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Early Human Development Sep 2019There are few published data on the efficacy and safety of prednisolone in preterm infants with bronchopulmonary dysplasia (BPD).
BACKGROUND
There are few published data on the efficacy and safety of prednisolone in preterm infants with bronchopulmonary dysplasia (BPD).
AIMS
To describe the use of chronic prednisolone therapy in a population of infants with severe BPD, examine potential benefits on respiratory status, and document potential effects on growth.
STUDY DESIGN
Single-center retrospective cohort study.
SUBJECTS
Preterm infants who had received ≥30 days of prednisolone for the treatment of severe BPD.
OUTCOME MEASURES
Weekly changes in Pulmonary Severity Score (PSS), as well as weekly changes in weight, length, and head circumference during prednisolone therapy.
RESULTS
Forty-three infants (mean birth weight 729 g; mean gestational age 26 weeks) were identified. The average age at start of prednisolone treatment was 42.5 ± 5.9 weeks; while the median duration and median cumulative dose of prednisolone therapy were 67 (IQR 57-107) days and 61.3 (IQR 39.9-93.3) mg/kg, respectively. PSS decreased after 1 week of prednisolone therapy (mean difference, 0.19; 95% Cl, 0.01 to 0.37; p = 0.03). No further reduction in PSS was noted despite continued treatment. Length z-scores decreased after 4 weeks of continued treatment (mean difference 0.6; 95% CI 0.01 to 1.1; P = 0.04), while weight and head circumference did not change.
CONCLUSIONS
In one of the first reports on prednisolone therapy for severe BPD, we describe that long-term prednisolone is associated with modest short-term improvement in PSS, but impairs linear growth. Our results suggest a risk-benefit profile of prednisolone that does not favor long-term use in infants with severe BPD.
Topics: Bronchopulmonary Dysplasia; Child Development; Female; Glucocorticoids; Humans; Infant, Extremely Premature; Infant, Newborn; Male; Prednisolone
PubMed: 31265946
DOI: 10.1016/j.earlhumdev.2019.06.007 -
Prednisolone 20 mg vs 40 mg in complex regional pain syndrome type I: A randomized controlled trial.Journal of Clinical Neuroscience :... Jul 2023High dose of corticosteroid has been found beneficial in complex regional pain syndrome type I (CRPS-I). We report the efficacy and safety of prednisolone 20 mg versus... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
High dose of corticosteroid has been found beneficial in complex regional pain syndrome type I (CRPS-I). We report the efficacy and safety of prednisolone 20 mg versus 40 mg in CRPS-I in an open label randomized controlled trial.
METHODS
The patients with CRPS-I of the shoulder joint with a CRPS score of ≥8 were included. Their demographic details, comorbidities, and underlying etiology were noted. The severity of CRPS was assessed using a 0-14 CRPS scale, the pain using a 0-10 Visual Analogue Scale (VAS), and sleep quality using a 0-10. Daily Sleep Interference Scale (DSIS). Patients were randomized to prednisolone 40 mg/day (group I) or 20 mg/day (group II) for 14 days, then tapered to 10 mg in group I and to 5 mg in group II by 1 month. Thereafter both groups received prednisolone 5 mg/day for 2 months. The primary outcome was a >50% reduction in VAS score, and secondary outcomes were a reduction in CRPS score, DSIS score, and adverse events.
RESULTS
Fifty patients were included, and their baseline characteristics were comparable. At one month, all the patients had >50% reduction in the VAS score. The effect size was 0.38 (95% CI 0.93-0.20; p = 0.20). On the Kaplan-Mayer analysis, the improvement in the VAS score (Hazard ratio-1.43, 95 % CI-0.80-2.56, p = 0.22) and the CRPS score (HR-0.79,95 % CI-0.45-1.39; p = 0.41) was insignificant between the two groups. The DSIS score improved in group II (HR-1.85,95 % Cl-1.04-3.31,p = 0.04). Group I patients needed frequent adjustment of antidiabetic drugs (14 vs 6; p = 0.04).
CONCLUSION
The efficacy of prednisolone 20 mg is not inferior to 40 mg in CRPS-I, and is safe in diabetic patients.
LIMITATIONS
This is an open label randomized controlled trial with small sample size without a placebo arm.
Topics: Humans; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Prednisolone; Pain Measurement
PubMed: 37257216
DOI: 10.1016/j.jocn.2023.05.017 -
BMJ Open Nov 2019Topical steroids are the cornerstone in controlling the inflammation after cataract surgery. Prednisolone acetate and difluprednate are the two main products for this... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Topical steroids are the cornerstone in controlling the inflammation after cataract surgery. Prednisolone acetate and difluprednate are the two main products for this purpose. However, it is unclear which one should be used in terms of effectiveness and safety.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Medline via PubMed, Cochrane Central Register of Controlled Trials, Web of science and clinicaltrials.gov were searched through 10 January 2018, and updated on 20 July 2019, in addition to researching the references' lists of the relevant articles.
ELIGIBILITY CRITERIA
Randomised-controlled trials (RCTs) comparing difluprednate and prednisolone acetate regardless of the dosing regimen used.
DATA EXTRACTION AND SYNTHESIS
Two independent authors assessed the included RCTs regarding the risk of bias using the Cochrane tool. Relevant data were extracted, and meta-analysis was conducted using a random-effects model. The Grading of Recommendations Assessment, Development, and Evaluation approach was used to appraise the evidence quality.
RESULTS
We included six RCTs with 883 patients: 441 received difluprednate and 442 received prednisolone acetate. The evidence quality was graded as moderate for corneal oedema and intraocular pressure and low for anterior chamber (AC) clearance. After small incision cataract surgery, difluprednate was superior in clearing AC cells at 1 week (OR=2.5, p>0.00001) and at 2 weeks (OR=2.5, p=0.04), as well as clearing the AC flare at 2 weeks (OR=6.7, p=0.04). After phacoemulsification, difluprednate was superior in terms of corneal clarity at 1 day (OR=2.6, p=0.02) and 1 week after surgery (OR=1.96, p=0.0007). No statistically significant difference was detected between both agents at 1 month in effectiveness. Also, both agents were safe, evaluated by the ocular hypertension (OR=1.23, p=0.8).
CONCLUSION
With low-to-moderate certainty, difluprednate and prednisolone acetate are safe agents for controlling the inflammation after cataract surgery. Difluprednate showed significant superiority in terms of AC cells and AC flare at 2 weeks postoperatively.
Topics: Animals; Anti-Inflammatory Agents; Cataract Extraction; Fluprednisolone; Humans; Postoperative Care; Postoperative Complications; Prednisolone
PubMed: 31678934
DOI: 10.1136/bmjopen-2018-026752 -
Equine Veterinary Journal Sep 2022Topical dexamethasone and prednisolone are currently the mainstay treatment for equine ophthalmic inflammatory diseases, such as equine recurrent uveitis. Comparative...
BACKGROUND
Topical dexamethasone and prednisolone are currently the mainstay treatment for equine ophthalmic inflammatory diseases, such as equine recurrent uveitis. Comparative pharmacokinetic studies in horses are lacking and current guidelines are mainly based on empirical data and extrapolation from other species.
OBJECTIVES
To investigate the penetration and local concentrations of topically applied dexamethasone and prednisolone in normal equine ocular fluids and serum.
STUDY DESIGN
Prospective randomised experimental pharmacokinetic study.
METHODS
Twenty-one Shetland ponies without ophthalmic disease were treated bilaterally topically every 2 hours during 24 hours to obtain steady state drug concentrations. One eye was treated with 0.15 mg of dexamethasone disodium phosphate (0.1%), and the other eye was simultaneously treated with 1.5 mg of prednisolone acetate (1%). Serum samples were taken prior to the induction of general anaesthesia. Aqueous and vitreous humour samples were taken during euthanasia at time points after administration of the last dose (t = 5 min, t = 15 min, t = 30 min, t = 60 min, t = 90 min, t = 120 min, t = 180 min). Each pony was randomly assigned to one time point, and three ponies were sampled per time point. Dexamethasone and prednisolone concentrations were measured by liquid chromatography-mass spectrometry.
RESULTS
The mean dexamethasone concentration in aqueous humour was 32.4 ng/mL (standard deviation [SD] 10.9) and the mean prednisolone concentration was 321.6 ng/mL (SD 96.0). In the vitreous and in serum samples concentrations of both corticosteroids were below the limit of detection (LOD 2.5 ng/mL).
MAIN LIMITATIONS
The study group was limited to subjects without evidence of current ophthalmic disease. A limited number of time points were measured.
CONCLUSIONS
Potentially effective dexamethasone and prednisolone concentrations were measured in the anterior chamber, but vitreal concentrations were negligible. Systemic uptake was low. Therefore, treatment with only topically administered corticosteroids is deemed insufficient in horses in cases of posterior uveitis. Further studies evaluating other routes of administration are warranted.
Topics: Animals; Dexamethasone; Eye Diseases; Horse Diseases; Horses; Phosphates; Prednisolone; Prospective Studies
PubMed: 34706129
DOI: 10.1111/evj.13526 -
Indian Journal of Pediatrics Feb 2019To compare the outcomes of adrenocorticotrophic hormone (ACTH) and Prednisolone therapy in children with West syndrome. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To compare the outcomes of adrenocorticotrophic hormone (ACTH) and Prednisolone therapy in children with West syndrome.
METHODS
The study was done at a tertiary health centre for children. The pediatric neurologist at the centre enrolled children into the study based on the inclusion and exclusion criteria. They were evaluated in detail, classified according to etiologic type and then, randomly assigned into two treatment groups, either ACTH or Prednisolone. They were followed at regular intervals till 6 mo.
RESULTS
There was no difference between ACTH and Prednisolone groups with respect to all the outcomes measured. Cessation of spasms was achieved in 6/15 (40%) in Prednisolone group and 9/18 (50%) in ACTH group (p = 0.3906). The average time for achieving cessation was 6.9 and 8 d in ACTH and Prednisolone groups respectively (p = 0.7902). The relapse rates were 18.18 and 50% in ACTH and Prednisolone groups respectively (p = 0.28). The side-effects profile, subsequent epilepsy rates and improvement in milestones were similar in both the treatment groups.
CONCLUSIONS
There is no significant difference in children treated with ACTH and Prednisolone. Study results cannot be generalized due to small sample size. However, Prednisolone can be a suitable alternative to ACTH in resource poor settings.
Topics: Adrenocorticotropic Hormone; Child, Preschool; Drug-Related Side Effects and Adverse Reactions; Epilepsy; Female; Humans; India; Infant; Male; Prednisolone; Single-Blind Method; Spasm; Spasms, Infantile; Treatment Outcome
PubMed: 30232789
DOI: 10.1007/s12098-018-2782-1 -
Drug Testing and Analysis Nov 2020Twenty-two pharmaceutical formulations containing prednisolone or prednisone commercially available in Italy, Belgium, Spain, Brazil, and India were analyzed through a... (Observational Study)
Observational Study
Twenty-two pharmaceutical formulations containing prednisolone or prednisone commercially available in Italy, Belgium, Spain, Brazil, and India were analyzed through a specific gas chromatography combustion isotope ratio mass spectrometry (GC-C-IRMS) method. All of them showed typical non-endogenous δ C values, except for the Belgian nasal spray, Sofrasolone®, with a less depleted C content (-17.84 ± 0.18‰). Observational studies were performed on two volunteers in therapy with Sofrasolone® to confirm the applicability of the method and to suggest adequate interpretation criteria also in the case of drugs with less negative δ C values. Urine samples were collected before, during, and within the 36 hours after the administration of the spray. Both δ C values and urinary concentrations of prednisolone and prednisone were evaluated. All samples were subjected to an adequate pre-treatment (enzymatic hydrolysis, liquid/liquid extraction, and two sequential HPLC steps) before injection to the GC-C-IRMS instrument, according to the method recently developed and validated in our laboratory. Pregnanediol (PD), tetrahydro-11-deoxycortisol (THS), and pregnanetriol (PT) were selected as endogenous reference compounds (ERC). The excretion profile was estimated through liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) method used routinely for the quali-quantitative detection of glucocorticoids. δ C values and urinary levels of prednisolone and prednisone were also determined after the intake of one single vial of Sintredius®, a prednisolone oral formulation with a conventional more negative δ C value (-29.28 ± 0.25‰). Finally, the potential masking effect that combined therapy with Sofrasolone® and Sintredius® could induce on the IRMS findings was investigated.
Topics: Administration, Intranasal; Administration, Oral; Adult; Carbon Isotopes; Doping in Sports; Drug Compounding; Female; Gas Chromatography-Mass Spectrometry; Humans; Male; Prednisolone; Prednisone; Substance Abuse Detection; Young Adult
PubMed: 32529794
DOI: 10.1002/dta.2876 -
Journal of Equine Veterinary Science Sep 2023This research was performed to compare the effects of prednisolone and fluorometholone on intraocular pressure (IOP) and Schirmer tear test (STT) in the normal equine...
This research was performed to compare the effects of prednisolone and fluorometholone on intraocular pressure (IOP) and Schirmer tear test (STT) in the normal equine eye. Sixteen normal mares aged between 6 and 10 years were used for this study. Horses were randomly assigned to two groups. Eight horses in the first group received 0.2 mL of topical 1% prednisolone in one eye and the contralateral eye was used as control (0.2 mL of saline was instilled). The second group received 0.2 mL of 0.1% fluorometholone in a randomly selected eye and the contralateral eye served as control and received 0.2 mL of saline. STT values and IOP were determined using STT strips and rebound, respectively, at the baseline, and 30-, 60-, 90-, and 180-minutes post eyedrop instillation. Mean (SD) IOPs at the baseline in the treated eyes of the first and second groups were 28.5 (5.4) and 27.5 (4.9) mm Hg, respectively. STT values at the baseline in the treated eyes of the first and second groups were 26.0 (1.8) mm/min and 24.0 (4.0) mm/min, respectively. Neither prednisolone nor fluorometholone caused significant changes in the IOP during 3 hours of monitoring (P > .05). There were no significant differences in the mean levels of STT in the control and treatment eyes, either between groups or within each group (P > .05). In conclusion, one dose (0.2 mL) of 1% prednisolone or 0.1% fluorometholone after 3 hours did not alter the IOP and STT in healthy horses. Further research for a longer period on normal horses and horses with uveitis is warranted.
Topics: Horses; Animals; Female; Intraocular Pressure; Fluorometholone; Prednisolone; Tears; Ophthalmic Solutions
PubMed: 37348824
DOI: 10.1016/j.jevs.2023.104840 -
Medicina Clinica Aug 2020To explore the efficacy treatment regimen in refractory PBC. (Review)
Review
BACKGROUND AND AIM
To explore the efficacy treatment regimen in refractory PBC.
METHODS
Triple treatment including ursodeoxycholic acid, prednisolone and immunosuppressant was prescribed to 47 refractory patients. Biochemistries, immune parameters, non-invasive liver fibrosis assessments were measured during follow-up.
RESULTS
Triple therapy resulted in significant decrease in ALP, GGT, ALT, AST, TBIL, ALB, IgG, IgM, APRI, FIB-4 and S-INDEX. The biochemical cumulative normalization rates of ALP and other biochemical parameters were higher in long-term follow-up. Poor outcome was observed in patients with lower ALB, higher TBIL, PT, sp100 positivity and advanced liver pathology at baseline. Osteoporosis and bone fracture were observed in 15% patients.
CONCLUSIONS
Triple therapy is associated with marked decrease and normalization of ALP and other parameters. ALB, TBIL, PT, sp100 and pathology were related with poor outcome. Osteoporosis should be closely monitored.
Topics: Humans; Immunosuppressive Agents; Liver Cirrhosis, Biliary; Prednisolone; Ursodeoxycholic Acid
PubMed: 32600985
DOI: 10.1016/j.medcli.2020.03.013 -
Aquatic Toxicology (Amsterdam,... Mar 2024Synthetic glucocorticoids are often found in surface waters and can cause harmful effects to aquatic organisms such as amphibians. In this work we evaluated the effects...
Synthetic glucocorticoids are often found in surface waters and can cause harmful effects to aquatic organisms such as amphibians. In this work we evaluated the effects of the drugs prednisone (PD) and prednisolone (PL) on developmental, molecular, blood, biochemical and histological markers. Aquarana catesbeianus tadpoles were exposed for 16 days to environmentally relevant concentrations of 0, 0.1, 1 and 10 µg/L of both drugs. PD increased the transcript levels of the enzyme deiodinase III (Dio3), the hormones cortisol and T4 and delayed development. Changes in the thyroid gland occurred after tadpoles were exposed to both drugs, with a reduction in the diameter and number of follicles and an increase/or decrease in area. Also, both drugs caused a decrease in lymphocytes (L) and an increase in neutrophils (N), thrombocytes, the N:L ratio and lobed and notched erythrocytes. Increased activity of the enzymes superoxide dismutase, glutathione S-transferase and glucose 6-phosphate dehydrogenase was observed after exposure to PD. Furthermore, both drugs caused an increase in the activity of the enzymes catalase and glutathione peroxidase. However, only PD caused oxidative stress in exposed tadpoles, evidenced by increased levels of malondialdehyde and carbonyl proteins. Both drugs caused an increase in inflammatory infiltrates, blood cells and melanomacrophages in the liver. Our results indicate that PD was more toxic than PL, affecting development and causing oxidative stress.
Topics: Animals; Larva; Prednisone; Prednisolone; Water Pollutants, Chemical; Oxidative Stress
PubMed: 38387247
DOI: 10.1016/j.aquatox.2024.106869 -
Neurology Jun 2023Bell palsy is the third most frequent diagnosis in children with sudden-onset neurologic dysfunction. The cost-effectiveness of treating Bell palsy with prednisolone in... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND AND OBJECTIVES
Bell palsy is the third most frequent diagnosis in children with sudden-onset neurologic dysfunction. The cost-effectiveness of treating Bell palsy with prednisolone in children is unknown. We aimed to assess the cost-effectiveness of prednisolone in treating Bell palsy in children compared with placebo.
METHODS
This economic evaluation was a prospectively planned secondary analysis of a double-blinded, randomized, placebo-controlled superiority trial (Bell Palsy in Children [BellPIC]) conducted from 2015 to 2020. The time horizon was 6 months since randomization. Children aged 6 months to <18 years who presented within 72 hours of onset of clinician-diagnosed Bell palsy and who completed the trial were included (N = 180). Interventions were oral prednisolone or taste-matched placebo administered for 10 days. Incremental cost-effectiveness ratio comparing prednisolone with placebo was estimated. Costs were considered from a health care sector perspective and included Bell palsy-related medication cost, doctor visits, and medical tests. Effectiveness was measured using quality-adjusted life-years (QALYs) based on Child Health Utility 9D. Nonparametric bootstrapping was performed to capture uncertainties. Prespecified subgroup analysis by age 12 to <18 years vs <12 years was conducted.
RESULTS
The mean cost per patient was A$760 in the prednisolone group and A$693 in the placebo group over the 6-month period (difference A$66, 95% CI -A$47 to A$179). QALYs over 6 months were 0.45 in the prednisolone group and 0.44 in the placebo group (difference 0.01, 95% CI -0.01 to 0.03). The incremental cost to achieve 1 additional recovery was estimated to be A$1,577 using prednisolone compared with placebo, and cost per additional QALY gained was A$6,625 using prednisolone compared with placebo. Given a conventional willingness-to-pay threshold of A$50,000 per QALY gained (equivalent to US$35,000 or £28,000), prednisolone is very likely cost-effective (probability is 83%). Subgroup analysis suggests that this was primarily driven by the high probability of prednisolone being cost-effective in children aged 12 to <18 years (probability is 98%) and much less so for those <12 years (probability is 51%).
DISCUSSION
This provides new evidence to stakeholders and policymakers when considering whether to make prednisolone available in treating Bell palsy in children aged 12 to <18 years.
TRIAL REGISTRATION INFORMATION
Australian New Zealand Clinical Trials Registry ACTRN12615000563561.
Topics: Child; Humans; Prednisolone; Cost-Benefit Analysis; Bell Palsy; Drug Therapy, Combination; Australia
PubMed: 37072220
DOI: 10.1212/WNL.0000000000207284