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1.
Allergol Immunopathol (Madr) ; 52(5): 80-84, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39278855

RESUMEN

BACKGROUND: Ragweed (Ambrosia elatior) has become invasive in Europe, causing significant respiratory issues. Subcutaneous allergen immunotherapy (SCIT) has long been used to manage pollen allergies, but sublingual immunotherapy (SLIT) has gained interest. OBJECTIVE: This study aimed to evaluate the clinical benefits of ragweed SLIT under real-world in a cohort of Hungarian patients allergic to ragweed pollen. METHODS: We retrospectively reviewed the clinical records of 57 patients during the 2015 and 2016 ragweed pollen seasons. Patients were divided into two groups: Group 1 (n = 29), who had not received immunotherapy, and Group 2 (n = 28), who had previously undergone immunotherapy with another sublingual preparation. All patients were treated with Oraltek® ragweed for 4-6 months, initiating 2-4 months before the pollen season and rest of the period was 2 months of the 2016 pollen season. Symptom score (SS), medication score (MS), and combined symptom and medication score (CSMS) were evaluated intra- and intergroup. RESULTS: Pollen counts were consistent between 2015 and 2016. All patients showed significant improvement in SS, MS, and CSMS, with a large effect size (>0.8). Group 2 had significantly lower SS and CSMS in 2015 because of prior immunotherapy. By 2016, both groups exhibited marked improvements, with Group 1 showing a 75% improvement in CSMS. No local or systemic reactions were recorded, indicating a high safety profile. CONCLUSIONS: Ragweed SLIT significantly improved symptoms and reduced use of medication in patients allergic to ragweed pollen. The treatment was effective even in patients with previous immunotherapy, with a high benefit-risk ratio demonstrated by the absence of adverse reactions. These findings support the use of Oraltek SLIT for managing ragweed pollen allergy.


Asunto(s)
Alérgenos , Ambrosia , Antígenos de Plantas , Rinitis Alérgica Estacional , Inmunoterapia Sublingual , Humanos , Inmunoterapia Sublingual/métodos , Masculino , Femenino , Estudios Retrospectivos , Rinitis Alérgica Estacional/terapia , Rinitis Alérgica Estacional/inmunología , Adulto , Ambrosia/inmunología , Alérgenos/inmunología , Alérgenos/administración & dosificación , Hungría , Antígenos de Plantas/inmunología , Antígenos de Plantas/administración & dosificación , Persona de Mediana Edad , Adulto Joven , Extractos Vegetales/administración & dosificación , Resultado del Tratamiento , Adolescente , Polen/inmunología
2.
Ophthalmol Ther ; 13(10): 2661-2677, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-39133376

RESUMEN

INTRODUCTION: The purpose of this study is to assess the real-life efficacy and tolerance of a new preservative-free, surfactant-free latanoprost (PFSF-LAT) formulation. METHODS: Retrospective, multicentre, non-comparative, observational study in patients with ocular hypertension or open angle glaucoma, naïve or non-naïve to previous intraocular pressure (IOP)-lowering treatment, and treated for at least 3 months with the study eye drop. IOP for worse eye, ocular signs and symptoms, and concomitant use of artificial tears were collected at study drug initiation and at last visit under treatment. Reasons for discontinuing the study eye drop (if relevant) and investigators' satisfaction were also assessed. RESULTS: In the per protocol population (103 eyes; 63 naïve, 39 switched, 1 not classified because of missing data), IOP decreased significantly (p < 0.001) from 21.6 ± 5.0 mmHg at baseline to 16.1 ± 3.5 mmHg at the end of the study (mean reduction of - 5.5 ± 4.6 mmHg; - 25.5%). IOP in naïve patients was significantly improved, with a mean reduction of 7.1 mmHg (- 30.7%), which was within expected latanoprost IOP-lowering effect. Interestingly, in previously treated patients, switching to PFSF-LAT also allowed for a further 2.9 mmHg decrease in IOP (p < 0.001). The incidence of ocular side effects at study initiation was significantly (p < 0.001) reduced from 31.1% to 11.3% in the overall population, and from 65.0% to 7.5% in switched patients. This included conjunctival hyperaemia and superficial punctate keratitis (from 42.5% to 2.5% and from 37.5% to 2.5% in switched patients, respectively). According to investigators, tolerance and efficacy of the study eye drop were satisfactory or very satisfactory in 98.1% and 83.2% of patients, respectively. CONCLUSION: PFSF-LAT is an efficient treatment for patients with glaucoma with an improved tolerance profile. It can be considered as initial therapy in naïve patients or in patients with poor ocular tolerance to previous IOP-lowering eye drops.

3.
J Alzheimers Dis ; 100(3): 987-998, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38968046

RESUMEN

Background: Previous studies have shown a possible association between statin use and a decreased risk of dementia, but the association has not been sufficiently established, especially in the super-aging society of Japan. Objective: This study aimed to determine the association between statin use and the risk of dementia among Japanese participants aged> =65 years old. Methods: Data from the Longevity Improvement and Fair Evidence (LIFE) Study were utilized, including medical and long-term care (LTC) claim data from 17 municipalities between April 2014 and December 2020. A nested case-control study was conducted with one case matched to five controls based on age, sex, municipality, and year of cohort entry. We used a conditional logistic regression model to calculate the odds ratios (ORs) and 95% confidence intervals (95% CIs). Results: This study included 57,302 cases and 283,525 controls, with 59.7% of the participants being woman. After adjusting for potential confounders, statin use was associated with a lower risk of dementia (OR, 0.70; 95% CI: 0.68-0.73) and Alzheimer's disease (OR: 0.66; 95% CI: 0.63-0.69). Compared with non-users, the ORs of dementia were as follows: 1.42 (1.34-1.50) for 1-30 total standardized daily dose (TSDD), 0.91 (0.85-0.98) for 31-90 TSDD, 0.63 (0.58-0.69) for 91-180 TSDD, and 0.33 (0.31-0.36) for >180 TSDD in dose-analysis. Conclusions: Statin use is associated with a reduced risk of dementia and Alzheimer's disease among older Japanese adults. A low cumulative statin dose is associated with an increased risk of dementia, whereas a high cumulative statin dose is a protective factor against dementia.


Asunto(s)
Demencia , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Femenino , Masculino , Japón/epidemiología , Anciano , Estudios de Casos y Controles , Demencia/epidemiología , Demencia/prevención & control , Anciano de 80 o más Años , Factores de Riesgo
4.
Brain Behav ; 14(7): e3631, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-39034358

RESUMEN

OBJECTIVES: The objectives of this real-life study were to analyze the reversion of chronic migraine (CM) to episodic migraine (EM) with fremanezumab, evaluate its benefit on the symptomatology, and determine the influence of possible clinical features on the reversion. BACKGROUND: The clinical manifestations of CM have a high impact on the quality of life of patients, and monoclonal antibodies such as fremanezumab are used as prophylactic treatment. METHODS: Diagnosed CM patients treated for at least 3 months with monthly fremanezumab were interviewed. The data to assess efficacy were before treatment and at the time of the interview: monthly headache days (MHDs), daily headache hours (DHHs), monthly symptomatic medication days (MSMDs), percentage of patients with symptomatic medication overuse (SMO), and pain intensity with the numerical rating scale (NRS) score. Possible predictors of reversion were analyzed: percentage of patients treated for at least 12 months, hypertension, diabetes mellitus, depression, anxiety, symptomatic control with non-steroidal anti-inflammatory drugs (NSAIDs), triptans or both, and amitriptyline prophylaxis. RESULTS: A total of 54 patients were included, of whom 40 (74.1%) were converters to EM. There were significant improvements in converters compared to pre-treatment in MHDs (28.0 vs. 5.0 days), as well as on the variables DHHs, MSMDs, and SMO. The percentage of erenumab failures was significantly higher in non-converters than in converters, as was the percentage of patients with anxiety. CONCLUSIONS: High reversion from CM to EM was achieved with fremanezumab and notable symptomatological improvement, establishing previous failure to erenumab and anxiety as possible detrimental factors for reversion.


Asunto(s)
Trastornos Migrañosos , Humanos , Trastornos Migrañosos/tratamiento farmacológico , Femenino , Masculino , Adulto , Persona de Mediana Edad , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales/farmacología , Toxinas Botulínicas Tipo A/administración & dosificación , Toxinas Botulínicas Tipo A/farmacología , Enfermedad Crónica , Resultado del Tratamiento , Resistencia a Medicamentos , Calidad de Vida
5.
Pediatr Pulmonol ; 2024 Jun 27.
Artículo en Inglés | MEDLINE | ID: mdl-38934778

RESUMEN

BACKGROUND & OBJECTIVES: Despite the availability of biologics for severe pediatric asthma, real-life studies reporting on drivers behind initiating biologics and their alignment with the Global Initiative for Asthma (GINA) recommendations are lacking. METHODS: We performed analysis within the pediatric asthma noninvasive diagnostic approaches study, a prospective cohort of 6- to 17-year-old children with severe asthma. Information was collected on demographic factors, symptom control, treatment, comorbidities, and diagnostic tests from medical records and questionnaires. We divided patients into "starters" or "nonstarters" based on the clinical decision to initiate biologics and performed multivariate logistic regression analysis to identify drivers behind initiating therapy. Additionally, we assessed patient suitability for biologics according to key factors in the GINA recommendations: Type 2 inflammation, frequency of exacerbations, and optimization of treatment adherence. RESULTS: In total, 72 children (mean age 11.5 ± 3.0 years, 65.3% male) were included (13 starters). Initiation of biologics was associated with a higher GINA treatment step (adjusted odds ratio's [aOR] = 5.0, 95%CI 1.33-18.76), steroid toxicity (aOR = 21.1, 95%CI 3.73-119.91), frequency of exacerbations (aOR = 1.6, 95%CI 1.10-2.39), improved therapy adherence (aOR = 1.7, 95%CI 1.10-2.46), Caucasian ethnicity (aOR = 0.20, 95%CI 0.05-0.80), ≥1 allergic sensitization (aOR = 0.06, 95%CI 0.004-0.97), and allergic rhinitis (aOR = 0.13, 95%CI 0.03-0.65). Furthermore, steroid toxicity was identified as an important factor for deviation from the current recommendations on biologic prescription. CONCLUSIONS: We identified multiple drivers and inhibitors for initiating biologics, and showed the clinical need for biologics in severe pediatric asthmatics suffering from steroid toxicity. These findings may help refine asthma management guidelines.

6.
J Environ Manage ; 360: 121047, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38761616

RESUMEN

Green roofs are well studied for the environmental, social, and economic services these provide. As a result, green roofs are widespread and within the common vernacular of city residents. Green roof bylaws and construction standards are present in many cities in North America, rooting the presence of this green infrastructure within urban landscapes. Although examples of green roofs constructed decades ago exist, rarely are green roofs monitored over such long periods, and in ways that allow for experimentation, analysis, and conclusions about performance or function. In this study we present findings on plant cover and biomass from a green roof testing facility in Toronto, Canada that was monitored for over a decade. We examine the contributions of growing media, planting, and irrigation in the first seven years (2011-2021) of the eleven-year monitoring period. We found that during this maintenance phase period (2011-2017), plant cover and biomass was highest in modules planted with Sedum, included organic media, and were irrigated, whereas non-irrigated modules planted with forbs and grasses had the poorest performance regardless of media type. Following the stoppage of irrigation, and the post maintenance phase (2017-2021), modules initially planted with Sedum continued to sustain cover and biomass whereas planted forbs and grasses mostly disappeared, and these treatments were overtaken by Sedum. Our findings demonstrate that with irrigation, plantings of forbs and grasses can sustain plant cover and biomass. However, Sedum buffers against major changes to environmental conditions or abrupt changes to maintenance, adding insurance against failure of extensive green roofs.


Asunto(s)
Biomasa , Conservación de los Recursos Naturales , Conservación de los Recursos Naturales/métodos , Canadá , Ciudades , Plantas
7.
Expert Opin Drug Saf ; : 1-5, 2024 May 08.
Artículo en Inglés | MEDLINE | ID: mdl-38717372

RESUMEN

BACKGROUND: Alopecia areata (AA) is a non-scarring disorder characterized by hair loss that greatly affects patients' quality of life and has a chronic, recurring course. This disease is marked by an inflammatory process, mainly on an autoimmune basis primarily regulated by Janus kinase (JAK). RESEARCH DESIGN AND METHODS: We conducted a retrospective study evaluating the safety of JAKi in a real-world setting in 91 AA patients, with a specific focus on the assessment of infectious events. RESULTS: Overall, 34 infectious events were observed in 28 patients (30.8%), among them 17 patients (60.7%) suspended treatment with JAKi until the infection was clinically resolved. Only in one case the infectious event led to a permanent discontinuation of the treatment. The data we observed in the study are consistent with results reported in clinical trials. CONCLUSION: It can be stated that, during treatment with JAKi in AA patients, infectious events may occur, but in most cases these events are easily manageable and do not result in permanent discontinuation of the drug.

8.
Foods ; 13(9)2024 May 03.
Artículo en Inglés | MEDLINE | ID: mdl-38731781

RESUMEN

This study focused on the osmotic dehydration (OD) of ready-to-eat spinach leaves combined with the pulsed electric field (PEF) pre-treatment. Untreated and PEF-treated (0.6 kV/cm, 0-200 pulses) spinach leaves were osmotically dehydrated at room temperature for up to 120 min. The application of PEF (0.6 kV/20 pulses) prior to OD (60% glycerol, 25 °C, 60 min) lowered water activity (aw = 0.891) while achieving satisfactory product acceptability (total sensory hedonic scoring of 8). During the storage of the product (at 4, 8, 12, and 20 °C for up to 30 d), a significant reduction in total microbial count evolution was observed (9.7 logCFU/g for the untreated samples vs. 5.1 logCFU/g for the PEF-OD-treated samples after 13 d of storage at 4 °C). The selection of these PEF and OD treatment conditions enabled the extension of the product shelf life by up to 33 d under chilled storage. Osmotically treated spinach could find application in ready-to-eat salad products with an extended shelf life, which is currently not possible due to the high perishability of the specific plant tissue.

9.
Cardiovasc Diabetol ; 23(1): 4, 2024 01 03.
Artículo en Inglés | MEDLINE | ID: mdl-38172901

RESUMEN

BACKGROUND: The diabetogenic effect of statins has been well established by clinical trials, Mendelian randomisation studies and meta-analyses. According to large clinical trials, PCSK9 inhibitors (PCSK9i) have no deleterious impact on glucose metabolism. However, few real-life studies have yet evaluated the long-term effects of these drugs on glucose homeostasis and their impact on new-onset diabetes (NODM). METHODS: We studied 218 patients treated with either alirocumab or evolocumab (70% with familial hypercholesterolemia) for at least three years (PCSK9iG). We studied the NODM rate in the nondiabetic group at baseline (168) and overall glucose metabolism control in the whole group. Incidental DM was compared with two groups. The first was a propensity score matching (PSM)-selected group (n = 168) from the database of patients attending the Reus lipid unit (Metbank, n = 745) who were not on PCSK9i (PSMG). The second was a subgroup with a similar age range (n = 563) of the Di@bet.es study (Spanish prospective study on diabetes development n = 5072) (D@G). The incidence was reported as the percentage of NODM cases per year. RESULTS: The fasting glucose (FG) level of the subjects with normoglycaemia at baseline increased from 91 (86-95.5) to 93 (87-101) mg/dL (p = 0.014). There were 14 NODM cases in the PCSK9i group (2.6%/y), all among people with prediabetes at baseline. The incidence of NODM in PSMG and D@G was 1.8%/y (p = 0.69 compared with the PCSK9iG). The incidence among the subjects with prediabetes was 5.1%/y in the PCSK9iG, 4.8%/y in the PSMG and 3.9%/y in the D@G (p = 0.922 and p = 0.682, respectively). In the multivariate analysis, only the FG level was associated with the development of NODM in the PCSK9iG (OR 1.1; 95% CI: 1.0-1.3; p = 0.027). Neither FG nor A1c levels changed significantly in patients with DM at baseline. CONCLUSION: A nonsignificant increase in NODM occurred in the PCSK9iG, particularly in patients with prediabetes, compared with the PSMG and D@G groups. Baseline FG levels were the main variable associated with the development of DM. In the subjects who had DM at baseline, glucose control did not change. The impact of PCSK9i on glucose metabolism should not be of concern when prescribing these therapies.


Asunto(s)
Diabetes Mellitus , Inhibidores de Hidroximetilglutaril-CoA Reductasas , Estado Prediabético , Humanos , Inhibidores de PCSK9 , Proproteína Convertasa 9 , Control Glucémico , Estudios Prospectivos , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/tratamiento farmacológico , Diabetes Mellitus/epidemiología , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Glucosa , Factores de Riesgo
10.
Oral Maxillofac Surg ; 28(1): 373-383, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-37099046

RESUMEN

PURPOSE: Adult idiopathic condylar resorption (AICR) mainly affects young women, but generally accepted diagnostic standards are lacking. Patients often need temporomandibular joint (TMJ) surgery, and often jaw anatomy is assessed by CT as well as MRI to observe both bone and soft tissue. This study aims to establish reference values for mandible dimensions in women from MRI only and correlate them to, e.g., laboratory parameters and lifestyle, to explore new putative parameters relevant in AICR. MRI-derived reference values could reduce preoperative effort by allowing physicians to rely on only the MRI without additional CT scan. METHODS: We analyzed MRI data from a previous study (LIFE-Adult-Study, Leipzig, Germany) of 158 female participants aged 15-40 years (as AICR typically affects young women). The MR images were segmented, and standardized measuring of the mandibles was established. We correlated morphological features of the mandible with a large variety of other parameters documented in the LIFE-Adult study. RESULTS: We established new reference values for mandible morphology in MRI, which are consistent with previous CT-based studies. Our results allow assessment of both mandible and soft tissue without radiation exposure. Correlations with BMI, lifestyle, or laboratory parameters could not be observed. Of note, correlation between SNB angle, a parameter often used for AICR assessment, and condylar volume, was also not observed, opening up the question if these parameters behave differently in AICR patients. CONCLUSION: These efforts constitute a first step towards establishing MRI as a viable method for condylar resorption assessment.


Asunto(s)
Mandíbula , Cóndilo Mandibular , Adulto , Humanos , Femenino , Cóndilo Mandibular/diagnóstico por imagen , Cóndilo Mandibular/cirugía , Valores de Referencia , Mandíbula/diagnóstico por imagen , Articulación Temporomandibular/cirugía , Imagen por Resonancia Magnética
11.
Turk J Ophthalmol ; 53(6): 356-368, 2023 Dec 21.
Artículo en Inglés | MEDLINE | ID: mdl-38126607

RESUMEN

Objectives: This study aimed to report the demographic and clinical characteristics of diabetic macular edema (DME) patients treated with intravitreal injection (IVI) of anti-vascular endothelial growth factors (anti-VEGF) and provide an overview of outcomes during routine clinical practice in Türkiye. Materials and Methods: This retrospective, real-world study included 1,372 eyes (854 patients) treated with a pro re nata protocol by 21 ophthalmologists from 8 tertiary clinics on the Asian side of the Marmara region of Türkiye (MARMASIA Study Group). Five cohort groups were established by collecting the patients' baseline and 3, 6, 12, 24, and 36-month follow-up data, where each subsequent cohort may include the previous. Changes in best-corrected visual acuity (BCVA, approximate ETDRS letters) and central macular thickness (CMT, µm), number of visits and IVI, and rates of anti-VEGF switch and intravitreal dexamethasone implant (IDI) combination were evaluated. Results: The 3, 6, 12, 24, and 36-month cohorts included 1372 (854), 1352 (838), 1185 (722), 972 (581), and 623 (361) eyes (patients), respectively. The mean baseline BCVA and CMT were 51.4±21.4 letters and 482.6±180.3 µm. The mean changes from baseline in BCVA were +7.6, +9.1, +8.0, +8.6, and +8.4 letters, and in CMT were -115.4, -140.0, -147.9, -167.3, and -215.4 µm at the 3, 6, 12, 24, and 36-month visits (p<0.001 for all). The median cumulative number of anti-VEGF IVI was 3.0, 3.0, 5.0, 7.0, and 9.0, respectively. The overall anti-VEGF switch and IDI combination rates were 18.5% (253/1372 eyes) and 35.0% (480/1372 eyes), respectively. Conclusion: This largest real-life study of DME from Türkiye demonstrated BCVA gains inferior to randomized controlled trials, mainly due to the lower number of IVI. However, with the lower baseline BCVA and higher IDI combination rates in our cohorts, these gains were relatively superior to other real-life study counterparts.


Asunto(s)
Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Humanos , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Retinopatía Diabética/complicaciones , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/tratamiento farmacológico , Factores de Crecimiento Endotelial/uso terapéutico , Dexametasona , Estudios Retrospectivos , Turquía , Diabetes Mellitus/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto
12.
J Allergy Clin Immunol Pract ; 11(12): 3752-3762.e2, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37652349

RESUMEN

BACKGROUND: Omalizumab (OMA) dramatically improves disease control and quality of life in patients with chronic urticaria (CU). OBJECTIVE: We aimed to evaluate the discontinuation patterns of OMA and their determinants in a cohort of French patients with CU. METHODS: We conducted a retrospective multicenter study in 9 French tertiary referral hospitals. All patients diagnosed with either spontaneous (CSU) and/or inducible (CIndU) CU who received at least 1 injection of OMA between 2009 and 2021 were included. We analyzed OMA drug survival and investigated possible determinants using Kaplan-Meier curves and log-rank tests. RESULTS: A total of 878 patients were included in this study; 48.8% had CSU, 10.1% CIndU, and 41.1% a combination of both. OMA was discontinued in 408 patients, but the drug was later reintroduced in 50% of them. The main reason for discontinuing treatment was the achievement of a well-controlled disease in 50% of patients. Half of the patients were still being treated with OMA 2.4 years after the initiation of treatment. Drug survival was shorter in patients with CIndU and in those with an autoimmune background. In atopic patients, OMA was discontinued earlier in patients achieving a well-controlled disease. A longer OMA drug survival was observed in patients with a longer disease duration at initiation. CONCLUSION: In French patients with CU, the drug survival of OMA appears to be longer than that observed in previous studies conducted elsewhere, highlighting discrepancies in prescription and reimbursement possibilities. Further studies are warranted to develop customized OMA treatment schemes based on individual patterns.


Asunto(s)
Antialérgicos , Urticaria Crónica , Urticaria , Humanos , Omalizumab/uso terapéutico , Antialérgicos/uso terapéutico , Urticaria/tratamiento farmacológico , Urticaria/inducido químicamente , Estudios Retrospectivos , Calidad de Vida , Enfermedad Crónica , Urticaria Crónica/tratamiento farmacológico , Urticaria Crónica Inducible , Resultado del Tratamiento
13.
J Pers Med ; 13(7)2023 Jun 29.
Artículo en Inglés | MEDLINE | ID: mdl-37511681

RESUMEN

Background: Insufficient data are available on the long-term "real-life" safety profile of omalizumab in children. This study evaluated the long-term safety of omalizumab in a pediatric cohort with severe asthma or chronic spontaneous urticaria (CSU). Methods: A monocentric, prospective study evaluated the long-term safety of omalizumab in patients aged 6-18 years. Each patient completed the standardized MedDRA questionnaire to identify adverse events (AEs). Results: In total, 23 patients, median age 15 (14-18) years, affected by severe asthma (60.8%) or CSU (39.2%), treated with omalizumab for 2 (1-4) years were enrolled. The most common AEs belong to the system organ class (SOC) of general disorders and administration-site conditions (37.17%). Skin and subcutaneous tissue problems represent the second most frequently reported AEs (24.35%). Central nervous system and musculoskeletal disorders were quite frequent (15.38% and 8.97%, respectively). Other adverse events were tachycardia (5.12%), vertigo and abdominal pain (2.60% and 3.86%, respectively), and dry eye (1.3%). Only one patient reported herpes virus infection during treatment (1.3%). No cases of anaphylaxis, hemopathies, uronephropathies, respiratory, psychiatric, hepatobiliary, or oncological pathologies were reported. Conclusions: Long-term "real-life" treatment with omalizumab in children appears well tolerated. Its safety and efficacy profile makes omalizumab an excellent alternative in severe asthma and CSU in children.

14.
Viruses ; 15(4)2023 04 11.
Artículo en Inglés | MEDLINE | ID: mdl-37112927

RESUMEN

In this retrospective comparative study, we evaluated the effectiveness of remdesivir (RDSV) in patients with SARS-CoV-2 pneumonia. Individuals hospitalized between March 2020 and August 2022 at S.M. Goretti Hospital, Latina, with a positive test for SARS-CoV-2 and, concomitantly, pneumonia, were included. The overall survival was the primary endpoint. The composite secondary endpoint included death or progression in severe ARDS at 40 days. The study population was stratified according to treatment into two groups: the RDSV group (patients treated with RDSV-based regimens) and the no-RDSV group (patients treated with any other, not RDSV-based, regimens). Factors associated with death and progression to severe ARDS or death were assessed by multivariable analysis. A total of 1153 patients (632 belonging to the RDSV group and 521 to the no-RDSV group) were studied. The groups were comparable in terms of sex, PaO2/FiO2 at admission, and duration of symptoms before hospitalization. Further, 54 patients (8.5%) in the RDSV group and 113 (21.7%) in the no-RDSV group (p < 0.001) died. RDSV was associated with a significantly reduced hazard ratio (HR) of death (HR, 0.69 [95% CI, 0.49-0.97]; p = 0.03), compared to the no-RDSV group, as well as a significantly reduced OR of progression in severe ARDS or death (OR, 0.70 [95% CI 0.49-0.98]; p = 0.04). An overall significantly higher survival rate was observed in the RDSV group (p < 0.001, by log-rank test). These findings reinforce the survival benefit of RDSV and support its routine clinical use for the treatment of COVID-19 patients.


Asunto(s)
COVID-19 , Síndrome de Dificultad Respiratoria , Humanos , SARS-CoV-2 , Estudios Retrospectivos , Tratamiento Farmacológico de COVID-19 , Síndrome de Dificultad Respiratoria/tratamiento farmacológico , Antivirales/uso terapéutico
15.
Eur J Cancer ; 187: 25-35, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37099946

RESUMEN

BACKGROUND: Immunotherapy has improved the survival of patients with stage IV melanoma. In responders, clinical benefits may be long-lasting and persist even after treatment discontinuation. The optimal duration of anti-PD1 (anti-Programmed cell death-1) therapy in metastatic melanoma patients remains to be elucidated. Moreover, limited data are available on clinical outcomes of patients that discontinued anti-PD1 immunotherapy in a real-life setting. The aim of this study was to evaluate the progression-free survival (PFS) in patients with metastatic melanoma who interrupted anti-PD-1 treatment in the in the absence of disease progression. METHODS: We retrospectively reviewed patients with advanced/metastatic melanoma treated with anti-PD1 immunotherapy at 23 Italian Melanoma Intergroup (IMI) centres. The study investigated the risk of relapse in patients who stopped anti-PD1 therapy due to CR (Complete response), treatment-related toxicity, or by their own choice after a long period of treatment. Clinical and biological factors associated with or without recurrence were evaluated. RESULTS: The study population included 237 patients. The median age of patients was 68.9 years (standard deviation: 13; range 33-95). The median time on treatment was 33 months (standard deviation: 18, 7; range 1-98). Among the 237 patients, 128 (54%) interrupted the anti-PD1 for CR, 74 patients (31.2%) for adverse events (37 patients in CR, 27 patients in partial response (PR), ten patients in stable disease (SD), and 35 patients (14.8%) by their own choice (12 patients in CR, 17 patients in PR, and 6 patients in SD). After a mean follow-up of 21 months (range 1-81), PFS after anti-PD1 discontinuation was 85.7%. Thirty-four patients (14.3%) developed disease progression after a median of 12 months (range 1-35): ten patients (29.4%) after discontinuation in CR, 17 patients (50%) after discontinuation for treatment-related toxicity (seven in CR, five in PR, five in SD), and seven (20.6%) after discontinuation due to the patient's decision (two in CR, four in PR, one in SD). Only 7.8% of patients who interrupted in CR (10/128), along with 23% of patients who interrupted for limiting toxicity (17/74) and 20% of patients who interrupted by their own choice (7/35), developed recurrence. Regarding patients who discontinued therapy because of CR, we observed a negative association between recurrence and site of primary melanoma, especially mucosal sites (p = <0.05, HR (Hazard ratio) 15.57 IC (confidence interval) 95% 2.64-91.73). Moreover, M1b patients who achieved a CR showed a lower number of relapses (p = <0.05, HR 3.84 IC 95% 1.40-8.48). CONCLUSIONS: This study shows in a real-life setting that, with anti-PD-1 therapy, long-lasting responses, can be maintained after anti-PD1 interruption. In 70.6% of cases, recurrences were observed among patients who did not obtain a CR at treatment discontinuation.


Asunto(s)
Melanoma , Recurrencia Local de Neoplasia , Humanos , Anciano , Estudios Retrospectivos , Melanoma/patología , Progresión de la Enfermedad , Supervivencia sin Progresión , Síndrome
16.
Adv Ther ; 40(5): 2509-2514, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36944819

RESUMEN

INTRODUCTION: The efficacy and safety of upadacitinib in atopic dermatitis have been defined in clinical trials, but long-term real-life experience, essential for clinical decision-making, is still limited. We aimed to assess the effectiveness and tolerance of upadacitinib in a real-life cohort of adults and adolescents with severe atopic dermatitis in whom previous systemic therapies largely failed. METHODS: Retrospective cohort study collecting data from adults and adolescents treated with upadacitinib 15 or 30 mg per day between July 2021 to August 2022. The outcomes for effectiveness were evaluated by the percentage of patients who achieved a validated Investigator's Global Assessment for atopic dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and/or an improvement of at least 75% on the Eczema Area and Severity Index (EASI 75) at the end of the follow-up. All treatment-emergent adverse events were collected. RESULTS: A total of 29 patients were included (22 adults and 7 adolescents), with a median follow-up of 54.4 weeks. At the end of the follow-up, 23 patients (79.3%) reached a vIGA-AD of 0/1, and 24 patients (82.7%) achieved EASI 75. Among patients treated with upadacitinib after initial failure of first- and/or second-line treatment with biologics or baricitinib, 5/7 patients (71.4%) reached a vIGA-AD score of 0/1. Disease control was slightly better in adults than in adolescents (81.8% vs 71.4% reached the efficacy endpoint, respectively). Response rate in patients with upadacitinib 15 mg seemed better than in clinical trials or network meta-analysis. Safety data were reassuring; lipid changes were the most frequent adverse event. CONCLUSION: This real-life study confirms the effectiveness of upadacitinib, particularly for the treatment of atopic dermatitis recalcitrant to conventional systemic agents, biologics or baricitinib. Induced lipid changes require close follow-up.


Asunto(s)
Dermatitis Atópica , Humanos , Adulto , Adolescente , Dermatitis Atópica/tratamiento farmacológico , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Método Doble Ciego , Lípidos/uso terapéutico , Resultado del Tratamiento
17.
Am J Infect Control ; 51(9): 999-1003, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-36905985

RESUMEN

BACKGROUND: Blood culture contamination is associated with health care costs and potential patient harm. Diversion of the initial blood specimen reduces blood culture contamination. We report results of the "real-life" clinical implementation of this technique. METHODS: Following an educational campaign, use of a dedicated diversion tube was recommended prior to all blood cultures. Blood culture sets taken from adults using a diversion tube were defined as "diversion sets," those without, "non-diversion" sets. Blood culture contamination and true positive rates were compared for diversion and nondiversion sets and to nondiversion historical controls. A secondary analysis investigated efficacy of diversion by patient age. RESULTS: Out of 20,107 blood culture sets drawn, the diversion group included 12,774 (60.5%) and the nondiversion group 8,333 (39.5%) sets. The historical control group included 32,472 sets. Comparing nondiversion to diversion, contamination decreased by 31% (5.5% [461/8333] to 3.8% [489/12744], P < .0001]. Contamination was also 12% lower in diversion than historical controls [3.8% (489/12744) vs 4.3% (1,396/33,174) P = .02)]. The rate of true bacteremia was similar. In older patients, contamination rate was higher, and the relative reduction associated with diversion decreased (54.3% amongst 20-40-year-olds vs 14.5% amongst >80-year-olds). CONCLUSIONS: Use of a diversion tube in the ED reduced blood culture contamination in this large real life observational study. Efficacy decreased with increasing age, which requires further investigation.


Asunto(s)
Bacteriemia , Recolección de Muestras de Sangre , Adulto , Humanos , Anciano , Cultivo de Sangre/métodos , Mejoramiento de la Calidad , Bacteriemia/prevención & control , Costos de la Atención en Salud , Contaminación de Equipos
18.
Pharmaceuticals (Basel) ; 16(3)2023 Mar 08.
Artículo en Inglés | MEDLINE | ID: mdl-36986509

RESUMEN

Cystic fibrosis (CF) is a potentially fatal monogenic disease that causes a progressive multisystemic pathology. Over the last decade, the introduction of CF transmembrane conductance regulator (CFTR) modulator drugs into clinical practice has profoundly modified the lives of many people with CF (PwCF) by targeting the fundamental cause of the disease. These drugs consist of the potentiator ivacaftor (VX-770) and the correctors lumacaftor (VX-809), tezacaftor (VX-661), and elexacaftor (VX-445). In particular, the triple combination of CFTR modulators composed of elexacaftor, tezacaftor, and ivacaftor (ETI) represents a life-changing therapy for the majority of PwCF worldwide. A growing number of clinical studies have demonstrated the safety and efficacy of ETI therapy in both short- and long-term (up to two years of follow-up to date) and its ability to significantly reduce pulmonary and gastrointestinal manifestations, sweat chloride concentration, exocrine pancreatic dysfunction, and infertility/subfertility, among other disease signs and symptoms. Nevertheless, ETI therapy-related adverse effects have also been reported, and close monitoring by a multidisciplinary healthcare team remains vital. This review aims to address and discuss the major therapeutic benefits and adverse effects reported by the clinical use of ETI therapy for PwCF.

19.
J Cosmet Dermatol ; 22(8): 2259-2267, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-36973603

RESUMEN

BACKGROUND: Dermocosmetic products are often used to maintain or enhance the tolerance and effectiveness of medical anti-acne therapies. Recent discoveries about the pathophysiology of acne-prone skin indicate that skincare products may help maintain homeostasis around the sebaceous gland progenitor cells, thereby preventing microcomedone formation. AIMS: To evaluate the tolerance and effectiveness of a dermocosmetic product containing Silybum marianum fruit extract (SMFE) in adolescents and young adults with acne-prone skin. PATIENTS/METHODS: This real-life, international, observational, multicenter study was conducted in patients aged 12-25 years with mild-to-moderate acne. Patients (N = 4230) used the product twice daily for 8-12 weeks, either alone before ("initial group") or after an anti-acne therapy ("maintenance group"), or in association with their usual prescribed anti-acne therapies ("association group"). The tolerance, effectiveness, and cosmetic properties of the product were assessed. Patient quality of life (QoL) was also evaluated. RESULTS: Dermatologists rated the tolerance of the product as "good" or "very good" in about 95% of the patients and the effectiveness of the product as "effective" or "highly effective" in about 80% of the patients, with a significant reduction in the mean global evaluation of acne (GEA) grade (-36% ± 39%, p < 0.0001) at study end. The QoL of most patients (80%) improved by the end of the study, and the majority (79% to 94%) appreciated the cosmetic properties of the product. Overall, the product was a clinical success in >84% of patients. CONCLUSIONS: This dermocosmetic product can be used by adolescents and young adults with acne-prone skin to limit the initial or chronic use of medical anti-acne therapies.


Asunto(s)
Acné Vulgar , Cosméticos , Humanos , Adulto Joven , Adolescente , Calidad de Vida , Estudios Longitudinales , Silybum marianum , Frutas , Acné Vulgar/tratamiento farmacológico , Cosméticos/uso terapéutico , Resultado del Tratamiento
20.
Adv Life Course Res ; 55: 100525, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36942643

RESUMEN

OBJECTIVE: Following a life course perspective, this study examines the link between partnership trajectories and three dimensions of psychological well-being: psychological health, overall sense of self-worth and quality of life. BACKGROUND: Assuming that life outcomes are the result of prior decisions, experiences and events, partnership histories can be seen as a resource for psychological well-being. Furthermore, advantages or disadvantages from living with or without a partner should accumulate over time. While previous cross-sectional research has mainly focused on the influence of partnership status or a status change on well-being, prior longitudinal studies could not control for reverse causality of well-being and partnership trajectories. This research addresses the question of how different patterns of partnership biographies are related to a person's well-being in middle adulthood. Selection effects of pre-trajectory well-being as well as current life conditions are also taken into account. METHOD: Using data from the German LifE Study, the partnership trajectories between ages of 16 and 45 are classified by sequence and cluster analysis. OLS regression is then used to examine the link between types of partnership trajectories and depression, self-esteem and overall life satisfaction at age 45. RESULTS: For women, well-being declined when experiencing unstable non-cohabitational union trajectories or divorce followed by unpartnered post-marital trajectories. Men suffered most from being long-term single. The results could not be explained by selection effects of pre-trajectory well-being. CONCLUSION: While women seem to 'recover' from most of the negative effects of unstable partnership trajectories through a new partnership, for men it was shown that being mainly unpartnered has long-lasting effects on their psychological well-being.


Asunto(s)
Acontecimientos que Cambian la Vida , Calidad de Vida , Masculino , Humanos , Femenino , Adulto , Persona de Mediana Edad , Estudios Transversales , Matrimonio/psicología , Divorcio/psicología
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