ABSTRACT
Reporting and analysis of Adverse Events Following Immunization (AEFIs) are the cornerstones of vaccine safety surveillance prompting causality assessment and signal detection. This paper describes the impact of the Italian Pharmacovigilance System of vaccines over a 10-year period (2008-2017). The reporting rate (RR) per all distributed dose was calculated. Serious AEFIs and causality assessments for fatal cases were described. The main results from signal detection were reported. During the study period, 46,430 AEFIs were reported with an overall RR of 17.2 per 100,000 distributed doses. Italy showed the highest number of reports among European countries. Only 4.4% of the reports came from citizens. Of the total, 12.7% were classified as serious with a RR over the study period of 2.20 per 100,000 distributed doses. They were mainly related to hyperpyrexia and usually had a positive outcome. Fatal outcomes were reported in 0.3% of the cases and were primarily associated with the influenza vaccine in elderly patients. None of these outcomes had a consistent causal association with the vaccination. Febrile convulsions by the measles, mumps, rubella and varicella vaccines and intussusception by the rotavirus vaccine were among the highlighted signals. The reporting rate and the analysis of serious events from 10 years support the good risk/benefit profiles of vaccines.
Subject(s)
Pharmacovigilance , Vaccination/adverse effects , Vaccines/adverse effects , Adolescent , Adult , Aged , Chickenpox Vaccine/adverse effects , Child , Child, Preschool , Drug and Narcotic Control , Humans , Infant , Italy , Measles-Mumps-Rubella Vaccine/adverse effects , Middle Aged , Rotavirus Vaccines/adverse effects , Vaccines, Combined/adverse effects , Young AdultABSTRACT
Von Hippel-Lindau disease is a rare autosomic dominant hereditary tumoral syndrome characterized by mutation of the VHL gene. Here follows the first reported case of a patient (20 year old male) affected by Von Hippel-Lindau (VHL) disease, was referred to our Department because of the occurrence of a hard lump at the right aspect of the pelvis, who presented a primary mildly differentiated chondrosarcoma of the right iliac wing (confirmed by CT scan). Chondrosarcoma of the iliac wing, treated by surgical resection and reconstruction of the pelvis with appropriately shaped bone allograft fixed with plates and screws. At one year follow-up, the patient shows no signs of recurrence. Conventional treatment for chondrosarcoma of the iliac wing would be either wide or radical resection (hemipelvectomy), or amputation. The described treatment is unusual in that it is dependent on patient's choice to privilege quality of life due to the awareness of being affected by a genetic disease with an inauspicious prognosis.
Subject(s)
Bone Neoplasms/pathology , Chondrosarcoma/pathology , Ilium , von Hippel-Lindau Disease/pathology , Adult , Humans , Ilium/diagnostic imaging , Ilium/pathology , Male , Pelvic Bones/diagnostic imaging , Pelvic Bones/pathology , Quality of Life , RadiographyABSTRACT
PURPOSE: Chronic osteomyelitis is a surgical disease that require significant dedication from surgeons to eradicate. Osteomyelitis can result from a variety of etiologies but most often is a consequence of trauma (open fractures) to a long bone. This type includes osteomyelitis secondary to a contiguous focus of infection (after trauma and its surgical treatment: osteosynthesis). Here we are reporting one case of post-traumatic chronic osteomyelitis of the humerus. PATIENTS AND METHODS: A 34-years-old man presented with a post-traumatic chronic osteomyelitis due to an open fractur of the diaphysis humerus. We proposed a one-step surgical treatment, including fistulectomy, sequestrectomy, opening of the proximal and distal intramedullary canal. Antimicrobial therapy should be followed by close observation and treatment with appropriate antibiotics. RESULTS: A clinical control at 30 days from the intervention revealed that: no secretion; negative cultured exam; second-intention healing of the skin. CONCLUSIONS: Treatment requires isolation of the pathogens, significant debridement for removal of all infective and necrotic material, both of bone origin and soft-tissue one. Is is necessary not to close the foci: in this way we leave an external drainage, which is able to provide a tissues sterilization by secretion drainage and by the effects of the systemic antimicrobial therapy. Our results indicate that this long-term problem can be solved by a one-stage procedure that provide spontaneous second- healing of the skin defects, excluding the bony and soft tissue reconstruction.
