无创通气在双胞胎早产儿新生儿呼吸窘迫综合征中的随机对照研究
发布时间：2018-08-16 07:43
【摘要】：目的无创通气中最常见的两种通气方式--经鼻持续正压通气和经鼻间歇正压通气已经被证明是一种对早产儿新生儿呼吸窘迫综合征非常有效的治疗策略,总体有效率在60%以上;在临床工作中,哪一种方式更加有利于减少新生儿气管插管、减少新生儿后遗症和并发症,目前国际上对此还是没有统一的认识。由于国内外的类似研究在基本临床资料特征、特别是母孕期疾病定性和定量平衡上存在一定的差异性(如母孕期血糖8mmol/l和15mmol/l均定性为“高”,在统计分析时定义为具有同质性;实际上,这两个血糖值对早产儿的各个器官发育的影响是不一致的,因此可能潜在影响主要临床结局和次要临床结局,在统计学上具有非同质性),我们推测这些差异性可能在其中扮演了重要的作用。因此,本研究的目的是在既往定性平衡研究的基础上,完全去除母孕期疾病的影响后,评价两种通气方式对插管率和后遗症、并发症的影响。方法我们在2011年1月至2014年7月实施了一项单中心的临床随机对照研究,本研究主要针对双胞胎早产儿,这些早产儿被诊断为新生儿呼吸窘迫综合征。在这对双胞胎中,一个早产儿随机给予经鼻持续正压通气,另一个给予经鼻间歇正压通气。在这些早产儿被明确诊断新生儿呼吸窘迫综合征的情况下,肺泡表面活性物质作为一种抢救性治疗手段,与家属协商并取得家属同意后予以气管内滴入。本研究的主要结局指标为在100天内的气管插管率;次要结局指标则包括早产儿的相关并发症,如支气管肺发育不良,早产儿视网膜病变,颅内出血,新生儿败血症,肺泡表面活性物质的管理次数和剂量,新生儿坏死性小肠结肠炎,动脉导管未闭,以及无创通气的不良反应等等。结果143对被诊断为新生儿呼吸窘迫综合征的早产儿被纳入本研究,其中129对最终完成了本研究随访。与经鼻持续正压通气相比较,经鼻间歇正压通气并没有明显减少气管插管率(11.9%vs 19.6%,P=0.080);考虑到早产儿新生儿呼吸窘迫综合征和胎龄大小存在明显的负性相关,为了避免胎龄差异性过大引起结果解释的不一致,我们根据胎龄设置了亚组。在亚组分析中,也没有表现出来明显的统计学差异(11.1%vs19.7%,P=0.087)。与此同时,也考虑到胎龄和肺泡表面活性物质可能存在交互反应,这种交互作用可能对插管率有明显影响,我们也做了交互分析,结果也没有显示这种交互作用可以影响插管率(χ2=0.234,P=0.628)。与此同时,在次要结局指标中,也没有发现差异性存在统计学意义。结论在本次双胞胎中进行的随机对照研究中,我们完全消除了母亲孕期疾病对新生儿的影响。结果显示,与经鼻持续正压通气相比较,经鼻间歇正压通气并没有显著性降低早产儿患新生儿呼吸窘迫综合征时的气管插管率。我们的结果暗示,在类似的既往研究中,母亲孕期疾病定性平衡的不一致可能是导致目前国际上存在这种差异的重要原因之一。
[Abstract]:Objective The two most common modes of noninvasive ventilation, transnasal continuous positive pressure ventilation and transnasal intermittent positive pressure ventilation, have been proved to be very effective in the treatment of neonatal respiratory distress syndrome in premature infants with an overall efficiency of more than 60%; which is more conducive to reducing neonatal tracheal intubation in clinical work There is still no international consensus on this issue. Similar studies at home and abroad, especially on the qualitative and quantitative balance of maternal and pregnant diseases, have some differences (such as maternal blood glucose 8 mmol/l and 15 mmol/l are both "high" in statistical analysis. Defined as homogeneity; in fact, the effects of these two blood glucose values on the development of various organs in premature infants are inconsistent, and therefore may potentially affect major clinical outcomes and secondary clinical outcomes, which are statistically heterogeneous. We speculate that these differences may play an important role in this study. Methods From January 2011 to July 2014, we conducted a single-center randomized controlled clinical study on twin preterm infants who were treated with two different ventilation methods. In these twins, one premature infant was randomly given continuous positive nasal pressure ventilation and the other was given intermittent positive nasal pressure ventilation. The primary outcome measure was the intubation rate within 100 days. Secondary outcome measures included complications associated with premature infants, such as bronchopulmonary dysplasia, retinopathy, intracranial hemorrhage, neonatal sepsis, and management of alveolar surfactant. Results 143 pairs of premature infants diagnosed with neonatal respiratory distress syndrome were included in the study. 129 pairs of them were eventually followed up. Compared with continuous positive nasal pressure ventilation, intermittent positive nasal pressure ventilation was performed. There was no significant reduction in intubation rate (11.9% vs 19.6%, P = 0.080); considering the significant negative correlation between neonatal respiratory distress syndrome and gestational age, we set up subgroups according to gestational age in order to avoid inconsistent interpretation of the results caused by excessive gestational age differences. At the same time, considering the possible interaction between gestational age and alveolar surfactant, which may have a significant effect on intubation rate, we also made an interactive analysis, and the results did not show that this interaction can affect the intubation rate (2 = 0.234, P = 0.628). At the same time, in the second time, in the second time Conclusion In this randomized controlled study of twins, we completely eliminated the effects of maternal illness during pregnancy on newborns. The results showed that nasal intermittent positive pressure ventilation did not significantly reduce the incidence of neonatal premature infants compared with nasal continuous positive pressure ventilation. Our results suggest that inconsistencies in the qualitative balance of maternal illness during pregnancy may be one of the important reasons for this difference internationally.
【学位授予单位】：第三军医大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R722.6
[Abstract]:Objective The two most common modes of noninvasive ventilation, transnasal continuous positive pressure ventilation and transnasal intermittent positive pressure ventilation, have been proved to be very effective in the treatment of neonatal respiratory distress syndrome in premature infants with an overall efficiency of more than 60%; which is more conducive to reducing neonatal tracheal intubation in clinical work There is still no international consensus on this issue. Similar studies at home and abroad, especially on the qualitative and quantitative balance of maternal and pregnant diseases, have some differences (such as maternal blood glucose 8 mmol/l and 15 mmol/l are both "high" in statistical analysis. Defined as homogeneity; in fact, the effects of these two blood glucose values on the development of various organs in premature infants are inconsistent, and therefore may potentially affect major clinical outcomes and secondary clinical outcomes, which are statistically heterogeneous. We speculate that these differences may play an important role in this study. Methods From January 2011 to July 2014, we conducted a single-center randomized controlled clinical study on twin preterm infants who were treated with two different ventilation methods. In these twins, one premature infant was randomly given continuous positive nasal pressure ventilation and the other was given intermittent positive nasal pressure ventilation. The primary outcome measure was the intubation rate within 100 days. Secondary outcome measures included complications associated with premature infants, such as bronchopulmonary dysplasia, retinopathy, intracranial hemorrhage, neonatal sepsis, and management of alveolar surfactant. Results 143 pairs of premature infants diagnosed with neonatal respiratory distress syndrome were included in the study. 129 pairs of them were eventually followed up. Compared with continuous positive nasal pressure ventilation, intermittent positive nasal pressure ventilation was performed. There was no significant reduction in intubation rate (11.9% vs 19.6%, P = 0.080); considering the significant negative correlation between neonatal respiratory distress syndrome and gestational age, we set up subgroups according to gestational age in order to avoid inconsistent interpretation of the results caused by excessive gestational age differences. At the same time, considering the possible interaction between gestational age and alveolar surfactant, which may have a significant effect on intubation rate, we also made an interactive analysis, and the results did not show that this interaction can affect the intubation rate (2 = 0.234, P = 0.628). At the same time, in the second time, in the second time Conclusion In this randomized controlled study of twins, we completely eliminated the effects of maternal illness during pregnancy on newborns. The results showed that nasal intermittent positive pressure ventilation did not significantly reduce the incidence of neonatal premature infants compared with nasal continuous positive pressure ventilation. Our results suggest that inconsistencies in the qualitative balance of maternal illness during pregnancy may be one of the important reasons for this difference internationally.
【学位授予单位】：第三军医大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R722.6
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