Notice bibliographique
Résumé
Background: Alcoholic hepatitis (AH) results from hepatic inflammation, oxidative damage, cholestasis and apoptosis, all of which induce a vicious cycle that leads to liver and secondary organ failure associated with poor prognosis. Study Design: Vital Therapies' study VTI-208 was conducted in subjects with AH, using an extracorporeal hepatocellular therapy system (ELAD) containing human C3A hepatoma cells, to determine if ELAD can increase survival in AH. C3A cells express acute phase response and immune-modulatory proteins and growth factors and may provide anti-inflammatory therapy and support hepatocellular function in early stages of AH. Inclusion/Exclusion Criteria: Subjects >18yrs old with a clinical or histologic diagnosis of AH, bilirubin >8mg/dl, Maddrey DF >32, MELD 35, platelets 40,000, and without severe concomitant disease, uncontrolled sepsis or bleeding, hemodynamic instability or need for chronic dialysis. Intervention: Subjects were randomized to either 3-5 days continuous ELAD therapy plus standard of care (SOC) or to SOC alone. Endpoint: Overall survival (OS) assessed by Kaplan-Meier analysis. Pre-specified subgroups included subjects with MELD and age >/< baseline median. Results: From 2013-2015, 203 subjects were enrolled (96 ELAD and 107 SOC), at 40 sites worldwide. Comparison of baseline characteristics showed no significant differences between groups and within subgroups, including treatment with steroids or pentoxifylline. There was no significant difference in serious adverse events between groups and no unexpected serious adverse events were related to the cellular component. In an intent-to-treat (ITT) analysis, there was no significant difference in OS (52.1% vs 52.3%). Subgroup analysis showed strong trends toward improved OS in groups in which MELD or age were lower than baseline medians. The majority of subjects (n=120) presented with MELD <28 and in this group, ELAD was associated with a trend toward higher OS (71% vs 57%, p=0.077). A similar trend was seen in younger subjects (n=101) (67% vs 55%, p=0.167). Although not pre-specified, survival in subjects with a combination of MELD and age less than baseline median (n=59) was significantly better in ELAD than SOC (100% vs 73%, p=0.006) at 91 days. After 100 days, survival was fairly stable in all subject groups. Conclusion: There was no difference in OS between ELAD and SOC but there was a trend toward survival benefit in patients with MELD <28 or age <47 years. These data suggest ELAD may be a favorable AH treatment modality in younger patients with sufficient renal function and less severe coagulopathy. A study to confirm the survival benefit in this population is in preparation and is scheduled to start in 2016.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,048 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; les deux têtes enseignantes s’accordent sur ce qui est montré ici.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».