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-

作用方式-

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-

权益机构-

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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383

项与贝雷克坦相关的文献（医药）

2025-05-01·Current Pediatric Reviews

Comparison of the Effectiveness of Beraksurf and Curosurf Exogenous Surfactants in the Treatment of Respiratory Distress Syndrome in Preterm Neonates: A Double-blind Randomized Study in the West of Iran

Article

作者: Parsa, Narges Mohammadi ; Jenabi, Ensiyeh ; Hatami, Behnaz ; Basiri, Behnaz ; Eghbalian, Fatemeh

Background:To date, few studies have compared the effectiveness of exogenous surfactant therapy with Curosurf and Beraksurf in the treatment of respiratory distress syndrome (RDS) in preterm neonates.Objective:Since surfactant has a significant impact on the treatment of neonates with RDS, this study was conducted to introduce a more effective method for treating preterm neonates with RDS.Methods:The present clinical trial was conducted on 140 preterm neonates with RDS in the NICU department of two specialized university hospitals in Hamadan, western Iran. In one group, we used the Iranian-made surfactant Beraksurf, and in another group, we used the Italian-made surfactant Curosurf. In the end, the checklist for the two groups was completed. Data analysis was performed using SPSS version 22, and a significance level of 5% was considered for all tests.Results:The comparison of the frequency distribution of maternal corticosteroid administration, response to treatment and need for re-intubation, associated disorders, and mortality among neonates of the two groups of Beracsurf and Curosurf surfactant did not show a significant difference (p=0.962, 0.763, 0.725 and 0.149, respectively). Further, the comparison of the mean number of days requiring respiratory support, days free from respiratory support, and hospitalization days among neonates of the two groups of Beracsurf and Curosurf surfactant injection did not show a significant difference (p=0.910, 0.725, and 0.898, respectively). Additionally, the comparison of the time of initiation of feeding and the time of reaching maximum feeding among neonates of the two groups of Beracsurf and Curosurf surfactant injection also did not show significant differences (p=0.881 and 0.903, respectively).Conclusion:Based on the fact that Beracsurf and Curosurf surfactants did not show significant differences in the treatment outcomes of RDS in preterm neonates, it is suggested that the Iranianmade surfactant, Beracsurf, should be used for the treatment of these neonates due to its cost-effectiveness and availability compared to Curosurf.

2025-03-01·Iranian journal of medical sciences

A Comparison of the Effect of Beractant (Beracsurf) and Proctant Alpha (Curosurf) in Neonatal Respiratory Distress: A Randomized Controlled Trial.

Article

作者: Najib, Khadijeh Sadat ; Barzegar, Hamide ; Davoodi, Marzieh ; Rezaei, Mehrdad

BackgroundSurfactant treatment has revolutionized the management of respiratory distress syndrome (RDS) in preterm infants. The present study compared the effectiveness and adverse effects of two natural surfactants, Beracsurf and Curosurf, in premature infants with RDS who required surfactant administration.MethodsEighty-four newborns were enrolled in this double-blind randomized controlled trial study, which was conducted in Shiraz, Iran, from 2021 to 2022. The study included all preterm neonates with RDS, who required intubation for stabilization, were on continuous positive airway pressure (CPAP), required oxygen of more than 30% to maintain saturation 90-95%, or had CPAP failure. Using a simple random allocation method, the participants were randomly assigned to receive either Beractant as the case group or Proctant Alpha as the control group. The study assessed outcomes such as hospital length, number of surfactant administration, duration of respiratory support, complications, and mortality in both groups. Data were analyzed using SPSS software and applying independent t tests, Mann-Whitney tests, and Chi square tests.ResultsEighty-four neonates were enrolled in the study, with 37 in the control group and 47 in the case group. The duration of hospital stay in the control group was 18.07±13.04 days, while it was 23.59±14.03 days in the intervention group (P=0.07). There were no differences between the two groups in terms of the fraction of inspired oxygen (FIO₂) (P=0.46), and complications (P=0.82). However, the intubation period in the Curosurf group was significantly lower (P=0.03). The mortality rate in the Curosurf group was 24.3% (95% CI=10.5%-38.1%); while in the Beracsurf group, it was 10.6% (95% CI=1.8%-19.5%) (P=0.09).ConclusionBeracsurf had comparable efficacy to Curosurf and could be considered a viable alternative.Trial Registration Number: IRCT20120126008827N3.

2024-11-29·Cureus

Comparison of Efficacy of Beractant (SURVANTA®) and Poractant Alfa (CUROSURF®) in Preterm Infants With Respiratory Distress Syndrome in Tawam Hospital, Al Ain, UAE: A Retrospective Study

Article

作者: Rahmani, Mohamed ; Alabdullatif, Mustafa ; Abdulrahman, Sarah ; Zaineh, Alaa ; El Khatib, Feryal ; Abusallout, Nour ; Butt, Fahad ; Hamwi, Sara ; Mohamad, Huda

Introduction Respiratory distress syndrome (RDS) is a leading cause of morbidity and mortality among preterm infants, necessitating effective treatment strategies. This study compared the efficacy of Beractant (SURVANTA®) to Poractant alfa (CUROSURF®) in treating RDS in preterm infants admitted to Tawam Hospital in the UAE. Methodology This retrospective study included preterm infants from 23+0 to 36+6 weeks of gestation with a diagnosis of RDS and treatment by Beractant or Poractant alfa within 48 hours of life between January 2020 and March 2023. Data collected from electronic medical records of Tawam Hospital include infant and maternal demographics, primary outcome parameters, such as bronchopulmonary dysplasia (BPD) and/or mortality, and secondary outcome parameters, such as surfactant redosing, air leak syndrome, and other complications. Results A total of 258 infants met the inclusion criteria: 178 were treated with Beractant, and 80 were treated with Poractant alfa. After adjusting the confounding factors, the occurrence of bronchopulmonary dysplasia (BPD) was not statistically significant, showing rates of 68.7% (n=46) in the Poractant group and 47.5% (n=75) in the Beractant group (p=0.71). Likewise, there was no significant difference in mortality rates between the two groups, with 22.5% (n=18) in the Poractant group and 11.8% (n=21) in the Beractant group (p=0.33). Furthermore, the combined incidence of BPD or mortality was also not statistically significant, recorded at 53.4% (n=95) for the Beractant group compared to 73.8% (n=59) for the Poractant group (p=0.93). However, the need for surfactant redosing and air leak syndrome was significantly lower in the Poractant group compared to the Beractant group, 26.2% (n=21) vs 45.5% (n=81), p < 0.00001 and 8.8% (n=7) vs 14.6% (n=26), p = 0.05, respectively. There was no difference in the incidence of other outcomes such as pulmonary hemorrhage, periventricular leukomalacia (PVL), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), significant patent ductus arteriosus (PDA), and retinopathy of prematurity (ROP) that required treatment. Conclusion There was no significant difference in the rates of bronchopulmonary dysplasia or mortality between Poractant alfa (CUROSURF®) and Beractant (SURVANTA®) in preterm infants suffering from respiratory distress syndrome. Poractant alfa (CUROSURF®) showed a reduced need for surfactant redosing and a lower incidence of air leak syndrome. However, the rates of other outcomes, including significant patent ductus arteriosus (PDA), intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP), periventricular leukomalacia (PVL), and necrotizing enterocolitis (NEC), were comparable in both treatment groups. Further randomized prospective studies are necessary to evaluate these types of surfactants and investigate their efficacy as well as both short- and long-term outcomes.

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


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)	糧艱衊憲夢淵顧艱繭範(窪築蓋餘遞糧糧夢鬱鹽) = 壓鬱糧淵鏇遞鑰鹽淵糧獵觸鑰鑰觸襯鑰醖選繭 (餘顧淵顧蓋衊衊齋夢顧, 範夢壓範範積壓艱觸鏇 ~ 網廠築範範淵壓艱醖膚) 更多	-	2011-09-20
				Poractant Alfa (Poractant Alfa Arm)	糧艱衊憲夢淵顧艱繭範(窪築蓋餘遞糧糧夢鬱鹽) = 衊淵構範願餘鑰壓觸艱獵觸鑰鑰觸襯鑰醖選繭 (餘顧淵顧蓋衊衊齋夢顧, 構窪齋簾膚觸積觸遞鹽 ~ 鏇鬱餘鹽顧鬱鹽築範獵) 更多
NCT00767039 (Pubmed \| J Perinatol)	临床4期	呼吸窘迫综合征	50	Poractant alfa	餘積憲積選鑰鹽獵蓋襯(鏇構鏇壓鹽築積選壓鑰) = 鹹構壓壓淵衊憲餘鹽鹽範襯齋獵積齋鑰醖簾蓋 (選鹹衊鏇壓廠構鏇積餘 )	-	2010-10-01
				Beractant	餘積憲積選鑰鹽獵蓋襯(鏇構鏇壓鹽築積選壓鑰) = 蓋製鏇蓋膚窪積範糧遞範襯齋獵積齋鑰醖簾蓋 (選鹹衊鏇壓廠構鏇積餘 )