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1.
Inorg Chem ; 58(17): 11599-11605, 2019 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-31424206

RESUMO

The phase separation observed at low temperature (below circa 600 K) in the U1-yCeyO2-x system and for values of y between roughly 0.34 and 0.5 purportedly involves fluorite structures only. However, for y values above 0.5, an oxygen-deficient C-type bixbyite is also reported. In this work, the phase separation in U0.54Ce0.46O2-x has been reexamined using X-ray and neutron diffraction. Below a critical temperature, the existence of two fluorite related structures in the miscibility gap is confirmed: a stoichiometric U0.54Ce0.46O2 phase and an oxygen-deficient U0.54Ce0.46O2-x phase. Although the former is indeed a fluorite, we show that the other end-member phase has a C-type bixbyite structure. This would suggest that the oxygen-deficient phase can be described as a bixbyite over the entire cerium composition range.

2.
Chemistry ; 24(9): 2085-2088, 2018 Feb 09.
Artigo em Inglês | MEDLINE | ID: mdl-29266495

RESUMO

A recent trend in the development of new optimized materials makes use of crystalline domains having nanometer sizes for which characterization methods at the atomic scale are mandatory. Amongst them is pair-distribution function analysis (PDF-analysis), a diffraction technique that has already shown that a short-range or "local" atomic structure of a given domain, having a lower symmetry than the average long-range structure, often exists in many compounds having valuable properties for industrial applications, such as pyrochlores, spinels, and doped ceria among others. However, the manner by which these domains are arranged to produce the average long-range structure is still an open question. Herein, the first structural model that accounts for both the local structure (inside a given domain) and the long-range structure (averaged over all domains) that is observed in the PDF of uranium dioxide is presented. The structural model describes domain walls in such a way as to preserve the uranium coordination polyhedron and to obey the needed symmetry rules. The proper description of domain walls is an important step in the understanding and the modelling of nanostructured materials.

3.
Inorg Chem ; 57(12): 7064-7076, 2018 Jun 18.
Artigo em Inglês | MEDLINE | ID: mdl-29862807

RESUMO

In hyper-stoichiometric uranium oxide, both neutron diffraction work and, more recently, theoretical analyses report the existence of clusters such as the 2:2:2 cluster, comprising two anion vacancies and two types of anion interstitials. However, little is known about whether there exists a region of low deviation-from-stoichiometry in which defects remain isolated, or indeed whether at high deviation-from-stoichiometry defect clusters prevail that contain more excess oxygen atoms than the di-interstitial cluster. In this study, we report pair distribution function (PDF) analyses of UO2 and UO2+ x ( x ≈ 0.007 and x ≈ 0.16) samples obtained from high-temperature in situ neutron scattering experiments. PDF refinement for the lower deviation from stoichiometry sample suggests the system is too dilute to differentiate between isolated defects and di-interstitial clusters. For the UO2.16 sample, several defect structures are tested, and it is found that the data are best represented assuming the presence of center-occupied cuboctahedra.

4.
Dermatol Surg ; 43(12): 1448-1457, 2017 12.
Artigo em Inglês | MEDLINE | ID: mdl-28595250

RESUMO

BACKGROUND: There are requirements for long-term, objective comparisons of hyaluronic acid (HA) dermal fillers. OBJECTIVE: To compare efficacy and tolerability of ART FILLER Universal (AFU) and ART FILLER Fine lines (AFFL) with the existing HA fillers for the treatment of nasolabial folds and crow's feet. MATERIALS AND METHODS: Prospective, randomized, rater- and patient-blind, split-face comparison of AFU with JUVEDERM Ultra 3 (JUV) and AFFL with FIRST LINES PureSense (FLPS). The severity of nasolabial folds and crow's feet was assessed by independent blinded evaluators using the Lemperle scale at baseline, day (D) 30/D45, D90, and D180. Tolerability, Global Aesthetic Improvement Scale (GAIS), wrinkle volumes, and skin thickness and density were also measured at D30/D45, D90, and D180. RESULTS: At D30 and D180 respectively, 61 and 57 patients were assessed. Scores for nasolabial folds and crow's feet showed statistically significant improvements at D30, D90, and D180. AFU and AFFL were noninferior to JUV and FLPS, respectively. Most patients showed GAIS improvements, maintained until at least D180 and significant increases of collagen synthesis in crow's feet and nasolabial folds. Treatments were well tolerated. CONCLUSION: AFU and AFFL are noninferior to comparators. The methodology used represents a novel approach to augment existing clinical assessment of HA fillers.


Assuntos
Preenchedores Dérmicos/administração & dosagem , Ácido Hialurônico/administração & dosagem , Envelhecimento da Pele , Adulto , Idoso , Técnicas Cosméticas , Preenchedores Dérmicos/uso terapêutico , Olho , Feminino , Humanos , Ácido Hialurônico/uso terapêutico , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Sulco Nasogeniano , Estudos Prospectivos , Método Simples-Cego , Pele
5.
BMJ Ment Health ; 27(1)2024 Apr 12.
Artigo em Inglês | MEDLINE | ID: mdl-38609318

RESUMO

BACKGROUND: Use of psychostimulants and relative drugs has increased worldwide in treatment of attention-deficit hyperactivity disorder (ADHD) in adolescents and adults. Recent studies suggest a potential association between use of psychostimulants and psychotic symptoms. The risk may not be the same between different psychostimulants. OBJECTIVE: To assess whether amphetamine or atomoxetine use is associated with a higher risk of reporting symptoms of psychosis than methylphenidate use in adolescents and adults, particularly in patients with ADHD. METHODS: Using VigiBase, the WHO's pharmacovigilance database, disproportionality of psychotic symptoms reporting was assessed among adverse drug reactions related to methylphenidate, atomoxetine and amphetamines, from January 2004 to December 2018, in patients aged 13-25 years. The association between psychotic symptoms and psychostimulants was estimated through the calculation of reporting OR (ROR). FINDINGS: Among 13 863 reports with at least one drug of interest, we found 221 cases of psychosis with methylphenidate use, 115 with atomoxetine use and 169 with a prescription of an amphetamine drug. Compared with methylphenidate use, amphetamine use was associated with an increased risk of reporting psychotic symptoms (ROR 1.61 (95% CI 1.26 to 2.06)]. When we restricted the analysis to ADHD indication, we found a close estimate (ROR 1.94 (95% CI 1.43 to 2.64)). No association was found for atomoxetine. CONCLUSION: Our study suggests that amphetamine use is associated with a higher reporting of psychotic symptoms, compared with methylphenidate use. CLINICAL IMPLICATIONS: The prescription of psychostimulants should consider this potential adverse effect when assessing the benefit-risk balance.


Assuntos
Estimulantes do Sistema Nervoso Central , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Metilfenidato , Transtornos Psicóticos , Adulto , Humanos , Adolescente , Anfetamina/efeitos adversos , Metilfenidato/efeitos adversos , Cloridrato de Atomoxetina/efeitos adversos , Estimulantes do Sistema Nervoso Central/efeitos adversos
6.
Psychopharmacology (Berl) ; 240(1): 199-202, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36515735

RESUMO

RATIONALE: While meta-analyses of clinical trials found that lurasidone and partial dopamine agonists (brexpiprazole and aripiprazole) were the antipsychotics less likely to cause QTc prolongation, and sertindole, amisulpride, and ziprasidone were the most frequently associated with this adverse drug reaction; no real-world studies have investigated this risk between the different antipsychotics. OBJECTIVES AND METHODS: Using data recorded from 1967 to 2019 in VigiBase®, the World Health Organization's Global Individual Case Safety Reports database, we performed disproportionality analysis to investigate the risk of reporting QT prolongation between 20 antipsychotics. RESULTS: Sertindole had the highest risk of reporting QT prolongation, followed by ziprasidone and amisulpride. Lurasidone was associated with the lowest risk. First-generation antipsychotics were associated with a greater QT prolongation reporting risk (ROR, 1.21; 95%CI, 1.10-1.33) than second-generation antipsychotics. A positive correlation was found between the risk of reporting QT prolongation and affinity for hERG channel (R2 = 0.14, slope = Pearson coefficient = 0.41, p value = 0.1945). CONCLUSIONS: This large study in a real-world setting suggests that sertindole and ziprasidone were the antipsychotics drugs associated with the highest risk of QT prolongation reporting. Our results suggest that lurasidone is less associated with QT interval prolongation reports. Our study also suggests that antipsychotics with the higher hERG affinity are more associated with to QT prolongations reports.


Assuntos
Antipsicóticos , Síndrome do QT Longo , Humanos , Antipsicóticos/efeitos adversos , Amissulprida , Cloridrato de Lurasidona/efeitos adversos , Farmacovigilância , Síndrome do QT Longo/induzido quimicamente , Síndrome do QT Longo/epidemiologia
7.
J Cosmet Dermatol ; 22(2): 473-485, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-35770300

RESUMO

BACKGROUND: Hyaluronic acid-based fillers have an immediate volumizing effect for the treatment of dermal contour deformities and to smooth dermal depressions formed by the loss of volume. A previous study on 2016-2018 has shown the efficacy and safety of the HA-based filler ART FILLER® Volume on the midface only, but not in a comparative manner. METHODS: In this context, an 18 months prospective randomized single-blind study of the non-inferiority of ART FILLER® Volume versus the reference product Juvéderm Voluma® was performed on the midface, temple, and jawline, and non-comparative study on the chin. The efficacy and the longevity were evaluated for the selected face areas via dedicated clinical scoring systems after a single filler injection without any re-touch or re-injection. The short- and long-term adverse effects were also recorded. RESULTS: The observations confirmed the non-inferiority of ART FILLER® Volume versus the reference product on the different injected areas. For both fillers, the beneficial effects on volumes restoration were maintained 18 months post-injection; however, these effects were diminished among the time. Furthermore, injections of Art Filler® Volume were well tolerated by the subjects and showed less acute side effects compared with the reference product that may be explained by a lower induction of inflammation.


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Envelhecimento da Pele , Humanos , Ácido Hialurônico , Técnicas Cosméticas/efeitos adversos , Método Simples-Cego , Estudos Prospectivos , Face , Preenchedores Dérmicos/efeitos adversos
8.
Clin Cosmet Investig Dermatol ; 16: 1795-1805, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37465030

RESUMO

Purpose: Injectable hyaluronic acid-based fillers are commonly used for the correction of skin contour irregularities and to smooth skin depressions formed by volume loss during the aging process. These fillers are particularly efficient to restore perioral skin depressions/wrinkles or to correct topographical anomalies. The European directives require a continuous evaluation of the performance of these medical devices, particularly for CE marked products. Methods: An 18-month prospective randomized single-blind study for the efficacy and safety of ART FILLER Universal (AFU) was performed on the lips, the nasolabial folds, and the marionettes lines. The evaluations were performed on 153 subjects enrolled in this study. The efficacy, the longevity, and the safety were evaluated for the injected areas via area specific clinical scoring after a single injection with the filler and with no re-touch. Results: We showed here that filler injection induced potent improvements of volume restoration after a single injection on all the treated areas. These beneficial properties of the filler were significant 3 weeks after injection and during the whole study period. Moreover, injections of the filler were well tolerated by the subjects. The recorded adverse events are routinely seen with HA fillers for face volume corrections, and most of these local reactions resolved within 14 days. Conclusion: AFU was well tolerated and showed a continuous efficacy for at least 18 months, in exploratory analyses.

9.
J Cosmet Dermatol ; 22(9): 2448-2456, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37128822

RESUMO

INTRODUCTION: Art Filler Volume (AFV) is a hyaluronic acid (HA)-based filler formulated with "Tri-Hyal" technology, a unique combination of three sizes of HA chains. This study assessed AFV efficacy and safety over 18 months when used to restore midface volume. METHODS: During this open-label study, a maximum of 1.8 mL AFV was injected into each cheek area on Day 0 (D0). Subjects were evaluated at D21, when, if necessary, a retouch could be performed (maximum 1.2 mL per cheek). Subjects were evaluated at seven follow-up visits through to D540. The primary assessment was based on the evolution of the Medicis Midface Volume Scale (MMVS) grade on D21. Secondary outcomes were local and general adverse events, investigator- and subject-assessed Global Aesthetic Improvement Scale scores and changes in self-esteem. RESULTS: Of the 79 healthy Caucasians enrolled (mean age 54.8 years), 25 required a second injection. In the intention-to-treat population, mean overall MMVS scores improved significantly from D0 (3.2 ± 0.4) to D21 (1.8 ± 0.6) and D42 (1.7 ± 0.6) (all p < 0.0001). MMVS scores for each cheek also improved significantly, irrespective of retouch on D21: 22% of injections showed a persistent benefit at D540 without retouch. The most common adverse events were pain on palpation (19%), erythema (15%) and edema (13%); most were mild or moderate and resolved within 2 weeks. CONCLUSION: AFV produces a sustained objective and subjective midface volume restoration in female and male subjects, often without retouching, and was well tolerated.


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Envelhecimento da Pele , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Ácido Hialurônico , Técnicas Cosméticas/efeitos adversos , Face , Bochecha , Satisfação do Paciente , Resultado do Tratamento
10.
J Dermatolog Treat ; 34(1): 2216323, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37577796

RESUMO

BACKGROUND: NCTF®135HA is a bio-revitalizing solution containing hyaluronic acid designed to compensate for skin dehydration, fatigue, and fine wrinkles associated with endogenous and environmental aging. METHODS: We conducted a randomized, active-controlled study to evaluate the efficacy and tolerability of NCTF®135HA injections on the face (crow's feet), neck, and décolleté regions. Subjects were randomly assigned (3:1) to receive three NCTF®135HA treatment sessions plus twice-daily anti-aging moisturizer cream or cream alone (control). The primary outcome was the reduction in superficial wrinkles between baseline and Day (D)75 in the three areas, assessed by profilometric measures, clinical scoring, subjective changes, and tolerability. RESULTS: 146 subjects were randomized to NCTF®135HA (n = 107) or control (n = 38). At D75 and D120, NCTF®135HA significantly reduced wrinkles in all three areas and improved facial radiance scores compared with the control. Skin hydration significantly increased 7 d after the last NCTF®135HA injection. Self-esteem scales showed statistically significant improvements at D75 and D120 in subjects treated with NCTF®135HA versus baseline. Most adverse events were mild, resolved within 48 h, and were related to the injection procedure. CONCLUSION: NCTF®135HA is an effective and well-tolerated treatment to reduce the skin signs of aging. The results are significantly superior to a routine anti-aging cream alone.(Funded by Laboratories FILLMED; ID-RCB number: 2018-A03167-48; clinicaltrials.gov number: NCT05609617).


Assuntos
Ácido Hialurônico , Envelhecimento da Pele , Humanos , Estudos Prospectivos , Pele , Resultado do Tratamento , Rejuvenescimento
11.
J Cosmet Dermatol ; 22(2): 464-472, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-35718985

RESUMO

BACKGROUND: Age-related changes of facial soft tissue cause clinical signs of facial aging such as lip atrophy, marionette lines, and an accentuated nasolabial fold. These changes can be modified using dermal fillers. AIMS: To evaluate efficacy, longevity, and safety of a cross-linked hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips, nasolabial folds, and marionette lines. MATERIALS AND METHODS: This prospective, multi-center trial evaluated injections of three different areas (lips, nasolabial fold alone, or with marionette wrinkles) with a soft tissue filler containing 25 mg/ml cross-linked hyaluronic acid and 0.3% lidocaine. Primary endpoint was the aesthetic correction 3 weeks after one injection session without touch-up. Follow-up was 18 months. Assessments were performed using the Global Aesthetic Score (GAS), clinical scoring based on photographic scales, high-frequency ultrasound imaging, and the Global Aesthetic Improvement Scale (GAIS). RESULTS: In total, 100 subjects were injected. GAS improved significantly for all treatment indications at 3 weeks (p < 0.0001). Success rates were highest for nasolabial folds (98.4%), followed by marionette lines (94.4%) and lips (73.5%). After 18 months post-injection, success was observed in 91%, 88%, and 33% of subjects injected into nasolabial folds, marionette lines, and lips, respectively. GAIS scored highest for nasolabial folds (SGAIS: 71%; IGAIS: 40%), followed by marionette lines (SGAIS: 56%; IGAIS: 33%) and lips (SGAIS: 30%; IGAIS: 22%) at 18 months follow-up. CONCLUSIONS: The filler demonstrated high efficacy and safety in all indications. Regional differences in longevity were evident. Thus, the necessity of regional retreatments should be discussed with patients before injection.


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Envelhecimento da Pele , Humanos , Lábio , Técnicas Cosméticas/efeitos adversos , Ácido Hialurônico/efeitos adversos , Estudos Prospectivos , Sulco Nasogeniano , Resultado do Tratamento , Preenchedores Dérmicos/efeitos adversos
12.
J Cosmet Laser Ther ; 14(2): 111-6, 2012 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-22373036

RESUMO

PURPOSE: To assess the long-term results of the treatment of oculofacial asymmetries using a combined injection schedule for injections of hyaluronic acid, with a specific micro cannula and botulinum toxin. METHOD: A retrospective study was conducted from January 2009 to January 2010. Patients were treated in the Alcazar Eye Clinic and Oculoplastic Department in Princess Grace Hospital, Monaco. We selected patients complaining of asymmetrical periorbital features who received treatment with hyalurostructure and botulinum toxin injection in one or more sessions. Nine patients were selected and presented with the following symptoms: asymmetry of eyebrow position (2 patients), superior orbital hollow (2 patients), tear trough (2 patients) and orbital volume (ocular prosthesis) (3 patients). The objective was to evaluate the efficiency of combined treatment in one or more sessions on these oculofacial asymmetries. Hyaluronic acid injections were done using hyalurostructure. Hyaluronic acid gel (Restylane Lidocaine) was used with a 25 gauge reinforced micro-cannula (pix'l +, Thiebaud). This was combined with injections of botulinum toxin (azzalure*) to areas of muscular hyperaction. Follow-up was done at 1 year by clinical examination, photography and patient satisfaction. Complications of this combined treatment have been identified. RESULTS: At 1-year follow-up, 88% of patients were satisfied or very satisfied with their results. There were no more complications secondary to both treatments in the same session. It was not noticed more hematomas and bruises than in classical injection method. The action of toxin is constant over time despite the association of hyaluronic acid injections. CONCLUSION: Combined treatments with toxin and hyaluronic acid in oculofacial asymmetries are efficient and can be proposed in the same session. These treatments must be repeated to maintain and optimize muscle contraction and volume loss. Use of hyalurostructure and botulinum toxin treatment in the same session is effective and safe.


Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Fármacos Dermatológicos/uso terapêutico , Assimetria Facial/tratamento farmacológico , Ácido Hialurônico/análogos & derivados , Fármacos Neuromusculares/uso terapêutico , Adulto , Técnicas Cosméticas , Quimioterapia Combinada , Olho , Feminino , Humanos , Ácido Hialurônico/uso terapêutico , Masculino , Satisfação do Paciente , Estudos Retrospectivos
13.
Materials (Basel) ; 15(9)2022 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-35591326

RESUMO

The phase field approach was developed in the last 20 years to handle radiation damage in materials. This approach bridges the gap between atomistic simulations extensively used to model first step of radiation damage at short time and continuum approach at large time. The main advantage of such an approach lies in its ability to compute not only the microstructure at the nanometric scale but also to calculate generalized susceptibilities such as elastic constants under irradiation. After a brief description of the rate theory, used to model the microstructure induced by irradiation, we briefly discuss the foundation of the phase field method, highlighting not only its advantages, but also its limitations in comparison with the rate theory. We conclude this presentation by proposing future orientations for computing the microstructure in irradiated materials.

14.
J Affect Disord ; 297: 189-193, 2022 01 15.
Artigo em Inglês | MEDLINE | ID: mdl-34699855

RESUMO

BACKGROUND: While case reports and clinical trials reported withdrawal syndrome after reduction and/or discontinuation of antidepressant drugs, no large study has been conducted to compare the risk between the different antidepressants. METHODS: Using data recorded from January 1st, 1988, and December 31st, 2020 in VigiBase®, the World Health Organization's Global Individual Case Safety Reports database, we performed disproportionality analysis to investigate the risk of reporting withdrawal syndrome in patients treated by short half-life antidepressants compared with patients treated by long half-life antidepressants. In addition, we aimed to better inform clinical practice by comparing 15 antidepressants for the risk of reporting withdrawal syndrome. RESULTS: Among the 338,498 reports with antidepressants of interest, we found 15,507 cases of withdrawal syndrome. Short half-lives antidepressants were associated with an increased risk of reporting a withdrawal syndrome compared to long half-life antidepressants (ROR 5.38; 95% CI 5.16-5.61). The risk was higher for 18-44 years old (ROR 6.88; 95% CI 6.17-7.62), women (ROR 1.38; 95% CI 1.33-1.43) and patients treated with Paroxetine, Desvenlafaxine, Venlafaxine and Duloxetine. LIMITATIONS: The limitations of this study stem from the case-reporting process. CONCLUSIONS: This large observational study in a real-world setting suggests that the use of short half-life antidepressants increases the risk of reporting withdrawal syndrome compared to long half-life antidepressants. Among the most common antidepressants, paroxetine and serotonin-noradrenaline reuptake inhibitors are associated with a greater risk of reporting withdrawal syndrome, while agomelatine and vortioxetine present a lower risk. Additional studies are needed to corroborate our results.


Assuntos
Antidepressivos , Farmacovigilância , Adolescente , Adulto , Antidepressivos/efeitos adversos , Feminino , Humanos , Inibidores Seletivos de Recaptação de Serotonina/efeitos adversos , Vortioxetina , Organização Mundial da Saúde , Adulto Jovem
15.
J Psychopharmacol ; 35(12): 1441-1448, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34318729

RESUMO

AIM: To compare different ß-adrenoceptor antagonists for the risk of reporting nightmare. METHODS: The study involved two approaches: first, we investigated in VigiBase®, the World Health Organization Individual Case Safety Report (ICSR) database, the disproportionality between exposure to each ß-adrenoceptor antagonists and reports of nightmares between 1967 and 2019. Second, in a pharmacoepidemiological-pharmacodynamic analysis, we assessed whether use of ß-adrenoceptor antagonists with moderate and high lipid solubility or strong 5-HT1A affinity were associated with an increased risk of reporting nightmares. We conducted multivariate logistic regression to estimate reporting odds ratios (RORs) of nightmares compared to all other adverse drug reactions. RESULTS: Of the 126,964 reports recorded with ß-adrenoceptor antagonists, 1138 (0.9%) were nightmares. The highest risk of reporting a nightmare was found with exposure of pindolol (adjusted ROR 2.82, 95%CI, 2.19-3.61), metoprolol (1.89, 1.66-2.16), and alprenolol (1.77, 1.06-2.97). Compared to use of low lipid solubility ß-adrenoceptor antagonists, use of moderate or high lipid solubility ß-adrenoceptor antagonists were significantly more associated with nightmare reports (aROR moderate vs. low 1.72, 95%CI 1.47-2.00 and aROR high vs. low 1.84, 95%CI 1.53-2.22). Use of moderate or high 5-HT1A affinity of ß-adrenoceptor antagonists was associated with an increased ROR of nightmares compared with low 5-HT1A affinity of ß-adrenoceptor antagonists (aROR moderate vs. low 1.22, 95%CI 1.04-1.43 and aROR high vs. low 2.46, 95%CI 1.93-3.13). CONCLUSION: In our large pharmacovigilance study, nightmares are more frequently reported for pindolol and metoprolol, and among ß-adrenoceptor antagonists with high lipid solubility and high 5-HT1A receptor affinity.


Assuntos
Antagonistas Adrenérgicos beta/efeitos adversos , Sonhos/efeitos dos fármacos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacoepidemiologia , Farmacovigilância , Bases de Dados de Produtos Farmacêuticos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Humanos
16.
Drug Saf ; 43(12): 1315-1322, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33078372

RESUMO

INTRODUCTION: In the stressful context of the coronavirus disease 2019 (COVID-19) pandemic, some reports have raised concerns regarding psychiatric disorders with the use of hydroxychloroquine. In this study, we reviewed all psychiatric adverse effects with hydroxychloroquine in COVID-19 patients, as well as in other indications, reported in VigiBase, the World Health Organization's (WHO) global database of individual case safety reports. METHODS: First, we analyzed all psychiatric adverse effects, including suicide, of hydroxychloroquine in COVID-19 patients reported to 16 June 2020. We also performed disproportionality analysis to investigate the risk of reporting psychiatric disorders with hydroxychloroquine compared with remdesivir, tocilizumab, or lopinavir/ritonavir prescribed in COVID-19 patients. We used reporting odds ratios (RORs) and their 95% confidence intervals (CIs) to calculate disproportionality. Second, we sought to examine the psychiatric safety profile of hydroxychloroquine in other indications (before 2020). RESULTS: Among the 1754 reports with hydroxychloroquine in COVID-19 patients, we found 56 psychiatric adverse effects. Half of these adverse effects were serious, including four completed suicides, three cases of intentional self-injury, and 12 cases of psychotic disorders with hallucinations. Compared with remdesivir, tocilizumab, or lopinavir/ritonavir, the use of hydroxychloroquine was associated with an increased risk of reporting psychiatric disorders (ROR 6.27, 95% CI 2.74-14.35). Before 2020, suicide was the main cause of death among all adverse drug reactions reported with hydroxychloroquine, followed by cardiac adverse effects (cardiomyopathy) and respiratory failure. CONCLUSIONS: This pharmacovigilance analysis suggests that COVID-19 patients exposed to hydroxychloroquine experienced serious psychiatric disorders, and, among these patients, some committed suicide. Further real-world studies are needed to quantify the psychiatric risk associated with hydroxychloroquine during the COVID-19 pandemic.


Assuntos
Antivirais/efeitos adversos , Tratamento Farmacológico da COVID-19 , Alucinações/induzido quimicamente , Hidroxicloroquina/efeitos adversos , Psicoses Induzidas por Substâncias/etiologia , Comportamento Autodestrutivo/induzido quimicamente , Suicídio/estatística & dados numéricos , Monofosfato de Adenosina/efeitos adversos , Monofosfato de Adenosina/análogos & derivados , Adulto , Idoso , Idoso de 80 Anos ou mais , Alanina/efeitos adversos , Alanina/análogos & derivados , Anticorpos Monoclonais Humanizados/efeitos adversos , Bases de Dados de Produtos Farmacêuticos , Combinação de Medicamentos , Feminino , Alucinações/epidemiologia , Humanos , Lopinavir/efeitos adversos , Masculino , Transtornos Mentais/induzido quimicamente , Transtornos Mentais/epidemiologia , Pessoa de Meia-Idade , Psicoses Induzidas por Substâncias/epidemiologia , Ritonavir/efeitos adversos , Comportamento Autodestrutivo/epidemiologia , Tentativa de Suicídio/estatística & dados numéricos , Adulto Jovem
17.
Plast Reconstr Surg Glob Open ; 8(12): e3274, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33425589

RESUMO

The first phase of this study showed that ART FILLER Universal filler (AFU; FILORGA Laboratories) and ART FILLER Fine lines (AFFL) were non-inferior to JUVÉDERM Ultra 3 (Allergan) and FIRST LINES PureSense (Teoxane), respectively. The clinical benefits of AFU and AFFL on nasolabial folds and crow's feet persisted until at least Day 180. This article reports results from an open-label extension phase that assessed the tolerability and efficacy of AFU and AFFL for up to 18 months based on clinical evaluation and ultrasound high-frequency imaging. METHODS: Eligible subjects were enrolled at D180 and assessed on D270, D360, and D540. The primary outcome measured was local tolerability. Secondary outcomes measured included: proportion of subjects in whom the severity of nasolabial folds and crow's feet remained at least 1 point below the baseline measurement (Lemperle scale); general safety; Global Aesthetic Improvement Scale scores by subjects and investigators; wrinkle volumes; and skin thickness by high-frequency ultrasound. RESULTS: Adverse events were consistent with the product information and the initial study. No serious adverse events were recorded. In exploratory analyses, wrinkle correction with AFU and AFFL is sustained for at least 18 months: 48.4% and 98.3% of subjects respectively still showed at least a 1-point decrease in the mean Lemperle score compared with the baseline. The benefits were sustained irrespective of whether subjects received additional injections. Modifications in wrinkle volume and skin thickness at D540 were statistically significant compared with the baseline. CONCLUSION: AFU and AFFL were well tolerated and, in exploratory analyses, showed a sustained efficacy for at least 18 months.

18.
Plast Reconstr Surg ; 136(5 Suppl): 235S-257S, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26441104

RESUMO

The use of injectable fillers enables facial sculpting through treatment of volume depletion and modeling of facial contours. Injectable fillers are among the most frequently performed minimally invasive cosmetic procedures.However, treatment of the lower third of the face can be challenging and requires expertise in facial anatomy. In this article, the authors provide a comprehensive review of the anatomy of the lower third of the face, highlighting danger zones. In addition, the authors describe their preferred approach and detailed technique used in the treatment of each specific area, namely the jawline, prejowl sulcus, melomental folds, and lips.


Assuntos
Técnicas Cosméticas , Face/anatomia & histologia , Ácido Hialurônico/administração & dosagem , Humanos , Injeções Intradérmicas
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