Tratamentul infectiilor cu Candida

15 Noiembrie, 2010 - 13:10

Noile studii privind infectiile cu Candida si noutati privind managementul rezistentei la echinocandin s-au aflat printre temele principale ale sesiunilor de lucru privind medicamentele antifungice ale celei de-a 48-a reuniuni anuale a Societatii Americane pentru Boli Infectioase (Infectious Diseases Society of America (IDSA).

Epidemiologia Candida

Candida albicans ramane specia cea mai prevalenta asociata cu candidoza invaziva, insa speciile non-albicans incep acum sa fie izolate la peste 50% dintre pacienti, potrivit datelor unui studiu raportat de oamenii de stiinta de la Rutgers State University, SUA (abstract 636).

Girish Prajapati si colegii sai au analizat fisele medicale a 183 de pacienti, din 14 spitale, care aveau un diagnostic la externare de candidoza invaziva, pe o perioada de 3 ani (2005-7). Obiectivul lor principal a fost determinarea prevalentei si distributiei diferitelor specii de Candida.

C. albicans a fost izolata la 92 de paciente (50,3%). Candida non-albicans a fost izolata la 100 de pacienti: C. glabrata a fost specia izolata cel mai frecvent (27% dintre 183 de pacienti), urmata de C. tropicalis (14,2%) si C. parapsilosis (12,0%). La 13 pacienti au fost izolate specii multiple de Candida.

Cercetatorii au incercat de asemenea sa vada daca exista factori specifici asociati cu un raspuns nefavorabil la un tratament antifungic (infectie stabila sau agravata) la pacientii cu infectie invaziva cu Candida non-albicans.

Desi nu au existat suficiente informatii pentru a intelege in totalitate diferentele intre grupurile de tratament, analiza multivariata a indicat ca tratamentul doar cu fluconazol si admisia la terapie intensiva au fost ambele asociate semnificativ cu esecul tratamentului.

20% dintre pacientii cu infectie cu Candida non-albicans au fost tratati doar cu fluconazol (raspuns nefavorabil 50%), in timp ce 80% au primit alte medicamente antifungice, cu sau fara fluconazol (raspuns nefavorabil 27%).

Intr-un al studiu, Aarthi Narasimhan si colegii (UCSF Fresno, SUA) au analizat retrospectiv factorii de risc si rezultatele infectiilor cu Candida in sange, la 28 de pacienti de la terapie intensiva tratati intre 2007 si 2009 (abstract 629). Candida glabrata a fost raspunzatoare pentru 11 cazuri (39%).

Studiile anterioare derulate la scara mai larga au aratat ca utilizarea anterioara a fluconazol este un factor de risc independent pentru infectia cu C. glabrata din sange, iar acest lucru a fost observat si in studiul UCSF: 5 din 11 pacienti cu C. glabrata primisera anterior fluconazol, comparativ cu nici un pacient cu infectie provocata de alte specii de Candida. Cercetatorii au observat de asemenea o tendinta de crestere a mortalitatii la grupul infectat cu C. glabrata (mortalitate la 30 de zile 63% vs. 57%).

Medicii care prescriu medicamentele adesea nu folosesc doze antifungice standard

Un studiu privind utilizarea medicamentelor in SUA a constatat ca medicii care prescriu medicamentele adesea nu folosesc dozele standard de echinocandine pentru tratarea infectiilor fungice invazive (abstract 666).

Studiul a investigat utilizarea caspofungin si micafungin pe o perioada de trei ani (2007-9) prin analizarea datelor dintr-o baza de date a spitalelor din SUA.

Dozele standard pentru tratamentul intraspitalicesc erau caspofungin 50mg zilnic, ca doza de mentinere pentru candidoza invaziva sau aspergiloza, si micafungin 100mg zilnic pentru candidoza invaziva si 100mg sau 150mg zilnic pentru aspergiloza. (Micafungin nu este autorizat pentru aspergiloza invaziva).

Dozajul "non-standard" a inclus cresterea sau descresterea dozelor de antifungice in timpul spitalizarii sau utilizarea unor doze non-standard de antifungice jogos casino online.

Au fost analizate datele pentru 494 de pacienti: 214 pacienti au primit caspofungin pentru candidoza si 66 pentru aspergiloza, iar 164 au primit micafungin pentru candidoza si 50 pentru aspergiloza. Majoritatea pacientilor au primit echinocandin ca parte a terapiei combinate cu alte medicamente antifungice, in special pentru tratarea aspergilozei.

S-a constatat ca caspofungin are rate mai ridicate de utilizare a dozelor standard decat micafungin: pentru candidoza, dozajul standard a fost utilizat pentru 85% dintre pacientii tratati cu caspofungin si 66% dintre pacientii tratati cu micafungin, in timp ce pentru aspergiloza, dozajul standard a fost utilizat pentru 89% dintre pacientii tratati cu caspofungin si 76% dintre pacientii tratati cu micafungin (doza de 150mg fiind administrata la 12 pacienti).

Durata terapiei a fost mai mare la administrarea de micafungin decat in cazul caspofungin, atunci cand s-au folosit doar aceste medicamente (o medie de 10,8 vs. 5,5 zile pentru aspergiloza si 8,8 vs 6,8 zile pentru candidoza). Atunci cand s-a folosit terapia combinata, durata tratamentului cu echinocandin a fost usor mai mare pentru caspofungin (cu <2 zile mai mare pentru candidoza si <1 zi mai mare pentru aspergiloza).

Nu s-a efectuat nicio analiza statistica, iar studiul nu a implicat date clinice sau evaluarea factorilor de confuzie care ar putea justifica diferentele de prescriere observate.

Blane Schilling (Aspen Healthcare Metrics, SUA) a raportat acest studiu. El a spus ca constatarea cea mai marcanta a fost ca clinicienii folosesc multe doze diferite, pentru ambele medicamente. A fost chiar surprins sa vada plaja de variatii de la dozele standard.

Caspofungin a fost mai mult utilizat la doze standard, iar cercetatorul a sugerat ca poate acest lucru se datoreaza faptului ca acest medicament este disponibil de mai mult timp, iar doza este neschimbata de la prima punere pe piata. in cazul micafungin, poate exista o confuzie mai mare in randul medicilor prescriptori deoarece doza a variat de-a lungul anilor.

Cercetatorii mentioneaza ca costul caspofungin si al micafungin este competitiv la dozajul standard. Nu s-a efectuat o analiza economica privind datele studiului. Totusi, Dr. Schilling a notat ca orice crestere a dozei standard sau a duratei terapiei are un impact asupra costurilor.

Programe de gestiune antimicrobiana in terapia antifungica

Programele de gestiune antimicrobiana (antimicrobial stewardship programmes - ASP) devin tot mai importante pentru utilizarea optima a medicamentelor. La Ohio State University Medical Center, se fac pasi pentru a imbunatati managementul candidemiei folosind o abordare ASP. Un scop este de a evita intarzierile in initierea unui tratament eficient (abstract 609).

Medicii din spital sunt notificati imediat cand un laborator de microbiologice identifica drojdie pe coloratia gram din sange. De la inceputul lui 2010, s-au introdus notificari ASP suplimentare in timpul saptamanii de lucru (de luni pana vineri, 7am-5pm). Impactul notificarii ASP a farmacistului sau al initierii terapiei antifungice a fost evaluat prin compararea timpului care trece pana la tratament inainte de (26 de cazuri) si dupa (24 de cazuri) modificare.

Cu interventia ASP a farmacistului, s-a observat o scadere semnificativa a timpului care trece pana la initierea unei terapii antifungice eficiente (o medie de 1,4 ore vs. 9,9 ore cu vechiul sistem). Totusi, 75% dintre episoade apareau in afara orelor normale de program, caz in care media era de 11,1 ore pana la initierea unui tratament eficient.

Rezistenta la echinocandin

La un simpozion ISDA privind rezistenta la echinocandin in infectiile cu Candida, vorbitorii au subliniat ca desi pot aparea mutatii ale genelor tinta, acestea nu conduc neaparat la rezistenta si, pana in prezent, in practica clinica incidenta esecului tratamentului este redusa.

Michael Pfaller (University of Iowa, SUA) a spus ca punctele de control (breakpoints) initiale clinice CLSI (MIC ≤2 si ≥2mcg/ml pentru detectarea izolatilor sensibili si a celor ne-sensibili) nu mai sunt adecvate datorita unor date noi privind tulpinile cu mutatii Fks dobandite, care pot avea un MIC <2 dar au fost asociate cu esecul tratamentului.

El a explicat ca CLSI a convenit asupra unui sistem revizuit de puncte de control clinice mai mici. Spre deosebire de punctele de control anterioare, acestea sunt specifice pentru specii si au o clasificare in trei stadii: sensibil, intermediar si rezistent.

Punctul de control sensibil este valoarea standard epidemiologica (cut-off) - aceasta defineste limita superioara a distributiilor MIC "tip salbatic" (fara mecanism de rezistenta dobandit) si poate ajuta la detectarea aparitiei unor tulpini de Candida cu sensibilitate redusa.1 pentru C. albicans, pentru toate cele trei echinocandine, noul punct de control MIC pentru sensibilitate este ≤0.25, punctul de control intermediar este 0.5, iar punctul de control de rezistenta este ≥1.

Profesorul Pfaller a precizat ca tulpinile cu mutatii Fks nu sunt intotdeauna rezistente la echinocandine insa se pot afla in grupul intermediar de sensibilitate. El a comentat ca frecventa tulpinilor ne-sensibile de Candida difera de la o specie la alta, in functie de varsta pacientului si regiunea geografica. De mare ingrijorare, in special in America de Nord, este aparitia rezistentei la echinocandin (si azol) a izolatilor de C. glabrata.

Dezvoltarea rezistentei la echinocandin care conduce la esec clinic este asociata cu substituirile de amino acizi in subunitatile Fks ale sintazei de glucan (tinta pentru echinocandin) care scade sensibilitatea enzimelor la agentul antifungic.

Totusi, David Perlin (New Jersey Medical School, SUA) a subliniat ca nu toate mutatiile Fks au acelati potential de esec al tratamentului. Tot el a notat ca experimentele au aratat ca rezistenta asociata cu mutatiile Fks poate veni cu un cost in ceea ce priveste starea celulei, ceea ce ar putea explica nivelul redus de rezistenta observat.

Izolatii cu scoruri MIC ridicate pot raspunde la terapie. Sintaza glucanului retine sensibilitatea la medicamentele antifungice astfel incat situatia poate fi cel mai bine descrisa ca toleranta a medicamentului mai degraba decat rezistenta, a sugerat profesorul Perlin. El spune ca esecul clinic datorat organismelor tolerante la medicamente este nefrecvent, de aproximativ 1% (poate de 3% cu C. glabrata) insa este raportat tot mai mult Bonus Fara Depunere

Relevanta clinica a izolatilor de Candida rezistenti la echinocandin a fost discutata de Luis Ostrosky-Zeichner (University of Texas, SUA). El a fost de acord ca in prezent clinicienii se confrunta cu o incidenta redusa de reaparitie a infectiei (breakthrough) (esecul tratamentului) in practica.

Spitalele raporteaza rate de reinfectare de aproximativ 2%, a spus el, adaugand ca o evaluare sistematica a pacientilor care au primit terapia cu echinocandin2 a aratat ca esecul tratamentului este mai mare in cazul Candida decat al Aspergillus.

Profesorul Ostrosky-Zeichner a spus ca reinfectarea este cea mai probabila la urmatoarele grupuri: pacienti cu transplanturi, pacienti cu malignitati hematologice sau alti pacienti cu imunodepresie; pacienti cu corpuri straine/sursa de infectie necontrolata sau pacienti cu expunere prelungita la echinocandin. Daca reinfectarea apare, optiunile sunt utilizarea unei doze mai mari de medicamente antifungic, schimbarea clasei de medicamente sau incercarea unei terapii combinate, insa toate acestea sunt abordari experimentale deocamdata.

Profesorul Ostrosky-Zeichner a spus ca datele privind strategiile cu doza ridicata sunt greu de interpretat. Totusi, a reiesit ca terapia cu doza mare de echinocandin este sigura. S-a referit la un studiu recent 3 in care se compara caspofungin 50mg/zi (dupa o doza de atac de 70mg) sau 150mg/zi.

Efectele secundare au fost similare la cele doua grupuri. Au existat de asemenea semne ca doza mare poate fi mai eficienta, cu un raspuns general favorabil mai ridicat la sfarsitul tratamentului (71.6% vs. 77.9%) si o recidiva mai redusa la doua saptamani (8.2% vs. 1.7%).

William Hope (Manchester, UK) a mentionat ca datele farmacokinetice/farmacodinamice privind tratamentul candidozei nesensibile la echinocandin sunt inca limitate. El a fost de acord ca echinocandinele au un index terapeutic larg si sunt netoxice chiar si in doze mari, ex. micafungin 800mg/zi sau caspofungin 150mg/zi. Dar si-a exprimat de asemenea dubiile daca este posibila administrarea unei cantitati suficiente de medicament antifungic pentru a "invinge" si trata adecvat o mutatie Fks1.

Profesorul a raportat date de pe un model de C. albicans de la soareci cu mutatie Fks1 ser645 care nu era tratabila chiar si la doze mari de echinocandin. Parerea sa este ca izolatii cu aceste mutatii ar trebui considerati rezistenti si nu tratati in continuare cu echinocandin. Este neclar, spune el, daca si alte mutatii sau mutatii in alte specii de Candida vor raspunde diferit.

(Joanna Lumb, editor medical, Londra, Regatul Unit)

Referinte

1. Pfaller MA, Boyken L, Hollis RJ, et al. Wild-type MIC distributions and epidemiological cutoff values for the echinocandins and Candida spp. (Distributii MIC "tip salbatic" si valori standard epidemiologice pentru echinocandine si Candida spp.) J Clin Microbiol 2010;48:52-6.

2. Sun HY, Singh N. Characterisation of breakthrough invasive mycoses in echinocandin recipients: an evidence-based review. (Caracterizarea micozelor invazive recidivante la pacientii tratati cu echinocandin: analiza bazata pe evidente) Int J Antimicrob Agents 2010;35:211-8.

3. Betts RF, Nucci M, Talwar D, et al. A multicenter, double-blind trial of a high-dose caspofungin treatment regimen versus a standard caspofungin treatment regimen for adult patients with invasive candidiasis (Studiu multicentric, dublu-orb al unui regim de tratament cu doza mare de caspofungin vs. un regim de tratament standard cu caspofungin la pacientii adulti cu candidoza invaziva). Clin Infect Dis 2009;48:1676-84.

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Sunteti de acord cu modificarea examenului de rezidentiat propusa de ministrul Sanatatii?
Da
40%
Nu
60%
Total voturi: 5