Editoriale - SN Vol 7 No 4, Dicembre 2000

From: Subject: Editoriale - SN Vol 7 No 4, Dicembre 2000 Date: Fri, 17 Sep 2004 16:54:50 +0200 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_0000_01C49CD7.0C040BF0"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2800.1106 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C49CD7.0C040BF0 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.hospvd.ch/swiss-noso/i94a2.htm Editoriale - SN Vol 7 No 4, Dicembre 2000

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Volume 9, numero 4, 2002

Prevenzione della = trasmissione dei=20 prioni durante la tonometria e l'esame del fondo = dell'occhio

Anne Iffenecker, = Christian=20 Ruef, Zurigo, per la Swiss-Noso-CJD-Task=20 Force*

Con la collaborazione = dei=20 seguenti oftalmologi : B. Frueh (Societ=E0 svizzera di oftalmologia), = Berna; R.=20 Kovacs, Zurigo; J. Messerli, Basilea; A.B. Safran, Ginevra.

La malattia di Creutzfeldt-Jakob (MCJ) e la sua nuova variante (vMCJ) = sollevano delle domande importanti a proposito del rischio di = trasmissione dei=20 prioni durante la tonometria o l'esame del fondo dell'occhio. I prioni = sono=20 delle proteine patogene responsabili della MCJ. Sono presenti non = solamente in=20 grande quantit=E0 nel sistema nervoso centrale e nella parte posteriore=20 dell'occhio, ma anche nella parte anteriore nei pazienti colpiti dalla = malattia=20 (http.//www.doh.gov.uk/cjd/consultation/cjdmanagement.pdf<= /A>). Non=20 esiste ancora il modo di individuare le persone asintomatiche infettate = dalla=20 MCJ o dalla vMCJ.

In questo contesto, =E8 importante valutare il rischio di = trasmissione=20 iatrogena della MCJ o della vMCJ a partire dagli strumenti in contatto = con la=20 cornea e adattare la prevenzione secondo il rischio.

Caso di MCJ in relazione alla = cornea=20

Si contano 267 casi di trasmissione iatrogena della MCJ, tra i quali = 3 fanno=20 seguito a un trapianto della cornea (Brown P & al., Neurol 2000). Il = primo=20 caso =E8 apparso in una donna di 55 anni che presentava delle = manifestazioni=20 neurologiche della MCJ, 18 mesi dopo aver subito un trapianto della = cornea=20 proveniente da un donatore sintomatico. I dati istopatologici hanno = confermato=20 la diagnosi della MCJ nel donatore e nell'ospite (Duffy P & al., N = Engl J=20 Med 1974). Il secondo caso =E9 stato descritto in un paziente di 63 = anni, con=20 sintomi della MCJ e morto 15 mesi dopo un trapianto della cornea. = L'autopsia di=20 questo paziente conferm=F2 la diagnosi, ma non si ha nessuna = informazione sul=20 donatore (Uchiyama K & al., Dementia 1994). Il terzo caso concerne = una=20 paziente di 45 anni, la quale ha subito due trapianti di cornea: il = primo=20 trapianto, effettuato nel 1965, proveniva da un donatore sintomatico di=20 un'encefalopatia spongiforme confermata istologicamente; nessuna = annotazione =E8=20 stata fatta per il secondo trapianto effettuato nel 1982. La paziente = =E8 morta=20 otto mesi dopo le prime manifestazioni cliniche che richiamavano la MCJ, = ma non=20 ha subito nessuna autopsia. Questo ultimo caso =E8 stato descritto nel = 1997, cio=E8=20 32 anni dopo il primo trapianto (Heckmamm & al., J Neurol Neurosurg=20 Pscichiatry 1997).

A partire da queste tre osservazioni, la diagnosi della MCJ =E8 stata = confermata istologicamente solo nei primi due casi. Solo due donatori = erano=20 sintomatici della MCJ. Nel caso descritto da Heckmann, il periodo = d'incubazione=20 della MCJ era molto pi=F9 lungo rispetto a quello degli altri due casi. = Anche se=20 il tempo di latenza tra l'inoculazione e l'inizio della MCJ varia = generalmente=20 da 15 mesi a 30 anni (Brown P., Neurology 2000), la trasmissione = iatrogena della=20 MCJ a partire da un trapianto di cornea resta incerta per il terzo caso, = con una=20 diagnosi non confermata istologicamente nella paziente trapiantata. Dati = sperimentali hanno apportato delle informazioni supplementari.

I dati sperimentali sulla presenza di prioni: = tessuto=20 dell'occhio/fasi della malattia

I dati sperimentali confermano la possibilit=E0 di trasmissione delle = malattie=20 legate ai prioni a partire dai trapianti di cornee infette (Manuelidid E = &=20 al., N Engl J Med 1977).

=B7 La cornea

Tateischi (Tateischi J, Lancet 1985) ha rilevato una trasmissione = della MCJ=20 in un topo al quale avevano inoculato intracerebralmente la cornea di un = uomo di=20 70 anni sintomatico e morto della MCJ. Dopo un lungo periodo di = incubazione=20 (1037 giorni), il topo ha manifestato i primi segni dell'infezione.

=B7 L'epitelio della cornea

Marsh (Marsh RF & al., Science 1975) ha osservato la presenza di = prioni=20 nella cornea e nel suo epitelio. Descrive la trasmissione di una = encefalopatia=20 animale simile alla MCJ partendo dall'epitelio della cornea di un = criceto=20 malato. L'epitelio infetto (10 ^4.8ID₅₀/0.05 ml di=20 sospensione) =E8 stato inoculato nel cervello di altri criceti. Questi = si sono=20 ammalati nel corso dei seguenti 6 mesi. Secondo Marsh, gli agenti = patogeni=20 potrebbero replicarsi nelle fibre nervose del tessuto della cornea. = Questi dati=20 dimostrano la presenza dei prioni nell'epitelio della cornea.

=B7 I differenti tessuti = dell'occhio=20

Hogan (Hogan RN, Ophtalmic Res 1986) trova dei prioni in diversi = tessuti=20 dell'occhio, al momento delle fasi asintomatiche e sintomatiche della = malattia.=20 Per dimostrare questo, ha inoculato dei prioni della scrapia nel = cervello dei=20 topi: 50 giorni dopo l'inoculazione, quando i topi erano ancora = asintomatici, il=20 titolo infettivo dei prioni era alto nel cervello, nella retina e nel = nervo=20 ottico (10⁸ a 10⁹ID₅₀unit=E0/ml, = unit=E0 espressa=20 in dosi causanti un'infezione nei 50% dei casi). I prioni erano presenti = nella=20 cornea (titolo infettivo : 10^5.4ID₅₀/ml), = nell'epitelio=20 pigmentato della retina (10^6.6ID₅₀/ml) e nel = cristallino=20 (10^5.2ID₅₀/ml). 70 giorni dopo l'iniezione, i = topi sono=20 diventati sintomatici della malattia senza un cambiamento significativo = dei=20 titoli infettivi rispetto alla fase precedente. Questo studio dimostra = la=20 presenza di prioni nella parte anteriore e posteriore dell'occhio, sia = nella=20 fase sintomatica che nella fase asintomatica della malattia. Pero' non = valuta il=20 rischio di trasmissione della malattia durante le due fasi.

=B7 Fase asintomatica e rischio di = trasmissione

Flechsig ha dimostrato che degli strumenti in contatto per almeno 5 = minuti=20 con il cervello di topo asintomatico possono trasmettere i prioni = (Flechsig E=20 & al., Molecular Medicine 2001). Questo tipo di trasmissione non =E9 = ancora=20 stata dimostrata dopo semplice contatto con la cornea.

Detezione di prioni =

Wadsworth ha identificato tramite Western Blot, la proteina patogena=20 PrP^SC responsabile della MCJ nella retina, nel nervo ottico, = ma non=20 nella cornea, nell'iride, nell'umore acqueo e neanche nel cristallino. = Il=20 Western Blot non =E9 abbastanza sensibile per poter affermare che non ci = sono=20 effettivamente delle PrP^SC nei tessuti della parte anteriore=20 dell'occhio. Wadsworth stima che nel caso le PrP^SC fossero = presenti=20 nei tessuti della parte anteriore dell'occhio, il livello = d'infettivit=E0 sarebbe=20 di 1/4000 volte inferiore a quello trovato nel cervello. Comunque = rappresenta un=20 livello d'infettivit=E0 non trascurabile.

=B7 Conclusione sui dati =

I casi clinici di trasmissione iatrogena della MCJ sono = esclusivamente legati=20 ai trapianti della cornea e non permettono di trarre conclusioni sul = rischio da=20 semplice contatto con la cornea. Fino ad oggi nessun caso di = trasmissione dei=20 prioni =E9 stato dichiarato tramite le lacrime con la congiuntiva o con=20 l'apposizione di strumenti sulla superficie della cornea. Questi casi = clinici=20 sono casi eccezionali rispetto alle migliaia di trapianti della cornea = praticati=20 ogni anno. D'altro canto i donatori descritti sono sintomatici. Questo = non ci da=20 informazioni sul rischio di trasmissione della MCJ a partire da pazienti = asintomatici. Anche se i dati sperimentali rivelano la presenza di = prioni nella=20 cornea e in particolare nell'epitelio, il rischio di trasmissione=20 dell'infettivit=E0 a partire da questi tessuti =E8 probabilmente molto = debole, al di=20 fuori dei trapianti della cornea. Questo rischio, ancora teorico al di = fuori dei=20 trapianti della cornea, non pu=F2 essere trascurato.

Rischio di trasmissione dei prioni secondo il tipo = di=20 strumento

-=20 I coni del tonometro ad applanazione di Goldmann e le lenti a contatto = per=20 oftalmoscopia sono in contatto diretto con la superficie della cornea.=20 Teoricamente possono rappresentare un rischio di trasmissione della MCJ. =

-=20 I metodi indiretti di misura della pressione oculare o dell'esame del = fondo=20 dell'occhio: i pneumotonometri, le lenti senza contatto per = oftalmoscopia=20 indiretta che non entrano in diretto contatto con la cornea. Questi = metodi=20 indiretti non presentano particolari problemi nel rischio di = trasmissione dei=20 prioni. Non ci sono precauzione particolari da prendere.

-=20 I tonometri di tipo Tonopen XL non presentano un rischio particolare = poich=E9 la=20 testa del tonometro che entra in contatto con la superficie della cornea = =E8=20 ricoperta da un cappuccio usa e getta.

-=20 Lenti a contatto per la fotocoagulazione al laser: su queste lenti non = sono=20 stati fatti particolari studi, i quali avrebbero permesso di ricorrere = ad altri=20 metodi di trattamento e non solo al metodo classico. Le procedure di = trattamento=20 restano quelle proposte dai fabbricanti.

Criteri di valutazione del rischio di trasmissione = della MCJ=20 nei pazienti

La Gran Bretagna e la Francia sono i paesi pi=F9 toccati = dall'epidemia della=20 vMCJ. In questi paesi, i medici ricercano, durante l'anamnesi dei = pazienti, i=20 fattori di rischio per la MCJ o la vMCJ (http:/cclinsudest.univ-lyon1.fr/prevention/faq/OPHTALM.pd= f; http://www.rcophth.ac.uk/cjd_ophthalmology.html). = Questi=20 fattori di rischio sono gi=E0 stati inclusi nelle precedenti = pubblicazioni=20 (Swiss-Noso 1996;3:9-11 et 1999;6:21). Si basano sugli antecedenti = personali o=20 famigliari dei pazienti o su delle manifestazioni cliniche evocatrici = della=20 malattia. Il Royal College of Ophtalmologists of London suggerisce che = nelle=20 situazioni seguenti bisognerebbe sospettare nei pazienti un possibile = contagio=20 da MCJ o da vMCJ:

-=20 i pazienti anziani o di et=E0 media che presentano un calo della vista=20 inspiegabile, o che hanno una emianopsia omonima senza lesioni = proliferative=20 provate n=E9 incidenti vascolari cerebrali rivelati con IRM o scanner, = sapendo che=20 nella forma classica della MCJ, una proporzione significativa dei malati = presenta dei disturbi visivi;

-=20 i pazienti con meno di 50 anni che nell'anno precedente hanno accusato = sintomi=20 neurologici o psichiatrici e che hanno consultato uno specialista, = sapendo che=20 per le altre forme della MCJ, i disturbi della visione possono mancare = (http://www.rcophth.ac.uk/cjd_ophthalmology.html). =

Misure da mettere in atto in funzione del rischio = della=20 MCJ

Riferendoci ai criteri inglesi e ai fattori di rischio gi=E0 = conosciuti, =E8=20 possibile differenziare i pazienti a rischio dal resto della popolazione = e=20 prendere in tal caso delle precauzioni particolari.

Per la popolazione a rischio, tre opzioni indipendenti sono proposte = per i=20 coni e per le lenti a contatto: un trattamento chimico a base di = ipoclorito di=20 sodio o di soda, il ricorso a degli strumenti monouso, l'utilizzo di = lenti a=20 contatto autoclavabili a 134=B0C per 18 minuti. Queste opzioni hanno il = vantaggio=20 di ridurre il rischio di trasmissione dei prioni da questi strumenti, ma = presentano degli inconvenienti che rendono difficile il loro utilizzo in = routine=20 per la popolazione generale. Sembra sproporzionato adattare queste = misure al=20 resto della popolazione. Per la popolazione senza fattori di rischio=20 identificati, il metodo classico di disinfezione degli strumenti resta=20 accettabile.

=B7 Popolazioni senza fattori di rischio: = trattamento=20 classico

Il trattamento classico di disinfezione dei coni riutilizzabili e = delle lenti=20 a contatto =E8 realizzato con un prodotto contenete aldeidi. Le aldeidi = sono=20 efficaci contro i batteri, i virus e i funghi, ma inefficaci contro i = prioni e=20 capaci di fissarli (Brown P, J Inf Dis 1982; Taylor DM, Lancet 1988; = Gibbs CJ, J=20 Neurol Neurosurg Psychiatry 1994; Flechsig E, Molec Med 2001). Per i = pazienti=20 che non presentano rischi particolari di trasmissione dei prioni, il = trattamento=20 classico degli strumenti, entrati in contatto con la loro cornea, =E8 = accettabile.=20 Per evitare l'essiccamento e la fissazione delle proteine sulla = superficie degli=20 strumenti, un trattamento preliminare alla disinfezione =E8 da = realizzare senza=20 ritardo (A. Iffenecker, C. Ruef, Swiss-Noso 2002).

=B7 Popolazione a rischio: 3 opzioni indipendenti=20 (Fig.1)

Per la popolazione a rischio si raccomanda di usare altri metodi = oltre il=20 trattamento classico per ridurre tutti i rischi, anche minimi, di = trasmissione=20 dei prioni dagli strumenti di tonometria o per il fondo dell'occhio. Tre = opzioni=20 possono essere prese in considerazione.

=B7 Opzione 1: trattamento chimico, senza=20 aldeidi

E' sempre importante evitare l'essiccamento degli strumenti e di = cominciare=20 senza tardare il trattamento preliminare alla disinfezione.

L'ipoclorito di sodio con il 2% di cloro libero, usato per un'ora a=20 temperatura ambiente =E8 efficace contro i batteri, i virus, i funghi e = contro i=20 prioni (Brown P, J Inf Dis 1986; Taylor DM, Arch Virol 1994). = L'idrossido di=20 sodio 1M usato nelle stesse condizioni =E8 efficace contro i batteri, i = virus e i=20 funghi e riduce in modo significativo il titolo infettivo dei prioni = (Taylor DM,=20 Arch Virol 1994; Brown P, J Inf Dis 1986). I prismi dei tonometri e le = lenti a=20 contatto possono essere riutilizzate fino a 100 volte dopo l'immediata = pulizia e=20 la disinfezione in una soluzione d'ipoclorito di sodio al 2% (2.5% nei = test=20 effettuati da Haag-Streit AG), o con la soda 1M, per un'ora a = temperatura=20 ambiente (20=B0C nell'esempio de Haag-Streit AG), a condizione che non = siano gi=E0=20 danneggiati (Haag-Streit AG 2002, Dok. Nr.:9202920006601040).

Nel caso dell'utilizzo di uno di questi due prodotti, tre risciacqui = completi=20 successivi con acqua sterile sono necessari (volume d'acqua sterile = equivalente=20 a quello utilizzato durante la disinfezione, con un minimo di 10 ml per=20 risciacquo) (http://www.rcophth.ac.uk/cjd_ophthalmology.html). = Questo=20 permette di assicurare l'innocuit=E0 per l'occhio durante il riutilizzo = dello=20 strumento. In seguito gli strumenti saranno essiccati e conservati in = una=20 scatola chiusa pulita e asciutta.

Inconveniente: la tossicit=E0 di questi prodotti in caso di = risciacquo=20 insufficiente degli strumenti, e in caso di schizzi sulle mucose o sulla = pelle=20 del personale. Cos=EC, questo metodo =E8 difficilmente applicabile di = routine per=20 tutti i pazienti.

=B7 Opzione 2: strumenti monouso=20

Esistono degli strumenti monouso per la tonometria e l'esame del = fondo=20 dell'occhio. Rimpiazzano gli strumenti riutilizzabili o permettono di = evitare il=20 contatto diretto con la cornea (Tabella 1).

- Tonosafe (Haag-Streit = AG), coni=20 monouso, per rimpiazzare coni riutilizzabili

-Tonometer Shields = (Domedics AG),=20 protezione in latex dei coni riutilizzabili.

-Stery Cup (Hagg-Streit = AG)=20 protezione in plastica dei vetri a tre specchi.

Inconveniente: un tempo d'adattamento all'utilizzo di questi = strumenti =E8=20 necessario per acquisire un'esperienza sufficiente per conseguire una = buona=20 qualit=E0 dell'esame.

Tabella 1 : Strumenti monouso

Strumento

Nome commerciale

Referenza e prezzo

Cono del = tonometro

Tonosafe=AE

Tonometer = Shields=AE

Haag Streit AG., = ref.=20 1005507, prezzo :146 Fr per 100 pezzi Domedics AG. , ref. 8200, = prezzo :=20 98 Fr per confezione di 144 pezzi sterili

Vetro a tre = specchi

Stery = Cup=AE

Haag-Streit AG., = ref.=20 1005900, prezzo : 181 Fr per confezione di 64 = pezz

Figura 1: Schema decisionale sulle = misure di=20 prevenzione del rischio della MCJ dopo esami tonometrici o del fondo=20 dell=92occhio

=B7 Opzione 3: lenti a contatto = autoclavabili

I coni tonometrici e le lenti a contatto sono termosensibili. Non = possono=20 essere quindi autoclavati a 134 =B0C per 18 minuti, unico metodo di=20 sterilizzazione capace di ridurre significativamente l'infettivit=E0 = legata ai=20 prioni (Taylor DM, Arch Virol 1994).

In commercio esiste un modello particolare di lenti a contatto = termostabili=20 L134=AE (Luneau SARL), autoclavabili a 134 =B0C per 18 minuti. Possono = sopportare=20 100 cicli di sterilizzazione mediante autoclave senza una maggiore = degradazione=20 a queste condizioni (prove effettuate da Luneau SARL). Sono disponibili = in=20 Svizzera (Ryser Optik AG., al prezzo di Fr. 877.- al pezzo) e gi=E0=20 commercializzate in Francia e in Danimarca. In caso di utilizzo di = queste lenti=20 conviene seguire le raccomandazioni sui trattamenti preliminari alla=20 sterilizzazione proposte dal fabbricante.

Inconvenienti: fragili e pi=F9 pesanti delle lenti a contatto = classiche.

Coni tonometrici termostabili riutilizzabili non esistono.

Conclusioni

Il rischio di trasmissione iatrogena delle malattie legate ai prioni = a=20 partire da strumenti entrati in contatto con la cornea e in particolare = con il=20 suo epitelio =E8 molto debole. Non pu=F2 essere tuttavia ignorata. La = frequenza=20 degli esami tonometrici o del fondo dell'occhio giustifica la = valutazione di=20 questo rischio. L'anamnesi basata su semplici criteri permette di = individuare i=20 pazienti a rischio e di intraprendere precauzioni specifiche = (trattamento=20 chimico senza aldeidi o scelta di particolari strumenti) che portano a = ridurre i=20 rischi di trasmissione dei prioni durante questi esami.

*Swiss-Noso=20 CJD-Task Force (Creutzfeldt-Jakob Disease): C. Ruef (Presidente), A. = Iffenecker,=20 P-A. Raeber, L. Amsler, F. Cavin, P. Francioli, N. Troillet, M-L. = Herrero, E.=20 Bernasconi, H-R. Widmer, D. Pittet, H. Sax, A. Widmer, M. Wenk, H. = Schenk, K.=20 Muehlemann

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