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目的:探讨肺表面活性物质(PS)羊膜腔注射预防早产儿呼吸窘迫综合征(NRDS)的药代动力学机制及疗效。方法:(1)药代动力学研究。实验动物为妊娠25天的兔胎。将0.1ml PS注入羊膜腔内,分别于1h、2h、4h(Ⅰ组、Ⅱ组、Ⅲ组)娩出兔胎并处死;气管内给药PS 0.1ml或生理盐水0.1ml(Ⅳ组、对照组)后1h,娩出兔胎并处死。各组留取兔胎末端肺组织检测DPPC浓度。(2)临床研究:妊娠28～32周胎肺不成熟早产病例。随机分为3组:PS羊膜腔给药组,分娩前将固尔苏1支注入羊膜腔内;PS气管内给药组,新生儿娩出后立即将固尔苏1支经气管插管注入支气管内;对照组,出生前后不予PS预防性给药。结果:(1)药代动力学:Ⅰ组与Ⅳ组比较,兔胎肺组织中DPPC含量无明显差异[(1.133±0.402)mg/g肺组织vs(1.170±0.145)mg/g肺组织,P>0.05],两组均明显高于对照组[(0.684±0.158)mg/g肺组织,P均<0.01]。Ⅱ组、Ⅲ组兔胎肺组织中DPPC含量较Ⅰ组明显下降,与对照组的差异无统计学意义(P>0.05)。(2)临床研究:3组新生儿孕龄、出生体重无明显差异。PS羊膜腔给药组及PS气管内给药组新生儿NRDS发生率无明显差异(13.3%vs 14.3%,P>0.05),显著低于对照组(35%)(P均<0.05);两组持续正压通气的频率无明显差异(16.6%vs 22.8%,P>0.05),均显著低于对照组(57.5%)(P均<0.05)。新生儿住院时间PS羊膜腔给药组为(27.8±9.6)天,PS气管内给药组为(26.8±11.7)天,均显著短于对照组[(33.7±11.8)天](P均<0.05)。PS羊膜腔给药组及气管内给药组新生儿均存活,对照组死亡4例。结论:PS羊膜腔给药可显著降低早产儿NRDS发生率并改善预后,可取得和气管内给药一样的效果,临床应用风险小,操作简单,值得临床推广应用。
Objective: To investigate the pharmacokinetics and efficacy of amnioinjection of pulmonary surfactant (PS) in the prevention of respiratory distress syndrome (NRDS) in preterm infants. Methods: (1) Pharmacokinetic study. Experimental animals for 25 days of pregnancy rabbit. Rabbits were delivered at 1h, 2h, 4h (group Ⅰ, group Ⅱ, group Ⅲ) and sacrificed respectively. Intratracheal PS 0.1ml or saline 0.1ml (group Ⅳ, control group ) After 1h, the rabbit was delivered and executed. DPPH concentrations were detected in each group by collecting the end of the rabbit lung tissue. (2) clinical research: 28 to 32 weeks of gestation fetal immature premature birth cases. Randomly divided into 3 groups: PS amniotic cavity administration group, one part of Guer Su Su was injected into the amniotic cavity before delivery; PS intratracheal drug delivery group, immediately after birth, Guer Su Su 1 was injected into the bronchial tube Within the control group, PS prophylaxis was not given before and after birth. Results: (1) Pharmacokinetics: There was no significant difference in DPPC content in rabbit lung tissue between group Ⅰ and group Ⅳ [(1.133 ± 0.402) mg / g lung tissue vs (1.170 ± 0.145) mg / g lung tissue, P> 0.05], both groups were significantly higher than the control group [(0.684 ± 0.158) mg / g lung tissue, P <0.01]. The content of DPPC in group Ⅱ and group Ⅲ decreased significantly compared with group Ⅰ, but there was no significant difference between group Ⅱ and group Ⅲ (P> 0.05). (2) clinical research: three groups of newborns gestational age, birth weight no significant difference. There was no significant difference in neonatal NRDS incidence between PS amniotic cavity administration group and PS tracheal administration group (13.3% vs 14.3%, P> 0.05), which was significantly lower than that of control group (35%) (P <0.05) There was no significant difference in the frequency of continuous positive airway pressure between the two groups (16.6% vs 22.8%, P> 0.05), which were significantly lower than those in the control group (57.5%, P <0.05). The neonatal hospital stay was (27.8 ± 9.6) days in amniotic cavity administration group and (26.8 ± 11.7) days in PS tracheal administration group, both of which were significantly shorter than that in control group [(33.7 ± 11.8) days] (P < 0.05). PS amniotic cavity administration group and endotracheal administration group of newborns all survived, the control group died in 4 cases. CONCLUSIONS: Amniotic administration of PS can significantly reduce the incidence of NRDS in preterm infants and improve the prognosis. It can achieve the same effect as intratracheal administration, and has the advantages of low risk in clinical application and simple operation, which is worthy of clinical application.