UNTIL last year, the kidney was the only organ which had been transplanted with subsequent significant prolongation of life. There had been nine reported attempts at orthotopic liver transplantation; seven in Denver 2 2 + 2 3 and one each in Bostonle and P a r i~.~ Two of these patients had succumbed within a few hours after operat i~n ,~, 22 and none had lived for longer than 23 days.This dismal picture has changed within the last 9 months, inasmuch as seven consecutive patients treated with orthotopic liver transplantation from July 23, 1967 to March 17, 1968 all passed through this previously lethal operative and postoperative period. Three of the recipients are still alive after 9, 23$, and 1 months; the others died after 2, 3%, 454, and 6 months.
MethodsThe Recipients. Summary information for the seven patients is given in Table 1. Their ages were 13 months to 16 years. Six were females. The indications for transplantation, which had been established by earlier explorations at other hospitals, were
Results at 12 months suggest that sirolimus can be used as base therapy in the prophylaxis of acute renal transplant rejection, and has a safety profile that differs from CsA.
Sirolimus and cyclosporine (CsA) prevent acute rejection in man when used as primary therapies in triple drug regimens. Sirolimus does not act via the calcineurin pathway and therefore is not expected to produce the same renal side-effects. This paper presents the pooled 2-year data analysis of renal function parameters from two open-label, randomized, multicenter studies. Patients (18-68 years) receiving a primary renal allograft were randomized to receive concentration-controlled sirolimus (n Ω 81) or CsA (n Ω 80), in combination with azathioprine and steroids (n Ω 83), or mycophenolate mofetil (MMF) and steroids (n Ω 78). From week 10 through year 2, calculated glomerular filtration rate (GFR) was significantly higher in sirolimus-than in CsA-treated patients (69.3 vs. 56.8 mL/min, at 2 years, p Ω0.004). Serum uric acid was significantly higher in the CsA-treated patients and magnesium was significantly lower; these parameters were more likely to be within normal limits in the sirolimus group. Mean serum potassium and phosphorus were lower in sirolimus-treated patients. In conclusion, sirolimus, when administered as primary therapy in combination with azathioprine or MMF, has a favorable safety profile compared to CsA with regards to renal function.
MMF proved superior to AZA as a posttransplant immunosuppressant in conjunction with cyclosporine and corticosteroids. MMF-treated groups showed reduced incidence and severity of rejection episodes, similar graft survival, and better graft function over 12 months.
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