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Titolo:
A COMPARISON OF TACROLIMUS (FK-506) AND CYCLOSPORINE FOR IMMUNOSUPPRESSION IN LIVER-TRANSPLANTATION
Autore:
BUSUTTIL RW; MCDIARMID S; KLINTMALM GB; GOLDSTEIN R; MILLER CM; SCHWARTZ M; SHAW BW; ROBERTS JP; HEBERT MF; ESQUIVEL CO; NAKAZATO P; WIESNER RH; KROM RAF; KALAYOGLU M; DALESSANDRO AM; MARSH JW; PETERS MG; BURDICK J; KLEIN A; LEWIS WD; JENKINS R; THISTLETHWAITE JR; EMOND JC; JUSKO WJ; DAMBROSIO R; BUELL D; FITZSIMMONS WE;
Indirizzi:
BAYLOR UNIV,MED CTR,3500 GASTON AVE DALLAS TX 75246 BAYLOR UNIV,MED CTR DALLAS TX 75246 UNIV CALIF LOS ANGELES LOS ANGELES CA 00000 MT SINAI MED CTR NEW YORK NY 10029 UNIV NEBRASKA OMAHA NE 68182 UNIV CALIF SAN FRANCISCO SAN FRANCISCO CA 00000 CALIF PACIFIC MED CTR SAN FRANCISCO CA 00000 MAYO CLIN & MAYO FDN ROCHESTER MN 55905 UNIV WISCONSIN MADISON WI 00000 WASHINGTON UNIV,SCH MED ST LOUIS MO 00000 JOHNS HOPKINS UNIV HOSP BALTIMORE MD 00000 NEW ENGLAND DEACONESS HOSP BOSTON MA 00000 UNIV CHICAGO CHICAGO IL 60637 SUNY COLL BUFFALO BUFFALO NY 00000 FUJISAWA USA DEERFIELD IL 00000
Titolo Testata:
The New England journal of medicine
fascicolo: 17, volume: 331, anno: 1994,
pagine: 1110 - 1115
SICI:
0028-4793(1994)331:17<1110:ACOT(A>2.0.ZU;2-X
Fonte:
ISI
Lingua:
ENG
Soggetto:
FK-506 IMMUNOSUPPRESSION; RESCUE IMMUNOSUPPRESSION; CARDIAC TRANSPLANTATION; ALLOGRAFT SURVIVAL; CLINICAL-TRIAL; FK506; STREPTOMYCES; EXPERIENCE; INVITRO; RATS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
41
Recensione:
Indirizzi per estratti:
Citazione:
R.W. Busuttil et al., "A COMPARISON OF TACROLIMUS (FK-506) AND CYCLOSPORINE FOR IMMUNOSUPPRESSION IN LIVER-TRANSPLANTATION", The New England journal of medicine, 331(17), 1994, pp. 1110-1115

Abstract

Background. Tacrolimus (FK 506), a macrolide compound isolated from abacterium, is a potent immunosuppressant with activity in solid-organtransplants. Most immunosuppressive regimens for liver transplantation are based on cyclosporine. Methods. We conducted an open-label, randomized, multicenter trial to compare the efficacy and safety of tacrolimus-based and cyclosporine-based immunosuppressive regimens for patients receiving a first liver transplant. A total of 478 adults and 51 children (less than or equal to 12 years of age) were randomly assignedat the time of transplantation to receive tacrolimus (n = 263) or cyclosporine (n = 266) and were followed for one year. The primary end points were patient and graft survival at one year. The secondary end points were the incidence of acute rejection, corticosteroid-resistant rejection, and refractory rejection (continued rejection after two courses of corticosteroids and an intervening course of muromonab-CD3). Results. According to Kaplan-Meier analysis, actuarial patient-survival rates at day 360 were 88 percent for both the tacrolimus and cyclosporine groups (P = 0.85; 95 percent confidence interval for the difference, -5.4 to 6.6 percent), and graft-survival rates were 82 percent and 79 percent, respectively (P = 0.55; 95 percent confidence interval forthe difference, -4.8 to 9.7 percent). Acute rejection occurred in 154patients in the tacrolimus group and 173 patients in the cyclosporinegroup (P<0.002), corticosteroid-resistant rejection occurred in 43 and 82 patients, respectively (P<0.001), and refractory rejection occurred in 6 and 32 patients, respectively (P<0.001). Tacrolimus was associated with a higher incidence of adverse events requiring withdrawal from the study, primarily nephrotoxicity and neurotoxicity; 37 patients in the tacrolimus group and 13 in the cyclosporine group discontinued the study because of adverse events (P<0.001). Conclusions. After one year, immunosuppressive regimens based on tacrolimus and cyclosporine were comparable in terms of patient and graft survival. Tacrolimus wasassociated with significantly fewer episodes of acute, corticosteroid-resistant, or refractory rejection, but substantially more adverse events requiring discontinuation of the drug.

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Documento generato il 16/07/20 alle ore 16:45:38