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Rifampin is an enzymatic inducer known to increase steroid metabolism. We studied two patients with giant cell arteritis in whom rifampin caused nonresponsiveness to prednisone treatment. A prednisone pharmacokinetics study was done. When rifampin-prednisone treatment must be used in giant cell arteritis, we propose increasing the prednisone dosage to 2 mg/kg per day.
To test the efficacy and toxicity of recombinant human growth hormone (rhGH, Protropin, Genentech), we reviewed our experience of its administration of rhGH to pediatric renal transplant recipients. Endogenous growth hormone (GH) levels were measured after stimulation with L-dopa and clonidine in growth retarded children whose height (ht) was greater than or equal to 2 standard deviations (SD) below the mean for age. Criteria for receiving rhGH were either subnormal GH levels (< 10 ng/ml) or a zero growth velocity over the preceding year despite normal GH levels after stimulation. The dose of rhGH administered subcutaneously was 0.1 mg/kg/day for 6 days/week. The efficacy of rhGH was evaluated using growth velocity index (GVI) and height standard deviation (Z) score. Catch-up growth was defined as an increase in Z score (delta Z) > or = 0.4. Twenty patients (17 with subnormal GH levels and 3 with normal GH levels but zero GVI) consented to rhGH treatment. Seventeen patients (14 males, 6 pubertal) have completed one year or more of rhGH therapy and are the subjects of this analysis. All 17 patients were receiving cyclosporine and 12 were receiving prednisone during rhGH therapy. Six of the 17 patients (35%) demonstrated catch-up growth (delta Z + 1.3 +/- 0.13). By regression analysis, the only factor noted to affect rhGH response was the concurrent use of prednisone. All five patients not receiving prednisone demonstrated catch-up growth compared to only 1 of 12 patients receiving prednisone (P < 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)
The effect of 7 month prednisone administration on cancellous and compact bone remodeling in dogs was evaluated by means of histomorphometric and tetracycline labeling methods. It was found that treatment with prednisone resulted in decrease of bone mass which was caused by increased bone resorption as well as considerable diminution of bone formation. In the iliac bone those were manifested by increase in resorption of trabecular surface, decrease in osteoid surface, and reduction in the osteoid thickness, indicating, with a simultaneous decrease in mineralization rate, slowing down of the appositional rate of newly formed bone tissue. In the rib cortical bone treatment with prednisone resulted in increase of the resorption sites together with decrease of the formation sites and tetracycline-labeled osteons. Reduction in the osteoid thickness as well as in the mineralization rate was also observed. The changes of bone remodeling parameters due to prednisone, although proceeding in the same direction in both types of bone tissue, were more marked in the spongy bone than in the compact bone.
Prednisone was administered orally for 4 weeks at a dosage of 1.1 mg/kg of body weight/d, in divided dose every 12 hours, to a group of healthy adult dogs (n = 12). Intravenous glucose tolerance testing was performed before and after the 28-day regimen in each dog, as well as in dogs of a control group (n = 6). Glucose metabolism was evaluated by measurement of preprandial plasma insulin and glucose concentrations, total insulin secretion, and fractional clearance of glucose. Mean preprandial plasma insulin and glucose concentrations were not increased after the 4-week regimen of prednisone. Total insulin secretion in response to an IV administered glucose load was not increased in treated dogs, compared with pretreatment values or with values for control dogs. The fractional clearance of glucose was also not altered in dogs given prednisone. Results indicate that anti-inflammatory doses of prednisone, given orally for 4 weeks, probably do not alter insulin sensitivity or glucose tolerance in clinically normal dogs.
Primary Sjögren's syndrome is a systemic autoimmune exocrinopathy characterized by a lymphoplasmacytic infiltrate and destruction of salivary and lacrimal glandular tissues. There is no widely accepted or effective systemic therapy for this disorder. The purpose of this 6-month randomized, double-blinded, placebo-controlled study was to examine the effects of prednisone (30 mg, alternate days), piroxicam (20 mg, daily), or placebo on the salivary, lacrimal and immunologic alterations of primary Sjögren's syndrome. Eight patients were enrolled in each group. Salivary and lacrimal function were assessed at entry and at the completion of treatment. Labial minor salivary gland tissue was obtained at these times and examined for intensity of infiltration (focus scores) and for the relative proportion of glandular elements. Serologic and subjective evaluations were done as well, and patients were monitored for therapy-related side effects. Neither active treatment led to significant improvement in salivary or lacrimal function, although prednisone improved salivary flow in selected patients and was associated with positive subjective responses. Prednisone also significantly decreased the serum total protein, IgG, IgA, and sedimentation rate and increased the white cell count. There were no significant alterations in either focus scores or the percentage of glandular component tissues of minor glands with either active treatment. This study demonstrated that 6 months of prednisone or piroxicam at the doses utilized failed to improve the histological or functional parameters of salivary and lacrimal glands in primary Sjögren's syndrome.
OBJECTIVE: To compare the efficacy of corticotropin (ACTH) (150 U/m2/day) and prednosone (2 mg/kg/day) given for 2 weeks, in suppressing clinical spasms and hypsarrhythmic electroencephalogram (EEG) in infantile spasms (IS). AACTH and prednisone are standard treatments for IS. ACTH at high doses causes severe dose- and duration-dependent side effects, but may be superior to prednisone, based on retrospective or uncontrolled studies. Blinded prospecive studies have shown equal efficacy of prednisone and low-dose ACTH, and low versus high-dose ACTH. DESIGN: A prospective, randomized, single-blinded study. SUBJECTS AND METHODS: Patient population consisted of consecutive infants fulfilling entry criteria, including the presence of clinical spasms, hypsarrhythmia (or variants) during a full sleep cycle video-EEG, and no prior steroid/ACTH treatment. Response required both cessation of spasms and elimination of hypsarrhythmia by the end of the 2-week treatment period, as determined by an investigator "blinded" to treatment. Treatment of responders was tapered off over 12 days; those failing one hormone were crossed-over to the other. RESULTS: OF 34 eligible infants, 29 were enrolled. Median age of patients was 6 months. Twenty-two infants were "symptomatic" with known or suspected cause, and seven were cryptogenic (two normal). Of 15 infants randomized to ACTH, 13 responded by EEG and clinical criteria (86.6%); Seizures stopped in an additional infant, but EEG remained hypsarrhythmic (considered a failure). Four of the 14 patients given prednisone responded (28.6%,, with complete clinical-EEG correlation), significantly less than with ACTH, (chi2 test). CONCLUSIONS: Using a prospective, randomized approach, a 2-week course of high-dose ACTH is superior to 2 weeks of prednsone for treatment of IS, as assessed by both clinical and EEG criteria.
The objective of this study was to ascertain the complications and the efficacy of low-dose aspirin (LDA) and prednisone therapy in women with pregnancy loss and "lupus anticoagulants" (LAC). During the period 1985 to 1993, 255 patients with two or more pregnancy losses (RPL) were tested for LAC with an activated partial thromboplastin time (aPTT) and a tissue thromboplastin inhibition index (TTI, normal value < 1.3). The diagnosis of LAC was established if two TTI values were > or = 1.3 or if a prolonged aPTT was measured in the patient's plasma that did not correct to normal by 1:1 mixing with normal plasma. We excluded patients with RPL who had only anticardiolipin antibodies. We treated 28 pregnancies in 21 women with LDA/prednisone for RPL associated with LAC. Therapy with LDA/prednisone was initiated as soon as a viable pregnancy was diagnosed. Therapy was continued until delivery in all but one case. Prednisone dose was minimized by measuring TTI and aPTT every 2 weeks and adjusting the dosage to maintain a TTI < or = 1.2 and to correct the aPTT to less than 36 seconds. Among the 28 pregnancies there were four (14%) first-trimester spontaneous abortions and four (14%) second-trimester fetal deaths. Of 20 surviving neonates (72%), seven were delivered after 37 weeks and 13 before 37 weeks (mean 35.9 +/- 2.3 weeks, range 31.5 to 40.4 weeks). Pre-term premature rupture of membranes occurred in three pregnancies, hypertensive disorders in six, and four small-for-gestational-age neonates were delivered (two stillborn). Mean birth weight of 20 surviving neonates was 2736 +/- 763 gm (range 900 to 3920 gm). Mean daily prednisone dose in 20 live births was 24.1 +/- 8.5 (SD) mg (range 11.3 to 49.3 mg/day) with mean duration of LDA/prednisone therapy of 185 +/- 40 days (range 97 to 223 days). Maximum prednisone dose was 60 mg/day (mean 36.8 +/- 12.7 mg/day). Only one serious maternal complication of LDA/prednisone therapy was observed. One neonate had talipes equinovarus that resolved without surgical therapy. LDA/prednisone therapy seemed effective and reasonably well tolerated in this population. These findings should be confirmed in a prospective, controlled investigation if such a trial can be organized and performed.
OBJECTIVES: Idiopathic colonic inflammation and ulceration have been described in HIV infection, but only as isolated case reports. We have been treating this condition with a uniform corticosteroid protocol and now report our results. METHODS: We describe the cases of eight patients with HIV infection who had diarrhea for more than 4 wk and inflammation and/or ulceration in the colon at endoscopy, confirmed by biopsy, without any invasive pathogens despite extensive evaluation. Each patient was treated with prednisone, starting at 40 mg/day, then tapered according to a standardized protocol. RESULTS: The diarrhea completely resolved in three patients and partially improved in five. One patient had some improvement but was unable to tolerate the prednisone because of a severe exacerbation of anal warts. He responded to subtotal colectomy. After a minimum follow-up of 8 months (mean, 17 months), only one patient (complete response to prednisone) was found to have an enteric pathogen. In this patient, cytomegalovirus colitis was diagnosed 15 months after prednisone was started. CONCLUSION: Idiopathic colonic inflammation or ulceration in HIV infection (1) may respond to corticosteroid therapy without life-threatening side effects and (2) is only rarely followed by the detection of a recognized pathogen. These observations suggest that enteric pathogens are not missed by standard techniques.
OBJECTIVE: To investigate the effects of Tripterygium wilfordii (TW) and prednisone on hypothalamic-pituitary-adrenal (HPA) axis in adjuvant arthritis (AA). METHODS: Experimental rats were divided into five groups at random, namely the normal group, model group, TW group, prednisone group and alternative group. Rats were given and intradermal injection of complete Freun d's adjuvant in right hind paws to induce adjuvant arthritis. The levels of plasma adrenocorticotropic hormone (ACTH) and cortisol, adrenal weights and pathological changes were studied at the end of experiment. RESULTS: The levels of plasma ACTH and cortisol and adrenal weights in TW group were significantly higher than those in normal group. On the contrary, decreased plasma ACTH and cortisol levels and atrophic adrenal cortex were observed in prednisone group. The levels of plasma ACTH and cortisol and adrenal weights in alternative group were not significantly different from those in normal group. CONCLUSION: TW may play anti-inflammatory role by the activation of the HPA axis, and alternative application of TW and prednisone could keep the normal function of HPA axis, they were complementary to each other.
PURPOSE: To compare the effectiveness of intravenous (i.v.) methylprednisolone pulse therapy and oral prednisone when used as the initial treatment of patients with mild or moderate thyroid-associated ophthalmopathy. METHODS: Thirty-three consecutive patients with thyroid-associated ophthalmopathy in Helsinki and Turku University Hospitals were randomly assigned either i.v. methylprednisolone pulse therapy (group A, n = 18) or oral prednisone (group B, n = 15). Treatment outcomes were measured by subjective changes in the grade of diplopia and quantitatively in several ophthalmic variables at 3 and 12 months. Any decision to proceed with additional treatment at 3 months was made on clinical grounds. The study was open in respect of both the initial treatment and the need for additional therapy. RESULTS: No significant differences in the grade of diplopia, proptosis or soft tissue activity scores were noted between groups A and B from 0 to 3 months. However, group A required additional forms of therapy at 3 months less frequently than did group B (p = 0.038). CONCLUSIONS: Our data suggest that i.v. methylprednisolone pulse therapy and oral prednisone are equally effective as initial treatments for thyroid-associated ophthalmopathy where diplopia, proptosis and signs of soft tissue inflammation are concerned. When additional treatment is required, i.v. methylprednisolone pulse therapy may be more effective than oral prednisone. However, the study's limitations meant that any decision to give additional treatment after the initial therapy was made on clinical grounds.
Oral corticosteroids are the main therapeutic choice for systemic lupus erythematosus (SLE). Adverse reactions to systemic corticosteroids rarely occur and the etiology is unclear in most cases. A 14-year-old girl with newly diagnosed SLE developed a pruritic bullous eruption while on prednisone. The patient had been treated successfully in the hospital with intravenous methylprednisolone. In preparation for discharge, the steroid preparation was changed to prednisone to which the patient reacted with a development of new crops of bullous lesions. Skin biopsy specimens of lesional areas showed a bullous eruption consistent with erythema multiforme. The patient underwent immediate and delayed hypersensitivity tests. Intradermal and patch tests to liquid prednisone were positive. The patient was discharged on oral methylprednisolone and has not had recurrence of the skin lesions. In conclusion, a case of prednisone sensitivity in a patient with SLE is presented here. An alternative preparation, methylprednisolone, was used to successfully treat her underlying condition.
Although the introduction of cyclosporine-prednisone immunosuppression has improved early renal graft survival, chronic rejection remains a major cause of longterm graft dysfunction. This study retrospectively examined 69 cases of chronic rejection among 643 primary renal allograft recipients treated with cyclosporine-prednisone immunosuppression from July 1981 to October 1989. Chronic rejection was defined as a rejection episode diagnosed greater than 90 days posttransplantation with characteristics of progressive nonacute renal function deterioration, confirmed, in most cases, by renal biopsy. This group was compared with an equal-sized matched cohort. Among cadaveric recipients, 61 of 456 patients (13.4%) displayed chronic rejection, whereas among living-related recipients, 8 of 187 patients (4.3%) developed chronic rejection. The average time from the date of transplantation to diagnosis of chronic rejection was 15 +/- 14 months. One- and three-year graft survivals following diagnosis of chronic rejection were 51% (30/59) and 25% (13/51), respectively, compared with the cohort one- and three-year graft survivals of 98% (58/59) and 86% (32/37) at similar periods posttransplantation. HLA mismatch, PRA status, blood transfusion history, lipid levels, cyclosporine trough levels, incidence of prior acute rejection, and initial graft dysfunction were not significantly different between the chronic rejection group and the matched cohort. Hypertension and proteinuria were significantly associated with chronic rejection (P less than 0.001). Of 58 biopsies performed, findings solely consistent with chronic rejection were observed in 9 cases (15%) and "acute upon chronic" rejection in 49 cases (83%). Treatment of acute concomitants improved the renal function in 43% (27/63) by the time of hospital discharge. Nonetheless, at 12 months the incidence of improved renal function eroded to 22% (13/59), suggesting that the benefit was relatively short-lived. Although the overall incidence of chronic rejection in this group of cyclosporine-prednisone-treated patients was lower than previous azathioprine-prednisone cohorts, the clinical presentation and progression of chronic rejection was similar. Additionally, the incidence of chronic rejection within this series was lower among living-related recipients versus cadaveric recipients of donor organs.
Fourteen patients were enrolled in a placebo-controlled double-blind randomized trial of 8 weeks of treatment for active lupus nephritis. Seven patients received prednisone at a dose of 1 mg kg(minus sign1) day(minus sign1) plus misoprostol at a dose of 200 &mgr;g P.O. Q.I.D.; 7 patients received prednisone plus placebo. The patients included 12 females, 2 males; 3 African-Americans, 3 Asians, 5 Hispanics, and 3 Caucasians. There were no serious side effects associated with prednisone or misoprostol treatment during the 8-week study period. Laboratory measures obtained at baseline, 4, 8, and 12 weeks included complete blood count (CBC), ESR, C reactive protein (CRP), serum creatinine, creatinine clearance, 24-h urine protein excretion, C3, C4, and anti-double stranded DNA (anti-dsDNA). Statistical analysis was conducted assessing change in measures over time in the entire study group by paired t-tests. The effect of treatment on change over time was examined by analysis of covariance. Log transformation of the variables was performed prior to statistical analysis. For the entire study group, the mean levels of ESR, CRP, 24-h protein excretion, C3, C4, and anti-dsDNA were improved at 4, 8, and 12 weeks. The mean ESR at baseline was 70 plus minus 8 compared to 42 plus minus 8 at 12 weeks (p < 0.01). The mean CRP at baseline was 0.6 plus minus 0.2 compared to 0.2 plus minus 0.1 at 12 weeks (p < 0.01). The 24-h protein excretion was 4367 plus minus 769 mg at baseline compared to 2512 plus minus 709 mg at 12 weeks (p = 0.02). The mean C3 at baseline was 40 plus minus 4 mg dl(minus sign1) compared to 60 plus minus 4 mg dl(minus sign1) at 12 weeks (p < 0.01). The mean C4 at baseline was 14 plus minus 1 mg dl(minus sign1) compared to 23 plus minus 2 mg dl(minus sign1) at 12 weeks (p < 0.01). The mean anti-dsDNA at baseline was 4268 plus minus 1780 compared to 316 plus minus 111 at 12 weeks (p < 0.001). The baseline serum creatinine (1.12 plus minus.15 mg dl(minus sign1)) and creatinine clearance (82 plus minus 15 ml min(minus sign1)) were not significantly changed at 12 weeks (1.10 plus minus 0.2 mg dl(minus sign1) and 80 plus minus 17 ml min(minus sign1), respectively). Comparing the misoprostol treatment group to the placebo group, there were no statistically significant differences for ESR, CRP, creatinine, creatinine clearance, 24-h protein excretion, C3, C4, or anti-dsDNA at any time points. However, comparing the misoprostol treatment group at 4 weeks to the placebo group, a more rapid decrease in anti-dsDNA (reduction of 3297 plus minus 2374) was observed in the misoprostol treatment group versus 304 plus minus 409 in the placebo group), as well as lower mean anti-dsDNA levels (464 plus minus 140) in the misoprostol treatment group versus 4118 plus minus 3834 in the placebo group). Also, the C3 and C4 levels at 12 weeks in the misoprostol treatment group (67 plus minus 5 and 27 plus minus 3 mg dl(minus sign1), respectively) were greater than levels in the placebo group (52 plus minus 4 and 19 plus minus 3 mg dl(minus sign1), respectively). The data demonstrate that oral prednisone is effective in reducing proteinuria and improving the biological markers of disease activity (i.e., ESR, CRP, C3, C4, and anti-dsDNA) following short-term treatment of active lupus nephritis. Additionally, the more rapid change in anti-dsDNA levels and superior normalization of complement levels in the treatment group, although not statistically significant, are consistent with a biologic effect of misoprostol on lymphocyte function and the production of a pathogenic autoantibodies.
OBJECTIVES: Thalidomide combined with conventional chemotherapies including oral melphalan shows significant anti-myeloma activity. To address this issue, feasibility and efficacy of a three drug combination consisting of intravenous (i.v.) melphalan, thalidomide and prednisone [M(i.v.)PT] was evaluated in advanced myeloma patients. PATIENTS AND METHODS: Twenty-four advanced myeloma patients were treated with multiple cycles of a regimen consisting of low dose i.v. melphalan (20 mg/m2) at d 1, thalidomide at the dose of 50-100 mg/d given continuously and oral prednisone at the planned dose of 50 mg/d every other day. Intravenous melphalan was administered every fourth month. Median time from diagnosis was 40 months (range: 8-144 months). Fifteen patients (66%) had previously been treated with a combination of thalidomide and dexamethasone or with thalidomide alone. RESULTS: Overall, on an intent-to treat basis, 14 patients responded: three achieved near complete remission (nCR), seven achieved partial response (PR), four minimal response (MR). Six patients showed stable disease (SD) and four-disease progression. Interestingly, of five patients who had previously progressed while on thalidomide and prednisone, one reached nCR, two PR and one MR. After a median follow up of 14 months, median progression free survival was 9 months. Response duration was longer than that induced by the previous line of treatment in eight patients (33%). Thalidomide-associated toxicity mainly consisted of constipation, tingling and sedation. CONCLUSIONS: M(i.v.)PT is an effective regimen, which can overcome resistance to thalidomide plus prednisone in advanced myeloma with acceptable toxicity.
Two patients with acute, rapidly progressive generalized vasculitis initially had symptoms of asthma. Progressive increase in severity of asthma was followed by systemic disease, including pulmonary infiltrative disease, mononeuritis multiplex, and abdominal pain. Examination of the tissues demonstrated vasculitis with eosinophilia, and clinically both cases appeared in a near terminal state. High-dose prednisone did not induce a remission. In particular, the lesions of mononeuritis multiplex progressed after initiation of high-dose prednisone. The addition of azathioprine to the regimen was followed by a gradual and then complete remission of clinical and laboratory abnormalities, except for some residual nerve damage and asthma of varying severity in the two patients. These two patients, whose cases are classified as the allergic granulomatosis variant of polyarteritis nodosa, have had a remission of seven and almost two years, respectively, after combined prednisone-azathioprine therapy.
A 40-year-old woman with clinical and laboratory features of myasthenia gravis, hyperthyroidism, and polymyositis responded to treatment with prednisone alone. Symptoms of myasthenia gravis appeared first followed by hyperthyroid symptoms. Triiodothyronine, thyroxine, and thyroid uptake were elevated as were serum levels of CPK, SGOT, SGPT, and LDH. Muscle biopsy specimen showed mild type II fiber atrophy and a small focus of inflammatory cells. Two weeks after initiation of prednisone, 100 mg every other day, the ESR declined from 44 to 12 mm/hr, serum enzyme values became normal, and the weakness improved. Over the ensuing four months, the thyroid function values returned to normal and the patient no longer needed any anticholinesterase drug. At present, she is functionally normal except for mild defects in eye movement and she takes no medication. Physicians should consider treating patients who have several concurrent autoimmune diseases with prednisone to see if all conditions can be brought under control with one simple therapy.
A 6-year old girl had chronic thrombocytopenia and substantial platelet function abnormality associated with detectable IgM antiplatelet antibody. Treatment with prednisone was followed by an improvement in bleeding time, although in vitro platelet function deteriorated. This observation suggests an effect of prednisone on hemostasis that is independent of platelet function. Further trials of prednisone in patients with similar platelet function abnormalities who have a substantial bleeding tendency would appear indicated.
The conditions of three children with dermatomyositis and one child with polymyositis were treated for nine to 31 months with combined prednisone and intravenous methotrexate (1 mg/kg/wk) when prednisone alone was ineffective in controlling the disease or when there were substantial steroid-related toxic effects. All children showed a major clinical improvement within three months despite concomitant reduction of the prednisone dose. Three children completely recovered; one patient relapsed and died. The toxic effects of methotrexate included elevated liver transaminases (3/4), nausea (2/4), abdominal pain (2/4), bone pain (2/4), mild neutropenia (1/4), and mild pruritus (1/4). Intravenous methotrexate is an effective adjunct to steroid therapy in the treatment of steroid-resistant or life-threatening dermatomyositis-polyositis or dermatomyositis-polymyositis complicated by severe steroid-related effects.