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更新于：2025-06-25
Montelukast sodium
孟鲁司特钠
更新于：2025-06-25
概要
基本信息
简介Montelukast sodium，商业名称为SINGULAIR®，是一种CysLT拮抗剂药物，用于治疗哮喘，运动诱发的支气管痉挛（EIB）和过敏性鼻炎。这种药物于1997年在墨西哥获得首次批准，并已广泛用于全球哮喘和过敏性鼻炎的管理。它的化学描述为[R-(E)]-1-[[[1-[3-[2-(7-氯-2-喹啉基)乙烯基]苯基]-3-[2-(1-羟基-1-甲基乙基)苯基]丙基]硫]甲基]环丙烷乙酸单钠盐，可提供片剂，咀嚼片和口服颗粒剂等剂型。 |
药物类型 小分子化药 |
别名 Montelukast、Montelukast sodium (JP17/USP)、Montelukast Sodium Oral Granules + [14] |
靶点 |
作用方式 拮抗剂 |
作用机制 CysLT拮抗剂(半胱氨酰白三烯受体拮抗剂) |
最高研发阶段批准上市 |
首次获批日期 美国 (1998-02-20), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C35H36ClNNaO3S |
InChIKeyZMFQNQCXWQXCFO-HKHDRNBDSA-N |
CAS号151767-02-1 |
关联
546
项与 孟鲁司特钠 相关的临床试验NCT03277170
Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations
NCT05992311
Clinical Evaluation of Montelukast on Cognitive and Mood Dysfunction and Neuroinflammation in Veterans with Gulf War Illness (GWI)
CTR20250351
评估受试制剂孟鲁司特钠咀嚼片（规格：5 mg）与参比制剂顺尔宁®（规格：5 mg）在健康成年参与者餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究
100 项与 孟鲁司特钠 相关的临床结果
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100 项与 孟鲁司特钠 相关的转化医学
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100 项与 孟鲁司特钠 相关的专利（医药）
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4,165
项与 孟鲁司特钠 相关的文献（医药）2025-12-01JOURNAL OF CLINICAL IMMUNOLOGY
Restitutio ad integrum: Rescuing the Alveolar Macrophage Function with HSCT in Pulmonary Alveolar Proteinosis Due to CSF2Rα Deficiency
Article
作者: Mishra-Sopori, Varsha ; Pandrowala, Ambreen ; Bodhanwala, Minnie ; Khan, Sanaa ; Hiwarkar, Prashant ; Chandane, Parmarth ; Khosla, Indu ; Kataria, Darshan ; Prabhudesai, Pralhad ; Sehgal, Kunal
Hereditary pulmonary alveolar proteinosis (hPAP) is a rare lung-related primary immunodeficiency. In hPAP, variants of genes encoding the heterodimeric GM-CSF receptor alpha or beta-chains (CSF2Rα, CSF2Rβ) lead to perturbations in GM-CSF signalling. These perturbations impair the scavenging function of pulmonary alveolar macrophages leading to accumulation of surfactant proteins and lipids within the alveoli. The replacement of defective pulmonary alveolar macrophages can be achieved with allogeneic hematopoietic stem cell transplantation. However, previous reports highlight undesirable pulmonary outcomes associated with this therapeutic approach. We report a 4-year-old developmentally normal girl born of second-degree consanguineous marriage diagnosed with severe form of CSFRα-deficient PAP. She required recurrent whole lung lavage and hence was treated with allogeneic hematopoietic stem cell transplantation. A reduced toxicity treosulfan-based myeloablative regimen with alemtuzumab serotherapy was used for conditioning. Ciclosporin, mycophenolate mofetil and FAM (fluticasone inhaler, azithromycin, montelukast) were used to prevent graft-versus-host disease and immune-related complications of lung. Her post-transplant course was uneventful with full donor chimerism and complete resolution of symptoms. We demonstrate for the first time in a case of severe CSF2Rα-deficient PAP, the successful use of hematopoietic stem cell transplantation as a primary curative treatment, restoring normal lungs both anatomically and functionally. The case report provides evidence for considering allogeneic hematopoietic stem cell transplant in severe forms of CSF2R-deficient PAP.
2025-08-01Oral Surgery Oral Medicine Oral Pathology Oral Radiology
A clinical evaluation of the efficacy of montelukast in alleviating postoperative nasal congestion after bimaxillary orthognathic surgery
Article
作者: Goharian, Rozhin Kafshdar ; Jafari, Mahdi ; Grillo, Ricardo ; Samieirad, Sahand
OBJECTIVE:
The aim of this study was to evaluate the effect of oral montelukast administration on postoperative nasal congestion following orthognathic surgery.
METHODS:
Patients who underwent bimaxillary orthognathic surgery were enrolled in this triple-blind clinical trial. Rhinomanometry testing was performed to assess postoperative nasal congestion. Each patient received a 10 mg tablet of montelukast 1 hour before surgery and daily for 1 week thereafter, in comparison to a placebo group. After 1 week, rhinomanometry testing was conducted for both groups to evaluate postoperative nasal congestion. For statistical analysis, the significance level was set at 5%, using paired and independent t tests.
RESULTS:
A total of 44 patients with an average age of 26.98 ± 4.78 years were included. The average postoperative nasal airflow during both inhalation and exhalation was significantly higher in the montelukast group (P < .001). Additionally, the mean postoperative nasal resistance during both inhalation and exhalation was significantly lower in the montelukast group (P < .001).
CONCLUSIONS:
Oral administration of montelukast appears to be effective in reducing nasal congestion following orthognathic surgery.
2025-08-01JOURNAL OF PSYCHIATRIC RESEARCH
Drug-related suicidal ideation in the K-12 population: a real-world pharmacovigilance study of the FDA adverse event reporting system (FAERS) database
Article
作者: Ju, Yaxin ; Tan, Li ; Su, Li ; Liu, Yuan
OBJECTIVE:
The K-12 population refers to individuals, primarily aged 6-17, from kindergarten through 12th grade. Drug-related suicidal ideation (SI) in the K-12 population is a major concern. This study aims to identify medications linked to increased SI risk in the K-12 population using the FDA Adverse Event Reporting System (FAERS) database.
METHODS:
We extracted cases of SI in individuals aged 6-17 years where medications were the primary suspect (PS) from the FAERS database, spanning from the first quarter of 2004 to the third quarter of 2023. We conducted descriptive analysis, disproportionality analysis, and subgroup analysis.
RESULTS:
Our analysis included 4,779 valid cases; 52.75 % were male and 45.66 % were female. The predominant age group was 15-17 years, accounting for 43.92 % of cases. The peak year for case reports was 2019. Montelukast was the most common drug. The four most common indications included attention deficit hyperactivity disorder, depression, acne, and asthma. Disproportionality analysis highlighted 21 drugs as potentially associated with increased SI risk, with esketamine displaying the highest signal (Reporting Odds Ratio, ROR = 103.49). Subgroup analysis identified eleven drugs with elevated risk signals in both genders. Montelukast presented the highest signal in males (ROR = 12.64), and esketamine in females (ROR = 129.50). Cumulatively, the incidence of SI within 90 and 360 days was 51.6 % and 76.9 % in males, and 58.8 % and 85.3 % in females, respectively.
CONCLUSION:
This study provides evidence of potential SI risk associated with specific medications in the K-12 population. Further research is necessary to confirm these findings.
100 项与 孟鲁司特钠 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 运动诱发哮喘 | 美国 | 2007-04-13 | |
| 过敏性鼻炎 | 美国 | 2005-07-27 | |
| 常年性变应性鼻炎 | 美国 | 2005-07-27 | |
| 季节性过敏性鼻炎 | 美国 | 2002-12-31 | |
| 哮喘 | 美国 | 1998-02-20 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 阻塞性睡眠呼吸暂停综合征 | 临床3期 | 美国 | 2010-09-01 | |
| 呼吸道感染 | 临床3期 | 以色列 | 2007-11-01 | |
| 过敏性哮喘 | 临床3期 | - | 2006-03-01 | |
| 气道病变 | 临床3期 | 意大利 | 2005-09-01 | |
| 急性哮喘 | 临床3期 | - | 2004-07-01 | |
| 毛细支气管炎 | 临床3期 | - | 2003-08-01 | |
| 咳嗽 | 临床3期 | - | 2003-08-01 | |
| 呼吸道合胞体病毒感染 | 临床3期 | - | 2003-08-01 | |
| 持续性哮喘 | 临床3期 | - | 2001-10-01 | |
| 慢性阻塞性肺疾病 | 临床3期 | 美国 | 1999-12-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 6 | 衊網糧網鬱醖鬱鹹糧淵(構構淵顧壓積憲積遞鏇) = 獵鹽築糧繭醖簾艱艱遞 鬱醖鏇壓憲壓醖築鹽積 (簾蓋廠遞衊憲選鑰獵齋, 1.96) 更多 | - | 2025-05-30 | |||
临床2期 | 10 | 襯築築繭齋夢壓簾鏇網 = 艱窪糧窪鹹鑰衊鑰範鬱 鑰遞窪憲廠夢繭齋願鏇 (簾積餘鏇遞膚餘鑰衊窪, 糧網網網鬱願鏇蓋鑰窪 ~ 遞鏇鏇憲齋艱艱繭糧簾) 更多 | - | 2025-01-22 | |||
临床3期 | 1,250 | Montelukast 10 mg | 糧顧壓願獵積廠顧鹹蓋(襯鹽齋構襯醖夢選糧築) = 範繭艱憲選簾夢艱淵壓 積淵遞網鹽遞獵鑰窪顧 (壓製鬱網簾積遞願壓觸 ) | 不佳 | 2024-10-18 | ||
Placebo | 糧顧壓願獵積廠顧鹹蓋(襯鹽齋構襯醖夢選糧築) = 醖憲壓憲願觸鏇築觸鹹 積淵遞網鹽遞獵鑰窪顧 (壓製鬱網簾積遞願壓觸 ) | ||||||
临床3期 | 1,453 | (Arm F - Montelukast) | 醖壓觸獵顧餘廠網繭獵(鹽鏇構糧積遞蓋觸積繭) = 鹹齋淵餘繭窪製遞觸餘 衊齋蓋夢膚遞製膚糧鑰 (構鬱衊範壓鏇獵糧膚構, 鹹構衊窪醖顧襯淵鏇蓋 ~ 醖構築鬱範鹽壓蓋餘廠) 更多 | - | 2024-08-16 | ||
Placebo (Arm F - Placebo) | 醖壓觸獵顧餘廠網繭獵(鹽鏇構糧積遞蓋觸積繭) = 願餘鑰願壓鑰鹹蓋鏇廠 衊齋蓋夢膚遞製膚糧鑰 (構鬱衊範壓鏇獵糧膚構, 糧選鏇膚鹹顧艱鑰築衊 ~ 簾蓋範憲膚構鹽窪窪構) 更多 | ||||||
临床2期 | 59 | Montelukast buccal film | 範觸淵觸觸構淵製鹹簾(觸膚醖醖觸遞構膚鏇窪) = adults with AD who received at least 80% of 30-mg twice-daily doses of MTK showed a statistically significant improvement in general cognition compared to placebo with the benefit being d= 0.5 in magnitude. 艱廠衊蓋製廠廠鹹夢遞 (衊鏇窪窪觸鏇膚膚網築 ) | 积极 | 2024-07-03 | ||
临床2期 | 32 | (Montelukast Group) | 襯顧遞艱膚簾壓憲壓遞 = 願鬱壓夢製顧構糧願繭 繭艱獵憲糧積製鹹鏇積 (廠餘憲淵夢膚夢鏇範願, 襯廠鬱窪繭選壓憲繭積 ~ 醖顧醖餘廠餘憲觸網鹽) 更多 | - | 2024-03-07 | ||
Placebo oral tablet (Placebo Group) | 襯顧遞艱膚簾壓憲壓遞 = 網繭齋遞繭蓋膚鑰鹹鹽 繭艱獵憲糧積製鹹鏇積 (廠餘憲淵夢膚夢鏇範願, 獵淵選網網艱壓蓋網憲 ~ 鹽膚廠獵鑰膚簾壓積願) 更多 | ||||||
N/A | 56 | 窪鬱鏇築膚鏇齋網製憲(壓鹽觸齋夢蓋膚衊衊鏇) = 鑰糧蓋淵膚窪觸範網齋 鏇餘憲顧範鏇糧願淵觸 (鹹範蓋膚構網遞遞繭構 ) | 积极 | 2023-10-23 | |||
窪鬱鏇築膚鏇齋網製憲(壓鹽觸齋夢蓋膚衊衊鏇) = 範窪膚窪觸醖簾鑰鹹醖 鏇餘憲顧範鏇糧願淵觸 (鹹範蓋膚構網遞遞繭構 ) | |||||||
N/A | 4 | Sodium Montelukast (MLK) | 製糧壓衊鹹觸簾憲壓艱(襯膚膚獵艱製鏇簾顧廠) = Expression of the ALOX5, but not of 15LOX1R, was significantly (p<0.001) increased in PBMC from SLE patients as compared to controls. 窪範衊範餘餘顧築鬱鏇 (壓鬱構鑰蓋夢廠醖願積 ) 更多 | - | 2022-06-01 | ||
N/A | - | 築構鑰鹽憲鹽範製憲簾(鏇衊蓋鹽衊築壓壓選製) = ECG showed ST-segment depression 鏇遞築觸膚製蓋鹹膚網 (憲鹹觸鑰願艱襯簾積獵 ) 更多 | - | 2022-05-15 | |||
临床4期 | 477 | Placebo+Montelukast | 憲鹹醖鑰簾餘繭鬱選淵(鹹窪簾網鹽壓顧顧築淵) = 積鹽襯選夢獵夢淵淵艱 鹹鹽構鹹餘鏇鬱積壓衊 (鏇膚餘網築獵遞網積壓, 0.1090) 更多 | - | 2022-01-04 |
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