Retrospective Analysis of 30 Patients Who Underwent Liver Transplantation Without Use of Steroids G. Tisone, M. Angelico, G. Orlando, G.P. Palmieri, F. Strati, D. Di Paolo, and C.U. Casciani S INCE the early 1960s, steroids (S) have always been considered a mainstone in the immunosuppressive therapy for liver transplantation (LTx). 1 Despite the intro- duction of several new and powerful immunosuppressants, S are still commonly used in LTx. Since the beginning of the 1990s, some authors have proposed S withdrawal at differ- ent times after the operation. 2–4 At our institution, we have carried out a prospective randomized trial comparing the classic triple-immunosuppressive regimen consisting in cy- closporine A, azathioprine, and prednisone versus double therapy without prednisone. This has led to the suspension of S therapy as well as protocol biopsies. The aim of this study was to retrospectively analyze the entire series of 30 patients (pts) who underwent LTx without use of S. PATIENTS AND METHODS Thirty pts were considered for the present study. There were 24 males and 6 females. Mean age was 50.6 years (range: 31–59). UNOS status was I for 3 pts, II for 10 pts, and III for 17 pts. Mean follow-up was 16.6 months (range: 3–33). Pts with follow-up less than 3 months were excluded. Indications to LTx were post- hepatitis C cirrhosis (12), post-hepatitis B (HBV) cirrhosis (6), post-alcoholic cirrhosis (6), criptogenetic cirrhosis (3), Wilson disease (1), HBV-related fulminant hepatic failure (1), and primary biliary cirrhosis (1). Operation was performed according to the standard technique 5 and using veno-venous bypass. Biliary recon- struction was performed through a choledoco-choledocal anasto- mosis; a T tube was inserted. Immunosuppression was based on Neoral (cyclosporine A mi- croemulsion) and azathioprine. Cyclosporine A was started at a dosage of 8 mg/kg per day; daily doses were then adjusted depending on blood through levels and side effects (deterioration of renal function, hypertension, headache, tremors, etc.). Azathio- prine was started at a dosage of 1 mg/kg per day; doses were modified according mainly to white blood cell count. Liver and kidney function, as well as cyclosporine A blood through levels, electrolytes, and blood cells were monitored daily in the first 2 weeks, every other day in the 3rd and 4th weeks, then depending on patient conditions. A color-doppler ultrasonography was performed on days 1, 7, 30, and 90 to assess graft perfusion. A trans-Kehr cholangiography was performed on days 7 and 90 to evaluate the patency of biliary anastomosis. On day 90, the T tube was removed. Protocol biopsies were routinely performed at the end of the implan- tation, on days 7, 30, and 90 and yearly for the first 23 pts, whereas just at the end of the implantation and on day 7 for the last 7 pts (unless they were HCV positive: in this case, also on day 90). To evaluate the outcome of this patient population we consid- ered the following endpoints: patient and graft survival, graft and kidney function, incidence of acute rejection, and infectious and metabolic complications. RESULTS Initial graft function was normal in 19 pts (63.3%). Nine pts (30%) had an initial poor function (defined as ALT peak 1500 U/mL plus PT 15 in the first days after the opera- tion, followed by complete normalization of both parameters), whereas 2 (6.7%) had a primary nonfunction (defined as ALT peak 1500 U/mL plus PT 15 in the first days after the operation, followed by death or re-LTx). Graft and kidney functions in the first 3 months and at 1 year after transplan- tation were good and are reported in Tables 1 and 2. Twenty-one pts (70%) experienced at least one episode of acute rejection. According to the classic grading sys- tems, 6,7 we had 7 cases of mild acute rejection, 11 of moderate, and 3 of severe. Just two cases (6.7%) of severe acute rejection were treated. Infectious complications were evaluated according with already described criteria 8 and their incidence is reported in Table 3. Twenty-one pts (70%) had 27 infectious episodes, some of them experiencing more than one episode and type of infectious complications. In particular, one patient fea- tured first a body temperature 38°C plus a WBC count 10,000 cell/mL, then a body temperature 38°C plus a WBC From the Surgical Clinic—S. Eugenio Hospital “Tor Vergata” University of Rome, Rome, Italy. Address reprint requests to Dr G. Tisone, c/o Osp. Seugenio, Clinica Chirurgica, Viale Dell’Umanesimo 10, 00144 Roma, Italy. Table 1. Liver and Kidney Function in the First 3 Months after LTx ● ALT 2 days 1035  1209 ● ALT 5 days 104  70 ● ALT 30 days 23  12 ● ALT 90 days 38  52 ● Bilirubin 7 days 14.7  7.4 ● Bilirubin 30 days 4.3  2.0 ● Bilirubin 90 days 1.4  0.9 ● Creatinine 7 days 1.7  0.4 ● Creatinine 90 days 2.0  0.3 -7 pts required dialysis 0041-1345/99/$–see front matter © 1999 by Elsevier Science Inc. PII S0041-1345(99)00611-9 655 Avenue of the Americas, New York, NY 10010 2908 Transplantation Proceedings, 31, 2908–2909 (1999)