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2.
N Engl J Med ; 381(14): 1321-1332, 2019 10 03.
Artigo em Inglês | MEDLINE | ID: mdl-31577874

RESUMO

BACKGROUND: In the majority of patients with chronic spontaneous urticaria, most currently available therapies do not result in complete symptom control. Ligelizumab is a next-generation high-affinity humanized monoclonal anti-IgE antibody. Data are limited regarding the dose-response relationship of ligelizumab and the efficacy and safety of ligelizumab as compared with omalizumab and placebo in patients who have moderate-to-severe chronic spontaneous urticaria that is inadequately controlled with H1-antihistamines at approved or increased doses, alone or in combination with H2-antihistamines or leukotriene-receptor antagonists. METHODS: In a phase 2b dose-finding trial, we randomly assigned patients to receive ligelizumab at a dose of 24 mg, 72 mg, or 240 mg, omalizumab at a dose of 300 mg, or placebo, administered subcutaneously every 4 weeks for a period of 20 weeks, or a single 120-mg dose of ligelizumab. Disease symptoms of hives, itch, and angioedema were monitored by means of weekly activity scores. The main objective was to determine a dose-response relationship for the complete control of hives (indicated by a weekly hives-severity score of 0, on a scale from 0 to 21, with higher scores indicating greater severity); the primary end point of this response was assessed at week 12. Complete symptom control was indicated by a weekly urticaria activity score of 0 (on a scale from 0 to 42, with higher scores indicating greater severity). Safety was analyzed throughout the trial. RESULTS: A total of 382 patients underwent randomization. At week 12, a total of 30%, 51%, and 42% of the patients treated with 24 mg, 72 mg, and 240 mg, respectively, of ligelizumab had complete control of hives, as compared with 26% of the patients in the omalizumab group and no patients in the placebo group. A dose-response relationship was established. At week 12, a total of 30%, 44%, and 40% of the patients treated with 24 mg, 72 mg, and 240 mg, respectively, of ligelizumab had complete control of symptoms, as compared with 26% of the patients in the omalizumab group and no patients in the placebo group. In this small and short trial, no safety concerns regarding ligelizumab or omalizumab emerged. CONCLUSIONS: A higher percentage of patients had complete control of symptoms of chronic spontaneous urticaria with ligelizumab therapy of 72 mg or 240 mg than with omalizumab or placebo. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT02477332.).


Assuntos
Antialérgicos/administração & dosagem , Anticorpos Anti-Idiotípicos/administração & dosagem , Anticorpos Monoclonais Humanizados/administração & dosagem , Omalizumab/administração & dosagem , Urticária/tratamento farmacológico , Adulto , Idoso , Antialérgicos/efeitos adversos , Anticorpos Anti-Idiotípicos/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Doença Crônica , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Imunoglobulina E/sangue , Imunoglobulina E/imunologia , Masculino , Pessoa de Meia-Idade , Omalizumab/efeitos adversos , Gravidade do Paciente , Indução de Remissão , Urticária/imunologia , Adulto Jovem
5.
G Ital Dermatol Venereol ; 154(4): 480-487, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30717578

RESUMO

INTRODUCTION: Omalizumab, has been used for almost two decades, mainly in allergic asthma and chronic spontaneous urticaria for which it is highly beneficial. Smaller studies have evaluated the effects of omalizumab in atopic dermatitis (AD). Current treatments options, such as cyclosporine and azathioprine have limited effect on AD and numerous side effects. The recently introduced biologic dupilumab (anti-IL4) shows promising results, however with conjunctivitis as a prevalent side effect. We evaluate the current evidence for the use of omalizumab in AD. EVIDENCE ACQUISITION: Systematic literature searches were performed in PubMed, Web of Science, Embase and Clinicaltrials.gov to identify any study (case reports, case series, and controlled trials) evaluating the effect of treatment with omalizumab in AD. EVIDENCE SYNTHESIS: Thirty-four studies (12 single case studies, 15 case series, 5 prospective studies and 2 small pilot randomized placebo-controlled trials [RCTs]), including a total of 214 patients with median of 3, ranging from 1-35 patients were identified. A total of 169 patients (79.0%) experienced a beneficial effect from treatment, ranging from little to complete response, whereas 45 patients (21.0%) reported no or negative effect from omalizumab treatment. CONCLUSIONS: Omalizumab is a safe and well-tolerated treatment with some clinical benefit in AD patients. However, the lack of larger RCTs and possible publication bias limit the recommendation of omalizumab for use in clinical practice for AD. Newer and more effective treatments exist and should be prioritized.


Assuntos
Antialérgicos/administração & dosagem , Dermatite Atópica/tratamento farmacológico , Omalizumab/administração & dosagem , Antialérgicos/efeitos adversos , Humanos , Omalizumab/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
7.
Trials ; 20(1): 66, 2019 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-30658660

RESUMO

BACKGROUND: People with allergic rhinitis (AR) often seek help from Chinese medicine due to dissatisfaction with conventional treatments. Lung-spleen qi deficiency syndrome (LSQDS) is the most common type of AR, and the Chinese herbal medicine formula bi min fang (BMF) is commonly prescribed for AR patients with LSQDS. However, direct evidence supporting its efficacy and safety is not available, and its potential mechanism of action remains unclear. METHODS/DESIGN: This paper presents a double-blind, double-dummy, randomized controlled trial. After a 2-week run-in period, 80 AR patients with LSQDS will be recruited and randomly allocated to the BMF group or the control group in a 1:1 ratio. The patients in the BMF group will receive BMF and the placebo for levocetirizine hydrochloride orally, while the control group participants will receive levocetirizine hydrochloride and the placebo for BMF orally. All participants will receive 4 weeks of treatment and 12 weeks of follow-up. The primary outcome is a change in the Total Nasal Symptom Score (TNSS). Secondary outcomes include changes in scores for the standard version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)), and visual analog scale (VAS); changes in serum levels of the cytokines interleukin-4, interferon-γ, transforming growth factor ß-1, and interleukin-17; and changes in the gut microbiota composition in the stool. The TNSS, RQLQ(S), and VAS will be recorded at the beginning of, middle of and after the treatment period and at the end of each month in the 3-month follow-up period. Blood and stool samples will be collected at baseline and the end of the treatment. The aforementioned four cytokines will be detected in the serum using enzyme-linked immunosorbent assays, and the stool gut microbiota will be detected using 16S ribosomal ribonucleic acid sequencing. Any side effects of the treatment will be recorded. DISCUSSION: The results of this trial will provide consolidated evidence of the effect of BMF on AR and the potential mechanism by which BMF acts. This study will be the first to explore the mechanism of action of Chinese herbal medicine on the gut microbiota in AR. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IPR-17010970 . Registered on 23 March 2017.


Assuntos
Antialérgicos/administração & dosagem , Medicamentos de Ervas Chinesas/administração & dosagem , Rinite Alérgica/tratamento farmacológico , Administração Oral , Adolescente , Adulto , Idoso , Antialérgicos/efeitos adversos , China , Citocinas/sangue , Método Duplo-Cego , Esquema de Medicação , Medicamentos de Ervas Chinesas/efeitos adversos , Feminino , Microbioma Gastrointestinal/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Rinite Alérgica/sangue , Rinite Alérgica/diagnóstico , Rinite Alérgica/microbiologia , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
8.
Dermatol Ther ; 32(3): e12848, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30697883

RESUMO

BACKGROUND: Mastocytosis describes a heterogeneous group of disorders arising from a clonal proliferation of mast cells. Given the lack of curative treatments for the cutaneous form, there is a significant need for superior therapies. Omalizumab is a recombinant DNA-derived humanized IgG monoclonal antibody that selectively binds to human immunoglobulin E (IgE). It represents a potential treatment for the management of cutaneous mastocytosis, which currently has no standard treatment. METHODS: Two patients were treated with subcutaneous omalizumab 300 mg every 4 weeks. DISCUSSION: Patient 1 experienced 50% reduction in cutaneous infiltration and moderate improvement in pruritus. Patient 2 underwent 90% complete clearance of cutaneous lesions and reported full resolution of pruritus. The median duration of treatment was 24 weeks and time to response was 8 weeks. No significant changes in tryptase levels were observed. Both patients experienced injection site reactions. CONCLUSION: We provide evidence from two cases supporting the efficacy of IgE-mediated therapy in the treatment of cutaneous mastocytosis. Even at a higher-than-standard dose (300 mg vs. 150 mg), the drug was well-tolerated. As we await the results of pivotal clinical trials, omalizumab appears to be a promising treatment option in patients with cutaneous mastocytosis unresponsive to traditional therapies.


Assuntos
Antialérgicos/administração & dosagem , Mastocitose Cutânea/tratamento farmacológico , Omalizumab/administração & dosagem , Adulto , Antialérgicos/efeitos adversos , Antialérgicos/farmacologia , Feminino , Humanos , Imunoglobulina E/imunologia , Injeções Subcutâneas , Mastocitose Cutânea/imunologia , Pessoa de Meia-Idade , Omalizumab/efeitos adversos , Omalizumab/farmacologia , Prurido/tratamento farmacológico , Prurido/etiologia , Resultado do Tratamento
9.
Acta Ophthalmol ; 97(5): 505-509, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30479070

RESUMO

PURPOSE: To investigate whether exposure to antazoline-naphazoline eye drops in the first trimester of pregnancy was associated with an increased risk of malformations in humans. METHODS: All women giving live birth between 1997 and 2011 in Denmark were included in this nationwide cohort study. All women redeeming at least one prescription of antazoline-naphazoline eye drops during the first 84 days of pregnancy were identified. Logistic regression was used to estimate the odds ratios of malformations among exposed offspring compared to non-exposed offspring. RESULTS: We identified 977 706 births between 1997 and 2011. A total of 3061 women (0.32%) were exposed to antazoline-naphazoline eye drops in the first trimester of pregnancy. The rate of congenital malformations was 3.0% (n = 93) in exposed offspring and 3.5% (n = 33 594) in unexposed offspring. First-trimester exposure to antazoline-naphazoline was not associated with major congenital malformations overall (odds ratio: 0.88, 95% confidence interval: 0.71-1.09) or with any specific major malformation. The number of redeemed prescriptions was unchanged during all trimesters of pregnancy as compared to before and after pregnancy (p < 0.05). CONCLUSION: Exposure to antazoline-naphazoline eye drops in the first trimester of pregnancy appears not to be associated with increased teratogenic risk.


Assuntos
Anormalidades Induzidas por Medicamentos/epidemiologia , Antazolina/efeitos adversos , Nafazolina/efeitos adversos , Vigilância da População/métodos , Sistema de Registros , Anormalidades Induzidas por Medicamentos/etiologia , Adulto , Antazolina/administração & dosagem , Antialérgicos/administração & dosagem , Antialérgicos/efeitos adversos , Dinamarca/epidemiologia , Feminino , Seguimentos , Humanos , Incidência , Recém-Nascido , Masculino , Nafazolina/administração & dosagem , Descongestionantes Nasais/administração & dosagem , Descongestionantes Nasais/efeitos adversos , Soluções Oftálmicas , Gravidez , Resultado da Gravidez , Primeiro Trimestre da Gravidez , Estudos Retrospectivos , Fatores de Risco , Adulto Jovem
10.
Expert Opin Investig Drugs ; 28(1): 73-84, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30513028

RESUMO

INTRODUCTION: Prostaglandin D2 (PGD2) is a major cyclooxygenase mediator that is synthesized by activated human mast cells and other immune cells. The biological effects of PGD2 are mediated by D-prostanoid (DP1), DP2 (CRTH2) and thromboxane prostanoid (TP) receptors that are expressed on several immune and non-immune cells involved in allergic inflammation. PGD2 exerts various proinflammatory effects relevant to the pathophysiology of allergic disorders. Several selective, orally active, DP2 receptor antagonists and a small number of DP1 receptor antagonists are being developed for the treatment of allergic disorders. AREAS COVERED: The role of DP2 and DP1 receptor antagonists in the treatment of asthma and allergic rhinitis. EXPERT OPINION: Head-to-head studies that compare DP1 antagonists with the standard treatment for allergic rhinitis are necessary to verify the role of these novel drugs as mono- or combination therapies. Further clinical trials are necessary to verify whether DP2 antagonists as monotherapies or, more likely, as add-on therapies, will be effective for the treatment of different phenotypes of adult and childhood asthma. Long-term studies are necessary to evaluate the safety of targeted anti-PGD2 treatments.


Assuntos
Asma/tratamento farmacológico , Receptores Imunológicos/antagonistas & inibidores , Receptores de Prostaglandina/antagonistas & inibidores , Rinite Alérgica/tratamento farmacológico , Adulto , Animais , Antialérgicos/administração & dosagem , Antialérgicos/efeitos adversos , Antialérgicos/farmacologia , Asma/imunologia , Criança , Desenho de Fármacos , Humanos , Mastócitos/imunologia , Prostaglandina D2/metabolismo , Receptores Imunológicos/metabolismo , Receptores de Prostaglandina/metabolismo , Rinite Alérgica/imunologia
11.
J Investig Allergol Clin Immunol ; 29(5): 338-348, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30222111

RESUMO

Chronic spontaneous urticaria (CSU) is a heterogeneous condition that can severely impact quality of life. Consequently, rapid disease control is essential. First-line treatment of the symptoms of CSU is the licensed dose of second-generation H1 antihistamines. For second-line treatment, this dose may be increased by up to 4 times. In patients who fail to respond to higher doses of H1 antihistamines, omalizumab for up to 24 weeks is recommended to achieve disease control. After this 24-week period, the patient's response to omalizumab should be assessed in order to identify refractory patients. Optimal management of refractory patients has not been established. Therefore, the aim of the present consensus document, which was drafted by allergists and dermatologists with specific expertise in treating urticaria, was to define specific patient profiles based on differences in their response to omalizumab. We also developed a treatment algorithm based on the specific response profile. After a comprehensive literature review, a group meeting was held to discuss issues related to the therapeutic management of patients with CSU that had not been addressed in previous studies. The experts considered both the available evidence and their own clinical experience with omalizumab. We believe that implementation of the proposed algorithm will optimize management of CSU patients who are refractory to antihistamines, reduce disease-related costs, and improve quality of life.


Assuntos
Antialérgicos/uso terapêutico , Omalizumab/uso terapêutico , Antialérgicos/administração & dosagem , Antialérgicos/efeitos adversos , /etiologia , Ensaios Clínicos como Assunto , Gerenciamento Clínico , Humanos , Omalizumab/administração & dosagem , Omalizumab/efeitos adversos , Qualidade de Vida , Resultado do Tratamento
12.
Dermatol Ther ; 32(1): e12752, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30238582

RESUMO

Antihistamines are the first-line treatment option for chronic urticaria. In recent years, omalizumab, an anti-immunoglobulin-E humanized monoclonal antibody, has been used in patients with recalcitrant disease. The present study aimed to retrospectively evaluate the efficacy and safety of omalizumab and determine whether there was a difference between complete and partial responses to omalizumab with respect to age, gender, disease duration and coexistence of angioedema. From May 2014 to December 2016, a total of 40 refractory chronic urticaria patients were treated with omalizumab. Complete response was observed in 19 (47.5%) patients, and partial response was observed in 18 (45%) patients. There were no statistically significant differences between the rates of complete and partial responses in patients with respect to gender, age, and disease duration. However, complete response was more frequent (60%) in patients without angioedema. Remission was observed in 40.5% (n = 15) of patients, and the follow-up time was 5.5 ± 2.4 months. There was a statistically significant association between remission and coexistence of angioedema (p < .05). Eighty-seven percent (13/15) of the remission patients did not have angioedema. Thus, omalizumab can be used effectively and safely in refractory chronic urticaria patients. However, the coexistence of angioedema may be an unfavorable factor for complete response and remission.


Assuntos
Angioedema/complicações , Antialérgicos/uso terapêutico , Omalizumab/uso terapêutico , Urticária/tratamento farmacológico , Adulto , Idoso , Angioedema/diagnóstico , Angioedema/imunologia , Antialérgicos/efeitos adversos , Doença Crônica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Omalizumab/efeitos adversos , Recidiva , Indução de Remissão , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Turquia , Urticária/complicações , Urticária/diagnóstico , Urticária/imunologia , Adulto Jovem
13.
Pediatr Emerg Care ; 35(2): e30-e31, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-28169979

RESUMO

Common cold is an acute illness affecting pediatric population in particular. The use of antihistamines is a common practice, with cetirizine being a frequently used drug with a good safety profile. However, adverse events due to the use of antihistamines have been rarely reported, such as drug-induced dystonia with the use of cetirizine. In our present case, dystonia due to the intake of cetirizine was observed, which the patient responded well to the use of benzodiazapines, namely, clonazepam. We report this case to highlight the occurrence of this adverse event with the use of cetirizine.


Assuntos
Antialérgicos/efeitos adversos , Anticonvulsivantes/uso terapêutico , Cetirizina/efeitos adversos , Clonazepam/uso terapêutico , Distúrbios Distônicos/induzido quimicamente , Doença Aguda , Criança , Humanos , Masculino
14.
Br J Dermatol ; 180(1): 56-66, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-29927483

RESUMO

BACKGROUND: Omalizumab is approved as an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in patients with inadequate response to H1-antihistamine treatment. The urticaria control test (UCT) is a reliable, concise tool developed as an alternative to the 7-day urticaria activity score (UAS7) - the standard for CSU disease activity assessment. OBJECTIVES: This prospective, open-label, phase IV study evaluated the efficacy and safety of omalizumab in French adult patients with CSU nonresponsive to H1-antihistamine treatment. MATERIALS AND METHODS: Patients [n = 136; stratified 1 : 2 (with angio-oedema : without angioedema)] received omalizumab 300 mg subcutaneously every 4 weeks for 12 weeks. Study assessments included UCT, UAS7, angio-oedema activity score and d-dimer levels (exploratory objective). RESULTS: At Week 12, 74·6% of the patients achieved disease control [UCT score ≥ 12 (primary endpoint)] and 67·7% of patients showed well-controlled disease (UAS7 ≤ 6). There was a strong negative correlation between UCT score and UAS7 at Week 12 (Spearman's correlation coefficient -0·839). Mean plasma d-dimer concentration was elevated at baseline (1002·1 ng mL-1 ) and decreased notably at Week 8 (455 ng mL-1 ). Among the nine patients with a very high baseline d-dimer concentration (> 3000 ng mL-1 ), eight were responders (UAS7 ≤ 6) at Week 12. CONCLUSIONS: Omalizumab was efficacious in patients with CSU nonresponsive to H1-antihistamines. The UCT was a reliable tool for disease assessment and the scores correlated well with UAS7. This study does not support the usefulness of d-dimer to monitor long-term disease prognosis in adult urticaria; however, it may indicate patients who respond to omalizumab.


Assuntos
Antialérgicos/administração & dosagem , Antagonistas dos Receptores Histamínicos H1/farmacologia , Omalizumab/administração & dosagem , Urticária/tratamento farmacológico , Adulto , Antialérgicos/efeitos adversos , Doença Crônica/tratamento farmacológico , Resistência a Medicamentos , Feminino , França , Antagonistas dos Receptores Histamínicos H1/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Omalizumab/efeitos adversos , Estudos Prospectivos , Qualidade de Vida , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Inquéritos e Questionários , Resultado do Tratamento , Urticária/diagnóstico , Urticária/patologia
15.
Medwave ; 18(7): e7347, 2018 Nov 23.
Artigo em Espanhol, Inglês | MEDLINE | ID: mdl-30507897

RESUMO

INTRODUCTION: Chronic rhinosinusitis is a high prevalence chronic inflammatory disease that involves nasal mucosa and paranasal sinuses. Immunoglobulin E is an inflammatory mediator that plays an etiopathogenic role in this condition, so omalizumab, an anti-immunoglobulin E monoclonal antibody, might be a therapeutic alternative. METHODS: We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified five systematic reviews that included five primary studies overall, of which two correspond to randomized trials. We concluded it is not clear whether omalizumab leads to an improvement in the nasal polyps scale, quality of life, general well-being or nasal symptoms in patients with chronic rhinosinusitis, because the certainty of the evidence is very low. On the other hand, omalizumab is probably associated with frequent adverse effects.


Assuntos
Omalizumab/uso terapêutico , Rinite/tratamento farmacológico , Sinusite/tratamento farmacológico , Antialérgicos/efeitos adversos , Antialérgicos/farmacologia , Antialérgicos/uso terapêutico , Doença Crônica , Bases de Dados Factuais , Humanos , Pólipos Nasais/tratamento farmacológico , Pólipos Nasais/imunologia , Omalizumab/efeitos adversos , Omalizumab/farmacologia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Rinite/imunologia , Sinusite/imunologia
16.
BMC Complement Altern Med ; 18(1): 243, 2018 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-30170584

RESUMO

BACKGROUND: The first-line agents comprising antihistamines for chronic urticaria, are not completely satisfactory. Tripterygium wilfordii Hook F (TwHF), a Chinese herb, has been developed into several Tripterygium agents and have definite effects on autoimmune and inflammatory diseases. In chronic urticaria, however, their values of practical application remain unclear. The aim of this study was to investigate the efficacy and safety of TwHF in patients with chronic urticaria. METHODS: Several databases were systematically searched including PubMed, Embase, Cochrane Central Register of Controlled Trials, China Network Knowledge Infrastructure, Chinese Scientific Journals Database, Wan Fang Database, and Chinese Biomedicine. Randomized controlled trials comparing antihistamines with TwHF or Tripterygium agents in combination with antihistamines were included. Revman5.3 was utilized to calculate risk ratios (RR) with 95% confidence intervals (CI). This study was registered with PROSPERO, number CRD42018091595. RESULTS: Twenty-one trials with 2565 participants were included in this analysis. Meta-analysis showed that, when antihistamines were combined with TwHF and Tripterygium agents, the curative effect in cases of chronic urticaria was superior to that of antihistamines alone (RR: 1.40; 95% CI: 1.33-1.46). The incidence rates of gastrointestinal disorder (RR: 2.91; 95% CI: 1.70-4.99) and menstrual disorder (RR: 6.00; 95% CI: 1.79-20.13) in drug combination groups were higher than those in controls, while other adverse events were similar between the two groups. After treatment, Dermatology Life Quality Index (RR: 1.23; 95% CI: 1.09-1.40), quality of sleep (RR: 1.50; 95% CI: 1.07-2.12), and daily activity (RR: 1.49; 95% CI: 1.25-1.78) were all improved. Furthermore, drug combination groups demonstrated less relapse (RR: 0.34; 95% CI: 0.25-0.45). CONCLUSIONS: TwHF and Tripterygium agents, in combination with antihistamines, appear to be more effective than antihistamines alone. Nevertheless, adverse events cannot be ignored. Large sample, multi-center, high-quality clinical studies are needed to verify the exact effects and safety of TwHF and Tripterygium agents in treatment of chronic urticaria.


Assuntos
Antialérgicos , Extratos Vegetais , Tripterygium/química , Urticária/tratamento farmacológico , Antialérgicos/efeitos adversos , Antialérgicos/uso terapêutico , Doença Crônica , Feminino , Humanos , Masculino , Extratos Vegetais/efeitos adversos , Extratos Vegetais/uso terapêutico
17.
J Cataract Refract Surg ; 44(10): 1220-1229, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30193927

RESUMO

PURPOSE: To assess the safety and efficacy of a 0.38% submicron formulation of loteprednol etabonate (LE) gel for the treatment of postoperative inflammation and pain after cataract surgery. SETTING: Forty-five United States ophthalmology practices. DESIGN: Double-masked vehicle-controlled randomized parallel group study. METHODS: Patients 18 years of age or older with anterior chamber cells grade 2 or higher on day 1 after uncomplicated cataract surgery were randomized to 14 days of treatment with LE gel 2 times a day, LE gel 3 times a day, or vehicle. Hierarchical primary endpoints were the proportion of patients with resolution of anterior chamber cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events, intraocular pressure (IOP), biomicroscopy, visual acuity, ophthalmoscopy, and tolerability (drop comfort and ocular symptoms). RESULTS: The intent-to-treat population included 514 patients. Significantly more patients in the LE gel 2 times a day and 3 times a day groups compared with the vehicle group had complete resolution of anterior chamber cells (26.9% and 28.7% versus 9.3%) and reported grade 0 pain (73.7% and 73.1% versus 47.7%) on day 8 (P < .001 vs vehicle for all). The safety findings were unremarkable, with 1 patient experiencing an IOP increase of 10 mm Hg or higher while on LE gel. More than 75% of patients in each group reported no drop discomfort. CONCLUSION: In this study, submicron loteprednol etabonate gel 0.38% appeared safe and effective in the treatment of postoperative inflammation and pain whether instilled 2 times or 3 times a day.


Assuntos
Antialérgicos/uso terapêutico , Dor Ocular/tratamento farmacológico , Inflamação/tratamento farmacológico , Etabonato de Loteprednol/uso terapêutico , Facoemulsificação/efeitos adversos , Complicações Pós-Operatórias , Adulto , Idoso , Idoso de 80 Anos ou mais , Antialérgicos/efeitos adversos , Método Duplo-Cego , Dor Ocular/etiologia , Feminino , Géis , Humanos , Inflamação/etiologia , Pressão Intraocular , Etabonato de Loteprednol/efeitos adversos , Masculino , Microscopia Acústica , Pessoa de Meia-Idade , Oftalmoscopia , Resultado do Tratamento , Acuidade Visual/fisiologia
19.
Expert Rev Clin Immunol ; 14(9): 771-780, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30113236

RESUMO

INTRODUCTION: Acid suppressant medications (ASMs), such as proton pump inhibitors and histamine-2 receptor antagonists, are used often and throughout the lifespan. These medications have been linked to the development of a variety of allergic diseases. Areas covered: This review discusses prior studies investigating the association between acid ASM exposure and the development of allergic diseases. We performed a thorough literature search to identify potentially relevant studies for inclusion. In summary, exposure to these medications prenatally, in childhood and in adulthood, may increase the risk of allergic diseases. The current evidence is limited by primarily observational study design and potential bias and confounding. The mechanism of action is not yet known, but there are several proposed theories. Expert commentary: There is a growing body of evidence to support that exposure to acid ASMs increases the risk of developing allergic diseases. Further research is needed to not only clarify this relationship but to define the potential mechanism of action. If further research confirms these observations, we believe that could warrant changes in the patterns of prescribing and use of acid ASMs.


Assuntos
Antialérgicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Refluxo Gastroesofágico/tratamento farmacológico , Antagonistas dos Receptores Histamínicos/efeitos adversos , Hipersensibilidade/epidemiologia , Efeitos Tardios da Exposição Pré-Natal/epidemiologia , Inibidores da Bomba de Prótons/efeitos adversos , Adolescente , Adulto , Antialérgicos/uso terapêutico , Viés , Feminino , Refluxo Gastroesofágico/complicações , Humanos , Hipersensibilidade/etiologia , Gravidez , Inibidores da Bomba de Prótons/uso terapêutico , Risco
20.
Expert Opin Drug Saf ; 17(9): 859-868, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30032673

RESUMO

INTRODUCTION: Antihistamines are easily accessible and cover the vast majority of the medical therapy of allergic rhinitis. However, their systemic administration may more frequently associate with their well-known side-effect, sedation, which is a serious problem in persons in safety-critical jobs such as aviation. We have a poor understanding whether a non-sedative antihistamine has an impact on vigilance when hypobaric hypoxia occurs during flight. METHODS: In this randomized, placebo-controlled, double-blind, cross-over study the effect of 20 mg bilastine was compared to 10 mg cetirizine and to placebo (20 mg pyridoxine) in 33 individuals at ground level and at 4,000 m altitude simulated in hypobaric chamber. Levels of vigilance, ultrashort memory, combined distributive attention, monotony tolerance and peripheral blood oxygen saturation (SpO2) were assessed. RESULTS: Bilastine did not impair the tested abilities in comparison with the control groups either at ground level or hypobaric hypoxia. Administration of cetirizine increased the number of errors at ground level. At the simulated altitude, already impaired results were additionally demonstrated with regards to the distributive attention test. CONCLUSIONS: From the two examined antihistamines, bilastine should be the preferred medication for by individuals who require constant attention and are exposed to hypobaric hypoxia.


Assuntos
Benzimidazóis/efeitos adversos , Cetirizina/efeitos adversos , Cognição/efeitos dos fármacos , Antagonistas dos Receptores Histamínicos H1 não Sedativos/efeitos adversos , Piperidinas/efeitos adversos , Adulto , Altitude , Antialérgicos/administração & dosagem , Antialérgicos/efeitos adversos , Câmaras de Exposição Atmosférica , Aviação , Benzimidazóis/administração & dosagem , Cetirizina/administração & dosagem , Estudos Cross-Over , Método Duplo-Cego , Feminino , Antagonistas dos Receptores Histamínicos H1 não Sedativos/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Piperidinas/administração & dosagem
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