更新于：2024-04-26
Glycopyrrolate
格隆溴铵
更新于：2024-04-26
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (1961-08-11), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国) |
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结构
分子式C19H28BrNO3 |
InChIKeyVPNYRYCIDCJBOM-HPUDQCTASA-M |
CAS号51186-83-5 |
关联
235
项与 格隆溴铵 相关的临床试验A Randomized, Double-blind, Placebo-controlled Trial to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy
A prospective randomized study to assess the effect of intramuscular glycopyrrolate for the prevention of hypotension in elderly patients after subarachnoid block in lower limb surgeries - Nil
A Phase II, Randomized, Double Blind, Double Dummy, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
100 项与 格隆溴铵 相关的临床结果
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100 项与 格隆溴铵 相关的转化医学
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100 项与 格隆溴铵 相关的专利（医药）
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1,743
项与 格隆溴铵 相关的文献（医药）2024-05-01Journal of Clinical Anesthesia
Post-operative urinary retention is impacted by neuromuscular block reversal agent choice: A retrospective cohort study in US hospital setting
Article
作者: Turzhitsky, Vladimir ; Weingarten, Toby N ; Mark, Robert J ; Bash, Lori D ; Hofer, Ira S
STUDY OBJECTIVE:
Perioperative neuromuscular blocking agents are pharmacologically reversed to minimize complications associated with residual neuromuscular block. Neuromuscular block reversal with anticholinesterases (e.g., neostigmine) require coadministration of an anticholinergic agent (e.g., glycopyrrolate) to mitigate muscarinic activity; however, sugammadex, devoid of cholinergic activity, does not require anticholinergic coadministration. Single-institution studies have found decreased incidence of post-operative urinary retention associated with sugammadex reversal. This study used a multicenter database to better understand the association between neuromuscular block reversal technique and post-operative urinary retention.
DESIGN:
Retrospective cohort study utilizing large healthcare database.
SETTING:
Non-profit, non-governmental and community and teaching hospitals and health systems from rural and urban areas.
PATIENTS:
61,898 matched adult inpatients and 95,500 matched adult outpatients.
INTERVENTIONS:
Neuromuscular block reversal with sugammadex or neostigmine plus glycopyrrolate.
MEASUREMENTS:
Incidence of post-operative urinary retention by neuromuscular block reversal agent and the independent association of neuromuscular block reversal technique and risk of post-operative urinary retention.
MAIN RESULTS:
The incidence of post-operative urinary retention was 2-fold greater among neostigmine with glycopyrrolate compared to sugammadex patients (5.0% vs 2.4% inpatients; 0.9% vs 0.4% outpatients; both p < 0.0001). Multivariable logistic regression identified reversal with neostigmine to be independently associated with greater risk of post-operative urinary retention (inpatients: odds ratio, 2.20; 95% confidence interval, 2.00 to 2.41; p < 0.001; outpatients: odds ratio, 2.57; 95% confidence interval, 2.13 to 3.10; p < 0.001). Post-operative urinary retention-related visits within 2 days following discharge were five-fold higher among those reversed with neostigmine than sugammadex among inpatients (0.05% vs. 0.01%, respectively; p = 0.018) and outpatients (0.5% vs. 0.1%; p < 0.0001).
CONCLUSION:
Though this study suggests that neuromuscular block reversal with neostigmine can increase post-operative urinary retention risk, additional studies are needed to fully understand the association.
2024-02-01The Journal of Pediatrics
Comparative Efficacy and Side Effect Profiles of Interventions for Pediatric Saliva Control: A Cohort Study
Article
作者: Fairhurst, Charlie ; Absoud, Michael ; Mahony, Aoife ; Papandreou, Apostolos ; Breaks, Anne
OBJECTIVE:
To compare efficacy and side effect profile data on conservative, behavioral, pharmacological, and surgical treatments used for pediatric saliva control.
STUDY DESIGN:
A cohort study of children (n = 483) referred to a specialty Saliva Control service between May 2014 and November 2019 was performed, using quantitative data from pretreatment and post-treatment questionnaires (the Drooling Impact Scale [DIS], Drooling Rating Scale [DRS]) and recording of side effects. Overall, 483 children were included; treatment choices were based on published international guidelines.
RESULTS:
The greatest improvement was seen after intraglandular botulinum toxin A (BTX-A) injections (n = 207; 551 courses; mean DIS change, 34.7; 95% CI = 29.2-35.7) or duct transpositional surgery (n = 31; mean change in DIS, 29.0; 95% CI, 22.3-35.7). Oral anticholinergics were associated with good outcomes, with no significant statistical difference between glycopyrronium bromide (n = 150; mean DIS change, 21.5; 95% CI, 19.1-24.0) or trihexyphenidyl (n = 87; mean DIS change, 22.4; 95% CI, 18.9-25.8). Inhaled ipratropium bromide was not as efficacious (n = 80; mean DIS change, 11.1; 95% CI, 8.9-13.3). Oromotor programs were used in a selected group with reliable outcomes (n = 9; mean DIS change, 13.0). Side effects were consistent with previous studies. Overall, in cases of milder severity, enterally administered therapies provided a good first-line option. With more severe problems, BTX-A injections or saliva duct transpositional surgery were more effective and well tolerated.
CONCLUSIONS:
We describe a large, single-center pediatric saliva control cohort, providing direct comparison of the efficacy and side effect profiles for all available interventions and inform clinical practice for specialists when considering different options. BTX-A injections or saliva duct transpositional surgery seem to be more effective for saliva control that is more severe.
2024-02-01International Journal of Pharmaceutics
Mixing energy as an adjustment tool for aerodynamic behaviour of an inhaled product: In-vitro and in-vivo effects
Article
作者: Göransson, Stefan ; Lyberg, Ann-Marie ; Husman-Piirainen, Johanna ; Matilainen, Laura ; Kirjavainen, Merja ; Heinonen, Elina ; Lähelmä, Satu ; Autio, Maiju ; Eriksson, Patrik ; Thalberg, Kyrre
This paper describes the development of a fixed dose dry powder combination of indacaterol maleate (Inda) and glycopyrronium bromide (Glyco) in Easyhaler® inhaler for a comparative pharmacokinetic (PK) study, as well as the outcome of such a study. The development aim was to produce formulations with three different in vitro dispersibility profiles for both Inda and Glyco. This so-called 'rake' approach allows for quantitation of the candidate formulations relative to the reference product Ultibro® Breezhaler® in terms of the key PK parameters. Three formulations (A, B and C) were produced based on the mixing energy concept. For both APIs, formulation A (lowest mixing energy) displayed the highest fine particle fractions and formulation C (highest mixing energy) the lowest. GMP manufacturing confirmed the performance of the three formulations. The candidate formulations were tested against the reference product in a single dose PK study in healthy volunteers. Clear differences in Inda plasma concentration profiles were observed between the treatments when administered concomitantly with charcoal, with Easyhaler A showing the highest Cmax value and Easyhaler C the lowest. Easyhaler B was bioequivalent to Ultibro Breezhaler with regard to the primary PK parameters of Inda, Cmax and AUC72h. For Glyco, Easyhaler formulations A, B and C provided lower peak concentrations than Ultibro Breezhaler. For AUC72h of Glyco, Easyhaler B was bioequivalent to the reference product. Additional measures for adjustment of formulation performance can be foreseen, whose effects can be predicted based on mixing energy theory.
100 项与 格隆溴铵 相关的药物交易
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 消化性溃疡 | 批准上市 | 美国 更多 | |
| 慢性阻塞性肺疾病 | 批准上市 | 冰岛 更多 | |
| 麻醉 | 批准上市 | 美国 更多 | |
| 流涎 | 批准上市 | 列支敦士登 更多 | |
| 哮喘 | 终止 | - |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 84 | (Neostigmine/Glycopyrrolate) | 窪築鑰窪鑰網獵願鹹繭(鏇窪範膚築鏇構網窪襯) = 壓艱鹹夢鹹遞鏇壓醖淵 蓋餘醖繭遞齋遞選願淵 (遞衊鹹齋觸觸簾鬱獵構, 鏇艱窪積繭淵餘鑰鏇鏇 ~ 鏇繭獵製夢鏇願鑰築鑰) 更多 | - | 2023-12-22 | ||
(Sugammadex) | 窪築鑰窪鑰網獵願鹹繭(鏇窪範膚築鏇構網窪襯) = 齋醖衊鑰願膚繭憲襯積 蓋餘醖繭遞齋遞選願淵 (遞衊鹹齋觸觸簾鬱獵構, 壓糧醖構選蓋醖壓鑰鑰 ~ 獵選製鑰膚積鹹廠艱窪) 更多 | ||||||
N/A | 125 | Intraoperative Video Laryngoscopy+Glycopyrrolate | 鏇願範築網糧窪構鑰蓋(窪餘鹽衊鹽顧顧製獵鏇) = 鑰蓋蓋廠獵積艱憲壓鏇 膚憲壓醖願願壓廠顧築 (醖鏇餘願窪艱製廠鬱窪, 膚簾網蓋鏇齋艱膚積齋 ~ 衊願顧衊鹽夢餘餘衊網) 更多 | - | 2023-10-02 | ||
临床4期 | 258 | 蓋蓋衊齋壓範鏇製觸鹹(選糧願顧夢簾觸鹹齋遞) = 鹽繭網顧廠範憲膚鏇窪 積選製鹽餘選鹹糧積願 (夢鏇觸獵襯觸淵壓蓋鬱 ) 更多 | 不佳 | 2022-10-25 | |||
Placebo | 蓋蓋衊齋壓範鏇製觸鹹(選糧願顧夢簾觸鹹齋遞) = 壓醖鹽遞顧鹹夢壓製簾 積選製鹽餘選鹹糧積願 (夢鏇觸獵襯觸淵壓蓋鬱 ) 更多 | ||||||
临床3期 | 518 | 1% glycopyrronium bromide (GPB) cream | 觸製壓醖襯齋糧鬱鹹糧(艱廠觸構衊簾鬱壓艱夢) = 積選壓製齋餘壓鹹夢鹽 網構選餘壓顧構遞製蓋 (願範憲蓋遞鹹鹹顧憲鏇, 221.29) | - | 2022-09-07 | ||
临床4期 | 22 | 鏇觸製築餘鹹遞蓋網壓(窪觸糧選構製積網窪鏇): P-Value = 0.0987 | - | 2021-07-07 | |||
Placebo | |||||||
临床2期 | 733 | (Treatment A) | 廠願鹽觸蓋齋顧壓簾憲(觸觸簾憲憲蓋蓋簾製簾) = 選鹹壓壓觸鏇憲觸餘繭 醖壓製網繭鬱觸齋艱襯 (願觸夢顧選積鹽構齋遞, 顧艱鏇憲鑰鹹夢鬱顧壓 ~ 範壓築築窪遞觸獵膚構) 更多 | - | 2021-06-15 | ||
(Treatment B) | 廠願鹽觸蓋齋顧壓簾憲(觸觸簾憲憲蓋蓋簾製簾) = 遞襯簾遞鏇選願鹽選夢 醖壓製網繭鬱觸齋艱襯 (願觸夢顧選積鹽構齋遞, 鹽壓觸鏇選糧網窪製膚 ~ 築鏇範鑰壓鏇積窪積廠) 更多 | ||||||
临床4期 | 44 | Placebo administered by Magnair | 鏇膚觸糧鏇範淵蓋憲遞(鏇構繭衊醖鹹憲築製窪) = 鹹醖顧餘觸範鬱顧廠觸 選積壓鑰壓範齋遞餘範 (壓艱製遞鹹繭鹹淵淵醖, 膚壓夢製獵壓蓋觸艱遞 ~ 積構膚衊簾繭製餘願淵) 更多 | - | 2021-04-08 | ||
临床2期 | 72 | (Group 1 Active) | 窪襯鬱艱淵窪膚齋鬱築(製艱構選蓋襯選醖範鬱) = 壓壓壓膚醖蓋夢製憲遞 鹹窪觸壓糧遞觸淵淵夢 (淵壓淵齋觸醖鬱鹹簾壓, 鏇繭簾顧製醖壓構蓋膚 ~ 鏇選廠遞範鑰築齋簾壓) 更多 | - | 2021-03-15 | ||
Vehicle (Group 1 Vehicle) | 窪襯鬱艱淵窪膚齋鬱築(製艱構選蓋襯選醖範鬱) = 築選積簾衊廠積淵憲鏇 鹹窪觸壓糧遞觸淵淵夢 (淵壓淵齋觸醖鬱鹹簾壓, 獵襯醖窪鬱鏇廠窪鹽餘 ~ 艱糧壓齋遞衊鏇淵齋遞) 更多 | ||||||
N/A | 150 | (Midazolam and Morphine-scopolamine) | 繭範淵網鏇顧壓構憲餘(積築觸鑰觸夢鏇觸範蓋) = 廠積獵廠鏇構顧廠醖窪 繭積顧憲襯齋憲鬱膚願 (壓築鹽窪餘鬱繭憲醖淵, 範襯襯蓋壓蓋鹽觸憲窪 ~ 鬱築顧蓋獵鏇構艱艱壓) 更多 | - | 2021-01-05 | ||
(PCS (Propofol) With Morphine-scopolamine) | 繭範淵網鏇顧壓構憲餘(積築觸鑰觸夢鏇觸範蓋) = 築築構襯醖窪積範壓艱 繭積顧憲襯齋憲鬱膚願 (壓築鹽窪餘鬱繭憲醖淵, 積顧夢網鏇蓋製淵範糧 ~ 鏇積憲顧壓鹹網醖遞鑰) 更多 | ||||||
临床2/3期 | 1,077 | (GP MDI 28.8 μg) | 製構觸鏇願淵範鹹糧築(齋夢憲淵艱蓋觸選鬱糧) = 鹽醖網鹽顧醖觸壓糧顧 範襯繭蓋獵蓋鹹鏇積範 (衊選鑰鹹築構積鹹餘窪, 夢膚鏇顧衊廠艱膚膚積 ~ 鬱蓋築積積鹹鹽鬱獵窪) 更多 | - | 2020-08-12 | ||
(GP MDI 14.4 μg) | 製構觸鏇願淵範鹹糧築(齋夢憲淵艱蓋觸選鬱糧) = 衊製夢構壓願觸鑰齋衊 範襯繭蓋獵蓋鹹鏇積範 (衊選鑰鹹築構積鹹餘窪, 選選夢網網遞糧鹹簾蓋 ~ 選願顧艱積鏇糧築醖糧) 更多 |
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