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albumin (Zenalb)

✓ Approved

Kedrion · 细胞治疗 · 细胞治疗

什么是 albumin？

albumin 是一种细胞治疗，由Kedrion研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

商品名Zenalb
公司Kedrion
药物类别细胞治疗
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, Kedrion

治疗适应症

albumin 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Vascular disordersThrombosis✓ Approved

相关研究文献

PubMedCarbohydrate polymers2026-06-13

Hierarchical construction of a superhydrophobic and superior intrinsically flame-retardant phosphorylated microcrystalline cellulose bio-based composite aerogel.

Lang Wenchao W, Jia Haoyi H, Wang Zhe Z, Wu Ningjing N

The practical deployment of cellulose aerogels in the thermal-insulation fields is severely constrained by their inherent hygroscopicity, flammability, and fragility. Integrating superior flame-retardancy with superhydrophobicity in cellulose-based aerogel remains a significant challenge. Herein, phosphorous-containing microcrystalline cellulose (PMCC) was utilized as an intrinsically flame-retardant bio-based matrix, and a hierarchical organic-inorganic network was engineered via methyltrimethylsilane crosslinking coupled with in situ self-assembly of modified silica (MSiO2) nanoparticles. The resulting MPMCC-MSiO2 composite aerogels featured a hierarchically multiscale porous architecture in which MSiO2 and poly(methylsilsesquioxane) (PMSQ) micro/nanoscale particles were uniformly integrated throughout the coarse three-dimensional pore matrix framework. This configuration of the MPMCC-MSiO2 aerogel enabled superhydrophobicity across different cross-sections with excellent self-cleaning, achieving water contact angles (WCA) up to 151°. Moreover, the organic-inorganic dual crosslinked network significantly reinforced mechanical performance, delivering compressive moduli of MPMCC-MSiO2-2 reaching 5.50 MPa, corresponding to enhancements of 491.4% relative to PMCC aerogel. Notably, the limiting oxygen index (LOI) of the MPMCC2-MSiO2-2 aerogel increased from 36.8% for the PMCC aerogel to 60.0%, attributed to the phosphorus/silicon synergistic flame-retardant effect. The integration of ultra-high flame-retardancy, superhydrophobicity, and structural robustness renders this MPMCC-MSiO2 bio-based composite aerogel promising for advanced, sustainable thermal insulation applications.

PMID 42285677
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PubMedBreast cancer (Tokyo, Japan)2026-06-13

Low protein, high risk: hypoalbuminemia predicts adverse outcomes after mastectomy in 37,848 breast cancer patients.

Schaschinger Thomas T, Niederegger Tobias T, Diatta Fortunay F, Matar Dany Y DY et al.

Hypoalbuminemia is a well-known marker of poor nutritional status and has been linked to adverse outcomes in various surgical specialties. However, its role in mastectomy remains underexplored. This study investigates the impact of hypoalbuminemia on 30-day postoperative outcomes in patients undergoing mastectomy for breast cancer. Using data from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database from 2011 to 2021, we identified 37,848 female breast cancer patients who underwent mastectomy without concurrent reconstructive procedures and had documented preoperative serum albumin levels measured within 30 days of surgery. Patients were stratified by albumin level (< 3.5 g/dL vs. ≥3.5 g/dL). Multivariate logistic regression was used to assess the association between hypoalbuminemia and postoperative 30-day outcomes. ROC analysis identified albumin thresholds predictive of complications. Among 37,848 patients, 3,210 (8.5%) were hypoalbuminemic. Hypoalbuminemia was significantly associated with higher rates of any complication (16% vs. 10%; OR 1.4, p < 0.001), surgical complications (10% vs. 5.5%; OR 1.5, p < 0.001), medical complications (0.37% vs. 0.13%; OR 1.8, p < 0.001). Similarly, readmissions were significantly more frequent in hypoalbuminemic patients (7.0% vs. 3.9%; OR 1.6, p < 0.001). The need for transfusion was over three times higher (5.0% vs. 1.4%, p < 0.001), and hypoalbuminemia was associated with longer hospital stays (2.2 vs. 1.3 days, p < 0.001). Subgroup analysis revealed that these trends persisted across both total and radical mastectomy procedures. Optimal albumin thresholds for predicting complications ranged from 3.7 to 4.1 g/dL, depending on the type of complication. Preoperative hypoalbuminemia is an independent predictor of increased postoperative morbidity following mastectomy. Clinicians may consider selective albumin assessment as a pragmatic tool for identifying patients with increased physiological vulnerability who may benefit from targeted preoperative optimization strategies, rather than as a stand-alone indicator of nutritional deficiency; however, further research is needed to establish optimal testing strategies and confirm clinical benefits.

PMID 42286386
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PubMedClinical therapeutics2026-06-13

Development and Validation of a Risk Stratification Model Incorporating Serum Lactate and Albumin for Predicting Enteral Nutrition Feeding Intolerance in Patients With Sepsis.

Ge YueYue Y, Ye Dan D, Shi TianTian T, Li Fei F et al.

Enteral nutrition feeding intolerance (ENFI) is a common complication in patients with sepsis and may compromise nutritional support and clinical recovery. This study aimed to develop and validate a risk stratification model incorporating serum lactate (LAC) and albumin (ALB) for predicting ENFI in patients with sepsis. A total of 258 patients were screened for eligibility according to predefined inclusion and exclusion criteria. The final complete-case cohort comprised 230 patients with sepsis who received enteral nutrition between December 2021 and June 2025, including 88 patients in the ENFI group and 142 in the non-ENFI group. Clinical variables and laboratory indicators obtained within 24 hours before enteral nutrition initiation were analyzed. Predictors were screened using least absolute shrinkage and selection operator regression and entered into multivariable logistic regression for model construction. Model performance was evaluated by receiver operating characteristic analysis, calibration analysis, bootstrap internal validation, and decision curve analysis. Lactate levels were significantly higher in the ENFI group than in the non-ENFI group (median [interquartile range], 2.70 [2.00-3.86] vs 1.82 [1.19-2.48] mmol/L; P < 0.001), whereas ALB levels were significantly lower (27.83 ± 5.02 vs 32.82 ± 4.33 g/L; P < 0.001). Least absolute shrinkage and selection operator regression identified 4 predictors: ALB, Acute Physiology and Chronic Health Evaluation II (APACHE II) score, LAC, and mechanical ventilation. Multivariable analysis showed that decreased ALB (odds ratio [OR] = 0.80; 95% CI, 0.74-0.86), increased APACHE II score (OR = 1.09; 95% CI, 1.01-1.17), increased LAC (OR = 2.03; 95% CI, 1.50-2.85), and mechanical ventilation (OR = 2.52; 95% CI, 1.28-5.10) were independent predictors of ENFI (all P < 0.05). The 4-variable model achieved an area under the curve of 0.854 (95% CI, 0.803-0.905), outperforming single indicators. Bootstrap internal validation yielded a corrected area under the curve of 0.845, and the Hosmer-Lemeshow test indicated good fit (P = 0.299). Decision curve analysis reported a positive net clinical benefit across a threshold probability range of 10% to 70%. A 4-variable prediction model anchored by LAC and ALB and further incorporating APACHE II score and mechanical ventilation showed good discrimination for predicting ENFI in patients with sepsis. This model may provide a practical tool for early risk stratification and may help support individualized enteral nutrition monitoring in clinical practice.

PMID 42285825
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PubMedFertility and sterility2026-06-13

Artificial intelligence in the in vitro fertilization laboratory: a committee opinion.

Practice Committees of the American Society for Reproductive Medicine, Society of Reproductive Biologists and Technologists

Artificial intelligence has already been portrayed as a tool that will impact different areas of laboratory function, most importantly embryo selection. The current state of artificial intelligence in the in vitro fertilization laboratory is described. Information about how it may be implemented in the laboratory is provided, and, despite the large cohort of patients studied, caution is recommended in interpreting the retrospective data.

PMID 42285874
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PubMedJournal of pharmaceutical sciences2026-06-13

Change management considerations for orally inhaled and nasal drug products and other drug device combination products in the European Union.

Calderini Marielle M, Grand-Demars Beatrice B, Nagao Lee L

In this paper, the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), discusses the current regulatory landscape associated with change management of orally inhaled and nasal drug products (OINDP) and other drug device combination products in the European Union. The paper also describes current challenges related to alignment of regulatory expectations, particularly for integral drug device combination products, and proposes topics for further discussion with regulatory agencies and stakeholders to help advance alignment. To further illustrate current challenges and industry approaches to meeting change management requirements, we also present results of an IPAC-RS benchmarking survey and case studies, and outcome from interactions with notified bodies and regulatory agencies. This document is intended to be used as a guideline for industry alignment.

PMID 42285437
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PubMedJournal of colloid and interface science2026-06-13

Reinforcement of bovine serum albumin-based interfaces by the addition of genipin and carboxymethyl cellulose: Effect of pH.

Felix Manuel M, Lendel Christofer C, Fielden Matthew M, Carrera-Sanchez Cecilio C et al.

Protein based interfacial films are a vital component of encapsulated functional food. The stability and mechanical performance of bovine serum albumin (BSA) films can be significantly enhanced through two complementary strategies: (i) electrostatic complexation for example with carboxymethyl cellulose (CMC), and (ii) interfacial covalent cross linking of BSA by genipin (GNP). Quartz crystal microbalance (QCM), interfacial small amplitude oscillatory shear rheology (iSAOS), and atomic force microscopy (AFM) were combined to quantify mass adsorption, viscoelastic film development, and interfacial morphology of BSA, both alone and in mixtures with CMC and/or GNP at pH 3.0 and 7.0. Attractive electrostatic interactions between BSA and CMC led to interfaces with the highest viscoelastic shear moduli (G' = 0.069 ± 0.004 N/m for BSA + CMC at pH 3.0). At neutral pH genepin enhanced the properties of a BSA film from predominantly liquid like to predominantly solid-like. These findings demonstrate that electrostatic complexation and interfacial cross-linking provide two complementary pathways for the reinforcement of protein-based interfacial films and reveal new routes for enhancing mechanical stability of encapsulated ingredients.

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