Publications by authors named "Iolanda Mazzucchelli"

29 Publications

  • Page 1 of 1

The dynamical interplay of perinatal leptin with birthweight and 3-month weight, in full-term, preterm, IUGR mother-infant dyads.

J Matern Fetal Neonatal Med 2020 Nov 8:1-7. Epub 2020 Nov 8.

Neonatal Unit and Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italia.

Objective: To evaluate the dynamical interplay between perinatal leptin concentrations and neonatal weight evolution until 3 months of age.

Methods: In a prospective observational study, maternal, cord blood and neonatal plasma leptin concentrations were correlated to birthweight and 3-month weight in 26 full-term, 20 preterm, and 17 intrauterine growth restriction (IUGR) mother-neonate couples.

Results: The median of maternal, cord blood, neonatal leptin concentrations were significantly different among the three groups ( = 0.010; <0.001; =0.041 correspondingly). In the respect of the full-term group, higher concentrations were reported in preterm and IUGR mothers and lower concentrations in cord blood and neonatal plasma. The post-hoc comparisons showed that maternal concentrations were significantly higher in the IUGR group ( = 0.005 vs full-term), cord blood concentrations resulted always significantly lower (preterm, IUGR vs full-term  < 0.001) and neonatal concentrations were significantly lower in the preterm group ( = 0.018 vs full-term). Neonatal birthweight and 3-month weight were always significantly different among groups ( < 0.001), even if preterm and IUGR still had lower weight than full-term, the percent increasing of weight between birth and 3-month demonstrated that preterm and IUGR infants have grown significantly faster, (preterm, IUGR vs full-term  < 0.001). The univariable analysis showed a maternal leptin association with offspring' birthweight ( = -38%,  = 0.006) and with 3-month weight ( = -43%,  = 0.002). Accounting for confounders, these associations lost significance. Cord blood leptin concentrations positively correlated with birthweight and with 3-month weight (both,  < 0.001). The latter correlation, when adjusting for birthweight became negative ( = -43%  < 0.001).

Conclusion: Our results showed that maternal leptin levels lost their influence on neonatal weight when considering confounders. At 3-month, once birthweight adjusted, the percent increasing of weight was statistically larger in preterm and IUGR than the full-term group and the correlation between cord blood leptin and weight turned negative, from positive at birth. These data may be a clue for further investigation on the relationship between perinatal leptin concentrations and catch-up growth.
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http://dx.doi.org/10.1080/14767058.2020.1839750DOI Listing
November 2020

Relationship between saliva and plasma rufinamide concentrations in patients with epilepsy.

Epilepsia 2020 07 20;61(7):e79-e84. Epub 2020 Jun 20.

Division of Clinical and Experimental Pharmacology, Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.

The assay of saliva samples provides a valuable alternative to the use of blood samples for therapeutic drug monitoring (TDM), at least for certain categories of patients. To determine the feasibility of using saliva sampling for the TDM of rufinamide, we compared rufinamide concentrations in paired samples of saliva and plasma collected from 26 patients with epilepsy at steady state. Within-patient relationships between plasma rufinamide concentrations and dose, and the influence of comedication were also investigated. Assay results in the two tested fluids showed a good correlation (r  = .78, P < .0001), but concentrations in saliva were moderately lower than those in plasma (mean saliva to plasma ratio = 0.7 ± 0.2). In eight patients evaluated at three different dose levels, plasma rufinamide concentrations increased linearly with increasing dose. Patients receiving valproic acid comedication had higher dose-normalized plasma rufinamide levels than patients comedicated with drugs devoid of strong enzyme-inducing or enzyme-inhibiting activity. Overall, these findings indicate that use of saliva represents a feasible option for the application of TDM in patients treated with rufinamide. Because rufinamide concentrations are lower in saliva than in plasma, a correction factor is needed if measurements made in saliva are used as a surrogate for plasma concentrations.
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http://dx.doi.org/10.1111/epi.16584DOI Listing
July 2020

Oral vitamin A supplementation for ROP prevention in VLBW preterm infants.

Ital J Pediatr 2020 Jun 3;46(1):77. Epub 2020 Jun 3.

Neonatal Unit and Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Vitamin A administration may decrease any stage of retinopathy of prematurity (ROP) in preterm infants. To evaluate whether vitamin A oral supplementation could be preventive in ROP incidence and severity in VLBW infants, we compared results from 31 preterm infants, (< 1500 g or < 32 weeks) who, during a previous investigation, prospectively received 3000 UI/kg/die oral retinol palmitate drops, for 28 days, with 31 matching preterm newborns hospitalized in our NICU the same period, as control group. Although ROP incidence was similar, in the supplemented group, we had 9 cases of ROP grade 1, no ROP grade ≥ 2, in the un-supplemented group, 4 cases of ROP grade 1 and 6 ROP grade ≥ 2 (p = 0.018). The percentage of babies requiring treatment for ROP was 0 in treated and 16.6 in the un-treated group (p = 0.020). Moreover, Vitamin A administration showed a protective effect with an 88% risk reduction of developing severe ROP. Since vitamin A parenteral/IM administration presents some awareness, the results of this investigation may be important to plan further trials to confirm the usefulness of oral administration in mitigating the ROP severity of VLBW infants.ClinicalTrials.gov NCT02102711; may 03/06/2014.
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http://dx.doi.org/10.1186/s13052-020-00837-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7268228PMC
June 2020

Leptin affects the inflammatory response after STEMI.

Nutr Metab Cardiovasc Dis 2020 06 21;30(6):922-924. Epub 2020 Feb 21.

Division of Cardiology, Ospedale "Città della Salute e della Scienza di Torino", Department of Medical Sciences, Università di Torino, Italy.

Leptin is an adipose tissue-derived hormone primarily involved in the regulation of food intake. Leptine has been shown to have a much broader role than just regulating body weight and appetite in response to food intake: among the others, it has been associated with increased ROS production and inflammation, factors involved in the restoration of an effective myocardial reperfusion after myocardial revascularization. Our study, to our best knowledge, is the first showing a direct relationship between leptin serum levels, inflammatory mediators of the ischemia reperfusion damage and effective myocardial reperfusion in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention. Our findings suggest that leptin serum levels are directly associated with the inflammatory response during an acute myocardial infarction and may have a role in risk stratification in this clinical setting.
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http://dx.doi.org/10.1016/j.numecd.2020.02.004DOI Listing
June 2020

Rapid detection of bacteria in bloodstream infections using a molecular method: a pilot study with a neonatal diagnostic kit.

Mol Biol Rep 2020 Jan 22;47(1):363-368. Epub 2019 Oct 22.

UOC Neonatology and Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Neonatal sepsis is a life-threatening condition and its early diagnosis is crucial for infant survival. Identifying responsible pathogens is a key step. Blood culture (BC) is the gold standard, but more rapid and specific diagnostic methods are needed. We evaluated the reliability and utility of 3 h turnaround time diagnostic molecular kit, "EuSepScreen lattanti "CE IVD marked, (EuSepScreen lattanti, Eurospital Spa Trieste, Italy) specifically targeted to detect 4 pathogens in neonatal sepsis: Klebsiella pneumoniae (KP), Escherichia coli (EC), Streptococcus agalactiae (GBS), and Lysteria monocytogenes. We evaluated 69 neonates, 40 full term and 29 preterm infants, with suspected bloodstream infection, who, overall the routine clinical procedures, were tested using the molecular kit. Kit results were compared to BC outcomes. Nineteen cases for early onset sepsis (EOS) were evaluated, 2 of them resulted positive to a molecular kit and to BC (both for GBS and EC). In the 50 cases of suspected late onset sepsis (LOS), 7 infants reported positive and coincident results to both the methods, in 3 further cases the molecular kit identified pathogens (EC) in neonates with negative BC result; in 10 cases BC revealed etiological pathogens exceeding the molecular kit possibility of identification. In case of EOS, results of the molecular kit were coincident to these of BC, but available in 3 h turnaround time, which is an advantage, so the kit may actually be an "add-on tool" for EOS, with reference to EC and GBS, but a larger study with a greater number of EOS cases are needed to validate its usefulness in the NICU. Regarding LOS the restricted panel of identifiable microorganisms failed to provide timely information for sepsis diagnosis, highlighting the need of enlarged number microorganisms for the diagnosis of LOS.Trial registration number: NCT03884894.
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http://dx.doi.org/10.1007/s11033-019-05138-2DOI Listing
January 2020

The role of immature platelet fraction (IPF%) in full-term and preterm infants: Italian data of a promising clinical biomarker in neonates.

Int J Lab Hematol 2020 02 12;42(1):e10-e13. Epub 2019 Jul 12.

Neonatal Unit and Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.

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http://dx.doi.org/10.1111/ijlh.13071DOI Listing
February 2020

Levels and effectiveness of oral retinol supplementation in VLBW preterm infants.

Int J Immunopathol Pharmacol 2018 Mar-Dec;32:2058738418820484

1 Neonatal Immunology Laboratory, UOC Neonatology and Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Retinol palmitate oral administration is convenient, but it is difficult to assess/monitor its nutritional status in preterm infants and literature is controversial about the administration route and the effectiveness of vitamin A supplementation. We primarily evaluated retinol plasma levels to assess the vitamin A nutritional status in preterm infants (<1500 g; 32 weeks) after 28 days of oral supplementation (3000 IU/kg/day, retinol palmitate drops), in addition to vitamin A standard amount as suggested by European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines. We then observed the rate of typical preterm pathologies in the supplemented group (31 newborns) and in 10 matching preterm infants, hospitalized in neonatal intensive care unit (NICU) in the same period, who received neither vitamin A supplementation nor parents allowed plasma sampling. Oral integration resulted in constant retinol plasma concentration around the desired level of 200 ng/mL, but without statistical increase during the study period. Due to the complexity of vitamin A metabolism and the immaturity of preterm infant's organs, retinol supplementation may had first saturated other needy tissues; therefore, plasmatic measures may not be consistent with improved global vitamin A body distribution. Therefore, achieving a constant retinol concentration is a valuable result and supportive for oral administration: decreasing levels, even after parenteral/enteral supplementation, were reported in the literature. In spite of favourable trend and no adverse events, we did not report statistical difference in co-morbidities. This investigation confirms the necessity to perform further trials in preterm newborns, to find an index reflecting the complex nutritional retinol status after oral administration of vitamin A, highlighting its effectiveness/tolerability in correlated preterm infant's pathologies.
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http://dx.doi.org/10.1177/2058738418820484DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6311539PMC
July 2019

An Italian Prospective Experience on the Association Between Congenital Cytomegalovirus Infection and Autistic Spectrum Disorder.

J Autism Dev Disord 2017 May;47(5):1490-1495

Neonatal Immunology Laboratory, Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, 27100, Pavia, Italy.

The aim of this retrospective study, with prospective data collection, was to correlate congenital cytomegalovirus (CMV) infection with autism spectrum disorder (ASD) and to define its prevalence. Seventy proven congenitally-infected infants, born between 2007 and 2012, were referred to our centre for CMV diagnosis and follow-up, which consisted of a consolidated protocol allowing an early evaluation of autism. We considered four children 2-year old, two of whom, at the age of 3, were diagnosed with ASD demonstrating a 2-3 fold higher prevalence (2.86%), than that in general Italian population (0.66-1.36%).Our protocol enabled us to make the earliest diagnosis and highlight the role of the virus among other causes of autism, which may be a long term sequela of congenital CMV.
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http://dx.doi.org/10.1007/s10803-017-3050-3DOI Listing
May 2017

Inherited human IRAK-1 deficiency selectively impairs TLR signaling in fibroblasts.

Proc Natl Acad Sci U S A 2017 01 9;114(4):E514-E523. Epub 2017 Jan 9.

Laboratory of Human Genetics of Infectious Diseases, Necker Branch, INSERM U1163, 75015 Paris, France;

Most members of the Toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) families transduce signals via a canonical pathway involving the MyD88 adapter and the interleukin-1 receptor-associated kinase (IRAK) complex. This complex contains four molecules, including at least two (IRAK-1 and IRAK-4) active kinases. In mice and humans, deficiencies of IRAK-4 or MyD88 abolish most TLR (except for TLR3 and some TLR4) and IL-1R signaling in both leukocytes and fibroblasts. TLR and IL-1R responses are weak but not abolished in mice lacking IRAK-1, whereas the role of IRAK-1 in humans remains unclear. We describe here a boy with X-linked MECP2 deficiency-related syndrome due to a large de novo Xq28 chromosomal deletion encompassing both MECP2 and IRAK1 Like many boys with MECP2 null mutations, this child died very early, at the age of 7 mo. Unlike most IRAK-4- or MyD88-deficient patients, he did not suffer from invasive bacterial diseases during his short life. The IRAK-1 protein was completely absent from the patient's fibroblasts, which responded very poorly to all TLR2/6 (PAMCSK, LTA, FSL-1), TLR1/2 (PAMCSK), and TLR4 (LPS, MPLA) agonists tested but had almost unimpaired responses to IL-1β. By contrast, the patient's peripheral blood mononuclear cells responded normally to all TLR1/2, TLR2/6, TLR4, TLR7, and TLR8 (R848) agonists tested, and to IL-1β. The death of this child precluded long-term evaluations of the clinical consequences of inherited IRAK-1 deficiency. However, these findings suggest that human IRAK-1 is essential downstream from TLRs but not IL-1Rs in fibroblasts, whereas it plays a redundant role downstream from both TLRs and IL-1Rs in leukocytes.
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http://dx.doi.org/10.1073/pnas.1620139114DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5278481PMC
January 2017

Safety, growth, and support to healthy gut microbiota by an infant formula enriched with functional compounds.

Clin Nutr 2017 02 27;36(1):238-245. Epub 2015 Nov 27.

Neonatal Unit and Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Neonatal Immunology Laboratory, Neonatal Unit and Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Background & Aims: Safety and growth adequacy of infant formulae enriched by functional ingredients need stringent evaluation by means of randomized controlled trials (RCTs), therefore we performed a double-blind RCT to evaluate an infant formula enriched with galacto-oligosaccharides, beta-palmitate, and acidified milk vs. a standard infant formula.

Methods: Weight, length, head circumference and fecal bacteria (Bifidobacteria, BIF/Clostridia, CLO) were measured in healthy full term infants, at baseline - as before 21 days of life - at 60 and 135 days thereafter. A group of 51 neonates received the enriched formula (ENR), 59 the standard one (ST). Parents were trained to daily register gastrointestinal diseases.

Results: All the infants grew homogeneously increasing the anthropometric parameters and complying with WHO and Italian standards: the mean (SD) difference in daily weight between ENR and ST groups was -0.74 (1.13) g/day, corresponding to a 90% CI of -2.62 to 1.13 g/day, well within the postulated interval of equivalence of -3.9 to +3.9 g/day. A statistical improvement in BIF concentration in the microbiota of infants fed by ENR was recorded. There was no between-group change in logCLO, but logBIF increase was higher at T2 vs. T0 in ENR (treatment × time interaction = 0.71, 95% CI 0.08-1.34, p = 0.028) than in ST neonates. This corresponds to estimated mean (95% CI) values of 8.37 (8.04-8.69) log-units for ENR vs. 8.08 (7.77-8.39) log-units for ST neonates. Gastrointestinal effects were mild and similar, with no statistical difference between two groups.

Conclusion: Safety and growth ability of the enriched formula has been confirmed. A positive effect on neonatal gut microbiota, consisting of increased fecal BIF counts at T2 vs. baseline has been shown too. Nonetheless, larger RCTs are needed to estimate with greater precision the effective potential attributable to the enriched formula on neonatal microbiota, with particular reference to the mode of delivery.
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http://dx.doi.org/10.1016/j.clnu.2015.11.006DOI Listing
February 2017

Maternal and neonatal outcomes in pregnant women with autoimmune diseases in Pavia, Italy.

BMC Pediatr 2015 Dec 18;15:217. Epub 2015 Dec 18.

Neonatal Unit and Neonatal Intensive Care Unit, IRCCS San Matteo Hospital Foundation, Pavia, Italy.

Background: The increased number of childbearing women with autoimmune diseases leads to a growing interest in studying relationship among maternal disease, therapy, pregnancy and off-spring. The aim of this study was to determine the impact of autoimmune disease on pregnancy and on neonatal outcome, taking into account the maternal treatment and the transplacental autoantibodies passage.

Methods: We studied 70 infants born to 70 pregnant women with autoimmune disease attended in Fondazione IRCCS Policlinico San Matteo, Pavia, Italy from June 2005 to June 2012. Maternal and neonatal characteristics were collected and relevant clinical, laboratory, therapeutics, sonographic and electrocardiographic investigations were recorded and analyzed.

Results: We observed a high rate of spontaneous abortions in medical history, 29 %, and 18.6 % of preterm births and 22.9 % of low birth weight (< 2500 g). Transplacental autoantibodies passage wasn't related to maternal or obstetrical complication, but anti-Ro/SSA positive pregnancies correlated with abnormal fetal heart rate (P = 0.01). Pregnant women on therapy showed an higher incidence of maternal (p = 0.002), obstetric (p = 0.007) complications and an increased rate of intrauterine growth restriction (p = 0.01) than the untreated ones.

Conclusions: Autoimmune diseases in pregnancy require to be carefully monitored to ensure the best possible management of mothers, fetuses and newborns due to the high rate of morbidity specially in case of maternal polytherapy and/or anti-Ro/SSA positivity.
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http://dx.doi.org/10.1186/s12887-015-0532-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4683757PMC
December 2015

Expression and function of toll-like receptors in human circulating endothelial colony forming cells.

Immunol Lett 2015 Nov 8;168(1):98-104. Epub 2015 Oct 8.

Laboratory of Neonatal Immunology, Fondazione IRCCS Policlinico "San Matteo", Pavia, Italy; Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico "San Matteo", Pavia, Italy.

Mature endothelial cells are known to sense microbial products through toll-like receptors (TLRs), a family of membrane proteins which serve as pathogen recognition and signaling elements; however, there are limited data in the literature about the expression and function of TLRs in human circulating endothelial colony forming cells (ECFCs), which are considered the most likely endothelial precursors. We expanded and differentiated in vitro umbilical cord blood (UCB) and adult peripheral blood (PB) ECFCs and studied the expression of TLR1 to TLR10 mRNA by qPCR analysis, and we further characterized TLR function in ECFCs through functional assays including in vitro ECFC growth and differentiation, assessment of cytokine production, and measurement of intracellular Ca(2+) signals. Both UCB- and PB-ECFCs had detectable mRNA levels of all the TLRs from 1 to 10; TLR4, a sensor of Gram-negative bacterial lipopolysaccharide (LPS), had a higher level compared to other TLRs. Exposure to LPS induced cytokine production, although with less efficiency compared to PB-mononuclear cells. However, no effect of LPS was seen on ECFC growth and differentiation, and no increase in intracellular Ca(2+) concentrations, which is essential for ECFC proliferation, was observed after exposure to increasing amounts of LPS. Our data show that all TLRs from 1 to 10 are constitutively expressed in ECFCs, and suggest that TLR4 is functional in ECFCs, but its activation through its ligand LPS does not affect ECFC growth and differentiation.
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http://dx.doi.org/10.1016/j.imlet.2015.09.014DOI Listing
November 2015

A prospective study of direct medical costs in a large cohort of consecutively enrolled patients with refractory epilepsy in Italy.

Epilepsia 2015 Jul 4;56(7):1162-73. Epub 2015 Jun 4.

Unit of Clinical and Experimental Pharmacology, Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.

Objective: To evaluate direct medical costs and their predictors in patients with refractory epilepsy enrolled into the SOPHIE study (Study of Outcomes of PHarmacoresistance In Epilepsy) in Italy.

Methods: Adults and children with refractory epilepsy were enrolled consecutively at 11 tertiary referral centers and followed for 18 months. At entry, all subjects underwent a structured interview and a medical examination, and were asked to keep records of diagnostic examinations, laboratory tests, specialist consultations, treatments, hospital admissions, and day-hospital days during follow-up. Study visits included assessments every 6 months of seizure frequency, health-related quality of life (Quality of Life in Epilepsy Inventory 31), medication-related adverse events (Adverse Event Profile) and mood state (Beck Depression Inventory-II). Cost items were priced by applying Italian tariffs. Cost estimates were adjusted to 2013 values.

Results: Of 1,124 enrolled individuals, 1,040 completed follow-up. Average annual cost per patient was € 4,677. The highest cost was for antiepileptic drug (AED) treatment (50%), followed by hospital admissions (29% of overall costs). AED polytherapy, seizure frequency during follow-up, grade III pharmacoresistance, medical and psychiatric comorbidities, and occurrence of status epilepticus during follow-up were identified as significant predictors of higher costs. Age between 6 and 11 years, and genetic (idiopathic) generalized epilepsies were associated with the lowest costs. Costs showed prominent variation across centers, largely due to differences in the clinical characteristics of cohorts enrolled at each center and the prescribing of second-generation AEDs. Individual outliers associated with high costs related to hospital admissions had a major influence on costs in many centers.

Significance: Refractory epilepsy is associated with high costs that affect individuals and society. Costs differ across centers in relation to the characteristics of patients and the extent of use of more expensive, second-generation AEDs. Epilepsy-specific costs cannot be easily differentiated from costs related to comorbidities.
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http://dx.doi.org/10.1111/epi.13030DOI Listing
July 2015

Enteral nutrition and infections: the role of human milk.

Early Hum Dev 2014 Mar;90 Suppl 1:S57-9

Neonatal Unit and Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Neonatal Immunology Laboratory, Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Human milk (HM) is known as the best nutrition for newborns and support the optimal growth of infants, providing essential substances, nutrients, bioactive and immunologic constituents. HM also grants a favorable microbial colonization with attendant priming/maturation of the gut. The bioactive and immunologic elements of HM demonstrated to protect offspring against infection and inflammation and contribute to immune maturation. Some of these elements are being investigated in order to be used to ameliorate formula milk. A formula milk similar to breast milk may help neonatal gut to build a microbiota near to the one of the breast fed infants, improving the neonate's protection against pathogens. The aim of this review is to summarize the most significant bioactive constituents of HM that own natural anti-infectious properties and contribute to neonatal immune defense.
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http://dx.doi.org/10.1016/S0378-3782(14)70019-2DOI Listing
March 2014

The early administration of Lactobacillus reuteri DSM 17938 controls regurgitation episodes in full-term breastfed infants.

Int J Food Sci Nutr 2014 Aug 17;65(5):646-8. Epub 2014 Mar 17.

Neonatal Immunology Laboratory, Neonatal Unit and Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo , Pavia , Italy .

Forty breastfed full-term infants were randomly, double blind assigned to receive orally Lactobacillus reuteri (L. reuteri) DSM 17938, 5 drops/daily (10(8) colony-forming units), for 4 weeks (n = 20) or an identical placebo (n = 20), starting before third day of life. They underwent basal and final visit to monitor growth parameters and gastrointestinal (GI) disease. Parents registered daily: crying minutes, stool frequency and consistency, numbers of regurgitations, adverse events. Secretory IgA (sIgA) has been measured in saliva on 28th day. Treated infants demonstrated a reduction in daily regurgitations at the end of treatment (p = 0.02), three neonates in the placebo group only needed simethicone for GI pain, sIgA level was similar in both groups. Random casualty produced an unbalanced gender distribution in the groups, but this bias did not affect the results. Therefore, early administration of L. reuteri DSM 17938 resulted beneficial in preventing regurgitation episodes during the first month of life.
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http://dx.doi.org/10.3109/09637486.2014.898251DOI Listing
August 2014

The red cell distribution width (RDW): value and role in preterm, IUGR (intrauterine growth restricted), full-term infants.

Hematology 2014 Sep 13;19(6):365-9. Epub 2013 Nov 13.

Objective: To measure the red cell distribution width (RDW) ranges at birth and to evaluate potential association with typical neonatal diseases: patent of the ductus arteriousus (PDA), bronchopulmonary dysplasia (BPD), and late-onset sepsis (LOS) mortality.

Methods: Forty-six full-term, 41 preterm, and 35 intrauterine growth restricted (IUGR) infants participated in this retrospective, observational study. RDW was measured before 3 days of life (T0) in all infants, and at first month of life (T1) in preterm/IURG patients.

Results: RDW% mean (standard deviation) at T0 was: 15.65 (1.18) in full-term newborns; 17.7 (2.06) in preterm; 17.45 (1.81) in IUGR. A negative correlation (r = -0.51; P < 0.001) between RDW and gestational age was found. RDW at T1 was: 17.25 (2.19) in the preterm group; 17.37 (2.56) in IUGR group. Fourteen preterm infants reported: 12 PDA, 5 LOS, 4 BPD, and 3 died; 10 IUGR infants had: 4 PDA, 6 LOS, 3 BPD, and 1 died. RDW of IUGR infants suffering from those pathologies was not statistically different compared with unaffected infants, while preterm newborns with pathologies reported higher RDW: PDA vs. PDA absent: P = 0.008 at T0; P < 0.002 at T1. BPD vs. BPD absent: P < 0.005 at T1. LOS vs. LOS absent: P < 0.005 at T0. RDW in preterm/IUGR population was associated with early mortality, T0: dead 21.2 (2.7) vs. alive 16.7 (1.7), P < 0.0001.

Conclusion: RDW and gestational age at birth were negatively correlated. High RDW resulted to be an indication of risk for critical newborns. This parameter can be inexpensively and routinely verified and further studies are required to confirm its prognostic role in neonatal pathologies.
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http://dx.doi.org/10.1179/1607845413Y.0000000141DOI Listing
September 2014

Diagnostic performance of triggering receptor expressed on myeloid cells-1 and CD64 index as markers of sepsis in preterm newborns.

Pediatr Crit Care Med 2013 Feb;14(2):178-82

Laboratory of Neonatal Immunology, Neonatal Intensive Care Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Objective: CD64 index and triggering receptor expressed on myeloid cells-1 are biomarkers on neutrophil polymorphonuclear cells with crucial role in sepsis. The study aim is to assess diagnostic performance, individually and combined, of CD64 index and triggering receptor expressed on myeloid cells-1 (surface marker/soluble form), in late-onset sepsis of preterm infants.

Design: Observational study.

Setting: Neonatal ICU.

Patients: Sixteen septic and 16 control preterm infants, gestational age younger than 32 weeks and/or birth weigh less than 1500 g.

Measurement And Main Results: Seventy preterm infants, free of sepsis were enrolled into the study. CD64 index and triggering receptor expressed on myeloid cells-1 were measured once between day 5 and 15 of life (T0) and once between day 16 and 25 (T1). At T1, 16 infants were assigned to septic group because of reported signs of sepsis and positive blood culture. From the remaining 54 infants, 16 of them who always remained free of sepsis had a blood sample at T1 and constituted the control group (n = 16). Comparing T1 vs T0, triggering receptor expressed on myeloid cells-1 polymorphonuclear cells percentage was significantly lower (p = 0.002) in septic group but not in control group; soluble triggering receptor expressed on myeloid cells-1 concentration did not show significant differences in both groups; CD64 index significantly increased (p = 0.0004) in septic group, while no difference was found in control group. Comparing septic with control group at T0, no differences were found in any markers. At T1, triggering receptor expressed on myeloid cells-1 polymorphonuclear cells percentage was significantly lower (p = 0.003) and CD64 index was higher (p = 0.00019) in septic infants. Triggering receptor expressed on myeloid cells-1 polymorphonuclear cells receiver operating characteristic curve indicated cutoff 62.12%, sensitivity 56.2%, specificity 93.5%, and area under the curve 0.8. CD64 index receiver operating characteristic curve indicated cutoff 2.85, sensitivity 87.5%, specificity 100%, and area under the curve 0.95. Combination of the two indexes was not useful in increasing individual diagnostic power.

Conclusions: Despite limited sample size, CD64 index demonstrated to be a promising biomarker, with high specificity, to diagnose late-onset sepsis. Further investigations are needed to substantiate these findings. Triggering receptor expressed on myeloid cells-1 showed less valuable diagnostic role.
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http://dx.doi.org/10.1097/PCC.0b013e31826e726dDOI Listing
February 2013

Nutritional needs of premature infants.

J Matern Fetal Neonatal Med 2011 Oct 16;24 Suppl 1:27-9. Epub 2011 Sep 16.

Neonatal Intensive Care Unit and Neonatal Immunology Laboratory, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Preterm birth is the leading cause of perinatal morbidity and mortality in developed countries. Many innovation in neonatology have raised survival rates in the two past decades, but despite progress in neonatal intensive care, nutrition and growth of preterm infants are still critical points for neonatologists around the world and extrauterine growth restriction remains a common problem. Since growth is recognized as a major problem, in 2010, the European Society of Pediatric Gastroenterology and Nutrition published recommendations on enteral nutrition for preterm infants. The aim of this review is to revise nutritional needs of premature infants, taking into consideration the recommendations of ESPGHAN and the recent international literature.
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http://dx.doi.org/10.3109/14767058.2011.607568DOI Listing
October 2011

Development and validation of an HPLC-UV detection assay for the determination of rufinamide in human plasma and saliva.

Anal Bioanal Chem 2011 Aug 5;401(3):1013-21. Epub 2011 Jun 5.

Clinical Pharmacology Unit, Department of Internal Medicine and Therapeutics, University of Pavia, Via Ferrata 9, 27100 Pavia, Italy.

The development of a simple and rapid high-performance liquid chromatography (HPLC) method for the determination of the new antiepileptic drug rufinamide (RFN) in human plasma and saliva is reported. Samples (250 μl) are alkalinized with ammonium hydroxide (pH 9.25) and extracted with dichloromethane using metoclopramide as internal standard. Separation is achieved with a Spherisorb silica column (250 × 4.6 mm i.d., 5 μm) at 30 °C using as mobile phase a solution of methanol/dichloromethane/n-hexane 10/25/65 (vol/vol/vol) mixed with 6 ml ammonium hydroxide. The instrument used was a Shimadzu LC-10Av chromatograph and flow rate was 1.5 ml min(-1), with a LaChrom L-7400 UV detector set at 230 nm. Calibration curves are linear [r(2) = 0.998 ± 0.002 for plasma (n = 10) and r(2) = 0.999 ± 0.001 for saliva (n = 9)] over the range of 0.25-20.0 μg ml(-1), with a limit of quantification at 0.25 μg ml(-1). Precision and accuracy are within current acceptability standards. The assay is suitable for pharmacokinetic studies in humans and for therapeutic drug monitoring.
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http://dx.doi.org/10.1007/s00216-011-5126-9DOI Listing
August 2011

A novel LAMA3 mutation in a newborn with junctional epidermolysis bullosa herlitz type.

Neonatology 2011 25;99(3):188-91. Epub 2010 Sep 25.

Department of Internal Medicine and Therapeutics, Clinical Pharmacology Unit, University of Pavia, Pavia, Italy.

The case of a male neonate of 41 weeks' gestation who developed blistering of the skin immediately after birth is described. His parents were consanguineous Tunisians. Electron microscopy of a cutaneous biopsy showed skin cleavage within the lamina lucida and immunoepitope mapping revealed a complete absence of laminin 332 expression. These findings referred to the diagnosis of junctional epidermolysis bullosa (JEB) Herlitz type. The neonate died at 3 months of age due to sepsis. Molecular analysis of laminin 332 chain genes LAMA3, LAMB3 and LAMC2 disclosed a novel homozygous nonsense mutation in LAMA3 (p.Y955X). Clinical and laboratory analyses are essential for the diagnosis of JEB subtypes, and molecular analysis screening is crucial to manage a new pregnancy in families with suspected cases of JEB.
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http://dx.doi.org/10.1159/000314076DOI Listing
August 2011

BNP concentrations and cardiovascular adaptation in preterm and fullterm newborn infants.

Early Hum Dev 2010 May 20;86(5):295-8. Epub 2010 May 20.

Pediatric Cardiology, Department of Paediatrics, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy.

To evaluate and compare cardiovascular adaptation of 36 preterm and 34 fullterm newborns, we analyzed BNP concentration and echocardiographic parameters at day 3 of life and at day 28 (+/-2). On day 3 BNP concentrations (pg/ml) resulted higher in PDA preterm group (n=11; 125, IQR 56.1-301) than preterm without PDA (n=25; 25.5 IQR 10.9-49; p<0.001) than fullterms (n=34; 55.1 IQR 23.6-82.7; p=0.013). No difference resulted in all groups at 28days (respectively: 12.7 IQR 4.9-23.8; 15.6 IQR 10-22; 8.9 IQR 5.6-20.6). Because of the newborns' growth, all echocardiographic parameters increased with linear relationship with body weight. On day 3 BNP concentration and echocardiographic parameters were not correlated besides LA/AO in preterms with PDA (p=0.0015). On day 28, BNP was significantly correlated with mVTI (p=0.019), M (p=0.007) and LA (p=0.005) in fullterms and only with LA (p=0.007) in preterms. In conclusion, BNP concentrations and echocardiographic measures confirm that preterm, and fullterm newborns conduct themselves in a similar manner during the transition from foetal to post-natal circulation, reaching low levels at a month of life. The presence of PDA during first days of life has no significant impact in this adaptation. LA is the echocardiographic parameter mostly related to BNP concentration in the newborns.
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http://dx.doi.org/10.1016/j.earlhumdev.2010.04.003DOI Listing
May 2010

Changes in lamotrigine pharmacokinetics during pregnancy and the puerperium.

Ther Drug Monit 2008 Aug;30(4):544-7

Clinical Pharmacology Unit, Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.

To assess changes in the pharmacokinetics of the anti-epileptic drug lamotrigine (LTG) during pregnancy, plasma LTG concentrations at steady-state were determined at different intervals during 11 pregnancies in 10 women with epilepsy stabilized on long-term LTG therapy. In the five pregnancies that could be assessed both during gestation and after delivery, plasma LTG concentrations increased on average by 164% (range +75 to +351%) between the last observation during pregnancy and the puerperium (P < 0.05). When all pregnancies monitored during pregnancy were considered, plasma LTG concentrations declined by an average of 20% (range -64% to +13%) between the first and the last assessment before delivery. These findings confirm that plasma LTG concentrations decrease markedly during pregnancy and that, at least in some cases, this effect occurs as early as the first trimester. Because there is a large interindividual variability in the magnitude and time course of the pregnancy-associated pharmacokinetic changes, it is desirable to establish baseline plasma LTG concentrations in all women of childbearing potential and to monitor LTG levels at frequent intervals during pregnancy and the puerperium.
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http://dx.doi.org/10.1097/FTD.0b013e318178e2a9DOI Listing
August 2008

A novel enantioselective microassay for the high-performance liquid chromatography determination of oxcarbazepine and its active metabolite monohydroxycarbazepine in human plasma.

Ther Drug Monit 2007 Jun;29(3):319-24

Clinical Pharmacology Unit, Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.

A simple and innovative assay is described that allows the determination of the antiepileptic drug oxcarbazepine and the chiral separation of the two enantiomers of its active metabolite monohydroxycarbazepine (licarbazepine). The assay requires liquid-liquid extraction of the sample (200 microL) into tert-butyl methyl ether and dichloromethane, drying of the organic phase under a nitrogen stream, reconstitution with the mobile phase, and injection in the high-performance liquid chromatography system after filtering. Separation of oxcarbazepine, R-(-)-monohydroxycarbazepine, S-(+)-monohydroxycarbazepine, and the second-step metabolite 10,11-trans-dihydroxycarbamazepine (racemate) is achieved with a Chiralcel ODR column and potassium hexafluorophosphate/acetonitrile as mobile phase. Detection is by ultraviolet absorbance at 210 nm. Standard curves are linear (r2 > or = 0.999) over the range of 0.1 to 25 microg/mL for each analyte with a limit of quantification of 0.1 microg/mL (1 ng injected) for all compounds. Within-day and between-day precision is better than 12% and within-day and between-day accuracy is between 99% and 116% for each compound. These performance characteristics are adequate for pharmacokinetic studies and for therapeutic drug monitoring. However, because the two enantiomers of monohydroxycarbazepine exhibit similar pharmacologic activity, nonenantioselective assays are likely to be more cost-effective for therapeutic drug monitoring purposes.
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http://dx.doi.org/10.1097/FTD.0b013e318058a2c2DOI Listing
June 2007

Stereoselective determination of vigabatrin enantiomers in human plasma by high performance liquid chromatography using UV detection.

J Chromatogr B Analyt Technol Biomed Life Sci 2007 Jul 8;854(1-2):63-7. Epub 2007 Apr 8.

Clinical Pharmacology Unit, Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.

A rapid and simple high-performance liquid chromatographic method for the determination of the R-(-)- and S-(+)-enantiomers of the antiepileptic drug vigabatrin in human plasma is described. After adding the internal standard (1-aminomethyl-cycloheptyl-acetic acid), plasma samples (200 microL) are deproteinized with acetonitrile and the supernatant is derivatized with 2,4,6 trinitrobenzene sulfonic acid (TNBSA). Separation is achieved on a reversed-phase cellulose-based chiral column (Chiralcel-ODR, 250 mm x 4.6 mm i.d.) using 0.05 M potassium hexafluorophosphate (pH 4.5)/acetonitrile/ethanol (50:40:10 vol/vol/vol) as mobile phase at a flow-rate of 0.9 mL/min. Chromatographic selectivity is improved by concentrating the derivatives on High Performance Extraction Disk Cartridges prior to injection. Detection is at 340 nm. Calibration curves are linear (r(2)> or =0.999) over the range of 0.5-40 microg/mL for each enantiomer, with a limit of quantification of 0.5 microg/mL for both analytes. The assay is suitable for therapeutic drug monitoring and for single-dose pharmacokinetic studies in man.
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http://dx.doi.org/10.1016/j.jchromb.2007.03.042DOI Listing
July 2007

Fetal exposure to GABA-acting antiepileptic drugs generates hippocampal and cortical dysplasias.

Epilepsia 2007 Apr;48(4):684-93

INMED, INSERM U29, Université de la Méditerranée, Campus de Luminy, Marseille, France.

Purpose: The management of epilepsy during pregnancy entails a number of concerns. While seizures may affect adversely maternal and fetal outcome, antiepileptic drugs (AEDs) may increase the incidence of congenital abnormalities and possibly affect postnatal cognitive development in the offspring. Experimental animal studies can aid in assessing teratogenic features associated with individual AEDs and/or with seizures, and to identify the mechanisms involved. The purpose of this study was to investigate the consequences of prenatal exposure to (a) different AEDs and (b) maternal seizures on brain maturational processes in rats.

Methods: Pregnant rats received from embryonic days 14 to 19 intraperitoneal injections of carbamazepine (20 mg/kg/day), vigabatrin (200 mgkg/day), and valproate (100 mg/kg/day) at doses not widely different from those used clinically. Pups exposed to AEDs in utero were analyzed postnatally. Animals born to "kindled" pregnant animals that had experienced one generalized convulsive seizure per day during the same gestational period were analyzed in parallel.

Results: Prenatal exposure to vigabatrin and valproate, which act on GABA signaling, induced hippocampal and cortical dysplasias, which were likely to result from a neuronal migration defect and neuronal death. By contrast, offspring of rats exposed to carbamazepine (which at the dose used produced low plasma concentrations) or to generalized convulsive seizures showed no clear-cut evidence of dysplasias.

Conclusions: We suggest that AEDs that increase the extracellular concentration of GABA might induce severe neuronal migration disorders. Drugs acting through other molecular targets would also perturb cortical maturation. The potential clinical relevance of these results should be a subject of future research.
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http://dx.doi.org/10.1111/j.1528-1167.2007.01056.xDOI Listing
April 2007

Increased apparent oral clearance of valproic acid during intake of combined contraceptive steroids in women with epilepsy.

Epilepsia 2006 Sep;47(9):1569-72

IRCCS Institute of Neurology C Mondino Foundation, Pavia, Italy.

Purpose: To determine potential changes in total and unbound serum valproic acid (VPA) concentrations at steady-state during a cycle of intake of combined hormonal contraceptive (HC) steroids.

Methods: Blood samples were collected from nine women stabilized on VPA monotherapy on two separate randomized occasions: (i) at the end of the 4- to 7-day HC-free interval, and (ii) on the last day of the HC intake period. Trough concentrations of VPA in serum and serum ultrafiltrates were determined by fluorescence polarization immunoassay.

Results: In all women, total and unbound VPA concentrations were higher during the HC-free interval than during HC intake (means +/- SD: 425 +/- 184 vs. 350 +/- 145 micromol/L, respectively, for total VPA, p = 0.002, and 55 +/- 37 vs. 39 +/- 25 micromol/L, respectively, for unbound VPA, p = 0.005). Compared with the HC-free interval, HC intake was associated with a mean 21.5% increase in VPA total apparent oral clearance (from 8.0 +/- 5.2 to 9.7 +/- 6.4 ml/h/kg, p = 0.01) and a 45.2 % increase in VPA unbound apparent oral clearance (from 79 +/- 81 to 115 +/- 121 ml/h/kg, p = 0.029).

Conclusions: The apparent oral clearance of total and unbound VPA increases during the HC intake period compared with the HC-free interval, probably due to induction of glucuronosyltransferase by ethinylestradiol. The magnitude of the change varies across individuals, being potentially clinically relevant in some cases. Serum VPA concentrations should be monitored when adding or discontinuing HC steroids, and possibly during the on-off intervals of a HC cycle.
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http://dx.doi.org/10.1111/j.1528-1167.2006.00629.xDOI Listing
September 2006

Changes in the disposition of oxcarbazepine and its metabolites during pregnancy and the puerperium.

Epilepsia 2006 Mar;47(3):504-9

Clinical Pharmacology Unit, Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.

Purpose: To determine potential changes in the plasma concentrations of oxcarbazepine (OXC) and its metabolites during pregnancy and puerperium.

Methods: Five women receiving OXC monotherapy were followed prospectively during pregnancy and the puerperium. Four women were enrolled in the first trimester, and one woman, 2 weeks before delivery. Steady-state concentrations of OXC, its active R-(-)- and S-(+)-monohydroxy derivatives (MHD), and the additional metabolite carbamazepine-10,11-trans-dihydrodiol (DHD) were measured at regular intervals by an enantioselective HPLC assay. RESULTS. In all samples, S-(+)-MHD was the most abundant compound in plasma and accounted almost entirely for the amount of active moiety (defined as the molar sum of OXC, R-(-)-MHD, and S-(+)-MHD) found in the circulation. The dose-normalized concentrations of active moiety decreased markedly during gestation and, in four of the five patients, increased strikingly after delivery. Plasma concentrations of S-(+)-MHD mirrored closely the levels of the active moiety. Plasma concentrations of the parent drug and other metabolites also tended to decrease during pregnancy and to increase after delivery.

Conclusions: During treatment with OXC, S-(+)-MHD is by far the most abundant active compound in plasma. The concentration of this metabolite as well as the active moiety may decrease markedly during pregnancy and may increase severalfold after delivery. Because of these striking pharmacokinetic changes, the clinical response should be monitored closely in OXC-treated women throughout pregnancy and the puerperium.
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http://dx.doi.org/10.1111/j.1528-1167.2006.00459.xDOI Listing
March 2006

Human amniotic fluid cells are able to produce IL-6 and IL-8.

Am J Reprod Immunol 2004 Mar;51(3):198-203

Laboratori Sperimentali, Area Trapiantologica, IRCCS Policlinico San Matteo, Pavia, Italia.

Problem: In order to investigate the role of amniotic fluid cells (AFC) in the establishment of feto-maternal immune relationship, we evaluated their phenotype and capacity to produce cytokines.

Methods Of Study: CK 7-8, human leukocyte antigen (HLA)-I, HLA-DR, HLA-G, CD1d, CD34, CD45, CD14 surface antigens expression and the intracellular production of IL-4, IL-6, IL-8, IL-10, IL-12, interferon-gamma and tumor necrosis factor-1 were studied in cultured AFC and in eight samples immediately after amniocentesis using flow cytometry. IL-6 and IL-8 were detected by ELISA in all amniotic fluids and in all culture supernatants. Moreover, IL-6 and IL-8 mRNA were tested in nine samples.

Results: Cultured AFC express HLA-I, HLA-G and CK 7-8 and are able to produce IL-6 and IL-8, confirmed by presence of their mRNA. We quantified IL-6 and IL-8 levels in all amniotic fluids and in all supernatants.

Conclusion: Surface antigen expression of AFC are not specific of immune cells, but AFC are able to produce cytokines and we can postulate that they may participate in mechanisms involved in normal as well as pathological pregnancy.
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http://dx.doi.org/10.1111/j.1600-0897.2004.00137.xDOI Listing
March 2004

Regulatory CD4+CD25+ T cells in the peripheral blood of lung transplant recipients: correlation with transplant outcome.

Transplantation 2004 Mar;77(5):762-6

Department of General Surgery and Organ Transplantation, University of Pavia and IRCCS Policlinico San Matteo, Pavia, Italy.

Background: The subset of CD4+CD25+ regulatory T cells, recently identified in humans, may play a central role in the regulation of immune tolerance to graft survival.

Methods: This study assesses the frequency and functional profile of CD4+CD25+CD69- cells in the peripheral blood of lung transplant recipients (>3 years from transplantation), 10 of whom were in a stable clinical condition and 11 of whom demonstrated chronic rejection (bronchiolitis obliterans syndrome). We also studied a group of seven healthy subjects.

Results: The frequency of CD4+ T cells expressing CD25 (CD4+CD25+) and the highest levels (CD25) were lower in patients with bronchiolitis obliterans syndrome compared with healthy subjects and subjects in a stable clinical condition (P < or = 0.01). Purified CD4+CD25+ cells exhibited a regulatory functional profile in vitro: they were hyporesponsive, suppressed the proliferation of CD4+CD25- cells, and produced interleukin-10.

Conclusion: These results provide in vivo evidence that peripheral CD4+CD25+ T cells may represent an important regulatory subset in lung transplantation.
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http://dx.doi.org/10.1097/01.tp.0000116565.86752.6bDOI Listing
March 2004