High prevalence of HGV/GBV-C infection in polytransfused patients with thalassemia major.
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Adolescent↗
Biomedical subjects
V Carnelli
Publications and source records attributed to V Carnelli.
Thromboembolic events in beta thalassemia major: an Italian multicenter study.
Thromboembolic (TE) events have been frequently reported in beta-thalassemic patients in association with known risk factors such as diabetes, complex cardiopulmonary abnormalities, hypothyroidism, liver function anomalies, and postsplenectomy thrombocytosis. In a recent survey involving 9 Italian thalassemic centers, we identified 32 patients with TE episodes in a total of 735 subjects, of whom 683 had thalassemia major and 52 thalassemia intermedia, corresponding to 3.95 and 9.61%, respectively. There was a great variation in localization: the main one (16/32) was CNS, with a clinical picture of headache, seizures and hemiparesis. Other localizations were the pulmonary (3 patients), mesenteric (1 patient) and portal (2 patients) sites. There were 6 cases of deep venous thrombosis (2 in the upper limbs, 4 in the lower ones). Intracardiac thrombosis was found in 2 subjects and clinical and laboratory signs of DIC were observed in 2 others during pregnancy. Since our patients with TE events present a statistically significantly higher incidence of associated dysfunction (cardiomyopathy, diabetes, liver function anomalies, hypothyroidism) than those without TE events (50 vs. 13.8%), we suggest close monitoring of those patients who are at higher risk of developing TE events because of the presence of one or more of these predisposing factors.
Adolescent↗
QT interval prolongation and risk of life-threatening arrhythmias during toxoplasmosis prophylaxis with spiramycin in neonates.
We recently reported two cases of QT interval prolongation and cardiac arrest in newborns receiving antibiotic therapy with spiramycin, a macrolide agent extensively used for toxoplasmosis prophylaxis. In this study we assessed the effects of this drug on ventricular repolarization and on the potential risk of lethal arrhythmias in eight newborn infants in whom toxoplasmosis prophylaxis after birth was necessary. Electrocardiograms (ECGs) and echocardiograms were recorded during spiramycin therapy (350,000 i.u./kg/ day) and after its withdrawal. In a control group of eight healthy newborns matched for age and sex, no differences were found between two ECGs analogously recorded. The QT interval corrected for heart rate (QTc) was longer during spiramycin therapy than after drug withdrawal (448 +/- 32 msec vs 412 +/- 10 msec, +9%, p = 0.021). QTc dispersion, expressed as the difference between the longest and the shortest value in 12 different leads (QTcmax-min), was also higher during spiramycin therapy (60 +/- 32 msec vs 34 +/- 8 msec, +76%, p = 0.021), mainly because of a major lengthening of the longest QTc (QTcmax). QTc and QTc dispersion were markedly increased in the two newborns who experienced cardiac arrest after beginning treatment compared with the six neonates who had no drug-induced symptoms. During therapy seven of eight newborns had a rare abnormality in the thickening of the left ventricular posterior wall similar to that observed in patients with congenital long QT syndrome. This abnormality disappeared after drug withdrawal. Thus antibiotic therapy with spiramycin in the neonatal period may induce QT interval prolongation and increase QT dispersion. When this effect on ventricular repolarization is more marked, it may favor the occurrence of torsades des pointes and lead to cardiac arrest.
Anti-Bacterial Agents↗
Varicella in immunocompetent children in the first two years of life: role of treatment with oral acyclovir. Italian Acyclovir-Chickenpox Study Group.
An open multicenter study has been carried out to evaluate efficacy and tolerability of oral acyclovir in the treatment of varicella in immunocompetent patients in the first two years of life. Fifty-three children aged 3-24 months received acyclovir at 80 mg/Kg/day in four divided doses for 4 to 6 days; 24 of them were treated in the first 24 hours following disease onset, while the remaining 29 patients were enrolled within 48 hours. The assessment of evolution of disease signs and symptoms showed a rapid resolution of fever, itching and other constitutional symptoms, with interruption of vesicle formation and acceleration of cutaneous healing processes. No statistically significant differences have been demonstrated as to disease progression between patients treated in the first 24 hours, when compared with subjects receiving acyclovir in the following 24 hours. Acyclovir confirmed its excellent clinical and laboratory safety profile. By acting favorably on both the duration and severity of disease signs and symptoms, acyclovir treatment should be recommended in young children and infants with varicella, since a higher incidence of severe and complicated disease has been observed in these patient groups.
Acyclovir↗
Efficacy and safety of pidotimod in the treatment of recurrent respiratory infections in children.
The activity of pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) was evaluated in a double-blind, placebo-controlled, randomized, multicentre trial, on 120 pediatric patients affected by recurrent respiratory infections. The clinical course of acute infections was favourable both in placebo and in treatment group, but recovery was quicker with pidotimod than with placebo. Antibiotic therapy and time of hospitalization were shorter in the patients taking pidotimod, and main symptomatic parameters (pharyngalgia, dysphagia, mucous membrane inflammation, adenopathy, anorexia) receded quickly. In patients receiving the drug as well as in placebo group changes in laboratory parameters, indicating recovery from the acute infectious events, were observed. A significant trend to normalization of the immune response, evidenced by chemotaxis and leukocyte phagocytosis index, was found only in patients treated with pidotimod. A significant decrease in the risk of relapses was observed in patients treated with pidotimod (35%), as well as a reduction of hospitalization (86%) and a decreased antibiotic therapy (47%). If a relapse occurred, the response of treated patients was quicker (fever, antibiotic therapy, hospitalization). These findings allow to correlate the individual immune response activation to the resistance to recurrent infections and also to a better response to therapy in case of clinically relevant disease. No side effects were observed. Only in 12 patients (5 pidotimod, 7 placebo) mild reactions were observed, but they were attributed to concomitant antibiotic treatment or other factors. No alterations in main laboratory parameters were seen.(ABSTRACT TRUNCATED AT 250 WORDS)
Adjuvants, Immunologic↗
Therapeutic efficacy and safety of pidotimod in the treatment of urinary tract infections in children.
The activity of pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) was studied vs. placebo in a double-blind, randomized, multicentre trial, involving 60 pediatric patients with recurrent urinary tract infections. Recovery from acute events was quicker with pidotimod than with placebo (9.6 vs. 12.3 days). In treated patients antibiotic therapy was shorter (6.9 vs. 8.3 days) and main symptomatic parameters (body temperature, vesical tenesmus, stranguria, pollakiuria, total number of symptoms, total symptomatic intensity, rate of asymptomatic patients, haematuria, leukocyturia, positive urinary culture) receded quickly. In patients receiving the drug as well as in patients treated with placebo changes in laboratory parameters were observed, indicating recovery from the acute infectious disease. A significant trend to normalization of the immune response, expressed by chemotaxis and index of leukocyte phagocytosis, was found only in patients treated with pidotimod. After the acute episode a significant decrease of risk of relapses (69%) was observed in these patients. If a relapse occurs, the response of treated patients is quicker (duration of fever, total time of relapses) than for control patients. These findings allow to correlate the individual immune response activation to the resistance to recurrent infections and also to a better response to therapy if the disease occurs and becomes clinically relevant. No side effects were observed. Mild reactions (4 nausea/vomiting, 1 erythema) occurred only in 5 patients (2 pidotimod, 3 placebo) but were attributed to concomitant antibiotic therapy. No alterations of main laboratory parameters were found. These findings confirm the tolerability of the drug also in long-term treatment.(ABSTRACT TRUNCATED AT 250 WORDS)
Anti-Infective Agents, Urinary↗
Removal of white cells from red cells by transfusion through a new filter.
The effectiveness of a new filter (RC100) for the preparation of white cell-depleted red cells (RBCs) at the bedside was evaluated in vitro and in vivo using three RBC products: standard RBC concentrate (CPDA units), RBCs suspended in saline-adenine-glucose-mannitol additive solution after the removal of plasma (SAGM units), and RBCs suspended in SAGM after the removal of plasma and buffy coat (SAGM-BC units). Median RBC recovery was at least 92 percent when 2 units were administered through one filter; median values for residual white cells and platelets were less than or equal to 20 x 10(6) and less than or equal to 2.5 x 10(9) per 2 units, respectively. The in vivo study was carried out in 80 multiply transfused patients with thalassemia, 35 of whom had experienced frequent nonhemolytic transfusion reactions when given standard or buffy coat-free RBCs. During the 6-month study, each patient was given two transfusions of each type of RBC product One febrile nonhemolytic transfusion reaction occurred in each of two patients receiving SAGM-BC units, but in no other case. If the flow rate is not reduced, the median transfusion time is 35 minutes per CPDA unit and 15 minutes per SAGM and SAGM-BC unit. It is concluded that the transfusion of RBCs through the RC100 is a simple and effective procedure to administer white cell-depleted RBCs prepared at the bedside.
Blood Transfusion↗
Immunogenicity of a recombinant hepatitis B vaccine in hemophiliacs.
Yeast-recombinant vaccines against hepatitis B virus (HBV) are now available, but there is no information about whether or not they are immunogenic in patients with hemophilia and other congenital bleeding disorders. Twenty micrograms of a recombinant vaccine expressing the adw serotype of the hepatitis B surface antigen (HBsAg) were given to 41 patients negative for HBV markers and again after 1 and 6 months. Ten percent of the vaccinees had anti-hepatitis B surface antibody (anti-HBs) responses, with titers of 10 mIU/ml or more, 1 month after the first dose of vaccine. The percentage of anti-HBs-positive patients increased to 54% after the second dose and to 98% after the third dose, with only one non-responder. Hence, the recombinant vaccine was immunogenic, with percentages of seroconversion and anti-HBs titers similar to those achieved with plasma-derived vaccines.
Adolescent↗
Assessment for evidence of non A-non B hepatitis in patients given n-heptane-suspended heat-treated clotting factor concentrates.
Nineteen patients, (2 adults, 17 children) with inherited bleeding disorders were infused with n-heptane-suspended-heated clotting factor concentrates. Twelve of the nineteen were previously untreated. Six patients were infused with Profilnine Heat-Treated and 13 with Profilate Heat-Treated. Five separate centers participated and were given various lots of concentrates for use. Blood from the seventeen children was sampled prior to entry, at infusion, 2 weeks, 6 weeks, 12 weeks and 6 months after the first infusion. The two adults were sampled every 2 weeks. Twelve of the 19 patients were followed beyond six months. Three patients demonstrated a rise in ALT during the first six months of observation with levels above 2.5 times the upper limit of normal. One of these patients showed a parallel increment in a-CMV IgM titer and a second patient, an adult, had previously received many units of single donor blood components. During the second 6 month observation interval, two patients showed a rise in ALT. One of these patients had been exposed to only one lot of concentrate with no other viral cause being determined. Two additional patients had a moderate increase in ALT up to 98 U/L (normal less than 50). No patients were clinically ill or showed jaundice during these episodes. The hepatitis episode at 11 months in the patient using one lot of concentrate, might suggest a non-viral mechanism in this instance. This study indicates that these concentrates may be associated with episodes of ALT above 2.5 times the upper limit of normal in approximately 20% of the patients treated, but the etiology of the raised ALT may not always be Non A-Non B hepatitis.
Adult↗
Phase II trial of methylprednisolone pulse therapy in childhood chronic thrombocytopenia.
Nineteen children with chronic idiopathic thrombocytopenia (ITP) were treated with a single intravenous injection of methylprednisolone (MP), 15 mg/kg/day, for 3 consecutive days. The 3-day pulses gave rise to a positive and fast therapeutic response with increase of the platelet count in about three quarters of the patients. The platelet count remained above 50 X 10(9)/1 for more than 1 month in 10 children. Eight out of them still presented a safe platelet count (greater than 50 X 10(9)/1) 4 months after the onset of the therapy. The MP therapy improved the platelet count more in the older children and possibly in the females. No severe side effects were observed. Our results suggest that this therapeutic approach could be useful in the management of acute bleeding episodes in children with chronic ITP.
Adolescent↗
Hepatitis B vaccination of 113 hemophiliacs: lower antibody response in anti-LAV/HTLV-III-positive patients.
One-hundred thirteen adults and children with hemophilia or other congenital bleeding disorders were vaccinated against the hepatitis B virus. Each patient was given three subcutaneous injections of the vaccine at monthly intervals and then a fourth booster dose 14 months after the first. The vaccine was highly immunogenic, since 111 of 113 patients (98%) produced anti-HBs (10 mIU/ml or more). After the first three vaccine doses and after the booster dose, ten anti-LAV/HTLV-III-positive hemophiliacs produced anti-HBs but had a lower average titer than anti-LAV/HTLV-III-negative hemophiliacs. Of the 23 patients treated with concentrates in the 15 month postvaccination period only, none acquired HBV infection. Of the 50 patients treated with concentrates also in the 6 month prevaccination period, one developed hepatitis B. In summary, the vaccine was highly immunogenic in both children and adults with hemophilia; anti-LAV/HTLV-III-positive patients responded to the vaccine, but the average anti-HBs response was lower; no case of hepatitis B occurred in patients treated with concentrates only in the postvaccination period.
Adolescent↗
Hepatitis B virus infection in multitransfused haemophiliacs.
A longitudinal study of 44 haemophilic children, all in a treatment programme with factor concentrates, was undertaken to evaluate the occurrence, characteristics, and evolution of hepatitis B virus (HBV) infection. Twenty four children (55%) (group I) showed signs of HBV infection, while 20 (45%) (group II) did not. Age at onset of treatment, number of infusions, and total amount of concentrate received did not show significant differences between the two groups. In group I only four children (16%) had symptomatic acute hepatitis. Chronic liver disease was present in nine patients (38% of infected children). The early age of infection would seem to be an important factor for predicting chronic evolution. Evidence of delta infection in three children with severe liver disease seemed to confirm the high pathogenicity of this agent. Because of the risks associated with chronic HBV infection a careful follow up of patients positive for hepatitis B surface antigen is mandatory.
Age Factors↗
Transmission of non-A, non-B hepatitis by heat-treated factor VIII concentrate.
In-vitro and animal studies have shown that viral agents can be removed from or inactivated in clotting factor concentrates by physical or chemical treatment. However, clinical data have as yet not substantiated the results of these studies. 13 haemophilia A patients who had not been treated previously with blood or blood products were given a dry-heated factor VIII concentrate and were tested serologically over the next 12 months. Hepatitis developed in 11 patients (84%) and was invariably of type non-A, non-B. Morbidity was not related to the lot of the therapeutic material or to the number of infusions. The incubation period was either 5 or 8-11 weeks, and only 1 patient had symptoms. Aminotransferase elevation showed both monophasic and biphasic patterns. During the follow-up period signs of the disease disappeared in 10 patients (90%). These findings contrast with the absence of non-A, non-B hepatitis in chimpanzees given the same heated concentrate. Thus, clinical studies in first-exposure haemophiliacs are essential for the true evaluation of the safety of new "treated" concentrates.
Adolescent↗
Absence of antibodies to AIDS virus in haemophiliacs treated with heat-treated Factor VIII concentrate.
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Adolescent↗
[Biological monitoring of a sample of a school-age population exposed to environmental lead pollution in an area adjacent to a foundry].
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Child↗
Haemophilia in children. Current immunologic status of a pediatric population.
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Adolescent↗
SCE analysis in children exposed to lead emission from a smelting plant.
The frequency and location of SCE were evaluated in lymphocytes from peripheral blood cultures of 19 children living in a widely contaminated area and showing an increased absorption of lead. In the comparison between the exposed children and a control group living in an uncontaminated area, no significant differences were found in the mean values of SCE frequencies. The distributions of the SCE between chromosomes were proportional to chromosome length in both groups.
Adolescent↗
Chronic idiopathic thrombocytopenia treated with immunoglobulin.
Twenty five children with chronic idiopathic thrombocytopenic purpura followed from 6-96 months in 7 Italian paediatric departments were treated with high dose immunoglobulin according to a multicentre protocol. Positive responses were observed in 20 of 25 patients (80%) and negative responses in 5 of 25 (20%). On previous steroid treatment 7 of 10 positive responders were steroid resistant and 13 of 15 were steroid dependent. Within four weeks of beginning treatment 16 of 20 patients (80%) relapsed, while 4 of 20 (20%) maintained normal platelet values after 4-12 months' follow up. Statistical analysis of the platelet count on day five of treatment enabled us to divide positive responders into three groups: good, intermediate, and poor. The possible mode of action and clinical application of high dose immunoglobulin are discussed.
Adolescent↗