Budesonide for maintenance of remission in Crohnʼs disease: A systematic review and meta-analysis for the Cochrane Collaboration.
Notice bibliographique
Résumé
Corticosteroids have been shown to be effective for induction, but not maintenance of remission in Crohn's disease (CD). Significant concerns exist regarding their risk for adverse events, particularly when used for long treatment courses. Budesonide, a glucocorticoid with limited systemic bioavailability due to extensive first-pass hepatic metabolism, has been shown to be effective for induction of remission in CD. This systematic review and meta-analysis examined the efficacy and safety of budesonide for maintenance of remission in CD. MEDLINE, EMBASE, other electronic databases, reference lists of articles, and conference proceedings were searched. Trials comparing budesonide to a control treatment or comparing two doses of budesonide were included. The primary outcome was maintenance of remission up to 12 months following enrolment. Secondary outcomes included: time to relapse, mean change in CDAI, adverse events and study withdrawal. Two independent investigators reviewed studies for eligibility, and extracted the data. For the meta-analysis, a random or fixed effects model was chosen based on an assessment of heterogeneity, and studies were weighted using the Der-Simonian & Laird or the Mantel-Haenszel method accordingly. Eleven studies were included in the review. Budesonide 6 mg daily was no more effective than placebo for maintenance of remission at 3 months (RR 1.25,95% CI 1.00-1.58, P=0.05), 6 months (RR 1.15, 95% CI 0.95-1.39, P=0.14), or 12 months (RR 1.13, 95% CI 0.94-1.35, P=0.19). Budesonide was not more effective than weaning doses of prednisolone for maintenance of remission at 12 months (RR 0.79, 95% CI 0.55-1.13, P=0.20), but was better than mesalamine (RR of remission 2.51, 95% CI 1.03-6.12, P=0.04). Budesonide 3 mg daily was more effective than placebo at 3 months (RR 1.31,95% CI 1.03-1.67, P = 0.03), likely due to either selection bias or the residual effects of the methods used to induce remission. This benefit was not sustained at 6 months (RR 1.10, 95% CI 0.81-1.50, P=0.53), or 12 months (RR 1.04, 95% CI 0.84-1.30, P = 0.70). No differences were detected based on the different formulations or doses of budesonide or methods used to induce remission. The use of budesonide 6 mg resulted in slight improvements in CDAI scores at 12 months (WMD -23.49, 95% CI -46.65 to -0.32, P=0.05) and mean time to relapse of disease (WMD 59.93 days, 95% CI 19.02-100.84, P=0.004). Adverse events were more frequent in patients treated with 6 mg of budesonide compared with placebo (RR 1.49, 95% CI 1.01-2.19, P=0.05). Abnormal adrenocorticoid stimulation tests were seen more frequently in patients receiving both 6 mg daily (RR 2.88, 95% CI 1.72-4.82, P<0.0001) and 3 mg daily (RR 2.73, 95% CI 1.34-5.57, P=0.006) compared with placebo. Budesonide is not more effective than placebo for maintenance of remission in CD. Some modest benefits of budesonide are noted including lower CDAI scores and longer time to disease relapse. However, these benefits are offset by higher treatment-related adverse event rates and more frequent adrenocorticoid suppression in patients receiving budesonide. Therefore, budesonide is not recommended for maintenance of remission in Crohn's disease.
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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 | 0,007 | 0,016 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,016 | 0,024 |
| Bibliométrie | 0,007 | 0,006 |
| Études des sciences et des technologies | 0,001 | 0,000 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,002 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 0,000 |
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; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».