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  • Esmore DS
  • Spratt PM
  • Keogh AM
  • Chang VP
J Heart Transplant. 1989 May-Jun;8(3):194-9.

Since the commencement of the St. Vincent's Transplant Programme, 41 patients have undergone orthotopic heart transplantation, with low-dose cyclosporine and prednisolone as maintenance immunosuppression. An actuarial survival rate of 75% at 1 year resulted. To reduce early rejection-related death, azathioprine was chosen as an augmenting immunosuppressive agent to be administered as a prospective randomized trial. Sixty patients were randomized; 29 received low-dose cyclosporine plus azathioprine plus prednisolone (group A). Thirty-one patients received cyclosporine and azathioprine alone (group B). Both groups received a 7-day course of antithymocyte gamma globulin. One group B patient who underwent retransplantation was not analyzed. Actuarial survival for group A was 92% and group B 93%. The overall incidence of rejection for group A was 1.1 per patient and group B, overall, 2.3 episodes per patient. Group B patients who had persistent rejections were converted to group A protocol. Nine group B patients (30%) required conversion to maintenance steroids (group C). The overall incidence of infection was 1.6 episodes per patient and 1.3 episodes per patient for group A and group B, respectively. Two early deaths in group B and one in group A were unrelated to immunosuppressive protocol. One group A patient died at day 280 of multiorgan failure. There were no rejection- or infection-related deaths in the series. Hypertension occurred with equal frequency in both study groups. The cyclosporine and azathioprine protocol produces actuarial survival and morbidity rates comparable to those of a matched triple-therapy group. Thirty percent of patients in this protocol, however, will require maintenance steroids.

  • Kobashigawa J
  • Stevenson LW
  • Moriguchi J
  • Westlake C
  • Wilmarth J
  • et al.
J Heart Transplant. 1989 Jan-Feb;8(1):53-8.

Mild acute rejection progresses to moderate rejection in approximately one third of the cases. Standard rejection therapy would then be instituted with the attendant risk of infection and other side effects. We randomized 40 episodes of mild acute rejection (20 episodes in each group) to receive no additional therapy or to have the oral cyclosporine dose increased for 7 to 10 days with repeat endomyocardial biopsy performed. In the group with no additional therapy 30% progressed to moderate rejection, whereas in the group with increased doses of oral cyclosporine, 10% progressed to moderate rejection (p = 0.10). As the purpose of our study was to assess the efficacy of increased cyclosporine levels for preventing progression from mild to moderate rejection, the treated group was redefined according to whether the cyclosporine level increased by greater than or equal to 50% during the study. In this treated group average cyclosporine levels increased from 169 +/- 78 to 413 +/- 267 ng/ml. Progression to moderate rejection occurred in one of 21 cases (5%) compared with seven of 19 cases (37%) in the group without an increase in cyclosporine level (p less than 0.05). The transient increase in cyclosporine levels was well tolerated. This study demonstrates that the use of high dose oral cyclosporine to treat mild acute rejection is well tolerated and may reduce progression to moderate rejection when a significant increase in cyclosporine level is achieved.

  • Millis JM
  • McDiarmid SV
  • Hiatt JR
  • Brems JJ
  • Colonna JO
  • et al.

A group of 52 liver transplant patients was prospectively randomized to receive prophylactic immunosuppressive therapy consisting of either Orthoclone OKT3 for 14 days, azathioprine, and steroids (25 patients); or cyclosporine, azathioprine, and steroids (27 patients). The groups were similarly matched for age, diagnosis, and Child's classification. The patients were studied to determine the effect of these two regimens on the incidence of rejection, infection, renal dysfunction, and mortality. Seven rejection episodes, as determined by clinical and histological criteria, occurred in seven of 25 patients (28%) receiving OKT3 compared with 18 episodes in 27 patients (67%) receiving cyclosporine during the first 14 days after transplantation (P less than 0.02). In 20% of the OKT3 patients, CD3+ levels of greater than 10% developed during therapy, and 16% of the patients developed anti-OKT3 antibodies during OKT3 treatment. Five patients were retreated with OKT3 for steroid-resistant acute rejection episodes; all had resolution of the rejection episode. Infectious complications were similar in each group. Renal function, as measured by serum creatinine, was significantly better with OKT3 than with cyclosporine (P less than 0.003) at 14 days. We conclude that prophylactic OKT3 is effective in reducing the number of early rejection episodes after liver transplantation; after 14 days the incidence of rejection is similar; reuse of OKT3 has been successful in liver transplant patients; infectious complications are similar between OKT3 and cyclosporine; and OKT3 preserves renal function better than cyclosporine and is thus indicated in patients with compromised preoperative renal function.

  • Hegewald MG
  • O'Connell JB
  • Renlund DG
  • Lee HR
  • Burton NA
  • et al.
J Heart Transplant. 1989 Jul-Aug;8(4):303-9; discussion 309-10.

We have previously reported that murine antihuman monoclonal antibody OKT3 (Orthoclone OKT3) given for 14 days after heart transplantation is effective as immunosuppressive prophylaxis. The optimal protocol for OKT3 prophylaxis in heart transplantation is unknown, particularly the duration of OKT3 therapy. We conducted a consecutively allocated overlapping 6-month study with 68 heart transplant patients, comparing 14-day OKT3 (n = 34) to 10-day OKT3 treatment (n = 34). Both protocols included OKT3 given beginning 24 to 48 hours after operation, cyclosporine beginning on postoperative day 3, low-dosage steroids and azathioprine to prevent antibody production to OKT3, and a steroid pulse plus randomization to plus or minus vincristine after stopping OKT3. Pretransplant characteristics including age, sex, cause of congestive heart failure, and absence of positive pretransplant crossmatch were similar between the two groups. Although the infection rate was not significantly different between the two groups and mortality (one patient in each group) did not differ, 14-day prophylaxis decreased the number of treated rejection episodes per patient for the 6-month study (1.59 +/- 0.18 versus 2.24 +/- 0.19, p = 0.016). A 14-day course of OKT3 also decreased the risk of rejection during the 6-month follow-up period (p less than 0.05). In addition to having a decreased number of rejection episodes, patients in the 14-day protocol were also more likely to be withdrawn from maintenance steroids (79% versus 53%, p = 0.02). In conclusion, a measurable dose response efficacy can be demonstrated for 14-day versus 10-day OKT3 prophylaxis.(ABSTRACT TRUNCATED AT 250 WORDS)

  • van Dorp WT
  • Kootte AM
  • van Gemert GW
  • van Es LA
  • Paul LC
Scand J Infect Dis. 1989;21(1):75-80 doi: 10.3109/00365548909035683.

The incidence and severity of infectious complications were retrospectively investigated in 80 renal transplant patients who had been selected randomly to receive either cyclosporine (CsA) or azathioprine (Aza) in combination with low doses of corticosteroids. In the first 3 months, the incidence of infections was twice as high in the Aza-treated patients (p less than 0.05) which was due to an increase of predominantly minor infections. This increased incidence of infections was related to the increased number of anti-rejection treatments in the Aza-treated group. The types of infections were not different between the 2 treatment groups nor did the incidence of CMV infections differ. In the CsA-treated group, patients were randomly assigned at 3 months after transplantation to either continuation of CsA therapy or conversion to Aza. After conversion a small but not significant increase in predominantly minor infections was observed, which may be attributable to increased doses of corticosteroids given during the conversion. We conclude that in the first 3 months following transplantation, CsA therapy is associated with significantly less infections than Aza therapy; following conversion of CsA to Aza at 3 months only a small increase in the infection incidence is found.

  • van Dorp W.T
  • van Es LA
  • van Gemert GW
  • van der Woude FJ
Nephrol Dial Transplant. 1989;4(5):509.
XXVI Annual Congress of the European Renal Association
  • Snydman DR
  • Werner BG
  • Tilney NL
  • Kirkman RL
  • Milford EL
  • et al.
Transplant Proc. 1988 Dec;20(6 Suppl 8):24-30.
  • Brayman KL
  • Dafoe DC
  • Smythe WR
  • Barker CF
  • Perloff LJ
  • et al.
Arch Surg. 1988 Dec;123(12):1502-8 doi: 10.1001/archsurg.1988.01400360072012.

We report the interim results of a randomized, double-blind, placebo-controlled, clinical trial of prophylactic, live, attenuated cytomegalovirus (CMV) vaccination (Towne strain of CMV) of renal transplant candidates (RTCs). One hundred seventy-two RTCs were treated and subsequently underwent transplantation and followed up for at least one year and up to five years after transplantation. Eighty-eight RTCs received vaccine, and 84 received placebo. Results were analyzed according to the prevaccination serologic status (anti-CMV antibody titer) of the recipient (R- or R+) and the donor (D- or D+). The overall incidence of CMV disease was highest in the R-D+ group and almost absent in the R-D- group. There was no difference in the incidence of CMV infection or disease between vaccinated and respective placebo control recipients in either the R-D+, R+D+, R+D-, or R-D- groups. In contrast, the severity of CMV disease was significantly decreased in R-D+ vaccinees vs R-D+ placebo-treated recipients. Moreover, in the R-D+ group, one- and five-year cadaver renal allograft actuarial survival rates were 73% and 62%, respectively, for CMV vaccinees vs 40% and 25%, respectively, for control placebo patients. We conclude that seronegative cadaver RTCs may benefit from vaccination with live, attenuated, Towne strain CMV vaccine before transplantation.

  • Evans CM
  • Purohit S
  • Colbert JW
  • Lear PA
  • Makin T
  • et al.
J Antimicrob Chemother. 1988 Sep;22(3):363-9 doi: 10.1093/jac/22.3.363.

A randomized, controlled trial of the use of amoxycillin with clavulanic acid (Augmentin) for prophylaxis against wound infections following major surgery, including transplantation, in patients with chronic renal failure, was undertaken. Six of 22 control patients developed wound infections (27%) whereas no patient in the treatment group (24) developed a wound infection (P less than 0.05). After the termination of this trial, the next 35 consecutive patients received prophylactic amoxycillin/clavulanate; of these only two developed wound infections associated with leakage from their pancreatic anastomoses. All the wound infections were shown to be caused by bacteria sensitive to amoxycillin/clavulanate. Pharmacokinetic studies in patients have shown that a bactericidal concentration of the drugs was present for up to 20 h post-operatively in patients on dialysis, and in recipients of non-functioning renal transplants. In patients with normal renal transplant function excretion of the drug within 12 h was observed.

  • Waer M
  • Vanrenterghem Y
  • Roels L
  • Verberckmoes R
  • Hauglustaine D
  • et al.
Transpl Int. 1988 Jul;1(2):64-8 doi: 10.1007/BF00353821.

A total of 20 renal transplant patients with end-stage diabetic nephropathy entered a randomized controlled trial comparing preoperative, fractionated total lymphoid irradiation (TLI) (radiation dose, 20-30 Gy) with postoperative cyclosporin A (CsA). Both groups received postoperative low-dose methylprednisolone maintenance therapy. The 3-year patient and graft survival was similar for both groups (100% and 71% in the TLI and 75% and 75% in the CsA group, respectively). Rejection crises occurred significantly more frequently (P less than 0.01) in the TLI-treated recipients. The incidence of infectious or diabetic complications was not significantly different in both groups. It is concluded that TLI and CsA are both effective treatment modalities for cadaveric renal transplantation in diabetics; CsA, however, is superior in preventing rejection crises.