Gene/Protein Disease Symptom Drug Enzyme Compound
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 34,133 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous (RSV-IGIV) are licensed by the Food and Drug Administration for use in preventing severe lower respiratory tract infections caused by respiratory syncytial virus (RSV) in high-risk infants, children younger than 24 months with chronic lung disease (formerly called bronchopulmonary dysplasia), and certain preterm infants. This statement provides revised recommendations for administering RSV prophylaxis to infants and children with congenital heart disease, for identifying infants with a history of preterm birth and chronic lung disease who are most likely to benefit from immunoprophylaxis, and for reducing the risk of RSV exposure and infection in high-risk children. On the basis of results of a recently completed clinical trial, prophylaxis with palivizumab is appropriate for infants and young children with hemodynamically significant congenital heart disease. RSV-IGIV should not be used in children with hemodynamically significant heart disease. Palivizumab is preferred for most high-risk infants and children because of ease of intramuscular administration. Monthly administration of palivizumab during the RSV season results in a 45% to 55% decrease in the rate of hospitalization attributable to RSV. Because of the large number of infants born after 32 to 35 weeks' gestation and because of the high cost, immunoprophylaxis should be considered for this category of preterm infants only if 2 or more risk factors are present. High-risk infants should not attend child care during the RSV season when feasible, and exposure to tobacco smoke should be eliminated.
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PMID:Revised indications for the use of palivizumab and respiratory syncytial virus immune globulin intravenous for the prevention of respiratory syncytial virus infections. 1465 27

Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous (RSV-IGIV) are licensed by the Food and Drug Administration for use in preventing severe respiratory syncytial virus (RSV) infections in high-risk infants, children younger than 24 months with chronic lung disease (formerly called bronchopulmonary dysplasia), and certain preterm infants. This report summarizes the clinical trial information on which the guidance in the accompanying policy statement for administering RSV prophylaxis to certain children with a history of preterm birth, chronic lung disease, or congenital heart disease is based. On the basis of results of a recently completed clinical trial, palivizumab is appropriate for infants and young children with hemodynamically significant congenital heart disease. RSV-IGIV should not be used in children with hemodynamically significant heart disease. Palivizumab is preferred for most high-risk infants and children because of ease of intramuscular administration. Monthly administration of palivizumab during the RSV season results in a 45% to 55% decrease in the rate of hospitalization attributable to RSV. Because of the large number of infants born after 32 to 35 weeks' gestation and because of the high cost, immunoprophylaxis should be considered for this category of preterm infants only if 2 or more risk factors are present.
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PMID:Revised indications for the use of palivizumab and respiratory syncytial virus immune globulin intravenous for the prevention of respiratory syncytial virus infections. 1465 28

Palivizumab (Synagi) is a humanized monoclonal antibody that provides immunoprophylaxis against serious lower respiratory tract infections (LRTIs) caused by respiratory syncytial virus (RSV). RSV is the leading cause of hospitalization for LRTIs in infants, causing winter- or wet-season epidemics. In two double-blind, placebo-controlled trials, intramuscular palivizumab 15 mg/kg every 30 days for 5 months significantly reduced RSV-related hospitalizations by 55% in 1502 infants with prematurity and/or bronchopulmonary dysplasia/chronic lung disease (BPD/CLD) and by 45% in 1287 infants with hemodynamically significant congenital heart disease (HSCHD). Reductions were statistically significant versus placebo in infants with BPD/CLD, with all degrees of prematurity, and with acyanotic/other heart disease. Palivizumab was generally well tolerated, with < or =1.9% of recipients discontinuing treatment for tolerability reasons. In placebo-controlled trials, the most common potentially drug-related adverse events were fever, nervousness, injection-site reactions, and diarrhea. Drug-related events occurred in 7.2-11% of palivizumab recipients in controlled trials (vs 6.9-10% with placebo) and 0-7.9% in open-label trials. Very few serious potentially drug-related adverse events occurred in clinical trials; four occurred in 2 of 285 patients in one open-label trial. No significant anti-palivizumab antibodies developed during palivizumab use. Palivizumab trough serum concentrations were below the recommended 40 microg/mL in about 33% and up to 14% of children prior to their second and third palivizumab injections. In pharmacoeconomic studies, the cost of palivizumab per hospitalization averted was generally lowest in the highest-risk infants. Drug cost was generally the most influential factor in sensitivity analyses. In conclusion, prophylaxis with palivizumab significantly reduces the incidence of RSV-related hospitalization relative to placebo and is generally well tolerated in high-risk infants aged <2 years, including those with prematurity and BPD/CLD or HSCHD, which are risk factors for early or serious RSV infection. Palivizumab is approved for use in these patients. Other high-risk infants in whom palivizumab has not been formally assessed, such as those with immunodeficiency, cystic fibrosis, or location-specific risk factors (including extended hospital stays) might potentially benefit from palivizumab. The use of palivizumab in these other high-risk populations is likely to be determined as much by pharmacoeconomic considerations as by efficacy outcomes.
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PMID:Palivizumab: a review of its use as prophylaxis for serious respiratory syncytial virus infection. 1517 Mar 64

(1) Respiratory syncytial virus (RSV) infection is common in infants; it is usually mild except in high risk children. (2) Palivizumab, a monoclonal antibody against RSV, was the first preventive treatment to be marketed in France. The licence was recently extended in France to cover children under 2 years of age who have haemodynamically significant congenital heart disease. (3) Follow-up data from Spanish cohorts of premature infants and infants with bronchopulmonary dysplasia are now available. The data tend to agree, albeit with different levels of evidence, that palivizumab reduces the risk of hospitalisation for RSV infection (3.95% of infants treated with palivizumab, 13.25% of untreated infants), but has no impact on the need for intensive care or on overall mortality. There are no data on the overall risk of hospitalisation. (4) In a randomised double-blind placebo-controlled trial in 1287 infants under 2 years of age with haemodynamically significant heart disease, palivizumab had no effect on mortality. But it did reduce the rate of hospitalisation both for RSV infection (5.3% versus 9.7%) and for all causes (54.9% versus 62.3%). (5) Few adverse effects have been reported after five years of use. The estimated risk of anaphylactic reactions is less than 1 per 100 000 infants. The risk of adverse effects when an infant is treated during a second season is poorly documented. (6) Treatment costs about 5000 euros per season for a 6 kg child. (7) In practice, palivizumab seems useful for the following categories of infants: those aged less than 6 months who were born with a gestational age of less than 32 weeks and who had bronchopulmonary dysplasia at birth; formerly premature infants under 2 years of age who are receiving long-term treatment for pulmonary sequelae; and infants with haemodynamically significant heart disease.
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PMID:Palivizumab: new indication. Moderate reduction in hospitalisation rate. 1561 42

Respiratory syncytial virus infection continues to be one of the most important health problems in infancy. Active prophylaxis against this infection (i.e., vaccination) is not available. Therefore, protection of high-risk infants is possible only by passive prophylaxis with specific antibodies. Palivizumab (Synagis) and respiratory syncytial virus intravenous immune globulin are licensed by the US Food and Drug Administration for the prevention of severe lower respiratory tract infections caused by respiratory syncytial virus in infants with bronchopulmonary dysplasia, infants with a history of premature birth (< or =35 weeks gestational age) and children with hemodynamically significant congenital heart disease. Palivizumab is a humanized monoclonal antibody produced by recombinant DNA technology, directed to an epitope in the A antigenic side of the F-protein of the respiratory syncytial virus. This review discusses the characteristics of this drug in detail.
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PMID:Palivizumab in the prophylaxis of respiratory syncytial virus infection. 1620 63

To evaluate whether the system-based strategy for management of meconium aspiration syndrome (MAS) could reduce the morbidity and mortality rate of MAS in our institute, a prospective consecutive clinical observation was conducted. System-based strategy including appropriately trained the relevant medical staff to familiar with neonatal resuscitation program, early surfactant replacement or lavage following with high-frequency ventilator (HFV) and/or inhaled nitric oxide (iNO). Outcome measurements were the morbidity and mortality rates of MAS. All infants of MAS in the study period were included except cases of congenital malformations or cyanotic congenital heart disease (CHD). Oxygen, nasal continuous positive airway pressure (CPAP), and intermittent mandatory ventilation (IMV) were applied as clinically indicated. Surfactant was used as replacement or lavage therapy for MAS infants whose oxygen index (OI) exceeded 20 or value for AaDO2 exceeded 400 within 6 hours of age. High-frequency oscillator ventilation (HFO) was applied for infants of MAS that demonstrated intractable respiratory failure with conventional mechanical ventilation and 100% oxygen. Inhaled nitric oxide (iNO) was used with IMV or HFO for infants of persistent pulmonary hypertension (PPHN) when it was unresponsive to conventional therapy. Dexamethasone was prescribed in infants of severe hypotension that did not respond to dopamine and epinephrine. A series of 198 consecutive infants of MAS born in this hospital during 9 years were analyzed. There was no mortality. Fourteen infants developed PPHN, 11 had pneumothorax, 1 had pulmonary hemorrhage, 2 had neurologic sequelae because of severe asphyxia, and 2 developed bronchopulmonary dysplasia. Our results indicated that appropriately trained relevant medical staff with neonatal resuscitation program to avoid complicated MAS and early surfactant replacement or lavage following with HFO and/or iNO could reduce the morbidity and mortality rate of MAS even without extracorporeal membrane oxygenation (ECMO).
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PMID:System-based strategy for the management of meconium aspiration syndrome: 198 consecutive cases observations. 1630 81

Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in infants and young children worldwide. This study was conducted to determine the prevalence of RSV among high-risk children admitted with respiratory symptoms in a developing country. This is a multicenter study conducted among children less than 24 months of age and admitted to the hospital with respiratory symptoms. The inclusion criteria included: lower respiratory tract symptoms on admission, gestational age less than 35 weeks, and admission age less than six months, or children less than 24 months of age with a diagnosis of bronchopulmonary dysplasia requiring medical treatment or intervention during the last six months or with an uncorrected congenital heart disease (other than patent ductus arteriosus). Nasopharyngeal samples were obtained with one of the three standard methods: nasopharyngeal aspirate, nasopharyngeal wash or nasopharyngeal swab. RSV antigen was determined by enzyme immunoassay using Abbott TESTPACK RSV (No. 8100/2027-16). Statistical analysis was performed using Student's t-test and chi-square test. In this study, 332 children (135 females, 40.7%; 197 males, 59.3%) were included, and the nasopharyngeal specimens of 98 (29.5%) children were determined to be RSV-positive. There were no differences in sex, age of gestation, age of admission, family education, number of siblings and smoking at home for RSV-positive and -negative cases. Furthermore, underlying disease and duration of hospital and intensive care unit stay were similar among groups. Only otitis media was more common among RSV-positive cases. No fatality at hospital was recorded. Frozen samples revealed more negative results. Most cases presented during winter and the number of RSV-positive cases was higher in cold and economically poor areas. Premature children and children with underlying medical condition acquire RSV irrespective of other sociodemographic risk factors, and most of them are hospitalized. Thus, an RSV vaccine seems the most effective mode of protection to decrease morbidity and mortality.
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PMID:Respiratory syncytial virus epidemiology in Turkey. 1636 37

The new biology has the potential to provide mechanistic insights into the causes and progression of complex cardiopulmonary diseases such as congenital heart disease and bronchopulmonary dysplasia. Such research requires collaborative investigation supported by sophisticated infrastructures and core facilities. Translating basic observations to clinical outcomes will require networks for collaborative translational research. The research initiatives require excellently trained and motivated clinician-scientists, but there are numerous barriers to the training and support of clinician-scientists in cardiology and neonatology.
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PMID:The cardiopulmonary system: research and training opportunities. 1680 71

Palivizumab is a recombinant humanized monoclonal antibody against the F glycoprotein of respiratory syncytial virus (RSV). It has been licensed since 1999 in France for the prevention of serious lower respiratory-tract infection caused by RSV requiring hospitalization in children born at 35 weeks gestation or less and who are less than 6 months old at the onset of RSV season, or in children less than 2 years old who have received treatment for bronchopulmonary dysplasia within the last 6 months. Since 2003, it has been also licensed for children less than 2 years with hemodynamically significant heart disease. Its high cost leads french and foreign pediatric Societies to restrain its indications for children with the highest risk of severe illness.
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PMID:[Indications and prescription modalities of palivizumab in neonates]. 1793 52

Respiratory syncytial virus (RSV) immune globulin is a purified human hyperimmune globulin that provides passive immunity against complicated RSV disease in select groups of infants and young children. According to microneutralisation assay results, its RSV-neutralising antibody concentration was significantly greater than that of nonspecific immune globulin, thereby suggesting the potential for more reliable protection against RSV infection. In 2 randomised double-blind trials, prophylaxis with RSV immune globulin significantly reduced (vs no immune globulin) the incidence and severity of RSV disease in infants and young children with bronchopulmonary dysplasia, prematurity or bronchopulmonary dysplasia due to prematurity, or congenital heart disease (in 1 study). Treatment with RSV immune globulin did not significantly reduce the duration of hospitalisation and intensive care in children hospitalised with RSV infection in 2 randomised double-blind trials; however, a trend towards a significant treatment benefit was apparent in children with severe disease in 1 of these studies.
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PMID:Respiratory syncytial virus immune globulin. 1802 May 3


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