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These guidelines represent a GRADE-method revision of the recommendations produced by the Italian Society of Hemapheresis and Cell Manipulation (SIDEM) and the Italian Transplant Group for Bone Marrow Transplantation, Hematopoietic Stem Cells and Cell Therapy (GITMO) in 2013. Since 2013 several studies have been published that have strengthened the role of ECP in the management of GVHD. Thus, it was deemed appropriate to proceed with an update, with the aim to define uniform criteria for the application of ECP in adult and pediatric patients affected by GVHD throughout the national territory, in line with international guidelines, in maintaining of high standards of safety for patients and quality of the procedures provide. Post-HSCT GvHD therapies other than ECP and ECP therapy of other diseases, such as CTCL, are not covered by these guidelines.The development panel for this guideline includes professionals from various specialties who routinely interact in the management of the patient with GVHD, namely the transfusionist, the adult and pediatric hematologist, and the hospital pharmacist. A hematologist experienced in systematic reviews and GRADE guideline development ccordinated the development process, and an experienced transfusionist coordinated the assignment of tasks and reporting. External reviewers of the guideline included a patient representative.
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BACKGROUND/OBJECTIVES: Gestational Weight Gain (GWG) impacts maternal and fetal health; deviations from optimal ranges pose health risks. Maternal lifestyle before and during pregnancy strongly influences GWG. This study explores factors linked to inadequate GWG, focusing on Mediterranean Diet (MD) adherence and specific food consumption. SUBJECTS/METHODS: 178 pregnant women were enrolled at Fondazione IRCCS Policlinico San Matteo (Pavia) during pre-hospital care before birth meeting inclusion/exclusion criteria. Sociodemographic data, pre-pregnancy BMI, GWG, MD adherence, physical activity (PA) levels, and smoking habits were retrospectively collected. Validated questionnaires adapted for the target group, assessed MD adherence and PA level. Participants were classified into adequate (AGWG) and inadequate GWG groups following IOM guidelines. RESULTS: Among 200 pregnant women (aged 30-36), 37.1% experienced low GWG and 24.1% excessive GWG. Our study revealed a significant association between inadequate GWG and educational level (P = 0.011); pre-pregnancy BMI (P = 0.005); MD adherence (P = 0.008), and daily average consumption of vegetables (P < 0.001). Our results also showed that a lower risk of EGWG vs. AGWG was associated with daily average consumption of vegetables (RRR = 0.279, P = 0.004), while a higher risk of EGWG vs. AGWG was associated with high daily meat product consumption (> 1.5 portions/day) (RRR = 7.83, P = 0.03). CONCLUSION: These findings emphasize the importance of promoting lifestyle changes before and during pregnancy to tackle the increasing incidence of inadequate GWG and improve the health outcomes of both mother and child.
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COVID19 convalescent patient plasma units with high titer neutralizing antibody can be used to treat patients with severe disease. Therefore, in order to select suitable donors, neutralizing antibody titer against SARS CoV-2 needs to be determined. Because the neutralization assay is highly demanding from several points of view, a pre-selection of sera would be desirable to minimize the number of sera to be tested. In this study, a total of 140 serum samples that had been titrated for SARS-CoV-2 neutralizing antibody by microneutralization assay were also tested for the presence of anti-SARS-CoV2 antibody using 5 different tests: Architect® immunoassay (Abbott Diagnostics), detecting IgG against the nucleocapsid protein, LIAISON XL® (Diasorin) detecting IgG against a recombinant form of the S1/S2 subunits of the spike protein, VITROS® (Ortho Clinical Diagnostics), detecting IgG against a recombinant form of the spike protein, and ELISA (Euroimmun AG), detecting IgA or IgG against a recombinant form of the S1 subunit. To determine which immunoassay had the highest chance to detect sera with neutralizing antibodies above a certain threshold, we compared the results obtained from the five immunoassays with the titers obtained by microneutralization assay by linear regression analysis and by using receiver operating characteristic curve and Youden's index. Our results indicate that the most suitable method to predict sera with high Nab titer is Euroimmun® IgG, followed closely by Ortho VITROS® Anti-SARS-CoV-2 IgG.
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Immunosuppressive medication dosing errors are not unfrequent and may present a number of challenges to transplant clinicians. Tacrolimus (TAC) is a widely used immunosuppressant with a narrow therapeutic index and potential severe side effects, including neurotoxicity and kidney injury. We herein report a case of 60-year-old woman who underwent deceased-donor liver transplantation at our center and due to inadvertent TAC overexposure was admitted to the Intensive Care Unit because of severe neurologic impairment, kidney injury and arterial hypotension. This case was challenging because TAC is largely bound to erythrocytes, has a high molecular weight, is highly lipophilic, has a high distribution volume and cannot be removed by hemodialysis or plasmapheresis. Based on these considerations, we decided to replace TAC-saturated erythrocytes with blood-bank red cells with the aim to accelerate its clearance. The treatment was effective in decreasing TAC whole blood trough levels within the therapeutic ranges with a significant improvement of the patient's clinical status. Red-blood cell exchange is a potentially safe and effective means of managing severe and symptomatic TAC toxicity.
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Citaferese , Overdose de Drogas/terapia , Transfusão de Eritrócitos , Eritrócitos , Tacrolimo/efeitos adversos , Feminino , Humanos , Pessoa de Meia-Idade , Tacrolimo/administração & dosagemRESUMO
The aim of the present work was to assess the incidence of neuro-nephrotoxicity after a single-staggered dose of calcineurin inhibitors (CI) with different immunosuppressive approaches. From January to December 2006, all liver transplantation (LT) recipients at risk of renal or neurological complications treated with extracorporeal photopheresis (ECP) + mycophenolate mofetil + steroids and staggered introduction of CI (ECP group) were compared with a historical control group on standard CI-based immunosuppression. The ECP group included 24 patients with a mean model for end-stage liver disease (MELD) score of 19.9 +/- 11.1. The control group consisted of 18 patients with a mean MELD score of 12.5 +/- 5.2 (p = 0.012). In the ECP group CI were introduced at a mean of 9.2 +/- 6.2 d (4-31 d) after LT. Five patients in the ECP group presented acute neuro-nephrotoxicity after the first CI administration on post-transplant d 4, 5, 6, 6, and 14. Overall patient survival at one, six, and 12 months was 100%, 95.8%, and 95.8% in the ECP group vs. 94.4%, 77.7%, and 72.2% in the control group (p < 0.001). In conclusion, we showed that CI toxicity may occur after a single-staggered dose administration, ECP seems to be a valuable tool for managing CI-related morbidity regardless of the concomitant immunosuppressive regimen, being associated with a lower mortality rate in the early post-transplant course.
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Inibidores de Calcineurina , Doenças do Sistema Nervoso Central/induzido quimicamente , Rejeição de Enxerto/tratamento farmacológico , Imunossupressores/efeitos adversos , Nefropatias/induzido quimicamente , Transplante de Fígado , Calcineurina/sangue , Doenças do Sistema Nervoso Central/enzimologia , Doenças do Sistema Nervoso Central/terapia , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Rejeição de Enxerto/enzimologia , Humanos , Imunossupressores/administração & dosagem , Nefropatias/enzimologia , Nefropatias/terapia , Falência Hepática/cirurgia , Masculino , Pessoa de Meia-Idade , Fotoferese/métodos , Período Pós-Operatório , Prognóstico , Estudos Prospectivos , Fatores de Risco , Fatores de TempoRESUMO
BACKGROUND: ABO-incompatible (ABO-i) liver transplantation (LT) is a high-risk procedure due to the potential for antibody-mediated rejection (AMR) and cell-mediated rejection. The aim of the current report is to illustrate the results of a retrospective comparison study on the use of immunomodulation with therapeutic plasma exchange (TPE) associated to high-dose immunoglobulins (IVIg) and extracorporeal photopheresis (ECP) in ABO-i adult LT patients. PATIENTS AND METHODS: Between January 1996 and December 2005, 19 patients underwent ABO-i LT. The study was designed for a comparison between two groups of ABO-i LT. Group 1 (control group) consisted of 11 patients treated with TPE only. Group 2 (study group) included eight patients treated with TPE and IVIg. Moreover, all Group 2 patients received acute rejection prophylaxis with ECP. RESULTS: The graft survival at 6, 12, and 18 months was 63.6, 54.4, and 45.5% for Group 1 vs. 87.5, 87.5, and 87.5% for Group 2 (P < or = 0.001). In Group 1 there were 3(27.3%) cases of AMR; 5 (45.4%) biopsy-proven acute rejections (BPAR); 1 (9.1%) chronic rejection and 3 (27.3%) ischemic-type biliary lesions (ITBL). In Group 2 there were no cases of AMR, BPAR, chronic rejection, or ITBL (P = 0.013). CONCLUSION: At median follow-up of 568 days, TPE in combination with IVIg and ECP appears to protect the graft from AMR in ABO-i liver transplantation. Continued patient enrollment will allow validation of these preliminary observations or the opportunity to devise newer AMR-avoidance policies.