cells specific to Bactek® antigens at month 6 in comparison to baseline (P < 0·0001). A significant increase in total CD3+ T cells was also observed (P < 0·05). No significant differences were observed between baseline and month 6 in levels of total immunoglobulins, specific antibodies and B, T or NK cell subsets. A significant reduction in the patient's rate of RRTIs was observed compared with 1 year prior to initiation of therapy (P < 0·0001). The results demonstrate that long-term administration of a sublingual polyvalent bacterial preparation in patients with RRTIs exerts an immune stimulating effect on CD4 + T helper cell responses to bacterial antigens which could be associated with clinical benefit.
Intravenous immunoglobulin therapy for women with RRF and NK or NKT-like cell expansion was a safe and beneficial therapeutic strategy that associated with high clinical pregnancy and live birth rates.
The range of diseases in which intravenous immunoglobulin (IVIG) is effective has expanded significantly since its initial use in primary antibody deficiency. This biological medicine must comply with three conditions: therapeutic efficacy, clinical tolerance and viral safety. Factors relevant to the viral safety of IVIG include: effective use of donor exclusion criteria, screening of donations in order to exclude potentially infectious donations, testing of plasma pools for evidence of viral infection, validated steps for removal and/or inactivation of potentially present infectious agents, equipment cleaning, traceability of lots, and post-marketing follow-up of patients. Variables potentially affecting the risk and intensity of adverse events associated with administration of IVIG include: patient age, underlying condition, dose, concentration, IgA content, stabilizing agent and rate of infusion. Mild adverse reactions (headache, flushing, low backache, nausea) are often associated with a fast infusion rate, and respond rapidly on slowing the infusion. Very rare serious and potentially fatal side effects include: anaphylactic reactions, aseptic meningitis, acute renal failure, and thrombotic complications. Many of these serious adverse reactions have occurred in patients who had significant risk factors or underlying disease states. Clinicians should pay close attention to patient selection and consider the potential risk/benefit ratio versus alternate therapies.
Immunomodulation with IVIg in our selected group of RRF patients with immunologic alterations enhanced clinical pregnancy and live birth rates. Our results may facilitate the design of future clinical trials of IVIg in this pathology.
Data from this study demonstrate that prophylactic IVIG replacement therapy safely modulates HGG and specific antimicrobial antibodies. Our data also preliminarily suggest that IVIG replacement therapy might decrease the incidence of severe infection in heart recipients with HGG.
Infectious complication represents a significant source of morbidity and mortality in heart transplant recipients. To assess humoral immunity markers that can predict the development of infection, 38 consecutive recipients of heart transplants performed at a single center were prospectively studied. Induction therapy included daclizumab. Immunoglobulin (IgG, IgA, IgM) and complement factors (C3, C4, and factor B) were performed by nephelometry in peripheral blood samples obtained before transplantation, and 7 days and 1 month after transplantation. During a mean follow-up of 16.9 months, 13 patients had at least one episode of infection (34.2%). Eight of these were cytomegalovirus (CMV) infections treated with intravenous ganciclovir, 2 were bacterial pneumonia, 1 patient had bacterial septicemia, 1 patient had urinary tract infection, and 1 patient had pulmonary nocardiosis. No significant association was found between infection and age, sex, immunosuppression, CMV serostatus of donor and recipient, or treated rejection episodes. Pre-transplant IgG (below median value=1140 mg/dL; relative risk [RR] 3.69; 95% confidence interval [CI] 1.01-13.54; P=0.04) and post-transplant IgG levels at day 7 (below median value=679 mg/dL; RR 11.21; CI 1.04-89.48; P=0.022) were associated with an increase in the risk for developing infections. Early monitoring of immunoglobulin levels might help to identify the risk for developing infection in heart transplantation.
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