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Biomedical subjects

W Irish

Publications and source records attributed to W Irish.

At least 37 records · Page 2Linked to original sources
PubMed1998

A prospective, randomized trial to compare tacrolimus and prednisone with and without mycophenolate mofetil in patients undergoing renal transplantation: first report.

PURPOSE: Between September 20, 1995 and September 20, 1996, 120 patients were entered into a prospective, randomized trial comparing tacrolimus and prednisone with (61) and without (59) 2 gm. mycophenolate mofetil daily to determine whether mycophenolate mofetil was associated with a lower incidence of rejection. MATERIALS AND METHODS: Mean recipient age plus or minus standard deviation was 50.8+/-14.1 years (range 18.8 to 84.1). Mean donor age was 34.3+/-21.7 years (range 0.01 to 76). Of the donors 18 (15%) were older than 60 years. Mean cold ischemia time was 30.9+/-8.4 hours (range 14.2 to 49). Median followup was 8.6+/-0.5 months. RESULTS: The 6-month actuarial patient survival was 95%, 92% in the double therapy group and 98% in the triple therapy group (not significant). The 6-month actuarial graft survival was 88%, 84% in the double therapy group and 92% in the triple therapy group (not significant). The overall incidence of rejection and steroid resistant rejection was 34.2 and 4.2%, respectively. There was a strong trend toward less rejection in the mycophenolate mofetil group than in the double therapy group (26.2 versus 42.4%). Crossover was common, and was 42.6% from triple to double therapy and 18.6% from double to triple therapy. The reasons for discontinuation of mycophenolate mofetil were gastrointestinal toxicity, primarily diarrhea, or less commonly hematological toxicity, primarily neutropenia or thrombocytopenia. Gastrointestinal toxicity was ameliorated by separating the doses of tacrolimus and mycophenolate mofetil by 2 to 4 hours, and reducing the dose to 1 gm. daily. CONCLUSIONS: Mycophenolate mofetil appears to be a useful third agent with tacrolimus in patients undergoing renal transplantation, and is associated with a reduction in the rate of rejection and a low incidence of steroid resistant rejection. There is a high incidence of gastrointestinal toxicity associated with the 2 gm. daily dose but this complication is relatively straightforward to manage.

Actuarial Analysis↗
PubMed1997

Weaning of immunosuppression in liver transplant recipients.

Immunosuppression has been sporadically discontinued by noncompliant liver allograft recipients for whom an additional 4 1/2 years of follow-up is provided. These anecdotal observations prompted a previously reported prospective drug withdrawal program in 59 liver recipients. This prospective series has been increased to 95 patients whose weaning was begun between June 1992 and March 1996, 8.4+/-4.4 (SD) years after liver replacement. A further 4 1/2 years follow-up was obtained of the 5 self-weaned patients. The prospectively weaned recipients (93 livers; 2 liver/kidney) had undergone transplantation under immunosuppression based on azathioprine (AZA, through 1979), cyclosporine (CsA, 1980-1989), or tacrolimus (TAC, 1989-1994). In patients on CsA or TAC based cocktails, the adjunct drugs were weaned first in the early part of the trial. Since 1994, the T cell-directed drugs were weaned first. Three of the 5 original self-weaned recipients remain well after drug-free intervals of 14 to 17 years. A fourth patient died in a vehicular accident after 11 years off immunosuppression, and the fifth patient underwent retransplantation because of hepatitis C infection after 9 drug-free years; their allografts had no histopathologic evidence of rejection. Eighteen (19%) of the 95 patients in the prospective series have been drug free for from 10 months to 4.8 years. In the total group, 18 (19%) have had biopsy proved acute rejection; 7 (7%) had a presumed acute rejection without biopsy; 37 (39%) are still weaning; and 12 (13%, all well) were withdrawn from the protocol at reduced immunosuppression because of noncompliance (n=8), recurrent PBC (n=2), pregnancy (n=1), and renal failure necessitating kidney transplantation (n=1). No patients were formally diagnosed with chronic rejection, but 3 (3%) were placed back on preexisting immunosuppression or switched from cyclosporine (CsA) to tacrolimus (TAC) because of histopathologic evidence of duct injury. Two patients with normal liver function died during the trial, both from complications of prior chronic immunosuppression. No grafts suffered permanent functional impairment and only one patient developed temporary jaundice. Long surviving liver transplant recipients are systematically overimmunosuppressed. Consequently, drug weaning, whether incomplete or complete, is an important management strategy providing it is done slowly under careful physician surveillance. Complete weaning from CsA-based regimens has been difficult. Disease recurrence during drug withdrawal was documented in 2 of 13 patients with PBC and could be a risk with other autoimmune disorders.

Adult↗
PubMed1997

Gastrointestinal bleeding after liver transplantation.

To investigate the causes of gastrointestinal bleeding (GIB) and its impact on patient and graft survival after orthotopic liver transplantation (OLTx), the first 1000 consecutive OLTx using tacrolimus were studied. Our patient population consisted of 834 adults. The bleeding episodes of patients with GIB (n=74) were analyzed, and patients without GIB (n=760) were used as controls. The mean age, gender, and United Network for Organ Sharing status were similar in both groups. Endoscopy was done in 73 patients with GIB and yielded a diagnosis in 60 patients (82.2%): 39 with a single, and 21 with multiple GIB episodes. In the remaining 13 patients (17.8%), the bleeding source was not identified. Of 92 GIB episodes with endoscopic diagnoses, ulcers (n=25) were the most common cause of bleeding, followed by enteritis (n=24), portal hypertensive lesions (n=15), Roux-en-Y bleeds, and other miscellaneous events (n=28). The majority (73%) of the GIB episodes occurred during the first postoperative trimester. The patient and graft survival rates were statistically lower in the GIB group compared with the control group. The adjusted relative risk of mortality and graft failure was increased by bleeding. In summary, the cumulative incidence of GIB was 8.9%. Endoscopy identified the source of GIB in most cases. Ulcers were the most common cause of GIB after OLTx. The onset of GIB after OLTx was an indicator of decreased patient and graft survival.

Adolescent↗
PubMed1997

Factors determining the rate of referral, transplantation, and survival on dialysis in women with ESRD.

The determinants of referral for transplantation in women have not been well-studied. Similarly, factors determining survival on dialysis and the rate of transplantation in women remain controversial. Women have been reported to have lower rates of transplantation than men, and black women have the lowest rates of all groups. We questioned whether black women were referred at lower rates than whites and if race and other socioeconomic factors predicted referral, rate of renal transplantation, and patient survival on dialysis. All women in Allegheny or Philadelphia counties in Pennsylvania initiating dialysis between January 1, 1990, and December 31, 1992, were eligible for this study. Information was requested by questionnaire from each dialysis unit in these areas. Of the 383 eligible patients, completed questionnaires were obtained for 276 (72%). Ninety-three (54.7%) of the black patients and 57 (53.8%) of the white patients were referred for transplantation (P = 0.8). Declining the transplant option was the most common reason for nonreferral in both races. Patients with high school or greater education were approximately twice as likely to be referred than those with grade school educations (odds ratio [OR], 2.2; P = 0.04). Patients with coexisting illness were 67% (OR, 0.33; P = 0.004) less likely to be referred compared with patients with no other illnesses. Each additional year of age reduced the chances of being referred by 6% (OR, 0.94; P = 0.0001). Homemakers were 83% (P = 0.0008) and others 55% (P = 0.07) less likely to be referred compared with employed patients. Patients in Philadelphia County were 56% less likely to be referred compared with those in Allegheny County (P = 0.024). Race was not significantly associated with referral. Predictors of transplantation included age (RR, 0.96; confidence interval [CI], 0.93 to 0.99; P = 0.13), white race (RR, 2.2; CI, 1.3 to 4.0; P = 0.0053), presence of other illnesses (RR, 0.37; CI, 0.21 to 0.65; P = 0.0006), and employment status. White homemakers were 86% (RR, 0.14; CI, 0.03 to 0.6; P = 0.0082) less likely than those with other employment situations to receive a transplant. Factors predicting patient survival on dialysis included race, educational status, and presence of comorbid illnesses. White patients were approximately four times (RR, 3.7; CI, 1.7 to 8.1; P = 0.002) more likely to die than black patients. Patients with high school or greater education were 56% (RR, 0.44; CI, 0.2 to 0.92; P = 0.008) less likely to die than those with grade school education alone. Patients with at least one coexisting illness were approximately 1.7 times (RR, 1.68; CI, 1.1 to 2.4; P = 0.001) more likely to die than those without other illnesses. In summary, race was not a factor in referral for transplantation, but was predictive of transplantation and patient survival on dialysis. Socioeconomic factors such as educational status, age, and employment status were highly predictive of transplantation and long-term survival on hemodialysis. White homemakers unexpectedly received transplants less than any other group of dialysis patients. Further study is needed to determine why these potential transplant patients have declined or deferred transplantation.

Adolescent↗
PubMed1997

Cytomegalovirus infection after intestinal transplantation in children.

Sixteen episodes of cytomegalovirus (CMV) disease occurred in 10 of 41 children undergoing intestinal transplantation from 1990 to 1995. Stratification of CMV disease by donor (D)/recipient (R) serological status was as follows: 3 of 8, D+/R-; 3 of 9, D+/R+; 4 of 9, D-/R+; and 0 of 15, D-/R-. Treatment resulted in resolution of CMV disease in 93.3% of episodes. No deaths attributable to CMV disease occurred in this series. CMV in D+/R- children resulted in more extensive and persistent disease. However, patient and graft survival rates were similar in the different D/R subgroups and between children with and without CMV disease. Cumulative dose of steroid boluses (relative risk [RR], 1.59; 95% confidence interval [CI], 1.14-2.21) and history of steroid recycles (RR, 2.72; 95% CI, 1.21-6.13) were associated with CMV disease. These results suggest that although CMV-associated morbidity in pediatric intestinal transplant recipients was substantial, it was not associated with an increased rate of mortality or graft loss, even among high-risk D+/R- patients.

Adolescent↗
PubMed1996

Tacrolimus in pediatric renal transplantation.

Tacrolimus was used as the primary immunosuppressive agent in 69 pediatric renal transplantations between December 17, 1989, and June 30, 1995. Children undergoing concomitant or prior liver and/or intestinal transplantation were excluded from analysis. The mean recipient age was 10.3+/-5.0 years (range, 0.7-17.5 years). Seventeen (24.6%) children were undergoing retransplantation, and six (8.7%) had a panel reactive antibody level of 40% or higher. Thirty-nine (57%) cases were with cadaveric kidneys, and 30 (43%) were with living donors. The mean donor age was 28.0+/-14.7 years (range, 1.0-50.0 years), and the mean cold ischemia time for the cadaveric kidneys was 27.0+/-9.4 hr. The antigen match was 2.7+/-1.2, and the mismatch was 3.1+/-1.2. All patients received tacrolimus and steroids, without antibody induction, and 26% received azathioprine as well. The mean follow-up was 32+/-20 months. One- and 4-year actuarial patient survival rates were 100% and 95%. One- and 4-year actuarial graft survival rates were 99% and 85%. The mean serum creatinine level was 1.2+/-0.8 mg/dl, and the calculated creatinine clearance was 82+/-26 ml/min/1.73 m2. The mean tacrolimus dose was 0.22+/-0.14 mg/ kg/day, and the level was 9.5+/-4.8 ng/ml. The mean prednisone dose was 2.1+/-4.9 mg/day (0.07+/-0.17 mg/kg/day), and 73% of successfully transplanted children were off prednisone. Seventy-nine percent were not taking any antihypertensive medications. The mean serum cholesterol level was 158+/-54 mg/dl. The incidence of delayed graft function was 4.3%. The incidence of rejection was 49%, and the incidence of steroid-resistant rejection was 6%. The incidence of rejection decreased to 27% in the most recent 26 cases (January 1994 through June 1995). The incidence of new-onset diabetes was 10.1%; six of the seven affected children were able to be weaned off insulin. The incidence of cytomegalovirus disease was 13%, and that of posttransplant lymphoproliferative disorder was 10%; the incidence of posttransplant lymphoproliferative disorder in the last 40 transplants was 5% (two cases). All of the children who developed posttransplant lymphoproliferative disorder are alive and have functioning allografts. Based on this data, we believe that tacrolimus is a superior immunosuppressive agent in pediatric renal transplant patients, with excellent short- and medium-term patient and graft survival, an ability to withdraw steroids in the majority of patients, and, with more experience, a decreasing rate of rejection and viral complications.

Adolescent↗
PubMed1996

"Suboptimal" kidney donors: the experience with tacrolimus-based immunosuppression.

Female, pediatric, and older donors have been associated with inferior graft survival after renal transplantation. We analyzed these three subgroups in 397 patients receiving tacrolimus-based immunosuppression. There were no differences in recipient age, incidence of retransplantation, or percentage of sensitized patients. Female donors, compared with male donors, were associated with comparable 1- and 3-year patient survival rates (96% and 93% vs. 95% and 92%, respectively) and comparable 1- and 3-year graft survival rates (90% and 80% vs. 88% and 81%, respectively). Renal function was also similar. Recipients of pediatric en bloc kidneys, when compared with recipients of other cadaveric kidneys, also had comparable 1- and 3-year patient survival rates (94% and 94% vs. 95% and 91%, respectively) and comparable 1- and 3-year graft survival rates (84% and 84% vs. 89% and 79%, respectively). Renal function was better in recipients of en bloc kidneys, with a mean serum creatinine level of 1.4+/-1.8 mg/dl vs. 2.0+/-1.5 mg/dl (P=0.01). In contrast to the first two subgroups, donors over 60 years of age, when compared with donors under 60 years of age, were associated with worse 1- and 3-year patient survival rates (88% and 80% vs. 96% and 94%, respectively; P<0.03) and worse 1- and 3-year graft survival rates (74% and 62% vs. 91% and 83%, respectively; P<0.0001). Renal function was worse in the older donor group, with a serum creatinine level of 2.7+/-1.2 mg/ml vs. 1.9+/-1.5 mg/dl (P=0.01). We conclude that, under tacrolimus-based immunosuppression, kidneys from female or very young pediatric donors are not associated with adverse outcomes, whereas kidneys from donors over 60 years of age are associated with inferior outcomes.

Adult↗
PubMed1996

Transjugular intrahepatic portosystemic shunt in patients with end-stage liver disease: results in 85 patients.

Transjugular intrahepatic portosystemic shunt (TIPS) is becoming an accepted procedure as a bridge to orthotopic liver transplantation (OLT) in patients with end-stage liver disease (ESLD) and bleeding from portal hypertension. It allows the immediate control of acute bleeding and decreases the risk of recurrent acute bleeding while the patient is awaiting OLT. We review in this report, our experience with 85 patients who underwent a TIPS procedure for gastrointestinal variceal bleeding from September 1991 until April 1994. All patients had liver cirrhosis and all had previous sclerotherapy before TIPS. Child-Pugh score was calculated at enrollment, and all patients were evaluated for possible OLT. Thirteen patients were Child A, 49 were Child B, and 23 were Child C. Fifty-three patients were candidates for OLT, and 32 were not. TIPS was performed urgently in 25 patients. At a median follow-up of 582 days (range, 1 to 1,095), 35 patients underwent transplantation, 21 patients died, and 29 patients are still alive and did not undergo transplantation. Technical complications were observed in 7% of patients and new onset of clinical encephalopathy in 37%. The 30-day mortality rate after TIPS was 13%. Actuarial survival was 60% at 1 and 3 years. Child class C and urgent TIPS were shown to be two independent predictor factors for mortality. TIPS was shown to be a valuable procedure, not only as a bridge to OLT but also as palliation for bleeding from portal hypertension in patients who were not candidates for either surgical shunt or OLT. However, its role in bleeding patients with acceptable liver function needs further investigation.

Adult↗
PubMed1996

Factors associated with the development of candidemia and candidemia-related death among liver transplant recipients.

OBJECTIVE: The authors' objective was to identify factors associated with candidemia and candidemia-related death among adult liver transplant recipients. SUMMARY BACKGROUND DATA: Invasive candidiasis is the most common severe fungal infection occurring after liver transplantation and is associated with high morbidity and mortality rates. Although candidemia is not always found during invasive candidiasis, it has been considered as an indicator of invasive candidiasis in immunocompromised patients. METHODS: A time-matched case-control study of 26 patients with candidemia, which was defined as the isolation of Candida from at least one blood culture, and 52 control patients without candidemia was reported. Two control patients were matched with each case patient regarding time of transplantation and duration of follow-up. RESULTS: Between December 1985 and December 1992, candidemia developed in 1.4% of adult liver transplant recipients a median of 25 days after transplantation (range, 2-1690 days). The overall mortality rate among patients with candidemia was 81%, and 71% of these deaths were related to candidemia. Conditional logistic regression analysis was used to identify factors associated with candidemia, which were 1) hyperglycemia treated with insulin up to 2 weeks before candidemia (odds ratio [OR], 16.15; p = 0.002), and 2) exposure to more than three different intravenous antibiotics before development of candidemia (OR, 11.15; p = 0.005). The variables predictive of death related to candidemia were abdominal surgery performed up to 1 week before candidemia (relative risk [RR], 7.25; p = 0.02), high white blood cell count (RR, 1.10; p = 0.01), lower platelet count (RR, 0.99; p = 0.02), and elevated AST with candidemia (RR, 1.001; p = 0.01). CONCLUSIONS: Hyperglycemia that requires insulin and exposure to more than three antibiotics are the factors associated with the development of candidemia in liver transplant recipients. When candidemia develops shortly after abdominal surgery and in patients with elevated AST, high white blood cell count, or low platelet count, it is associated with a high mortality rate.

Adult↗
PubMed1996

Computer-guided randomized concentration-controlled trials of tacrolimus in autoimmunity: multiple sclerosis and primary biliary cirrhosis.

A randomized concentration-controlled clinical trial (RCCCT) is a trial design in which patients are randomized to predefined blood drug concentrations (low, medium, high). If the concentration ranges are sufficiently separated, this study design can reveal important blood concentration-response relations. Tacrolimus is a potent yet "infant" immunosuppressant for the treatment and prevention of graft rejection and has been shown to exhibit significant clinical activity in some immune-mediated disorders. A tacrolimus artificial intelligence modeling system (AIMS) was used to guide patient dosing to achieve target concentrations specified by the study protocols. In the Multiple Sclerosis study group, we were able to define a concentration range (0.3-0.7 ng/ml) that appeared to show efficacy and minimal tacrolimus toxicity. Patients randomized to the high zone (0.6-1.2 ng/ml) in the Primary Biliary Cirrhosis study group showed significant reduction (approximately 50%) in surrogate efficacy markers [aspartate aminotransferase (SGOT), alanine aminotransferase (SGPT)] compared with patients in the low zone (0.1-0.6 ng/ml). Therefore the RCCCT allowed the detection and delineation of clinically significant concentration-response relations in an ethical and efficient manner.

Artificial Intelligence↗
PubMed1995

Evaluating glioma therapies: modeling treatments and predicting outcomes.

BACKGROUND: Intra-arterial chemotherapy with carmustine (BCNU) and interstitial radiation therapy with the use of stereotactically placed 125I sources are aggressive local therapies for malignant glioma. These therapies emerged in the 1980s and both appeared promising in phase II studies but yielded disappointing results in subsequent randomized controlled trials by the Brain Tumor Cooperative Group (BTCG). Florell and colleagues had prepared us for the possibility that brachytherapy would have less impact on survival than anticipated from the phase II experience by demonstrating that patients who were judged eligible for interstitial radiation, but treated conventionally, lived significantly longer than those who were ineligible and had better than average outcomes. PURPOSE: To further examine the impact of patient selection on outcome, we used the database of Florell et al. to assess the survival of patients with malignant glioma who were eligible or ineligible for chemotherapy by three intra-arterial methods, one of which was similar to that employed by the BTCG in its randomized, controlled trial evaluating intra-arterial BCNU. METHODS: The medical records and computed tomography (CT) scans of 102 consecutive patients with malignant glioma receiving standard treatment (i.e., maximum feasible surgical resection, external-beam radiotherapy, and often adjuvant systemic chemotherapy) at a single cancer center in Canada during the calendar years 1988 and 1989 were used for this analysis. Based on CT imaging and blind to outcome, an interventional neuroradiologist decided which patients were eligible or ineligible for intra-arterial chemotherapy via injection of two major arteries, via injection of one major artery, or via selective middle-cerebral artery injection. A Karnofsky performance score of greater than or equal to 60 was required. The percent of eligible patients, the median survival time, and the distribution of prognostic factors were analyzed for each group of eligible and ineligible patients. Median survival times were compared with the use of the generalized Wilcoxon (Breslow) test. All P values were based on two-tailed tests. RESULTS: For two-vessel treatment, 72.5% of the patients (74 of 102) were eligible; the eligible patients on average lived longer than the ineligible patients (14.8 versus 3.5 months; P < .00001). For one-vessel treatment, 48% of the patients (49 of 102) were eligible; again, the eligible patients lived longer than the ineligible patients (18.4 versus 5.1 months; P < .00001). For middle-cerebral artery treatment, 30% of the patients (31 of 102) were eligible, and these eligible patients did live somewhat longer than the ineligible patients, but this result did not reach statistical significance (13.6 versus 9.9 months; P = .1304). Trends were similar for patients with glioblastoma multiforme and anaplastic glioma. The median duration of survival was 11.4 months for all patients. CONCLUSIONS: Patients who were eligible for intra-arterial chemotherapy lived significantly longer or somewhat longer (depending on the selection criteria used) than patients who were ineligible and had better than expected outcomes. Patients who were judged eligible for intra-arterial chemotherapy by the two-vessel method and the control group in the BTCG phase III trial of intra-arterial chemotherapy had similar median survival times (14.8 versus 14.0 months). IMPLICATIONS: Modeling treatments with the use of a comprehensive clinical and imaging database of unselected, conventionally treated patients may help investigators decide if new therapies warrant definitive evaluation in randomized trials by measuring the degree to which patient selection may have enhanced phase II study outcomes.

Adolescent↗
PubMed1995

Incidence and risk factors associated with the development of cytomegalovirus disease after intestinal transplantation.

From May 1990 to March 1993, 38 patients (21 adults and 17 children) received 40 allografts that included the small bowel (14 isolated small bowel, 21 small bowel and liver, and 5 multivisceral transplantations). Fifteen patients (39%) had 26 episodes of CMV disease: 7 with one episode, 6 with two, and 1 each with three and four. CMV enteritis accounted for 21 (81%) of the episodes, hepatitis and pneumonitis for 2 each, and a viral syndrome for 1. Cox's proportional hazards univariate and multivariate analyses showed that significant first-episode risk factors were: CMV seropositive donors for negative recipients (relative risk [RR], 3.86; P = 0.02), the average daily plasma trough level of tacrolimus (RR, 2.15; P = 0.04), and total amount of steroid boluses (RR, 2.90; P = 0.02). CMV disease recurrence factors were: CMV seronegative recipients (RR, 8.60; P = 0.02) and total amount of steroid bolus pulses (RR, 12.39; P = 0.004). Because long courses of ganciclovir prophylaxis could not prevent the development of CMV disease, avoidance of CMV seropositive grafts in seronegative recipients and new strategies to prevent heavy immunosuppression without the penalty of rejection will be necessary to ameliorate this problem in intestinal transplant recipients.

Adolescent↗
PubMed1995

Clinical and virological monitoring of human cytomegalovirus infection in 294 heart transplant recipients.

Two hundred and ninety-four heart transplant recipients (HTR) were followed prospectively for a mean of 44.9 +/- 28.4 (range 1.0-100.8 months) after transplantation (tx). Immunosuppression was based on cyclosporine, azathioprine, and steroids, supplemented by a 7-day course of antithymocyte globulins. All patients were virologically monitored by inoculating aliquots of 2 x 10(5) peripheral blood polymorphonuclear leukocytes (PMNs) onto human embryonic lung fibroblasts monolayers grown in shell vials for early cytomegalovirus (CMV) identification and quantification (viremia). The same number of PMNs was cytocentrifuged onto glass slides for direct CMV pp65 antigen detection and quantification (antigenemia). Heparinized blood samples were collected weekly during the first 3 months following tx and at least twice a week if antigenemia and viremia levels were increasing. After 3 months, samples were collected if antigenemia and viremia persisted or when clinically indicated. The overall incidence of CMV infection was 53.4% (157/294). Only 32.4% (51/157) of the viremic patients required antiviral treatment because of symptomatic infection. Of the remaining 106 untreated CMV viremic HTR, 104 were asymptomatic while 2 had only mild clinical symptoms. The overall incidence of CMV infection in pre-tx CMV seropositive (CMV+) HTR was 50.9% (136/267); 75.7% (103/136) were asymptomatic and 24.3% (33/267); 75.7% (103/136) were asymptomatic and 24.3% (33/136) were symptomatic. The overall incidence of CMV infection in pre-tx CMV-seronegative (CMV-) HTR was 77.8% (21/27; P = 0.007 vs. seropositive HTR). Among 22 CMV- HTR with CMV+ donor, 20 (90.9%) had a CMV infection and all of them were symptomatic (versus 1 of 5 (20%) CMV- HTR with CMV- donor; P = 0.002, Fisher's exact test). The median numbers of circulating CMV-infected PMNs detected at the onset of clinical symptoms by the antigenemia and viremia assays were 385/2 x 10(5) and 100/2 x 10(5), respectively.

Adolescent↗
PubMed1995

A prospective randomized trial of FK506-based immunosuppression after renal transplantation.

A group of 204 adult patients was entered into a prospective, randomized trial comparing FK506/prednisone with FK506/azathioprine/prednisone after renal transplantation between August 1, 1991 and October 11, 1992. The purpose of the study was to see if the addition of azathioprine would reduce the incidence of rejection and improve graft survival. The recipient population was unselected, with 61 (30%) patients undergoing retransplantation, 37 (18%) having a panel-reactive antibody greater than 40%, and 33 (16%) over 60 years of age. The mean recipient age was 43.8 +/- 13.7 years (range 17.6-78). The mean donor age was 34.0 +/- 20.1 years (range 0.3-75); 13% of the cadaveric kidneys were from pediatric donors less than 3 years of age and were transplanted en bloc. The mean cold ischemia time was 31.4 +/- 8.4 hr. Living donors were the source of 13% of the kidneys. The mean follow-up was 22 +/- 4 months (range 12-29). Overall one-year actual patient survival was 94%. Overall one-year actual graft survival was 87%. Patients starting on double therapy had a one-year actual patient survival of 96% and a one-year actual graft survival of 92%. Patients starting on triple therapy had a one-year actual patient survival of 91% (P = ns compared with double therapy), and a one-year actual graft survival of 82% (P < 0.02, compared with double therapy). Overall results with first cadaver transplants included a one-year actual patient survival of 94% and one-year actual graft survival of 88%, with no differences between double and triple therapy. The overall incidence of rejection was 48%, with 54% in the double therapy group and 41% in the triple therapy group (P < .07). The incidence of steroid-resistant rejection requiring antilymphocyte therapy (OKT3 or ATGAM) was 13%, and was not different between the double and triple therapy groups. The mean serum creatinine was 1.8 +/- 0.8 mg/dl. The mean BUN was 33 +/- 21 mg/dl, with no significant difference between the therapy groups. The mean serum cholesterol was 192 +/- 49 mg/dl. A total of 56% of the patients are off prednisone, and 35% of the patients are not taking any antihypertensive medications. Other complications included cytomegalovirus--14%; new-onset diabetes--16% (half of which was reversible); and posttransplant lymphoproliferative disorder--1%.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗
PubMed1995

FK506 in pediatric kidney transplantation--primary and rescue experience.

Between 14 December 1989 and 17 December 1993, 43 patients undergoing kidney transplantation alone at the Children's Hospital of Pittsburgh received FK506 as the primary immunosuppressive agent. The mean recipient age was 10.2 +/- 4.8 years (range 0.7-17.4 years), with 7 (16%) children under 5 years of age and 2 (5%) under 2 years of age. Fifteen (35%) children underwent retransplantation, and 5 (12%) had a panel-reactive antibody level greater than 40%. Twenty-two (51%) transplants were with cadaveric donors and 21 (49%) were with living donors. The mean follow-up was 25 +/- 14 months; there were no deaths; 1- and 3-year actuarial graft survival was 98% and 85%. The mean serum creatinine and blood urea nitrogen were 1.2 +/- 0.6 mg/dl and 26 +/- 11 mg/dl; the calculated creatinine clearance was 75 +/- 23 ml/min per 1.73 m2. Twenty-four (62%) patients have been successfully withdrawn from steroids and 24 (62%) require no anti-hypertensive medication. Improved growth was seen, particularly in pre-adolescent children off steroids. Between 28 July 1990 and 2 December 1993, 24 children were referred for rescue therapy with FK506, 14.6 +/- 16.4 months (range 1.1-53.2 months) after transplantation. Nineteen (79%) were referred because of resistant rejection; 4 (17%) were referred because of proteinuria; 1 (4%) was switched because of steroid-related obesity. There were no deaths; 1- and 2-year graft survival was 75% and 68%; 17 (71%) patients were successfully rescued, including 1 of 2 patients who arrived on dialysis; 4 (24%) of the successfully rescued patients were weaned off steroids.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗