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A prospective randomized trial of fk506 versus cyclosporine after human pulmonary transplantation

Griffith, BP and Bando, KO and Hardesty, RL and Armitage, JM and Keenan, RJ and Pham, SM and Paradis, IL and Yousem, SA and Komatsu, K and Konishi, H and Fung, JJ and Starzl, TE (1994) A prospective randomized trial of fk506 versus cyclosporine after human pulmonary transplantation. Transplantation, 57 (6). 848 - 851. ISSN 0041-1337

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We have conducted a unique prospective randomized study to compare the effect of PK506 and cyclosporine (CsA) as the principal immunosuppressive agents after pulmonary transplantation. Between October 1991 and March 1993, 74 lung transplants (35 single lung transplants [SLT], 39 bilateral lung transplant [BLT]) were performed on 74 recipients who were randomly assigned to receive either FK or CsA. Thirty-eight recipients (19 SLT, 19 BLT) received FK and 36 recipients (16 SLT, 20 BLT) received CsA. Recipients receiving FK or CsA were similar in age, gender, preoperative New York Heart Association functional class, and underlying disease. Acute rejection (ACR) was assessed by clinical, radiographic, and histologic criteria. ACR was treated with methylprednisolone, 1 g i.v./day, for three days or rabbit antithymocyte globulin if steroid-resistant.During the first 30 days after transplant, one patient in the FK group died of cerebral edema, while two recipients treated with CsA died of bacterial pneumonia (1) and cardiac arrest (1) (P=NS). Although one-year survival was similar between the groups, the number of recipients free from ACR in the FK group was significantly higher as compared with the CsA group (P<0.05). Bacterial and viral pneumonias were the major causes of late graft failure in both groups. The mean number of episodes of ACR/ 100 patient days was significantly fewer in the FK group (1.2) as compared with the CsA group (2.0) (P<0.05). While only one recipient (1/36=3%) in the group treated with CsA remained free from ACR within 120 days of transplantation, 13% (5/38) of the group treated with FK remained free from ACR during this interval (P<0.05). The prevalence of bacterial infection in the CsA group was 1.5 episodes/100 patient days and 0.6 episodes/100 patient days in the FK group. The prevalence of cytomegaloviral and fungal infection was similar in both groups.Although the presence of bacterial, fungal, and viral infections was similar in the two groups, ACR occurred less frequently in the FK-treated group as compared with the CsA-treated group in the early postoperative period (<90 days). Early graft survival at 30 days was similar in the two groups, but intermediate graft survival at 6 months was better in the FK group as compared with the CsA group. © 1994 by Williams and Wilkins.


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Item Type: Article
Status: Published
CreatorsEmailPitt UsernameORCID
Griffith, BP
Bando, KO
Hardesty, RL
Armitage, JM
Keenan, RJ
Pham, SM
Paradis, IL
Yousem, SAyousem@pitt.eduYOUSEM
Komatsu, K
Konishi, H
Fung, JJ
Starzl, TEtes11@pitt.eduTES11
Centers: Other Centers, Institutes, Offices, or Units > Thomas E. Starzl Transplantation Institute
Date: 1 January 1994
Date Type: Publication
Journal or Publication Title: Transplantation
Volume: 57
Number: 6
Page Range: 848 - 851
DOI or Unique Handle: 10.1097/00007890-199403270-00013
Institution: University of Pittsburgh
Refereed: Yes
ISSN: 0041-1337
Other ID: uls-drl:31735062113596, Starzl CV No. 1568
Date Deposited: 08 Apr 2010 17:26
Last Modified: 02 Feb 2019 13:56


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