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PubMedDate not supplied

Nontapering versus tapering prednisone in acute exacerbations of asthma: a pilot trial.

Controversy exists as to whether or not the dose of prednisone should be tapered in patients discharged from the emergency department after initial treatment for an acute exacerbation of asthma. We assessed the rates of relapse and rebound in a group of 28 patients treated with a nontapering course of prednisone and compared their outcomes to an historical control group of 48 patients treated with a typical tapering course of prednisone. We found no significant difference in the rates of relapse or rebound between the nontapering dose patients and the tapering dose patients within either 21 days of discharge or within 10 days after stopping prednisone. Fifty-four percent of study patients reported adverse effects that could be attributed to prednisone. Our preliminary findings suggest that tapering of prednisone may not be needed in these patients.

Acute Disease↗
PubMed1979

Effect of prednisone on plasma testosterone levels and on duration of phases of the menstrual cycle in hyperandrogenic women.

A group of 106 women of reproductive age with laboratory and clinical evidence of hyperandrogenism was treated with prednisone. The daily dosage varied between 7.5 and 10 mg. Ovulatory activity was assessed prior to and during therapy by basal body temperature and observation of changes in the cervical os and cervical mucus. Plasma testosterone levels were significantly suppressed by prednisone therapy. This was associated with initiation of ovulatory activity in 5 of 14 (35.7%) amenorrheic patients and 10 of 11 (90.9%) anovulatory patients. In 81 ovulatory patients, prednisone therapy resulted in statistically significant shortening of the follicular phase and lengthening of the luteal phase of the menstrual cycle. The mean length of the menstrual cycle was unchanged. Significant correlations between percentage suppression of plasma testosterone and shortening of the follicular phase or lengthening of the luteal phase were observed. Suppression of plasma testosterone by prednisone was maximal after 2 months of treatment, while the effect on the phases of the menstrual cycle was progressive with duration of treatment. The effects of prednisone at daily dosages of 7.5 or 10 mg were not significantly different. These results suggest that prednisone therapy in hyperandrogenic women exerts an effect on both phases of the menstrual cycle, possibly related to suppression of plasma testosterone levels.

Adult↗
PubMed1985

A therapeutic index that predicts the individual effects of prednisone in patients with cirrhosis.

Our aim was to construct an index that accurately predicts the degree of benefit or harm that prednisone therapy holds for patients with liver cirrhosis. The admission and survival data of 488 patients with cirrhosis who participated in a controlled clinical trial of prednisone in a dosage of 10-15 mg daily (251 patients) versus placebo (237 patients) and who were observed for up to 12 yr were analyzed using Cox's multiple regression model. Four variables each provided significant therapeutic information: antinuclear factor (p = 0.02) and large piecemeal necroses (p = 0.02) were associated with a beneficial effect, whereas ascites (p = 0.0004) and large regenerative nodules (p = 0.0007) were associated with a harmful effect of prednisone. From these four variables a therapeutic index was constructed. For a given patient the therapeutic index is a measure of how big the effect will be if prednisone is given. The gain in survival time obtained by administering prednisone according to the therapeutic index was estimated to be 349 yr, mainly confined to 217 patients with a significant positive (121) or negative (96) therapeutic index. The therapeutic index may prove useful for the optimal administration of prednisone treatment in new patients with cirrhosis.

Antibodies, Antinuclear↗
PubMed1987

Early intervention with short courses of prednisone to prevent progression of asthma in ambulatory patients incompletely responsive to bronchodilators.

The effect of high orally administered doses of prednisone for 1 week early in the course of an acute exacerbation of asthma incompletely responsive to bronchodilators was examined in 41 patients randomly assigned to receive either prednisone or an identical appearing placebo. All 22 of the patients who received prednisone improved during the week of treatment, although one had a subsequent exacerbation 5 days after discontinuing the study medication. Of the 19 who received placebo, eight required rescue intervention (P = less than 0.004) in association with continued symptoms, increased frequency of metered-dose inhaler use, and decreased pulmonary function; the other 11 improved at about the same rate as those who received prednisone. Although the mean initial FEV1 was suggestively lower among those who did not improve and required intervention, there was considerable overlap with those who improved spontaneously, and no reliable distinguishing characteristics were found at entry into the study that could serve as predictors of those who would or would not improve spontaneously. There were no clinically important adverse effects from the prednisone. Because continued symptoms of asthma often result in emergency care or hospitalization, these data support early intervention with orally administered prednisone for acute exacerbations that do not respond fully to bronchodilators, at least in those patients with a prior history of a protracted course or emergency care.

Adolescent↗
PubMed2002

Intravenous immunoglobulin or high-dose methylprednisolone, with or without oral prednisone, for adults with untreated severe autoimmune thrombocytopenic purpura: a randomised, multicentre trial.

BACKGROUND: Treatment of adults with autoimmune thrombocytopenic purpura (AITP) is based more on individual experience than on results of controlled studies. We compared intravenous immunoglobulin with high-dose methylprednisolone in untreated adults with severe AITP and assessed efficacy of subsequent oral steroids compared with placebo. Primary outcome was number of days with platelet count greater than 50 x 10(9)/L within the first 21 days. METHODS: We did a randomised multicentre trial based on a 232 design. 122 adults with severe AITP (platelet count < or =20 x 10(9)/L) were randomly assigned to receive either intravenous immunoglobulin or high-dose methylprednisolone on days 1-3 (randomisation A), and then to receive either oral prednisone or placebo (randomisation B) on days 4-21. Analysis was by intention to treat. FINDINGS: Six patients were excluded from the analysis. The number of days on which platelet counts were above 50 x 10(9)/L was 18 in 56 patients receiving intravenous immunoglobulin and 14 in 60 receiving high-dose methylprednisolone (p=0.02). Percentage of patients who had platelet counts over 50 x 10(9)/L on days 2 and 5 was 7% and 79%, respectively, in the intravenous immunoglobulin group compared with 2% and 60%, respectively, in the high-dose methylprednisolone group (p=0.04). During the second treatment period, prednisone was more effective than placebo for all short-term endpoints. Patients who received intravenous immunoglobulin and prednisone had platelet count greater than 50 x 10(9)/L for 18.5 days (p=0.005), and those treated with high-dose methylprednisolone and prednisone had this count for 17.5 days. INTERPRETATION: Intravenous immunoglobulin and oral prednisone seems to be more effective than high-dose methylprednisolone and oral prednisone in adults with severe AITP, although the latter treatment is effective and well tolerated.

Adult↗
PubMed1994

Randomised trial of intravenous immunoglobulin G, intravenous anti-D, and oral prednisone in childhood acute immune thrombocytopenic purpura.

The most serious complication of childhood acute immune thrombocytopenic purpura (ITP), intracranial haemorrhage, occurs in about 1% of children with platelet counts below 20 x 10(9)/L. We conducted a randomised study to explore three treatment options in this high-risk group. 146 children (> 6 months and < 18 years old) with typical acute ITP and platelet counts of 20 x 10(9)/L or lower were randomised to receive high-dose intravenous immunoglobulin G (IVIgG) 1 g/kg on 2 consecutive days (n = 34), 0.8 g/kg once (n = 35), intravenous anti-D 25 micrograms/kg on 2 consecutive days (n = 38), or oral prednisone 4 mg/kg per day with tapering and discontinuation of prednisone by day 21 (n = 39). The rate of response as reflected by the number of days with platelet counts at 20 x 10(9)/L or lower and the time taken to achieve a platelet count 50 x 10(9)/L or more was significantly faster for both IVIgG groups than for the anti-D group (p < 0.05); the difference between prednisone and IVIgG was significant (p < 0.05) only for the IVIgG 0.8 g/kg group, and responses to the two IgG groups were similar. These differences in response rates were reflected in the percentages of children with platelet counts of 20 x 10(9)/L or lower at 72 hours following the start of treatment: 3% (IVIgG 0.8 g/kg x 1), 6% (IVIgG 1 g/kg x 2), 18% (anti-D), and 21% (oral prednisone 4 mg/kg/day). Treatment-associated toxicities included a fall in haemoglobin with anti-D (to less than 100 g/L in 24% of cases); weight gain with oral prednisone; and fever, nausea, vomiting, and headache with IVIgG. On the basis of these results, intravenous anti-D cannot be recommended as initial therapy for children with acute ITP and platelet counts of 20 x 10(9)/L or lower. A single dose of 0.8 g/kg IVIgG offers the fastest recovery for the least treatment; additional IgG or oral prednisone can be reserved for the one-third of children who continue to have platelet counts of 20 x 10(9)/L or less at 48-72 hours after the start of treatment.

Adolescent↗
PubMed1998

Comparison of intramuscular triamcinolone and oral prednisone in the outpatient treatment of acute asthma: a randomized controlled trial.

STUDY OBJECTIVE: To determine whether a one-time dose of triamcinolone diacetate, 40 mg intramuscular (i.m.), given to adult patients treated in the emergency department for mild to moderate exacerbation of asthma would decrease the rate of relapse during the following week, compared with a nontapering course of oral prednisone, 40 mg/day over 5 days. METHODS: A randomized, double-blind, controlled clinical trial was conducted at two university-affiliated community teaching hospitals with a combined annual census of 97,000. Patients were eligible if they were between the ages of 18 and 50 years, had an initial peak expiratory flow rate of less than 350 L/minute, and were to be discharged from the ED taking steroids. Patients were randomly assigned to receive either triamcinolone (40 mg i.m.) and placebo tablets or a placebo injection and prednisone (40 mg/day orally for 5 days). Patients were instructed to use a beta-agonist metered-dose inhaler, to continue other routine medications, to complete symptom diary cards, and to return in 7 to 10 days for follow-up. The main outcome measure was relapse, which was defined as an unscheduled visit to a physician's office or ED for worsening or persistent symptoms within 7 days of the initial ED visit. RESULTS: A total of 168 patients were initially enrolled; 6 patients were withdrawn for protocol violations and 8 because they could not be contacted for follow-up. A total of 154 patients were available for outcome analysis, 78 in the triamcinolone group and 76 in the prednisone group. There were no differences between the two patient groups with regard to demographics, smoking history, weight, or symptom severity. Mean initial peak flows were 244+/-64 L/minute for the triamcinolone group and 245+/-83 L/minute for the prednisone group. Fifty percent of the study patients were current smokers. The relapse rates were 9.0% (7/78) in the triamcinolone group and 14.5% (11/76) in the prednisone group (P=.29). The absolute difference in relapse rates was 5.5% (95% confidence interval [CI], 4.6% to 15.6%). There was no difference in symptom frequency or severity between the two groups during the first 5 days of outpatient treatment. Analysis between the groups stratified for smoking showed no difference in relapse rate between smokers and nonsmokers. CONCLUSION: A single dose of triamcinolone diacetate, 40 mg i.m., produced a relapse rate similar to that of prednisone, 40 mg/day orally for 5 days, after ED treatment of mild to moderate exacerbations of asthma. Intramuscular triamcinolone would appear to be an attractive alternative when compliance with a daily oral regimen is of concern.

Acute Disease↗
PubMed1990

Prednisone administration in recent onset type I diabetes.

The aim of our study was to investigate the efficacy of prednisone to preserve pancreatic beta-cell function in patients with recent-onset Type I diabetes mellitus (IDDM). Twenty-five patients with IDDM, aged 24 +/- 6 years, entered the trial within 8 weeks of the onset of diabetes. They were allocated, according to a single blind randomized protocol, to one of the following treatments: (A) prednisone (15 mg/day), (B) indomethacin (100 mg/day), (C) placebo. All treatments lasted 8 months and all patients achieved satisfactory metabolic control with a multi-injection regimen (three injections/day) within a few weeks, and maintained it throughout the entire period of observation. Only minor side effects were observed in the prednisone-treated patients. A lower insulin requirement was observed in the prednisone group than in other patients at 12 months (0.33 +/- 0.11 vs 0.57 +/- 0.06 U/kg/day, P less than 0.05), 18 months (0.34 +/- 0.11 vs 0.64 +/- 0.06, P less than 0.05) and 24 months (0.38 +/- 0.10 vs 0.63 +/- 0.05, P less than 0.05). Endogenous insulin release, evaluated as urinary C-peptide, was higher in the prednisone group than in other patients at 3, 6, 9, 12, 18 and 24 months (P less than 0.05). ANOVA confirmed differences among the three groups. Our study indicates that prednisone administration, at low doses and for a long period of time, effectively restored endogenous insulin release in IDDM patients.

Adolescent↗
PubMed1985

Effects of cimetidine and ranitidine on the conversion of prednisone to prednisolone.

Prednisone is a glucocorticoid that must be converted in vivo to prednisolone for pharmacologic activity. We examined the effects of the H2-receptor antagonists cimetidine and ranitidine on the time course of plasma prednisolone concentrations after an oral dose of prednisone. Nine healthy men received each of three oral treatments in a double-blind, balanced, crossover manner: cimetidine (300 mg every 6 hours), ranitidine (150 mg twice a day), or placebo for 4 days, with prednisone (40 mg) taken also on day 4. Serial blood and urine samples were collected for 30 hours after prednisone dosing. Prednisone and prednisolone plasma and urine concentrations were analyzed by HPLC. No differences were found between treatments in the maximum prednisolone plasma concentration, t1/2, apparent volume of distribution, and AUC. Cimetidine reduced the mean (+/- SD) ratio of prednisone dose to the plasma prednisolone AUC (16.6 +/- 2.9 L/hr) below that ratio after ranitidine (19.2 +/- 4.2 L/hr) and placebo (19.3 +/- 2.8 L/hr), and resulted in the lowest fractional excretion of prednisolone in the urine (5.2% +/- 2.2%, 9.8% +/- 4.5%, and 12.4% +/- 4.9%, respectively). The minor alterations in prednisolone kinetics during concomitant cimetidine dosing are not likely to induce clinically significant alterations in steroid effect.

Administration, Oral↗
PubMed2004

Treatment of pure membranous lupus nephropathy with prednisone and azathioprine: an open-label trial.

BACKGROUND: The aim of this study was to report the outcome of pure membranous lupus nephropathy treated with prednisone and azathioprine (AZA). METHODS: Consecutive patients with pure membranous lupus glomerulonephritis (World Health Organization [WHO] Va and Vb) from 4 regional hospitals were recruited for an open-label treatment trial consisting of prednisone and AZA. Remission status was evaluated at 12 months. Maintenance treatment with low-dose prednisone and AZA was continued indefinitely for those who achieved remission. Factors predictive of initial renal remission and subsequent relapse were studied by statistical analyses. RESULTS: Thirty-eight patients (31 women and 7 men) were studied. The mean age was 35.0 +/- 9.2 years, and the duration of systemic lupus erythematosus was 48.5 +/- 59 months. Seventeen (45%) patients had WHO class Va lupus nephritis, whereas 21 (55%) had class Vb disease. Two patients withdrew from the protocol because of idiosyncratic reactions to AZA. At 12 months, 24 (67%) patients achieved complete remission (CR), 8 (22%) achieved partial remission (PR), and 4 (11%) were treatment resistant. Patients who achieved CR or PR were maintained on low-dose prednisone and AZA. Over a mean follow-up period of 90.4 +/- 59 months, 6 (19%) patients had relapse of nephritis (proteinuric flare in 4 and nephritic flare in 2). The cumulative risk of renal relapse was 12% at 36 months and 16% at 60 months. No particular clinical variables were found to predict renal remission or relapses. Over a mean follow-up of 90 months, 13% of patients had decline of creatinine clearance by 20%, but none had doubling of serum creatinine. Renal outcome was not significantly worse in patients presenting with nephrotic syndrome. Treatment generally was well tolerated. CONCLUSION: A combination of prednisone and AZA is reasonably effective for the initial treatment of pure membranous lupus nephritis. Severe adverse effects are uncommon. The additional efficacy of AZA in comparison with prednisone alone has to be confirmed with randomized, controlled trials.

Adult↗
PubMed1991

Effect of a short course of prednisone in the prevention of early relapse after the emergency room treatment of acute asthma.

BACKGROUND: Relapse after the treatment of acute asthma in the emergency room is common (occurring in 25 to 30 percent of cases) and is not accurately predicted by any available measurements. We studied the usefulness of prednisone in reducing this high rate of relapse. METHODS: One hundred twenty-two patients treated in the emergency room for acute exacerbations of asthma were assigned in a randomized, double-blind fashion to receive at discharge either prednisone for eight days (the dose being tapered from 40 to 0 mg per day) or matching placebo. Ninety-three were subsequently discharged from the emergency room and participated in the trial. On days 1, 7, and 14 after discharge, the patients were assessed during home visits with spirometry and diary-card review; they were contacted by telephone on day 21. Relapse was defined as an unscheduled medical visit occasioned by the patient's perceived need for further asthma treatment. RESULTS: The overall risk of relapse was significantly lower in the prednisone group (P less than 0.05), with a significantly reduced rate of relapse during the first 10 days of follow-up (3 of 48, as compared with 11 of 45 in the placebo group; P less than 0.05). Thereafter (days 11 through 21), there was no further significant difference in relapse rates between treatment groups (five in the prednisone group and six in the placebo group). During the first week after discharge, patients receiving prednisone reported significantly lower mean (+/- SD) daily symptom scores for shortness of breath (1.4 +/- 0.4 vs. 2.5 +/- 0.4, P less than 0.01) and less frequent use of an inhaled bronchodilator (5.2 +/- 0.5 vs. 6.9 +/- 0.2 puffs per day, P less than 0.05) than patients receiving placebo. Subsequently, symptom scores and bronchodilator use were similar in the two groups. CONCLUSIONS: A short course of prednisone reduced early relapse rates after the treatment of acute asthma in the emergency room, an effect limited to the period of steroid administration.

Acute Disease↗
PubMed2000

A comparison of inhaled fluticasone and oral prednisone for children with severe acute asthma.

BACKGROUND: Inhaled corticosteroids are effective in the treatment of children with asthma. It is uncertain how inhaled corticosteroids compare with oral corticosteroids in the management of severe acute disease. METHODS: We performed a double-blind, randomized trial involving 100 children five years of age or older who had severe acute asthma (indicated by a forced expiratory volume in one second [FEV1] that was less than 60 percent of the predicted value) and in whom the results could be evaluated. All were treated with an aggressive bronchodilator regimen and received one dose of either 2 mg of inhaled fluticasone through a metered-dose inhaler with a spacer or 2 mg of oral prednisone per kilogram of body weight. They were assessed hourly for up to four hours. RESULTS: The mean (+/-SD) base-line FEV1 as a percentage of the predicted value was 46.3+/-12.5 in the fluticasone group (51 subjects) and 43.9+/-9.9 in the prednisone group (49 subjects). The FEV1 increased by a mean of 9.4+/-12.5 percentage points in the fluticasone group and by 18.9+/-9.8 percentage points in the prednisone group four hours after therapy (P< 0.001). None of the children in the prednisone group had a reduction in FEV1 as a percentage of the predicted value from base line to four hours, as compared with 25 percent of those in the fluticasone group (P<0.001). Sixteen (31 percent) of the children treated with fluticasone were hospitalized, as compared with five (10 percent) of those treated with prednisone (P=0.01). CONCLUSIONS: Children with severe acute asthma should be treated with oral prednisone and not with inhaled fluticasone or a similar inhaled corticosteroid.

Administration, Inhalation↗
PubMed2003

A randomized, double-blinded, placebo-controlled trial of intermittent administration of interleukin-2 and prednisone in subjects infected with human immunodeficiency virus.

Intermittent administration of interleukin (IL)-2 produces significant and sustained increases in CD4(+) T lymphocyte count in human immunodeficiency virus (HIV)-infected subjects but can be associated with dose-limiting toxicities. The primary objective of this study was to determine whether concomitant administration of prednisone could decrease these toxicities. HIV-seropositive adults receiving highly active antiretroviral therapy (HAART) were randomized to receive either (1) intermittent subcutaneous IL-2 and placebo, (2) intermittent subcutaneous IL-2 and prednisone, (3) intermittent prednisone, or (4) intermittent placebo. Prednisone decreased levels of proinflammatory cytokines during IL-2 cycles but, despite induction of expression of CD25, blunted increases in IL-2-associated CD4(+) T lymphocyte count. Whereas intermittent administration of IL-2 reduced basal proliferation of CD4(+) T cells, this effect was inhibited by prednisone, suggesting that prednisone potentially interferes with IL-2's long-term effects on survival of T lymphocytes.

Anti-HIV Agents↗
PubMed1990

Decreases of proteinuria during alternate-day prednisone therapy in nephrotic syndrome.

Treatment of patients with membranous glomerulonephritis with prednisone on alternate days results in a decreased proteinuria on non-prednisone days. We have studied this phenomenon in more detail in 14 patients (11 M, 3 F) with membranous glomerulonephritis. Mean age +/- SD of the patients was 47 +/- 14 years, mean endogenous creatinine clearance 94 +/- 35 ml/min, and median proteinuria 8.8 g/24 h (range 5.0-30.0 g/24 h). Glomerular filtration rate (GFR, inulin clearance), effective renal plasma flow ERPF, PAH clearance), and proteinuria were measured on a control day (C), and six days after the start of alternate-day prednisone treatment, on the third non-prednisone day (NP3, 24-28 h after the last dose of prednisone). Proteinuria decreased from 6.1 mg/min (3.2-9.8 mg/min) (C) to 2.5 mg/min (1.0-7.7 mg/min) at NP3 (median, interquartile range; P less than 0.01), the percentage decrease averaged 45 +/- 8%. The decrease of proteinuria was correlated with baseline GFR (r = 0.75; P less than 0.01). GFR and ERPF did not change significantly, but filtration fraction decreased significantly from 14.5 +/- 0.8% (C) to 13.5 +/- 0.9% (NP3; P less than 0.05). Fractional excretion of albumin, IgG, and transferrin decreased significantly, by -40 +/- 8%, -52 +/- 6%, and -52 +/- 7% respectively. Fractional excretion of beta 2-microglobulin decreased significantly less by -12 +/- 10%. We conclude that proteinuria is decreased on non-prednisone days in patients with membranous glomerulonephritis treated with alternate-day steroids. The observed decrease of filtration fraction suggests that a reduction of glomerular pressure is involved. In addition, the magnitude of the decrease of proteinuria might indicate a change in glomerular permselectivity characteristics.

Adult↗
PubMed1991

Renal transplantation and red blood cell sodium transport: role of prednisone treatment.

This study assesses the role of prednisone and endogenous digoxin-like immunoreactivity (EDLI) in the increased Na+ pump activity in renal allograft patients. Red blood cell (RBC) Na+ transport activities and plasma concentrations of EDLI were measured in ten controls and ten renal allograft recipients (5 hypertensive) while undergoing treatment with cyclosporin, prednisone, and azathioprine, and also after prednisone withdrawal. As compared to controls, prednisone-treated patients showed an increased Na+ pump activity (0.323/h vs 0.571, P less than 0.05) and decreased RBC Na+ concentration (6.69 mM vs 4.99, P less than 0.05). They also showed a decrease in the activity of cotransport, countertransport, and passive Na+ efflux (0.02/h vs 0.005, P less than 0.05; 207 mumol/l vs 35, P less than 0.05; 0.02/h vs 0.005 respectively, P less than 0.05). After prednisone withdrawal, normotensive and hypertensive patients showed RBC Na+ transport system activities and RBC Na+ concentration similar to those of controls. EDLI was not detected in controls or in patients. We conclude that prednisone treatment increased the Na+ pump activity, and decreased the RBC Na+ concentration. Moreover, it induced a decrease in the activity of secondary RBC Na+ transport systems. This study provides no evidence for a modulatory role of EDLI in the RBC Na+ pump activity. Neither parameters can be presumed to be a marker of hypertension in these patients.

Adult↗
PubMed1992

Vertebral osteoporosis in rheumatoid arthritis patients: effect of low dose prednisone therapy.

The effect of low dose prednisone therapy on spinal bone mass is controversial. We measured lumbar trabecular and cortical bone mineral density (BMD) in 74 rheumatoid arthritis (RA) patients by dual energy quantitative computerized tomography in a cross-sectional study. The presence of vertebral deformities was evaluated on a lateral spine radiograph. Patients who had never been treated with corticosteroids (n = 44) were compared with patients on long-term low dose (less than or equal to 10 mg/day) prednisone therapy (n = 30). After correction for confounding variables the lumbar BMD was highly significantly influenced by prednisone therapy in postmenopausal patients (estimated influence -31.2% on trabecular BMD and -37.2% on cortical BMD). Vertebral deformities were also significantly more frequent in prednisone treated postmenopausal patients. No negative effect of prednisone treatment could be demonstrated in male patients. In contradiction to previous reports we conclude that long-term prednisone therapy may be associated with development of spinal osteoporosis in postmenopausal RA patients, even when low doses are used.

Arthritis, Rheumatoid↗
PubMed1990

Management of chronic middle ear effusion with prednisone combined with trimethoprim-sulfamethoxazole.

Fifty-three patients were enrolled and evaluable in a randomized, double-blinded controlled clinical trial comparing prednisone for 7 days plus trimethoprim-sulfamethoxazole (TMP/SMZ) for 30 days vs. TMP/SMZ alone in treating chronic middle ear effusion (MEE). Clearing of the effusion in both ears or in one when only one was involved was called complete resolution; clearing in one of two affected ears was called partial resolution. The outcomes 2 weeks after initiation of therapy of 26 patients initially treated with prednisone plus TMP/SMZ were complete resolution in 20, partial resolution in three, and unchanged in three. The outcomes in 27 patients initially treated with TMP/SMZ alone were complete resolution in eight, partial resolution in three, unchanged in 13 and development of acute otitis media in three (P less than 0.01 for complete resolution). Two weeks after initiation of therapy, patients with a MEE that failed to clear were crossed over to the alternative regimen. Overall 29 of 41 patients (71%) who received oral prednisone plus TMP/SMZ initially or after the crossover had complete resolution of their middle ear effusion at 2 weeks after starting prednisone and TMP/SMZ. Five of 35 (14%) patients treated with prednisone plus TMP/SMZ and one of six (17%) patients treated with TMP/SMZ alone who had complete resolution at 4 weeks required subsequent referrals for tympanostomy tubes. A course of prednisone for 7 days plus TMP/SMZ for 30 days with monthly follow-up should be considered in children with MEE persisting beyond 6-8 weeks before referral for tympanostomy tube placement.

Chronic Disease↗
PubMed1999

A pilot study on the safety and effectiveness of immunosuppression without prednisone after liver transplantation.

BACKGROUND: Corticosteroids are commonly used in the immunosuppression therapy after liver transplantation, yet are associated with considerable side effects. Retrospective studies have shown that corticosteroids can be safely withdrawn from months to years after transplant. We prospectively investigated the effects of early immunosuppression without the use of corticosteroids on graft outcome and transplant complications. METHODS: Forty-five patients undergoing liver transplantation were randomized to receive immunosuppression composed of cyclosporine microemulsion and azathioprine with (n=22) or without prednisone (n=23), in conventional doses. In those patients who received prednisone, this was withdrawn within 3 months after transplant. The median follow-up of survivors was 14 months (range: 6-24). The study end points were to determine graft survival and function, infectious complications, including hepatitis C virus (HCV)-RNA levels in HCV-infected recipients, acute rejection, kidney function, and metabolic complications. RESULTS: Eleven deaths occurred, 6 of which were in the prednisone group. Two-year survival did not differ between patients treated with or without prednisone (70.2% vs. 78.3%, P=0.83), nor did the causes of death. No differences were observed with regard to graft function, renal function, and infectious complications. In the subset of patients who received transplants for HCV-related cirrhosis, the dynamics of virus replication HCV-RNA was faster among those treated with prednisone. The incidence and severity of acute rejection was similar in the two groups. More than 80% of acute rejections in both groups were classified as mild or moderate and underwent spontaneous resolution. Only two patients in each group had severe acute rejection requiring additional treatment with high-dose steroids. Patients receiving prednisone tended to have greater biochemical signs of cholestasis, higher serum cholesterol and glucose levels, and more frequent insulin requirement than those treated without corticosteroids. CONCLUSIONS: Liver transplantation can be performed safely without using corticosteroids in the early postoperative course, and there is no need for routine aggressive steroid treatment of established acute rejections.

Adult↗