Safety and pharmacokinetics of medical cannabis preparation in a monocentric series of young patients with drug resistant epilepsy
| Autor: | Valeria Marini, Pietro Astuni, Sebastiano Barco, Francesca Mattioli, Elisa De Grandis, L Manfredini, Giuliana Cangemi, Carmen Fucile, Lino Nobili, Giulia Milano, Maria Margherita Mancardi, Marcella Gherzi, Maria Grazia Calevo |
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| Rok vydání: | 2019 |
| Předmět: |
Complementary and Manual Therapy
Adult Male medicine.medical_specialty Drug Resistant Epilepsy Dose Adolescent Drug-resistant epilepsy Cannabidiol (CBD) Medical Marijuana 03 medical and health sciences Epilepsy Young Adult 0302 clinical medicine Pharmacokinetics Internal medicine Medical cannabis galenic preparation medicine Humans 030212 general & internal medicine Delta-9-tetrahydrocannabinol (THC) Prospective Studies Prospective cohort study Adverse effect Child Advanced and Specialized Nursing medicine.diagnostic_test biology Dose-Response Relationship Drug business.industry biology.organism_classification medicine.disease Childhood Complementary and alternative medicine Therapeutic drug monitoring Child Preschool Female Cannabis business 030217 neurology & neurosurgery |
| Zdroj: | Complementary therapies in medicine. 51 |
| ISSN: | 1873-6963 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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