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Dublin Core
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Title
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January 2021 List
Text
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Citation List Month
January 2021 List
URL Address
<a href="http://doi.org/10.1016/j.ctim.2020.102402" target="_blank" rel="noreferrer noopener">http://doi.org/10.1016/j.ctim.2020.102402</a>
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
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Safety and pharmacokinetics of medical cannabis preparation in a monocentric series of young patients with drug resistant epilepsy
Publisher
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Complementary Therapies in Medicine
Date
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2020
Subject
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Adolescent; Adult; Child; Female; Humans; Male; Child Preschool; Dose-Response Relationship Drug; Young Adult; Prospective Studies; Cannabidiol (CBD); Childhood; Delta-9-tetrahydrocannabinol (THC); Drug-resistant epilepsy; Medical cannabis galenic preparation; Drug Resistant Epilepsy/drug therapy; Medical Marijuana/administration & dosage/adverse effects/pharmacokinetics
Creator
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Gherzi M; Milano G; Fucile C; Calevo MG; Mancardi MM; Nobili L; Astuni P; Marini V; Barco S; Cangemi G; Manfredini L; Mattioli F; De Grandis E
Description
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OBJECTIVES: To evaluate safety and pharmacokinetic parameters (PK) of medical cannabis in add-on for children and young adults with drug-resistant epilepsy. DESIGN, SETTING: Ten patients (4 females, 6 males, age 2.5-23.2 years) were enrolled in a prospective open trial with a galenic preparation (decoction) of Italian cannabis (FM2, ratio THC:CBD = 3:5, range THC 5.2-7.2 %; CBD 8.2-11.1 %). Patients received the first dose in Hospital, progressively augmented by CBD dose titration (from 1 to 4 mg/kg/day). OUTCOME MEASURES: In order to assess safety, blood parameters, heart rates and electrocardiograms (ECGs) were evaluated before the enrollment and during the follow up. The PK study was performed measuring THC and CBD concentrations by UHPLC-MS/MS in plasma samples collected during the first administration and at each follow-up visit. RESULTS: Two out of ten patients stopped the treatment for adverse events (detected in 6/10: gastroenteric, sleep or behavioral disorders) and difficulties in drug supply. We observed minor ECG alterations in two patients and asymptomatic transient reductions of fibrinogen after 6 months of therapy. The PK study during follow-up revealed statistically significant correlations between THC-CBD blood concentrations and: volumes of decoction, FM2 and THC-CBD daily dosages. CONCLUSIONS: The present study, although with some limitations, shows a good safety profile of medical cannabis in children and young patients with drug-resistant epilepsy and encourages the possibility of further studies with oral cannabis-based drugs. The correlations between THC-CBD plasma concentrations and their administered dosages underline the need of a therapeutic drug monitoring for cannabinoids therapy.
Identifier
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<a href="http://doi.org/10.1016/j.ctim.2020.102402" target="_blank" rel="noreferrer noopener">10.1016/j.ctim.2020.102402</a>
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Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
2020
Adolescent
Adult
Astuni P
Barco S
Calevo MG
Cangemi G
Cannabidiol (CBD)
Child
Child Preschool
childhood
Complementary Therapies in Medicine
De Grandis E
Delta-9-tetrahydrocannabinol (THC)
Dose-Response Relationship Drug
Drug Resistant Epilepsy/drug therapy
Drug-resistant epilepsy
Female
Fucile C
Gherzi M
Humans
January 2021 List
Male
Mancardi MM
Manfredini L
Marini V
Mattioli F
Medical cannabis galenic preparation
Medical Marijuana/administration & dosage/adverse effects/pharmacokinetics
Milano G
Nobili L
Prospective Studies
Young Adult