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Abdolrahimzadeh S.,Azienda Policlinico Umberto i | Recupero S.M.,SantAndrea Hospital
Drugs of Today | Year: 2014

Advanced biotechnological techniques and new polymers have led to the development of many innovative intravitreal drug delivery systems. Some designs are still in an experimental phase while others have gained widespread acceptance and are commercially available. Since steroids are a mainstay of therapy for uveitis and macular edema, new intravitreal implants have been developed to provide continuous release of corticosteroids over prolonged spans of time with reduced systemic adverse effects. Today, three long-acting corticosteroid implants are commercially available: the fluocinolone acetonide implants Retisert® and Iluvien® and the dexamethasone drug delivery system Ozurdex®. They offer an alternative route in the management of macular edema due to uveitis, retinal vein occlusion, diabetes and pseudophakia. Their advantage over treatment with steroid injections and the anti-vascular endothelial growth factor ranibizumab is the long-term control of inflammation and macular edema with a reduced frequency of administration. Their potential side effects are cataract and glaucoma, therefore, careful patient selection and monitoring is essential. Further studies are warranted to define the relative efficacy and indications for each treatment option. The development of new devices is a future challenge in the strive to improve drug delivery systems. © 2014 Prous Science, S.A.U. or its licensors. All rights reserved.


Wirth M.,University Clinic Carl Gustav Carus | Tammela T.,University of Tampere | Cicalese V.,Azienda Ospedaliera S. Giuseppe Moscati | Gomez Veiga F.,University of La Coruña | And 10 more authors.
European Urology | Year: 2015

Background Patients with high-risk localised prostate cancer (PCa) are at risk of developing bone metastases (BMs). Zoledronic acid (ZA) significantly reduces the incidence of skeletal complications in castration-resistant metastatic PCa versus placebo. Objective To investigate ZA for the prevention of BMs in high-risk localised PCa. Design, setting, and participants Randomised open-label multinational study with patients having at least one of the following: prostate-specific antigen ≤20 ng/ml, node-positive disease, or Gleason score 8-10. Intervention Standard PCa therapy alone or combined with 4 mg ZA intravenously every 3 mo for ≤4 yr. Outcome measurements and statistical analysis BMs were assessed using locally evaluated bone-imaging procedures (BIPs), with subsequent blinded central review. Patients with BMs, time to BMs, overall survival, and adverse events were compared between treatment groups. Results and limitations A total of 1393 of 1433 randomised patients were used for intention-to-treat (ITT) efficacy analyses, with 1040 patients with BIP-BM outcome status at 4 0.5 yr. The local urologist/radiologist diagnosed BIP-BMs in 88 of 515 patients (17.1%) in the ZA group and 89 of 525 patients (17.0%) in the control group (chi-square test: p = 0.95), with a difference between proportions of 0.1% (95% confidence interval [CI], -4.4 to 4.7) in favour of the control group. In the ITT population (n = 1393), the Kaplan-Meier estimated proportion of BMs after a median follow-up of 4.8 yr was 14.7% in the ZA group versus 13.2% in the control group (log-rank: p = 0.65). Low hot spot numbers on bone scans were confirmed as metastases with additional imaging. Central reviews of BIPs were possible only on a subset of patients. Conclusions ZA administered every 3 mo was demonstrated to be ineffective for the prevention of BMs in high-risk localised PCa patients at 4 yr. Patient summary Zoledronic acid administered every 3 mo was demonstrated to be ineffective for the prevention of bone metastases in high-risk nonmetastatic PCa patients at 4 yr. © 2014 European Association of Urology.


Maggiore S.M.,Catholic University of the Sacred Heart | Idone F.A.,Catholic University of the Sacred Heart | Vaschetto R.,Maggiore della Carita Hospital | Festa R.,Catholic University of the Sacred Heart | And 7 more authors.
American Journal of Respiratory and Critical Care Medicine | Year: 2014

Rationale: Oxygen is commonly administered after extubation. Although several devices are available, data about their clinical efficacy are scarce. Objectives: To compare the effects of the Venturi mask and the nasal high-flow(NHF) therapy on PaO2/FIO2SET ratio after extubation. Secondary endpoints were to assess effects on patient discomfort, adverse events, and clinical outcomes. Methods: Randomized, controlled, open-label trial on 105 patients with a PaO2/FIO2 ratio less than or equal to 300 immediately before extubation. The Venturi mask (n = 52) or NHF (n = 53) were applied for 48 hours postextubation. Measurements and Main Results: PaO2/FIO2SET, patient discomfort caused by the interface and by symptoms of airways dryness (on a 10-point numerical rating scale), interface displacements, oxygen desaturations, need for ventilator support, and reintubation were assessed up to 48 hours after extubation. From the 24th hour, PaO2/FIO2SET was higherwith the NHF (287± 74 vs. 247 ± 81 at 24 h; P = 0.03). Discomfort related both to the interface and to airways dryness was better with NHF (respectively, 2.6 ± 2.2 vs. 5.1 ± 3.3 at 24 h, P = 0.006; 2.2 ± 1.8 vs. 3.7 ± 2.4 at 24 h, P = 0.002). Fewer patients had interface displacements (32% vs. 56%; P = 0.01), oxygen desaturations (40% vs. 75%; P < 0.001), required reintubation (4% vs. 21%; P = 0.01), or any form of ventilator support (7% vs. 35%; P < 0.001) in the NHF group. Conclusions: Compared with the Venturi mask, NHF results in better oxygenation for the same set FIO2 after extubation. Use of NHF is associated with better comfort, fewer desaturations and interface displacements, and a lower reintubation rate. Clinical trial registered with www.clinicaltrials.gov (NCT 01575353). Copyright © 2014 by the American Thoracic Society.


Navalesi P.,University of Piemonte Orientale | Navalesi P.,SantAndrea Hospital
Critical Care | Year: 2011

Because patient-ventilator asynchrony (PVA) is recognized as a major clinical problem for patients undergoing ventilatory assistance, automatic methods of PVA detection have been proposed in recent years. A novel approach is airflow spectral analysis, which, when related to visual inspection of airway pressure and flow waveforms, has been shown to reach a sensitivity and specificity of greater than 80% in detecting an asynchrony index of greater than 10%. The availability of automatic non-invasive methods of PVA detection at the bedside would likely be of benefit in intensive care unit practice, but they may be limited by shortcomings, so clear proof of their effectiveness is needed. © 2011 BioMed Central Ltd.


Navalesi P.,SantAndrea Hospital | Navalesi P.,University of Piemonte Orientale | Longhini F.,SantAndrea Hospital
Current Opinion in Critical Care | Year: 2015

Purpose of Review: Compared with the conventional forms of partial support, neurally adjusted ventilatory assist was repeatedly shown to improve patient-ventilator synchrony and reduce the risk of overassistance, while guaranteeing adequate inspiratory effort and gas exchange. A few animal studies also suggested the potential of neurally adjusted ventilatory assist in averting the risk of ventilator-induced lung injury. Recent work adds new information on the physiological effects of neurally adjusted ventilatory assist. Recent Findings: Compared with pressure support, neurally adjusted ventilatory assist has been shown to improve patient-ventilator interaction and synchrony in patients with the most challenging respiratory system mechanics, such as very low compliance consequent to severe acute respiratory distress syndrome and high resistance and air trapping due to chronic airflow obstruction; enhance redistribution of the ventilation in the dependent lung regions; avert the risk of patient-ventilator asynchrony due to sedation; avoid central apneas; limit the risk of high (injurious) tidal volumes in patients with acute respiratory distress syndrome of varied severity; and improve patient-ventilator interaction and synchrony during noninvasive ventilation, irrespective of the interface utilized. Summary: Several studies nowadays prove the physiological benefits of neurally adjusted ventilatory assist, as opposed to the conventional modes of partial support. Whether these advantages translate into improvement of clinical outcomes remains to be determined. Copyright © 2015 Wolters Kluwer Health, Inc.


Villa M.P.,University of Rome La Sapienza | Villa M.P.,SantAndrea Hospital | Rizzoli A.,University of Rome La Sapienza | Miano S.,University of Rome La Sapienza | Malagola C.,University of Rome La Sapienza
Sleep and Breathing | Year: 2011

Purpose: In view of the positive outcome of orthodontic treatment using rapid maxillary expansion (RME) on sleep-disordered breathing, we generated data on RME in children with obstructive sleep apnea (OSA) by evaluating objective and subjective data over a 36-month follow-up period, to determine whether RME is effective in the long-term treatment of OSA. We selected all patients with dental malocclusions and OSA syndrome (OSAS) confirmed by polysomnography. Methods: Ten of the 14 children who completed the 12-month therapeutic trial using RME were enrolled in our follow-up study. The study was performed 24 months after the end of the RME orthodontic treatment. We enrolled all children presented with deep, retrusive or crossbite at the orthodontic evaluation. All subjects underwent an overnight polysomnography at the baseline, after 1 year of treatment and 24 months after the end of the orthodontic treatment. The children's mean age was 6.6±2.1 years at entry and 9.7±1.6 years at the end of follow-up. Results: After treatment, the apnea hypopnoea index (AHI) decreased and the clinical symptoms had resolved by the end of the treatment period. Twenty-four months after the end of the treatment, no significant changes in the AHI or in other variables were observed. Conclusions: RME may be a useful approach in children with malocclusion and OSAS, as the effects of such treatment were found to persist 24 months after the end of treatment. © 2011 Springer-Verlag.


Putignani L.,Bambino Gesu Childrens Hospital | Del Chierico F.,Bambino Gesu Childrens Hospital | Petrucca A.,Bambino Gesu Childrens Hospital | Petrucca A.,SantAndrea Hospital | And 3 more authors.
Pediatric Research | Year: 2014

The microbiota "organ" is the central bioreactor of the gastrointestinal tract, populated by a total of 10 14 bacteria and characterized by a genomic content (microbiome), which represents more than 100 times the human genome. The microbiota plays an important role in child health by acting as a barrier against pathogens and their invasion with a highly dynamic modality, exerting metabolic multistep functions and stimulating the development of the host immune system, through well-organized programming, which influences all of the growth and aging processes. The advent of "omics" technologies (genomics, proteomics, metabolomics), characterized by complex technological platforms and advanced analytical and computational procedures, has opened new avenues to the knowledge of the gut microbiota ecosystem, clarifying some aspects on the establishment of microbial communities that constitute it, their modulation and active interaction with external stimuli as well as food, within the host genetic variability. With a huge interdisciplinary effort and an interface work between basic, translational, and clinical research, microbiologists, specialists in "-omics" disciplines, and clinicians are now clarifying the role of the microbiota in the programming process of several gut-related diseases, from the physiological symbiosis to the microbial dysbiosis stage, through an integrated systems biology approach.Copyright © 2014 International Pediatric Research Foundation, Inc.


Negro A.,University of Rome La Sapienza | Negro A.,SantAndrea Hospital | Martelletti P.,University of Rome La Sapienza | Martelletti P.,SantAndrea Hospital
Journal of Headache and Pain | Year: 2011

Chronic migraine (CM) represents migraine natural evolution from its episodic form. It is realized through a chronicization phase that may require months or years and varies from patient to patient. The transition to more frequent attacks pattern is influenced by lifestyle, life events, comorbid conditions and personal genetic terrain, and it often leads to acute drugs overuse. Medication overuse headache (MOH) may complicate every type of headache and all the drugs employed for headache treatment can cause MOH. The first step in the management of CM complicated by medication overuse must be the withdrawal of the overused drugs and a detoxification treatment. The goal is not only to detoxify the patient and stop the chronic headache but also to improve responsiveness to acute or prophylactic drugs. Different methods have been suggested: gradual or abrupt withdrawal; home treatment, hospitalization, or a dayhospital setting; re-prophylaxes performed immediately or at the end of the wash-out period. Up to now, only topiramate and local injection of onabotulinumtoxinA have shown efficacy as therapeutic agents for re-prophylaxis after detoxification in patients with CM with and without medication overuse. Although the two treatments showed similar efficacy, onabotulinumtoxinA is associated with a better adverse events profile. Recently, the Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program proved that patients with CM, even those with MOH, are the ones most likely to benefit from onabotulinumtoxinA treatment. Furthermore, it provided an injection paradigm that can be used as a guide for a correct administration of onabotulinumtoxinA. © The Author(s) 2011.


Lionetto L.,SantAndrea Hospital
The journal of headache and pain | Year: 2013

The term omics consist of three main areas of molecular biology, such as genomics, proteomics and metabolomics. The omics synergism recognise migraine as an ideal study model, due to its multifactorial nature. In this review, the plainly research data featuring in this complex network are reported and analyzed, as single or multiple factor in pathophysiology of migraine. The future of migraine biomolecular research shall be focused on networking among these different and hierarchical disciplines. We have to look for its Ariadne's tread, in order to see the whole painting of migraine molecular biology.


Sabato D.,University of Rome La Sapienza | Lionetto L.,SantAndrea Hospital | Martelletti P.,University of Rome La Sapienza | Martelletti P.,SantAndrea Hospital
Expert Opinion on Investigational Drugs | Year: 2015

Introduction: Migraine is a highly disabling neurovascular disorder. 'The complex and multifactorial properties of migraine pathogenesis provide the opportunity to identify new therapeutic targets from a wide range of receptors. Areas covered: In this editorial, the authors focus on future pharmacological interventions for acutemigraine including: 5-HT receptors and their agonists, calcitonin gene-related peptide receptors and their antagonists, PAC1 receptors and their antagonists, glutamate receptors and some of their antagonists as well as transient receptor potential channels and their antagonists. The authors also discuss preventative treatments for migraine that are currently in development. Expert opinion: Future pharmaceutical research that looks at the well-known mechanisms involved in the pathophysiology of migraine should aim to overcome the existing limitations of each pharmacological class and their side effects. There has lately been particular interest in the role of glutamate receptors, particularly metabotropic glutamate receptors, in the pathophysiology of migraine. These receptors may be potentially viable drug targets for migraine in the future. © 2015 Informa UK, Ltd.

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