Safety of Two-Hour Intermittent Intravenous Infusions of Tacrolimus in the Allogeneic Hematopoietic Stem Cell Transplantation Unit
Notice bibliographique
Résumé
Background: Administering intravenous (IV) tacrolimus by 24-hour continuous IV infusion (CIV), as recommended by the product monograph, poses significant logistical challenges in the allogeneic hematopoietic stem cell transplantation (alloHSCT) unit because it requires a dedicated central venous catheter lumen. Consequently, at our institution, tacrolimus has been administered via two-hour intermittent IV infusions (IIV) every twelve hours in the alloHSCT unit. Administration by IIV is not the standard of practice and shorter infusion times are cautioned due to higher rates of nephrotoxicity, neurotoxicity and infusion-related reactions (IRRs), although there is a paucity of data to support these claims. The primary objective of this retrospective study was to evaluate the safety of a two-hour IIV of tacrolimus in an adult alloHSCT population. Efficacy was evaluated as a secondary endpoint. Methods and patients: We performed a retrospective chart review of all patients who received IV tacrolimus at our institution from January 2002-January 2016. We reviewed 104 patients who received 118 treatment courses of tacrolimus by IIV (TCTIV) (median number of doses per TCTIV = 22, range 1-158). Primary outcomes collected include rates of nephrotoxicity, neurotoxicity and IRRs that occurred during TCTIV. The incidence of acute graft-versus-host disease (aGVHD) and disease relapse within 180 days of transplant were collected to evaluate efficacy. Results and discussion: There were sixteen incidences (13.6%) of nephrotoxicity, defined as a doubling of serum creatinine from baseline. Nephrotoxicity resolved in all but six (5.1%) cases. Precipitating factors for nephrotoxicity unrelated to tacrolimus were identified by the physician in all six cases. There were 41 incidences (34.7%) of neurotoxicity [seizure, posterior reversible encephalopathy syndrome (PRES), tremor, paresthesia, visual disturbance], of which, eight (6.8%) were considered serious (seizure and/or PRES). All neurotoxicity reverted to baseline or resolved completely. One (.1%) grade 2 infusion reaction occurred and resolved without discontinuation of tacrolimus. In the subset of patients who received tacrolimus for the prevention of aGVHD (n = 43), fifteen patients (34.9%) developed grade II-IV aGVHD. Nine patients (8.7%) experienced relapse of their disease. Conclusions: We propose that a two-hour IIV of tacrolimus is a safe method of administration in an adult alloHSCT setting. Additional safety and efficacy data from other institutions will provide external validity to this conclusion.
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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) | 0,000 | 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 tête enseignante, 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 ».