Current immunosuppression protocols in heart transplantation commonly employ an inductive phase preoperatively, which often is followed by triple therapy (azathioprine, cyclosporine, and prednisone). From 1981 to June 1987, 119 heart transplants were performed in 114 patients. Group I (n = 19) received cyclosporine preoperatively and postoperatively, as well as steroid intraoperatively and postoperatively. Group II (n = 100) received antilymphocyte globulin postoperatively and interval cyclosporine orally 5 to 7 days postoperatively when the antilymphoblast globulin was discontinued. Methylprednisolone was given intraoperatively, and 1 mg/kg was given postoperatively. Steroid was tapered to 20 mg/day within 4 weeks. Cyclosporine was removed from the early postoperative regimen to reduce the deleterious renal effects. Steroid was used in low doses and tapered quickly to lessen steroid-related complications. There was one cyclosporine-related kidney failure in group I and none in group II. In no patient was cyclosporine discontinued because of adverse effects. The rate of rejection remains acceptable. There have been eight deaths as a result of rejection (three in group I and five in group II). Three patients have died of infection (one in group I and two in group II). Since January 1987 no postoperative protective isolation has been used. Overall survival is 77%, and no patient has exhibited late coronary atherosclerosis on follow-up coronary angiography. The regimen of immunosuppression that has evolved is safe and effective and has long-term benefits.

Antilymphocyte Serum↗

PubMedDate not supplied

Clinical trials of cyclosporin in IDDM.

The results of uncontrolled trials in immunomodulation of insulin-dependent diabetes mellitus (IDDM) led to randomized controlled trials in Canada and Europe. In the Canadian open study, the rate of clinical remissions (target control of glycemia maintained with less than or equal to 0.15 U.kg-1.day-1 insulin) was unexpectedly high among 81 subjects who had been treated with cyclosporin for at least 3 mo (mean serum trough levels approximately 125 ng/ml by radioimmunoassay). Subjects entered the study within 14 wk of onset of symptoms and received 6 wk of insulin therapy. The clinical remission rate at 1 yr was 46%; of these patients, 84% were not receiving insulin. An effect on beta-cell function was suggested by recovery of plasma glucagon-stimulated C-peptide levels into the normal range in many patients, with maintenance of levels through 1 yr in patients in remission. On the basis of these findings, the French and Canadian-European study groups conducted randomized double-blind controlled trials of cyclosporin, which confirmed the results of the open studies in terms of clinical remission. The Canadian-European study also demonstrated enhancement of beta-cell function by cyclosporin by 3 mo, which was maintained for 1 yr. In the Canadian open study, most patients relapsed within a few weeks after discontinuation of cyclosporin, indicating the need for longer-term immunomodulatory therapy for maintenance of remission. The nature and degree of structural change in kidney biopsies from patients in these studies are under assessment. The results strongly support the hypothesis that autoimmune mechanisms mediate beta-cell damage in many patients with IDDM.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMedDate not supplied

The side effects of cyclosporin A: clinical and histologic findings following 31 canine heterotopic cardiac allotransplants.

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Animals↗