Article(id=1291339081653408255, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291339021272211834, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.02.002, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1721923200000, receivedDateStr=2024-07-26, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808828985, onlineDateStr=2026-08-04, pubDate=1737993600000, pubDateStr=2025-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808828985, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808828985, creator=13041195026, updateTime=1785808828985, updator=13041195026, issue=Issue{id=1291339021272211834, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1737993600000', pubDateStr='2025-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808814590, creator='13041195026', updateTime=1785808814590, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=159, endPage=163, ext={EN=ArticleExt(id=1291339082026701312, articleId=1291339081653408255, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trail of poractant alfa combined with mechanical ventilation in the treatment of children with very low body mass and NRDS, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To observe the clinical efficacy and safety of different doses of poractant alfa injection combined with mechanical ventilation in the treatment of children with very low body mass and neonatal respiratory distress syndrome (NRDS).
Methods According to cohort method, children with very low body mass and NRDS were divided into control group and treatment group. On basis of mechanical ventilation, control group were treated with 100 mg·kg-1 poractant alfa injection; treatment group were treated with 200 mg·kg-1 poractant alfa injection. The clinical curative effect, recovery related indexes, ventilation function, blood gas indexes [partial pressure of carbon dioxide (PaCO2), pH, partial pressure of oxygen (PaO2)], inflammatory factors [interleukin (IL)-6, C-reactive protein (CRP)] and complications in the two groups were compared, and the safety was evaluated.
Results There were 43 cases in control group and 43 cases in treatment group. After treatment, there was significant difference in total response rate between treatment group and control group [93.02% (40 cases/43 cases) vs 76.74% (33 cases/43 cases), P<0.05]. After treatment, injection frequencies in treatment group and control group were (1.02±0.15) and (1.47±0.50) times, oxygen inhalation time was (90.45±7.31) and (116.72±10.24) h, mechanical ventilation time were (81.27±6.81) and (99.69±9.05) h, hospitalization time was (12.15±2.07) and (16.29±2.53) d, fraction of inspired oxygen were (36.39±4.07)% and (40.54±5.13)%, positive end-expiratory pressure were (3.64±0.53) and (4.05±0.69) cmH2O, peak inspiratory pressure were (20.12±1.45) and (22.69±1.62) cmH2O, PaCO2 were (31.45±4.21) and (37.72±5.06) mmHg, pH were 7.36±0.30 and 7.21±0.27, PaO2 were (83.46±6.45) and (78.58±5.93) mmHg, levels of serum IL-6 were (36.21±4.03) and (54.83±5.69) ng·L-1, CRP levels were (8.03±2.11) and (11.28±3.06) mg·L-1, and the differences were statistically significant (all P<0.05). There was significant difference in incidence of complications between treatment group and control group [9.31% (4 cases/43 cases) vs 25.57% (11 cases/43 cases), P<0.05]. The adverse drug reactions were mainly on rash, gastrointestinal dysfunction and irritability in treatment group, while which in control group were rash and gastrointestinal dysfunction. There was no significant difference in total incidence of adverse drug reactions between treatment group and control group [9.30% (4 cases/43 cases) vs 6.98% (3 cases/43 cases), P>0.05].
Conclusion 200 mg·kg-1 poractant alfa injection combined with mechanical ventilation can promote the recovery of children with very low body mass and NRDS, improve ventilation function and blood gas indexes, alleviate inflammatory response and reduce complications, and the safety is good.
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目的 比较不同剂量猪肺磷脂注射液联合机械通气治疗极低体质量新生儿呼吸窘迫综合征（NRDS）患儿的临床疗效及安全性。
方法 将极低体质量NRDS患儿按队列法分为对照组和试验组。2组患儿均行机械通气，对照组予以100 mg·kg-1猪肺磷脂注射液治疗；试验组予以200 mg·kg-1猪肺磷脂注射液治疗。比较2组患儿的临床疗效、恢复相关指标、通气功能、血气指标[血二氧化碳分压（PaCO2）、pH、血氧分压（PaO2）]、炎症因子[白细胞介素（IL）-6、C反应蛋白（CRP）]、并发症，并进行安全性评估。
结果 对照组入组43例、试验组入组43例。治疗后，试验组和对照组的总有效率分别为93.02%（40例/43例）和76.74%（33例/43例），在统计学上差异有统计学意义（P<0.05）。治疗后，试验组和对照组的使用猪肺磷脂注射液次数分别为（1.02±0.15）和（1.47±0.50）次，吸氧时间分别为（90.45±7.31）和（116.72±10.24）h，机械通气时间分别为（81.27±6.81）和（99.69±9.05）h，住院时间分别为（12.15±2.07）和（16.29±2.53）d，吸入氧浓度分别为（36.39±4.07）%和（40.54±5.13）%，呼气末正压分别为（3.64±0.53）和（4.05±0.69）cmH2O，吸气峰压分别为（20.12±1.45）和（22.69±1.62）cmH2O，PaCO2分别为（31.45±4.21）和（37.72±5.06）mmHg，pH分别为7.36±0.30和7.21±0.27，PaO2分别为（83.46±6.45）和（78.58±5.93）mmHg，血清IL-6含量分别为（36.21±4.03）和（54.83±5.69）ng·L-1，血清CRP含量分别为（8.03±2.11）和（11.28±3.06）mg·L-1，在统计学上差异均有统计学意义（均P<0.05）。试验组和对照组的并发症发生率为9.31%（4例/43例）和25.57%（11例/43例），在统计学上差异有统计学意义（P<0.05）。试验组的药物不良反应主要有皮疹、胃肠功能障碍、烦躁不安；对照组的药物不良反应主要有皮疹、胃肠功能障碍。试验组和对照组的药物不良反应总发生率分别为9.30%（4例/43例）和6.98%（3例/43例），在统计学上差异无统计学意义（P>0.05）。
结论 200 mg·kg-1猪肺磷脂注射液联合机械通气能够促进极低体质量NRDS患儿恢复，改善通气功能和血气指标，缓解炎症反应，减少并发症，且安全性较高。
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江余明（1981-），男，副主任医师，主要从事新生儿危重症的临床诊疗工作
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