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The treatment of cluster headaches with prednisone.

Nineteen patients obstinate with cluster headaches whose pain was not mitigated by standard treatment (Methysergide, caffeine, ergotamine preparation, phenobarbital and analgesics) underwent a double blind control study with single crossover for the evaluation of prednisone therapy. Compared to placebo, a single oral dose of prednisone in 17 cases produced sustained improvement. Maintenance administration of prednisone was also effective in decreasing the frequency of attacks; however a single dose of the steroid when headaches began was effective.

Adult↗

[Treatment of acute optic neuritis with high dose of prednisone].

OBJECTIVE: The benefit of glucocorticoid for the treatment of acute optic neuritis remains controversial. The efficacy of oral prednisone in 12 patients (14 eyes) with acute optic neuritis was reviewed. METHODS: The time of visual symptoms before treatment was 3-15 days. The visual acuities were worse than 0.1 in all patients, with positive relative afferent pupillary defect. Visual field defect and delay latency of P100 in pattern VEP were also found. The regimen of glucocorticoid therapy was oral prednisone, starting with 160 mg daily followed by reducing the dosage by 20 mg every three days until 40 mg per day was attained and then tapering the dosage at 70 mg every other day until stoppage of the drug. The treatment was 3-11 months and 9 patients were followed up more than one year. RESULTS: The visual acuities improved rapidly and stable. After 4 days, the visual acuity was 0.2 or better in 10 eyes. It was better than 0.6 in 12 eyes at 15 days. At 6 months, all had the visual acuity better than 0.7, with 85.7% equal or better than 1.0. CONCLUSIONS: The regimen of oral prednisone beginning with 160 mg followed by tapering for three months would be feasible. Pattern VEP was a sensitive and credible sign for evaluating the extent of demyelination.

Acute Disease↗

[Evaluation of prednisone treatment in children with IgA nephropathy and Schönlein-Henoch nephropathy according to the Waldo protocol with regard to pathomorphologic changes in renal biopsy].

UNLABELLED: The aim of the study was to analyse effectiveness of long term alternate-day prednisone treatment according the protocol of Waldo (Pediatr. Nephrol. 1993, 7, 529) in children with IgA nephropathy (IgAN) and Schönlein-Henoch nephritis (HSN). Eight pts: 6 with IgAN, mean age 10.1 yrs and 2 with HSN aged 10.3 and 14.3 yrs were treated with use of alternate-day prednisone for 2.3 to 3.92 (mean 2.90 yrs). Renal biopsies were performed in all patients 2 to 72 (mean 16 mths) after onset and were graded according the classification of WHO. All pts had normal serum creatinine concentrations at presentation. 3 pts had proteinuria > 1 g/1.73 m2 per day at onset and 5 pts had macroscopic or microscopic haematuria and/or increased proteinuria and/or III grade WHO in renal biopsy. After treatment haematuria and proteinuria disappeared in 2 pts and decreased in 6 pts. Hypertension (2/8), hypercalciuria (2/8), mild weight gain (6/8) and low bone density in lumbar region (5/8) were observed during the treatment. CONCLUSIONS: 1. Long term alternate-day prednisone treatment according the protocol of Waldo allows to decrease haematuria and proteinuria in children with IgAN and HSN 2. Side effects of therapy were observed in 62.5% pts.

Adolescent↗

Deflazacort versus prednisone in patients with giant cell arteritis: effects on bone mass loss.

OBJECTIVE: To compare bone mass loss due to deflazacort versus prednisone in longterm treatment of patients with giant cell arteritis (GCA) in a randomized double blind comparative trial. METHODS: Seventy-four patients were included in a prospective multicenter study. Half received deflazacort (DFZ) and the other half prednisone (PR) for a minimum of 12 months. Calcium and vitamin D supplements were also provided to all subjects. Our intent was (1) to evaluate bone mineral density, using dual energy x-ray absorptiometry, at baseline and comparatively at 3, 6, and 12 mo; vertebral fractures by Meunier score and size variations after 12 mo treatments were also analyzed; (2) to assess calcium/phosphate metabolism modifications in both groups at baseline and after 12 mo. RESULTS: No significant difference was observed between the 2 groups in terms of treatment efficacy. Patients taking PR were slightly older on average versus the DFZ group (74 vs 70 yrs). Bone mass loss between entry and month 12 was not statistically different in the PR group (-0.026 +/- 0.007 g/cm2) compared to the DFZ group (-0.03 +/- 0.005 g/cm2). No significant difference was found in Meunier score variations (0.77 and 1.18 in the PR and DFZ groups, respectively; p = 0.3), nor in vertebral size variations (-0.4 and -0.2 in the PR and DFZ groups, respectively; p = 0.4). There was no difference in calcium/phosphate metabolism evaluations at month 12. CONCLUSION: In older patients taking longterm glucocorticoids who are at risk of osteoporosis, deflazacort did not result in less bone loss than prednisone.

Absorptiometry, Photon↗

Pituitary-adrenal axis responsiveness to ovine corticotropin releasing hormone in patients with rheumatoid arthritis treated with low dose prednisone.

Ovine corticotropin-releasing hormone (oCRH) stimulation tests were performed in 8 female patients with active rheumatoid arthritis treated chronically with daily low dose prednisone and 16 age matched female controls. Patients were tested on the day of treatment, 12 h after their last prednisone dose, and after withholding prednisone for 36 h. Basal levels of plasma ACTH and to a lesser extent plasma cortisol levels were elevated before each test, and significant increases in ACTH and cortisol were induced with oCRH. The dose response relationship between total ACTH and total cortisol was shifted to the right, suggesting that the patient group had mildly deficient adrenocortical responsiveness compensated for by elevated basal evening ACTH concentrations. It is not known whether the neuroendocrine abnormalities demonstrated are due to an intrinsic preexisting abnormality, active disease, drug therapy or all these factors.

Adrenocorticotropic Hormone↗

[Comparison of the effectiveness of budesonide and prednisone in the maintenance treatment of pulmonary sarcoidosis].

The aim of this investigation was to compare inhaled budesonide vs oral prednisone in the maintenance phase treatment of pulmonary sarcoidosis. Double-blind controlled study was performed in 40 patients with stage II or III pulmonary sarcoidosis. After initial systemic 6 weeks treatment with prednisone (40 reduced to 20 mg daily) patients were allocated either to systematically (P) or topically (B) treated group. P patients continued with 10 mg prednisone daily, B patients were given inhaled budesonide 1.6 mg daily. The progress of treatment was assessed by serial radiography, spirometry, serum ACE activity and plasma cortisol levels. All patients completed the 12 months treatment. Using a numerical score to assess changes on the chest radiograms P patients improved by 1.7 +/- 0.66 points; B patients improved by 1.15 +/- 0.81 points. Spirometric changes were insignificant. Serum ACE fell from 107 +/- 51 U/L in the P group and 92 +/- 40 U/L in the B group to 46 +/- 11 U/L and 38 +/- 21 U/L respectively during the initial phase of treatment. In the maintenance phase ACE levels remained lower than initial ones in both groups. Morning cortisol plasma levels studied in 10 patients (5 in each group) decreased significantly during the initial phase. Thereafter cortisol levels remained low in the P patients returning to the lower limit of normal values in the B patients. We conclude that inhaled budesonide may be a safe and effective alternative to oral steroids in the maintenance treatment of pulmonary sarcoidosis especially in the early, stage II, disease.

Administration, Inhalation↗

Fludarabine + prednisone +/- alpha-interferon followed or not by alpha-interferon maintenance therapy for previously untreated patients with chronic lymphocytic leukemia: long term results of a randomized study.

BACKGROUND AND OBJECTIVES: Fludarabine is an effective therapy for patients with chronic lymphocytic leukemia (CLL) and interferon-alpha (IFN-alpha) has been reported to have anti-leukemic activity in CLL patients. A randomized study was designed to evaluate whether the addition of IFN-alpha to a first-line treatment with fludarabine and prednisone could increase the response rate in patients with advanced CLL and whether IFN-alpha given as maintenance therapy could improve the duration of response. DESIGN AND METHODS: One hundred and thirty-three patients were randomized to receive fludarabine (25 mg/m2/i.v., days 9-13) and prednisone (20 mg/m2, days 1, 3, 5, 7 and 14 and 40 mg/m2, days 9-13) (arm A: 66 patients) or in addition to the same schedule, IFN-alpha (2 MUI/sc, days 1, 3, 5, 7, 9, 11, 13 and 15) (arm B: 67 patients). Seventy-eight patients responsive to therapy entered the post-remission phase of the study in which 41 patients were randomized to receive IFN-alpha (3 MUI three times a week) and 37 to clinical observation. RESULTS: A similar response rate (complete responses + partial responses) was observed in the 2 arms: 86% for arm A and 84% for arm B (p = 0.4). A longer response duration was observed in patients who achieved a complete response (p = 0.001) and in patients who received maintenance therapy with IFN-alpha (p < 0.05). However, the quality of response was the only significant and independent factor influencing response duration (p < 0.01). No benefits in terms of infection-related mortality and morbidity could be ascribed to IFN-alpha administration. INTERPRETATION AND CONCLUSIONS: In previously untreated CLL patients with advanced disease a high response rate is obtained from first-line fludarabine and prednisone and no benefit is derived from the addition of IFN-alpha to this regimen. The achievement of a good quality response to therapy was the only independent predictor of a prolonged response.

Adult↗

Cough variant asthma: usefulness of a diagnostic-therapeutic trial with prednisone.

Cough variant asthma is characterized as a persistent, nonproductive cough with minimal or no wheezing and dyspnea. The diagnosis can be overlooked or misdisagnosed. We describe the severity of cough, the misery of some patients who have this syndrome and the usefulness of a diagnostic-therapeutic trial in ten patients with cough variant asthma. We evaluated ten patients whose chief complaint was persistent nonproductive cough. During the course of evaluation, all patients received a diagnostic-therapeutic trial of prednisone for cough variant asthma after other major causes of cough had been excluded. The duration of cough ranged from 2 months to 20 years. Some patients had significant side effects from coughing including interference with social life, work and sleep, urinary incontinence, stool incontinence, hoarseness, and vomiting. After a diagnostic-therapeutic trial with prednisone, nine patients reported significant improvement of cough in three days. One patient required 2 weeks of therapy for optimal improvement. All were subsequently controlled primarily with inhaled conticosteroids. The diagnosis of cough variant asthma may not be made for a prolonged time. A short course of prednisone as a diagnostic-therapeutic trial can establish a diagnosis and be followed by an effective method of control of cough by inhaled corticosteroids.

Adolescent↗

Adjuvant prednisone therapy in pharyngitis: a randomised controlled trial from general practice.

BACKGROUND: Acute pharyngitis is a frequent and well-documented complaint in general practice but the associated suffering has remained largely unaddressed in the literature. Evidence, however, from five randomised controlled trials suggests that corticosteroids may be useful in relieving pain and discomfort arising from the condition. AIM: To determine if short-acting oral therapy with prednisone was more effective than placebo in alleviating the suffering from acute pharyngitis in adults in a general practice setting. DESIGN OF STUDY: Randomised placebo-controlled trial. SETTING: General practice in Israel. METHOD: Patients with acute pharyngitis were randomised to receive 60 mg prednisone orally for 1 or 2 days, or identical placebo treatment. The main outcome measures were throat pain, measured by a visual analogue scale at 12, 24, 48 and 72 hours after presentation, time off work, fever, dysphagia, recurrence of symptoms and bacterial recurrence. RESULTS: Patients treated with prednisone experienced more rapid throat pain resolution than those in the placebo group. No adverse effects were reported nor any differences between the two groups regarding either symptom or positive bacterial culture recurrence. CONCLUSION: Short-acting oral steroid therapy is effective for shortening throat pain duration in acute pharyngitis.

Adolescent↗

The effect of subsequent therapies in patients with chronic lymphocytic leukemia previously treated with prednisone and either cladribine or chlorambucil.

We present the long-term follow-up and results of subsequent treatments in patients with chronic lymphocytic leukemia treated initially with cladribine + prednisone or chlorambucil + prednisone in a randomized, cross-over study. We found higher complete and overall responses rates in patients who received cladribine + prednisone as first and second-line treatment but no significant differences in survival.

Aged↗

[Observation on clinical therapeutic effect of acupoint-injection therapy combined with prednisone on nephrotic syndrome and effect on immunologic function].

OBJECTIVE: To search for the best method for increasing clinical therapeutic effect on nephrotic syndrome. METHODS: Forty-one cases were randomly divided into 2 groups. The treatment group (n=22) were treated with acupoint-injection of Chinese medicine combined with prednisone, and the control group (n=19) with prednisone. Their therapeutic results were observed and compared. RESULTS: The complete remission rate of 45.5% and the total effective rate of 86.4% in the treatment group were significantly higher than 31.6% and 63.2% in the control group, with a significant difference between the two groups in the total effective rate (P < 0.05); in the treatment group, blood lipids decreased, plasma proteins raised and immunologic function improved. CONCLUSION: Acupoint-injection of Chinese medicine combined with prednisone can significantly increase therapeutic effect on nephrotic syndrome and strengthen immunologic function.

Acupuncture Points↗

Gemcitabine plus mitoxantrone and prednisone in the palliative treatment of hormone-resistant prostate cancer (HRPC): A phase II study (GOAM 01.01 study).

BACKGROUND: The present exploratory phase II study was performed to evaluate the activity and tolerability of adding a second agent (gemcitabine) to the well-tolerated mitoxantrone/prednisone regimen in patients with locally advanced or metastatic prostate cancer no longer responsive to hormonal treatment. PATIENTS AND METHODS: Forty-three patients with hormone-refractory prostate cancer (HRPC) were included in the study from May 2000 to April 2004. Their median age was 71 years (range, 56-81) and their median Karnofsky performance status (KPS) was 90 (range, 70-100). The treatment schedule consisted of intravenous (i.v.) mitoxantrone (8 mg/m2 on day 1), i.v. gemcitabine 800 mg/m2 on days 1 and 8, recycled every 21 days and oral prednisone administered at a dose of 10 mg per day. Hormonal treatment with LHRH was continued in all patients. Up to six cycles of treatment were planned in the absence of progressive disease. RESULTS: Sixteen patients had measurable disease (six patients only measurable disease, ten patients bone disease plus measurable disease) and 27 patients had only bone disease. Concerning the PSA levels, a partial response (PR) was observed in 15 patients (38%), stable disease (SD) in 16 patients (41%) and progressive disease (PD) in eight patients (21%). The objective response was evaluable in 16 patients; one patient was not evaluable because he had received only one cycle. Ten patients (63%) had SD and five patients (31%) PD. In the ten evaluable patients with objective SD, depending upon the PSA response, three PR, six SD and one PD were observed. Among the five patients who progressed, three PD and two SD were observed as a PSA response. Pain remission was recorded in 15/41 patients (36%) and the KPS remained stable in most patients. The median overall survival was 15 months (range, 1-41) (95% CI: 10-20 months). The 1-year survival rate was 61%. Hematological toxicity was mild: G 3-4 neutropenia was observed in five (12%) patients. There were no neutropenic, fevers. No significant non-hematological toxicity was observed. CONCLUSION: The mitoxantrone, gemcitabine and prednisone combination, in accordance with the present regimen, was feasible, had a palliative effect, good tolerance and antitumor activity. Nonetheless, our results do not seem to be superior to those previously described for mitoxantrone plus prednisone.

Adenocarcinoma↗

Prednisone-induced osteoporosis: an overlooked and undertreated adverse effect.

CONTEXT: Glucocorticoids are used for a variety of medical conditions. This class of drugs is arguably the most common cause of iatrogenic osteoporosis, but studies have shown that physicians are not investigating and treating glucocorticoid-induced osteoporosis. OBJECTIVE: To determine whether primary care physicians (osteopathic and allopathic) are evaluating and treating adult patients at risk for osteoporosis secondary to long-term prednisone use. METHODS: Electronic medical records from three primary care practices (family medicine, geriatric medicine, and internal medicine) were retrospectively reviewed to identify patients who were taking at least 2.5 mg of prednisone per day for 8 weeks or longer. Records were then grouped according to whether patients had undergone bone mineral density screening and had been given therapy to prevent or treat bone loss. Whether patients had comorbid risk factors for secondary osteoporosis (according to the National Institutes of Health Consensus Development Conference Statement on Osteoporosis) was noted to determine whether treatment was given because of prednisone use or because of the comorbid risk factors. Statistical analysis was performed using a Pearson product moment correlation 2-tailed chi2 test. RESULTS: The medical records of 49 patients met inclusion criteria (19 men, 30 women; mean age, 61 years; age range, 21-89 years). A statistically significant difference was found in physician evaluation practices for patients with vs patients without comorbid risk factors (82.1% vs 38.1%; P=.002). CONCLUSION: Primary care physicians do not routinely evaluate patients for osteoporosis secondary to glucocorticoid treatment, especially when patients do not have comorbid risk factors for osteoporosis.

Adult↗

Randomized, double-blind trial of deflazacort versus prednisone in juvenile chronic (or rheumatoid) arthritis: a relatively bone-sparing effect of deflazacort.

Thirty-four children with juvenile chronic (rheumatoid) arthritis were recruited to a randomized, double-blind study of deflazacort (an oxazolone derivative of prednisone) vs prednisone. All had been receiving glucocorticoid therapy for at least 1 year and required at least 5 mg/d of prednisolone (usually as 10 mg every 2 days). Thirty-one children completed the study. Bone density trends were measured in the spine by dual photon absorptiometry and in the forearm by single photon quantitative computed tomography at 3-monthly intervals. Trends (velocities) in bone and soft tissue growth were calculated. In the spine, bone growth correlated well with indices of soft tissue growth, but covariance analysis showed a significant advantage (P less than .007) of deflazacort when spinal bone mineral growth was compared to body surface area and weight. In part this was due to a temporary interruption in weight by children receiving deflazacort, whose gain in height was comparable with that of the prednisone group. Some children in both groups improved clinically and showed catch-up growth; in these children relative spinal bone mineral growth velocities were about twice those observed for height and weight. It is concluded that during the first year of deflazacort, their spinal bone mineral content at a level that was appropriate for their height and weight. Further observations are required to establish whether this advantage can be maintained subsequently. The anti-inflammatory effects of the two glucocorticoids appeared similar.

Adolescent↗

Clearance of prednisone in isolated perfused livers of normal and uremic rats. Effects of acute and chronic cyclosporin A administration.

The influence of cyclosporin A (CsA) on the hepatic clearance of prednisone (HCP) was studied in isolated perfused livers of normal and chronic uremic rats perfused with a hemoglobin-free medium containing prednisone at an initial concentration of 635 +/- 129 micrograms/liter. Prednisone concentration was measured by a normal phase HPLC technique. Addition of CsA to the perfusate in livers of normal rats resulted in an increase of HCP by 38% from 10.8 +/- 2.4 to 14.9 +/- 3.4 ml/min/liver (p less than 0.01). In livers of uremic rats no effect was observed. Acute pretreatment with a large dose (120 mg) of CsA/kg/day ip for 1 day resulted in a 41% increase of HCP in livers of normal rats from 10.8 +/- 2.4 to 15.2 +/- 3.2 ml/min/liver (p less than 0.01). No effect was observed in livers of uremic rats. Chronic pretreatment with a CsA dose of 16 mg/kg/day ip continuously infused for 1 week reduced the HCP by 26% in livers obtained from normal rats and by 29% in livers of uremic rats, 10.8 +/- 2.4 to 8.0 +/- 1.7 ml/min/liver (p less than 0.01) and 14.7 +/- 1.1 to 10.4 +/- 1.2 ml/min/liver (p less than 0.01), respectively, whereas pretreatment with 7 mg/kg/day sc of CsA for 4 weeks resulting in blood CsA concentrations below 350 ng/ml had no influence.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

The combination of prednisone and colchicine in patients with primary sclerosing cholangitis.

Primary sclerosing cholangitis is a cholestatic liver disease characterized by inflammation and fibrosis of the biliary tract. The cause of the disease is unknown, and no effective medical treatment exists. In this study, 12 patients received a combination of low-dose prednisone (10 mg/day) and colchicine (0.6 mg bid). Their course was compared with that of a group of concurrent historical controls. At 6 and 12 months, there was significantly more improvement in liver test results over baseline values in patients receiving prednisone and colchicine than in the untreated controls. At 24 months, however, no significant differences in biochemical tests were appreciated between treated and untreated patients. Analysis of serial liver biopsies showed no differences in histologic change in the two groups. During the 2 yr of follow-up, there were two deaths in the control group but none in the treated group. Four untreated patients developed ascites; gastrointestinal bleeding developed in three untreated patients, one of whom developed ascites. In contrast, in the treated group, ascites and bleeding developed in only one patient. We conclude that the combination of colchicine and prednisone does not retard histologic progression or progression of standard liver tests after 2 yr of therapy. There is a trend toward less clinical deterioration and improved survival after 2 yr of treatment. On the basis of these findings, we would not advocate empiric use of these drugs for patients with primary sclerosing cholangitis, but suggest that, if they are to be used at all in PSC, they be evaluated in a controlled clinical trial as treatment for this as yet incurable disease.

Adult↗

Effect of recombinant alpha 2 interferon with or without prednisone in Chinese HBsAg carrier children.

Ninety Chinese hepatitis B surface antigen (HBsAg) carrier children, aged 2-17 years, positive for hepatitis B e antigen (HBeAg) and hepatitis B virus DNA on at least three occasions in 6 months, were randomized into 3 groups. Thirty children received syrup vitamin B complex as control, 29 received 6 weeks of placebo syrup followed by 16 weeks of recombinant alpha 2b-interferon [intron A (rIFN2b)], 5 x 10(6) u/m2 subcutaneously thrice weekly; and 31 received 6 weeks of syrup prednisone (0.6 mg/kg tailed to 0.2 mg/kg) followed by 16 weeks of recombinant alpha 2b-interferon as above. The placebo/prednisone syrup was given on a double-blind basis. At 24 months of follow-up, persistent loss of hepatitis B virus DNA occurred in none of the children in the control group, in one child receiving recombinant alpha 2b-interferon alone, who also seroconverted to anti-HBe and anti-HBs and in five children receiving interferon with steroid priming (p = 0.0571 compared with controls), with four seroconverting to anti-HBe and one also seroconverting to anti-HBs. A rise of transaminases to above twice the upper limit of normal levels during the first 7 months of follow-up occurred in one subject in the control group, four in the group receiving alpha 2b-interferon alone and nine in the group receiving recombinant alpha 2b-interferon with steroid priming (p = 0.0144 compared with controls). Side effects of the steroid were negligible; those of recombinant alpha 2b-interferon were transient and acceptable. We conclude that 6 weeks of prednisone followed by 16 weeks of recombinant alpha 2b-interferon is of use in inducing persistent loss of hepatitis B virus DNA (16.1 per cent) and e-seroconversion (12.9 per cent) in a proportion of Chinese HBsAg carrier children: the prednisone probably enhances the immunomodulatory effect of recombinant alpha 2b-interferon.

Adolescent↗

T lymphocyte subsets in chronic AgHBe positive hepatitis and the effects of prednisone therapy.

T lymphocyte subsets were studied in 18 patients with chronic AgHBe positive hepatitis. The study was carried out before, during and after a ten week course of prednisone therapy. There was no statistically significant difference during and after prednisone therapy in patients with hepatitis as to the total lymphocyte number and T lymphocyte subsets. The CD4/CD8 ratio was significantly decreased when compared with that of the normal controls, as the result of a reduction in CD4 T lymphocyte population before the beginning of the therapy. The patients did not respond to prednisone therapy.

CD4-CD8 Ratio↗