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Deprecated: Implicit conversion from float 269.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Orv+Hetil 2020 ; 161 (44): 1858-1871 Nephropedia Template TP
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A szekletmikrobiota-transzplantacio technologiajanak es minosegiranyitasi hatterenek ujragondolasa a SARS-CoV-2 viruspandemia kapcsan #MMPMID33130602
Nagy GG; Tudlik Z; Gergely L; Konya J; Orosi P; Rakoczi E; Szabo J; Varvolgyi C; Vitalis E; Paragh G
Orv Hetil 2020[Nov]; 161 (44): 1858-1871 PMID33130602show ga
Osszefoglalo. A szekletmikrobiota-transzplantacio (faecalismikrobiota-transzplantacio - FMT) a Clostridioides difficile fertozes (CDI) kezeleseben nemzetkozileg szeles korben elfogadott, megfelelo szakmai hatter mellett vegezve biztonsagos, potencialisan eletmento, koltseghatekony, valamint a hospitalizacios ido es az orvos-beteg talalkozasok jelentos redukalasara kepes eljaras. Az FMT elvegzesere egyes orszagokban magas szintu minosegiranyitasi hatterrel mukodo, celfeladatra szervezodott donor- es szekletbankok rendezkedtek be. Mashol, igy peldaul hazankban, az eljarashoz az egyertelmu jogi szabalyozasi kornyezet, a standardizalt technologiai hatter es a finanszirozas hianya miatt nem egyseges a hozzaferes. Regota idoszeru tovabba, hogy a heterogen, nemegyszer haztartasi eszkozokkel elokeszitett beavatkozasok helyett a nemzetkozi es legujabban mar a hazai ajanlasokban is megfogalmazott, a betegbiztonsagot legjobban garantalo elvarasok mellett tortenjen a szeklettranszplantacio. Az uj koronavirus (SARS-CoV-2) okozta pandemia megjelenese eroteljes szakmai erv orszagos szinten az FMT minosegiranyitasi kornyezetenek es technologiai hatterenek ujragondolasara, mert a SARS-CoV-2 egyszerre jelent kockazatot a CDI miatt korhazban kezelt serulekeny betegpopulacionak, es egyben veszelyezteti az FMT biztonsagossagat mind a recipiens, mind pedig az eljarast vegzo egeszsegugyi szemelyzet tekinteteben. Ezekre a szakmai es tarsadalmi kihivasokra reagalva, a szeles koru beteghozzaferes es a legmagasabb szintu betegbiztonsag garantalasara, a Debreceni Egyetemen uj eljarasrendet dolgoztunk ki az FMT vegzesere. Ezen eljarasrendnek a COVID-19-pandemia miatt modositott, a fagyasztottgraftbank uzemeltetese es a rendszerszemlelet tekinteteben relevans elemeit ismertetjuk. Javasolt, hogy orszagos szinten hasonlo, megfelelo minosegiranyitasi es technologiai kornyezettel, a SARS-CoV-2-fertozes kizarasat is integralo donorszuresi rendszerrel, tovabba fagyasztottgraft-banki hatterrel mukodo laboratoriumok vegyenek reszt a szeklettranszplantaciok vegzeseben. Felmerul tovabba, hogy az eljarast a szamos analogia es a donor-recipiens koncepcio alapjan a sejt- es szovettranszplantaciokra vonatkozo szabalyozorendszer keretei koze ajanlott beagyazni. Orv Hetil. 2020; 161(44): 1858-1871. Summary. Stool transplantation (faecal microbiota transplantation - FMT) is a widely accepted, potentially life-saving, cost-effective medical intervention for the treatment of Clostridioides difficile infection (CDI), which has an acceptable safety profile if performed with an appropriate professional background. FMT can significantly reduce hospitalization time and the number of patient visits. National donor and stool banks with high-standard quality management systems were established in certain countries for supporting the procedures. In other regions, including Hungary, patient access is not uniform due to the lack of clear legal regulations, standardized technology or financial reimbursement. It has been expected for a long time to replace the heterogenous techniques, occasionally utilizing household equipment with a technology providing improved patient safety and fulfilling international and recently published local FMT guidelines. The emergence of the novel coronavirus (SARS-CoV-2) pandemic is a very powerful argument in favour of urgently reconsidering the quality management and technological background of FMT procedures. SARS-CoV-2 is a major threat to the vulnerable patients suffering from CDI and also impose risks for the recipient and healthcare personnel involved in carrying out the transplantation. New FMT guidelines were implemented at the University of Debrecen to address these professional and public challenges, to provide wide patient access and to guarantee the highest achievable patient safety. Relevant elements of this new protocol are presented, focusing on a systemic quality management approach, on the operation of a frozen stool bank and on a modified donor screening algorithm taking the risks of COVID-19 into consideration. We suggest that laboratories with proper quality assurance and technological conditions, implementing SARS-CoV-2 donor screening and operating a frozen graft bank should participate in faecal microbiota transplantations. It is also recommended that, based on the analogies and the similar donor-recipient concept, FMT should be embedded under the organ tissue and cell transplantation polices in Hungary. Orv Hetil. 2020; 161(44): 1858-1871.
Orv+Hetil 2020 ; 161 (44): 1858-1871
