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1.
J Laryngol Otol ; 135(10): 858-863, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34423758

RESUMO

OBJECTIVE: This study evaluated the post-operative indications for sinonasal topical steroid treatment using a corticosteroid (steroid)-eluting, sinus-bioabsorbable device and its effects in patients with eosinophilic chronic rhinosinusitis. METHOD: Post-operative courses were investigated in two groups: group A with patients who underwent sinonasal topical steroid treatment, and group B with control patients who did not. RESULTS: Group A was significantly younger than group B (p < 0.01), and the pre-operative computed tomography score was significantly higher in group A than in group B (p < 0.05). In the post-operative stage, the nasal symptoms questionnaire component of olfactory loss and the post-operative endoscopic appearance score were significantly worse in group A than in group B (p < 0.01). CONCLUSION: These data suggest that younger age, more severe rhinosinusitis and post-operative olfactory loss led to the need for sinonasal topical steroid treatment to prevent relapsing inflammation after functional endoscopic sinus surgery in patients with eosinophilic chronic rhinosinusitis.


Assuntos
Endoscopia/métodos , Seios Paranasais/cirurgia , Rinite/cirurgia , Sinusite/cirurgia , Esteroides/administração & dosagem , Implantes Absorvíveis/efeitos adversos , Administração Tópica , Adulto , Idoso , Estudos de Casos e Controles , Doença Crônica , Eosinofilia/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos do Olfato/epidemiologia , Seios Paranasais/efeitos dos fármacos , Período Pós-Operatório , Recidiva , Estudos Retrospectivos , Rinite/tratamento farmacológico , Índice de Gravidade de Doença , Sinusite/tratamento farmacológico , Esteroides/uso terapêutico , Tomografia Computadorizada por Raios X/estatística & dados numéricos
2.
Drug Deliv ; 28(1): 229-239, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33501873

RESUMO

PURPOSE: The work aimed to develop a co-loaded loratadine and sulpiride nasal nanoemulsion for allergic rhinitis management. METHODS: Compatibility studies were conducted adopting differential scanning calorimetry and Fourier transform infrared spectroscopy. Nanoemulsion formulations were prepared using soybean lecithin, olive oil and tween 80. Sodium cholate and glycerol were employed as co-surfactants. Nanoemulsions were assessed for viscosity, pH, droplet size, polydispersity index, zeta potential, electrical conductivity, entrapment, In vitro drug release and corresponding kinetics. Stability of the selected formulation was investigated. The biological effectiveness was evaluated in rabbit models of ovalbumin-induced allergic rhinitis by measuring TNF-α, TGF-ß and IL-1. RESULTS: Compatibility studies revealed absence of drug/drug interactions. Nanoemulsions exhibited > 90% entrapment efficiency. The selected nanoemulsion demonstrated small droplet size (85.2 ± 0.2 nm), low PDI (0.35 ± 0.0) and appropriate Zeta Potential (-23.3 ± 0.2) and stability. It also displayed enhanced in vitro drug release following the Higuashi Diffusion and Baker-Lonsdale models. The mean relative mRNA expression of TNF-α, IL-1 and TGF-ß significantly decreased from 9.59 ± 1.06, 4.15 ± 0.02 and 4.15 ± 0.02 to 1.28 ± 0.02, 1.93 ± 0.06 and 1.56 ± 0.02 respectively after treatment with the selected nanoemulsion formulation. CONCLUSION: The results reflected a promising potent effect of the combined loratadine and sulpiride nasal nanoemulsion in managing the symptoms of allergic rhinitis.


Assuntos
Antagonistas de Dopamina/administração & dosagem , Emulsões , Antagonistas não Sedativos dos Receptores H1 da Histamina/administração & dosagem , Loratadina/administração & dosagem , Mucosa Nasal/efeitos dos fármacos , Rinite Alérgica/metabolismo , Sulpirida/administração & dosagem , Tensoativos , Administração Intranasal , Animais , Varredura Diferencial de Calorimetria , Modelos Animais de Doenças , Antagonistas de Dopamina/farmacologia , Combinação de Medicamentos , Liberação Controlada de Fármacos , Glicerol , Antagonistas não Sedativos dos Receptores H1 da Histamina/farmacologia , Técnicas In Vitro , Interleucina-1/metabolismo , Lecitinas , Loratadina/farmacologia , Nanoestruturas , Mucosa Nasal/metabolismo , Azeite de Oliva , Ovalbumina , Seios Paranasais/efeitos dos fármacos , Seios Paranasais/metabolismo , Polissorbatos , Coelhos , Rinite Alérgica/induzido quimicamente , Colato de Sódio , Glycine max , Espectroscopia de Infravermelho com Transformada de Fourier , Sulpirida/farmacologia , Fator de Crescimento Transformador beta/efeitos dos fármacos , Fator de Crescimento Transformador beta/metabolismo , Fator de Necrose Tumoral alfa/efeitos dos fármacos , Fator de Necrose Tumoral alfa/metabolismo
3.
Int Forum Allergy Rhinol ; 10(5): 604-609, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32107886

RESUMO

BACKGROUND: Eosinophilic chronic rhinosinusitis (eCRS) is an inflammatory endotype of CRS. Contemporary treatment includes creation of a "neo-sinus" cavity and postoperative corticosteroid irrigations. Not all patients gain control with local therapy. This study aims to determine, in patients with polyp recurrence, the most common sinuses involved. METHODS: A prospective case-series was conducted on consecutive adult (≥18 years) post-FESS eCRS patients followed for a minimum of 12 months. All patients had a neo-sinus cavity created surgically and used corticosteroid irrigations daily for 3-6 months, then tapered to disease control. Sinus cavities were assessed by endoscopy on last follow-up. Polyp recurrence was defined as a score of 5 or 6 in the MLMES in ≥3 sinus cavities. Patient-reported outcomes based on SNOT22 and NSS, frequency of corticosteroid irrigations, and courses of systemic antibiotics and corticosteroid were collected. The pattern of sinus involvement was analyzed. RESULT: A total of 342 sinus cavities were assessed (mean ± standard deviation, 54.9 ± 13.4 years, 43.2% female). Polyp recurrence occurred in 4.3% (6.4% of patients, n = 7 unilateral) of sinus cavities. Frontal and ethmoid sinus cavities were most affected in those with polyp recurrence, compared to the maxilla and sphenoid (100% vs 100% vs 53% vs 53%, p < 0.01). Although those patients with polyp recurrence utilized more systemic corticosteroids courses per year (0.4 ± 0.4 vs 0.1 ± 0.3, p < 0.01), the use of corticosteroid irrigations was similar (% >4/week; 66.7% vs 48.9%, p = 0.13). Prior surgery was more common in patients with polyp recurrence (86.7% vs 53.5%, p = 0.01). CONCLUSION: The frontal and ethmoid sinuses were most affected in those patients with polyp recurrence. Whether the disease is more active in this location or topical therapy has limited access requires further evaluation.


Assuntos
Eosinofilia/patologia , Pólipos Nasais/patologia , Rinite/patologia , Sinusite/patologia , Adulto , Idoso , Doença Crônica , Eosinofilia/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pólipos Nasais/terapia , Seios Paranasais/efeitos dos fármacos , Seios Paranasais/patologia , Seios Paranasais/cirurgia , Estudos Prospectivos , Recidiva , Rinite/terapia , Sinusite/terapia
6.
Int Arch Allergy Immunol ; 179(4): 281-289, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31091524

RESUMO

BACKGROUND: Based on endoscopic examination, chronic rhinosinusitis (CRS) is divided into chronic inflammation with (CRSwNP) or without nasal polyps (CRSsNP). On the basis of the pathomechanism of inflammation, CRS is divided into endotypes. Eosinophilic CRSwNP with coexisting bronchial asthma and hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) is a real therapeutic challenge. AIM: Comparative analysis of the results of treatment of patients with CRSwNP, bronchial asthma, or hypersensitivity to NSAIDs (NSAID-exacerbated respiratory disease, NERD), using antileukotrienes (leukotriene receptor antagonists, LTRAs) or intranasal glucocorticoids or both drugs together after endoscopic sinus surgery (ESS). MATERIAL AND METHODS: 33 patients (11 male, 33%) with NERD divided into three groups treated with LTRAs or intranasal glucocorticoids or both drugs together were assessed in terms of general well-being, state of pathological changes, and olfactory disorders using the following tools: Sino-Nasal Outcome Test, Visual Analogue Scale, Brief Identification Smell Test, and Lund-Kennedy score before and at 12 months after surgery. CT assessments were made prior to surgery using the Lund-MacKay scale. RESULTS: Comparable efficacy of treatment with nasal steroids and antileukotrienes was found after 12 months of observation of patients. CONCLUSIONS: The results suggest comparable efficacy of treatment with nasal steroids and antileukotrienes in patients with NERD after ESS. Treatment with montelukast and mometasone has not been shown to be superior to both drugs administered separately.


Assuntos
Asma Induzida por Aspirina/tratamento farmacológico , Antagonistas de Leucotrienos/uso terapêutico , Pólipos Nasais/tratamento farmacológico , Seios Paranasais/efeitos dos fármacos , Rinite/tratamento farmacológico , Sinusite/tratamento farmacológico , Adulto , Idoso , Asma Induzida por Aspirina/complicações , Asma Induzida por Aspirina/cirurgia , Doença Crônica , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Pólipos Nasais/cirurgia , Seios Paranasais/cirurgia , Período Pós-Operatório , Rinite/cirurgia , Sinusite/cirurgia , Esteroides/uso terapêutico , Resultado do Tratamento
7.
J Manag Care Spec Pharm ; 25(8): 941-950, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30843454

RESUMO

BACKGROUND: A corticosteroid-eluting sinus implant was recently approved by the FDA as a drug to treat adult patients with nasal polyps who have undergone previous endoscopic sinus surgery (ESS) of the ethmoid sinuses. ESS is performed in an operating room under general anesthesia, whereby diseased tissue and bone are removed to provide improved drainage. ESS typically involves dissection of 1 or more of the 4 paired sinus cavities (maxillary, ethmoid, sphenoid, or frontal). The implant, containing 1,350 mcg of mometasone furoate, is inserted by a physician in an office setting and offers controlled localized release of corticosteroid to the polypoid sinus tissue. The implant has demonstrated significant improvements in clinical testing; however, little research has been conducted on its economic impact. OBJECTIVE: To evaluate and quantify the budget impact to a commercial payer of using this implant instead of ESS in patients with nasal polyps after a previous ESS. Since essentially all patients with recurrent nasal polyps after ESS are patients with chronic sinusitis (CS) diagnosis, this study also identified patients with CS with nasal polyposis (CSwNP) for consistency with the patient population studied in clinical trials evaluating the implant. METHODS: A budget impact analysis was conducted from a U.S. commercial payer perspective over a 1-year time horizon with patients who received the implant or revision ESS. Primary outcomes of interest were annual total and per-member per-month (PMPM) direct health care costs. Costs were estimated using a decision analysis model, assuming 50% implant utilization as an alternative to revision ESS in eligible patients, with other levels (25%, 75%) also considered. The model utilized the results of a recently published analysis of 86,052 patients in the Blue Health Intelligence database, results from published clinical trials evaluating the implant, a literature review, and published Medicare national payment amounts. RESULTS: A commercial health plan with 1 million members could anticipate 1,000 CSwNP patients as candidates for receiving the implant or revision ESS. Estimated direct treatment costs for refractory CSwNP using only revision ESS are $11.03 million ($0.92 PMPM). If the implant replaced surgery in 50% of cases and if 63% those patients received a second treatment with the implant during the year, the estimated total cost savings would be $2.56 million ($0.21 PMPM). Cost savings associated with using the implant changed to $0.11 PMPM and $0.32 PMPM with implant adoption of 25% and 75%, respectively. CONCLUSIONS: In a large commercially insured U.S. population, annual revision ESS costs are substantial. Using the implant instead of revision ESS could result in considerable cost savings for payers at various levels of adoption. DISCLOSURES: This study was sponsored by Intersect ENT, which was involved in study design and manuscript review. Ernst and Imhoff are employed by CTI Clinical Trial and Consulting Services, which contracted with Intersect ENT to conduct this study. Ernst and Imhoff also report other financial support from Intersect ENT during the conduct of the study. DeConde reports personal fees from Intersect ENT during the conduct of the study, as well as personal fees from Optinose, Stryker Endoscopy, and Olympus, outside the submitted work. Manes reports grants from Intersect ENT during the conduct of the study, as well as grants from Optinose and Sanofi outside the submitted work.


Assuntos
Doença Crônica/economia , Pólipos Nasais/economia , Próteses e Implantes/economia , Sinusite/economia , Esteroides/economia , Adolescente , Orçamentos , Doença Crônica/tratamento farmacológico , Endoscopia/métodos , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , Medicare/economia , Pólipos Nasais/tratamento farmacológico , Pólipos Nasais/cirurgia , Seios Paranasais/efeitos dos fármacos , Seios Paranasais/cirurgia , Sinusite/tratamento farmacológico , Sinusite/cirurgia , Esteroides/uso terapêutico , Resultado do Tratamento , Estados Unidos
8.
Eur Arch Otorhinolaryngol ; 276(5): 1397-1403, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30788581

RESUMO

PURPOSE: Budesonide improves the prognosis of chronic rhinosinusitis (CRS). However, few reports have examined whether its use for nasal irrigation, compared to normal saline, improves the prognosis of patients after endoscopic sinus surgery (ESS). We compared the effects of nasal irrigation with budesonide and normal saline in CRS patients after ESS. METHODS: Sixty CRS patients who had undergone ESS were randomly divided into an experimental group (30 patients), which used budesonide nasal irrigation, and a control group (30 patients), which used normal saline nasal irrigation. All patients received regular follow-up evaluations and were assessed via questionnaires, including the Lund-Kennedy endoscopic score (LKES), the symptom visual analog scale (VAS), the 22-item Sino-Nasal Outcome Test (SNOT-22), the Short-Form 36-Item Questionnaire (SF-36), the Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS) and a side effects scale. RESULTS: Scores of polyposis, mucosal edema, secretions and total score of LKES; VAS scores of nasal blockage, hyposmia and rhinorrhea; and SNOT-22 results in both groups were significantly improved 3 months after ESS. Scores of polyposis, mucosal edema, secretions and scarring and total score of LKES in experimental group were significantly better than in control group 3 months after ESS. No significant differences were observed in SF-36, SAS or SDS before or 3 months after ESS within or between the two groups. The side effects of the two groups were not significantly different. CONCLUSIONS: Nasal irrigation improved the prognosis of CRS patients after ESS. Budesonide nasal irrigation had a better effect than normal saline nasal irrigation.


Assuntos
Budesonida/administração & dosagem , Endoscopia , Lavagem Nasal/métodos , Obstrução Nasal , Seios Paranasais , Rinite , Sinusite , Adulto , Anti-Inflamatórios/administração & dosagem , Doença Crônica , Endoscopia/efeitos adversos , Endoscopia/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Obstrução Nasal/diagnóstico , Obstrução Nasal/etiologia , Obstrução Nasal/prevenção & controle , Seios Paranasais/diagnóstico por imagem , Seios Paranasais/efeitos dos fármacos , Seios Paranasais/cirurgia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/prevenção & controle , Prognóstico , Rinite/diagnóstico , Rinite/cirurgia , Sinusite/diagnóstico , Sinusite/cirurgia , Resultado do Tratamento
9.
Expert Rev Clin Pharmacol ; 11(12): 1163-1170, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30457411

RESUMO

Introduction: Chronic rhinosinusitis (CRS) is a broad heterogeneous inflammatory disorder of the nose and paranasal sinuses, resulting from the dysfunctional interplay between host immunity, defective epithelial barrier, and environmental factors. CRS with nasal polyps (CRSwNP) is considered a more severe clinical phenotype with greater burden of symptoms and higher relapse rate, especially with comorbid asthma or aspirin sensitivity. Available treatment options after endoscopic sinus surgery (ESS) - systemic corticosteroids or revision surgery - have significant risks and limitations. Areas covered: Bioabsorbable, steroid-eluting implants have been studied extensively for the ability to dilate and re-establish sinus patency by the localized, controlled delivery of topical corticosteroids to diseased sinonasal lining and nasal polyps. This review provides a comprehensive, up to date analysis of the literature regarding a novel, office-based, mometasone furoate (MF) sinus implant that may treat patients with recurrent CRSwNP after ESS. Expert commentary: Clinical evidence has demonstrated the safety and efficacy of steroid-eluting implant in the reduction of polyp size, symptom burden, and the need for revision sinus surgery. MF sinus implants may play an important role in the management of patients with recurrent polyposis after sinus surgery.


Assuntos
Furoato de Mometasona/administração & dosagem , Pólipos Nasais/tratamento farmacológico , Rinite/tratamento farmacológico , Sinusite/tratamento farmacológico , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/farmacologia , Doença Crônica , Implantes de Medicamento , Endoscopia/métodos , Humanos , Furoato de Mometasona/farmacologia , Pólipos Nasais/cirurgia , Seios Paranasais/efeitos dos fármacos , Seios Paranasais/patologia , Recidiva , Rinite/patologia , Sinusite/patologia
10.
Int Forum Allergy Rhinol ; 8(11): 1233-1241, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30281941

RESUMO

BACKGROUND: Postoperative care is an important factor affecting the outcome of endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS). The aim of this study was to test the effect of mometasone furoate (MF)-soaked biodegradable nasal dressings (BNDs) on endoscopic appearance in CRS patients with nasal polyps (CRSwNP) after ESS. METHODS: This study was a prospective, randomized, double-blinded, placebo-controlled study. A total of 64 CRSwNP patients with bilateral ESS were enrolled and randomly given 4 mL or 8 mL of MF-soaked BNDs (NasoPore) in 1 nasal cavity and the same amount of normal saline-soaked BNDs in the contralateral side. The BNDs were removed on the 7th or 14th postoperative day. Perioperative sinus endoscopy (POSE) and Lund-Kennedy scores were collected, on the 7th or 14th postoperative days and at 1, 2, and 3 postoperative months. RESULTS: The POSE and Lund-Kennedy scores showed that in the 4-mL, 1-week group, no significant differences between the sides treated with MF-soaked BNDs and the normal saline-soaked control were observed at any postoperative visits. In the 4-mL, 2-week group, significant differences were found at the 2-week and 1-month postoperative visits but not at the 2-month and 3-month visits. In the 8-mL, 1-week group, significant differences were found at the 1-week, 1-month, and 2-month postoperative visits but not at the 3-month visit. In the 8-mL, 2-week group, significant differences were found at all postoperative visits. CONCLUSION: This study reveals that MF-impregnated BNDs improve the endoscopic appearance in the healing process of CRSwNP after ESS.


Assuntos
Anti-Inflamatórios/administração & dosagem , Bandagens , Furoato de Mometasona/administração & dosagem , Pólipos Nasais/tratamento farmacológico , Rinite/tratamento farmacológico , Sinusite/tratamento farmacológico , Administração Intranasal , Adulto , Idoso , Doença Crônica , Método Duplo-Cego , Endoscopia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pólipos Nasais/cirurgia , Procedimentos Cirúrgicos Nasais , Seios Paranasais/efeitos dos fármacos , Seios Paranasais/cirurgia , Rinite/cirurgia , Sinusite/cirurgia , Cicatrização/efeitos dos fármacos , Adulto Jovem
11.
Int Forum Allergy Rhinol ; 8(4): 513-521, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29341450

RESUMO

BACKGROUND: Eosinophilic chronic rhinosinusitis (ECRS) is a disease characterized by eosinophilic inflammatory infiltrate and a local type 2 cytokine milieu. Current animal models fail to recapitulate many of the innate and adaptive immunologic hallmarks of the disease, thus hindering the development of effective therapeutics. In the present study, mice were exposed intranasally to the cysteine protease papain, which shares functional similarities with parasitic proteases and aeroallergens, to generate a rapidly inducible murine model of eosinophilic rhinosinusitis. METHODS: C57BL/6 mice were intranasally instilled with 20 µg papain or heat-inactivated papain (HP) on days 0-2 and days 7-10, and then euthanized on day 11. Nasal lavage fluid (NALF) was analyzed to quantify eosinophils and inflammatory cytokine secretion. Sinonasal tissue was sectioned and stained for goblet cells or homogenized to analyze cytokine levels. Serum samples were assayed for immunoglobulin E (IgE) by enzyme-linked immunoassay. Sinonasal mucosal tissue was dissociated and analyzed by flow cytometry. RESULTS: Compared with HP treatment, papain induced significant eosinophilia in NALF, goblet cell hyperplasia, innate and adaptive immune cell infiltration, type 2 cytokine production, and IgE responses. Flow cytometric analysis of sinonasal tissues revealed significant inflammatory cell infiltration and interleukin-13-producing cell populations. CONCLUSION: In this study, we demonstrated that the cysteine protease papain induces allergic sinonasal eosinophilic rhinosinusitis and resembles T-helper 2 cell inflammation and innate immune characteristics of ECRS. This model permits further study into the molecular mechanisms underlying ECRS pathology and provides a model system for the evaluation of potential pharmacologic interventions.


Assuntos
Modelos Animais de Doenças , Eosinófilos/efeitos dos fármacos , Papaína/toxicidade , Rinite/induzido quimicamente , Sinusite/induzido quimicamente , Animais , Doença Crônica , Citocinas/metabolismo , Eosinófilos/metabolismo , Feminino , Células Caliciformes/patologia , Masculino , Camundongos Endogâmicos C57BL , Líquido da Lavagem Nasal/citologia , Líquido da Lavagem Nasal/imunologia , Seios Paranasais/efeitos dos fármacos , Seios Paranasais/patologia , Rinite/sangue , Rinite/imunologia , Rinite/patologia , Sinusite/sangue , Sinusite/imunologia , Sinusite/patologia
12.
Int Forum Allergy Rhinol ; 8(4): 471-481, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29350840

RESUMO

BACKGROUND: Topical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid-eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 µg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days. METHODS: A randomized, sham-controlled, double-blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery. Eligible patients were randomized (2:1) and underwent in-office bilateral placement of 2 implants or a sham procedure. All patients used the MF INCS 200 µg once daily. Co-primary efficacy endpoints were the change from baseline in nasal obstruction/congestion score and bilateral polyp grade, as determined by an independent panel based on centralized, blinded videoendoscopy review. RESULTS: Patients treated with implants experienced significant reductions in both nasal obstruction/congestion score (p = 0.0074) and bilateral polyp grade (p = 0.0073) compared to controls. At day 90, implants were also associated with significant reductions in 4 of 5 prespecified secondary endpoints compared to control: proportion of patients still indicated for repeat sinus surgery (p = 0.0004), percent ethmoid sinus obstruction (p = 0.0007), nasal obstruction/congestion (p = 0.0248), and decreased sense of smell (p = 0.0470), but not facial pain/pressure (p = 0.9130). One patient experienced an implant-related serious adverse event (epistaxis). CONCLUSION: Significant improvements over a range of subjective and objective endpoints, including a reduction in the need for sinus surgery by 61%, suggest that MF sinus implants may play an important role in management of recurrent NP.


Assuntos
Implantes de Medicamento/uso terapêutico , Furoato de Mometasona/uso terapêutico , Mucosa Nasal/efeitos dos fármacos , Pólipos Nasais/terapia , Seios Paranasais/cirurgia , Sinusite/terapia , Adulto , Doença Crônica , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mucosa Nasal/fisiologia , Mucosa Nasal/efeitos da radiação , Seios Paranasais/efeitos dos fármacos , Seios Paranasais/patologia , Placebos , Recidiva
13.
Int Forum Allergy Rhinol ; 7(8): 813-820, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28558147

RESUMO

BACKGROUND: Postoperative wound healing after endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS) is an important factor in procedural success. Local steroids and separation of opposing mucosa are commonly implemented to optimize healing. A bioabsorbable, fluticasone propionate (FP)-eluting implant, SinuBand FP, was assessed for its safety and efficacy when used in patients with CRS and nasal polyps, who were indicated for ESS including bilateral anterior and posterior ethmoidectomy. METHODS: A first-in-human, randomized, partially double-blind, single-tertiary-referral-center, controlled trial enrolling 30 patients receiving 2 of 3 treatments (1 per sinus, intrapatient control): SinuBand FP, SinuBand (without FP), or standard nasal pack (Merocel®). Primary outcome measures were local safety, ocular safety (intraocular pressure [IOP], lens opacity), and 24-hour urine cortisol. Secondary measures (evaluated by independent review of postoperative video endoscopies) were ethmoid inflammation, polyp score, adhesion formation, and Lund-Kennedy score. Patient-reported outcomes of postoperative pain, nasal congestion, and nasal discharge were collected. RESULTS: Of 30 enrolled patients (used for safety analysis), 27 patients completed the trial. SinuBand FP showed local safety, ocular safety, and no significant change in 24-hour urine cortisol. SinuBand FP showed a trend to do better concerning inflammation. Concerning polyp score SinuBand FP did significantly better compared to Merocel (p = 0.03). No significance compared to SinuBand without corticosteroids (p = 0.97). Adhesions were comparable across treatments. Patient reported pain was nominally lower in the SinuBand group. CONCLUSION: SinuBand FP was well tolerated and showed evidence of efficacy. A larger study is needed to further evaluate and confirm the benefits of SinuBand FP.


Assuntos
Implantes Absorvíveis , Anti-Inflamatórios/administração & dosagem , Implantes de Medicamento/administração & dosagem , Fluticasona/administração & dosagem , Procedimentos Cirúrgicos Nasais , Adulto , Idoso , Idoso de 80 Anos ou mais , Método Duplo-Cego , Endoscopia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Seios Paranasais/efeitos dos fármacos , Seios Paranasais/cirurgia , Período Pós-Operatório , Resultado do Tratamento , Adulto Jovem
14.
Am J Rhinol Allergy ; 31(2): 96-104, 2017 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-28452705

RESUMO

BACKGROUND: Upper airway inflammation is one of the most commonly identified causes of chronic cough, although the underlying mechanism is not clear. This study compared normal saline solution nasal-pharyngeal irrigation (NSNPI) and fluticasone propionate nasal spray (FPNS) treatment for chronic cough associated with allergic rhinitis (AR). METHODS: Patients with suspected AR to house-dust mite were enrolled, and the symptom of cough was assessed by a cough symptom score and the Leicester Cough Questionnaire, and cough response to capsaicin was evaluated. AR was assessed by using the visual analog scale (VAS) and the Mini Juniper Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ). Mediators, including histamine, leukotriene C4, and prostaglandin D2, and the major basic protein from nasal lavage fluid (NLF) were examined. The patients were treated with NSNPI (the NSNPI group) or FPNS (the FPNS group) for 30 days, after which they were reassessed. RESULTS: Forty-five of 50 patients completed this study. The scores of the cough symptom and the Leicester Cough Questionnaire, and the capsaicin cough threshold all improved statistically after NSNPI but did not change after FPNS. There were statistically significant changes in the evaluations of the MiniRQLQ and the mediators, including histamine and leukotriene C4, in the NLF in the NSNPI group. However, significant changes were found in the assessments of VAS, MiniRQLQ, and all above mediators including histamine, leukotriene C4, and prostaglandin D2, and the major basic protein in the NLF of the FPNS group. Furthermore, the assessments of VAS and all the mediators were reduced more in the FPNS group compared with those in the NSNPI group. CONCLUSION: The patients with suspected AR to house-dust mite reported a better relief of the cough symptom after 30 days of treatment with NSNPI compared with that after nasal corticosteroid.


Assuntos
Tonsila Faríngea/patologia , Tosse/prevenção & controle , Fluticasona/uso terapêutico , Seios Paranasais/patologia , Rinite Alérgica/terapia , Cloreto de Sódio/uso terapêutico , Irrigação Terapêutica , Tonsila Faríngea/efeitos dos fármacos , Adolescente , Adulto , Idoso , Animais , Antígenos de Dermatophagoides/imunologia , Doença Crônica , Tosse/etiologia , Humanos , Pessoa de Meia-Idade , Sprays Nasais , Seios Paranasais/efeitos dos fármacos , Pyroglyphidae/imunologia , Rinite Alérgica/complicações , Adulto Jovem
15.
Am J Rhinol Allergy ; 30(6): 414-417, 2016 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-28124652

RESUMO

BACKGROUND: Topical antibiotics, delivered optimally as high-volume culture-directed sinus irrigations, are being increasingly used for recalcitrant chronic rhinosinusitis (CRS). Their impact on subjective and objective outcome measures, however, is still unclear. OBJECTIVE: To assess if the use of topical antibiotics in recalcitrant CRS is associated with improved 20-Item Sino-Nasal Outcome Test and Lund-Kennedy endoscopic scores, and to determine the negative posttreatment culture "control" rate. METHODS: Patients were included in the study if they met diagnostic criteria for CRS, received high-volume topical antibiotic sinus irrigations twice daily for 1 month, between December 2009 and May 2015, and had undergone endoscopic sinus surgery. The primary outcome was the 20-Item Sino-Nasal Outcome Test score. Secondary outcomes were the Lund-Kennedy endoscopic score and a negative posttreatment culture "control" rate. Paired t-tests were used to compare pre- and posttreatment scores. Patients with cystic fibrosis were analyzed separately. RESULTS: Of the 58 patients included, 47% had nasal polyposis, 57% had asthma, 16% had aspirin sensitivity, and 55% had environmental allergies. The median Lund-Mackay computed tomography score was 11 (interquartile range, 6-16), and the median time to follow-up was 8 weeks (interquartile range, 6-10 weeks). The 20-Item Sino-Nasal Outcome Test scores improved from pre- to posttreatment period, although this was not significant mean 1.5 [confidence interval {CI} 1.3, 1.7] to mean 1.3 [CI 1.1, 1.6]; p = 0.16). Lund-Kennedy endoscopic scores, however, significantly improved from pre- to posttreatment (mean 4.9 [CI 4.3, 5.6] to mean 4.1 [CI 3.5, 4.7]; p = 0.05). Of the 47 patients with complete culture data, 72% had negative posttreatment culture results, defined as "controlled." Only one patient discontinued treatment, related to discomfort from irrigations. CONCLUSION: In patients with recalcitrant CRS, the use of topical antibiotics trended toward improvement in symptom severity and significantly improved endoscopic appearance. Furthermore, 72% had negative posttreatment culture results, meaning microbiological "control." The results of this study support the use of high-volume culture-directed topical antibiotics, and, in the future, more rigorous prospective studies are warranted.


Assuntos
Antibacterianos/uso terapêutico , Seios Paranasais/efeitos dos fármacos , Rinite/tratamento farmacológico , Sinusite/tratamento farmacológico , Irrigação Terapêutica , Administração Tópica , Doença Crônica , Endoscopia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Seios Paranasais/microbiologia , Seios Paranasais/patologia , Recidiva , Resultado do Tratamento
16.
Adv Exp Med Biol ; 884: 13-9, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26542595

RESUMO

Granulomatosis with polyangiitis (GPA), a disease capable of affecting any organ, most often acts upon the upper respiratory tract. Diagnostic imaging is primarily represented by computed tomography (CT) of paranasal sinuses. The aim of this study was to define the characteristic changes in paranasal CT in patients with GPA and to evaluate diagnostic usefulness of the Lund-Mackey scoring system (L-M System). The study encompassed 43 patients with GPA of the mean age of 47.7 ± 12.8 years who were treated topically with mupirocin. We found that inflammation occurred mainly in the maxillary sinuses (72%). The mean L-M score was 5.8 ± 6.1. The right maxillary sinus had the highest percentage (12.6%) of score hits of 1, i.e., partial opacification and the left ostiomeatal complex had the highest percentage (7.6%) of score of 2, i.e., complete opacification or obstruction. The following changes were the most characteristic for GPA: sinus mucosal thickening, widespread bone damage, and osteogenesis. We conclude that the long-term topical mupirocin treatment of GPA may inhibit nasal bone damage, but also may led to permanent rhinological changes of the rhinosinusitis type. The Lund-Mackey staging system is a useful diagnostic imaging option in GPA patients.


Assuntos
Granulomatose com Poliangiite/diagnóstico por imagem , Tomografia Computadorizada Multidetectores , Seios Paranasais/diagnóstico por imagem , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Administração Tópica , Adulto , Antibacterianos/administração & dosagem , Feminino , Granulomatose com Poliangiite/tratamento farmacológico , Humanos , Masculino , Seio Maxilar/diagnóstico por imagem , Pessoa de Meia-Idade , Mupirocina/administração & dosagem , Osso Nasal/diagnóstico por imagem , Mucosa Nasal/diagnóstico por imagem , Osteogênese , Seios Paranasais/efeitos dos fármacos , Valor Preditivo dos Testes , Resultado do Tratamento
17.
Int Forum Allergy Rhinol ; 6(3): 233-7, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26679480

RESUMO

BACKGROUND: Nasal steroids are a critical part of the management of patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) after endoscopic sinus surgery (ESS). Increasingly, practitioners are using budesonide respules delivered to the sinonasal cavities, which is an off-label use, in lieu of traditional nasal steroids. There has been little research comparing budesonide with traditional nasal steroids and the most effective delivery method of budesonide. METHODS: A randomized controlled trial was performed on patients after ESS for CRSwNP in a tertiary care center. Patients were randomized into 1 of 3 groups: group A received fluticasone nasal spray twice daily; group B received budesonide respules via a mucosal atomization device (MAD) twice daily; and group C received budesonide respules instilled via the vertex-to-floor (VF) position twice daily. Primary endpoints were 22-item Sino-Nasal Outcome Test (SNOT-22) and Lund-Kennedy scores at 6 months. RESULTS: Thirty-two patients were enrolled in the study, 23 of whom completed the 6-month trial. There were no significant differences among groups A, B, and C with respect to age, gender, asthma, aspirin sensitivity, or previous ESS. Group B had a statistically significant greater reduction in SNOT-22 and Lund-Kennedy scores at the primary endpoint of 6 months compared to groups A and C. Group C had the next greatest reduction, which was statistically significant, followed by group A. CONCLUSION: Patients treated with budesonide after ESS for CRSwNP had greater improvement in SNOT-22 and Lund-Kennedy scores compared to fluticasone at 6 months. The data supports the use of budesonide respules, particularly with a MAD, over fluticasone for CRSwNP patients after ESS.


Assuntos
Budesonida/uso terapêutico , Fluticasona/uso terapêutico , Pólipos Nasais/tratamento farmacológico , Seios Paranasais/efeitos dos fármacos , Rinite/tratamento farmacológico , Sinusite/tratamento farmacológico , Adulto , Doença Crônica , Endoscopia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pólipos Nasais/cirurgia , Sprays Nasais , Nebulizadores e Vaporizadores , Seios Paranasais/cirurgia , Rinite/cirurgia , Rinoplastia , Sinusite/cirurgia , Resultado do Tratamento
18.
Vojnosanit Pregl ; 72(10): 937-41, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26665562

RESUMO

INTRODUCTION: Primary mucosal melanoma of the sinonasal tract is a rare neoplasm, accounting for less than 1% of all melanomas. It has an aggressive and unpredictable biologic behavior characterized by frequent incidence of local recurrence, local and distant metastasis of the disease. CASE REPORT: This report summarizes the results of the previous research concerning sinonasal mucosal melanoma, and by the example of the two patients suffering from mucosal melanoma, we described clinical and histopathological features of this rare neoplasm and our experience in its diagnosis and treatment. CONCLUSION: Only histopathological analysis complemented by immunobistochemical analysis contributes to early and accurate diagnosis of the disease.


Assuntos
Melanoma/patologia , Mucosa Nasal/patologia , Neoplasias dos Seios Paranasais/patologia , Seios Paranasais/patologia , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Biomarcadores Tumorais/análise , Biópsia , Feminino , Humanos , Imuno-Histoquímica , Masculino , Melanoma/química , Melanoma/terapia , Mucosa Nasal/química , Mucosa Nasal/efeitos dos fármacos , Mucosa Nasal/cirurgia , Cuidados Paliativos , Neoplasias dos Seios Paranasais/química , Neoplasias dos Seios Paranasais/terapia , Seios Paranasais/química , Seios Paranasais/efeitos dos fármacos , Seios Paranasais/cirurgia , Radioterapia Adjuvante , Tomografia Computadorizada por Raios X , Resultado do Tratamento
19.
Am J Rhinol Allergy ; 29(6): 435-40, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26637583

RESUMO

BACKGROUND: Fungus-driven inflammation is proposed to play an important role in the pathogenesis of chronic rhinosinusitis (CRS). Previous studies evaluated the efficacy of intranasal amphotericin B (AMB) in the treatment of patients with CRS, but the results were controversial. The purpose of this study was to evaluate the efficacy of 100 µg/mL of AMB nasal irrigation as postoperative care after functional endoscopic sinus surgery (FESS). METHODS: Patients with CRS who received FESS for treatment were recruited and randomly assigned to two groups at 1 month after surgery. Patients in the AMB group received 100 µg/mL of AMB nasal irrigation daily for 2 months, and those in the normal saline (NS) group received NS solution nasal irrigation daily for 2 months. Pre-FESS, pre-irrigation, and postirrigation sinonasal symptoms were assessed by questionnaires, and the patients received endoscopic examination, acoustic rhinometry, smell test, and saccharine transit test. RESULTS: Seventy-seven patients were enrolled between June 2012 and December 2014. Among the patients who completed the study, 38 received AMB irrigation, and 39 received NS solution irrigation. Although all the patients reported improvement after irrigation, there was no difference in outcome between patients who received AMB and those who received NS solution. CONCLUSION: Our study showed that nasal irrigation with 100 µg/mL of AMB did not confer a greater benefit than that of NS solution nasal irrigation in post-FESS care.


Assuntos
Anfotericina B/administração & dosagem , Endoscopia/métodos , Lavagem Nasal/métodos , Cuidados Pós-Operatórios/métodos , Rinite/cirurgia , Sinusite/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/administração & dosagem , Doença Crônica , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Seios Paranasais/efeitos dos fármacos , Seios Paranasais/cirurgia , Estudos Retrospectivos , Rinite/tratamento farmacológico , Sinusite/tratamento farmacológico , Resultado do Tratamento , Adulto Jovem
20.
J Pediatric Infect Dis Soc ; 4(2): 163-70, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-26407418
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