A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

EFC18418 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older.
Study details include:
* The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks.
* The treatment duration will be up to 52 weeks.
* The number of visits will be 9 site visits and 20 phone/home visits.

开始日期2025-02-12

申办/合作机构

Sanofi

[+1]

CTR20250190

/ RecruitingN/A

单中心、随机、开放、单次给药的糠酸莫米松乳膏人体生物等效性研究（药代动力学对比研究/初步剂量持续时间-效应研究/关键体内生物等效性研究）

主要目的：1) 通过血药浓度分析，比较糠酸莫米松乳膏受试制剂与参比制剂局部用药后的体内暴露量，评价糠酸莫米松乳膏的系统安全性； 2)通过观测糠酸莫米松使皮肤血管收缩致皮肤变白的作用，探索达到半数最大效应（Emax）的剂量持续时间（ED50）；再在ED50剂量持续时间下评价受试制剂和参比制剂在健康受试者体内的生物等效性。次要目的：观察健康受试者皮肤外用糠酸莫米松乳膏的安全性。

开始日期2025-02-10

申办/合作机构

浙江百代医药科技有限公司

NCT06834360

/ Recruiting临床3期

EFC18419 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older.
Study details include:
* The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks.
* The treatment duration will be up to 52 weeks.
* The number of visits will be 9 site visits and 20 phone/home visits.

开始日期2025-02-06

申办/合作机构

Sanofi

[+1]

100 项与糠酸莫米松相关的临床结果

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100 项与糠酸莫米松相关的转化医学

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100 项与糠酸莫米松相关的专利（医药）

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2,035

项与糠酸莫米松相关的文献（医药）

2025-05-01·ANALYTICAL BIOCHEMISTRY

Different manipulations for resolving the overlapped spectra of novel anti-asthmatic combination: Green-blue-white triple evaluation tools

Article

作者: Khalil, Hawa ; Bahgat, Eman A ; Reda, Alaa ; Fawzy, Michael Gamal

This work represents different spectrophotometric techniques for concurrent quantification of Indacaterol (IND) and Mometasone furoate (MOM); co-formulated inhalation capsules to control asthma symptoms. Direct spectrophotometric (D⁰) approach was applied for IND assay. While, absorption factor (AF), ratio difference (RD), mean centering of the ratio spectra (MC), and continuous wavelet transform (CW) techniques were utilized for MOM quantification. The applied methods' validation was accomplished relative to the ICH guidelines. Within the linearity range of (4-20 μg/mL), these approaches provided accurate and precise assessment of IND and MOM in laboratory-synthetic mixtures and pharmaceutical formulation with determination coefficients higher than 0.9997. Moreover, the proposed methods demonstrated good detection and quantification levels. The respective LOD and LOQ for IND were (0.33 μg/mL) and (1.01 μg/mL). While, the LOD and LOQ for MOM were ranging from (0.16-0.30 μg/mL) and (0.47-0.91 μg/mL), respectively. Statistical comparison revealed no significant differences between the findings derived from the proposed methods and the reported one. The applied methods' environmental effect was cheeked using Analytical Greenness Calculator (AGREE), Blue Applicability Grade Index (BAGI), and Red-Green-Blue 12 (RGB12). All the utilized metrics showed reliable scores, approving that the proposed methods were adhered to the sustainability principles.

2025-02-01·THORAX

Inhaled corticosteroids and major cardiovascular events in people with chronic obstructive pulmonary disease

Article

作者: Ioannides, Anne E ; Kallis, Constantinos ; Whittaker, Hannah R ; Quint, Jennifer K

Background:

Whether inhaled corticosteroids (ICSs) reduce major adverse cardiovascular events (MACEs) in people with chronic obstructive pulmonary disease (COPD) is debated.

Objectives:

To establish, within people with COPD, (1) whether ICS reduced MACE rates (acute coronary syndrome (ACS), heart failure (HF), ischaemic strokes or cardiovascular-specific death) compared with long-acting bronchodilators; and (2) whether drug class, incident usership or patient cardiovascular history influenced the ICS-MACE relationship.

Methods:

We conducted a cohort study including patients with COPD in England, using Clinical Practice Research Datalink Aurum data, linked with Hospital Episode Statistics and Office of National Statistics death data, between 1 January 2010 and 31 December 2019. We implemented Cox proportional hazard regressions, adjusting for time interactions or using propensity score-adjusted models, as necessary. Our exposures included prescriptions of any ICS (vs any long-acting bronchodilators) and triple therapy (vs combination long-acting bronchodilators), determined during the year prior to follow-up. The outcomes of interest were MACE collectively and individual MACE subtypes.

Measurements and main results:

Among 113 353 people with COPD (mean age 67.9 years old, 53.3% male), ICS prescription was not associated with MACE (adjusted HR (95% CI)=0.98 (0.95, 1.02), p=0.41) but was associated with reduced HF, specifically, until year 6 of follow-up (average adjusted HR (95% CI)=0.91 (0.86, 0.96), p<0.001). HF reduction was driven by the ICS group containing mometasone furoate, beclomethasone, budesonide or ciclesonide (HR (95% CI)=0.89 (0.84, 0.94), p<0.001). Incident ICS use was associated with increased ACS (HR (95% CI)=1.27 (1.09, 1.47), p<0.001) but was not sustained beyond incident use. There was no association between triple therapy and MACE. Results did not differ by cardiovascular history.

Conclusions:

ICS did not reduce MACE, except HF, likely by reducing misclassified COPD exacerbations.

2025-02-01·Dermatology and Therapy

Baricitinib Provides Significant Improvements in Quality of Life and Functioning in Adults with Moderate-to-Severe Atopic Dermatitis with Baseline Body Surface Area ≤ 40% and Severe Itch

Article

作者: Liu, Chunyuan ; Kleyn, C Elise ; Otero-Asman, Joaquin R ; Reguiai, Ziad ; Augustin, Matthias ; Izu-Belloso, Rosa ; Grond, Susanne ; Nomura, Toshifumi ; Silvia Sabatino ; Napolitano, Maddalena

INTRODUCTION:

Patients with moderate-to-severe atopic dermatitis (AD), a body surface area (BSA) of ≤ 40%, and an itch numerical rating scale (NRS) score of ≥ 7 ("BARI itch dominant") have been characterized as an important group to consider for the oral janus kinase (JAK) 1/2 inhibitor baricitinib (BARI). Herein we aim to evaluate quality of life (QoL) and functioning outcomes in adult patients with BSA ≤ 40% and itch NRS ≥ 7 at baseline (BL) who received BARI 4 mg in the topical corticosteroid (TCS) combination trial BREEZE-AD7.

MATERIALS:

BREEZE-AD7 was a randomized, double-blind, placebo-controlled, parallel-group outpatient study involving adult patients with moderate-to-severe AD who received once-daily placebo or 2-mg or 4-mg BARI in combination with TCS for 16 weeks. Patients eligible for enrollment had to have BSA ≥ 10%. This post-hoc analysis focused on placebo and BARI 4 mg for patients with BSA ≤ 40% and itch NRS ≥ 7. QoL impairment was measured using a Dermatology Life Quality Index (DLQI) of ≤ 5, and functioning outcomes were assessed using the Work Productivity and Activity Impairment (WPAI) questionnaire. Data were reported descriptively. Last observation carried forward (LOCF) data were reported, excluding data collected after the first rescue therapy date or permanent study drug discontinuation. Non-responder imputation was used to account for missing data.

RESULTS:

At BL, patients with BSA ≤ 40% and itch NRS ≥ 7 had high QoL impairment. The mean DLQI score at BL for patients who received BARI 4 mg and placebo indicates a very large effect of AD on patients' QoL. Patients who received BARI and placebo experienced a significant itch burden and reported a similar itch NRS. At week 16, 61.5% of patients treated with BARI 4 mg indicated that it had no to only a small effect on their QoL (DLQI ≤ 5), versus 24.1% for patients receiving placebo (p < 0.01). A decrease in WPAI work impairment score of - 41.6 for BARI patients and - 7.0 for placebo patients was observed at week 16 (p < 0.01). Patients receiving BARI also observed a noticeable improvement in WPAI daily activity impairment of - 30.4 from baseline at week 16 compared to patients on placebo, who achieved - 12.2 (p < 0.01).

CONCLUSION:

Despite having high QoL impairment at baseline, patients with itch-dominant AD treated with BARI 4 mg showed marked benefits in QoL, daily life activity, and work function compared to placebo after 16 weeks of treatment. Limitations include the small sample size analyzed.

201

项与糠酸莫米松相关的新闻（医药）

2025-03-03

·SYNAPSE

Deciphering H1 receptor antagonists and Keeping Up with Their Recent Developments

The H1 receptor, also known as the histamine H1 receptor, plays a crucial role in the human body. It is primarily found in smooth muscle cells, endothelial cells, and nerve cells. Activation of the H1 receptor by histamine leads to various physiological responses, including vasodilation, increased vascular permeability, bronchoconstriction, and stimulation of sensory nerve endings. These responses are involved in allergic reactions, inflammation, and immune responses. Antagonists of the H1 receptor, commonly known as antihistamines, are widely used to treat allergies, hay fever, and other conditions associated with excessive histamine release. Understanding the role of the H1 receptor is essential for developing effective treatments for allergic and inflammatory disorders. The analysis of the target H1 receptor reveals a competitive landscape with multiple companies actively developing drugs. GSK Plc, Sanofi, Pfizer Inc., Bayer AG, and Novartis AG are among the companies with the highest number of approved drugs or drugs in advanced stages of development. The indications with the most approved drugs include Common Cold, Rhinitis, Allergic, Urticaria, Pruritus, and Hypersensitivity. Small molecule drugs are the most rapidly progressing drug type, indicating intense competition in this area. China, the United States, and Japan are the countries with the highest number of approved drugs, with China showing significant progress in the development of drugs targeting the H1 receptor. Overall, the target H1 receptor presents opportunities for further research and development, particularly in indications with high unmet medical needs. How do they work?H1 receptor antagonists, also known as H1 blockers or antihistamines, are a class of drugs that block the action of histamine at the H1 receptor. Histamine is a chemical released by the body during an allergic reaction, causing symptoms such as itching, sneezing, runny nose, and watery eyes. H1 receptor antagonists work by binding to the H1 receptors on cells, preventing histamine from binding and exerting its effects. From a biomedical perspective, H1 receptor antagonists are commonly used to treat allergic conditions, such as hay fever (allergic rhinitis), hives (urticaria), and allergic conjunctivitis. They help alleviate symptoms by reducing the effects of histamine, thereby relieving itching, sneezing, and other allergic reactions. There are different generations of H1 receptor antagonists, each with varying degrees of sedative effects. First-generation antihistamines, such as diphenhydramine and chlorpheniramine, can cause drowsiness and are often used for their sedative properties in addition to their antihistamine effects. Second-generation antihistamines, such as cetirizine, loratadine, and fexofenadine, are less likely to cause sedation and are preferred for daytime use. In summary, H1 receptor antagonists are drugs that block the action of histamine at the H1 receptor, providing relief from allergic symptoms. They are commonly used in the treatment of various allergic conditions and come in different generations with varying sedative effects. List of H1 receptor Antagonists The currently marketed H1 receptor antagonists include: Olopatadine Hydrochloride/Mometasone Furoate Monohydrate Chlorpheniramine Maleate/Codeine Phosphate Diphenhydramine Hydrochloride/Naproxen Sodium Recombinant interferon alfa-2b/Loratadine Rupatadine Fumarate Azelastine/mometasone Ebastine/Pseudoephedrine Hydrochloride Azelastine Hydrochloride/Fluticasone Propionate Chlorpheniramine Maleate/Hydrocodone Bitartrate/Pseudoephedrine Hydrochloride Alcaftadine The content above comes from the network. if any infringement, please contact us to modify.

2025-03-02

·SYNAPSE

Inventory of GPCR Targeted Drugs Applying for Listing (I)

This article will review currently applied listed GPCR-targeting drugs, and the associated popular GPCR class targets and drug development opportunities worth paying attention to. 1.Eli Lilly: Tirzepatide Target:GIPR + GLP-1R Tirzepatide is a novel GIPR and GLP-1R dual agonist developed by Eli Lilly. In preclinical and clinical trials, compared to selective GLP-1 receptor agonists, GIP/GLP-1 dual agonists have been shown to better control blood sugar and reduce weight. Therefore, it is receiving increasing attention as a new therapeutic drug for controlling blood sugar and weight. In 2022, Tirzepatide was approved for the first time in the United States for the treatment of adult type II diabetes as an adjunct to diet and exercise. Subsequently, Tirzepatide was approved in the European Union and Japan for the treatment of type II diabetes. 2.ChemoCentryx: Avacopan Target:C5aR Avacopan(Tavneos) is an orally administered, first-in-class selective complement 5a receptor (C5aR) antagonist, discovered and developed by ChemoCentryx. This drug is used as an adjunctive therapy for ANCA-associated vasculitis in adult patients. Anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) is a rare ("oligo-immune") systemic small-vessel vasculitis, with an estimated incidence of 3 per 100,000 annually, characterized by the presence of ANCAs in the serum. The entire course of AAV includes granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), eosinophilic granulomatosis with polyangiitis (EGPA), and drug-induced AAV. Despite its complex pathophysiology, research over the past approx. 20 years has determined the crucial role of the alternative complement pathway, particularly the interaction of C5a with the C5aR receptor in AAV. Avacopan was first approved for marketing in Japan on September 27, 2021, and was subsequently approved in the United States, European Union, Canada, and Australia for the treatment of adult patients with ANCA-associated vasculitis, granulomatosis with polyangiitis, and microscopic polyangiitis. In addition, research is ongoing for other potential clinical indications, such as hidradenitis suppurativa and C3 glomerulopathy. 3.Pfizer: Rimegepant Sulfate Target:CGRP Receptor Rimegepant is an orally administered CGRP receptor antagonist used for the acute treatment of migraine in adults, with or without aura. Initially developed by the BMS(BMS-742413), the newly established biotech company Biohaven Pharmaceutical acquired the exclusive global development and commercialization rights to Rimegepant in 2016. The Biohaven team conducted a series of clinical studies and analyses around Rimegepant and developed the derivative migraine nasal spray drug, Zavegepant. In May 2022, Pfizer announced that it would acquire Biohaven for a total cash consideration of approximately 11.6 billion USD. Rimegepant was first approved for marketing in the United States on February 27, 2020, and subsequently received approval in Israel, the United Arab Emirates, Kuwait, the European Union, and Iceland, among others. Currently, the drug is being tested in clinical trials for conditions like chronic sinusitis, nasal polyps, and trigeminal neuralgia. 4. Glenmark:RYALTRIS Target:H1R+GR RYALTRIS is a new compound prescription nasal spray developed by the Indian pharmaceutical company, Glenmark. This medication has the dual efficacy of activating glucocorticoid receptor (GR) and antagonizing histamine H1 receptor (H1R). Mometasone is a moderately potent synthetic corticosteroid that acts as a glucocorticoid receptor agonist, possessing anti-inflammatory, anti-itch, and vasoconstrictive properties. Olopatadine, on the other hand, is an antagonist of histamine H1 receptors used for the treatment of allergic conjunctivitis and rhinitis. Since histamine is the primary inflammatory mediator causing inflammation and allergic reactions, Olopatadine works by blocking the action of histamine receptors. Compared to other anti-allergic ophthalmic drugs, Olopatadine does not interfere with the cell membrane, thus offering good comfort and tolerability. RYALTRIS was first approved for marketing in Australia in 2019, and subsequently received approval for listing in South Africa, the UK, the US, Canada, and other countries. In 2019, Grand Pharmaceutical and Glenmark signed an exclusive licensing agreement, in which Glenmark granted Grand Pharmaceutical the exclusive rights to sell RYALTRIS in China. Glenmark would be responsible for the manufacture and supply of the authorized product, while Grand Pharmaceutical would be in charge of the clinical trials and registration work for the authorized product in China and can exclusively sell the approved product in China for 20 years upon approval. 5. Amgen:Erenumab Target:CGRP Erenumab is a human monoclonal antibody developed by Amgen and is the first monoclonal antibody drug targeting GPCR approved by the FDA. Erenumab can specifically bind to and antagonize the Calcitonin Gene-Related Peptide Receptor (CGRPR), thus preventing migraines. In April 2017, Amgen announced an expanded commercial collaboration with Novartis on Erenumab, which is being studied for the prevention of migraine. This expanded business cooperation is based on the global neuroscience collaboration established by Novartis and Amgen in 2015 in the areas of Alzheimer's disease and migraine. Novartis initiated two clinical trials in China in 2019 to evaluate the safety and efficacy of Erenumab injection in the treatment of migraines. Erenumab was first approved for marketing in the United States in 2018, and was subsequently approved in Australia, Iceland, Norway, Switzerland, Canada, and Japan. In addition to the treatment of migraines, clinical trial research is ongoing for other indications, including headaches, hot flashes, temporomandibular joint dysfunction syndrome, stable angina. 6. Kyowa Kirin:Evocalcet Target:CaSR Evocalcet is a Calcium-Sensing Receptor (CaSR) agonist developed by Kyowa Kirin, used for the treatment of hypercalcemia, secondary hyperparathyroidism, and other related conditions. Kyowa Kirin has applied for two clinical trials in China to evaluate the effectiveness of Evocalcet in treating secondary hyperparathyroidism in patients undergoing maintenance dialysis for chronic kidney disease. As of now, Evocalcet has only been approved for marketing in Japan. 7. Otsuka Pharmaceutical: Brexpiprazole Target:5-HT1A+5-HT2A+D2R Brexpiprazole is a serotonin-dopamine activity modulator developed by Otsuka Pharmaceutical, used as an adjunctive treatment for severe depression, schizophrenia, and agitation associated with dementia caused by Alzheimer's disease. Brexpiprazole is an atypical antipsychotic and a novel D2 dopamine and serotonin 1A partial agonist, known as a serotonin-dopamine activity modulator. It has a high affinity for serotonin, dopamine, and alpha-adrenergic receptors. Structurally, Brexpiprazole is very similar to another atypical antipsychotic drug, Aripiprazole, but Brexpiprazole has a different affinity for binding with dopamine and serotonin receptors. Compared to Aripiprazole, Brexpiprazole is less likely to produce adverse reactions mediated by partial agonist, such as extrapyramidal symptoms, due to its lower intrinsic activity at the D2 receptor. Brexpiprazole was first approved in the United States in 2015, and subsequently approved in Canada, Japan, and the European Union. In addition to treating depression, this drug is undergoing global clinical trials and research for multiple indications including agitation, schizophrenia, Alzheimer's disease, and performance anxiety. 8. Santen: Tapcom Target:PTGFR+βAR Tapcom is a combination eye drop medication containing Tafluprost and Timolol Maleate, developed by Santen. Tafluprost is a prostaglandin analogue used in ophthalmology to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Chemically, Tafluprost is a fluorinated analogue of prostaglandin F2-α. Timolol is a non-selective beta-adrenergic antagonist, used for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Tapcom was first approved for marketing in Japan in 2013, and subsequently received approval in countries including Iceland, France, Poland, and Germany. 9. Takeda:TeduglutideTarget:GLP-2R Teduglutide is a glucagon-like peptide-2 (GLP-2) analog developed by the British rare disease pharmaceutical giant, Shire Development, for the treatment of patients with short bowel syndrome (SBS) who require parenteral nutrition support. Teduglutide is comprised of 33 amino acids, and is manufactured using strains of E. coli that have been modified through DNA recombinant technology. Teduglutide differs from GLP-2 by one amino acid (alanine is replaced with glycine). This substitution results in Teduglutide having a longer duration of action than endogenous GLP-2 and a higher resistance to hydrolysis by the enzyme dipeptidyl peptidase-4. Teduglutide first received regulatory approval within the European Union in 2012, followed by approval in the United States and Japan, in all cases for the treatment of SBS. In 2019, Takeda Pharmaceuticals spent an astounding £46 billion to acquire Shire Development, in a move that has been dubbed as a "snake swallowing an elephant" merger in the pharmaceutical world. This acquisition propelled Takeda Pharmaceuticals into the list of top 10 global biopharmaceutical companies. Clinical research on the application of Teduglutide for the treatment of Crohn's Disease and kidney disorders was discontinued due to this acquisition. 10. AstraZeneca: Duaklir GenuairTarget:M3R+β2AR Duaklir Genuair is a combined Aclidinium Bromide/Formoterol Fumarate inhalation powder developed by AstraZeneca. This medication is used as a maintenance bronchodilator to alleviate the symptoms of disease in adults with chronic obstructive pulmonary disease (COPD). Among them, Aclidinium bromide is a novel long-acting muscarinic antagonist, and Formoterol fumarate is a long-acting β2 receptor agonist. Duaklir Genuair is administered by the Genuair dry powder inhaler twice a day and is the first combined medication that has shown a statistically significant improvement over monotherapy in terms of shortness of breath. Duaklir Genuair was first approved in the European Union in 2012, and subsequently in the United States in 2019, for the treatment of chronic obstructive pulmonary disease. The content above comes from the network. if any infringement, please contact us to modify.

2025-02-27

·医学新视点

春季鼻炎高发，如何治疗？一文了解鼻喷激素的相关知识

鼻炎一直困扰着众多患者，而鼻喷激素作为常用的治疗手段之一，不同的鼻喷激素在作用、用法用量、注意事项、禁忌证以及适用年龄范围上存在差异，牢记这些知识对于医生来说至关重要，以便更好地为患者开具针对性药物。药物作用机制糠酸莫米松鼻喷雾剂糠酸莫米松鼻喷雾剂作为糖皮质激素，它能与细胞内的糖皮质激素受体结合，进而抑制多种炎症相关基因的转录，减少炎症介质如组胺、白三烯等的合成与释放，降低鼻黏膜的炎症反应，从根源上减轻鼻塞、流涕、打喷嚏等鼻炎症状，对过敏性和非过敏性鼻炎均有显著疗效。布地奈德鼻喷雾剂其作用机制与糠酸莫米松鼻喷雾剂类似，通过干扰花生四烯酸代谢，抑制炎症介质产生，同时阻止细胞因子生成，发挥抗炎作用，有效减轻鼻黏膜充血、肿胀，降低鼻气道阻力，对季节性与常年性鼻炎效果良好，还在鼻息肉切除术后预防鼻息肉再生方面表现出色。丙酸氟替卡松鼻喷雾剂丙酸氟替卡松鼻喷雾剂能够高度选择性地与糖皮质激素受体结合，强力抑制炎症细胞的浸润和活化，减少炎症因子释放，高效缓解鼻痒、鼻塞、流涕等症状，主要用于预防和治疗季节性与常年性过敏性鼻炎，作用精准且强效。药物区别抗炎强度一般而言，丙酸氟替卡松的抗炎活性相对较强，能更有效地抑制炎症反应，但具体疗效还因个体差异和病情而异。糠酸莫米松和布地奈德的抗炎效果也较为显著，在临床上都被广泛应用且各有优势。药物剂型与稳定性 3种药物的剂型略有不同，这会影响药物在鼻腔内的分布和吸收情况。例如，不同的喷雾装置设计可能导致药物颗粒大小、喷射速度等存在差异，进而影响药物在鼻腔黏膜的附着和渗透效果。在稳定性方面，它们都有各自适宜的储存条件要求，以保证药物的有效性和安全性。适用人群偏好由于不同年龄人群的生理特点不同，药物在不同年龄段的安全性和有效性数据也有所差异。例如，糠酸莫米松适用于3岁及以上患者，相对来说在儿童中的应用经验较为丰富；布地奈德常用于6岁及以上人群，对一些特定年龄段的鼻炎患者可能效果更佳；丙酸氟替卡松适用于4岁及以上人群，在过敏性鼻炎的治疗中被广泛选择，医生会根据患者具体情况综合判断使用哪种药物更合适。用法用量及注意事项糠酸莫米松鼻喷雾剂（1）用法：使用前充分振摇容器，使药物均匀混合。清洁鼻腔后，头稍向前倾，将喷嘴轻轻插入鼻孔，朝向鼻腔外侧壁，避免喷向鼻中隔，按下喷雾器同时轻轻吸气，使药物均匀分布于鼻腔黏膜。（2）用量：本品适用于3岁及以上的鼻炎患者。成人和青少年（12岁及以上），常规剂量为每侧鼻孔100 μg（2喷），1次/d；3~11岁儿童，每侧鼻孔50 μg（1喷），1次/d。症状得到有效控制后，可在医生指导下逐渐降低使用频率，以最低有效剂量维持治疗效果。（3）建议用药时长：对于轻度鼻炎，一般建议使用1~2周，症状缓解后可尝试停药观察；中度鼻炎可能需要持续使用2~3个月，定期复诊评估病情后调整用药；重度且持续发作的鼻炎，用药时长可能会延长至3~6个月甚至更久，但需密切监测药物不良反应和病情变化，遵循医生的个体化治疗方案。（4）注意事项：使用过程中若出现鼻部刺激感、鼻出血等不良反应，应及时告知医生。鼻腔黏膜破损、感染时应避免使用该药物。儿童长期使用可能对生长发育有一定影响，因此儿童用药需严格遵循医嘱，并定期进行生长监测。此外，鼻喷激素可能会使鼻腔黏膜变薄、变脆弱，引发鼻腔干燥和刺激感、鼻出血、鼻溃疡和穿孔（罕见）等局部不良反应。鼻溃疡和穿孔是由于长期或不恰当使用所致，虽极为罕见，但也需警惕。长期使用还可能对内分泌系统产生轻微干扰，如影响肾上腺皮质功能，但规范使用很少发生。（5）禁忌证：对糠酸莫米松或处方中任何辅料过敏者禁用。布地奈德鼻喷雾剂（1）用法：初次使用时，需先对喷雾剂进行初始化操作，即对着空气按压喷头数次，直至喷出均匀的雾状药液。清洁鼻腔后，将喷头插入鼻孔，稍向外侧眼角方向倾斜，按压喷头的同时吸气，使药物到达鼻腔深部。（2）用量：适用于6岁及以上患者，3~6岁儿童需在医生谨慎评估后使用。成人及6岁以上儿童，起始剂量为每侧鼻孔64 μg（1喷），早晚各1次；维持剂量可减至每侧鼻孔32 μg（半喷），1次/d。3~6岁儿童，建议每侧鼻孔32 μg（半喷），1次/d，具体剂量应根据病情在医生指导下调整。（3）建议用药时长：与糠酸莫米松类似，轻度鼻炎用药1~2周左右评估是否停药；中度鼻炎大概持续2~3个月，根据病情和医生建议调整；重度鼻炎可能用药3~6个月及以上，期间要定期检查鼻腔状况和身体反应，确保用药安全有效。（4）注意事项：使用后应及时清洁喷头，防止药物残留堵塞喷头。如果在使用过程中出现鼻部干燥、瘙痒等不适，不要搔抓鼻腔，可适当使用生理盐水滴鼻缓解。肺结核、真菌或细菌感染的患者，在使用前需告知医生相关病史，谨慎使用。长期或不恰当使用鼻喷激素，也可能会对内分泌系统产生轻微干扰，如影响肾上腺皮质功能，但规范使用很少发生，同时也可能引发鼻腔局部不良反应。（5）禁忌证：对布地奈德或其他肾上腺皮质激素过敏者禁用。丙酸氟替卡松鼻喷雾剂（1）用法：使用前轻轻振摇瓶子，保证药物混合均匀。头略向前倾，将喷嘴插入鼻孔，朝鼻腔外侧壁倾斜，按压喷雾器同时缓慢吸气，使药物充分分布于鼻腔内。（2）用量：适用于4岁及以上的鼻炎患者。成人和12岁以上青少年，每侧鼻孔100 μg（2喷），1次/d；4~11岁儿童，每侧鼻孔50 μg（1喷），1次/d。症状缓解后，经医生评估可逐渐减少使用次数直至停药。（3）建议用药时长：轻度鼻炎患者使用1~2周后根据症状改善情况决定是否继续用药；中度鼻炎通常需持续用药2~3个月，期间定期复诊；重度鼻炎的用药时间可能长达3~6个月以上，且在长期使用过程中要特别注意药物的不良反应，尤其是眼部情况，需定期进行眼部检查。（4）注意事项：用药期间要格外注意鼻腔卫生，尽量避免接触过敏原和刺激性物质，如花粉、烟雾等。若用药后出现视力模糊、头痛等症状，应立即停药并咨询医生。长期使用该药物可能增加眼部不良反应的风险，如青光眼、白内障等，所以长期使用者和老年患者需定期进行眼部检查。此外，同样可能引发鼻腔局部不良反应，如鼻腔干燥、刺激感、鼻出血以及罕见的鼻溃疡和穿孔情况，这与药物对鼻腔黏膜的作用有关。长期使用还可能对内分泌系统产生一定影响，不过规范使用时这些影响较小。（5）禁忌证：对丙酸氟替卡松过敏者禁用。其他在使用任何鼻喷激素之前，清洁鼻腔是重要的第一步，可以使用生理盐水进行冲洗。冲洗时头部稍向前倾，让生理盐水从一侧鼻腔流入，另一侧流出，或者使用专门的鼻腔冲洗器按照说明书操作。喷药时，保持头部直立，插入喷头后按压同时轻轻吸气，喷完后不要立即用力擤鼻涕，以免药物排出影响疗效。此外，鼻喷激素应存放在阴凉、干燥处，避免阳光直射和高温环境，每次使用后及时清洁喷头，防止堵塞。总之，鼻喷激素在鼻炎治疗中具有重要作用，但正确的使用方法、对药物特性的了解以及严格遵守注意事项、禁忌证和建议用药时长是关键。患者务必在医生的专业指导下选择合适的鼻喷激素，并正确使用，以达到最佳的治疗效果，缓解鼻炎带来的不适，提高生活质量，畅享自由呼吸。同时，要留意鼻喷激素可能产生的局部和全身不良反应，一旦出现异常情况应及时就医，以便调整治疗方案，确保用药安全。相关阅读影响全球1/5人口！JAMA：过敏性鼻炎总不好？关注3大治疗策略欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。分享，点赞，在看，传递医学新知

100 项与糠酸莫米松相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00690	糠酸莫米松	R01AD09 R03BA07 D07XC03	DB14512

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性鼻窦炎伴鼻息肉	美国	Intersect ENT, Inc.	2017-12-08
哮喘	美国	Organon & Co.	2005-03-30
鼻息肉	美国	Organon & Co.	2004-12-15
过敏性鼻炎	中国	Schering-Plough Corp.	2000-07-14
皮炎	中国	Merck & Co., Inc.	1999-01-01
常年性变应性鼻炎	美国	Organon & Co.	1997-10-01
季节性过敏性鼻炎	美国	Organon & Co.	1997-10-01
斑秃	日本	Shionogi Pharma Co., Ltd.	1993-10-01
药物性皮炎	日本	Shionogi Pharma Co., Ltd.	1993-10-01
湿疹	日本	Shionogi Pharma Co., Ltd.	1993-10-01
渗出性红斑	日本	Shionogi Pharma Co., Ltd.	1993-10-01
红皮病性银屑病	日本	Shionogi Pharma Co., Ltd.	1993-10-01
脓疱疮	日本	Shionogi Pharma Co., Ltd.	1993-10-01
瘢痕疙瘩	日本	Shionogi Pharma Co., Ltd.	1993-10-01
盘状红斑狼疮	日本	Shionogi Pharma Co., Ltd.	1993-10-01
大疱性类天疱疮	日本	Shionogi Pharma Co., Ltd.	1993-10-01
糠疹	日本	Shionogi Pharma Co., Ltd.	1993-10-01
痒疹	日本	Shionogi Pharma Co., Ltd.	1993-10-01
银屑病	日本	Shionogi Pharma Co., Ltd.	1993-10-01
炎症	美国	Organon & Co.	1987-04-30

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性鼻窦炎	临床3期	美国	Lyra Therapeutics, Inc.	2022-01-24
常年性鼻炎	临床3期	中国	四川大冢制药有限公司	2019-04-10
鼻塞	临床3期	阿根廷	PH & T SpA	2012-10-01
打喷嚏	临床3期	阿根廷	PH & T SpA	2012-10-01
季节性鼻炎	临床3期	-	Organon & Co.	2008-08-01
鼻粘膜充血	临床3期	-	Organon & Co.	2008-07-01
间歇性哮喘	临床3期	-	Organon & Co.	2008-05-01
腺样体肥大	临床3期	-	Organon & Co.	2007-08-01
慢性阻塞性肺疾病	临床3期	-	Organon & Co.	2006-10-01
慢性阻塞性肺疾病	临床3期	-	Novartis AG	2006-10-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04849390 (ACESO, UEGW2024)	临床2期	嗜酸粒细胞性食管炎	59	ESO-101 800 µg	獵糧壓遞簾鏇網壓繭鏇(衊製廠網選顧夢衊簾獵) = 齋壓鹽襯淵簾鑰廠築糧廠獵觸襯構窪餘醖簾艱 (夢壓觸窪夢夢襯鹽製鹹, 88.42) 更多	积极	2024-10-13
				Placebo	獵糧壓遞簾鏇網壓繭鏇(衊製廠網選顧夢衊簾獵) = 壓構網顧鹹獵構夢製觸廠獵觸襯構窪餘醖簾艱 (夢壓觸窪夢夢襯鹽製鹹, 65.11) 更多
NCT03979209 (CTgov)	临床1期	慢性鼻窦炎	16	Nasal Mometasone Rinse (Mometasone 1mg)	鹽醖淵襯積鹹襯製繭願(夢觸範製醖廠獵糧積廠) = 鏇構獵艱齋繭鏇願膚網獵壓遞鏇壓鬱襯襯製憲 (醖窪窪衊醖繭鬱餘膚願, 觸窪顧衊鏇遞願鑰蓋衊 ~ 製醖夢鹽淵鬱糧顧築選) 更多	-	2024-08-12
				Nasal Mometasone Rinse (Mometasone 2mg)	鹽醖淵襯積鹹襯製繭願(夢觸範製醖廠獵糧積廠) = 積夢獵鹽鹹醖製廠鏇築獵壓遞鏇壓鬱襯襯製憲 (醖窪窪衊醖繭鬱餘膚願, 積夢範築艱構膚淵鏇窪 ~ 醖鬱觸糧壓壓糧壓繭鏇) 更多
ENDO2024	N/A	肾上腺皮质功能不全 \| 成长不全	-	Dulera (mometasone furoate and formoterol fumarate)	壓獵齋糧遞願淵積繭蓋(鑰願鏇獵鑰蓋蓋衊餘鏇) = 簾網廠選廠獵窪蓋構蓋憲繭窪網製壓壓糧鏇遞 (淵顧觸觸製壓齋製鏇鏇 )	-	2024-06-01
ACESO (Biospace) 人工标引	临床2期	嗜酸粒细胞性食管炎	43	ESO-101	築餘網觸襯衊繭齋獵範(糧積鹽蓋艱積顧範鹹窪) = met with a statistically significant reduction of the peak eosinophil count (p=0.0318) compared to placebo. 積構膚襯膚範鏇製齋網 (繭鏇廠鹽膚壓積製鑰築 )	积极	2023-12-05
				placebo
WSC2023	N/A	阻塞性睡眠呼吸暂停综合征	56	Acupuncture+Montelukast Sodium+Mometasone Furoate Nasal Spray	廠築淵衊醖憲鑰願衊壓(衊襯齋艱簾糧鬱鏇遞襯) = 廠範衊獵製壓範鹹衊遞壓窪艱憲鑰夢憲衊廠艱 (鹽鑰鑰餘醖鹽膚壓鏇繭 )	积极	2023-10-23
				Montelukast Sodium+Mometasone Furoate Nasal Spray	廠築淵衊醖憲鑰願衊壓(衊襯齋艱簾糧鬱鏇遞襯) = 壓獵觸顧壓艱齋衊選觸壓窪艱憲鑰夢憲衊廠艱 (鹽鑰鑰餘醖鹽膚壓鏇繭 )
NCT04041609 (CTgov)	临床2期	慢性鼻窦炎	71	LYR-210 (LYR-210 (Low Dose))	獵選範築壓廠範顧襯選(鑰顧遞蓋簾選壓鹽淵淵) = 簾網範襯簾蓋鹽衊蓋淵淵築鹽蓋遞構窪壓鹽蓋 (廠顧淵醖鹹選觸衊顧鬱, 鬱繭製築窪襯範醖範鏇 ~ 繭壓範鑰廠繭鑰壓廠鹹) 更多	-	2023-06-06
				LYR-210 (LYR-210 (High Dose))	獵選範築壓廠範顧襯選(鑰顧遞蓋簾選壓鹽淵淵) = 廠糧願範製鏇壓鏇構廠淵築鹽蓋遞構窪壓鹽蓋 (廠顧淵醖鹹選觸衊顧鬱, 繭糧鹹艱簾鹹蓋膚齋艱 ~ 獵蓋觸獵淵鬱獵鑰醖遞) 更多
AAAAI2021	N/A	-	37	Indacaterol/Mometasone Furoate low-dose	製構廠夢衊遞糧顧齋窪(蓋餘窪積淵願願獵網鹹) = 廠製鹹夢糧鹽選簾獵廠鏇襯壓襯簾簾顧淵願顧 (遞鏇醖鑰醖簾積範醖顧 ) 更多	-	2021-02-01
				Indacaterol/Mometasone Furoate medium-dose	製構廠夢衊遞糧顧齋窪(蓋餘窪積淵願願獵網鹹) = 廠淵齋廠憲網獵構衊鬱鏇襯壓襯簾簾顧淵願顧 (遞鏇醖鑰醖簾積範醖顧 ) 更多
NCT03705793 (CTgov)	临床4期	过敏性鼻炎 \| 慢性鼻窦炎	53	Mometasone Furoate Nasal Irrigation (Mometasone Furoate Nasal Irrigation)	襯築鏇壓願憲壓窪築糧(構鏇窪觸醖積齋糧艱衊) = 廠蓋醖繭衊衊襯淵網鹽構膚襯繭顧鹹築製壓艱 (窪憲衊網積壓憲築廠窪, 糧壓餘網窪窪範製築構 ~ 齋製鏇選顧艱衊蓋餘衊) 更多	-	2020-12-19
				Mometasone Nasal Spray (Mometasone Nasal Spray)	襯築鏇壓願憲壓窪築糧(構鏇窪觸醖積齋糧艱衊) = 觸觸選鑰衊鬱鏇繭淵艱構膚襯繭顧鹹築製壓艱 (窪憲衊網積壓憲築廠窪, 壓製憲齋餘廠艱夢憲餘 ~ 獵糧鑰鏇製鏇構憲餘鏇) 更多
NCT01850823 (CTgov)	临床3期	季节性过敏性鼻炎	880	Mometasone Nasal Spray (NASONEX® Nasal Spray (Schering Corporation))	觸淵構齋艱顧獵鏇廠構(膚繭窪窪範襯簾選鬱鏇) = 鹽簾製衊憲壓窪夢襯製膚夢觸鏇顧鑰積選衊艱 (衊構齋壓鏇網夢襯膚鏇, 窪淵糧顧夢願鹹觸選餘 ~ 鏇觸醖選範鏇艱製淵觸) 更多	-	2020-08-19
				Mometasone nasal spray (Mometasone Nasal Spray (Watson Laboratories, Inc))	觸淵構齋艱顧獵鏇廠構(膚繭窪窪範襯簾選鬱鏇) = 網築膚餘製網遞積艱顧膚夢觸鏇顧鑰積選衊艱 (衊構齋壓鏇網夢襯膚鏇, 餘願鹽願積膚鑰鑰襯齋 ~ 鏇鏇齋鏇衊鹹積顧築糧) 更多
Pubmed \| Pulm Pharmacol Ther	N/A	哮喘	739	Mometasone furoate 80 μg (Breezhaler®)	餘衊鏇鹽齋鏇鹹淵膚襯(憲衊蓋網壓衊夢構衊網) = 醖齋鹽醖鹹鏇願構鑰鬱鬱餘鏇積範網製願積壓 (壓鬱觸製壓夢遞繭衊簾, -34 ~ 89)	-	2020-06-01