The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) earlier this year recommended to suspend some marketing authorisations for Gadolinium Containing Contrast Agents (GCCAs) based on linear chelators due to the potential risk of gadolinium retention in the human body. These recommendations have recently been re-evaluated by EMA's Committee for Medicinal Products for Human Use (CHMP), and confirmed the final opinion of the European Medicines Agency. This editorial provides an overview of the available GCCAs and summarises the recent evidence of gadolinium retention. Moreover, a critical appraisal of the strengths and limitations of the scientific evidence currently available on gadolinium retention is given. Key points • EMA recommended suspension of some EU marketing authorisations of four linear GCCAs. • Brain MRI findings indicating gadolinium retention have been confirmed by mass spectrometry.• Current scientific evidence for gadolinium retention has several methodological limitations.• No clear clinical evidence exists indicating that gadolinium retention causes neurotoxicity.• Long-term safety of GCCAs, however, remains unclear.
Balancing immunosuppression to prevent rejection in solid organ transplant (SOT) recipients remains challenging. Torque teno virus (TTV), a commensal non-pathogenic virus, has been proposed as marker of functional immunity: higher loads correspond to over-immunosuppression, and lower loads to under-immunosuppression. This review offers an overview of the current evidence of the association between TTV-load and infection and rejection after SOT. A systematic literature search strategy, deposited in the PROSPERO registry, resulted in 548 records. After screening, 23 original and peer-reviewed articles were assessed investigating the association between TTV-load, infection and/or rejection in SOT. The Quality in Prognostic Studies (QUIPS)-tool was used to assess the risk of bias. Meta-analysis with random-effects was performed on results with similar outcomes and exposure measures. Most of the included studies involved retrospective cohorts in which the TTV-load was measured longitudinally, within the first 2 years post-transplantation. Infection outcomes differed between studies and included viral, bacterial, parasitic and fungal infections. Rejection was defined by biopsy confirmation or initiation of rejection treatment. Twelve out of 16 studies reported an association between high TTV-load and infections, whereas 13 out of 15 reported an association between low TTV-load and rejection. Meta-analysis showed an increased risk of infection (OR: 1.16, 95% CI:1.03-1.32; HR: 1.05, 95% CI: 0.97-1.14) and a decreased risk of rejection (OR: 0.90, 95% CI: 0.87-0.94; HR: 0.74, 95% CI: 0.71-0.76) per 1 log TTV-load increase. The qualitative assessment showed varying risks of bias in the included studies. This systematic review and meta-analysis indicates that blood TTV-load measured within the first 2 years after SOT is associated with the risk of infection or allograft rejection, although substantial risk of bias in the studies included warrant cautious interpretation. The results in this review provide a rationale for larger, prospective, studies into TTV as marker of infection and rejection after SOT.
Introduction:The most of research to date indicates that children who have received a renal transplant are not at elevated risk of COVID-19 infection and generally have a mild illness course. Children are recognized as having a lower risk of severe COVID-19 infection than adults, although the most of pediatric renal transplant recipients had mild symptoms, severe illness and death have been reported in a small proportion of patients. Materials and Methods: Between March 2020 and October 2021, COVID-19 was researched in kidney transplant recipients under the age of 19 who were followed at Başkent University Transplantation Center. We documented the clinical characteristics and prognosis of pediatric kidney transplant recipients with COVID-19 disease. Results: We present 26 cases of COVID-19 infection from 215 pediatric patients with kidney transplantation. The average age of the patients was 14.2 (range 4-19), with 11 of them were female. The mean follow-up time after transplantation was 66.8 (range 6-148) months. In 16 patients (61.5%), fever was the most frequent symptom. Seventeen patients (65%) had mild respiratory symptoms such as cough, chest pain and loss of smell. Our 5 patients (21%) needed hospitalization. Four of them also developed acute kidney ınjury. One of these patients was hospitalized with a diagnosis of COVID-19 infection one week after being treated with IVIG and rituximab for acute antibody-mediated rejection. That patient developed significant lung disease and multi-organ failure. The second patient was a 5-year-old male who was admitted to the hospital due to diarrhea and required fluid and electrolyte replacement. Other hospitalized patients developed pneumonia but did not require intubation and recovered fully with antibiotic, antiviral and supportive therapy. Most of our patients (80.7%) had minor symptoms and recovered completely after receiving supportive treatment. Conclusion: According to our experience, COVID-19 is generally overcome with mild symptoms in pediatric renal transplant patients. Due to new vaccines and new virus strains, the clinical picture may alter in coming years.
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