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1.
Article | IMSEAR | ID: sea-219169

ABSTRACT

Introduction:Adenoidectomy is currently considered the treatment of choice for relief of the nasal airway obstruction due to adenoid hypertrophy. Evidence suggests that topical nasal steroid sprays can cause a reduction in adenoid size. We aim to compare the effectiveness of fluticasone propionate, mometasone furoate (MF) and saline nasal sprays in relieving the signs and symptoms of adenoid hypertrophy and in reducing the size of the adenoids. MaterialsandMethods: We conducted a randomized comparative study on 60 patients divided into three groups A, B, C (20 each). Group A patients treated with fluticasone propionate nasal spray (400 μg/day), Group B patients treated with MF nasal spray (100 μg/day), and Group C patients treated with saline spray (0.65% w/v in purified water which is made isotonic and buffered). Treatment was given up to 12 weeks with follow‑up at 4, 8, and 12 weeks and at each follow‑up visit assessment was done. Final data were analyzed using SPSS software version 21 and numerical variables associated with different groups were analyzed and analysis of variance test was used. Results: Diagnostic nasal endoscopy and X‑ray grades at day 1 among the study groups were not statistically significant, whereas, at 12 weeks results among fluticasone and mometasone groups were significantly better (P < 0.001) as compared to the saline group. There was a significant improvement in the symptoms under all the categories with the use of fluticasone and mometasone. Conclusion: In our study, both fluticasone propionate and MF were able to effectively reduce symptoms and signs of adenoid hypertrophy as well as help in reducing the size of the enlarged adenoid. Both these drugs were well tolerated by the patients

2.
Journal of Chinese Physician ; (12): 406-410, 2023.
Article in Chinese | WPRIM | ID: wpr-992318

ABSTRACT

Objective:To investigate the effects of fractional CO 2 laser, focused ultrasound and simple drug treatment of gynecological vulva white lesions. Methods:A prospective study was conducted on 126 patients with white lesions of the vulva admitted to Hainan Cancer Hospital from August 2018 to December 2020. They were divided into drug group, focused ultrasound group and fractional CO 2 laser group by random number table method, with 42 patients in each group. The drug group was treated with mometasone furoate cream or dexamethasone acetate cream, and the focused ultrasound group was treated with focused ultrasound; the fractional CO 2 laser group was treated with fractional CO 2 laser. The serum interleukin-2 (IL-2), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and human epidermal growth factor (EGF) levels before and after treatment, and Visual Analogue Scale (VAS) and Dermatology Life Quality Index (DLQI) scores of the three groups were compared. Results:Before treatment, there was no significant difference in the levels of IL-2, TNF-α, CRP and EGF among the three groups (all P>0.05). After treatment, the levels of IL-2, TNF-α, CRP and EGF in the three groups were significantly decreased, and the levels of IL-2, TNF-α, CRP and EGF in the focused ultrasound group and fractional CO 2 laser group were lower than those in the drug group, with statistically significant difference (all P<0.05). Before treatment, there was no significant difference in the white lesions, dry pruritus, sexual pain and chapped skin scores of the three groups (all P>0.05); After treatment, scores of all dimensions of the three groups were significantly decreased, and scores of all dimensions of the focused ultrasound group and fractional CO 2 laser were lower than those of the drug group, with statistical significance (all P<0.05). Before treatment, there was no significant difference in the scores of symptoms and feelings, daily activities and interpersonal relationship of the three groups (all P>0.05); After treatment, scores of all dimensions of the three groups were significantly decreased, and scores of all dimensions of the focused ultrasound group and fractional CO 2 laser were lower than those of the drug group, with statistical significance (all P<0.05). Conclusions:Fractional CO 2 laser has a remarkable effect in the treatment of gynecological vulva white lesions, which can reduce the level of inflammatory factors in patients, improve the pain condition, and improve the quality of life.

3.
Braz. j. otorhinolaryngol. (Impr.) ; 88(supl.5): 148-155, Nov.-Dec. 2022. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1420891

ABSTRACT

Abstract Objectives: Nigella sativa oil is known antiallergic and immunomodulatory effects. We aimed to compare this oil with mometasone furoate, a topical steroid, on a rat model in the prevention of allergic rhinitis symptoms. Methods: A total of 28 two-to-four-month-old Wistar Hannover rats weighing 250-350 g were randomly divided into four groups of seven, which included control, allergic rhinitis, mometasone furoate, and Nigella sativa oil groups. Loss of cilia, an increase of goblet cells, vascular proliferation, inflammatory cell count, eosinophil infiltration, and the degree of hypertrophy in chondrocytes were assessed by light microscopy. Results: The frequency of nasal scratching in the Nigella sativa oil group was found to be significantly lower compared with the allergic rhinitis group (p < 0.05). Typical inflammatory changes seen in allergic rhinitis were not detected in the Nigella sativa oil group. No inflammation was observed in 85.7% of both the healthy control group and the Nigella sativa oil group. In addition, no inflammation was observed in 71.4% of the mometasone furoate group, and this difference was found to be significant compared with the control group (p < 0.05). In addition, eosinophil infiltration, cilia loss, chondrocyte hypertrophy, vascular proliferation, and goblet cell increase were found to be significantly decreased in the mometazone furoate and Nigella sativa oil groups compared to the allergic rhinitis group (p < 0.05). Conclusion: According to the findings obtained from this study, we found anti-inflammatory and anti-allergic effects of Nigella sativa oil as equally effective as mometasone furoate in the treatment of experimentaly generated allergic rhinitis. Level of evidence: IV.

4.
Journal of Pharmaceutical Practice ; (6): 152-156, 2021.
Article in Chinese | WPRIM | ID: wpr-875677

ABSTRACT

Objective To establish a RP-HPLC method for determination of ketoconazole, mupirocin and mometasone furoate in compound ketoconazole ointment. Methods RP-HPLC was conducted on a Intersil ODS-3 column (250 mm×4.6 mm, 5 μm), with methanol-PBS with pH 5.5 (65:35) as the mobile phase and the column temperature was 45 ℃. The flow rate was 1.0 ml/min, and the detection wavelength was 248 nm. Results The methodological verification showed that ketoconazole, mupirocin and mometasone furoate had a good linearity (r≥0.9995). The inter/intra-day precisions were less than 3.0%, The recovery rates were between 90% and 108%. The stability and repeatability of RSD were also less than 3.0%, which met the requirements of method validation. The contents of the three components in three batches were determined by the new method. Conclusion The method is simple and reliable. It can provide a basis for the quality control of compound ketoconazole ointment and lay a foundation for its quality standard research.

5.
Article | IMSEAR | ID: sea-215346

ABSTRACT

Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation, bronchoconstriction and airway hyper responsiveness. The addition of an inhaled corticosteroid (ICS) to an inhaled long-acting β2-agonist (LABA) gives optimal control of asthma in most patients. There are few international studies regarding efficacy and safety of LABA/ICS. But in India there is paucity of such studies. Hence the present study was undertaken.METHODSA comparative, prospective, observational study was conducted among 120 patients attending the Out Patient Department of Chest Medicine and Pharmacology of Burdwan Medical College and Hospital, diagnosed as having mild to moderate chronic stable persistent bronchial asthma, receiving combination of LABA and ICS therapy, out of which 16 patients were lost due to follow up, and 104 patients were studied. Patients were divided into 2 groups. Group A received respicaps of combined formoterol 6 μg and budesonide 400 μg DPI, Group B received combined formoterol 6 μg and mometasone 400 μg DPI, twice daily. During exacerbations inhaled salbutamol was utilized as rescue medication. Spirometric parameters, clinical parameters, and adverse effects were recorded on three visits (at 4th, 8th and 12th weeks) and analysed by using different statistical tests.RESULTSComparable clinical improvement of spirometric parameters, Asthma Control Test score of both groups were observed (p-value>0.05). Adverse effects like tremor, pharyngitis, headache, oral candidiasis and dysphonia were recorded among both the groups which was statistically insignificant.CONCLUSIONPatients who received ICS with LABA in both groups experienced a statistically significant improvement in symptoms. Improvement was seen in spirometric parameters as well with a comparable degree of safety

6.
Journal of Pharmaceutical Practice ; (6): 322-327, 2020.
Article in Chinese | WPRIM | ID: wpr-823098

ABSTRACT

Objective To evaluate the pharmacodynamics and safety of the self-made compound ketoconazole ointment. Methods Using the disk diffusion test, 6 kinds of fungi and 2 kinds of bacteria were selected to investigate the effect of the self-made ointment and 3 commercial products on the diameter of the bacteriostatic circle. In addition, the skin irritation and skin allergies of the single and multiple applications were used to evaluate the safety of the self-made ointment. Results The self-made ointment was similar to the commercial products containing ketoconazole. They all showed remarkable bacteriostatic circle against the 6 kinds of fungi. For pseudomonas aeruginosa, none of the preparations contributed to visible bacteriostatic circle. For staphylococcus aureus, the bacteriostatic circle of the self-made ointment was similar to that of commercial mupirocin ointment and was significantly larger than other commercial products. After the treatment with the self-made ointment, the score of the skin irritation was below 0.5 and the sensitization rate was 0. There was no difference in tissue structure between treated and normal skin. Conclusion The self-made compound ketoconazole ointment has better safety and better antibacterial property than the commercial products. It is expected to be used for the treatment of superficial skin fugle infections.

7.
Int. arch. otorhinolaryngol. (Impr.) ; 23(3): 325-330, July-Sept. 2019. tab
Article in English | LILACS | ID: biblio-1040031

ABSTRACT

Abstract Introduction Oral antihistamines and intranasal corticosteroids have been shown to be effective and safe for the treatment of allergic rhinitis; however, the evidence suggests a level of superiority of corticosteroids, so they should be preferred over the former. Objective To know the prescription profile of two second generation antihistamines (cetirizine and levocetirizine) and two nasal corticosteroids (mometasone and furoateciclesonide) in a cohort of patients with allergic rhinitis, and to compare the clinical outcomes obtained. Methods A cohort study was carried including patients with allergic rhinitis treated with cetirizine, levocetirizine, mometasone furoate or ciclesonide. The improvement was evaluated with the total nasal symptoms score (TNSS). This scale yields results between 0 and 12. Zero indicates absence of symptoms. Results A total of 314 patients completed 12 weeks of follow-up. Seventy-five percent were treated with antihistamines, 20% with corticosteroids, and 5% with a combination of the above. The TNSS median for corticosteroid was 2.5 points; for antihistamines, its was 5 points, and for combination, it was 4 points. We found differences between corticosteroids and antihistamines. Conclusion The prescription percentage of second generation oral antihistamines is higher than that of intranasal corticosteroids. However, patients with allergic rhinitis treated with the second option obtained better control of symptoms.


Subject(s)
Humans , Male , Female , Infant , Child, Preschool , Child , Adolescent , Adult , Middle Aged , Aged , Aged, 80 and over , Adrenal Cortex Hormones/therapeutic use , Rhinitis, Allergic/drug therapy , Histamine Antagonists/therapeutic use , Drug Prescriptions , Administration, Intranasal , Cohort Studies , Treatment Outcome , Cetirizine/therapeutic use , Adrenal Cortex Hormones/administration & dosage , Colombia , Mometasone Furoate/therapeutic use
8.
Int J Pharm Pharm Sci ; 2019 Feb; 11(2): 12-16
Article | IMSEAR | ID: sea-205825

ABSTRACT

Objective: To develop and validate a simple and sensitive RP-HPLC method for the simultaneous determination of mometasone furoate (MOM) and formoterol fumarate (FOR) in pharmaceutical dosage forms. Methods: In RP-HPLC method, chromatographic separation was achieved using a mixture of a solvent system consisting of methanol–water (pH 3.5) in the ratio of 85:15 % v/v at a flow rate of 1 ml/min and detection was carried out at 225 nm. Results: The run time for the simultaneous estimation of drugs for the proposed method was 10 min as drugs eluted at 5.217 min (MOM) and 8.650 min (FOR). The linearity was found in the range of 33.33-299.97 μg/ml and 1-9 μg/ml for MOM and FOR, respectively. The values of limit of detection and limit of quantification were 3.634, 0.266 µg/ml and 11.014, 0.807 µg/ml, which indicates the sensitivity of the method for the estimation of MOM and FOR, respectively. The results of recovery studies for both the drugs were within the range i.e. 98.87-101.48 % which indicates the accuracy of the method. Relative standard deviation obtained from repeatability and reproducibility studies were less than 2% indicates the precision of the method. The proposed method was validated according to ICH guidelines. Conclusion: The proposed RP-HPLC method was found to be sensitive and precise because of the low LOD, LOQ and % RSD values (<2). The proposed work does not require acetonitrile and ion pairing reagent as compared to the reported methods. Therefore, method can be used preferably for routine analysis due to its simplicity and economic advantages.

9.
Article | IMSEAR | ID: sea-200840

ABSTRACT

Aim: To compare the therapeutic efficacy and safety of Rupatadine and mometasone with Levocetirizine which is most commonly used drug.To study the effects of levocetirizine, Rupatadine and mometasone on absolute eosino-phil count and IgE levels. Methodology:The participants were randomlydivided into 3 groups of 25 patients each and treated as follows: Group I: were treated with Levocetirizine 5mg OD for 14 days, Group II: were treated with Rupatadine 10mg OD for 14 days, Group III: were treated with Mometasone two sprays (50mcg of mometasone in each spray) in each nostril once daily (total daily dose of 200mcg) for 14 days. The patients were asked to report at the hospital after 14 day and they were followed up with regard to clinical improvement of symptoms and signs and any adverse effects as reported by the patient. Rhinoscopy finding, X-ray of para nasal sinus, improvement in symp-toms (sneezing, Itching, nasal discharge, nasal blockage and anosmia) Absolute eosinophils count, Serum IgE levels and adverse reports were studied and investigation were compared before and after treatment. Result: Rhinoscope finding showed treatment with mometasone became normal but X-Ray of para nasal sinus results showed levocetir-zine showed higher rate of improvement. In improvement of symptoms sneezing, itching and nasal discharge was high mometasone. In all groups post treatment there was no changes in Ig E and Absolute Eosinophil’s count. ADR reported with mometaxone. Conclusion: The three drugs, levocetirizine, rupatadine and mometasone were found to have similar levels of efficacy in controlling the symptoms of the allergic rhinitis. The physical signs improved better with mometasone than the other 2 drugs. The 3 drugs levocetirizine, rupatadine and mometasone had no significant effect on the absolute eosinophil count and the serum IgE levels. Adverse effects were found to be more with levoce-tirizine than the other two drugs. Considering this factor and also the fact that long term use of corticosteroids like mometasone is undesirable, rupatadine appears to be a better choice in the treatment of allergic rhinitis.

10.
China Pharmacy ; (12): 530-533, 2018.
Article in Chinese | WPRIM | ID: wpr-704621

ABSTRACT

OBJECTIVE: To investigate the effects of Yupingfeng granules on immune function and related indexes of children with allergic rhinitis (AR) complicated with bronchial asthma (BA). METHODS: Clinical information of 101 children with AR complicated with BA during Feb. 2014-Sept. 2017 were analyzed retrospectively, and they were divided into control group (47 cases) and observation group (54 cases) according to treatment plan. Control group was given Salmeterol xinafoate and fluticasone propionate powder for inhalation through mouth, one inhalation, twice a day+Mometasone furoate nasal spray 50 μg each nostril. Observation group was additionally given Yupingfeng granules 5 g orally, 3 times a day, for consecutive 2 weeks, drug withdrawal at 2 weeks interval, recycled 3 times. Both groups received treatment for consecutive 3 months. Clinical symptom and sign scores, the levels of T-lymphocyte subgroup (CD4+, CD8+, CD4+/CD8+), IL-4, IFN-γ and IgE before and after treatment, the occurrence of ADR were observed in 2 groups. RESULTS: Before treatment, there was no statistical significance in clinical symptom and sign scores, levels of T-lymphocyte subgroup, serum levels of IL-4, IFN-γ or IgE between 2 groups (P>0. 05). After treatment, clinical symptom and sign scores, CD4+, CD4+/CD8+, serum levels of IL-4 and IgE in 2 groups were all significantly lower than before treatment; observation group was significantly lower than control group. CD8+ and serum levels of IFN-y in 2 groups after treatment were significantly higher than before treatment; observation group was significantly higher than control group, with statistical significance (P<0. 05). There was no statistical significance in the incidence of ADR between 2 groups (P>0. 05). CONCLUSIONS: Yupingfeng granules can effectively improve immune function of children with AR complicated with BA, and relieve clinical symptom without increasing the occurrence of ADR.

11.
Rev. Univ. Ind. Santander, Salud ; 49(2): 340-350, Abril 5, 2017. tab, graf
Article in Spanish | LILACS | ID: biblio-897105

ABSTRACT

Resumen Introducción: La rinosinusitis aguda (RSA) es frecuente en primer nivel de atención y los pacientes pueden mejorar sin antibióticos.Objetivo: Análisis de costo efectividad de furoato de mometasona spray nasal (FMSN) comparado con amoxicilina en tratamiento de rinosinusitis aguda en México desde punto de vista del Sistema Nacional de Salud. Método: Análisis costo-efectividad comparando FMSN 200 mg dos veces al día y amoxicilina 500 mg tres veces al día. Resultados en términos de eficacia modelados como cambios en sistema de Calificación de Síntomas Mayores (MSS por siglas inglés). MSS consiste en cinco preguntas: rinorrea, goteo retro nasal, congestión, cefalea sinusal y dolor facial. Datos clínicos obtenidos de ensayo clínico aleatorizado. Costos expresados en pesos mexicanos 2016. Se realizó análisis de sensibilidad univariable y multivariables para algunos parámetros utilizados en el modelo. Resultados: Los costos proyectados fueron de $3,261 pesos con FMSN y $3,438 pesos con amoxicilina. FMSN fue asociado con ahorro de costos por paciente de $177 pesos comparado con amoxicilina en un periodo de dos semanas. La tasa incremental de costo-efectividad del FMSN lo ubica como dominante frente a amoxicilina. El análisis de sensibilidad confirma los ahorros globales de costos y la superioridad en términos de la eficacia. Conclusión: En pacientes con rinosinusitis aguda, no complicada, el tratamiento del, FMSN 200 mcg dos veces al día, produjo mejoras significativas de los síntomas en comparación con amoxicilina en pacientes sin infecciones bacterianas y es una alternativa costo efectiva para el Sistema Nacional de Salud Mexicano. Comentario editorial al finalizar el artículo.


Abstract Introduction: Acute rhinosinusitis (RSA) is a common cause of consultation on first level of attention and it can be solved without antibiotics use. Objective: Analysis of cost effectiveness of nasal spray mometasone furoate (NSMF) compared to amoxicillin in treatment of acute rhinosinusitis in Mexico from a National Mexican Health System perspective. Methods: Cost-effectiveness analysis comparing NSMF 200µg twice daily and amoxicillin 500mg three time daily. The effectiveness outcomes of the study were modeled as changes in the Major Symptom Score (MSS). MSS consists of five questions concerning rhinorrhea, post-nasal drip, nasal congestion, sinus headache, and facial pain. Clinical data were obtained from a randomized clinical trial. Cost were expressed in Mexican pesos 2016. Sensitivity analysis was conducted univariable and multivariable for some model parameters. Results: The projected costs were $3,261 pesos with NSMF and $3,438 pesos with amoxicillin. NSMF was associated with a cost savings per patient of $177 pesos versus amoxicillin over a 2 weeks period. The incremental cost-effectiveness ratio for NSMF dominated amoxicillin. The sensitivity analysis confirms overall cost savings and superiority in terms of effectiveness. Conclusion: In patients with non-complicated acute rhinosinusitis NSMF 200 µg twice daily produce significantly an improvement in symptoms compared to amoxicillin in patients without bacterial infections and is a cost-effective alternative for the National Health Mexican System. Editorial comment at the end of this article.


Subject(s)
Humans , Nose Diseases , Therapeutics , Cost-Benefit Analysis , Mometasone Furoate , Mexico
12.
Chinese Archives of Otolaryngology-Head and Neck Surgery ; (12): 95-98, 2017.
Article in Chinese | WPRIM | ID: wpr-692154

ABSTRACT

OBJECTIVE To compare the effect of intranasal corticosteroids-gelatin sponge and saline-gelatin sponge in the treatment of nasal adhesion.METHODS A total of 208 noses(170 patients) with nasal adhesions after receiving the endoscopic sinus surgeries from July,2012 to December,2015 were selected.All the cases were divided randomly into two groups:the treatment group and the control group.Both groups received separation treatments of the nasal adhesions.The intranasal corticosteroidsgelatin sponges were used as the separation material for the treatment group,while saline-gelatin sponges for the control group.The severity score and the time of treatment were evaluated as the indicators for curative efficacy of the treatment in each case.The differences of efficacy between two groups were analysed statistically.RESULTS The severity scores of the two groups after the treatment were both substantially lower than those before the treatment;The after-treatment severity scores of the treatment group were significantly lower than those of the control group;the times of treatment in the treatment group were substantially lower than those of the control group.The differences stayed for 3 months,and they became insignificant after 3 months.CONCLUSION The intranasal corticosteroids-gelatin sponge can be a quicker and more effective treatment of nasal adhesion in comparison with saline-gelatin sponge.

13.
Journal of Pharmaceutical Practice ; (6): 535-538,550, 2017.
Article in Chinese | WPRIM | ID: wpr-790812

ABSTRACT

Objective To prepare compound ketoconazole ointment and perform the stability study .Methods Ketocon-azole ,mupirocin and mometasone furoate were used as active pharmaceutical ingredients (API) .PEG mixture was used as ma-trix to prepare the ointment .Stability of the API in the ointment was evaluated by the stress tests .Results The optimal ratio of PEG400 to PEG3350 for the ointment matrix was 2:1 .Mometasone furoate and mupirocin in the ointment were stable to the high temperature(40 ℃)while ketoconazole had some degradation .The stability of the API was improved by addition of 0 .5% of L-A .During the accelerate test ,the ointment had no color change and the API percentages were above 98% .Conclu-sion The novel compound ketoconazole ointment was successfully prepared and the formulation stability was excellent .

14.
Tuberculosis and Respiratory Diseases ; : 60-68, 2017.
Article in English | WPRIM | ID: wpr-124432

ABSTRACT

BACKGROUND: Mucus hypersecretion from airway epithelium is a characteristic feature of airway inflammatory diseases. Tumor necrosis factor α (TNF-α) regulates mucin synthesis. Glucocorticoids including mometasone fuorate (MF) have been used to attenuate airway inflammation. However, effects of MF on mucin production have not been reported. METHODS: Effects of MF and budesonide (BUD) on the phorbol-12-myristate-13-acetate (PMA)–induction of mucin and TNF-α in human airway epithelial cells (NCI-H292) were investigated in the present study. Confluent NCI-H292 cells were pretreated with PMA (200 nM) for 2 hours. Subsequently, the cells were stimulated with MF (1–500 ng/mL) or BUD (21.5 ng/mL) for 8 hours. Dexamethasone (1 µg/mL) was used as the positive control. Real-time polymerase chain reaction was used to determine MUC2 and MUC5AC mRNA levels. The level of total mucin, MUC2, MUC5AC, and TNF-α in culture supernatants were measured using enzyme-linked immunosorbent assay. RESULTS: MF and BUD significantly suppressed MUC2 and MUC5AC gene expression in PMA-stimulated NCI-H292 cells. The inhibitory effects of the two steroid drugs were also observed in the production of total mucin, MUC2 and MUC5AC proteins, and TNF-α. CONCLUSION: Our findings demonstrated that MF and BUD attenuated mucin and TNF-α production in PMA-induced human airway epithelial cells.


Subject(s)
Humans , Budesonide , Dexamethasone , Enzyme-Linked Immunosorbent Assay , Epithelial Cells , Epithelium , Gene Expression , Glucocorticoids , Inflammation , Mometasone Furoate , Mucins , Mucus , Real-Time Polymerase Chain Reaction , RNA, Messenger , Tumor Necrosis Factor-alpha
15.
Braz. j. otorhinolaryngol. (Impr.) ; 82(5): 580-588, Sept.-Oct. 2016. tab, graf
Article in English | LILACS | ID: biblio-828219

ABSTRACT

ABSTRACT INTRODUCTION: Allergic rhinitis is considered the most prevalent respiratory disease in Brazil and worldwide, with great impact on quality of life, affecting social life, sleep, and also performance at school and at work. OBJECTIVE: To compare the efficacy and safety of two formulations containing mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis after four weeks of treatment. METHODS: Phase III, randomized, non-inferiority, national, open study comparing mometasone furoate in two presentations (control drug and investigational drug). The primary endpoint was the percentage of patients with reduction of at least 0.55 in nasal index score (NIS) after four weeks of treatment. Secondary outcomes included total nasal index score score after four and 12 weeks of treatment; individual scores for symptoms of nasal obstruction, rhinorrhea, sneezing, and nasal pruritus; as well as score for pruritus, lacrimation, and ocular redness after four and 12 weeks of treatment. The study was registered at clinicaltrials.gov with the reference number NCT01372865. RESULTS: The efficacy primary analysis demonstrated non-inferiority of the investigational drug in relation to the control drug, since the upper limit of the confidence interval (CI) of 95% for the difference between the success rates after four weeks of treatment (12.6%) was below the non-inferiority margin provided during the determination of the sample size (13.7%). Adverse events were infrequent and with mild intensity in most cases. CONCLUSION: The efficacy and safety of investigational drug in the treatment of persistent allergic rhinitis were similar to the reference product, demonstrating its non-inferiority.


Resumo Introdução: A rinite alérgica é considerada a doença respiratória mais prevalente no Brasil e em todo o mundo, com grande impacto na qualidade de vida; além de, afetar a vida social, o sono e também o desempenho na escola e no trabalho. Objetivo: Comparar a eficácia e segurança de duas formulações contendo furoato de mometasona no tratamento da rinite alérgica persistente leve, moderada ou grave por um período de quatro semanas. Método: Trata-se de um estudo nacional aberto de fase III, randomizado, de não inferioridade de comparação do furoato de mometasona em duas apresentações (medicação de controle e fármaco sob investigação). O ponto final primário foi o percentual de pacientes com redução mínima de 0,55 no escore de índice nasal (EIN) após quatro semanas de tratamento. Os desfechos secundários foram: escore NIS total após 4 e 12 semanas de tratamento; escores individuais para sintomas de obstrução nasal, rinorréia, espirros e prurido nasal, bem como escores para prurido, lacrimejamento e hiperemia conjuntival após 4 e 12 semanas de tratamento. O estudo foi registrado em clinicaltrials.gov com o número de referência NCT01372865. Resultados: A análise de eficácia primária demonstrou não inferioridade do fármaco sob investigação em relação à medicação de controle, visto que o limite superior do intervalo de confiança (IC) de 95% para a diferença entre os percentuais de sucesso após quatro semanas de tratamento (12,6%) situava-se abaixo da margem de não inferioridade proporcionada durante a determinação do tamanho da amostra (13,7%). Eventos adversos foram pouco frequentes e de leve intensidade na maioria dos casos. Conclusão: A eficácia e a segurança de um fármaco experimental no tratamento da rinite alérgica persistente foram similares às do produto de referência, o que demonstrou sua não inferioridade.


Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Aged , Anti-Allergic Agents/therapeutic use , Rhinitis, Allergic/drug therapy , Mometasone Furoate/therapeutic use , Severity of Illness Index , Treatment Outcome
16.
Chinese Journal of Biochemical Pharmaceutics ; (6): 67-69, 2016.
Article in Chinese | WPRIM | ID: wpr-496326

ABSTRACT

Objective To study the curative efficacy of mometasone furoate aqueous nasal spray combined with loratadine in the treatment of pediatric allergic rhinitis, and its effects on IL-10, IL-17 in serum.Methods 126 patients of pediatric allergic rhinitis who were admitted in our hospital from May 2011 to September 2013 were selected as research objects and randomly divided into treatment group and control group, 63 patients in each group.The control group were treated with loratadine, while the treatment group were treated with mometasone furoate aqueous nasal spray in combination with loratadine.The curative efficacy, scores of clinical symptoms and nasal examination, curing time, medication time and serum IL-10, IL-17 levels were compared between the two groups.Results The total therapeutic efficacy ratio in the treatment group was 98.41%, which was statistically higher than that of 80.95% in the control group (P<0.05).5 weeks after the treatment, scores of sneezing, runny nose, nasal congestion, nasal itching, eye itching and nasal examination in the treatment group were statistically lower than those in the control group (P<0.05).The curing time and medication time in the observation group were statistically shorter than those in the control group ( P <0.05 ) .The inflammatory factors, in comparison with the control group after treatment, the treatment group had statistically higher level of serum IL-10 and lower level of serum IL-17 ( P <0.05 ) . Conclusion Mometasone furoate aqueous nasal spray in combination with loratadine is effective for pediatric allergic rhinitis with a high therapeutic efficacy ratio.And it could significantly improve clinical symptoms, shorten treatment time, increase level of IL-10 and reduce level of IL-17.

17.
China Pharmacist ; (12): 1911-1913, 2016.
Article in Chinese | WPRIM | ID: wpr-503328

ABSTRACT

Objective:To investigate the clinical efficacy and safety of montelukast combined with mometasone furoate in the treat-ment of children with allergic rhinitis. Methods:Totally 91 children with allergic rhinitis were randomly divided into the observation group (n=46) and the control group (n=45) according to the random number table. The control group was given mometasone fu-roate, while the observation group was treated with montelukast additionally. Both groups were treated for two weeks. The symptom scores including nasal congestion, sneezing, itchy nose and runny nose, serum level changes of IL-4, IL-12 and IgE and adverse drug reactions before and after the treatment in both groups were evaluated and compared. Results:The total effective rate in the observation group (93. 48%) was significantly higher than that in the control group (75. 56%, P<0. 05). Compared with those before the treat-ment, the symptom scores in both groups were decreased after the treatment (P<0. 05), and those in the observation group were lower than those in the control groups (P<0. 05). After the treatment, the serum levels of IL-4 and IgE in both groups were significantly de-creased when compared with those before the treatment, while the IL-12 levels were increased significantly (P<0. 05), and the chan-ges in the observation group were more significantl than those in the control group (P<0. 05). There were no serious adverse drug re-actions during the treatment course in both groups. Conclusion:Montelukast combined with mometasone furoate in the treatment of al-lergic rhinitis shows more notable efficacy with higher security.

18.
Br J Med Med Res ; 2016; 12(3): 1-7
Article in English | IMSEAR | ID: sea-182187

ABSTRACT

Aims: The aim of the study is to compare the effect of Mometasone Fuorate and Levocetrizine in alleviating the symptom triad of Rhinorrhoea, Nasal obstruction and Sneezing in patients of Allergic Rhinitis. Study Design: Prospective cohort study. Place and Duration of Study: Department of Otolaryngology, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sevagram, between 1st April 2012 to 31st March 2014. Methodology: In this study 50 patients were assessed. The diagnosis was made on the basis of 1) Careful detailed history, 2) Clinical examinations, 3) ARIA Classification was used to classify the patients. Patients received, Group A: Mometasone furoate nasal spray 50 µg in each nostril twice daily for the first 7 days followed by once daily upto 8 weeks, Group B: Levocetrizine 5 mg in the night for 8 weeks. In followup period of 12 weeks Patients receivedGroup A: Mometasone furoate nasal spray 50 µg in each nostril once daily for 12 weeks. Group B: Levocetrizine 5 mg in the night for 12 weeks. Results: In patients with Intermittent Symptoms, 76% of the participants in the group A were found to be relieved of the nasal discharge as compared to 24% in the group B. This difference was found to be statistically significant (P = .0007). 83% of the participants in the group A were found to be relieved of the nasal obstruction as compared to 17% in the group B. This difference was found to be statistically significant (P = .0022). 61.5% of the participants in the group A were found to be relieved of the sneezing as compared to 48.5% in the group B. This difference was not found to be statistically significant (P=0.8017). In patients with Persistent Symptoms, 84.6% of the participants in the group A were found to be relieved of the nasal discharge as compared to 15.4% in the group B. This difference was found to be statistically significant (P = .0124). 100% of the participants in the group A were found to be relieved of the nasal obstruction as compared to 0% in the group B. This difference was found to be statistically significant (P = .0006). 75% of the participants in the group A were found to be relieved of the sneezing as compared to 25% in the group B. This difference was not found to be statistically significant (P = .5647). Conclusion: In this study we conclude that both Mometasone Fuorate and Levocetrizine are potent drugs for the management of allergic rhinitis but because of the local action and a high lipophilicity, longer retainability and induction of apoptosis of eosinophills in the nasal mucosa, patients taking Mometasone Fuorate as medication appreciate better relief in symptoms as compared to Levocetrizine.

19.
Chongqing Medicine ; (36): 1942-1945, 2015.
Article in Chinese | WPRIM | ID: wpr-468177

ABSTRACT

Objective To evaluate the efficacy and safety of mometasone furoate dry powder inhalation(MF DPI) in treating mild and moderate asthma .Methods The databases of PubMed ,EMBASE ,CINAHL were retrieved .The randomized ,controlled trials(RCT) on mometasone furoate dry powder inhalation in treating mild and moderate asthma were collected .The quality evalua‐tion and the data extraction were performed according to the Cochrane systematic evaluation method .The RevMan 5 .0 .2 software was adopted for conducting statistical analysis .Results A total of 9 RCT involving 1 795 patients with mild and moderate asthma were included .The meta‐analysis results showed that MF DPI 200 mcg/d improved FEV1(MD=0 .24 ,95% CI:0 .17 -0 .30) ,am‐PEF(MD= 25 .25 ,95% CI:8 .18 -42 .32) ,pmPEF(MD= 16 .00 ,95% CI:2 .10 -29 .90);MF DPI 400 mcg/d improved FEV1 (MD=0 .32 ,95% CI:0 .25-0 .39) ,amPEF(MD=36 .44 ,95% CI:23 .82-49 .05) ,pmPEF (MD=28 .50 ,95% CI:14 .11-42 .89) , which suggested that MF DPI 200 mcg/d and MF DPI 400 mcg/d improving FEV1 ,amPEF and pmPEF was higher than the place‐bo ;for reducing patient′s early morning dyspnea and albuterol dose ,MF DPI 200 mcg/d and MF DPI 400 mcg/d were superior to placebo .For reducing patient′s early morning wheezing ,MF DPI 200 mcg/d and MF DPI 400 mcg/d were not superior to placebo . For the occurrence of adverse events ,there was no statistical difference between MF DPI 200 mcg/d and MF DPI 400 mcg/d with placebo(P>0 .05) .Conclusion The existing evidence indicates that MF DPI has higher effect and safety in treating mild and mod‐erate asthma .

20.
Herald of Medicine ; (12): 341-343, 2015.
Article in Chinese | WPRIM | ID: wpr-461541

ABSTRACT

Objective To assess the clinical efficiency and side effects of topical mometasone furoate aqueous nasal spray for patients with naphazoline-induced rebound rhinitis. Methods A prospective, non-randomized and self-controlled study was applied. A total of 22 patients with naphazoline-induced rhinitis received two spray-puffs of 50 μg mometason furoate twice daily to each nostril in the morning for one week, followed by two spray-puffs of 50 μg mometason furoate once daily to each nostril every morning for another three weeks after withdrawn of naphazoline therapy. Nasal congestion was evaluated by visual an-alogue scale (VAS) recorded before and after treatment. Side effects like nose bleeding and perforation of the nasal septum was detected with rhinoscope. Results The statistical difference of VAS before and after treatment was significant. No adverse reac-tions as nose bleeding and perforation of the nasal septum were observed by the end of treatment. Conclusion It is safe and effective to use mometasone furoate aqueous nasal spray for treating rebound rhinitis induced by misuse of naphazoline nasal drop.

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