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Following the first successful trial of surfactant replacement therapy for preterm infants with respiratory distress syndrome (RDS) by Fujiwara in 1980, several animal-derived natural surfactants and synthetic surfactants have been developed. Synthetic surfactants were designed to overcome limitations of natural surfactants such as cost, immune reactions, and infections elicited by animal proteins contained in natural surfactants. However, first-generation synthetic surfactants that are protein-free have failed to prove their superiority over natural surfactants because they lack surfactant protein (SP). Lucinactant, a second-generation synthetic surfactant containing the SP-B analog, was better or at least as effective as the natural surfactant, suggesting that lucinactant could act an alternative to natural surfactants. Lucinactant was approved by the U. S. Food and Drug Administration in March 2012 as the fifth surfactant to treat neonatal RDS. CHF5633, a second-generation synthetic surfactant containing SP-B and SP-C analogs, was effective and safe in a human multicenter cohort study for preterm infants. Many comparative studies of natural surfactants used worldwide have reported different efficacies for different preparations. However, these differences are believed to due to site variations, not actual differences. The more important thing than the composition of the surfactant in improving outcome is the timing and mode of administration of the surfactant. Novel synthetic surfactants containing synthetic phospholipid incorporated with SP-B and SP-C analogs will potentially represent alternatives to natural surfactants in the future, while improvement of treatment modalities with less-invasive or noninvasive methods of surfactant administration will be the most important task to be resolved.
Subject(s)
Animals , Humans , Infant, Newborn , Cohort Studies , Infant, Premature , Pulmonary Surfactants , Surface-Active Agents , United States Food and Drug AdministrationABSTRACT
Objective To systematically assess the clinical effect and safety of Poractant Alfa Injection and ambroxol hydro-chloride in treating neonatal respiratory distress syndrome (NRDS) .Methods The home and abroad randomized controlled trials ( RCTs ) on the comparison of clinical effect and safety of Poractant Alfa Injection and ambroxol hydrochloride in treating NRDS were retrieved by computer .The literature quality was evaluated by the modified JADAD scale .Rev Man5 .3 .1 software was used for conducting the meta analysis .Results Twenty-four RCT were included .The meta analysis results showed that compared with ambroxol hydrochloride ,Poractant Alfa Injection for treating NRDS could more significantly increase the PH value (MD= -0 .02 , 95% CI:-0 .03- -0 .01 ,P<0 .01) ,increased the PaO2 value(MD= -2 .92 ,95% CI:-4 .59 - -1 .26 ,P<0 .01) ,decreased the PaCO2 value (MD=0 .95 ,95% CI:0 .12-1 .77 ,P=0 .02) ,reduced the FiO2 value(MD=0 .03 ,95% CI:0 .01-0 .05 ,P<0 .01) ,en-hanced the Pa O2/FiO2 ratio (MD= -7 .62 ,95% CI:-10 .87 - -4 .37 ,P<0 .01) ,reduced the short term complications (RR=1 .67 ,95% CI:1 .31-2 .12 ,P<0 .01) and long-term complications (RR=2 .85 ,95% CI:1 .14-7 .07 ,P=0 .02) ,shortened the hos-pitalization days (RR=3 .03 ,95% CI:0 .94 -5 .11 ,P<0 .01) as well as decreased the mortality rate (RR=1 .96 ,95% CI:1 .15-3 .34 ,P=0 .01) .However ,there were no statistical differences in the durations of continuous positive airway pressure (CPAP) me-chanical ventilation ,oxygen inhalation time ,time of clinical symptom outcome ,incidence rate of NRDS and total effective rate of treatment between the two groups .Conclusion Currently published evidences show that Poractant Alfa Injection is superior to am-broxol hydrochloride in treating NRDS ,however ,due to limited number of included RCD and medium quality ,the conclusion needs large scale and multicenter RCT verification .
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Objective To observe and analyze the Poractant Alfa Injection treatment of neonatal respiratory distress syndrome and the effect of nursing. Methods A total of 60 cases of neonatal respiratory distress syndrome were used as the research object, the patients were divided into two groups of test analysis, study group and control group of 30 patients, two groups of children were using Poractant Alfa Injection for treatment, the control group with routine nursing, the study group using humanized nursing, nursing effect comparison. Results After treatment and nursing, blood gas monitoring index in the study group, mechanical ventilation parameters were better than the control group, P<0.05, the difference was statistically significant. At the same time the study group with family satisfaction with care and compared with the control group increased significantly (P<0.05). Conclusion For children with neonatal respiratory distress syndrome during the treatment by Poractant Alfa Injection, The effect of humanistic nursing is more obvious, which can effectively improve the clinical symptoms of children, and the implementation of nursing intervention can also improve the satisfaction of the families of the children and the effect of treatment.
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Objective To observe and analyze the Poractant Alfa Injection treatment of neonatal respiratory distress syndrome and the effect of nursing. Methods A total of 60 cases of neonatal respiratory distress syndrome were used as the research object, the patients were divided into two groups of test analysis, study group and control group of 30 patients, two groups of children were using Poractant Alfa Injection for treatment, the control group with routine nursing, the study group using humanized nursing, nursing effect comparison. Results After treatment and nursing, blood gas monitoring index in the study group, mechanical ventilation parameters were better than the control group, P<0.05, the difference was statistically significant. At the same time the study group with family satisfaction with care and compared with the control group increased significantly (P<0.05). Conclusion For children with neonatal respiratory distress syndrome during the treatment by Poractant Alfa Injection, The effect of humanistic nursing is more obvious, which can effectively improve the clinical symptoms of children, and the implementation of nursing intervention can also improve the satisfaction of the families of the children and the effect of treatment.
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Objective To evaluate the effect of Budesonide combined with Poractant Alfa(pulmonary surfactants,PS) on preventing the bronchopulmonary dysplasia (BPD) in preterm infants.Methods One hundred and twenty preterm infants 6 hours after birth(gestational ages≤32 weeks and birth weights ≤1500 g)admitted to the Department of Newborn Medicine,the Affiliated Hospital of Southeast Medical University from October 2013 to February 2015 were randomly divided into 4 group(30 cases in each group).Group A was a control group,group B was neonatal respiratory distress syndrome(NRDS) group,group C was NRDS with PS group,and group D was NRDS with PS and Budesonide group.Thirty-two-week preterms without other diseases and without uptaking oxygen within 48 h were assigned as group A.Group B were treated by continuous uptaking oxygen with continuous positive airway pressure(CPAP) (oxygen uptaken lasting more than 48 h and oxygen concentrations more than 40％).Group C were treated with 100 mg/kg PS within 48 h on the basis of group B.Group D were treated with 0.25 mg/kg Budesonide suspension for inhalation on the basis of group C.The pH value,partial pressure of oxygen [pa(O2)],partial pressure of carbon dioxide [pa(CO2)] in the blood gas analysis were all detected in all groups before treatment,1,6,12,24 and 48 hours after using drug,respectively.All groups were also observed for whether to use respirator assisted ventilation,the duration of high oxygen use,the total time of uptaking oxygen,the rate of using PS again,the rate of BPD,the total hospitalization days and the adverse effects.The adverse effects included high blood pressure,high blood sugar,necrotizing enterocolitis and the incidence of nosocomial infection.Results Compared with group B,the pH value at 1 and 6 hours after using drugs,the pa(O2) and pa(CO2) at 1,6 and 12 hours after using drugs were improved obviously in the group C,and the differences were statistically significant (all P＜0.01).Compared with group B,the above indicators were improved more obvious in group D,and the differences were statistically significant (all P＜0.01).Moreover,compared with the group B,the oxygen inhalation duration,the rate of having a respirator assisted ventilation and using PS again,and the incidence of BPD were obviously decreased in other groups,the differences were statistically significant (all P＜0.05).The incidence of BPD in group D was less than that of group C,and the differences were statistically significant (3.33％ vs 10.00％,x2=4.00,P=0.046).The total oxygen time and the rate of adverse effects of each group were similar.The differences were not statistically significant (all P＞0.05).Conclusions Budesonide combined with Poractant Alfa can prevent BPD in preterm infants.Its effect is better than the simple use of Poractant Alfa,and the rate of adverse effects are not increased significantly.
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Objective To investigate the effect of poractant alfa injection(PS) on neonatal respiratory distress syndrome(NRDS).Methods According to the digital table,80 cases of NRDS were randomly divided into the control group (40 cases) and the treatment group (40 cases).Both two groups were treated by mechanical ventilation and conventional symptomatic,supportive treatment.The treatment group was given PS intratracheal injection,the control group was given 0.9％ sodium chloride injection intratracheal injection.The clinical symptoms,blood gas analysis and the improvement of X-ray chest film were dynamicly observed,the clinical efficacy was compared between the two groups.Results In the treatment group,PaO2 returned to ＞ 60mmHg time,PaCO2 returned to ＜ 50mmHg time,mechanical ventilation time were (2.13 ± 0.21) h,(12.56 ± 0.11) h,(18.2 ± 0.33) h,which were shorter than those in the control group [(12.41 ± 0.13) h,(89.87 ± 0.26) h,(76.13 ± 0.65) h,t =2.632,2.403,1.895,all P ＜ 0.05] ;39 cases in the treatment group were cured(97.5％),30 cases in the control group were cured(75.0％),the difference of cure rate between the two groups was statistically significant(x2 =8.53,P ＜ 0.05).The incidence rate of comnplications such as pulnonary hemorrhage,pneumothorax,intracranial hemorrhage in the treatment group was 7.5％,which was significantly lower than 32.5％ in the control group (x2 =7.81,P ＜ 0.05).Conclusion PS in the treatment of NRDS has obvious curative effect and less adverse reactions,it can be used in clinical application.
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PURPOSE: To compare the efficacy of the new drug calfactant with the commonly used drugs surfactant-TA and poractant alfa. MATERIALS AND METHODS: A total of 332 preterm infants at 24-31 weeks' gestation with respiratory distress syndrome (RDS) were enrolled and allocated to three groups according to the surfactant instilled; Group 1 (n=146, surfactant-TA), Group 2 (n=96, calfactant), and Group 3 (n=90, poractant alfa). The diagnosis of RDS and the decision to replace the pulmonary surfactant were left to the attending physician and based on patient severity determined by chest radiography and blood gas analysis. Data were collected and reviewed retrospectively using patient medical records. RESULTS: Demographic factors including gestational age, birth weight, Apgar score, clinical risk index for babies II score, and maternal status before delivery were not different between the study groups. Instances of surfactant redosing and pulmonary air leaks, as well as duration of mechanical ventilation, were also not different. Rates of patent ductus arteriosus, intraventricular hemorrhage (> or =grade III), periventricular leukomalacia, high stage retinopathy of prematurity, necrotizing enterocolitis (> or =stage II), and mortality were also similar, as was duration of hospital stay. Cases of pulmonary hemorrhage and moderate to severe bronchopulmonary dysplasia were increased in Group 3. CONCLUSION: Calfactant is equally as effective as surfactant-TA and poractant alfa. This was the first study comparing the efficacy of surfactant-TA, calfactant, and poractant alfa in a large number of preterm infants in Korea. Further randomized prospective studies on these surfactants are needed.
Subject(s)
Female , Humans , Infant, Newborn , Male , Biological Products/administration & dosage , Birth Weight , Bronchopulmonary Dysplasia/drug therapy , Gestational Age , Infant, Premature , Phospholipids/administration & dosage , Pulmonary Surfactants/administration & dosage , Republic of Korea , Respiration, Artificial , Respiratory Distress Syndrome, Newborn/drug therapy , Retrospective Studies , Risk , Treatment Outcome , Ventilator WeaningABSTRACT
PURPOSE: To compare the efficacy of the new drug calfactant with the commonly used drugs surfactant-TA and poractant alfa. MATERIALS AND METHODS: A total of 332 preterm infants at 24-31 weeks' gestation with respiratory distress syndrome (RDS) were enrolled and allocated to three groups according to the surfactant instilled; Group 1 (n=146, surfactant-TA), Group 2 (n=96, calfactant), and Group 3 (n=90, poractant alfa). The diagnosis of RDS and the decision to replace the pulmonary surfactant were left to the attending physician and based on patient severity determined by chest radiography and blood gas analysis. Data were collected and reviewed retrospectively using patient medical records. RESULTS: Demographic factors including gestational age, birth weight, Apgar score, clinical risk index for babies II score, and maternal status before delivery were not different between the study groups. Instances of surfactant redosing and pulmonary air leaks, as well as duration of mechanical ventilation, were also not different. Rates of patent ductus arteriosus, intraventricular hemorrhage (> or =grade III), periventricular leukomalacia, high stage retinopathy of prematurity, necrotizing enterocolitis (> or =stage II), and mortality were also similar, as was duration of hospital stay. Cases of pulmonary hemorrhage and moderate to severe bronchopulmonary dysplasia were increased in Group 3. CONCLUSION: Calfactant is equally as effective as surfactant-TA and poractant alfa. This was the first study comparing the efficacy of surfactant-TA, calfactant, and poractant alfa in a large number of preterm infants in Korea. Further randomized prospective studies on these surfactants are needed.
Subject(s)
Female , Humans , Infant, Newborn , Male , Biological Products/administration & dosage , Birth Weight , Bronchopulmonary Dysplasia/drug therapy , Gestational Age , Infant, Premature , Phospholipids/administration & dosage , Pulmonary Surfactants/administration & dosage , Republic of Korea , Respiration, Artificial , Respiratory Distress Syndrome, Newborn/drug therapy , Retrospective Studies , Risk , Treatment Outcome , Ventilator WeaningABSTRACT
Objective. To compare the complications among preterm infants treated with two different natural surfactants. Methods. In a randomized clinical trial, 150 preterm infants with Respiratory distress syndrome (RDS) treated with exogenous surfactant, were enrolled in the study. Group A consisted of 79 neonates that received poractant (curosurf). Seventy one newborn infants in group B were treated with beractant (Survanta). Results. The mean gestational age for group A and B were 29.40±2.90 wk and 29.50±2.73 wk (P=0.82), respectively. The demographic and clinical variables were similar in both groups. The mean duration of intubation (as a primary outcome) was significantly shorter in infants treated with poractant (3.13±1.80 vs 4.06±2.7 days p=0.05). The mean duration of need for oxygen and hospitalization of patients in group A and B were 17.73±22.25 vs 19.14±17.85days (p=0.67) and 24.89±26.41 vs 29.14±23.54 days (p= 0.32), respectively. There was no significant difference between groups with respect to mortality and morbidity, including pulmonary hemorrhage, intraventricular hemorrhage (IVH), patent ductus arteriosus, sepsis, and bronchopulmonary dysplasia (secondary outcome). Conclusions. In this study, infants who received poractant had shorter duration of intubation than infants treated with beractant, without any difference in the duration of oxygen therapy or hospitalization. There was no significant superiority of poractant over beractant.