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INTRODUCTION: A combination of self-reported questionnaire and administrative data could potentially enhance ascertainment of outcomes and alleviate the limitations of both in follow up studies. However, it is uncertain how access to only one of these data sources to assess outcomes impact study findings. Therefore, this study aimed to determine whether the study findings would be altered if the outcomes were assessed by different data sources alone or in combination. METHODS: At 50-year follow-up of participants in a randomized trial, we assessed the effect of antenatal betamethasone exposure on the diagnosis of diabetes, pre-diabetes, hyperlipidemia, hypertension, mental health disorders, and asthma using a self-reported questionnaire, administrative data, a combination of both, or any data source, with or without adjudication by an expert panel of five clinicians. Differences between relative risks derived from each data source were calculated using the Bland-Altman approach. RESULTS: There were 424 participants (46% of those eligible, aged 49 years, SD 1, 50% male). There were no differences in study outcomes between participants exposed to betamethasone and those exposed to placebo when the outcomes were assessed using different data sources. When compared to the study findings determined using adjudicated outcomes, the mean difference (limits of agreement) in relative risks derived from other data sources were: self-reported questionnaires 0.02 (-0.35 to 0.40), administrative data 0.06 (-0.32 to 0.44), both questionnaire and administrative data 0.01 (-0.41 to 0.43), and any data source, 0.01 (-0.08 to 0.10). CONCLUSION: Utilizing a self-reported questionnaire, administrative data, both questionnaire and administrative data, or any of these sources for assessing study outcomes had no impact on the study findings compared with when study outcomes were assessed using adjudicated outcomes.
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Betametasona , Autoinforme , Humanos , Femenino , Embarazo , Masculino , Betametasona/administración & dosificación , Betametasona/uso terapéutico , Persona de Mediana Edad , Encuestas y Cuestionarios , Corticoesteroides/administración & dosificación , Corticoesteroides/uso terapéutico , Estudios de Seguimiento , Efectos Tardíos de la Exposición Prenatal , Asma/tratamiento farmacológicoRESUMEN
BACKGROUND: The combined use of topical calcipotriol/betamethasone dipropionate (Cal/BDP) is commonly used and demonstrated to be effective for the management of psoriasis and is shown to confer local anti-inflammatory and immunoregulatory effects. The use of the two agents in combination is synergistic. Despite the demonstrated efficacy of topically applied combination Cal/BDP, successful management of a chronic, relapsing inflammatory skin disease such as psoriasis in the real-world setting may be hindered if patients do not adhere to the dosing or frequency of application recommendations from their prescriber. Patient preference for and satisfaction with the topical treatment vehicle have been shown to influence adherence. A recent analysis has determined that patients perceived Cal/BDP cream vehicle with PAD technology as having favorable characteristics. This randomized, split-body study was undertaken to further assess patient satisfaction with Cal/BDP cream and Cal/BDP foam formulations. TRIAL DESIGN: This was a split-body, subject-blind study. Study cream was administered in a single application to one side of the scalp and/or body; study foam was applied to the contralateral side. Patient self-administered questionnaires were completed before and after product application after a single site visit. RESULTS: Mean overall Vehicle Preference Measure (VPM) scores were higher for Cal/BDP cream than Cal/BDP foam (P=0.0043). Cal/BDP cream also achieved higher individual scores for ease of application, feeling to the touch, smell, and feeling on the skin (P<0.03). With regards to scalp application, subject assessments show that the cream was significantly more preferred in terms of limiting daily disruption (P=0.0008) Conclusion: Results of this study suggest that patients may prefer Cal/BDP cream over Cal/BDP foam for the management of psoriasis on the body and the scalp. Cal/BDP cream outperformed Cal/BDP foam on several specific measures of satisfaction and overall satisfaction measures. J Drugs Dermatol. 2024;23(8):607-611. doi:10.36849/JDD.7993.
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Betametasona , Calcitriol , Fármacos Dermatológicos , Combinación de Medicamentos , Prioridad del Paciente , Psoriasis , Crema para la Piel , Humanos , Psoriasis/tratamiento farmacológico , Psoriasis/psicología , Calcitriol/análogos & derivados , Calcitriol/administración & dosificación , Betametasona/administración & dosificación , Betametasona/análogos & derivados , Femenino , Masculino , Persona de Mediana Edad , Adulto , Fármacos Dermatológicos/administración & dosificación , Crema para la Piel/administración & dosificación , Administración Cutánea , Método Simple Ciego , Índice de Severidad de la Enfermedad , Anciano , Resultado del Tratamiento , Satisfacción del Paciente , Encuestas y CuestionariosRESUMEN
BACKGROUND: Particulate steroids are thought to exert their effects for long durations at injection sites. However, these types of steroids carry higher risks when used in epidural steroid injections. Catastrophic spinal cord complications, including sudden-onset paraplegia, have been reported due to intravascular particulate steroid preparations that cause embolisms and occlusion of blood vessels, resulting in spinal cord infarctions. Clinicians, therefore, recommend nonparticulate steroids to mitigate these adverse events. To our knowledge, this is the first retrospective study that addresses the effectiveness and safety of methylprednisolone, dexamethasone, and betamethasone when used in transforaminal epidural steroid injections (TFESIs) for the treatment of lumbar radiculopathy. OBJECTIVES: The primary goal of this study was to compare the proportion of patients who received injections of particulate steroids and required zero repeat injections within 12 months of their initial injection to the proportion of patients who received injections of nonparticulate steroids and also required zero repeat injections, as well as to compare the number of patients in the particulate cohort who required one or more repeat injections within 12 months of their initial injection to the number of patients in the nonparticulate cohort who required the same. The secondary goal was to evaluate the proportion of patients ultimately requiring surgery. STUDY DESIGN: This is a single-center, IRB-approved, retrospective study evaluating the safety and effectiveness of nonparticulate as compared to particulate steroid medications when used in TFESIs as minimally invasive treatments for chronic lumbar radiculopathy. SETTING: This study captured data (n = 1717) over a 4-year time frame (01/15/2018 to 01/15/2022). METHODS: The following data were collected from each patient's chart: age, gender, BMI, race, date of initial injection, number of repeat injections at the same lumbosacral level and on the same side within 12 months of the initial injection, and lumbar surgery date (if applicable). Inclusion criteria included: 1) having chronic low back pain of radicular etiology; 2) being at least 18 years old; 3) having experienced the failure of conservative therapy after 12 weeks (including physical therapy and/or medications); 4) having positive physical exam findings supporting nerve impingement (straight leg raise, slump test); and 5) showing lumbar MRI evidence of nerve impingement from disc herniation. Exclusion criteria included: 1) having received prior lumbar surgery at any level (L1-S1); 2) having been given prior TFESIs fewer than 6 months prior to initial injection; 3) having contracted a systemic infection at the proposed injection site; 4) undergoing active cancer treatment; and 5) having gotten any other spine injections. RESULTS: A significantly greater proportion of patients in the nonparticulate steroid cohort received 0 repeat injections (87.5% vs 71.4%, P < 0.001). The particulate steroid cohort demonstrated a significantly greater proportion of patients who received repeat injections within 12 months after the initial injections (12.5% vs 29.6%, P < 0.001). There were no significant differences among patients requiring surgery between the 2 cohorts. Other outcome measures included the identification of risk factors significantly associated with repeat injections. There was a statistically significant weak positive correlation between age and repeat injections (Pearson corr = 0.102; P < 0.001) and a weak negative correlation between ethnicity/race and repeat injections (point-biserial corr = -0.093; P < 0.001). No adverse events were reported. LIMITATIONS: Not all clinicians included in this study used each of the 3 steroid types, and all clinicians used either particulate or nonparticulate steroids exclusively. CONCLUSIONS: Our study demonstrates that the clinical outcomes associated with TFESIs of nonparticulate steroids are superior to those associated with TFESIs of particulate steroids when either variety of medication is used to treat lumbar radiculopathy. This is the first study to include a clinically useful predictive model using information on laterality, age, and steroid type.
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Betametasona , Dexametasona , Metilprednisolona , Radiculopatía , Humanos , Inyecciones Epidurales/métodos , Dexametasona/administración & dosificación , Dexametasona/efectos adversos , Estudios Retrospectivos , Betametasona/administración & dosificación , Metilprednisolona/administración & dosificación , Metilprednisolona/efectos adversos , Radiculopatía/tratamiento farmacológico , Masculino , Femenino , Persona de Mediana Edad , Adulto , Anciano , Antiinflamatorios/administración & dosificación , Vértebras LumbaresAsunto(s)
Aerosoles , Betametasona , Calcitriol , Fármacos Dermatológicos , Combinación de Medicamentos , Enfermedades de la Uña , Psoriasis , Humanos , Psoriasis/tratamiento farmacológico , Calcitriol/análogos & derivados , Calcitriol/administración & dosificación , Calcitriol/uso terapéutico , Betametasona/administración & dosificación , Betametasona/análogos & derivados , Betametasona/uso terapéutico , Fármacos Dermatológicos/administración & dosificación , Fármacos Dermatológicos/uso terapéutico , Enfermedades de la Uña/tratamiento farmacológico , Masculino , Femenino , Urea/administración & dosificación , Urea/uso terapéutico , Urea/análogos & derivados , Adulto , Resultado del Tratamiento , Persona de Mediana EdadRESUMEN
Betamethasone has been extensively used in medicine in recent years and poses potential hazards to aquatic organisms. This study investigated the reproductive toxic effects of betamethasone exposure in fish, employing female Japanese medaka (Oryzias latipes) as a model. Betamethasone exposure at environmentally relevant concentrations (0, 20, 200, and 2000â¯ng/L) for a period of 15 weeks resulted in its high accumulation in the ovary, leading to abnormal oogenesis in female Japanese medaka. The production of gonadotropins (LH and FSH) in the pituitary gland was inhibited, and sex steroid biosynthesis in the ovary was significantly influenced at the transcriptional level. The imbalance of androgens and estrogens resulted in a decrease in the E2/T ratio and hepatic VTG synthesis, and the suppression of estrogen receptor signaling was also induced. Furthermore, betamethasone exposure delayed spawning and reduced fertility in the F0 generation, and had detrimental effects on the fertilization rate and hatchability of the F1 generation. Our results showed that environmental betamethasone had the potential to adversely affect female fertility and steroid hormone dynamics in fish.
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Betametasona , Oryzias , Ovario , Reproducción , Contaminantes Químicos del Agua , Animales , Oryzias/fisiología , Femenino , Betametasona/toxicidad , Contaminantes Químicos del Agua/toxicidad , Reproducción/efectos de los fármacos , Ovario/efectos de los fármacos , Hipófisis/efectos de los fármacos , Fertilidad/efectos de los fármacos , Oogénesis/efectos de los fármacos , Exposición a Riesgos Ambientales , Hormonas Esteroides GonadalesRESUMEN
INTRODUCTION: Keloids, benign fibroproliferative tumours characterised by excessive fibroblast proliferation and over-deposition of extracellular matrix, pose a therapeutic challenge with high recurrence rates. Betamethasone (diprospan) injection (BI) is one of the most common non-invasive therapies for keloids. Pulsed dye laser (PDL) has the function of closing microvessels, which may become one of the auxiliary treatment methods of BI and may enhance its curative effect. Some studies suggest that the combination of a dual-wavelength dye laser (DWL) and BI may offer superior efficacy. This randomised controlled trial aims to evaluate whether the combined therapy of DWL+BI outperforms BI alone in treating keloids. METHODS AND ANALYSIS: This single-centre, parallel positive control, randomised trial evaluates the efficacy and safety of DWL (585 nm PDL+1064 nm neodymium-doped yttrium aluminium garnet) combined with BI for keloid treatment. Enrolling 66 adult patients, participants are randomised into DWL+BI or BI groups in a 1:1 ratio. Over 12 weeks, each group undergoes four treatment sessions, ensuring blinding for outcome assessors. Data collection occurs at multiple time points (4, 12, 24 and 52 weeks), with primary outcomes assessing the Vancouver Scar Scale (VSS) improvement rate 24 weeks after the last intervention. Secondary outcomes include VSS improvement rates, changes in keloid volume, changes in relative perfusion index measured by laser speckle contrast imaging, Patient and Observer Scar Assessment Scale results and patient satisfaction. Safety assessments include vital signs, laboratory tests, pregnancy tests and self-reports of adverse reactions. ETHICS AND DISSEMINATION: The results will be presented in peer-reviewed journals and at international conferences. This study is approved by the Ethics Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Register (ChiCTR2400080148).
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Betametasona , Queloide , Láseres de Colorantes , Humanos , Queloide/terapia , Queloide/tratamiento farmacológico , Betametasona/administración & dosificación , Betametasona/uso terapéutico , Láseres de Colorantes/uso terapéutico , Adulto , Femenino , Ensayos Clínicos Controlados Aleatorios como Asunto , Masculino , Terapia Combinada , Glucocorticoides/administración & dosificación , Glucocorticoides/uso terapéutico , Resultado del Tratamiento , Persona de Mediana Edad , Adulto Joven , AdolescenteRESUMEN
Glucocorticoids (GCs) are widely used as powerful anti-inflammatory and immunosuppressive therapeutics in multiple pathological conditions. However, compelling evidence indicates that they might promote neurodegeneration by altering mitochondrial homeostatic processes. Although the effect of dexamethasone on cell survival and homeostasis has been widely investigated, the effect of other glucocorticoids needs to be explored in more detail. In this report, we have compared the neurotoxicity induced by dexamethasone, prednisolone, betamethasone, and hydrocortisone in cultured neuroblastoma cells, through the analysis of several parameters such as cell viability, ER stress, oxidative stress, and mitochondrial fusion and fission markers. Interestingly, we have found that synthetic glucocorticoids may impact neuronal viability by affecting different cellular responses, suggesting that their therapeutic use should be consciously decided after careful consideration of benefits and detrimental effects.
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Supervivencia Celular , Glucocorticoides , Neuroblastoma , Estrés Oxidativo , Glucocorticoides/farmacología , Supervivencia Celular/efectos de los fármacos , Supervivencia Celular/fisiología , Neuroblastoma/patología , Línea Celular Tumoral , Humanos , Estrés Oxidativo/efectos de los fármacos , Estrés Oxidativo/fisiología , Estrés del Retículo Endoplásmico/efectos de los fármacos , Estrés del Retículo Endoplásmico/fisiología , Dexametasona/farmacología , Hidrocortisona/farmacología , Prednisolona/farmacología , Betametasona/farmacología , Neuronas/efectos de los fármacos , Neuronas/metabolismoRESUMEN
Mycosis fungoides palmaris et plantaris (MFPP) is a rare variant of mycosis fungoides (MF), a type of cutaneous T-cell lymphoma. MFPP primarily affects the palms and soles of the feet and is often misdiagnosed as dyshidrotic eczema due to its similar clinical presentation. This case report presents a middle-aged woman with MFPP whose initial presentation was mistaken for dyshidrotic eczema. Despite treatment with topical corticosteroids, the patient's lesions persisted, prompting further investigations that led to the diagnosis of MFPP. The patient was initiated on betamethasone dipropionate ointment and hydroxyzine for pruritus management, with a pivotal referral to oncology for comprehensive evaluation. This case highlights the importance of considering MFPP in the differential diagnosis of persistent eczematous lesions on the palms and soles, especially when treatment with topical corticosteroids is ineffective. J Drugs Dermatol. 2024;23(7):569-570. doi:10.36849/JDD.8474.
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Eccema Dishidrótico , Micosis Fungoide , Neoplasias Cutáneas , Humanos , Femenino , Micosis Fungoide/diagnóstico , Micosis Fungoide/tratamiento farmacológico , Micosis Fungoide/patología , Diagnóstico Diferencial , Persona de Mediana Edad , Eccema Dishidrótico/diagnóstico , Eccema Dishidrótico/tratamiento farmacológico , Neoplasias Cutáneas/diagnóstico , Neoplasias Cutáneas/patología , Neoplasias Cutáneas/tratamiento farmacológico , Betametasona/administración & dosificación , Betametasona/análogos & derivadosRESUMEN
Allergic conjunctival disease is an immune-mediated inflammatory disease of the conjunctiva. To develop clinically useful drugs, it is necessary to develop quantitative evaluation methods that reflect the clinical symptoms in experimental animal models. Allergic conjunctivitis model mice were systemically sensitised with ovalbumin (OVA) administered intraperitoneally and locally sensitised with OVA eye drops between day 14-28. Next, conjunctivitis induced by ocular administration of OVA solution to sensitised mice was evaluated based on tear volume. Additionally, we evaluated increase in tear volume induced by direct ocular instillation of histamine, compound 48/80, and carrageenan. An increase in antigen-induced tear volume was observed in the mice model. Additionally, direct instillation of histamine, compound 48/80, and carrageenan increased tear volume. Furthermore, levocabastine inhibited the increase in tear volume in antigen-induced allergic conjunctivitis and histamine- and compound 48/80-induced conjunctivitis models. In contrast, betamethasone suppressed carrageenan-induced tear volume but not histamine- or compound 48/80-induced tear volume. Histamine may be involved in increased tear volume in allergic conjunctivitis. Betamethasone is not directly involved in the action of histamine and is thought to suppress increase in tear volume. Evaluation of tear volume in a conjunctivitis mice model is highly quantitative; therefore, it is possible to evaluate drug efficacy. This is considered a useful index compared with conventional methods.
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Carragenina , Conjuntivitis Alérgica , Modelos Animales de Enfermedad , Histamina , Ovalbúmina , Lágrimas , Animales , Lágrimas/efectos de los fármacos , Lágrimas/metabolismo , Conjuntivitis Alérgica/tratamiento farmacológico , Conjuntivitis Alérgica/inmunología , Conjuntivitis Alérgica/inducido químicamente , Ratones , Femenino , p-Metoxi-N-metilfenetilamina/farmacología , Soluciones Oftálmicas , Betametasona/farmacología , Ratones Endogámicos BALB C , MasculinoRESUMEN
INTRODUCTION: Prenatal exposure to supraphysiological glucocorticoid (GC) levels may lead to long-lasting developmental changes in numerous biological systems. Our prior study identified an association between prenatal GC prophylaxis and reduced cognitive performance, electrocortical changes, and altered autonomic nervous system (ANS) activity in children aged 8-9 years. This follow-up study aimed to examine whether these findings persisted into adolescence. MATERIAL AND METHODS: Prospective observational follow-up study involving twenty-one 14- to 15-year-old adolescents born to mothers who received betamethasone for induction of fetal lung maturation in threatened preterm birth, but who were born with a normal weight appropriate for their gestational age (median 37+4 gestational weeks). Thirty-five children not exposed to betamethasone served as the reference group (median 37+6 gestational weeks). The primary endpoint was cognitive performance, measured by intelligence quotient (IQ). Key secondary endpoints included symptoms of attention-deficit/hyperactivity disorder (ADHD) and metabolic markers. Additionally, we determined electrocortical (electroencephalogram), hypothalamus-pituitary-adrenal axis (HPAA), and ANS activity in response to a standardized stress paradigm. RESULTS: No statistically significant group difference was observed in global IQ (adjusted mean: betamethasone 103.9 vs references 105.9, mean difference -2.0, 95% confidence interval [CI]: -7.12 to 3.12, p = 0.44). Similarly, ADHD symptoms, metabolic markers, the overall and stress-induced activity of the HPAA and the ANS did not differ significantly between groups. However, the betamethasone group exhibited reduced electrocortical activity in the frontal brain region (spectral edge frequency-adjusted means: 16.0 Hz vs 17.8 Hz, mean difference -1.83 Hz, 95% CI: -3.21 to -0.45, p = 0.01). CONCLUSIONS: In 14- to 15-year-old adolescents, prenatal GC exposure was not associated with differences in IQ scores or ANS activity compared to unexposed controls. However, decelerated electrocortical activity in the frontal region potentially reflects disturbances in the maturation of cortical and/or subcortical brain structures. The clinical significance of these changes remains unknown. Given the small sample size, selective participation/loss of follow-up and potential residual confounding, these findings should be interpreted cautiously. Further research is required to replicate these results in larger cohorts before drawing firm clinical conclusions.
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Betametasona , Glucocorticoides , Efectos Tardíos de la Exposición Prenatal , Humanos , Femenino , Embarazo , Adolescente , Glucocorticoides/efectos adversos , Estudios de Seguimiento , Estudios Prospectivos , Masculino , Sistema Hipotálamo-Hipofisario/efectos de los fármacos , Sistema Hipófiso-Suprarrenal/efectos de los fármacos , Desarrollo del Adolescente/efectos de los fármacos , Trastorno por Déficit de Atención con Hiperactividad , Cognición/efectos de los fármacosAsunto(s)
Betametasona , Glucocorticoides , Mandíbula , Tercer Molar , Extracción Dental , Diente Impactado , Humanos , Tercer Molar/cirugía , Diente Impactado/cirugía , Betametasona/administración & dosificación , Betametasona/uso terapéutico , Mandíbula/cirugía , Glucocorticoides/administración & dosificación , Glucocorticoides/uso terapéutico , Resultado del Tratamiento , Inyecciones , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/prevención & controlAsunto(s)
Betametasona , Glucocorticoides , Mandíbula , Tercer Molar , Extracción Dental , Diente Impactado , Humanos , Tercer Molar/cirugía , Diente Impactado/cirugía , Betametasona/administración & dosificación , Betametasona/uso terapéutico , Mandíbula/cirugía , Glucocorticoides/administración & dosificación , Glucocorticoides/uso terapéutico , Resultado del Tratamiento , InyeccionesRESUMEN
Small plaque psoriasis is the typical form of chronic plaque psoriasis affecting adults in South Korea. The effectiveness of calcipotriol/betamethasone dipropionate (Cal/BD) aerosol foam for large and small psoriasis plaques has not previously been examined. We performed a post hoc analysis of a recent, 4-week observational study of Cal/BD aerosol foam use in routine clinical practice in South Korea. Investigator Global Assessment response ([IGA] 0/1 at week 4), Patient Global Assessment response ([PaGA] 0/1 at week 4), change in Psoriasis Area and Severity Index (PASI), changes in psoriasis symptom scores, change in the Dermatology Life Quality Index (DLQI), and the proportion of patients achieving DLQI ≤5 were analyzed for patients with small (≤5 cm; n = 131) or large (>5 cm; n = 35) baseline plaque size. IGA response rates were similar for patients with small and large plaques (59.5% and 51.4% respectively). Similarly, there was no significant difference between the small and large groups in mean change in PASI (-2.20 vs -3.34), the proportions of patients with DLQI ≤5 (62.3% vs 54.3%) or PaGA 0/1 (29.2% vs 40.0%). Mean improvements in DLQI (-4.04 vs -6.20) and in psoriasis symptoms including itching (-1.50 vs -2.83), sleep loss (-0.67 vs -1.89), dryness (-1.57 vs -2.97), scaling (-1.21 vs -3.57), and redness (-1.17 vs -3.11) were greater in patients with large plaques than those with small plaques. Itching and DLQI differences were not statistically significant after adjustment for baseline characteristics. Stratification by body surface area affected eliminated statistically significant differences between the groups for most outcomes. In conclusion, this analysis suggests that Cal/BD aerosol foam is an effective, well-accepted treatment for adult patients with the small plaques typical of chronic plaque psoriasis in South Korea, as well as for those with large plaques.
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Aerosoles , Betametasona , Calcitriol , Fármacos Dermatológicos , Psoriasis , Calidad de Vida , Índice de Severidad de la Enfermedad , Humanos , Psoriasis/tratamiento farmacológico , Psoriasis/diagnóstico , Psoriasis/patología , Calcitriol/análogos & derivados , Calcitriol/administración & dosificación , Masculino , Betametasona/administración & dosificación , Betametasona/análogos & derivados , Femenino , República de Corea , Persona de Mediana Edad , Adulto , Resultado del Tratamiento , Fármacos Dermatológicos/administración & dosificación , Combinación de Medicamentos , AncianoRESUMEN
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.
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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 CutáneaRESUMEN
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.
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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 DolorRESUMEN
This cross-sectional study identifies the common diagnoses and physician encounter types associated with clotrimazole-betamethasone dipropionate prescriptions among Medicare enrollees in 2021.
Asunto(s)
Betametasona , Clotrimazol , Humanos , Betametasona/uso terapéutico , Betametasona/análogos & derivados , Clotrimazol/uso terapéutico , Enfermedades de la Piel/tratamiento farmacológico , Masculino , Femenino , Antifúngicos/uso terapéutico , Pautas de la Práctica en Medicina/estadística & datos numéricos , Combinación de Medicamentos , Persona de Mediana Edad , AdultoRESUMEN
The aim of this work was the development of a film-forming formulation (FFF) for the topical treatment of psoriasis that shows an increased substantivity compared to conventional semi-solid dosage forms. The developed formulation is an oleogel. It is based on a combination of castor oil and medium chain triglycerides, and the oil-soluble film former MP-30 (Croda GmbH, Nettetal, Germany), a polyamide that upon mixing with a polar oil entraps the oil und thus substantially increases the viscosity of the formulation up to a semisolid state. Betamethasone dipropionate (BDP) and calcipotriole (CA) were used as active pharmaceutical ingredients (APIs). Oleogels of different compositions were evaluated regarding substantivity, rheological properties, ex-vivo penetration into the skin and ex-vivo permeation through the skin. Marketed products were used as controls. It was found that the amount of betamethasone dipropionate penetrating and permeating into and through the skin from the film-forming formulation is at an intermediate value compared to the marketed products. The substantivity of the developed formulation is described by an amount of 57.7 % formulation that remains on the skin surface and is thus significantly higher compared to the marketed products. In the film forming formulation, the proportion of API penetrating the skin remains the same when the skin repetitively brought in contact with a piece of textile during the penetration experiment. In contrast with the in-market formulations tested, this proportion was reduced by up to 97 %. As a result, the developed formulations can lead to an increased patient compliance.
Asunto(s)
Betametasona , Compuestos Orgánicos , Psoriasis , Absorción Cutánea , Piel , Psoriasis/tratamiento farmacológico , Betametasona/administración & dosificación , Betametasona/análogos & derivados , Betametasona/química , Betametasona/farmacocinética , Animales , Compuestos Orgánicos/química , Compuestos Orgánicos/administración & dosificación , Absorción Cutánea/efectos de los fármacos , Piel/metabolismo , Fármacos Dermatológicos/administración & dosificación , Fármacos Dermatológicos/química , Fármacos Dermatológicos/farmacocinética , Calcitriol/análogos & derivados , Calcitriol/administración & dosificación , Calcitriol/química , Triglicéridos/química , Administración Cutánea , Aceite de Ricino/química , Porcinos , Viscosidad , Química Farmacéutica/métodos , ReologíaRESUMEN
Objective: To explore the early effectiveness and influence on cartilage of local injection of multimodal drug cocktail (MDC) during anterior cruciate ligament reconstruction (ACLR). Methods: Between February 2022 and August 2023, patients undergone arthroscopic ACLR using autologous hamstring tendons were selected as the study subjects. Among them, 90 patients met the selection criteria and were randomly divided into 3 groups ( n=30) according to the different injection drugs after ligament reconstruction. There was no significant difference in baseline data such as gender, age, body mass index, surgical side, disease duration, preoperative thigh circumference, and preoperative levels of tumor necrosis factor α (TNF-α), interleukin 6 (IL-6), IL-1, matrix metalloproteinase 3 (MMP-3), MMP-13, and aggrecan (ACAN) in synovial fluid between groups ( P>0.05). After the ligament reconstruction during operation, corresponding MDC (consisting of ropivacaine, tranexamic acid, and betamethasone in group A, and ropivacaine, betamethasone, and saline in group B) or saline (group C) were injected into the joint and tendon site, respectively. The length of hospital stay, postoperative tramadol injection volume, incidence of complications, degree of knee joint swelling and range of motion, visual analogue scale (VAS) score, International Knee Documentation Committee (IKDC) score, Lyshlom score, and Hospital for Special Surgery (HSS) score were recorded and compared between groups. The T2 * values in different cartilage regions were detected by MRI examination and the levels of TNF-α, IL-6, IL-1, MMP-3, MMP-13, and ACAN in synovial fluid were detected by ELISA method. Results: The patients in group A, B, and C were followed up (12.53±3.24), (13.14±2.87), and (12.82±3.32) months, respectively. All incisions healed by first intention. Compared with group C, group A and group B had shorter length of hospital stay, less tramadol injection volume, and lower incidence of complications, showing significant differences ( P<0.05); there was no significant difference between group A and group B ( P>0.05). The degree of knee swelling in group A was significantly less than that in group B and group C ( P<0.05), but there was no significant difference between group B and group C ( P>0.05). At 3, 6, 12, 24, and 48 hours after operation, VAS scores of group A and group B were significantly lower than those of group C ( P<0.05); at 72 hours after operation, there was no significant difference among the three groups ( P>0.05). At 3 days, 14 days, and 1 month after operation, the range of motion of knee joint in group A were significantly better than those in group C ( P<0.05), and there was no significant difference between the other groups ( P>0.05). At 1 month after operation, the IKDC score of group A and group B was significantly higher than that of group C ( P<0.05); there was no significant difference among the three groups at other time points ( P>0.05). There was no significant difference in Lyshlom score and HSS score among the three groups at each time point ( P>0.05). At 14 days after operation, the levels of IL-1 and IL-6 in the synovial fluid in groups A and B were significantly lower than those in group C ( P<0.05). There was no significant difference in the levels of TNF-α, MMP-3, MMP-13, and ACAN between groups A and B ( P>0.05). At 1 month after operation, there was no significant difference in the above indicators among the three groups ( P>0.05). At 3, 6, and 12 months after operation, there was no significant difference in the T2 * values of different cartilage regions among the three groups ( P>0.05). Conclusion: Injecting MDC (ropivacaine, tranexamic acid, betamethasone) into the joint and tendon site during ACLR can achieve good early effectiveness without significant impact on cartilage.
Asunto(s)
Reconstrucción del Ligamento Cruzado Anterior , Betametasona , Ropivacaína , Humanos , Reconstrucción del Ligamento Cruzado Anterior/métodos , Ropivacaína/administración & dosificación , Masculino , Betametasona/administración & dosificación , Femenino , Adulto , Metaloproteinasa 3 de la Matriz/metabolismo , Anestésicos Locales/administración & dosificación , Artroscopía , Lesiones del Ligamento Cruzado Anterior/cirugía , Agrecanos/metabolismo , Metaloproteinasa 13 de la Matriz/metabolismo , Ligamento Cruzado Anterior/cirugía , Resultado del Tratamiento , Tendones/trasplante , Cartílago/metabolismo , Factor de Necrosis Tumoral alfa/metabolismoRESUMEN
OBJECTIVE: This retrospective study aims to compare the efficacy rates in treating hypertrophic scars among four distinct groups of patients who either underwent fractional Erbium: yttrium-aluminum-garnet (Er:YAG) laser or microplasma radiofrequency technology as standalone treatments or in combination with compound betamethasone transdermal administration. METHOD: The study retrospectively examined 208 patients treated at our institution from April 2011 to December 2022 for hypertrophic scars, receiving no less than three treatments (with an interval of 8 weeks between each). The patients were categorized into four groups: the F group (treated with fractional Er:YAG laser), the F + B group (treated with fractional Er:YAG laser combined with compound betamethasone transdermal administration), the P group (treated with microplasma radiofrequency technology), and the P + B group (treated with microplasma radiofrequency technology combined with compound betamethasone transdermal administration). The therapeutic effects were evaluated based on the changes in the Vancouver Scar Scale (VSS) scores before and after treatment in these groups. RESULTS: There was no statistically significant difference in the VSS scores among the four groups before treatment. After undergoing three sessions of the aforementioned four types of treatment, all groups showed a decrease in VSS scores, with average posttreatment VSS scores for the F group scored 5.15 ± 2.084, F + B group scored 3.7 ± 1.781, P group scored 4.41 ± 1.933, and P + B group scored 3.16 ± 1.775, respectively. With an increasing number of treatments, the total effective rate gradually increased in all four groups, and the combination treatment using compound betamethasone transdermal administration proved more effective than the standalone treatment. CONCLUSION: All four treatments yielded favorable outcomes, with the combined therapy involving compound betamethasone transdermal administration proving more effective than the standalone treatments, meriting further clinical attention.