Notice bibliographique
Résumé
Introduction: Recurrent urinary tract infection (rUTI) in women is associated with widespread morbidity, massive antibiotic use, increasing antibiotic resistance, significant costs and is believed to be implicated in the etiology of infection phenotype of bladder pain syndrome (BPS).This is the first North American real-world, clinical experience evaluation of MV140, a novel bacterial sublingual vaccine developed for prevention of rUTI.Methods: Female participants with ≥3 documented UTI/year (≥3 one culture proven) underwent a three-month vaccination treatment period, nine-month efficacy period, and subsequent three-month followup (total 15 months).Primary outcome was no clinically diagnosed UTI (defined as symptoms requiring antibiotic therapy) following vaccination.Secondary outcomes included reduction in UTI compared to pre-vaccination, quality of life (QoL), global response assessment (GRA), microbiology, and safety.A sub-study evaluated subjects with rUTI and concurrent BPS.Results: Sixty-seven subjects (mean age 55.6 years, range 18-80), including 16 with BPS, were enrolled; 64 completed the three-month vaccination period and at least one post-vaccination assessment.Prior to vaccination, subjects reported 6.8±4.6 UTI/year.The UTI-free rate for the nine-month post-vaccination efficacy period was 40.6%.Compared to the UTI rate in the year prior to vaccination (0.56 UTI/subject/month), the reduction in UTI rate was 74.8% for the nine-month efficacy period (0.14 UTI/subject/month) post-vaccination.The total number of UTI and the number of patients reporting UTI decreased substantially for each three-month followup period, while the percentage of UTI-free subjects increased following vaccination.At the 12-month efficacy visit, 82% reported (GRA) that they were moderately/markedly improved; 59% were mostly satisfied, pleased, or delighted, while mean SF-12 improved by 1.5 points on QoL assessment.In the BPS sub-study, 6/16 subjects were UTI-free, while all 16 subjects had a reduction (overall 80%) in UTI compared to the year pre-vaccination (0.5 to 0.1 UTI/ subject/month).At 12 months, 13 subjects (81.3%) reported moderate or marked improvement, with eight reporting significant or almost complete resolution of their specific long-term bladder discomfort/pain and bothersome urinary frequency or urgency.In the entire group, 11 adverse events in nine subjects were potentially related to the vaccine; all were mild and resolved by three months.None of the 13 serious adverse events were related to the vaccine.Conclusions: This first Health Canada-approved North American experience with the sublingual vaccine, MV140, demonstrates its safety and potential effectiveness in real-world clinical practice in reducing UTI risk and rendering a significant number of women suffering from rUTI, including those with IC/BPS, completely UTI-free (and offering amelioration of BPS symptoms for those with BPS).
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 machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,001 | 0,000 |
| Communication savante | 0,002 | 0,001 |
| Science ouverte | 0,001 | 0,002 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,495 | 0,219 |
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; l’étiquette directe de Gemma et le classifieur distillé Codex 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 ».