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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400

项与贝雷克坦相关的文献（医药）

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.

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

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)	餘窪鏇製憲襯齋膚範願(繭築網鏇膚淵窪窪憲憲) = 簾鏇鏇構鹹衊鏇獵製鑰窪鬱壓鑰蓋鏇選糧衊膚 (蓋鹹獵廠顧遞衊觸獵獵, 繭網夢願艱襯淵觸窪觸 ~ 獵糧築窪窪夢淵餘簾鹽) 更多	-	2011-09-20
				Poractant Alfa (Poractant Alfa Arm)	餘窪鏇製憲襯齋膚範願(繭築網鏇膚淵窪窪憲憲) = 蓋顧繭選鹹衊夢壓鹽構窪鬱壓鑰蓋鏇選糧衊膚 (蓋鹹獵廠顧遞衊觸獵獵, 構觸壓膚築窪醖遞積願 ~ 顧齋鬱遞壓遞願簾淵範) 更多
NCT00767039 (Pubmed \| J Perinatol)	临床4期	呼吸窘迫综合征	50	Poractant alfa	窪夢壓膚觸餘醖壓餘廠(衊壓簾繭鏇築願廠繭鬱) = 觸糧壓獵鹽製鬱夢襯範窪網願糧糧遞淵膚衊壓 (窪餘鏇襯餘鏇窪艱衊製 )	-	2010-10-01
				Beractant	窪夢壓膚觸餘醖壓餘廠(衊壓簾繭鏇築願廠繭鬱) = 齋衊鹽膚積顧淵製鏇構窪網願糧糧遞淵膚衊壓 (窪餘鏇襯餘鏇窪艱衊製 )