Pharmacokinetics of cannabidiol in children with refractory epileptic encephalopathy.

Growing interest in the clinical use of cannabidiol (CBD) as adjuvant therapy for pediatric refractory epileptic encephalopathy emphasizes the need for drug treatment optimization. The aim of this study was to characterize the pharmacokinetics of CBD in pediatric patients with refractory epileptic encephalopathy receiving an oil-based oral solution. To evaluate CBD concentrations, six serial blood samples per patient were collected after the morning dose of CBD, at least 21 days after the beginning of treatment. Twelve patients who received a median (range) dose of 12.2 (5.3-19.4) mg/kg/d (twice daily) were included in the analysis. Median (range) CBD time to maximum plasma concentration, maximum plasma concentration, and area under the concentration versus time curve up to 6 hours after dosing were 3.2 hours (1.9-6.2), 49.6 ng/mL (14.4-302.0), and 226.3 ng ⋅ h/mL (70.5-861.3), respectively. CBD systemic exposure parameters were in the lower range of previous reports in pediatric patients receiving doses in a similar range. Most of our patients (83%) showed little CBD plasma level fluctuation during a dosing interval, comparable to that encountered after oral administration of an extended release drug delivery system. CDB administration was generally safe and well tolerated, and a novel levothyroxine-CBD interaction was recorded. Similar to other studies, large interindividual variability in CBD exposure was observed, encouraging the use of CBD therapeutic drug monitoring.

Application criteria of enteral nutrition in patients with anorexia nervosa: correlation between clinical and psychological data in a "lifesaving" treatment.

BACKGROUND: Data and research increasingly point to multiple factors in the genesis of eating-behavior disorders, but the lack of a clear etiological definition prevents a unique therapeutic or prognostic approach from being defined. Therapeutic approaches, as well as scientific research, have separately analyzed the psychological aspects and the clinical-nutrition aspects without integrating the variables or correlating clinical and psychological data. This work has several goals because it aims at considering the problem from the 2 different perspectives. Psychological and clinical variables are analyzed both separately and together in order to assess (a) the minimal criteria to define a cure as "lifesaving" and submit a patient to artificial nutrition; (b) the kind of implementation artificial nutrition should follow; (c) which indicators of the efficacy of artificial nutrition must be taken into account; (d) the results in nutrition terms that may be obtained during the follow-up; (e) if artificial nutrition may be used as a therapeutic tool; (f) if there are any psychological effects after artificial nutrition; (g) if there are any effects due to the patients' age; and (h) the correlation between the psychological profile of a patient and the acceptance of the nutrition treatment. METHODS: Several psychological and pharmacologic variables, together with clinical and anthropometric data and blood chemical values, were all considered. CONCLUSIONS: Besides defining minimal criteria for a "lifesaving" cure and proposing 2 ad hoc scales for the assessment of patients' subjective willingness toward feeding and for the objective measurement of feeding itself, clinical data and correlations with psychological data evidenced the importance of artificial nutrition and specifically of enteral nutrition as a therapeutic tool, allowing us to define the modalities of implementation of enteral nutrition. Results show that, because enteral nutrition did not deteriorate the psychological state of the patients, and was found to be accepted more positively than feeding orally in the most critical initial phase, it should be included in the therapy.

3% Amuchina is as effective as the 50% concentration in the prevention of exit-site infection in children on chronic peritoneal dialysis.

In a previous communication, we demonstrated that, in the prevention of exit-site infection (ESI) in children, the cleansing agent 50% Amuchina (electrolytic chloroxidizer. Amuchina SpA, Genoa, Italy) is more effective than 10% povidone iodine and as effective as 4% chlorhexidine, but with fewer adverse secondary effects. In the present study, we assessed, in an Argentine pediatric population, whether Amuchina 3% is as effective as Amuchina 50% in preventing ESI in children on chronic peritoneal dialysis. In an open-label, single-center prospective study, 27 children (mean age: 7.2 years; range: 1.7-17 years) used 3% Amuchina as a cleansing agent for the daily care of a healthy exit site. Of the 27 children, 14 were switched from 50% Amuchina to 3% Amuchina, and 13 were using the 3% Amuchina for the first time. The control group consisted of 18 patients who had previously used 50% Amuchina as a cleansing agent. We followed the recommendations of the International Society for Peritoneal Dialysis with regard to exit-site care, which include keeping the cleansing agent out of the sinus and rinsing the exit site with sterile water. Amuchina was used from the first post-implantation care of the exit site. No adverse secondary effects were seen with the use of Amuchina at either concentration. Patients using 3% Amuchina presented an ESI rate similar to that of patients using Amuchina 50%. The cost of 3% Amuchina was significantly lower than that of the 50% concentration, and it was even lower than the cost for 10% povidone iodine or 4% chlorhexidine. Although more research trials are needed to assess the efficacy of 3% Amuchina, we conclude that 3% Amuchina is the best and most cost-effective cleansing agent for the daily care of a healthy exit site in children on chronic peritoneal dialysis.