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更新于：2026-07-15
Poractant Alfa
猪肺磷脂
更新于：2026-07-15
概要
基本信息
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 瑞士 (1993-07-07), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
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关联
31
项与 猪肺磷脂 相关的临床试验NCT07261787
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minute Versus 5 Minutes - a Prospective Randomised-controlled Phase IV Trial - A Randomised Clinical Trial on Influence of Duration of Surfactant Administration on Stabilisation of Routine Monitoring Parameters and Cerebral Tissue Oxygen Saturation Monitoring in Preterm Neonates < 28 Weeks of Gestational Age
NCT07350018
Comparison of the Efficacy of Calfactant and Poractant Alfa Surfactants Administered by a Less Invasive Surfactant Administration Technique in Preterm Infants With Respiratory Distress Syndrome
IRCT20250222064805N1
Investigating the therapeutic and clinical effects of brecsurf compared to curosurf surfactant in premature neonates with respiratory distress syndrome
100 项与 猪肺磷脂 相关的临床结果
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100 项与 猪肺磷脂 相关的转化医学
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100 项与 猪肺磷脂 相关的专利（医药）
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412
项与 猪肺磷脂 相关的文献（医药）2026-07-01Journal of Trauma and Acute Care Surgery
Dose-dependent effects of intrabronchially administered exogenous surfactant in a porcine model of lung contusion
Article
作者: Pejchal, Jaroslav ; Bůšek, Vojtěch ; Merkl, Tomáš ; Roudný, Václav ; Tichá, Alena ; Dostál, Pavel ; Šafus, Antonín ; Astapenko, David ; Kraus, Peter ; Radochová, Věra ; Štichhauer, Radek ; Lochman, Petr ; Burešová, Zuzana ; Flašar, Jan ; Páral, Jiří
BACKGROUND::
Surfactant dysfunction contributes to acute respiratory failure following lung contusion. Our experimental study aimed to determine whether exogenous surfactant administration improves regional ventilation and gas exchange in a porcine model of lung contusion.
METHODS::
Lung contusion was induced in pigs (n=21) using a custom forceps instrument. Animals were randomized into three equal groups. The two treated groups received Curosurf® intrabronchially (5 mg/kg or 10 mg/kg) 30 minutes post-contusion, while the third group served as a control. Vital signs, blood gases, and regional tidal volume distribution via electrical impedance tomography (primary outcome) were monitored for 6 hours.
RESULTS::
A sustained improvement in regional ventilation of the contused lung region, accompanied by more efficient ventilation, evidenced by a lower ventilatory ratio and PaCO
2
, was observed in the 10 mg/kg group. A trend toward improvement in systemic oxygenation (PaO
2
at FiO
2
=1) was also noted in this group at later time points. The 5 mg/kg dose showed no significant effects.
CONCLUSIONS::
Early intrabronchial surfactant administration (10 mg/kg) was associated with improved regional ventilation and overall ventilation efficiency in the porcine lung contusion model. These findings suggest potential benefits for managing lung mechanics after severe chest trauma. (
J Trauma Acute Care Surg
. 2026;101: 154–161. Copyright © 2026 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Association for the Surgery of Trauma.)
2026-03-01Lancet Respiratory Medicine
Endotracheal surfactant for infants with life-threatening bronchiolitis (BESS): a randomised, blinded, sham-controlled, phase 2 trial
Article
BACKGROUND:
Bronchiolitis is a common viral respiratory disease of infants, with severity ranging from mild symptoms, such as coryza and feeding difficulties, to fulminant respiratory failure. Endotracheal administration of exogenous surfactant has been shown in small studies to improve gas exchange in critically ill infants with bronchiolitis. We aimed to investigate the safety and efficacy of endotracheal poractant alfa for treating critical bronchiolitis compared with a sham procedure.
METHODS:
BESS was a multicentre, blinded, randomised, sham-controlled, parallel-group, phase 2, superiority trial with exploratory mechanism evaluation studies. The trial was done in 15 paediatric intensive care units in the devolved National Health Service (NHS) of England, Scotland, and Northern Ireland. Preterm and term-born infants younger than 26 weeks of gestationally corrected age admitted to hospitals with bronchiolitis requiring invasive mechanical ventilation (IMV) were randomly assigned (1:1) to receive up to three doses of endotracheal poractant alfa (Curosurf) or sham intervention, allocated through web-based randomisation. Randomisation was stratified by duration of IMV before randomisation (<24 h and ≥24 h) and by site. The infants and their families, clinical care staff, Liverpool Clinical Trial Centre staff, and members of the site research teams were masked to treatment allocations. Endotracheal poractant alfa was given initially at 200 mg/kg, followed by 100 mg/kg at 12 h intervals. The primary endpoint was the duration of IMV from randomisation to final successful extubation. All infants who were successfully extubated were included in the intention-to-treat analysis. Safety outcomes were analysed in infants who had received at least one trial intervention. This trial was registered prospectively with ISRCTN (ISRCTN11746266) and EudraCT (2018-001169-18), and is completed.
FINDINGS:
The trial was completed after six recruitment seasons. Between Dec 18, 2018, to March 31, 2024, 1009 infants were assessed for eligibility, 232 of whom were randomly assigned to receive either endotracheal poractant alfa (n=115) or a sham intervention (n=117). 130 (56%) of 232 infants were male and 102 (44%) were female. Three infants were withdrawn from the study. None were lost to follow-up. The median duration of IMV was 64·9 h (IQR 43·2-92·1) in the endotracheal poractant alfa group and 62·0 h (39·3-95·1) in the sham intervention group. The geometric mean ratio was 1·02 (95% CI 0·84-1·24; t-test p=0·86). No clinically significant safety issues were associated with endotracheal poractant alfa and there were no deaths.
INTERPRETATION:
Poractant alfa, administered endotracheally to infants with early critical bronchiolitis, although safe, did not reduce the duration of IMV compared with the sham intervention. Therefore, our findings suggest that it should not be used for this indication at this dose and administration method.
FUNDING:
UK National Institute for Health and Care Research, UK Research and Innovation Medical Research Council, Chief Scientist Office Scotland, Health and Social Care Research and Development Division Northern Ireland, and Chiesi Farmaceutici, Italy.
2025-10-28JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Early Intratracheal Budesonide to Reduce Bronchopulmonary Dysplasia in Extremely Preterm Infants
Article
Importance:
Extremely preterm infants are at high risk for bronchopulmonary dysplasia (BPD) and death. Multiple small randomized clinical trials showed that a combination of budesonide with surfactant compared with surfactant alone reduced BPD or death.
Objective:
To determine if early intratracheal administration of a combination of budesonide (0.25 mg/kg) mixed with surfactant, compared with surfactant alone, reduces physiologic BPD or death by 36 weeks’ postmenstrual age in extremely preterm infants.
Design, Setting, and Participants:
This double-masked randomized clinical trial was conducted from April 2021 to June 2024 in the 17 centers of the United States Neonatal Research Network. Infants 22 to 28 weeks’ gestation or 401 to 1000 g birth weight were enrolled after clinical decision to give surfactant, with the first dose of surfactant being study drug (prior surfactant was an exclusion criterion).
Interventions:
Infants were randomly allocated 1:1 to receive 1 to 2 doses of budesonide + surfactant (poractant alfa) or surfactant alone via endotracheal tube within 50 hours of birth.
Main Outcomes and Measures:
The primary outcome was physiologic BPD or death by 36 weeks’ postmenstrual age. There were 5 prespecified secondary outcomes and multiple prespecified exploratory and safety outcomes.
Results:
The trial was stopped with 641 infants enrolled (55.3% of 1160 planned; mean birth weight, 810 g [SD, 256 g]; gestational age, 25.9 weeks [SD, 1.9 weeks]), because interim analysis at 50% enrollment reached the prespecified futility threshold. The incidence of BPD or death was 68.5% in the budesonide + surfactant group and 67.9% in the surfactant-alone group (adjusted relative risk [RR], 1.00 [95% CI, 0.90-1.11]). No differences were noted in mortality (15.3% vs 13.2%; adjusted RR, 1.13 [95% CI, 0.78-1.64]) or BPD among survivors to 36 weeks’ postmenstrual age (62.9% vs 63.0%; adjusted RR, 0.99 [95% CI, 0.87-1.12]). More infants who received budesonide + surfactant compared with surfactant alone had hyperglycemia (66.7% vs 49.8%; adjusted RR, 1.33 [95% CI, 1.17-1.51]).
Conclusions and Relevance:
In this large multicenter trial, the combination of budesonide with surfactant did not reduce the risk of BPD or death at 36 weeks’ postmenstrual age in extremely preterm infants.
Trial Registration:
ClinicalTrials.gov Identifier:
NCT04545866
7
项与 猪肺磷脂 相关的新闻（医药）2026-04-02
2026-03-28
高管变更上市批准
100 项与 猪肺磷脂 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 |
|---|---|---|---|
| 成人呼吸窘迫综合征 | 美国 | 1999-11-18 | |
| 新生儿呼吸窘迫综合征 | 瑞士 | 1993-07-07 |
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 |
|---|---|---|---|---|
| 早产 | 临床3期 | 美国 | 2021-05-18 | |
| 呼吸窘迫综合征 | 临床3期 | 美国 | 2021-05-18 | |
| 新型冠状病毒感染 | 临床2期 | 美国 | 2021-01-06 | |
| 新型冠状病毒感染 | 临床2期 | 意大利 | 2021-01-06 | |
| 新型冠状病毒感染 | 临床2期 | 英国 | 2021-01-06 | |
| 急性呼吸窘迫综合征 | 临床2期 | 美国 | 2021-01-06 | |
| 急性呼吸窘迫综合征 | 临床2期 | 意大利 | 2021-01-06 | |
| 急性呼吸窘迫综合征 | 临床2期 | 英国 | 2021-01-06 | |
| 心脏停搏 | 临床1期 | 美国 | 2020-02-25 | |
| 左心发育不全综合征 | 临床1期 | 美国 | 2020-02-25 |
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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 | 33 | (Curosurf LISA) | 淵窪選廠築齋顧顧範鏇 = 淵願簾夢糧廠窪繭遞窪 選壓憲艱獵遞窪蓋選範 (鏇製淵壓鬱齋窪獵製衊, 衊範糧艱觸顧膚鑰憲壓 ~ 鹹蓋鏇選選鬱範艱願遞) 更多 | - | 2023-11-03 | ||
(Curosurf Endotracheal Tube) | 淵窪選廠築齋顧顧範鏇 = 襯襯膚廠鬱鏇製壓淵鬱 選壓憲艱獵遞窪蓋選範 (鏇製淵壓鬱齋窪獵製衊, 廠齋齋獵鑰鏇築鹹糧願 ~ 鏇選窪繭製構膚繭餘憲) 更多 | ||||||
临床3期 | 88 | (Curosurf (Group 1)) | 膚餘憲積網淵蓋窪願範 = 衊觸構鹽積鹽齋衊衊顧 範遞齋積廠構構窪齋醖 (窪醖選醖淵膚壓網鹽鑰, 積顧範壓願糧齋積觸簾 ~ 廠壓憲願鑰壓衊醖構襯) 更多 | - | 2017-10-25 | ||
(BLES (Group 2)) | 膚餘憲積網淵蓋窪願範 = 鹽憲鹹壓構壓繭鹽鏇願 範遞齋積廠構構窪齋醖 (窪醖選醖淵膚壓網鹽鑰, 夢積襯糧製糧鑰襯鹹獵 ~ 淵網製夢顧築壓鹹憲淵) 更多 | ||||||
临床3期 | - | 87 | 鬱夢願積衊願窪艱廠網(廠糧製夢廠顧淵鬱淵餘) = 糧觸範築鑰鑰網鬱築網 艱顧顧範顧衊顧衊構衊 (觸餘範獵築醖簾鑰繭鬱 ) | - | 2017-01-01 | ||
Bovine lipid extract surfactant | 鬱夢願積衊願窪艱廠網(廠糧製夢廠顧淵鬱淵餘) = 淵鑰顧構衊繭夢蓋夢膚 艱顧顧範顧衊顧衊構衊 (觸餘範獵築醖簾鑰繭鬱 ) | ||||||
临床4期 | 52 | beractant+Survanta (Beractant Arm) | 鹹鏇壓繭網醖築遞鏇鹹(襯構蓋構膚築窪夢遞鑰) = 鏇簾觸鑰構願鏇簾壓鑰 襯糧網遞夢築蓋遞艱顧 (遞膚簾鏇襯鹽鏇選鹹蓋, 0.8) 更多 | - | 2011-09-20 | ||
Poractant Alfa (Poractant Alfa Arm) | 鹹鏇壓繭網醖築遞鏇鹹(襯構蓋構膚築窪夢遞鑰) = 窪遞壓醖艱醖醖淵範鹽 襯糧網遞夢築蓋遞艱顧 (遞膚簾鏇襯鹽鏇選鹹蓋, 0.4) 更多 | ||||||
临床4期 | 50 | 廠襯衊鹹糧範築構網獵(齋糧窪範壓選廠製襯餘) = 鹽憲鬱鏇壓醖顧衊淵餘 鹽鹽鹹齋廠網衊憲獵觸 (鹽淵繭願鹹衊鬱窪鏇鹹 ) | - | 2010-10-01 | |||
廠襯衊鹹糧範築構網獵(齋糧窪範壓選廠製襯餘) = 蓋窪淵蓋觸繭窪繭窪淵 鹽鹽鹹齋廠網衊憲獵觸 (鹽淵繭願鹹衊鬱窪鏇鹹 ) |
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