ADHERE: randomized controlled trial comparing renal function in de novo kidney transplant recipients receiving prolonged-release tacrolimus plus mycophenolate mofetil or sirolimus

ADHERE was a randomized, open-label, Phase IV study comparing renal function at Week 52 postkidney transplant, in patients who received prolongedrelease tacrolimus-based immunosuppressive regimens. On Days 0?27, patients received prolonged-release tacrolimus (initially 0.2 mg/kg/day), corticosteroids, and mycophenolate mofetil (MMF). Patients were randomized on Day 28 to receive either prolonged-release tacrolimus plus MMF (Arm 1) or prolongedrelease tacrolimus (?25% dose reduction on Day 42) plus sirolimus (Arm 2). The primary endpoint was glomerular filtration rate by iohexol clearance (mGFR) at Week 52. Secondary endpoints included eGFR, creatinine clearance (CrCl), efficacy failure (patient withdrawal or graft loss), and patient/graft survival. Tolerability was analyzed. The full-analysis set comprised 569 patients (Arm 1: 287; Arm 2: 282). Week 52 mean mGFR was similar in Arm 1 versus Arm 2 (40.73 vs. 41.75 ml/min/1.73 m2; P = 0.405), as were the secondary endpoints, except composite efficacy failure, which was higher in Arm 2 versus 1 (18.2% vs. 11.5%; P = 0.002) owing to a higher postrandomization withdrawal rate due to adverse events (AEs) (14.4% vs. 5.2%). Results from this study show comparable renal function between arms at Week 52, with fewer AEs leading to study discontinuation with prolonged-release tacrolimus plus MMF (Arm 1) versus lower dose prolonged-release tacrolimus plus sirolimus (Arm 2)

L’attenuazione per le basse frequenze per la protesi BAHA

L’impianto di protesi Baha (Bone-anchored hearing aid) è entrato nella pratica clinica da, ormai, più di trent’anni per il trattamento dell’ipoacusia bilaterale trasmissiva e mista e da più di dieci anni per il trattamento della sordità neurosensoriale monolaterale (SSD). E’ noto da tempo come, nei pazienti affetti da SSD, sia necessaria l’attenuazione dell’output dell’impianto al le basse frequenze. Ma non è chiaro, se la stessa attenuazione possa migliorare la performance uditiva in pazienti affetti da ipoacusia bilaterale, come nel caso di pazienti affetti da otosclerosi o otite media cronica. Lo scopo dello studio è quello di individuare il guadagno dell’impianto BAHA alle basse frequenze in modo da ottenere una buona performance uditiva in pazienti affetti da diverse patologie e di verificare se l’attenuazione delle basse frequenze sia utile anche nelle sordità bilaterali. Per lo studio sono stati analizzati retrospettivamente i dati clinici di 98 pazienti sottoposti ad impianto di protesi BAHA presso il reparto di Audiologia e Foniatria Universitaria dell’Ospedale di Pisa. Tra i pazienti selezionati per lo studio, 14 erano affetti da sordità neurosensoriale monolaterale, 6 da ipoacusia mista bilaterale dovuta ad otosclerosi, 24 da ipoacusia mista bilaterale causata da otite media o da esiti di chirurgia sull’orecchio e 14 da ipoacusia di conduzione monolaterale dovuta ad atresia auris. Tutti i pazienti sono stati sottoposti ad otomicroscopia, audiometria tonale (in cuffia e in campo libero), audiometria vocale, impedenziometria e valutazione del riflesso stapediale. Per i processori BAHA sono stati utilizzati software 4.0 e 5.0 che permettono di regolare la potenza della vibrazione per le singole frequenze così da poter fornire al paziente la migliore sensazione uditiva. E’ stata valutata, quindi, la differenza tra il guadagno predefinito e quello associato alla migliore sensazione uditiva ottenibile per il paziente, e indicato come guadagno differenziale (GD). In tutti i casi riportati la soglia uditiva in campo libero è risultata migliorata dopo l’impianto. Il riconoscimento vocale è migliorato dopo alcune sessioni di mappaggio del processore. Il guadagno differenziale a 250 Hz è risultato negativo non solo nei soggetti affetti da SSD, come era atteso, ma anche in quelli con ipoacusia mista per otite media, timpanosclerosi o otosclerosi. Il GD era positivo solo nei soggetti con ipoacusia trasmissiva. L’impianto BAHA è un’eccellente protesi uditiva ma sembra dare distorsione del segnale alle basse frequenze. La nostra convinzione è che questo comportamento sia da ricondurre alle caratteristiche intrinseche di trasmissione del suono per via ossea, in particolare al meccanismo legato all’inerzia dei fluidi labirintici. Infatti, se le finestre sono normali e i movimenti dei fluidi cocleari sono liberi, come nel caso di pazienti con ipoacusia di conduzione dovuta ad atresia auris o nei pazienti sottoposti ad interventi sull'orecchio con scarso recupero uditivo, il guadagno dell’impianto può essere neutro o positivo. Al contrario, se il meccanismo di conduzione risulta danneggiato, come nel caso dell’otosclerosi, si verificherà distorsione della trasmissione del suono alle basse frequenze, che dovrà essere ridotta mediante l’attenuazione dell’output delle stesse

Nasopharyngeal sarcoidosis: case reports and literature review

: Sarcoidosis is a multisystemic inflammatory chronic disease characterized by the presence of noncaseating granulomas most frequently in lungs and in intrathoracic lymph nodes. The nasopharyngeal form is unusual and noncommon in the ENT practice. Background and objectives: In order to establish a correct knowledge about this rare disease, we report two different cases of nasopharyngeal sarcoidosis moreover all the available literature is reviewed. Materials and methods: A systematic literature review was made through PubMed databases, according to the PRISMA guidelines (1), combining the following key words: Nasopharyngeal, Rhinopharynx, Sarcoidosis, in publications between 1951 and 2020. In addition, we reported our personal experience on the disease by describing two clinical cases that occurred at our clinic in November 2018 and June 2019. Results: 16 articles reported 27 cases of nasopharyngeal sarcoidosis. The number of males was 13 (48,2%) and the number of females was 14 (51,8%) with a mean age at the diagnosis of 35,28 ± 13.05 years old (range 5 - 64). In 16 (59,3%) cases nasopharyngeal sarcoidosis was associated with lungs and/or intrathoracic lymph nodes involvement; nasal obstruction was the most frequently reported symptom (51,8% of subjects). Conclusions: Nasopharyngeal sarcoidosis can mimic several disorders of the upper airway respiratory tract and it must therefore be considered in the differential diagnosis. A biopsy of nonspecific lesions in the nasopharynx is advisable to permit several early diagnosis of upper airway respiratory tract disorders including sarcoidosis

Building Kidney Exchange Programmes in Europe-An Overview of Exchange Practice and Activities

BACKGROUND: Considerable differences exist among the living donor Kidney Exchange Programmes (KEPs) that are in use and being built in Europe, contributing to a variation in the number of living donor transplants (Newsletter Transplant; International figures on donation and transplantation 2016). Efforts of European KEPs to exchange (best) practices and share approaches to address challenges have, however, been limited. METHODS: Experts from 23 European countries, collaborating on the European Network for Collaboration on Kidney Exchange Programmes Cooperation on Science and Technology Action, developed a questionnaire to collect detailed information on the functioning of all existing KEPs in Europe, as well as their opportunities and challenges. Following a comparative analysis, results were synthesized and interpreted by the same experts. RESULTS: The practices, opportunities and challenges reported by 17 European countries reveal that some of the 10 operating programs are mature, whereas others are in earlier stages of development. Over 1300 transplants were performed through existing KEPs up to the end of 2016, providing approximately 8% of their countries' living kidney donations in 2015. All countries report challenges to either initiating KEPs or increasing volumes. Some challenges are shared, whereas others differ because of differences in context (eg, country size, effectiveness of deceased donor program) and ethical and legal considerations (eg, regarding living donation as such, nonrelated donors, and altruistic donation). Transnational initiatives have started in Central Europe, Scandinavia, and Southern Europe. CONCLUSIONS: Exchange of best practices and shared advancement of national programs to address existing challenges, aided by transnational exchanges, may substantially improve access to the most (cost) effective treatment for the increasing number of patients suffering from kidney disease.status: publishe

Building Kidney Exchange Programmes in Europe: an overview of exchange practice and activities

BACKGROUND: Considerable differences exist among the living donor Kidney Exchange Programmes (KEPs) that are in use and being built in Europe, contributing to a variation in the number of living donor transplants (Newsletter Transplant; International figures on donation and transplantation 2016). Efforts of European KEPs to exchange (best) practices and share approaches to address challenges have, however, been limited. METHODS: Experts from 23 European countries, collaborating on the European Network for Collaboration on Kidney Exchange Programmes Cooperation on Science and Technology Action, developed a questionnaire to collect detailed information on the functioning of all existing KEPs in Europe, as well as their opportunities and challenges. Following a comparative analysis, results were synthesized and interpreted by the same experts. RESULTS: The practices, opportunities and challenges reported by 17 European countries reveal that some of the 10 operating programs are mature, whereas others are in earlier stages of development. Over 1300 transplants were performed through existing KEPs up to the end of 2016, providing approximately 8% of their countries' living kidney donations in 2015. All countries report challenges to either initiating KEPs or increasing volumes. Some challenges are shared, whereas others differ because of differences in context (eg, country size, effectiveness of deceased donor program) and ethical and legal considerations (eg, regarding living donation as such, nonrelated donors, and altruistic donation). Transnational initiatives have started in Central Europe, Scandinavia, and Southern Europe. CONCLUSIONS: Exchange of best practices and shared advancement of national programs to address existing challenges, aided by transnational exchanges, may substantially improve access to the most (cost) effective treatment for the increasing number of patients suffering from kidney disease