from ovarian endometriosis or not (n = 27 and n = 46, respectively). Clinical and pathological data have been compared. Results Patients with clear cell carcinomas arising from endometriosis tend to be significantly younger (51.4 ± 10.0 and 58.4 ± 11.2 years, p = 0.02). FIGO stage, laterality, prevalence of pure versus mixed histology, and presence of synchronous endometrial carcinoma were not significantly different between the two groups. Unilateral ovarian involvement was more frequent in cases arising in endometriosis (85% vs 63%, p = 0.04). Ascites was not found in any of the endometriosis-associated cancer cases vs 19.5% in patients without endometriosis. The presence of endometriosis did not affect 5-year overall survival rates. Conclusions Endometriosis per se does not appear to be associated with a lower stage tumor or to predict prognosis in ovarian clear cell cancers. Unilateral involvement and reduced presence of ascites may be linked to the cystic nature of endometriosis which frequently presents as monolateral and in which associated tumors are more likely to be longer confined to the ovary before spreading. © 2014 Elsevier Inc.

Bianchi M.,Mario Negri Institute | Clavenna A.,Mario Negri Institute | Bonati M.,Mario Negri Institute
European Journal of Clinical Pharmacology | Year: 2010

Objective: The objective of this study was to analyse inter-and intra-country quantitative and qualitative differences in anti-asthmatic prescriptions to children and adolescents. Methods: A literature search was performed in EMBASE and MEDLINE to identify pharmaco-epidemiological studies published from January 1, 2000 to December 31, 2008 in which anti-asthmatic prescription prevalence in out-hospital children was measured. A meta-analytic weighted average and 95% confidence intervals of prescription prevalences were calculated using a random-effect(s) model. Inter- and intra-country quantitative and, where possible, qualitative prescribing patterns were compared and assessed. Results: Twelve studies were identified (ten from Europe, one from Canada and one from the USA), but epidemiological indicators varied widely, and only eight were suitable for meta-analysis. The data from these studies revealed inter-country quantitative differences in prescription prevalences in the overall population ≤19 years, with Italy having a prescription prevalence of 19.0%, Canada, 18.0%, USA, 14.6%, Denmark, 13.9%, Norway, 9.1% and the Netherlands, 6.2%. The overall prevalence was 13.3%. The analysis of qualitative inter-country differences revealed that, except for Italy, inhalatory short-acting β-agonists were the most prescribed, followed by inhalatory corticosteroids. Conclusions: This first overall analysis of anti-asthmatic utilization studies in out-of-hospital children indicates a wide variability in anti-asthmatic prescription prevalence. It also reveals that epidemiological evaluations should be improved by using homogeneous indicators and, in order to validate the use of anti-asthmatic prescription as a proxy of disease, the diagnosis of asthma should accompany the data of prescriptions within the same population. © 2010 Springer-Verlag.

Erba G.,University of Rochester | Giussani G.,Mario Negri Institute | Juersivich A.,University of Rochester | Magaudda A.,Messina University | And 6 more authors.
Epilepsia | Year: 2016

Objective To investigate if, when, and to what extent visual information contained in a video-recorded event allows experienced epileptologists to predict the diagnosis of psychogenic nonepileptic seizures (PNES) without the aid of electroencephalography (EEG). Methods Five neurologists actively practicing in epilepsy centers in Italy and the United States were asked to review 23 videos capturing representative events of 21 unselected consecutive patients admitted for long-term video-EEG monitoring (VEM). Four raters were blind to EEG and clinical information; one rater was not. They were requested to (1) rate the videos for quality and content; (2) choose among four diagnoses: (a) epileptic seizures (ES); (b) PNES; (c) Other nonepileptic seizures (NES; (syncope, movement disorder, migraine, etc.); (d) "Cannot Say"; and (3) explain in their own words the main reasons leading to the diagnosis of choice. Results All raters predicted the diagnosis correctly in 7 of 23 videos (all ES or PNES) (30.4%), whereas all raters failed in 5 of 23 cases (three Other NES, one PNES, one Cannot Say) (21.7%). The conditions that facilitate, and those that interfere with, a confident diagnosis were predictable. Degree of accuracy among raters was not uniform and was consistently better in three raters. Two among the four blind raters were as accurate as the rater who was not blinded. Interrater agreement was "moderate" (k = 0.52) for the overall group; "moderate" for ES (k = 0.53); "substantial" for PNES (k = 0.63); "fair" for Other NES (k = 0.21) - similar to the results obtained in a previous study evaluating the reliability of combined video-EEG. Significance In about one third of cases, a confident diagnosis of PNES/ES can be established on clinical grounds based on video data alone. Our results benefit all affected patients, particularly those with no access to video-EEG monitoring units. © 2016 International League Against Epilepsy.

Bianchi M.,Mario Negri Institute | Clavenna A.,Mario Negri Institute | Sequi M.,Mario Negri Institute | Bortolotti A.,Regional Health Ministry | And 3 more authors.
BMC Pulmonary Medicine | Year: 2011

Background: Although anti-asthma medications are amongst those most frequently under or over prescribed it is generally accepted that prescriptions for such agents can be used as a proxy for disease prevalence. The aims of this study were to estimate prevalence and incidence of childhood asthma in a representative Italian area by analysing three years of anti-asthmatic prescriptions and hospitalizations of subjects with chronic or first time treatment, and to underline appropriateness of therapeutic choices.Methods: The analysis involved prescriptions given to 6-17 year olds between 2003 and 2005 in Italy's Lombardy Region. The youths were classified as potential asthmatics, based on the different degree of drug utilization: occasional, low or high users, and grouped as 'new onset' or 'chronic' cases based on the duration of therapy dispensed. The analysis of prescriptions and hospitalization rate of these groups provided an estimate of the 2005 asthma prevalence and incidence and allowed an estimation of the level of appropriateness of treatments.Results: During 2005, the estimated incidence of potential asthmatics was 0.8% and the estimated prevalence was 3.5%. When viewed retrospectively for two years, records showed that 47% of potential asthmatics received prescriptions also during 2004 and 30% also during 2003. During the three years considered, 7.5%, 2.8%, and 1.5% of high, low, and occasional users, respectively, were hospitalized for asthma. The most important inappropriateness found was the prescription of long acting beta adrenergics as first time treatment.Conclusions: This study allowed a proxy of asthma incidence, prevalence, and severity. The analyses highlighted a low compliance with the guidelines, suggesting that educational interventions are needed to obtain a more rational management of childhood asthma, especially in subjects starting therapy. © 2011 Bianchi et al; licensee BioMed Central Ltd.

Ricci E.,University of Milan | Cipriani S.,University of Milan | Chiaffarino F.,University of Milan | Malvezzi M.,Mario Negri Institute | Parazzini F.,University of Milan
Journal of Women's Health | Year: 2010

Background: Several randomized controlled trials (RCTs) have compared the effect of phytoestrogens (PEs) vs. placebos on bone density after menopause, with inconsistent results. Methods: We performed a systematic review to assess the overall effect of PEs on bone mineral density (BMD) in menopausal Western women. We searched for all RCTs comparing PEs with placebos conducted on perimenopausal or postmenopausal Western women, published from January 1990 to February 2010. The main outcome measure was the lumbar spine (LS) BMD. Results: We identified 17 studies on soy isoflavone (IFs) bone-sparing effects. Some studies did not report a difference between treated and untreated women, whereas others supported a significant role of IFs on slowing bone loss, although these studies suffered from an internal lack of consistency, as a positive effect emerged in some bone districts but not in others. Data on LS BMD were available in 12 studies including 1433 subjects overall. The effect of PEs on BMD (mg/cm2) was not statistically significant (mean difference 9.86?mg/cm2, 95% confidence interval [CI] -2.64-22.36) under a random-effects model. Excluding the genistein study, however, analyses of IF mixtures did not show a bone-sparing effect (0.73, 95% CI -2.79-4.25). No increasing effect emerged when dose and treatment duration were increased. Conclusions: Our review and meta-analysis suggest that IF mixtures are not effective in decreasing bone loss in perimenopausal and postmenopausal Western women. The role of isolated genistein and individual genetic capacity to metabolize IFs is still open to evaluation. © 2010, Mary Ann Liebert, Inc.

Bianchi M.,Mario Negri Institute | Clavenna A.,Mario Negri Institute | Sequi M.,Mario Negri Institute | Bortolotti A.,Regional Health Ministry | And 3 more authors.
Respiratory Medicine | Year: 2012

Aim: To estimate how many asthmatic children underwent spirometry testing in one year in a large Italian region, and evaluate sociodemographic determinants. Methods: Data were retrieved from the administrative databases that store all pharmacological and diagnostic prescriptions issued to individuals living in the Lombardy Region. The analysis involved prescriptions dispensed to all 6-17 year olds (1,047,241 subjects) during 2008. Youths were identified as asthmatics by a previously validated strategy. Number of subjects having ≥1 spirometry claims was calculated, and factors associated with the probability of undergoing spirometry were evaluated by multivariate analysis. Results: A total of 40,528 (3.9%) asthmatic subjects were identified. Only 30% of them underwent ≥1 spirometry during 2008, with differences between local health units (range 22-45%) and degree of anti-asthmatic use (26-35%). Moreover, in a multivariate analysis, the chance of undergoing spirometry was greater in boys than in girls (OR = 2.3). Conclusions: A low percentage of asthmatic children, especially girls (who are more at risk of developing severe disease in adulthood), underwent spirometry during 1-year period. This highlights a low compliance with guidelines in the monitoring of childhood asthma. Educational intervention is needed in order to encourage use of spirometry in primary care settings. © 2012 Elsevier Ltd. All rights reserved.

Kaguelidou F.,APHP | Pandolfini C.,Mario Negri Institute | Manzoni P.,Neonatology and Hospital Neonatal Intensive Care Unit | Choonara I.,University of Nottingham | And 2 more authors.
European Journal of Pediatrics | Year: 2012

Neonatal fungal infections are associated with substantial mortality and morbidity. Although prophylactic use of several antifungals has been proposed, this practice remains controversial. In order to evaluate the use of fluconazole prophylaxis in European NICUs, we conducted a cross-sectional survey by means of a structured questionnaire that was sent to European level II and III neonatal intensive care units, over a 9-month period, as part of a neonatal research FP7 European project. A total of 193 questionnaires from 28 countries were analysed. Use of antifungal prophylaxis was reported by 55% of the responders, and the most frequently used antifungal agent was fluconazole (92%). Main indications for prophylaxis were low gestational age (<28 weeks) and birth weight (<1,000 g). A dose of 3 mg/kg was used in 66% of NICUs using fluconazole, with an administration interval of 72 h in 52% of them. All responders acknowledged the need for additional trials on the efficacy of prophylactic fluconazole. Non-users of fluconazole prophylaxis were more likely to be influenced by the local incidence of candidiasis, the risk of increasing antifungal resistance and the absence of specific recommendations by paediatric societies. Conclusions: Major concerns about the use of fluconazole prophylaxis include its efficacy, the risk of emergence of resistant species and the absence of clear consensus to support routine use. Future studies that address these issues will contribute to a more rational use of fluconazole prophylaxis. © Springer-Verlag 2011.

Didoni A.,Mario Negri Institute | Sequi M.,Mario Negri Institute | Panei P.,National Health Research Institute | Bonati M.,Mario Negri Institute
European Journal of Clinical Pharmacology | Year: 2011

Objectives: To delineate the safety and tolerability profile of methylphenidate and atomoxetine in children and adolescents with attention deficit hyperactivity disorder (ADHD) monitored for more than 1 year. Design: A cohort study analyzing data from the national ADHD register on patients from the Lombardy Region treated with MPH or atomoxetine. Participants: A total of 229 children (median age 11 years, range 6-17), enrolled in 15 regional centers between June 2007 and May 2010. Results: The prevalence rate of pharmacological treatment for ADHD was 0.23%, whereas the estimated ADHD prevalence in the population was 0.95%. In total, 73.8% of patients had been treated with atomoxetine (10-90 mg daily) or MPH (10-75 mg daily); 22% of patients also received an additional psychotropic drug. Of the treated children, 26.9% discontinued the drug prior to 1 year of treatment, mostly because of adverse effects (28.6%). No new or unexpected adverse events (rate 39.2%) were encountered. Decreased appetite, headache, and unstable mood were the leading events. The most severe events occurred in two boys: one experienced absence seizures for the first time with MPH, the other experienced hallucinations with atomoxetine. Therapy was discontinued in ten male patients (7.7%) because of adverse events. All patients with adverse effects recovered well. Conclusions: A very low rate of ADHD prevalence was estimated in Italian children compared to that reported in other countries. Although the medications for ADHD are generally well tolerated, with only mild or minor adverse effects in most cases, their rational use can only be guaranteed by disseminating and monitoring evidence-based practices and by monitoring the safety and efficacy of treatments in both the short and long terms with appropriate tools and approaches. © 2011 Springer-Verlag.

Salvati E.,Regina Elena Cancer Institute | Scarsella M.,Regina Elena Cancer Institute | Porru M.,Regina Elena Cancer Institute | Rizzo A.,Regina Elena Cancer Institute | And 11 more authors.
Oncogene | Year: 2010

New anti-telomere strategies represent important goals for the development of selective cancer therapies. In this study, we reported that uncapped telomeres, resulting from pharmacological stabilization of quadruplex DNA by RHPS4 (3,11-difluoro-6,8,13-trimethyl-8H-quino[4,3,2-kl]acridinium methosulfate), trigger specific recruitment and activation of poly-adenosine diphosphate (ADP) ribose polymerase I (PARP1) at the telomeres, forming several ADP-ribose polymers that co-localize with the telomeric repeat binding factor 1 protein and are inhibited by selective PARP(s) inhibitors or PARP1-specific small interfering RNAs. The knockdown of PARP1 prevents repairing of RHPS4-induced telomere DNA breaks, leading to increases in chromosome abnormalities and eventually to the inhibition of tumor cell growth both in vitro and in xenografts. More interestingly, the integration of a TOPO1 inhibitor on the combination treatment proved to have a high therapeutic efficacy ensuing a complete regression of the tumor as well as a significant increase in overall survival and cure of mice even when treatments started at a very late stage of tumor growth. Overall, this work reveals the unexplored link between the PARP1 and G-quadruplex ligands and demonstrates the excellent efficacy of a multi-component strategy based on the use of PARP inhibitors in telomere-based therapy. © 2010 Macmillan Publishers Limited All rights reserved.

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