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PubMed1979

Somatomedin and growth hormone studies in pediatric renal allograft recipients who receive daily prednisone.

Plasma somatomedin (SM) activity and growth hormone (GH) concentration were measured in ten growth-retarded, well-nourished pediatric renal allograft recipients who received daily prednisone therapy. The SM activity ranged from 0.21 to 1.22 micron/mL, and it was subnormal in three patients. A significant correlation was found between SM activity and creatinine clearance. Serial SM levels were determined during a 24-hour period in five patients; SM activity decreased at six and 12 hours and returned to normal values by 24 hours. The 24-hour plasma GH concentrations ranged from 1.5 to 7.6 mg/mL. Peak GH concentrations ranged from 2.1 to 14.2 ng/mL after insulin-induced hypoglycemia and from 1.8 to 24.6 ng/mL after oral glucose loading. Sleeping GH peaks were absent in two patients. These results suggest that growth failure in renal allograft recipients who receive daily prednisone may result from (1) partial GH deficiency, (2) reduced SM levels owing to diminished allograft function, and (3) daily transient decrease in plasma SM levels after prednisone administration.

Adolescent↗
PubMedDate not supplied

Low-dose oral prednisone in the treatment of acute cardiac allograft rejection not associated with hemodynamic compromise.

The standard therapy for acute cardiac allograft rejection is intravenous methylprednisolone, usually in doses of about 3 gm per treatment. Treatment is undertaken in most cases solely on the basis of a histologic diagnosis of rejection, irrespective of hemodynamic status. To reduce total corticosteroid dose and administer therapy in an outpatient environment, low-dose oral prednisone protocols were developed for the treatment of acute rejection in the absence of important hemodynamic compromise. A high-dose oral prednisone pulse (2 gm total for the average 75 kg male patient) was used in the first month. Thereafter a series of low-dose oral prednisone pulses were used (range, 0.5 to 1.0 gm total for the average 75 kg male patient). Of 85 transplant recipients at risk, 188 rejection episodes were treated over a 1477 total patient-months of follow-up. The high-dose oral pulse resulted in successful therapy (no subsequent therapy required) in 34 of 65 treatments (52%). The low-dose oral pulse was successful in treating 80 of 123 treatments (65%). This approach to acute rejection did not appear to adversely affect patient or graft outcome based on progression of stable to unstable hemodynamics, survival (84% and 82%, 1- and 2-year actuarial survival, respectively), or left ventricular ejection fraction (0.56 +/- 0.09 and 0.54 +/- 0.08, at 1 and 2 years, respectively). There did not appear to be discriminating factors that determined the therapeutic outcome, other than the higher failure rate within 1 month of transplant. We conclude that acute allograft rejection in the absence of important hemodynamic compromise responds to lower-than-conventional doses of corticosteroids in the majority of cases.

Administration, Oral↗
PubMed1990

[Predictive factors of the response to treatment of myasthenia gravis with prednisone].

The influence of age at onset, sex, duration of disease and severity degree on the response to therapy have been evaluated in 30 patients with myasthenia gravis treated with prednisone. During the evaluation period (3 months as a maximum) the patients were only treated with prednisone. The evaluation of the response was based on the use of quantified tests of clinical fatigability. Among all the evaluated factors, only the age at onset seemed to have a predictive value of the response to prednisone therapy. The patients older than 40 years and particularly those older than 60 years showed a better response than younger patients.

Adult↗
PubMed1977

L-Asparaginase, vincristine, and prednisone for induction of first remission in acute lymphocytic leukemia.

L-Asparaginase was added to vincristine and prednisone for induction of first remission in 815 children with acute lymphocytic or acute undifferentiated leukemia. This combination resulted in an overall remission rate of 93%. The addition of L-asparaginse to the standard induction regimen using prednisone and vincristine did not significantly increase the morbidity or mortality rate during the induction period. The most common side effect was transient L-asparaginase-induced hyperglycemia. The safe administration of L-asparaginase i.m. and the dose efficacy of 6000 I.U./sq m were confirmed. For these reasons, L-asparaginase should be combined with vincristine and prednisone for the initial induction of children with acute lymphocytic or acute undifferentiated leukemia.

Adolescent↗
PubMed1989

Effectiveness of rubidomycin in induction therapy with vincristine, prednisone, and L-asparaginase for standard risk childhood acute lymphocytic leukemia: results of a Dutch phase III study (ALL V). A report on behalf of the Dutch Childhood Leukemia Study Group (DCLSG).

The Dutch Childhood Leukemia Study Group (DCLSG) performed a phase III study-Study (ALL) V-to evaluate the effectiveness of rubidomycin in induction therapy with vincristine, prednisone, and L-asparaginase for children (0-15 years) with standard risk acute lymphoblastic leukemia (ALL) (white blood cell [WBC] counts less than 50.10(9)/L, absence of mediastinal mass, and/or cerebromeningeal leukemia). Furthermore, the influence of initial patient and disease characteristics on the outcome was analyzed. Between May 1979 and December 1982, 240 patients entered the study and were randomized into two groups: group A (n = 122) received induction treatment with vincristine (VCR), prednisone (Pred), and L-asparaginase (L-Asp); for group B (n = 118), induction therapy consisted of VCR, Pred, L-Asp, and rubidomycin (Rub). All patients subsequently underwent cranial irradiation (doses adjusted to age) in combination with intrathecal methotrexate; maintenance therapy of 6-mercaptopurine and methotrexate for 5 weeks followed by vincristine and prednisone for 2 weeks was given for 24 months. The complete remission (CR) rate was similar in both groups (94.5%). Event-free survival (EFS) 5 years after diagnosis was higher in group B (62.5 +/- 4.5%) than in group A (54.7 +/- 4.5%), although the difference is not significant (p = 0.20). A high initial WBC (greater than or equal to 10.10(9)/L), age (greater than or equal to 10 years), a low platelet count (less than 100.10(9)/L), and a positive acid phosphatase reaction of the leukemic cells were unfavorable prognostic factors (p less than 0.05). Sex, French-American-British (FAB) classification group, immunophenotype, and treatment in specialized centers did not have a significant impact on event-free survival.

Adolescent↗
PubMed1989

[Observation on the treatment of systemic lupus erythematous with a Gentiana macrophylla complex tablet and a minimal dose of prednisone].

Sixty-two cases of systemic lupus erythematous (SLE) treated with Tab. Gentiana macrophylla complex 5 tablets three times per day or 10 tablets twice per day and prednisone 10-30 mg per day were reported. As controls, 19 cases of SLE were treated with prednisone alone at the same time. The results showed complete remission in 86.46% (50/62) cases in the observation group and 31.57% (6/19) cases in the control group. Eight cases of SLE treated with Tab. Gentiana m. complex alone also achieved complete remission in 6 cases and improvement in 2. There was very significant statistical difference between the two groups (P less than 0.001). The Tab. Gentiana m. complex was more effective on the improvement of nephropathy, arthralgia, erythema and restoration of ESR, LE cells and CH50, C3 than prednisone alone. No apparent side effects of Tab. Gentiana m. complex were found in this observation.

Adolescent↗
PubMedDate not supplied

[Effect of prednisone on skin tests with allergens].

A double blind study was carried out in 29 patients, 14 were treated with prednisone and 15 with placebo. Prednisone caused significant inhibition of the allergen-induced wheal and flare response, but did not suppress it. The control group, showed a significant rise in the allergen-induced wheal and flare response. The significance of the observed alterations is briefly discussed as well as their probable origin. It is suggested the use of prednisone in allergic patients who need symptomatic treatment, however, we must to think about the possibility for get false-negative results.

Adolescent↗
PubMed1985

A randomized trial of adjuvant combination chemotherapy with or without prednisone in premenopausal breast cancer patients with metastases in one to three axillary lymph nodes.

The impact of adding "low-dose" continuous prednisone (7.5 mg daily) to an adjuvant cyclophosphamide-methotrexate-5-fluorouracil chemotherapy regimen was investigated in a randomized trial of 505 pre- and perimenopausal patients with operable breast cancer and one to three axillary lymph node metastases (Ludwig Breast Cancer Study I). As a consequence of lower hematological toxicity a significantly higher dose of cyclophosphamide-methotrexate-5-fluorouracil could be administered with added prednisone (P less than 0.0001). However, at a median followup of 48 months, no improvement in terms of disease-free survival (P = 0.35) or overall survival (P = 0.73) was observed. Induced amenorrhea was associated with a longer disease-free survival for younger patients, patients who received lower cyclophosphamide-methotrexate-5-fluorouracil doses and patients with estrogen receptor-positive tumors. It is suggested that the chemotherapy regimen with or without prednisone may also influence tumor growth by suppression of ovarian endocrine function.

Adult↗
PubMed1988

CHOP regimen versus intermittent chlorambucil-prednisone in stage B chronic lymphocytic leukemia. Short term results from a randomized clinical trial. French Cooperative Group on Chronic Lymphocytic Leukemia.

In 1985, the French Cooperative Group on Chronic Lymphocytic Leukemia started a protocol based on the (A, B, C) staging system. This paper reports the first interim results in stage B patients who were randomized to receive either the CHOP regimen or intermittent chlorambucil plus prednisone. Out of the 199 stage B patients, randomized on the reference date of May 1 1988, 94 received chlorambucil plus prednisone (7 deaths) and 105 the CHOP regimen (6 deaths). Among the evaluable patients at the 6-month examination, 53% reached clinical remission or stage A in the chlorambucil-prednisone group while 77% died in the CHOP group (p = 0.002). This short-term result supports the effectiveness of the CHOP regimen previously demonstrated by group in stage C patients. More follow-up is needed to assess the benefit from the CHOP regimen in terms of survival in stage B patients.

Aged↗
PubMed1988

Simultaneous liquid-chromatographic determination of prednisone and prednisolone in plasma.

This high-performance liquid-chromatographic (HPLC) method for simultaneous determination of prednisone and its metabolite, prednisolone, in plasma is a modification of the method of Frey et al. (Clin Chem 1979;25:1944-7). Heparinized plasma (1.0 mL) with 0.1 mL of internal standard solution (11-deoxy-17-hydroxycorticosterone, 2 mg/L) is extracted with 7.0 mL of dichloromethane, then washed sequentially with 0.1 mol/L HCl, 0.1 mol/L NaOH, and deionized water, 2.0 mL each. The extract is evaporated and the residue reconstituted with 75 microL of mobile phase, methanol/H2O (40/60 by vol). Thirty microliters of this is injected onto a reversed-phase C6 column, which is eluted at 1.4 mL/min. Analytical recoveries of prednisone and prednisolone were 94-98% and 102-106%, respectively. Day-to-day precision (CV) was 3.8% for prednisone, 6.1% for prednisolone. We encountered no interference from the 21 other steroids and 25 drugs tested. This method is simple, accurate, and precise.

Chromatography, High Pressure Liquid↗
PubMed1987

Mitoxantrone, vincristine, and prednisone in adults with relapsed or primarily refractory acute lymphocytic leukemia and terminal deoxynucleotidyl transferase positive blastic phase chronic myelocytic leukemia.

A combination of mitoxantrone, vincristine, and prednisone was used to treat 19 patients with acute lymphocytic leukemia. Of these, 12 were patients with acute lymphoblastic leukemia (ALL) (9 in first relapse and 5 primarily refractory to standard induction therapy with daunorubicin, vincristine, and prednisone), 2 had a phenotypic ALL relapse after an initial diagnosis of acute myelocytic leukemia and 5 had terminal deoxynucleotidyl transferase positive blastic phase chronic myelogenous leukemia (BCML). Eight patients with ALL (and of these, four with primarily anthracycline resistant disease), and two with BCML achieved complete remission. Five patients died in induction (three ALL from sepsis and two BCML from bleeding), and five had progressive disease. Median duration of response was 5 months, with two primarily refractory ALL patients remaining in continuing complete remission at 28 and 31 months. Treatment was well tolerated, with minimal nausea and vomiting, and oral mucositis. Posttreatment transient hepatic dysfunction was seen in 80% of patients. Mitoxantrone, vincristine, and prednisone are an active combination for the treatment of relapsed or refractory ALL and of terminal deoxynucleotidyl transferase positive BCML. The finding that four of five primarily refractory ALL patients were induced in complete remission supports the contention that mitoxantrone and anthracyclines are not cross-resistant.

Adolescent↗
PubMed1977

Permanent withdrawal of prednisone in nekro-kidney transplantation.

Starting 2.5 (2.0-3.9) years after grafting prednisone (but not azathioprine) has been gradually reduced below the conventional maintenance dose of 10 mg per day in 43 and has up until now eventually been completely withdrawn in 23 out of 47 consecutive patients with a first nekro-kidney transplant, which was well functioning at 2 years after transplantation. There appeared to be an increased risk of rejection during reduction of prednisone from 10 to 2.5 mg per day, but 20 out of the 23 patients in whom prednisolone has by noe been completely withdrawn have maintained stable and normal graft function over an average period of 1.6 (0.1-3.0) years on zero prednisone.

Age Factors↗
PubMed1978

Primary systemic amyloidosis: comparison of melphalan and prednisone versus placebo.

Satisfactory treatment for primary amyloidosis does not exist. Because the amyloid fibrils consist of a portion of a monoclonal light chain, it appears reasonable to treat amyloidosis with alkylating agents that are effective against the plasma cells that synthesize monoclonal light chains. Fifty-five patients with primary systemic amyloidosis were randomized (double blind) to melphalan-prednisone or placebo. In comparison with the placebo group, patients given melphalan-prednisone were able to continue on treatment for a longer time and to receive larger doses before the code was broken. Among this group, the nephrotic syndrome disappeared in two patients and urinary excretion of protein was reduced by more than 50% in eight others. Of 13 patients who received melphalan-prednisone for more than 12 mo, 6 improved, 3 were stable, and 4 had progression of disease. Survival did not differ significantly between the groups.

Alkaline Phosphatase↗
PubMed1987

Researching osteoporosis in prednisone treated sarcoid patients.

Eighty-four normal subjects, 5 untreated sarcoid patients and 32 sarcoid patients under chronic prednisone therapy were submitted to Quantitative Computed Tomography (QCT) for Vertebral Cancellous Mineral Content (VCMC) evaluation. In the five untreated and in the 84 normal subjects, VCMC (given in mg/cm3) fell in the normal range found elsewhere. 22 of the 32 treated patients had lower than normal values. Osteoporosis (expressed through cancellous mineral loss) increased significantly (P less than .01) with increasing dose x time of prednisone therapy. We conclude that the bone loss is far more frequent than suspected in prednisone treated patients with sarcoidosis; yearly QCT could be a good tool for monitoring patients under chronic therapy.

Bone and Bones↗
PubMed1987

Influence of concomitant aspirin or prednisone on methotrexate synovial fluid concentration.

Methotrexate (MTX) is currently being used in the treatment of patients with rheumatoid arthritis. The purpose of this study was to investigate the effect of two classes of drugs, steroids and salicylates, on MTX synovial fluid concentrations. A novel canine model of monoarticular inflammation was used, in which each animal served as its own control with both inflamed and normal knees in the same animal. After the 6-week immunization process, animals in each group received either no drug (control), prednisone or aspirin (low dose and high dose) for 1 week before MTX. On the day of the study, each animal was given i.v. MTX, and serial serum and synovial fluid samples were obtained. Laboratory, histologic and clinical observations supported the presence of monoarticular inflammation. The end-of-infusion synovial MTX concentration in inflamed knees was significantly greater than in normal knees (P less than .05), but, 2 hr after the end of infusion, they were not different. The end-of-infusion ratio of synovial fluid MTX concentration to serum MTX concentration (both total and unbound) was significantly lower in the prednisone group than in the other treatment groups (P less than .05). The end-of-infusion ratio of the MTX synovial concentration in the inflamed knee compared with the normal knee at 2 hr was significantly lower in the prednisone group than in the other three treatment groups (P less than .05). These results have therapeutic implications for the use of MTX in treating rheumatoid arthritis.

Animals↗
PubMed1979

Ovarian irradiation and prednisone therapy following surgery and radiotherapy for carcinoma of the breast.

Following mastectomy, patients with operable breast cancer underwent postoperative irradiation of the chest wall and regional lymph nodes. They were then assigned at random to receive no further therapy, ovarian irradiation (2000 rads in 5 days) or ovarian irradiation in the same dosage plus prednisone, 7.5 mg daily. A total of 705 patients received the randomly assigned treatment and were followed for up to 10 years. In premenopausal patients who received ovarian irradiation the recurrence of breast cancer was delayed and survival prolonged, but not significantly. In premenopausal women aged 45 years or more ovarian irradiation plus prednisone therapy significantly delayed the recurrence of breast cancer (P = 0.02) and prolonged survival (P = 0.02); the survival expectancy of these patients was similar to that of the general population of the same age from the third year after the cancer operation. No value was demonstrated for ovarian irradiation with or without prednisone therapy in postmenopausal patients.

Adult↗
PubMed1985

A double blind crossover trial of prednisone versus placebo in the treatment of fibrositis.

Twenty patients with a diagnosis of fibrositis were entered into a double blinded crossover study to compare the effects of prednisone versus placebo. Each patient was randomly assigned to either prednisone 15 mg/day or placebo for 14 days of therapy and then therapy was switched for a further 14 days. The following measurements were assessed at baseline, end of Week 2 and end of Week 4: analogue scores for pain, sleep disturbance, morning stiffness and fatiguability, and dolorimetry readings of pain tolerance over 14 representative tender points. Overall there was no improvement while taking prednisone, indeed most measured variables showed a trend towards deterioration with this therapy.

Adult↗
PubMed1986

Stability of prednisone tablets submitted by U.S. hospitals.

The stability of prednisone tablets that had been stored in hospitals across the United States was studied. Through a voluntary FDA drug stability program, all hospital pharmacies in the United States were asked in October 1982 to complete a response card indicating information about prednisone tablets they had in stock. Based on the responses, FDA selected 117 samples (representing 18 manufacturers and all available tablet strengths) from pharmacies that represented an adequate cross section of the country. The samples were analyzed for content uniformity, strength, identification, dissolution, and the presence of other steroids. All samples met USP requirements for content uniformity and strength. Four samples failed to meet USP requirements for dissolution. Prednisone tablets appear to be stable when stored under actual marketplace conditions.

Drug Contamination↗