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1.
J Dermatolog Treat ; 35(1): 2357618, 2024 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-38797809

RESUMEN

BACKGROUND: Psoriasis significantly impacts patients' quality of life (QoL). Dissatisfaction and non-adherence are major barriers associated with topical treatments. A cream based on the polyaphron dispersion (PAD) Technology containing a fixed-dose of calcipotriol (CAL) and betamethasone dipropionate (BDP) was designed for a patient-friendly psoriasis management. The CAL/BDP PAD-cream demonstrated efficacy, convenience, and safety/tolerability in clinical trials. OBJECTIVES: This research assesses the real-world use, perception, satisfaction, and adherence of CAL/BDP PAD-cream among plaque psoriasis patients. METHODS: Between September-November 2023, psoriasis patients from Spain and Germany using or having used CAL/BDP PAD-cream for >2 weeks were recruited via Wefight network to complete a 30-questions online survey. Anonymized results were pooled for descriptive statistical analysis. RESULTS: The survey was completed by 129 patients (mean age: 43 years; 66% females; mean psoriasis duration: 12 years). Most patients (93%) were satisfied with CAL/BDP PAD-cream. The 66% reported high adherence (visual analogue scale 80-100) and 91% preferred CAL/BDP PAD-cream to their previous topical(s). Patients highlighted its ease/convenience of application, tolerability, and lack of itching/burning. CONCLUSIONS: Psoriasis patients treated with CAL/BDP PAD-cream in a real-world setting show high satisfaction, good adherence, and a positive perception of the product, suggesting that favorable outcomes observed in clinical trials translate to real clinical practice.


Asunto(s)
Betametasona , Calcitriol , Fármacos Dermatológicos , Cumplimiento de la Medicación , Satisfacción del Paciente , Psoriasis , Humanos , Psoriasis/tratamiento farmacológico , Calcitriol/análogos & derivados , Calcitriol/administración & dosificación , Femenino , Betametasona/análogos & derivados , Betametasona/administración & dosificación , Betametasona/uso terapéutico , Masculino , Adulto , Cumplimiento de la Medicación/estadística & datos numéricos , Alemania , Estudios Transversales , España , Persona de Mediana Edad , Fármacos Dermatológicos/administración & dosificación , Fármacos Dermatológicos/uso terapéutico , Calidad de Vida , Crema para la Piel/administración & dosificación , Encuestas y Cuestionarios , Combinación de Medicamentos , Administración Cutánea
2.
Pain Physician ; 27(4): E371-E382, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38805526

RESUMEN

BACKGROUND: Chronic primary musculoskeletal pain is multifaceted and 20% of the adult population lives with severe chronic pain and experience symptoms such as intense pain, depression, weakness, sleep problems, decreased quality of life and decreased emotional well-being. OBJECTIVES: This paper studies the efficacy of trigger point injections with ozone compared to standard steroid injection or combination therapy for the treatment of chronic musculoskeletal pain in patients with abnormal mitochondrial redox state. STUDY DESIGN: This is a prospective randomized clinical study conducted with 51 patients experiencing chronic musculoskeletal pain. SETTING: Medical Research Institute Hospital, Alexandria University. METHODS: By computer-generated random numbers the 51 patients were divided into 3 groups. Group A (17 patients) received ozone injection, group B (17 patients) received betamethasone injection and group C (17 patients) received combined ozone and betamethasone injections. The groups were compared based on the intensity of pain and correction of mitochondrial redox state of the patients. RESULTS: Three days after intervention, the visual analog scale (VAS) scores reported by patients were lower in group A compared to group B (with a mean difference 1.27, 95% confidence interval (CI) of 0.15-2.39 (P < 0.02). One and 3 weeks after intervention, VAS scores of patients were lower in groups A and C compared to group B. At one week the mean difference between A and B was 1.2, with a 95% CI of 0.15-2.25 (P < 0.02) and the mean difference between C and B was 1.73 with a 95% CI of 0.69-2.78 (P < 0.001). At 3 weeks the mean difference between A and B was 1.5 with a 95% CI of 0.2-2.87 (P < 0.01) and the mean difference between C and B was 2.27 with a 95% CI of 0.93-3.60 (P < 0.0001). The reduced/oxidized glutathione ratio after intervention was higher in groups A and C compared to group B (P > 0.008). The mitochondrial copy number was higher in group A compared to group B (P < 0.002). LIMITATION: This study didn't allow for the comparison of the experimental groups with a placebo or control group for musculoskeletal pain conditions in orderto establish the role of an abnormal mitochondrial redox state on the pathogenesis of patients from an ethical view. CONCLUSIONS: Ozone therapy or combined ozone and betamethasone treatment are  effective techniques for management of pain since it produced a significant reduction of muscle pain and increase of the pain free interval experienced by patients. Ozone therapy causes pain improvement which increases with time and it improves muscle oxygenation and mitochondrial function. TRIAL REGISTRATION: This study was approved by the Ethics Committee of Medical Research Institute (IORH: IOR 00088812) and was registered at the Pan African Clinical Trial Registry (www.pactr.org) under the identification number PACTR201908620943471. The registration this experiment started on 07/08/2019. This study's protocol followed the CONSORT guidelines and was performed under the relevant guidelines.


Asunto(s)
Dolor Crónico , Dolor Musculoesquelético , Ozono , Humanos , Ozono/uso terapéutico , Ozono/administración & dosificación , Dolor Musculoesquelético/tratamiento farmacológico , Estudios Prospectivos , Dolor Crónico/tratamiento farmacológico , Femenino , Masculino , Oxidación-Reducción/efectos de los fármacos , Adulto , Persona de Mediana Edad , Mitocondrias/efectos de los fármacos , Mitocondrias/metabolismo , Betametasona/administración & dosificación , Betametasona/uso terapéutico , Dimensión del Dolor
4.
JAMA ; 331(19): 1629-1637, 2024 05 21.
Artículo en Inglés | MEDLINE | ID: mdl-38656759

RESUMEN

Importance: The Antenatal Late Preterm Steroids (ALPS) trial changed clinical practice in the United States by finding that antenatal betamethasone at 34 to 36 weeks decreased short-term neonatal respiratory morbidity. However, the trial also found increased risk of neonatal hypoglycemia after betamethasone. This follow-up study focused on long-term neurodevelopmental outcomes after late preterm steroids. Objective: To evaluate whether administration of late preterm (34-36 completed weeks) corticosteroids affected childhood neurodevelopmental outcomes. Design, Setting, and Participants: Prospective follow-up study of children aged 6 years or older whose birthing parent had enrolled in the multicenter randomized clinical trial, conducted at 13 centers that participated in the Maternal-Fetal Medicine Units (MFMU) Network cycle from 2011-2016. Follow-up was from 2017-2022. Exposure: Twelve milligrams of intramuscular betamethasone administered twice 24 hours apart. Main Outcome and Measures: The primary outcome of this follow-up study was a General Conceptual Ability score less than 85 (-1 SD) on the Differential Ability Scales, 2nd Edition (DAS-II). Secondary outcomes included the Gross Motor Function Classification System level and Social Responsiveness Scale and Child Behavior Checklist scores. Multivariable analyses adjusted for prespecified variables known to be associated with the primary outcome. Sensitivity analyses used inverse probability weighting and also modeled the outcome for those lost to follow-up. Results: Of 2831 children, 1026 enrolled and 949 (479 betamethasone, 470 placebo) completed the DAS-II at a median age of 7 years (IQR, 6.6-7.6 years). Maternal, neonatal, and childhood characteristics were similar between groups except that neonatal hypoglycemia was more common in the betamethasone group. There were no differences in the primary outcome, a general conceptual ability score less than 85, which occurred in 82 (17.1%) of the betamethasone vs 87 (18.5%) of the placebo group (adjusted relative risk, 0.94; 95% CI, 0.73-1.22). No differences in secondary outcomes were observed. Sensitivity analyses using inverse probability weighting or assigning outcomes to children lost to follow-up also found no differences between groups. Conclusion and Relevance: In this follow-up study of a randomized clinical trial, administration of antenatal corticosteroids to persons at risk of late preterm delivery, originally shown to improve short-term neonatal respiratory outcomes but with an increased rate of hypoglycemia, was not associated with adverse childhood neurodevelopmental outcomes at age 6 years or older.


Asunto(s)
Betametasona , Glucocorticoides , Niño , Femenino , Humanos , Recién Nacido , Masculino , Embarazo , Betametasona/administración & dosificación , Betametasona/efectos adversos , Betametasona/uso terapéutico , Desarrollo Infantil/efectos de los fármacos , Estudios de Seguimiento , Glucocorticoides/administración & dosificación , Glucocorticoides/efectos adversos , Glucocorticoides/uso terapéutico , Recien Nacido Prematuro , Trastornos del Neurodesarrollo/inducido químicamente , Trastornos del Neurodesarrollo/epidemiología , Nacimiento Prematuro/prevención & control , Atención Prenatal , Estudios Prospectivos , Efectos Tardíos de la Exposición Prenatal/inducido químicamente
5.
Rev. Asoc. Méd. Argent ; 137(1): 15-18, mar. 2024. ilus
Artículo en Español | LILACS | ID: biblio-1552851

RESUMEN

Se presenta un caso femenino de dengue clásico (DC) en el marco de la epidemia 2023-2024 en la provincia de Misiones, con predominio de síntomas dermatológicos de exantemas máculo papulosos, habonosos y eritrodérmicos sobre los síntomas sindrómicos cardinales. Las lesiones presentan componente humoral y de extravasación, sin diátesis ni componentes purpúricos apreciables, presentando una rápida y efectiva evolución al eritema y la normalización con tratamiento antihistamínico y corticoide parenteral. De la misma manera se evalúan alteraciones analíticas hematológicas y hepáticas de gran magnitud, con escasa repercusión clínica, que se mensuran en función del riesgo relativo al dengue hemorrágico (DH) y el pronóstico de la paciente. (AU)


A female case of classic dengue (DC) is presented in the context of the 2023-2024 epidemic in the province of Misiones, with a predominance of dermatologic symptoms of maculopapular, hives, and erythrodermic rashes overlapping the cardinal syndromic symptoms. The lesions have a humoral and extravasation component, without any significant diathesis or purpuric components, showing rapid and effective progression to erythema and normalization with antihistamine and parenteral corticosteroid treatment. Similarly, hematologic and hepatic analytical alterations of great magnitude are evaluated, with little clinical impact, measured in terms of relative risk for hemorrhagic dengue (HD) and the prognosis of the patient. (AU)


Asunto(s)
Humanos , Femenino , Adulto , Dengue/complicaciones , Dengue/diagnóstico , Exantema/diagnóstico , Exantema/etiología , Argentina , Betametasona/uso terapéutico , Cetirizina/uso terapéutico , Dengue/terapia , Diagnóstico Diferencial , Exantema/tratamiento farmacológico , Acetaminofén/uso terapéutico
6.
BMC Pulm Med ; 24(1): 87, 2024 Feb 15.
Artículo en Inglés | MEDLINE | ID: mdl-38360614

RESUMEN

PURPOSE: Interstitial lung diseases (ILDs) are caused by inflammation and/or fibrosis of alveolar walls resulting in impaired gas exchange. Hypersensitivity pneumonitis (HP) is the third most common type of ILDs. Corticosteroids are the mainstay treatment for HP. The use of intramuscular (IM) betamethasone or intravenous (IV) dexamethasone as weekly pulse doses has shown higher benefit than daily oral prednisolone for HP patients. The aim of this study is to directly compare different corticosteroids in terms of effectiveness and in monetary values and perform an economic evaluation. METHODS: One hundred and seven patients were tested for pulmonary function tests (PFTs) and inflammatory markers to assess the treatment effectiveness. A cost-effectiveness analysis (CEA) was performed. ICERs between 3 treatment groups were calculated. RESULTS: Post treatment, Krebs von den Lungen-6 (KL-6) levels significantly improved in betamethasone group from 723.22 ± 218.18 U/ml to 554.48 ± 129.69 U/ml (p = 0.001). A significant improvement in erythrocyte sedimentation rate (ESR) occurred in the dexamethasone group from 56.12 ± 27.97 mm to 30.06 ± 16.04 mm (p = 0.048). A significant improvement in forced expiratory volume (FEV1), forced vital capacity (FVC) and six-minute walk distance (6MWD) was observed within the three treatment groups. A significant improvement in oxygen desaturation percentage (SpO2) occurred within dexamethasone and betamethasone groups. Betamethasone and dexamethasone were found more cost-effective than prednisolone as their ICERs fell in quadrant C. Furthermore, ICER between betamethasone and dexamethasone was performed; a small difference in cost was found compared to the higher benefit of betamethasone. CONCLUSION: Betamethasone and dexamethasone were found to be more effective than prednisolone in improving the inflammatory reaction and the clinical features of HP patients. Betamethasone was found to be the best intervention in terms of cost against the effect.


Asunto(s)
Alveolitis Alérgica Extrínseca , Enfermedades Pulmonares Intersticiales , Humanos , Economía Farmacéutica , Corticoesteroides/uso terapéutico , Alveolitis Alérgica Extrínseca/tratamiento farmacológico , Enfermedades Pulmonares Intersticiales/tratamiento farmacológico , Prednisolona/uso terapéutico , Betametasona/uso terapéutico , Dexametasona/uso terapéutico
7.
Obstet Gynecol ; 143(4): 468-474, 2024 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-38330411

RESUMEN

OBJECTIVE: To evaluate the efficacy of antenatal corticosteroids in reducing neonatal respiratory complications when administered to those at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. METHODS: This was a single-center, triple-blind, randomized, placebo-controlled trial in southern India enrolling pregnant participants at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. Computer-generated block randomization was used with participants randomized to either one course of intramuscular betamethasone or placebo. The primary outcome was a composite of treatment for respiratory distress in the neonate, defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life. Neonatal secondary outcomes were transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, hypoglycemia, stillbirth, and early neonatal death; maternal secondary outcomes were chorioamnionitis, postpartum hemorrhage, puerperal fever, and length of hospitalization. All analyses were based on intention to treat. A sample size of 1,200 was planned with 80% power to detect a 30% reduction in rates of respiratory distress. After a planned interim analysis, enrollment was stopped for futility. RESULTS: From March 2020 to August 2022, 847 participants were recruited, with 423 participants randomized to betamethasone and 424 participants randomized to placebo. There were 22 individuals lost to follow-up. There was no statistically significant difference in the primary outcome (betamethasone 4.9% vs placebo 4.8%, relative risk 1.03, 95% CI, 0.57-1.84, number needed to treat 786). There were no statistically significant differences in secondary neonatal or maternal outcomes. CONCLUSION: Betamethasone administered in the late-preterm period to those at risk for preterm delivery did not reduce the need for treatment of neonatal respiratory distress. CLINICAL TRIAL REGISTRATION: Clinical Trials Registry of India, CTRI/2019/09/021321.


Asunto(s)
Enfermedades del Recién Nacido , Nacimiento Prematuro , Síndrome de Dificultad Respiratoria del Recién Nacido , Síndrome de Dificultad Respiratoria , Recién Nacido , Embarazo , Femenino , Humanos , Nacimiento Prematuro/prevención & control , Betametasona/uso terapéutico , Corticoesteroides/uso terapéutico , Glucocorticoides/uso terapéutico , Síndrome de Dificultad Respiratoria del Recién Nacido/prevención & control , Enfermedades del Recién Nacido/prevención & control
8.
J Pain Symptom Manage ; 67(5): 393-401.e1, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38331232

RESUMEN

CONTEXT: Fatigue is one of the most uncomfortable physical symptoms seen in patients with advanced cancer. Previous studies have reported on the efficacy of corticosteroids from Western countries. OBJECTIVES: To assess the effectiveness of 4mg betamethasone improving fatigue among Japanese patients with advanced cancer. METHODS: A randomized, double-blind, placebo-controlled trial enrolled eligible patients with advanced cancer expected to survive 1-2 months, with an Eastern Cooperative Oncology Group Performance Status of 2-3, and experiencing fatigue according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-15-palliative criteria. Participants received twice-daily oral administration of 2 mg betamethasone (4 mg/d) or placebo for seven days, with fatigue assessed using EORTC QLQ-C15-PAL subscale and numerical rating scale (NRS) score (at baseline and day seven). The trial was registered under the University Hospital Medical Information Network (UMIN)000011913. RESULTS: Among the 267 screened patients, 81 were eligible, of which 70 were evaluable (betamethasone, 33; placebo, 37). The mean difference in the EORTC-QLQ-C15-PAL fatigue subscale was -8.2 (95% CIs: -22.3, 0.0; P = 0.178) and in a NRS for fatigue was -1.2 (95% CIs: -2.5, -0.01; P = 0.048), respectively. Emotional function, appetite loss, and global-health were slightly better in the betamethasone group than in the placebo group. CONCLUSION: The impact of betamethasone 4 mg/d on alleviating fatigue in patients with advanced cancer in the last weeks of life did not reach statistical significance in the EORTC-QLQ-C15-PAL as the primary endpoint, however, it was significant in the NRS, the secondary endpoint.


Asunto(s)
Neoplasias , Calidad de Vida , Humanos , Calidad de Vida/psicología , Betametasona/uso terapéutico , Cuidados Paliativos/psicología , Encuestas y Cuestionarios , Neoplasias/complicaciones , Neoplasias/tratamiento farmacológico , Neoplasias/psicología , Fatiga/tratamiento farmacológico , Fatiga/etiología
9.
Acta Biomater ; 176: 173-189, 2024 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-38244658

RESUMEN

Epidural steroid injection (ESI) is a common therapeutic approach for managing sciatica caused by lumbar disc herniation (LDH). However, the short duration of therapeutic efficacy and the need for repeated injections pose challenges in LDH treatment. The development of a controlled delivery system capable of prolonging the effectiveness of ESI and reducing the frequency of injections, is highly significant in LDH clinical practice. In this study, we utilized a thiol-ene click chemistry to create a series of injectable hyaluronic acid (HA) based release systems loaded with diphasic betamethasone, including betamethasone dipropionate (BD) and betamethasone 21-phosphate disodium (BP) (BD/BP@HA). BD/BP@HA hydrogel implants demonstrated biocompatibility and biodegradability to matched neuronal tissues, avoiding artificial compression following injection. The sustained release of betamethasone from BD/BP@HA hydrogels effectively inhibited both acute and chronic neuroinflammation by suppressing the nuclear factor kappa-B (NF-κB) pathway. In a mouse model of LDH, the epidural administration of BD/BP@HA efficiently alleviated LDH-induced sciatica for at least 10 days by inhibiting the activation of macrophages and microglia in dorsal root ganglion and spinal dorsal horn, respectively. The newly developed HA hydrogels represent a valuable platform for achieving sustained drug release. Additionally, we provide a simple paradigm for fabricating BD/BP@HA for epidural injection, demonstrating greater and sustained efficiency in alleviating LDH-induced sciatica compared to traditional ESI and displaying potentials for clinical translation. This system has the potential to revolutionize drug delivery for co-delivery of both soluble and insoluble drugs, thereby making a significant impact in the pharmaceutical industry. STATEMENT OF SIGNIFICANCE: Lumbar disc herniation (LDH) is a common degenerative disorder leading to sciatica and spine surgery. Although epidural steroid injection (ESI) is routinely used to alleviate sciatica, the efficacy is short and repeated injections are required. There remains challenging to prolong the efficacy of ESI. Herein, an injectable hyaluronic acid (HA) hydrogel implant by crosslinking acrylated-modified HA (HA-A) with thiol-modified HA (HA-SH) was designed to achieve a biphasic release of betamethasone. The hydrogel showed biocompatibility and biodegradability to match neuronal tissues. Notably, compared to traditional ESI, the hydrogel better alleviated sciatica in vivo by synergistically inhibiting the neuroinflammation in central and peripheral nervous systems. We anticipate the injectable HA hydrogel implant has the potential for clinical translation in treating LDH-induced sciatica.


Asunto(s)
Desplazamiento del Disco Intervertebral , Ciática , Ratones , Animales , Ciática/tratamiento farmacológico , Ciática/etiología , Desplazamiento del Disco Intervertebral/complicaciones , Desplazamiento del Disco Intervertebral/tratamiento farmacológico , Ácido Hialurónico , Hidrogeles/farmacología , Hidrogeles/uso terapéutico , Enfermedades Neuroinflamatorias , Betametasona/farmacología , Betametasona/uso terapéutico , Compuestos de Sulfhidrilo
10.
Diabet Med ; 41(2): e15262, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38017692

RESUMEN

AIMS: Bespoke glycaemic control strategies following antenatal corticosteroids for women with diabetes in pregnancy (DIP) may mitigate hyperglycaemia. This study aims to identify predictive factors for the glycaemic response to betamethasone in a large cohort of women with DIP. METHODS: Evaluation of a prospective cohort study of 347 consecutive DIP pregnancies receiving two doses of 11.4 mg betamethasone 24 h apart between 2017 and 2021 and treated with the Pregnancy-IVI intravenous insulin protocol. Regression modelling identified factors associated with maternal glycaemic time-in-range (TIR) and maternal insulin requirements following betamethasone. Factors associated with neonatal hypoglycaemia (glucose <2.6 mmol/L) in infants born within 48 h of betamethasone administration (n = 144) were investigated. RESULTS: The mean maternal age was 31.9 ± 5.8 years, with gestational age at betamethasone of 33.5 ± 3.4 weeks. Gestational diabetes was present in 81% (12% type 1; 7% type 2). Pre-admission subcutaneous insulin was prescribed for 63%. On-infusion maternal glucose TIR (4.0-7.8 mmol/L) was 83% [IQR 77%-90%] and mean on-IVI glucose was 6.6 ± 0.5 mmol/L. Maternal hypoglycaemia (<3.8 mmol/L) was uncommon (0.47 h/100 on-IVI woman hours). Maternal glucose TIR was negatively associated with indicators of insulin resistance (type 2 diabetes, polycystic ovary syndrome), late-pregnancy complications (pre-eclampsia, chorioamnionitis) and the 1-h OGTT result. Intravenous insulin requirements were associated with type of diabetes, pre-eclampsia and intrauterine infection, the 1-h OGTT result and the timing of betamethasone administration. Neonatal hypoglycaemia was associated with pre-existing diabetes but not with measures of glycaemic control. CONCLUSION: An intravenous infusion protocol effectively controls maternal glucose after betamethasone. A risk-factor-based approach may allow individualisation of therapy.


Asunto(s)
Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Enfermedades Fetales , Hiperglucemia , Hipoglucemia , Preeclampsia , Embarazo en Diabéticas , Recién Nacido , Embarazo , Femenino , Humanos , Adulto , Lactante , Diabetes Gestacional/tratamiento farmacológico , Diabetes Gestacional/epidemiología , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Betametasona/uso terapéutico , Hiperglucemia/prevención & control , Estudios Prospectivos , Hipoglucemia/inducido químicamente , Hipoglucemia/epidemiología , Hipoglucemia/prevención & control , Embarazo en Diabéticas/tratamiento farmacológico , Parto , Insulina/efectos adversos , Glucosa
11.
Fetal Diagn Ther ; 51(1): 92-100, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-37725930

RESUMEN

INTRODUCTION: Fetal intrapericardial teratoma is a rare tumor that can be diagnosed by antenatal ultrasonography early in pregnancy. CASE PRESENTATION: A fetal intrapericardial teratoma was detected on routine ultrasonography in the second trimester of pregnancy. At 31 weeks gestation, a marked increase in tumor size, fetal ascites, and pericardial effusion were observed, indicating that preterm delivery would be inevitable. Corticosteroid prophylaxis (24 mg of betamethasone in two doses of 12 mg 24 h apart) initiated for prophylaxis of respiratory distress syndrome led to a reduction in fetal ascites and pericardial effusion. Betamethasone therapy (4 mg/per day) was continued with the aim to postpone the expected date of delivery. Gestation was extended for more than 2 weeks. At 33 weeks and 5 days gestation, the neonate was delivered by elective cesarean section with ex utero intrapartum treatment and immediately submitted to fetal cardiac surgery. The infant was discharged from the hospital in good health about 4 months later. CONCLUSION: The present report draws attention to improvement in fetal status and extension of gestation achieved with maternal low-dose corticosteroid therapy on antenatal ultrasound finding of fetal ascites and pericardial effusion due to intrapericardial teratoma.


Asunto(s)
Neoplasias Cardíacas , Derrame Pericárdico , Teratoma , Recién Nacido , Embarazo , Humanos , Femenino , Derrame Pericárdico/diagnóstico por imagen , Derrame Pericárdico/terapia , Derrame Pericárdico/etiología , Cesárea , Ascitis , Pericardio/diagnóstico por imagen , Pericardio/patología , Pericardio/cirugía , Ultrasonografía Prenatal/efectos adversos , Teratoma/diagnóstico por imagen , Teratoma/tratamiento farmacológico , Teratoma/cirugía , Corticoesteroides , Betametasona/uso terapéutico , Neoplasias Cardíacas/diagnóstico por imagen , Neoplasias Cardíacas/tratamiento farmacológico , Neoplasias Cardíacas/cirugía
12.
Int J Surg ; 110(1): 183-193, 2024 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-37800559

RESUMEN

BACKGROUND: Postoperative pain after laminoplasty and laminectomy occurs partially from local trauma of the paraspinal tissue. Finding a multimodal analgesic cocktail to enhance the duration and effect of local infiltration analgesia is crucial. Because of the rapid onset and long duration of action of betamethasone, the authors hypothesized that, a pre-emptive multimodal infiltration regimen of betamethasone and ropivacaine reduces pain scores and opioid demand, and improves patient satisfaction following laminoplasty and laminectomy. MATERIALS AND METHODS: This prospective, randomized, open-label, blinded endpoint study was conducted between 1 September 2021 and 3 June 2022, and included patients between the ages of 18 and 64 scheduled for elective laminoplasty or laminectomy under general anesthesia, with American Society of Anesthesiologists classification I/II. One hundred sixteen patients were randomly assigned to either the BR (Betamethasone-Ropivacaine) group or the R (Ropivacaine) group in a 1:1 ratio. Each group received pre-emptive infiltration of a total of 10 ml study solution into each level. Every 30 ml of study solution composed of 0.5 ml of betamethasone plus 14.5 ml of saline and 15 ml of 1% ropivacaine for the BR group, and 15 ml of 1% ropivacaine added to 15 ml of saline for the R group. Infiltration of epidural space and intrathecal space were avoided and the spinous process, transverse process, facet joints, and lamina were injected, along with paravertebral muscles and subcutaneous tissue. Cumulative 48 h postoperative butorphanol consumption via PCA (Patient-controlled analgesia) was the primary outcome. Intention-to-treat (ITT) principle was used for primary analysis. RESULTS: Baseline characteristics were identical in both groups ( P >0.05). The cumulative 48 h postoperative butorphanol consumption via PCA was 3.0±1.4 mg in the BR group ( n =58), and 7.1±1.2 mg in the R group ( n =58) ( P <0.001). Overall cumulative opioid demand was lower at different time intervals in the BR group ( P <0.001), along with the estimated median time of first analgesia demand via PCA (3.3 h in the BR group and 1.6 h in the R group). The visual analog scale (VAS) score at movement and rest were also significantly lower until 3 months and 6 weeks, respectively. No side effects or adverse events associated with the intervention were observed in this study. CONCLUSIONS: Pre-emptive analgesia with betamethasone and ropivacaine provides better postoperative pain management following laminoplasty and laminectomy, compared to ropivacaine alone. This is an effective technique worthy of further evaluation.


Asunto(s)
Anestésicos Locales , Laminoplastia , Humanos , Adolescente , Adulto Joven , Adulto , Persona de Mediana Edad , Ropivacaína , Anestésicos Locales/uso terapéutico , Analgésicos Opioides/uso terapéutico , Betametasona/uso terapéutico , Laminectomía/efectos adversos , Butorfanol/uso terapéutico , Laminoplastia/efectos adversos , Estudios Prospectivos , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/etiología , Dolor Postoperatorio/prevención & control , Analgesia Controlada por el Paciente/métodos , Método Doble Ciego , Amidas/uso terapéutico
14.
Angew Chem Int Ed Engl ; 63(4): e202313952, 2024 Jan 22.
Artículo en Inglés | MEDLINE | ID: mdl-37994255

RESUMEN

16ß-Methylcorticoids are among the most important glucocorticoid steroids for the treatment of various dermatological disorders, respiratory infections, and other allergic reactions elicited during inflammatory responses of the human body. Betamethasone dipropionate, clobetasol propionate, and beclomethasone dipropionate are particularly noteworthy for their synthetic intractability. Despite five decades of research, these 16ß-methylcorticoids have remained challenging synthetic targets owing to insurmountable issues of reactivity, selectivity, and cost efficiency associated with all previously explored strategies. We herein report our practicability-oriented strategy toward the unified stereoselective synthesis of 16ß-methylcorticoids in 12.6-14.0 % overall yield from commercially available 9α-hydroxyandrost-4-ene-3,17-dione (9α-OH-AD). In this approach, the chiral C16ß-Me and C17α-OH groups of the corticosteroid D ring were installed via a substrate-controlled diastereo- and enantioselective Mn-catalyzed oxidation-reduction hydration of Δ4,9(11),16 -triene-3,20-dione. The C1-C2 double bond of the corticosteroid A ring was constructed using an unprecedented engineered 3-ketosteroid-Δ1 -dehydrogenase (MK4-KstD)-catalyzed regioselective Δ1 -dehydrogenation of Δ4,9(11) -diene-3,21-dione. This strategy provides a general method and a key precursor for the divergent synthesis of a variety of glucocorticoids and related steroidal drugs.


Asunto(s)
Beclometasona , Clobetasol , Humanos , Clobetasol/uso terapéutico , Betametasona/uso terapéutico , Esteroides , Corticoesteroides
15.
Contact Dermatitis ; 90(2): 153-160, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37828631

RESUMEN

BACKGROUND: Topical corticosteroids under occlusion have been used to enhance the treatment of eczema. However, no study has investigated the efficacy of a steroid-containing transdermal patch for the treatment of chronic hand eczema. METHODS: We conducted a randomized, controlled, assessor-blinded trial to determine the efficacy of a transdermal patch containing betamethasone dipropionate compared to topical betamethasone dipropionate ointment in the treatment of mild to moderate chronic hand eczema. The patients were included and assigned to receive either the transdermal patch once daily at night or the ointment twice daily for a period of 8 weeks. The outcomes were assessed using the Hand Eczema Severity Index (HECSI), Physical Global Assessment (PGA) score, self-reported compliance, level of patient satisfaction, quality of life, and side effects. RESULTS: Fifty-six patients completed this study. At 8 weeks, there was a significant reduction in the HECSI scores in both the transdermal patch and topical ointment groups compared to those measured at baseline (14.61 to 1.86, p < 0.001; 18.46 to 3.43, p < 0.001, respectively) without a statistically significant difference between the two groups. Similarly, the two groups did not show any significant difference in the PGA scores, quality of life and side effects. However, the transdermal patch group reported better compliance and a higher level of patient satisfaction than the topical ointment group. CONCLUSION: The transdermal corticosteroid patch has proven to be a safe and effective treatment, comparable to topical corticosteroids, after 8 weeks of use. Its sustained-release properties, along with once-daily use, can improve patient satisfaction and promote greater adherence to the treatment. TRIAL REGISTRATION: This study was registered with the Thai Clinical Trials Registry (www. CLINICALTRIALS: in.th) under registration number TCTR20220413003.


Asunto(s)
Dermatitis Alérgica por Contacto , Fármacos Dermatológicos , Eccema , Humanos , Pomadas , Calidad de Vida , Hidrogeles , Método Simple Ciego , Parche Transdérmico , Dermatitis Alérgica por Contacto/tratamiento farmacológico , Betametasona/uso terapéutico , Glucocorticoides/uso terapéutico , Eccema/tratamiento farmacológico , Corticoesteroides/uso terapéutico , Resultado del Tratamiento , Fármacos Dermatológicos/efectos adversos
16.
Eur Rev Med Pharmacol Sci ; 27(21): 10697-10704, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37975395

RESUMEN

BACKGROUND: Topical therapies represent the first-line treatment for mild-to-moderate psoriasis. Among various topical options, the fixed-dose combination of calcipotriene (Cal) and betamethasone dipropionate (BD) foam (Enstilar®, LEO Pharma, Ballerup, Denmark) showed superior efficacy to Cal and BD monotherapy and ointment and gel formulations. In addition, the Cal/BD foam is the only topical treatment allowed for either reactive treatment of relapse or twice-weekly maintenance use. Since treatment acceptability is crucial to optimize adherence, this paper presents a case series from a multicenter experience using the Cal/BD foam, to further characterize the use of this therapeutic approach. In addition, a narrative review of studies evaluating the acceptability of the Cal/BD foam, even compared with other formulations, is provided. CASE SERIES: The case series involved adult patients with mild-to-moderate psoriasis treated with the Cal/BD foam from October 2021 to June 2022. A clinical and dermoscopic evaluation of plaques was provided for all patients. Data from the clinical practice report complete clinical resolution of plaques in most patients after 4 weeks of active treatment with the Cal/BD foam, and the dermoscopic clearance after a maximum of 8 weeks. Full adherence to treatment was also reported. Literature evidence suggests that the Cal/BD foam is easy to apply and presents high cosmetic acceptance, rapid onset of action, high efficacy, optimal safety, and a high patient preference. The high satisfaction obtained with Cal/BD foam suggests that this formulation is better accepted than others. CONCLUSIONS: The Cal/BD foam represents a valuable approach for managing mild-to-moderate psoriasis, both in short and long-term treatment.


Asunto(s)
Fármacos Dermatológicos , Psoriasis , Adulto , Humanos , Fármacos Dermatológicos/uso terapéutico , Resultado del Tratamiento , Aerosoles/uso terapéutico , Psoriasis/tratamiento farmacológico , Betametasona/uso terapéutico , Administración Tópica , Combinación de Medicamentos , Estudios Multicéntricos como Asunto
17.
BMC Oral Health ; 23(1): 709, 2023 10 03.
Artículo en Inglés | MEDLINE | ID: mdl-37789351

RESUMEN

BACKGROUND: Recurrent Aphthous Stomatitis (RAS) is painful oral ulceration frequently treated with topical steroids. There is limited published evidence for the efficacy of any treatment for RAS and there remains a need for longitudinal randomised clinical trials to evaluate and compare the effectiveness of different therapies in the management of RAS. The aim of the current project was to assess the efficacy of betamethasone mouthwash and colchicine tablets, individually and combined, for the treatment of RAS, and to establish the optimum treatment period necessary for a significant reduction in the disease severity. METHODOLOGY: A randomised, prospective, parallel-group clinical trial was conducted over one year, to compare the efficacy of three therapies in RAS. One hundred and six patients were randomized into three groups; 35 received betamethasone mouthwash, 35 had colchicine tablets and 36 received both therapies. The response was evaluated quantitatively every 3 months for 1 year, using the Ulcer Severity Score (USS). RESULTS: For all three treatment regimes, the mean USS decreased by about 30% in the first 3 months (p < 0.001). Further improvement was noted for up to 9 months. At the end of the study, the mean USS had improved by 50% from 34.9 ± 7.2 before treatment to 17.5 ± 8.9 after treatment (p < 0.001). Of included participants, 86% showed significant clinical improvement by the end of the study. There were no significant differences in outcomes between the three regimes (p < 0.05). CONCLUSIONS: This clinical trial has provided evidence for the efficacy of betamethasone mouthwash and for colchicine tablets in the treatment of RAS and has shown that at least six months of treatment may be required for optimum effect. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN3267716. Date of clinical trial registration: 15/04/2018.


Asunto(s)
Estomatitis Aftosa , Humanos , Estomatitis Aftosa/tratamiento farmacológico , Colchicina/uso terapéutico , Antisépticos Bucales/uso terapéutico , Estudios Prospectivos , Betametasona/uso terapéutico
18.
J Plast Reconstr Aesthet Surg ; 87: 54-60, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37804648

RESUMEN

Infantile hemangiomas (IHs) of the lips are associated with an increased risk of incomplete involution and ulceration, causing disfigurement. Treatment with oral propranolol (OPT) has credible efficacy but takes months to complete. Thus, this study aimed to investigate the efficacy of intralesional betamethasone injection (IBI) as an alternative treatment for protruding localized IHs of the lips. To investigate the efficacies of OPT and IBI, we designed a prospective, noninferiority, parallel-group study. The primary outcome assessed was treatment response rate. Secondary outcome assessments included lesion size changes and surgical rate. Additionally, complication rates and treatment durations of OPT and IBI were compared. The treatment response rate of IBI was not inferior to that of OPT (95.7% vs. 76.0%, respectively; a difference of 19.7%, 95% confidence interval [CI], -4.4% to 41.6%). The average surgical rate in the IBI group was significantly lower than that in the OPT group (8.7% vs. 40%, respectively; p = 0.012), and the average duration of treatment for IBI was shorter than that of OPT (2.1 months vs. 6.3 months, respectively; p < 0.001). There were no severe adverse drug events in either group. If not managed properly, small, localized lip IHs may cause disfigurement in a child. Our study demonstrated that IBI is as effective as OPT in treating protruding localized lip IHs. Moreover, IBI treatment has a shorter duration and lower surgical rate than OPT. With proper care, IBI is an effective treatment modality for small and localized lip IHs.


Asunto(s)
Hemangioma , Neoplasias Cutáneas , Niño , Humanos , Lactante , Propranolol/efectos adversos , Labio/patología , Hemangioma/tratamiento farmacológico , Betametasona/uso terapéutico , Estudios Prospectivos , Resultado del Tratamiento , Neoplasias Cutáneas/tratamiento farmacológico , Antagonistas Adrenérgicos beta/uso terapéutico
19.
J Pediatr Surg ; 58(12): 2384-2390, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37813715

RESUMEN

INTRODUCTION: Fetuses with large lung lesions including congenital cystic adenomatoid malformations (CCAMs) are at risk for cardiopulmonary compromise. Prenatal maternal betamethasone and cyst drainage for micro- and macrocystic lesions respectively have improved outcomes yet some lesions remain large and require resection before birth (open fetal surgery, OFS), at delivery via an Ex Utero Intrapartum Treatment (EXIT), or immediately post cesarean section (section-to-resection, STR). We sought to compare prenatal characteristics and outcomes in fetuses undergoing OFS, EXIT, or STR to inform decision-making and prenatal counseling. METHODS: A single institution retrospective review was conducted evaluating patients undergoing OFS, EXIT, or STR for prenatally diagnosed lung lesions from 2000 to 2021. Specimens were reviewed by an anatomic pathologist. Lesions were divided into "CCAMs" (the largest pathology group) and "all lung lesions" since pathologic diagnosis is not possible during prenatal evaluation when care decisions are made. Prenatal variables included initial, greatest, and final CCAM volume-ratio (CVR), betamethasone use/frequency, cyst drainage, and the presence of hydrops. Outcomes included survival, ECMO utilization, NICU length of stay (LOS), postnatal nitric oxide use, and ventilator days. RESULTS: Sixty-nine percent (59 of 85 patients) of lung lesions undergoing resection were CCAMs. Among patients with pathologic diagnosis of CCAM, the initial, largest, and final CVRs were greatest in OFS followed by EXIT and STR patients. Similarly, the incidence of hydrops was significantly greater and the rate of hydrops resolution was lower in the OFS group. Although the rate of cyst drainage did not differ between groups, maternal betamethasone use varied significantly (OFS 60.0%, EXIT 100.0%, STR 74.3%; p = 0.0378). Notably, all OFS took place prior to 2014. There was no difference in survival, ventilator days, nitric oxide, NICU LOS, or ECMO between groups. In multiple variable logistic modeling, determinants of survival to NICU discharge among patients undergoing resection with a pathologic diagnosis of CCAM included initial CVR <3.5 and need for <3 maternal betamethasone doses. CONCLUSION: For CCAMs that remain large despite maternal betamethasone or cyst drainage, surgical resection via OFS, EXIT, or STR are viable options with favorable and comparable survival between groups. In the modern era there has been a shift from OFS and EXIT procedures to STR for fetuses with persistently large lung lesions. This shift has been fueled by the increased use of maternal betamethasone and introduction of a Special Delivery Unit during the study period and the appreciation of similar fetal and neonatal outcomes for STR vs. EXIT and OFS with reduced maternal morbidity associated with a STR. Accordingly, efforts to optimize multidisciplinary perinatal care for fetuses with large lung lesions are important to inform patient selection criteria and promote STR as the preferred surgical approach in the modern era. LEVEL OF EVIDENCE: Level IV.


Asunto(s)
Malformación Adenomatoide Quística Congénita del Pulmón , Quistes , Recién Nacido , Embarazo , Humanos , Femenino , Hidropesía Fetal/diagnóstico , Hidropesía Fetal/tratamiento farmacológico , Hidropesía Fetal/etiología , Cesárea/efectos adversos , Óxido Nítrico , Betametasona/uso terapéutico , Malformación Adenomatoide Quística Congénita del Pulmón/cirugía , Ultrasonografía Prenatal , Estudios Retrospectivos , Pulmón , Quistes/complicaciones
20.
J Oral Maxillofac Surg ; 81(12): 1549-1556, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37770014

RESUMEN

BACKGROUND: Pain, swelling, and trismus are common outcomes following impacted lower third molar surgery. PURPOSE: The purpose of the study was to evaluate the effect of betamethasone injection into the pterygomandibular space on the aforementioned sequelae of third molar surgery. STUDY DESIGN, SETTING, AND SAMPLE: A split-mouth, double-blind, randomized clinical trial was conducted on 40 patients with symmetrical bilateral impacted lower third molars. The surgeries were performed at an outpatient clinic under local anesthesia. PREDICTOR/EXPOSURE/INDEPENDENT VARIABLE: The predictor variable is the steroid treatment. The experimental group received a 1 mL (6 mg) betamethasone injection into the pterygomandibular space, while the control group received a normal saline. MAIN OUTCOME VARIABLE(S): The primary outcome variable was postoperative pain assessed using a visual analog scale. The secondary outcome variables were the number of analgesic tablets consumed, facial swelling, and trismus. COVARIATES: The age and sex of the patients, the direction of impaction, and the duration of surgery were recorded. ANALYSES: Comparisons between the groups were carried out using an unpaired t test. An analysis of variance test was used to assess intragroup differences. The significance was considered at P ≤ .05. RESULTS: Of the 265 patients initially screened for study enrollment, the final sample included 40 subjects, with a mean age of 28.3 years (±7.4), 28 (70%) were mal and 12 (30%) were female. There was no significant difference between the two groups concerning postoperative pain or the number of consumed analgesic tablets. However, the betamethasone group exhibited significantly reduced facial swelling and increased mouth opening. On the first postoperative day, the visual analog scale pain score did not significantly differ between the betamethasone group (6.0 ± 1.7) and the control group (6.8 ± 1.4), with a P value of 0.112. On the first postoperative day, facial swelling measured 4.2 ± 1.3 mm in the betamethasone group compared to 6.0 ± 0.9 mm in the control group (P < .001). Mouth opening in the betamethasone group was 30.8 ± 6.7 mm, while in the control group, it measured 21.9 ± 5.5 mm (P < .001). CONCLUSION AND RELEVANCE: Local betamethasone has no effect on pain after third molar surgery, but facial swelling and trismus are significantly reduced.


Asunto(s)
Betametasona , Diente Impactado , Humanos , Femenino , Adulto , Masculino , Betametasona/uso terapéutico , Tercer Molar/cirugía , Trismo/prevención & control , Extracción Dental , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/prevención & control , Analgésicos , Diente Impactado/cirugía , Edema/prevención & control
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