Treatment of hepatitis C in two paediatric patients using sofosbuvir during haematopoietic stem cell transplantation.

We report the first two paediatric cases of sofosbuvir treatment during high-intensity myeloablative conditioning and engraftment phases of haematopoietic stem cell transplantation. These reports highlight the safety of sofosbuvir during all phases of transplantation and the lack of interaction between sofosbuvir and alkylating or immunosuppressive agents.

Stability of a novel Lidocaine, Adrenaline and Tetracaine sterile thermosensitive gel: A ready-to-use formulation.

BACKGROUND: Superficial wounds that require suturing are often the reason children visit the Paediatric Emergency Department. Suturing is usually accompanied by perilesional administration of lidocaine, a local anaesthetic drug that improves pain tolerance. In paediatric patients, this approach has a low compliance because lidocaine has to be injected, which in children generates fear and anxiety, a sterile anaesthetic gel could improve the child compliance. OBJECTIVE: To develop a sterile and stable sterile gel capable of remaining in place over time for topical anaesthesia. METHOD: Different formulations were analysed by HPLC, by UV and fluorimetric detection. Two different sterilisation methods were tested. MAIN OUTCOME: To maintain the original stability of the gel also after sterilisation process. RESULTS: Four different gels were prepared and analysed; the most stable gel lasts over 3 months with a degradation less than 10%. CONCLUSION: The use of Poloxamer 407 guarantees stability of the preparation, showing a reduction in oxidative reaction, and gives the gel the right texture for application to a bleeding wound.

Complete Remission of a Refractory Acute Myeloid Leukemia with Myelodysplastic- and Monosomy 7-Related Changes after a Combined Conditioning Regimen of Plerixafor, Cytarabine and Melphalan in a 4-Year-Old Boy: A Case Report and Review of Literature.

Acute myeloid leukemia with myelodysplastic changes and monosomy 7 is a rare form of pediatric leukemia associated with very poor disease-free survival. The refractoriness of the disease is due to the protection offered by the bone marrow niche, making leukemic stem cells impervious to whatever chemotherapy or myeloablative regimen is chosen. Using a mobilizing agent for haematopoietic stem cells, Plerixafor, could sensitise leukemic cells to the myeloablative therapy. This approach was not previously used in a pediatric population, and in adult populations, was used in combination with busulphan with no difference in overall survival. We describe the case of a 4-year-old boy affected by refractory acute myeloid leukemia with myelodysplastic changes and monosomy 7. The child had never achieved a remission. We proposed a combined time-scheduled scheme of therapy with plerixafor and melphalan. Combining pharmacokinetics of plerixafor with pharmacokinetics and rapid and elevated myeloablative potential of melphalan in high dosage (200 mg/m²), we succeeded in mobilizing more than 85% of stem blasts immediately before infusion of Melphalan. The count of residual blasts after 8 h from melphalan infusion was only 1.3 cells/µL. The child achieved an engraftment at day +32 with full donor chimerism. Sixteen months after haematopoietic stem cell transplantation (HSCT), he is well and in complete remission. Our case suggests that the use of plerixafor before a conditioning therapy with melphalan could induce remission in acute myeloid leukemia refractory to the usual conditioning therapy in pediatric patients. This work adds strength to the body of knowledge regarding the "personalized" conditioning regimen for high-risk leukemic patients.

Experience of compounding total parenteral nutrition admixtures for preterm infants in a hospital pharmacy: evidence of calcium and phosphate compatibility problem.

OBJECTIVE: Parenterally fed preterm newborn infants require large amounts of calcium and phosphate in a low volume of solution. The lower the volume of solution, the higher is the possibility of precipitation of calcium hydrogen phosphate (CaHPO4). Precipitation could cause respiratory distress and pulmonary embolism, and the use of organic salts of calcium and phosphorus may reduce the likelihood of this problem. To date, no previous work on the stability of solutions with organic salts has been published in the literature. This study aims to evaluate the visible precipitation of calcium and phosphorus in total parenteral nutrition solutions. METHODS: 20 parenteral nutrition solutions were aseptically prepared in a laminar airflow hood in a clean room. The solutions are intended to facilitate precipitation, with the amino acid ratio below the standard concentration and other parameters also modulated to promote the precipitation of CaHPO4. The solutions contained dextrose, amino acids, calcium gluconate and fructose 1,6-bisphosphate. We did not use lipid emulsion so that we could see all precipitations. RESULTS: No visible precipitation was observed during 4 weeks of observation at 25°C. The only observed event was the change in colour of the solution, which became yellow, maybe because of a Maillard reaction. CONCLUSIONS: This study evaluated the compatibility of organic calcium and phosphorus in order to prevent the precipitation of CaHPO4 when preparing total parenteral nutrition solutions. The fact that no precipitation was observed is very significant as it indicates the compatibility of the ions, even though no instrumental analysis was performed.