贝雷克坦(Beractant) - 在研适应症：早产儿呼吸窘迫综合征，呼吸窘迫综合征_专利_临床

概要

基本信息

药物类型

生物药

别名

Beractant (USAN)、Surfacten

+ [2]

靶点-

作用机制-

治疗领域

呼吸系统疾病其他疾病

在研适应症

早产儿呼吸窘迫综合征呼吸窘迫综合征

非在研适应症-

原研机构

AbbVie, Inc.

在研机构

AbbVie, Inc.Mitsubishi Tanabe Pharma Factory Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期

日本 (1987-10-02),

呼吸窘迫综合征

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

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关联

17

项与贝雷克坦相关的临床试验

CTRI/2023/03/050375 / CompletedN/AIIT

Comparison Of Efficacy Between Beractant And Poractant-? In Respiratory Distress Syndrome Among Preterm Infants(28-34 Weeks Gestational Age) By Less InvasiveSurfactant Administration(LISA) Technique: A Randomized Controlled Trial

开始日期2023-03-15

申办/合作机构-

IRCT20120126008827N3 / Recruiting临床3期IIT

Comparison of therapeutic effects of Iranian surfactant (Beraksurf) with Cursorf in premature infants with respiratory distress admitted to the neonatal intensive care unit of Hafez and Namazi hospitals in Shiraz in 1400

开始日期2021-12-22

申办/合作机构

Shiraz University of Medical Sciences

IRCT20210501051148N1 / Completed临床3期IIT

Comparison of the Efficacy and Side-effects of Two Surfactants (Beraksurf, and Bles) in the Treatment of Respiratory Distress Syndrome among Preterm infants

开始日期2021-05-31

申办/合作机构

Kerman Medical University

100 项与贝雷克坦相关的临床结果

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100 项与贝雷克坦相关的转化医学

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100 项与贝雷克坦相关的专利（医药）

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396

项与贝雷克坦相关的文献（医药）

2024-10-01·American Journal of Physiology-Lung Cellular and Molecular Physiology

Comparative biophysical study of clinical surfactants using constrained drop surfactometry

Article

作者: Zuo, Yi Y.

A thorough investigation into the biophysical properties of four animal-derived clinical surfactant preparations was conducted through constrained drop surfactometry under physiologically relevant conditions. This comparative study unveiled unique in vitro biophysical characteristics among these clinical surfactants, establishing correlations between their chemical composition, lateral film structure, and biophysical functionality. The acquired knowledge offers essential insights for the precise and personalized design of clinical surfactant for the treatment of respiratory distress syndrome and other respiratory conditions.

2024-04-01·American Journal of Perinatology4区 · 医学

Pulmonary Complications in Premature Infants Using a Beractant or Poractant for Respiratory Distress Syndrome: A Retrospective Cohort Study

4区 · 医学

Article

作者: Siu, Kiu Lok ; Wong, Kin Lok

Objective Premature infants are at the risk of developing respiratory distress syndrome (RDS). Beractants and poractants are two commonly used natural surfactants. This retrospective cohort study aims to compare the incidence of pulmonary complications between beractant and poractant treatment groups. Study Design This study evaluated 29 patients treated with beractant and 49 patients treated with poractant. The primary outcome was the incidence of air leak syndrome (ALS) and pulmonary hemorrhage. Secondary outcomes included mortality and pulmonary outcomes, such as mechanical ventilation duration, oxygen dependence duration, fraction of inspired oxygen, and mean airway pressure (MAP) requirement. Logistic regression analyses were conducted to identify independent risk factors for significant primary outcomes. Results No significant difference was found in the demographics between the two groups. A significantly higher incidence of pulmonary hemorrhage was observed in the poractant group (14.3 vs. 0.0%, p = 0.038). The difference in the incidence of ALS between the groups was insignificant (p = 0.536). Logistic regression for the incidence of pulmonary hemorrhage identified coagulopathy as the only significant independent risk factor (odds ratio 39.855, 95% confidence interval [2.912–545.537]; p = 0.006). Secondary outcomes in both treatment groups were similar, except that patients in the poractant group had a higher MAP before surfactant therapy (9 vs. 8 cmH2O, p < 0.001). Conclusion This study showed a significantly higher incidence of pulmonary hemorrhage in the poractant group. Coagulopathy was identified as an independent risk factor for pulmonary hemorrhage. Future long-term prospective studies are essential to establish the temporal and causal relationships between coagulopathy and pulmonary hemorrhage in premature infants receiving surfactant therapy for RDS; hence, there is the need for a screening protocol before surfactant administration. Key Points

2024-02-28·Cureus

Predictors of Extubation Failure in Very Low Birth Weight Infants at a Tertiary Care Hospital in Al Ain: A Retrospective Study

Article

作者: Kasem, Sameh ; Siwji, Zohra ; Abu Sa'da, Omar ; Omar, Nuralhuda ; Pappachan, Binu ; Rahmani, Aiman ; Afzal, Uzma ; Varghese, Nisha

OBJECTIVESTo identify and analyze the factors leading to extubation failure among very low birth weight infants in a specific tertiary care setting in Al Ain, emphasizing clinical and demographic variables. The study used medical data of Very Low Birth Weight (VLBW) infants admitted to the Neonatal Intensive Care Unit (NICU) from 1st January 2015 to 31st December 2019, and evaluated the incidence and risk factors associated with extubation failure.METHODSData was collected from the hospital's electronic records and tabulated in Excel sheets, with extubation failure defined as reintubation due to deterioration of respiratory condition within seven days post-extubation. The data was collected from the period of 1st January 2015 to 31st December 2019. Inclusion criteria included babies admitted to the NICU with a gestational age of ≤ 32 weeks, or of birth weight ≤1500 grams who were intubated within the first seven days of life. Results were analyzed using SPSS software, version 9.0 (SPSS Inc., Chicago) to determine the risk factors for extubation failure and short-term outcomes.RESULTSGestational age, birth weight, antenatal steroids, mode of delivery, number of Survanta® (beractant intratracheal suspension) doses, Positive End-Expiratory Pressure (PEEP), Mean Airway Pressure (MAP), Mean Arterial Pressure (Blood Pressure (BP)), and Infectious Diseases (ID) (indicated by a positive blood culture) were found to be the key predictors of extubation failure in very low birth weight infants at a tertiary care hospital in Al Ain. The most common reasons for reintubation were FiO2 > 50% (23.53%), followed by Respiratory Acidosis (20.59%). Other factors, including maternal chorioamnionitis, Apgar scores, indication for intubation, caffeine, and pre-and post-extubation laboratory values, comorbidities, and hemoglobin (Hgb), creatinine and sodium levels were found to have no effect on the success of extubations.CONCLUSIONSThe results of this research indicate that factors such as gestational age, birth weight, prenatal steroid use, delivery method, the quantity of Survanta® doses, PEEP, MAP, MAP (BP), and ID (+ve blood culture) were the primary determinants of unsuccessful extubation in VLBW babies at a tertiary healthcare facility in Al Ain. The predominant cause for needing reintubation was a FiO2 level above 50%, followed by Respiratory Acidosis. Additional ®®investigations are required to validate these findings and pinpoint other potential predictors of extubation failure within this demographic.

100 项与贝雷克坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03096	贝雷克坦	R07AA02	DB06761

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
早产儿呼吸窘迫综合征	美国	AbbVie, Inc.	1991-07-01
呼吸窘迫综合征	日本	Mitsubishi Tanabe Pharma Factory Ltd.	1987-10-02

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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


NCT02294630 (Pubmed \| Pulm Pharmacol Ther)	临床2期	新生儿呼吸窘迫综合征	149	Aerosolized Beractant	蓋網鹽蓋鑰鏇構選製積(鏇醖鬱壓製築夢廠鹽蓋) = 11% 鹽窪廠鹽壓繭鏇膚網範 (糧觸艱醖壓餘獵網壓夢 ) 更多	-	2021-02-01
NCT00767039 (CAST, CTgov)	临床4期	动脉导管未闭 \| 成人呼吸窘迫综合征 \| 早产	52	beractant+Survanta (Beractant Arm)	鏇廠獵衊鹹衊願糧鹽遞(糧鹽糧願觸遞鑰築願夢) = 獵繭襯糧鏇窪窪獵淵壓蓋醖製鏇繭鬱艱鑰觸衊 (艱夢簾範窪糧構廠鑰艱, 範夢膚鏇觸膚構觸繭顧 ~ 鹽襯簾遞壓繭鏇觸窪壓) 更多	-	2011-09-20
				Poractant Alfa (Poractant Alfa Arm)	鏇廠獵衊鹹衊願糧鹽遞(糧鹽糧願觸遞鑰築願夢) = 選鏇簾醖鏇鏇艱願觸廠蓋醖製鏇繭鬱艱鑰觸衊 (艱夢簾範窪糧構廠鑰艱, 廠網夢網鏇膚範製願積 ~ 繭願糧製構憲願醖鬱遞) 更多
NCT00767039 (Pubmed \| J Perinatol)	临床4期	呼吸窘迫综合征	50	Poractant alfa	鹹鹹鏇簾憲窪觸齋獵遞(夢醖膚膚簾夢積範鬱選) = 蓋齋網窪醖鹹淵顧鹽廠壓廠鹽醖顧艱艱餘襯鹹 (範願襯蓋壓醖淵襯窪蓋 )	-	2010-10-01
				Beractant	鹹鹹鏇簾憲窪觸齋獵遞(夢醖膚膚簾夢積範鬱選) = 鑰鬱構鬱網壓鏇築廠繭壓廠鹽醖顧艱艱餘襯鹹 (範願襯蓋壓醖淵襯窪蓋 )