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D Stablein

Publications and source records attributed to D Stablein.

At least 37 records · Page 2Linked to original sources
PubMed1994

Analysis of hypertension in children post renal transplantation--a report of the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS).

Hypertension is common in children after renal transplantation and is associated with multiple factors. Data regarding the prevalence of post-transplant hypertension and the relationship between immunosuppressive drugs and the persistence of hypertension in a large population of North American children have not been available. This study was designed by the North American Pediatric Renal Transplant Cooperative Study to evaluate in a large diverse multicenter population of children the prevalence of hypertension post transplantation, the type of antihypertensive medications used to treat this hypertension and to determine the relationship between the blood pressure control and the immunosuppressive therapy. Analysis of 277 patients showed the following: (1) 70% of recipients required antihypertensive medications 1 month post transplant compared with 48% pre transplant; the incidence decreased to 59% at 24 months; (2) the majority of children received multiple drug therapy to control blood pressure; (3) hypertension can be controlled effectively despite inherent etiological factors, such as allograft source, prior hypertension and immunosuppressive therapy.

Adolescent↗
PubMed1993

Induction of HIV-1-neutralising and syncytium-inhibiting antibodies in uninfected recipients of HIV-1IIIB rgp120 subunit vaccine.

A recombinant human immunodeficiency virus 1 IIIB (HIV-1IIIB) gp120 subunit vaccine (IIIB-rgp120/HIV-1, Genentech) was tested for safety and immunogenicity in a randomised, double-blind, placebo-controlled phase-I trial. HIV-1-seronegative adult volunteers received three 100 micrograms or 300 micrograms doses of IIIB-rgp120/HIV-1 in alum adjuvant (10 vaccinees in each group), or alum adjuvant alone (8 vaccinees), at 0, 4, and 32 weeks by intramuscular injection. The three injections were well tolerated in both vaccine groups. Antibodies that neutralised homologous HIV-1IIIB were induced in 9 of 10 recipients after three 300 micrograms doses, and 6 of these 9 sera also neutralised heterologous HIV-1SF2. A dose response was evident, since three 100 micrograms injections induced lower titres of HIV-1IIIB neutralising antibodies and in fewer recipients (5 of 9) than the higher dose, with no neutralisation of HIV-1SF2. Similarly, syncytia-inhibiting, CD4-rgp120-blocking, and HIV-1IIIB V3-binding antibodies were induced in a dose dependent manner. Response to the 300 micrograms per dose vaccination occurred in a larger proportion of volunteers and at higher mean titres than seen in previous human trials with other recombinant envelope subunit vaccines or live vaccinia-env priming followed by envelope subunit boosting.

AIDS Vaccines↗
PubMed1993

Maintenance immunosuppression therapy and outcome of renal transplantation in North American children--a report of the North American Pediatric Renal Transplant Cooperative Study.

The North American Pediatric Renal Transplant Cooperative Study collects extensive data on all transplants entered into its registry. For this study we evaluated 568 cadaver kidney and 492 live-donor recipients with graft function at 30 days post transplant. Utilizing maintenance immunosuppressive therapy at 30 days post transplant, we evaluated patient and graft outcome, mortality and morbidity over the first 6 months post transplant. For cadaver kidney recipients, 36 patients were receiving prednisone and azathioprine (PA), 114 were maintained on prednisone and cyclosporine (PC) and 418 were on prednisone, cyclosporine and azathioprine (PCA). Patients receiving PA had a greater incidence of rejection prior to 30 days, a greater incidence of hospitalization for rejection and for hypertension over the next 6 months and a greater loss of allograft in the first 6 months compared with the other two groups. The only difference noted between PC and PCA was a lower serum creatinine in the PCA group at 6 months. For living-related kidney recipients, there were 78 patients maintained on PA, 97 on PC and 317 on PCA. Again patients receiving PA had a higher rate of hospitalization for rejection and a higher rate of graft loss. When patients receiving PC were compared with those receiving PCA, no differences were noted in the 6-month serum creatinine values, but a greater percentage of PCA patients were receiving antibiotics on day 30. We conclude that PA is poor therapy for both groups, PCA is ideal therapy for cadaver kidney recipients, but no beneficial effects are noted when PCA is used over PC for live-related donor kidney transplants.

Adolescent↗
PubMed1993

Factors predictive of sustained growth in children after renal transplantation. The North American Pediatric Renal Transplant Cooperative Study.

To ascertain growth and rehabilitation of children after transplantation, the North American Pediatric Renal Transplant Cooperative Study collected growth data on renal transplant recipients. From January 1987 through December 1990, a total of 1553 children with one or more transplants were entered into the study by its 75 participating centers. Of these, the first 300 children with a functioning graft and 2 years of linear growth data form the cohort for this study. For the total cohort of 300 patients, the mean (+/- SEM) baseline height z score was -2.41 +/- 0.09, and the change in z score determined after 2 years was 0.18 +/- 0.06 (p < 0.01). Children in the age group from birth to 1 year had the maximal deficit and had the maximal improvement in z score, gaining about 1 SD (p < 0.01). For the 2- to 5-year-old group, the change in z score was about 0.5 SD (p < 0.001). No improvement in z score was noted for children 6 to 17 years of age. Each increase in serum creatinine concentration of 90 mumol/L (1 mg/dl) was associated with -0.17 decrease in the z score (p < 0.001). Gender, donor source, history of previous transplantation, and prior dialysis were not associated with a significant change in the z score; thus the increased rate of growth during the first 2 post-transplantation years occurred mainly in subjects less than 6 years of age.

Adolescent↗
PubMed1992

The effect of donor age on graft survival in pediatric cadaver renal transplant recipients--a report of the North American Pediatric Renal Transplant Cooperative Study.

Data from the North American Pediatric Renal Transplant Cooperative Study were analyzed to determine the effect of donor age on graft survival for pediatric recipients of cadaver donor renal transplants. Between January 1, 1987, and November 16, 1990, 787 cadaver donor renal transplants in children less than 18 years of age were registered in the study. The ages of the donors were less than or equal to 5 years in 203 transplants, between 6 and 9 years in 87, between 10 and 39 in 389, and greater than or equal to 40 years in 108. The risk of graft loss was related to donor age by a proportional hazards analysis. The ideal donor age was 20-25 years. The risk of graft loss was increased by both young and old donor age. The risk of graft loss from a neonate donor was 2.7-fold that of the ideal donor, and the risk from a 50-year-old donor was 1.8-fold that of the ideal donor. The relationship between donor age and graft survival was not affected by the age of the recipient. Cold storage time had an added impact on graft survival: grafts with cold storage time greater than 24 hr were 1.5 times more likely to fail than grafts with shorter cold storage time for all donor ages. Analysis of the causes of graft failure revealed that 9.9% of grafts from donors less than or equal to 5 years of age were lost due to vascular thrombosis, primary nonfunction, and other technical causes, compared with 4.6% in 6-9, 4.4% in 10-39, and 2.8% in greater than or equal to 40-year-old donors. We conclude that kidneys from both young and old donors are at increased risk for graft loss, and this increased risk is seen in all recipient age groups. Many of the losses from the young donors--but not older donors--may be due to technical causes. Knowledge of these risks can be used to develop strategies for optimal utilization of kidneys from young and old donors.

Adolescent↗
PubMed1991

Graft thrombosis in pediatric renal transplant recipients. A report of the North American Pediatric Renal Transplant Cooperative Study.

Data from the North American Pediatric Renal Transplant Cooperative Study were analyzed to determine the incidence and possible causes of graft thrombosis in pediatric renal transplant recipients. Between January 1987, and November 1989, 1045 renal transplants in recipients less than 18 years of age were registered in the study, including 484 living-related donor and 561 cadaver donor transplants. There were 213 graft failures (67 LRD, 146 CAD), and of these 27 were caused by thrombosis (8 LRD, 19 CAD). Thrombosis occurred in 2.6% of all transplants and accounted for 22.5% (27/120) of all graft failures that occurred in the first 60 days following transplantation. Among the LRD recipients, there were 24 graft failures in those less than 6 years of age, and 7 of these were due to thrombosis, compared to 1 thrombosis in 43 graft losses in recipients greater than 6 years (P less than 0.01). In recipients less than 6 years old, the thrombosis rate for those who received transplants without prior dialysis was 4/32 (12.5%) versus 3/109 (2.8%) with prior dialysis. Among the CAD recipients, age of the recipient did not influence graft thrombosis. Donor age, however, was strongly associated with the risk of thrombosis, as was cold storage time. Donor age and cold storage time were not independently distributed within the population, with longer cold storage times required for younger donors. Both factors, however, independently affected outcome. Other factors, including prior nephrectomy, prior transplant, center size, and use of cyclosporine were not associated with increased risk of thrombosis in LRD or CAD recipients. We conclude that graft thrombosis is an important cause of renal graft loss in children. In LRD transplants the risk of graft thrombosis is increased in recipients less than 6 years old, and preliminary data suggest that the lack of prior dialysis may be associated with thrombotic risk in these patients. CAD transplant recipients who receive grafts from young donors, particularly those with long cold storage time, are at increased risk for graft failure due to thrombosis.

Adolescent↗
PubMed1990

A randomized study of the efficacy of adjuvant local graft irradiation following renal transplantation.

A prospective randomized study investigating the effectiveness of adjuvant local graft irradiation (LGI) following renal transplantation was performed at Georgetown University Hospital from 1983 until 1988. One hundred and thirty-eight patients were enrolled in the study with 117 patients receiving cadaver kidney transplantations and 21 patients receiving living related kidney transplantations. Seventy-one patients were randomized to receive adjuvant local graft irradiation consisting of 600 cGy in four fractions with chemical immunosuppression whereas the remaining 67 patients received chemical immunosuppression only (control group). The two groups were comparable at entry with respect to potentially important prognostic variables. Median follow-up for all patients was 30 months. The 3-year actuarial allograft success rate was 75% and 68% for the local graft irradiation and control groups, respectively. A nonsignificant trend favoring the irradiated group was noted. Subgroup analysis of the 21 recipients of kidneys from living related donors suggested an improvement in allograft survival for the local graft irradiation arm. Cadaver allograft survival was not significantly different between the two treatment arms. There was no apparent benefit in kidney function or time to the first rejection episode in the group receiving local graft irradiation.

Adult↗
PubMed1988

Psychological distress as a predictor of ventricular arrhythmias in a post-myocardial infarction population.

A prospective study examining the relationship between psychological distress and ventricular ectopy was conducted with 125 post-myocardial infarction patients equipped with a transtelephonic ECG monitor. Subjects were subsequently grouped according to the occurrence (n = 59) or nonoccurrence (n = 65) of ventricular arrhythmias over a 1-year period. Results indicated a direct relationship between self-reported distress levels and occurrence of ectopic beats. This relationship was unaltered by adjusting simultaneously for known predictors of arrhythmias, including cardiac risk, age, and the prescription of beta-blocker agents. Thus this study represents an initial demonstration in a post-myocardial infarction population that psychosocial factors have prognostic significance for arrhythmias and, presumably, sudden death.

Arrhythmias, Cardiac↗
PubMed1988

The effects of a transtelephonic surveillance and prehospital emergency intervention system on the 1-year course following acute myocardial infarction.

We evaluated the effect on morbidity and mortality of a post-myocardial infarction management and intervention system. One thousand four patients were prospectively randomized to an intervention group that included routine and emergency transtelephonic follow-up and ECG monitoring or to control; all subjects were followed for 1 year. For symptoms suggestive of myocardial ischemia, intervention patients telephoned the project emergency office, were instructed by a project nurse to self-administer intramuscular lidocaine with an auto-injector, and were then transported to the nearest emergency facility. Cardiac death or arrest was decreased 29% in intervention patients (p = 0.066), while all-cause mortality was decreased by 24% (p less than 0.11). Routine transtelephonic ECG monitoring detected ventricular ectopy in 48% of intervention patients, with almost 50% of these findings classified as complex forms. Ventricular ectopy detected during routine calls within 60 days of the acute myocardial infarction conferred a threefold increase in mortality (p = 0.001). In addition, control patients were 2.4 times more likely to be clinically depressed (p less than 0.03) and returned to work less quickly (p less than 0.03) when compared to intervention patients. Lidocaine injections were associated with an absence of ventricular ectopy on arrival at the Emergency Room in 64% and with a low incidence of lidocaine-associated side effects. There was only one case of unauthorized use of the self-injector. These findings demonstrate that an outpatient post-myocardial infarction transtelephonic surveillance program can be safely and effectively conducted, can detect complex ventricular arrhythmias of prognostic significance, can improve the quality of life, and may reduce 1-year cardiac mortality.

Clinical Trials as Topic↗
PubMed1988

Quality of life post-myocardial infarction: effects of a transtelephonic coronary intervention system.

The impact of an outpatient, risk-management system, including a transtelephonic electrocardiographic monitor and lidocaine injector, on the quality of life in post-myocardial infarction patients was examined. Patients (n = 238) were assigned randomly to either the system or to standard medical care (control). Quality of life was defined in terms of psychological status, return to work, and social functioning. Relative to control patients, system patients showed a significant decrease in concerns about physical functioning and symptoms, and, over time, reported less depressive affect. At 9-month follow-up, control patients were more than twice as likely to be in the range of clinical depression. Patients' perceptions of their ability to manage a recurrence of cardiac symptoms appeared to be related inversely to depressive affect. Moreover, a larger percentage of system patients (92%) had returned to work by the 9-month follow-up, compared with control patients (76%). There were, however, no significant differences between groups in the degree of impairment in social interaction. Overall, these results indicate that the use of a "system" encouraging patient participation in treatment can significantly improve qualify of life after a myocardial infarction.

Depression↗
PubMed1987

Comparison of unique leucovorin and 5-fluorouracil "escalating" and "maximum" dosage strategies.

In this study (GI 6384), regimens are compared which, in phase II investigations, produced 2-fold increases in the historical rates of objective and minor responses. These regimens were associated with overall survival exceeding 1 year. In arm 1, 5-fluorouracil (FUra) alone, 500 mg/m2 on days 1 through 5 was escalated in 25-mg/m2 increments in monthly courses to produce mild to moderate toxicity. This allows an examination of dose-response relationships and comparisons of therapeutic index. In arm 2, leucovorin (LV), was escalated from 25 to 250 to 500 mg/m2 beginning 1 hour before a bolus FUra (30 mg/kg) every 3 weeks. Arm 3 (not previously tested) employed LV (25 mg/m2) 1 hour before FUra (600 mg/m2) given weekly for 6 weeks. It tested the efficacy of low-dose LV. Arm 4 tested high-dose LV (500 mg/m2) as a 2-hour infusion beginning 1 hour before a bolus FUra (600 mg/m2) weekly for 6 weeks. In a preliminary analysis of this study, findings are statistically consistent with the anticipated high frequencies of objective response. It also finds evidence of biological activity across the wide range of LV dosages and that LV produces an apparent favorable change in FUra side effects from hematological to gastrointestinal toxicities. One or more regimens may favorably change the anticipated prognosis of patients with measurable cancer of the colon and rectum.

Age Factors↗
PubMed1985

Therapy for metastatic colorectal cancer with hepatic artery infusion chemotherapy using a subcutaneous implanted pump.

Sixty-two patients with metastatic colorectal carcinoma involving the liver were treated by hepatic intra-arterial chemotherapy using an implantable infusion pump. The 53 patients with metastases confined to the liver had a median survival (MS) of 17 months and an objective response rate of 32%. Four patients (8%) demonstrated a complete response (CR), with normal abdominal computed tomography (CT) scan results and plasma carcinoembryonic antigen (CEA) levels, and 13 patients (25%) demonstrated a partial response (PR), with at least a 50% decrease in the liver lesions by CT scan and at least a 50% decrease in CEA levels. Thirty patients (57%) had stable disease (S), and six patients (11%) had no response (NR). Nine patients with extrahepatic tumor plus hepatic metastases had an MS of only 4.9 months. None of these patients had an objective response, and only four patients had S. Quality of response was clearly associated with longevity. Forty patients treated with floxuridine (FUDR) and mitomycin (M) (F + M) showed a 20% objective response rate, while the 13 patients treated with FUDR and dichloromethotrexate (DCMTX) (F + D) attained a 69% objective response rate. Although F + D treatment appears to be superior, there may have been selection biases that make such an observation only preliminary. Twenty-six (49%) of the 53 patients developed hepatitis during infusion chemotherapy, which resolved after temporary cessation of the chemotherapy. Of the 17 patients with CR or PR, 12 patients (71%) had hepatitis, whereas only 14 (39%) of the 36 patients with S or NR had hepatitis. Eleven patients had evidence of peptic ulceration by endoscopic examination during the infusion chemotherapy. All the ulcers healed after chemotherapy was discontinued.

Adenocarcinoma↗
PubMed1985

Statistical aspects of intraperitoneal chemotherapy studies.

When designing adjuvant studies of intraperitoneal therapy, the presumed activity of the treatment on the peritoneal surface makes control of peritoneal recurrence a possible alternative to the survival endpoint. Consideration of the potential impact of different endpoints on study sample size is presented. Disease sites for application and issues of implementation unique to studies of this type are discussed.

Antineoplastic Agents↗
PubMed1983

Combination chemotherapy for locally advanced pancreatic cancer: equivalence to external beam irradiation and implication for future management.

Chemotherapy with 5-fluorouracil, doxorubicin, and mitomycin-C was administered to 17 patients with locally advanced pancreatic cancer. The median survival for these patients was 8 months. With a multiaxial retrospective analysis, the overall survival of this study group appears to be least equivalent to that reported with 6,000 photon rad alone or of neutrons, and compares favorably to that achieved with combined 6,000 photo rad plus 5-fluorouracil. Of 15 relapses, only 4 had presented with evidence of disseminated disease. Based upon this analysis we recommend additional studies of combination chemotherapy with radiation therapy in future prospective randomized trials.

Adult↗
PubMed1981

Intracerebral metastases in solid-tumor patients: natural history and results of treatment.

In order to determine the natural history and results of treatment of intracerebral metastases in solid-tumor patients, the records of 191 patients with an antemortem diagnosis of intracerebral metastasis made during the period from August 1974 to November 1978 were reviewed. Malignancies included lung (122 patients), breast (26), unknown primary (16), melanoma (8), colorectal (6), hypernephroma (4), and others (12). Favorable prognostic factors included solitary brain metastasis (P less than 0.001), ambulatory performance status (P less than 0.001), symptoms of headache (P less than 0.001), or visual disturbances (P less than 0.02), and estrogen receptor positivity in breast cancer patients (P = 0.055). Poor prognostic factors included advanced age (P less than 0.04) and evidence of impaired consciousness, i.e., disorientation, lethargy, stupor, or coma (P less than 0.007). Median survival time after diagnosis of intracerebral metastasis was 3.7 months for the entire series. In those patients with a single intracerebral metastasis and minimal tumor burden, the type of treatment used had a significant impact on survival. Those cases treated with surgery and radiation had a median survival time of 9.7 months versus 3.7 months for those treated with radiation alone (P less than 0.02). When using a proportional hazard regression analysis to adjust for the three most important prognostic factors, treatment (surgery and radiation versus radiation alone) still appeared to be important. Intracerebral metastases were the immediate or contributing cause of death in 50% of the patients in this series. Patients at greater risk of dying of intracerebral metastases included those in whom the brain was the first site of distant metastasis, those with an intracerebral metastasis from an unknown primary site, and those whose presentation of malignancy was with symptoms of a brain metastasis. Although the therapeutic goal in intracerebral metastases is generally palliative, it appears that there are categories of cases that may benefit from more aggressive treatment.

Adult↗